New EU Organic Regulations

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001 — 1
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►B REGULATION (EU) 2018/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 May 2018
on organic production and labelling of organic products and repealing Council Regulation (EC)
No 834/2007
(OJ L 150, 14.6.2018, p. 1)
Amended by:
Official Journal
No page date
►M1 Commission Delegated Regulation (EU) 2020/427 of 13 January 2020 L 87 1 23.3.2020
►M2 amended by Commission Delegated Regulation (EU) 2021/269 of 4 L 60 24 22.2.2021
December 2020
►M3 Regulation (EU) 2020/1693 of the European Parliament and of the L 381 1 13.11.2020
Council of 11 November 2020
►M4 Commission Delegated Regulation (EU) 2020/1794 of 16 September L 402 23 1.12.2020
2020
►M5 Commission Delegated Regulation (EU) 2021/642 of 30 October 2020 L 133 1 20.4.2021
►M7 Commission Delegated Regulation (EU) 2021/716 of 9 February 2021 L 151 5 3.5.2021
►M8 Commission Delegated Regulation (EU) 2021/1006 of 12 April 2021 L 222 3 22.6.2021
►M9 Commission Delegated Regulation (EU) 2021/1691 of 12 July 2021 L 334 1 22.9.2021
►M10 Commission Delegated Regulation (EU) 2021/1697 of 13 July 2021 L 336 3 23.9.2021
►M12 Commission Delegated Regulation (EU) 2023/207 of 24 November L 29 6 1.2.2023
2022
Corrected by:
►C1 Corrigendum, OJ L 270, 29.10.2018, p. 37 (2018/848)

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REGULATION (EU) 2018/848 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 30 May 2018
on organic production and labelling of organic products and
repealing Council Regulation (EC) No 834/2007
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation establishes the principles of organic production and

lays down the rules concerning organic production, related certification
and the use of indications referring to organic production in labelling
and advertising, as well as rules on controls additional to those laid
down in Regulation (EU) 2017/625.
Article 2
Scope
1. This Regulation applies to the following products originating from

agriculture, including aquaculture and beekeeping, as listed in Annex I
to the TFEU and to products originating from those products, where
such products are, or are intended to be, produced, prepared, labelled,
distributed, placed on the market, imported into or exported from the
Union:
(a) live or unprocessed agricultural products, including seeds and other

plant reproductive material;
(b) processed agricultural products for use as food;
(c) feed.
This Regulation also applies to certain other products closely linked to

agriculture listed in Annex I to this Regulation, where they are, or are
intended to be, produced, prepared, labelled, distributed, placed on the
market, imported into or exported from the Union.
2. This Regulation applies to any operator involved, at any stage of

production, preparation and distribution, in activities relating to the
products referred to in paragraph 1.
3. Mass catering operations carried out by a mass caterer as defined

in point (d) of Article 2(2) of Regulation (EU) No 1169/2011 are not
subject to this Regulation except as set out in this paragraph.
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Member States may apply national rules or, in the absence thereof,
private standards, on the production, labelling and control of products
originating from mass catering operations. The organic production logo
of the European Union shall not be used in the labelling, the presen
tation or the advertising of such products, and shall not be used to
advertise the mass caterer.
4. Except where otherwise provided, this Regulation applies without

prejudice to related Union legislation, in particular, legislation in the
fields of safety of the food chain, animal health and welfare, plant
health and plant reproductive material.
5. This Regulation applies without prejudice to other specific Union

law relating to the placing of products on the market and, in particular,
to Regulation (EU) No 1308/2013 of the European Parliament and of
the Council (1) and to Regulation (EU) No 1169/2011.
6. The Commission is empowered to adopt delegated acts in

accordance with Article 54 amending the list of products set out in
Annex I by adding further products to the list, or by amending those
added entries. Only products which are closely linked to agricultural
products shall be eligible for inclusion in that list.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘organic production’ means the use, including during the

conversion period referred to in Article 10, of production
methods that comply with this Regulation at all stages of
production, preparation and distribution;
(2) ‘organic product’ means a product resulting from organic

production, other than a product produced during the conversion
period referred to in Article 10. The products of hunting or fishing
of wild animals are not considered as organic products;
(3) ‘agricultural raw material’ means an agricultural product that has

not been subjected to any operation of preservation or processing;
(4) ‘preventive measures’ means measures that are to be taken by

operators at every stage of production, preparation and distribution
in order to ensure the preservation of biodiversity and soil quality,
measures for the prevention and control of pests and diseases and
measures that are to be taken to avoid negative effects on the
environment, animal health and plant health;
(1) Regulation (EU) No 1308/2013 of the European Parliament and of the

Council of 17 December 2013 establishing a common organisation of the
markets in agricultural products and repealing Council Regulations (EEC)
No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC)
No 1234/2007 (OJ L 347, 20.12.2013, p. 671).
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(5) ‘precautionary measures’ means measures that are to be taken by
operators at every stage of production, preparation, and distribution
to avoid contamination with products or substances that are not
authorised for use in organic production in accordance with this
Regulation, and to avoid the commingling of organic products
with non-organic products;
(6) ‘conversion’ means the transition from non-organic to organic

production within a given period, during which the provisions of
this Regulation concerning organic production apply;
(7) ‘in-conversion product’ means a product that is produced during

the conversion period referred to in Article 10;
(8) ‘holding’ means all the production units operated under single
management for the purpose of producing live or unprocessed
agricultural products, including products originating from aqua
culture and beekeeping, referred to in point (a) of Article 2(1) or
products listed in Annex I other than essential oils and yeast;
(9) ‘production unit’ means all assets of a holding, such as primary

production premises, land parcels, pasturages, open air areas,
livestock buildings or parts thereof, hives, fish ponds, containment
systems and sites for algae or aquaculture animals, rearing units,
shore or seabed concessions, and premises for the storage of crops,
of crop products, of algae products, of animal products, of raw
materials and of any other relevant inputs managed as described in
point (10), point (11) or point (12);
(10) ‘organic production unit’ means a production unit, excluding

during the conversion period referred to in Article 10, which is
managed in compliance with the requirements applicable to
organic production;
(11) ‘in-conversion production unit’ means a production unit, during

the conversion period referred to in Article 10, which is
organic production; it may be constituted of land parcels or
other assets for which the conversion period referred to in
Article 10 starts at different moments in time;
(12) ‘non-organic production unit’ means a production unit which is not

organic production;
(13) ‘operator’ means the natural or legal person responsible for

ensuring that this Regulation is complied with at every stage of
production, preparation and distribution that are under that
person’s control;
(14) ‘farmer’ means a natural or legal person, or a group of natural or

legal persons, regardless of the legal status of that group and its
members under national law, who exercises an agricultural
activity;
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(15) ‘agricultural area’ means agricultural area as defined in point (e) of
Article 4(1) of Regulation (EU) No 1307/2013;
(16) ‘plants’ means plants as defined in point (5) of Article 3 of Regu

lation (EC) No 1107/2009;
(17) ‘plant reproductive material’ means plants and all parts of plants,
including seeds, at any stage of growth that are capable of, and
intended for, producing entire plants;
(18) ‘organic heterogeneous material’ means a plant grouping within a

single botanical taxon of the lowest known rank which:
(a) presents common phenotypic characteristics;
(b) is characterised by a high level of genetic and phenotypic

diversity between individual reproductive units, so that that
plant grouping is represented by the material as a whole,
and not by a small number of units;
(c) is not a variety within the meaning of Article 5(2) of Council

Regulation (EC) No 2100/94 (1);
(d) is not a mixture of varieties; and
(e) has been produced in accordance with this Regulation;
(19) ‘organic variety suitable for organic production’ means a variety as

defined in Article 5(2) of Regulation (EC) No 2100/94 which:
(a) is characterised by a high level of genetic and phenotypical

diversity between individual reproductive units; and
(b) results from organic breeding activities referred to in

point 1.8.4 of Part I of Annex II to this Regulation;
(20) ‘mother plant’ means an identified plant from which plant repro
ductive material is taken for the reproduction of new plants;
(21) ‘generation’ means a group of plants constituting a single step in

the line of descent of plants;
(22) ‘plant production’ means production of agricultural crop products

including harvesting of wild plant products for commercial
purposes;
(1) Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant

variety rights (OJ L 227, 1.9.1994, p. 1).
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(23) ‘plant products’ means plant products as defined in point (6) of
Article 3 of Regulation (EC) No 1107/2009;
(24) ‘pest’ means a pest as defined in Article 1(1) of Regulation (EU)

2016/2031 of the European Parliament and of the Council (1);
(25) ‘biodynamic preparations’ means mixtures traditionally used in

biodynamic farming;
(26) ‘plant protection products’ means the products referred to in

(27) ‘livestock production’ means the production of domestic or domes

ticated terrestrial animals, including insects;
(28) ‘veranda’ means an additional, roofed, uninsulated, outdoor part of

a building intended for poultry, the longest side usually being
equipped with wire fencing or netting, with an outdoor climate,
natural and, where necessary, artificial illumination, and a littered
floor;
(29) ‘pullets’ means young animals of the Gallus gallus species that are
of an age of less than 18 weeks;
(30) ‘laying hens’ means animals of the Gallus gallus species that are
intended for the production of eggs for consumption and that are
of an age of at least 18 weeks;
(31) ‘usable area’ means usable area as defined in point (d) of

Article 2(2) of Council Directive 1999/74/EC (2);
(32) ‘aquaculture’ means aquaculture as defined in point (25) of

Article 4(1) of Regulation (EU) No 1380/2013 of the European
Parliament and of the Council (3);
(33) ‘aquaculture products’ means aquaculture products as defined in

point (34) of Article 4(1) of Regulation (EU) No 1380/2013;
(1) Regulation (EU) 2016/2031 of the European Parliament of the Council of

26 October 2016 on protective measures against pests of plants, amending
Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014
of the European Parliament and of the Council and repealing Council
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC,
2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).
(2) Council Directive 1999/74/EC of 19 July 1999 laying down minimum
standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53).
Council of 11 December 2013 on the Common Fisheries Policy, amending
Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and
repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004
and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).
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(34) ‘closed recirculation aquaculture facility’ means a facility on land
or in a vessel where aquaculture takes place within an enclosed
environment involving the recirculation of water and which
depends on permanent external energy input to stabilise the envi
ronment for the aquaculture animals;
(35) ‘energy from renewable sources’ means energy from renewable

non-fossil sources such as wind, solar, geothermal, wave, tidal,
hydropower, landfill gas, sewage treatment plant gas and biogases;
(36) ‘hatchery’ means a place for the breeding, hatching and rearing
through the early life stages of aquaculture animals, in particular
finfish and shellfish;
(37) ‘nursery’ means a place where an intermediate aquaculture

production system is applied between the hatchery and grow-out
stages. The nursery stage is completed within the first third of the
production cycle, with the exception of species undergoing a smol
tification process;
(38) ‘water pollution’ means pollution as defined in point (33) of

Article 2 of Directive 2000/60/EC and in point (8) of Article 3
of Directive 2008/56/EC of the European Parliament and of the
Council (1), in the waters to which each of those Directives
applies;
(39) ‘polyculture’ means the rearing in aquaculture of two or more

species, usually from different trophic levels, in the same culture
unit;
(40) ‘production cycle’ means the lifespan of an aquaculture animal or

alga, from the earliest life stage (fertilised eggs, in the case of
aquaculture animals) to harvesting;
(41) ‘locally grown species’ means aquaculture species which are

neither alien nor locally absent species within the meaning of
points (6) and (7), respectively, of Article 3 of Council Regu
lation (EC) No 708/2007 (2), as well as the species listed in
Annex IV to that Regulation;
(42) ‘veterinary treatment’ means all courses of a curative or preventive

treatment against an occurrence of a specific disease;
(43) ‘veterinary medicinal product’ means a veterinary medicinal

product as defined in point (2) of Article 1 of Directive
2001/82/EC of the European Parliament and of the Council (3);
(1) Directive 2008/56/EC of the European Parliament and of the Council of

17 June 2008 establishing a framework for community action in the field
of marine environmental policy (Marine Strategy Framework Directive)
(OJ L 164, 25.6.2008, p. 19).
(2) Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of
alien and locally absent species in aquaculture (OJ L 168, 28.6.2007, p. 1).
6 November 2001 on the Community code relating to veterinary medicinal
products (OJ L 311, 28.11.2001, p. 1).
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(44) ‘preparation’ means the operations of preserving or processing of
organic or in-conversion products, or any other operation that is
carried out on an unprocessed product without altering the initial
product, such as slaughtering, cutting, cleaning or milling, as well
as packaging, labelling or alterations made to the labelling relating
to organic production;
(45) ‘food’ means food as defined in Article 2 of Regulation (EC)

No 178/2002 of the European Parliament and of the Council (1);
(46) ‘feed’ means feed as defined in point (4) of Article 3 of Regu

lation (EC) No 178/2002;
(47) ‘feed materials’ mean feed materials as defined in point (g) of

Article 3(2) of Regulation (EC) No 767/2009 of the European
(48) ‘placing on the market’ means placing on the market as defined in

point (8) of Article 3 of Regulation (EC) No 178/2002;
(49) ‘traceability’ means the ability to trace and follow food, feed or
any product referred to in Article 2(1), and any substance intended
or expected to be incorporated into food, feed or any product
referred to in Article 2(1), through all stages of production, prep
aration and distribution;
(50) ‘stage of production, preparation and distribution’ means any stage

from the primary production of an organic product through its
storage, processing, transport, and sale or supply to the final
consumer, including, where relevant, labelling, advertising,
import, export and subcontracting activities;
(51) ‘ingredient’ means an ingredient as defined in point (f) of

Article 2(2) of Regulation (EU) No 1169/2011 or, for products
other than food, any substance or product used in the manufacture
or preparation of products that is still present in the finished
product, even in altered form;
(1) Regulation (EC) No 178/2002 of the European Parliament and of the Council
of 28 January 2002 laying down the general principles and requirements of
food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
of 13 July 2009 on the placing on the market and use of feed, amending
European Parliament and Council Regulation (EC) No 1831/2003 and
repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC,
Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and
96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1).
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(52) ‘labelling’ means any words, particulars, trade marks, brand name,
pictorial matter or symbol relating to a product that are placed on
any packaging, document, notice, label, ring or collar that
accompanies or refers to that product;
(53) ‘advertising’ means any presentation of products to the public, by

any means other than a label, that is intended or is likely to
influence and shape attitudes, beliefs and behaviours in order to
directly or indirectly promote the sale of products;
(54) ‘competent authorities’ means competent authorities as defined in

point (3) of Article 3 of Regulation (EU) 2017/625;
(55) ‘control authority’ means an organic control authority as defined in

point (4) of Article 3 of Regulation (EU) 2017/625, or an authority
recognised by the Commission or by a third country recognised by
the Commission for the purposes of carrying out controls in third
countries for the import of organic and in-conversion products into
the Union;
(56) ‘control body’ means a delegated body as defined in point (5) of

Article 3 of Regulation (EU) 2017/625, or a body recognised by
the Commission or by a third country recognised by the
Commission for the purposes of carrying out controls in third
countries for the import of organic and in-conversion products
into the Union;
(57) ‘non-compliance’ means non-compliance with this Regulation or

non-compliance with the delegated or implementing acts adopted
in accordance with this Regulation;
(58) ‘genetically modified organism’ or ‘GMO’ means a genetically

modified organism as defined in point (2) of Article 2 of
Directive 2001/18/EC of the European Parliament and of the
Council (1) which is not obtained through the techniques of
genetic modification listed in Annex I.B to that Directive;
(59) ‘produced from GMOs’ means derived in whole or in part from

GMOs but not containing or consisting of GMOs;
(60) ‘produced by GMOs’ means derived by using a GMO as the last

living organism in the production process, but not containing or
consisting of GMOs nor produced from GMOs;
(61) ‘food additive’ means a food additive as defined in point (a) of


12 March 2001 on the deliberate release into the environment of genetically
modified organisms and repealing Council Directive 90/220/EEC (OJ L 106,
17.4.2001, p. 1).
(2) Regulation (EC) No 1333/2008 of the European Parliament and of the
Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008,
p. 16).
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(62) ‘feed additives’ mean feed additives as defined in point (a) of
(63) ‘engineered nanomaterial’ means an engineered nanomaterial as

defined in point (f) of Article 3(2) of Regulation (EU)
2015/2283 of the European Parliament and of the Council (2);
(64) ‘equivalence’ means meeting the same objectives and principles by

applying rules which ensure the same level of assurance of
conformity;
(65) ‘processing aid’ means a processing aid as defined in point (b) of

Article 3(2) of Regulation (EC) No 1333/2008 for food and in
point (h) of Article 2(2) of Regulation (EC) No 1831/2003 for
feed;
(66) ‘food enzyme’ means a food enzyme as defined in point (a) of

(67) ‘ionising radiation’ means ionising radiation as defined in

point (46) of Article 4 of Council Directive 2013/59/Euratom (4);
(68) ‘prepacked food’ means prepacked food as defined in point (e) of

Article 2(2) of Regulation (EU) No 1169/2011;
(69) ‘poultry house’ means a fixed or mobile building for accom

modating flocks of poultry, which includes all surfaces covered
by roofs, including a veranda; the house may be subdivided into
separate compartments, each accommodating a single flock;
(70) ‘soil-related crop cultivation’ means production in living soil or in

soil that is mixed or fertilised with materials and products that are
allowed in organic production in connection with the subsoil and
bedrock;

Council of 22 September 2003 on additives for use in animal nutrition
(OJ L 268, 18.10.2003, p. 29).
(2) Regulation (EU) 2015/2283 of the European Parliament and of the Council of
25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011
of the European Parliament and of the Council and repealing Regulation (EC)
No 258/97 of the European Parliament and of the Council and Commission
Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
Council of 16 December 2008 on food enzymes and amending Council
Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive
2000/13/EC, Council Directive 2001/112/EC and Regulation (EC)
No 258/97 (OJ L 354, 31.12.2008, p. 7).
(4) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic
safety standards for protection against the dangers arising from exposure to
ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom,
96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014,
p. 1).
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(71) ‘unprocessed products’ means unprocessed products as defined in
point (n) of Article 2(1) of Regulation (EC) No 852/2004 of the
European Parliament and of the Council (1), irrespective of
packaging or labelling operations;
(72) ‘processed products’ means processed products as defined in

point (o) of Article 2(1) of Regulation (EC) No 852/2004, irre
spective of packaging or labelling operations;
(73) ‘processing’ means processing as defined in point (m) of

Article 2(1) of Regulation (EC) No 852/2004; this includes the
use of substances referred to in Articles 24 and 25 of this Regu
lation but does not include packaging or labelling operations;
(74) ‘integrity of organic or in-conversion products’ means the fact that

the product does not exhibit non-compliance which:
(a) in any stage of production, preparation and distribution affects

the organic or in-conversion characteristics of the product; or
(b) is repetitive or intentional;
(75) ‘pen’ means an enclosure that includes a part in which animals are
provided with protection from adverse weather conditions.
CHAPTER II
OBJECTIVES AND PRINCIPLES OF ORGANIC PRODUCTION
Article 4
Objectives
Organic production shall pursue the following general objectives:
(a) contributing to protection of the environment and the climate;
(b) maintaining the long-term fertility of soils;
(c) contributing to a high level of biodiversity;
(d) substantially contributing to a non-toxic environment;
(e) contributing to high animal welfare standards and, in particular, to

meeting the species-specific behavioural needs of animals;
(f) encouraging short distribution channels and local production in the

various areas of the Union;
of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
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(g) encouraging the preservation of rare and native breeds in danger of
extinction;
(h) contributing to the development of the supply of plant genetic

material adapted to the specific needs and objectives of organic
agriculture;
(i) contributing to a high level of biodiversity, in particular by using

diverse plant genetic material, such as organic heterogeneous
material and organic varieties suitable for organic production;
(j) fostering the development of organic plant breeding activities in

order to contribute to favourable economic perspectives of the
organic sector.
Article 5
General principles
Organic production is a sustainable management system that is based on

the following general principles:
(a) respect for nature’s systems and cycles and the sustainment and
enhancement of the state of the soil, the water and the air, of the
health of plants and animals, and of the balance between them;
(b) the preservation of natural landscape elements, such as natural

heritage sites;
(c) the responsible use of energy and natural resources, such as water,
soil, organic matter and air;
(d) the production of a wide variety of high-quality food and other

agricultural and aquaculture products that respond to consumers’
demand for goods that are produced by the use of processes that
do not harm the environment, human health, plant health or animal
health and welfare;
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(e) ensuring the integrity of organic production at all stages of the
production, preparation and distribution of food and feed;
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(f) the appropriate design and management of biological processes,
based on ecological systems and using natural resources which
are internal to the management system, using methods that:
(i) use living organisms and mechanical production methods;
(ii) practice soil-related crop cultivation and land-related livestock

production, or practice aquaculture which complies with the
principle of the sustainable exploitation of aquatic resources;
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(iii) exclude the use of GMOs, products produced from GMOs, and
products produced by GMOs, other than veterinary medicinal
products;
(iv) are based on risk assessment and the use of precautionary

measures and preventive measures, where appropriate;
(g) the restriction of the use of external inputs; where external inputs
are required or the appropriate management practices and methods
referred to in point (f) do not exist, the external inputs shall be
limited to:
(i) inputs from organic production; in the case of plant repro

ductive material, priority shall be given to varieties selected
for their ability to meet the specific needs and objectives of
organic agriculture;
(ii) natural or naturally-derived substances;
(iii) low solubility mineral fertilisers;
(h) the adaptation of the production process, where necessary and

within the framework of this Regulation, to take account of the
sanitary status, regional differences in the ecological balance,
climatic and local conditions, stages of development and specific
husbandry practices;
(i) the exclusion from the whole organic food chain of animal cloning,
of rearing artificially induced polyploid animals and of ionising
radiation;
(j) the observance of a high level of animal welfare respecting

species-specific needs.
Article 6
Specific principles applicable to agricultural activities and
aquaculture
As regards agricultural activities and aquaculture, organic production

shall, in particular, be based on the following specific principles:
(a) the maintenance and enhancement of soil life and natural soil
fertility, soil stability, soil water retention and soil biodiversity,
preventing and combating loss of soil organic matter, soil
compaction and soil erosion, and the nourishing of plants
primarily through the soil ecosystem;
(b) the limitation of the use of non-renewable resources and external

inputs to a minimum;
(c) the recycling of waste and by-products of plant and animal origin
as input in plant and livestock production;
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(d) the maintenance of plant health by preventive measures, in
particular the choice of appropriate species, varieties or hetero
geneous material resistant to pests and diseases, appropriate crop
rotations, mechanical and physical methods and protection of the
natural enemies of pests;
(e) the use of seeds and animals with a high degree of genetic
diversity, disease resistance and longevity;
(f) in the choosing of plant varieties, having regard to the particu

larities of the specific organic production systems, focussing on
agronomic performance, disease resistance, adaptation to diverse
local soil and climate conditions and respect for the natural
crossing barriers;
(g) the use of organic plant reproductive material, such as plant repro
ductive material of organic heterogeneous material and of organic
varieties suitable for organic production;
(h) the production of organic varieties through natural reproductive

ability and focussing on containment within natural crossing
barriers;
(i) without prejudice to Article 14 of Regulation (EC) No 2100/94 and

to the national plant variety rights granted under Member States’
national law, the possibility for farmers to use plant reproductive
material obtained from their own farms in order to foster genetic
resources adapted to the special conditions of organic production;
(j) in the choosing of animal breeds, having regard to a high degree of

genetic diversity, the capacity of animals to adapt to local
conditions, their breeding value, their longevity, their vitality and
their resistance to disease or health problems;
(k) the practice of site-adapted and land-related livestock production;
(l) the application of animal husbandry practices which enhance the

immune system and strengthen the natural defence against diseases,
including regular exercise and access to open air areas and
pastures;
(m) the feeding of livestock with organic feed composed of agricultural

ingredients resulting from organic production and of natural
non-agricultural substances;
(n) the production of organic livestock products derived from animals

that have been raised on organic holdings throughout their lives
since birth or hatching;
(o) the continuing health of the aquatic environment and the quality of
surrounding aquatic and terrestrial ecosystems;
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(p) the feeding of aquatic organisms with feed from sustainably
exploited fisheries in accordance with Regulation (EU)
No 1380/2013 or with organic feed composed of agricultural
ingredients resulting from organic production, including organic
aquaculture, and of natural non-agricultural substances;
(q) avoiding any endangerment of species of conservation interest that

might arise from organic production.
Article 7
Specific principles applicable to the processing of organic food
The production of processed organic food shall be based, in particular,

on the following specific principles:
(a) the production of organic food from organic agricultural ingredients;
(b) the restriction of the use of food additives, of non-organic

ingredients with mainly technological and sensory functions, and
of micronutrients and processing aids, so that they are used to a
minimum extent and only in cases of essential technological need or
for particular nutritional purposes;
(c) the exclusion of substances and processing methods that might be

misleading as regards the true nature of the product;
(d) the processing of organic food with care, preferably through the use
of biological, mechanical and physical methods;
(e) the exclusion of food containing, or consisting of, engineered

nanomaterials.
Article 8
Specific principles applicable to the processing of organic feed
The production of processed organic feed shall be based, in particular,

on the following specific principles:
(a) the production of organic feed from organic feed materials;
(b) the restriction of the use of feed additives and processing aids, so
that they are used to a minimum extent and only in cases of
essential technological or zootechnical needs or for particular nutri
tional purposes;
(c) the exclusion of substances and processing methods that might be

misleading as regards the true nature of the product;
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(d) the processing of organic feed with care, preferably through the use
of biological, mechanical and physical methods.
CHAPTER III
PRODUCTION RULES
Article 9
General production rules
1. Operators shall comply with the general production rules laid

down in this Article.
2. The entire holding shall be managed in compliance with the

requirements of this Regulation that apply to organic production.
3. For the purposes and uses referred to in Articles 24 and 25 and in

Annex II, only products and substances that have been authorised
pursuant to those provisions may be used in organic production,
provided that their use in non-organic production has also been auth
orised in accordance with the relevant provisions of Union law and,
where applicable, in accordance with national provisions based on
Union law.
The following products and substances referred to in Article 2(3) of

Regulation (EC) No 1107/2009 shall be allowed for use in organic
production, provided that they are authorised pursuant to that Regu
lation:
(a) safeners, synergists and co-formulants as components of plant

protection products;
(b) adjuvants that are to be mixed with plant protection products.
The use in organic production of products and substances for purposes

other than those covered by this Regulation shall be allowed, provided
that their use complies with the principles laid down in Chapter II.
4. Ionising radiation shall not be used in the treatment of organic

food or feed, and in the treatment of raw materials used in organic food
or feed.
5. The use of animal cloning, and the rearing of artificially induced

polyploid animals, shall be prohibited.
6. Preventive and precautionary measures shall be taken, where

appropriate, at every stage of production, preparation and distribution.
7. Notwithstanding paragraph 2, a holding may be split into clearly

and effectively separated production units for organic, in-conversion and
non-organic production, provided that for the non-organic production
units:
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(a) as regards livestock, different species are involved;
(b) as regards plants, different varieties that can be easily differentiated

are involved.
As regards algae and aquaculture animals, the same species may be

involved, provided that there is a clear and effective separation
between the production sites or units.
8. By way of derogation from point (b) of paragraph 7, in the case of

perennial crops which require a cultivation period of at least three years,
different varieties that cannot be easily differentiated, or the same
varieties, may be involved, provided that the production in question is
within the context of a conversion plan, and provided that the
conversion of the last part of the area related to the production in
question to organic production begins as soon as possible and is
completed within a maximum of five years.
In such cases:
(a) the farmer shall notify the competent authority, or, where appro
priate, the control authority or the control body, of the start of
harvest of each of the products concerned at least 48 hours in
advance;
(b) upon completion of the harvest, the farmer shall inform the
competent authority, or, where appropriate, the control authority
or the control body, of the exact quantities harvested from the
units concerned and of the measures taken to separate the products;
(c) the conversion plan and the measures to be taken to ensure the
effective and clear separation shall be confirmed each year by the
competent authority, or, where appropriate, by the control authority
or the control body, after the start of the conversion plan.
9. The requirements concerning different species and varieties, laid

down in points (a) and (b) of paragraph 7, shall not apply in the case of
research and educational centres, plant nurseries, seed multipliers and
breeding operations.
10. Where, in the cases referred to in paragraphs 7, 8 and 9, not all

production units of a holding are managed under organic production
rules, the operators shall:
(a) keep the products used for the organic and in-conversion production
units separate from those used for the non-organic production units;
(b) keep the products produced by the organic, in-conversion and

non-organic production units separate from each other;
(c) keep adequate records to show the effective separation of the

production units and of the products.
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accordance with Article 54 amending paragraph 7 of this Article by
adding further rules on the splitting of a holding into organic,
in-conversion and non-organic production units, in particular in
relation to products listed in Annex I, or by amending those added rules.
Article 10
Conversion
1. Farmers and operators that produce algae or aquaculture animals

shall comply with a conversion period. During the whole conversion
period they shall apply all rules on organic production laid down in this
Regulation, in particular the applicable rules on conversion set out in
this Article and in Annex II.
2. The conversion period shall start at the earliest when the farmer or
the operator that produces algae or aquaculture animals has notified the
activity to the competent authorities, in accordance with Article 34(1),
in the Member State in which the activity is carried out and in which
that farmer or operator’s holding is subject to the control system.
3. No previous period may be retroactively recognised as being part

of the conversion period, except where:
(a) the operator’s land parcels were subject to measures which were
defined in a programme implemented pursuant to Regulation (EU)
No 1305/2013 for the purpose of ensuring that no products or
substances other than those authorised for use in organic production
have been used on those land parcels; or
(b) the operator can provide proof that the land parcels were natural or
agricultural areas that, for a period of at least three years, have not
been treated with products or substances that are not authorised for
use in organic production.
4. Products produced during the conversion period shall not be

marketed as organic products or as in-conversion products.
However, the following products produced during the conversion period

and in compliance with paragraph 1 may be marketed as in-conversion
products:
(a) plant reproductive material, provided that a conversion period of at

least 12 months has been complied with;
(b) food products of plant origin and feed products of plant origin,
provided that the product contains only one agricultural crop
ingredient, and provided that a conversion period of at least 12
months before the harvest has been complied with.
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accordance with Article 54 amending point 1.2.2 of Part II of
Annex II by adding conversion rules for species other than those
regulated in Part II of Annex II on 17 June 2018, or by amending
those added rules.
6. The Commission shall, where appropriate, adopt implementing

acts specifying the documents to be supplied for the purpose of the
retroactive recognition of a previous period in accordance with
paragraph 3 of this Article.
Those implementing acts shall be adopted in accordance with the exa

mination procedure referred to in Article 55(2).
Article 11
Prohibition of the use of GMOs
1. GMOs, products produced from GMOs, and products produced by

GMOs shall not be used in food or feed, or as food, feed, processing
aids, plant protection products, fertilisers, soil conditioners, plant repro
ductive material, micro-organisms or animals in organic production.
2. For the purposes of the prohibition laid down in paragraph 1, with

regard to GMOs and products produced from GMOs for food and feed,
operators may rely on the labels of a product that have been affixed or
provided pursuant to Directive 2001/18/EC, Regulation (EC)
No 1829/2003 of the European Parliament and of the Council (1) or
Regulation (EC) No 1830/2003 of the European Parliament and of
the Council (2) or any accompanying document provided pursuant
thereto.
3. Operators may assume that no GMOs and no products produced

from GMOs have been used in the manufacture of purchased food and
feed where such products do not have a label affixed or provided, or are
not accompanied by a document provided, pursuant to the legal acts
referred to in paragraph 2, unless they have obtained other information
indicating that the labelling of the products concerned is not in
conformity with those legal acts.
4. For the purposes of the prohibition laid down in paragraph 1, with

regard to products not covered by paragraphs 2 and 3, operators using
non-organic products purchased from third parties shall require the
vendor to confirm that those products are not produced from GMOs
or produced by GMOs.

Council of 22 September 2003 on genetically modified food and feed
(OJ L 268, 18.10.2003, p. 1).
Council of 22 September 2003 concerning the traceability and labelling of
genetically modified organisms and the traceability of food and feed products
produced from genetically modified organisms and amending Directive
2001/18/EC (OJ L 268, 18.10.2003, p. 24).
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Article 12
Plant production rules
1. Operators that produce plants or plant products shall comply, in

particular, with the detailed rules set out in Part I of Annex II.

accordance with Article 54 amending:
(a) points 1.3 and 1.4 of Part I of Annex II as regards derogations;
(b) point 1.8.5 of Part I of Annex II as regards the use of in-conversion

and non-organic plant reproductive material;
(c) point 1.9.5 of Part I of Annex II by adding further provisions

concerning agreements between operators of agricultural holdings,
or by amending those added provisions;
(d) point 1.10.1 of Part I of Annex II by adding further pest- and

weed-management measures, or by amending those added measures;
(e) Part I of Annex II by adding further detailed rules and cultivation

practices for specific plants and plant products, including rules for
sprouted seeds, or by amending those added rules.
Article 13
Specific provisions for the marketing of plant reproductive material
of organic heterogeneous material
1. Plant reproductive material of organic heterogeneous material may

be marketed without complying with the requirements for registration
and without complying with the certification categories of pre-basic,
basic and certified material or with the requirements for other
categories, which are set out in Directives 66/401/EEC, 66/402/EEC,
68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC,
2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC or acts
adopted pursuant to those Directives.
2. Plant reproductive material of organic heterogeneous material as

referred to in paragraph 1 may be marketed following a notification of
the organic heterogeneous material by the supplier to the responsible
official bodies referred to in Directives 66/401/EEC, 66/402/EEC,
68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC,
2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC, made by
means of a dossier containing:
(a) the contact details of the applicant;
(b) the species and denomination of the organic heterogeneous material;

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(c) the description of the main agronomic and phenotypic characteris
tics that are common to that plant grouping, including breeding
methods, any available results from tests on those characteristics,
the country of production and the parental material used;
(d) a declaration by the applicant concerning the truth of the elements

in points (a), (b) and (c); and
(e) a representative sample.
That notification shall be sent by registered letter, or by any other

means of communication accepted by the official bodies, with confir
mation of receipt requested.
Three months after the date shown on the return receipt, provided that
no additional information was requested or that no formal refusal for
reasons of incompleteness of the dossier or non-compliance as defined
in Article 3(57) was communicated to the supplier, the responsible
official body shall be deemed to have acknowledged the notification
and its content.
After having expressly or implicitly acknowledged the notification, the

responsible official body may proceed to the listing of the notified
organic heterogeneous material. That listing shall be free of charge to
the supplier.
The listing of any organic heterogeneous material shall be

communicated to the competent authorities of the other Member
States and to the Commission.
Such organic heterogeneous material shall fulfil the requirements laid

down in the delegated acts adopted in accordance with paragraph 3.

accordance with Article 54 supplementing this Regulation by setting
out rules governing the production and marketing of plant reproductive
material of organic heterogeneous material of particular genera or
species, as regards:
(a) the description of the organic heterogeneous material, including the

relevant breeding and production methods and parental material
used;
(b) the minimum quality requirements for seeds lots, including identity,
specific purity, germination rates and sanitary quality;
(c) labelling and packaging;
(d) information and samples of production to be kept by the profes

sional operators;
(e) where applicable, maintenance of the organic heterogeneous

material.
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Article 14
Livestock production rules
1. Livestock operators shall comply, in particular, with the detailed

production rules set out in Part II of Annex II and in any implementing
acts referred to in paragraph 3 of this Article.

(a) points 1.3.4.2, 1.3.4.4.2 and 1.3.4.4.3 of Part II of Annex II by

reducing the percentages as regards the origin of animals, once
sufficient availability on the Union market of organic animals has
been established;
(b) point 1.6.6 of Part II of Annex II as regards the limit on organic

nitrogen linked to the total stocking density;
(c) point 1.9.6.2(b) of Part II of Annex II as regards the feeding of bee

colonies;
(d) points 1.9.6.3(b) and (e) of Part II of Annex II as regards the

acceptable treatments for the disinfection of apiaries and the
methods and treatments to fight against Varroa destructor;
(e) Part II of Annex II by adding detailed rules on livestock production

for species other than species regulated in that Part on 17 June
2018, or by amending those added rules, as regards:
(i) derogations as regards the origin of animals;
(ii) nutrition;
(iii) housing and husbandry practices;
(iv) health care;
(v) animal welfare.

acts regarding Part II of Annex II providing rules on:
(a) the minimum period to be complied with for feeding of suckling

animals with maternal milk, referred to in point 1.4.1(g);
(b) the stocking density and the minimum surface for indoor and
outdoor areas that are to be complied with for specific livestock
species to ensure that the developmental, physiological and etho
logical needs of animals are met in accordance with points 1.6.3,
1.6.4 and 1.7.2,
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(c) the characteristics of and technical requirements for the minimum
surface for indoor and outdoor areas;
(d) the characteristics of and technical requirements for buildings and

pens for all livestock species other than bees, to ensure that the
developmental, physiological and ethological needs of animals are
met in accordance with point 1.7.2;
(e) requirements for vegetation and the characteristics of protected

facilities and open air areas.

Article 15
Production rules for algae and aquaculture animals
1. Operators that produce algae and aquaculture animals shall

comply, in particular, with the detailed production rules set out in
Part III of Annex II and in any implementing acts referred to in
paragraph 3 of this Article.

(a) point 3.1.3.3 of Part III of Annex II as regards feed for carnivorous
aquaculture animals;
(b) point 3.1.3.4 of Part III of Annex II by adding further specific rules
on feed for certain aquaculture animals, or by amending those added
rules;
(c) point 3.1.4.2 of Part III of Annex II as regards veterinary treatments

for aquaculture animals;
(d) Part III of Annex II by adding further detailed conditions per

species for broodstock management, breeding and juvenile
production, or by amending those added detailed conditions.

acts laying down detailed rules per species or per group of species on
the stocking density, and on the specific characteristics for production
systems and containment systems, in order to ensure that the
species-specific needs are met.

4. For the purpose of this Article and of Part III of Annex II,
‘stocking density’ means the live weight of aquaculture animals per
cubic metre of water at any time during the grow-out phase and, in
the case of flatfish and shrimp, the weight per square metre of surface.
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Article 16
Production rules for processed food
1. Operators that produce processed food shall comply, in particular,

with the detailed production rules set out in Part IV of Annex II and in
any implementing acts referred to in paragraph 3 of this Article.

(a) point 1.4 of Part IV of Annex II as regards precautionary measures

and preventive measures to be taken by operators;
(b) point 2.2.2 of Part IV of Annex II as regards the types and

composition of products and substances that are allowed for use
in processed food, as well as conditions under which they may be
used;
(c) point 2.2.4 of Part IV of Annex II as regards the calculation of the

percentage of agricultural ingredients referred to in points (a)(ii) and
(b)(i) of Article 30(5), including the food additives authorised
pursuant to Article 24 for use in organic production that are
considered as agricultural ingredients for the purpose of such
calculations.
Those delegated acts shall not include the possibility of using flavouring
substances or flavouring preparations which are neither natural, within
the meaning of Article 16(2), (3) and (4) of Regulation (EC)
No 1334/2008 of the European Parliament and of the Council (1), nor
organic.
3. The Commission may adopt implementing acts laying down the

techniques authorised in the processing of food products.

Article 17
Production rules for processed feed
1. Operators that produce processed feed shall comply, in particular,

with the detailed production rules set out in Part V of Annex II and in
any implementing acts referred to in paragraph 3 of this Article.

Council of 16 December 2008 on flavourings and certain food ingredients
with flavouring properties for use in and on foods and amending Council
Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC)
No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).
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accordance with Article 54 amending point 1.4 of Part V of Annex II
by adding further precautionary and preventive measures to be taken by
operators, or by amending those added measures.
3. The Commission may adopt implementing acts laying down the

techniques authorised for use in the processing of feed products.

Article 18
Production rules for wine
1. Operators that produce products of the wine sector shall comply,

in particular, with the detailed production rules set out in Part VI of
Annex II.

(a) point 3.2 of Part VI of Annex II by adding further oenological

practices, processes and treatments that are prohibited, or by
amending those added elements;
(b) point 3.3. of Part VI of Annex II.
Article 19
Production rules for yeast used as food or feed
1. Operators that produce yeast to be used as food or feed shall

comply, in particular, with the detailed production rules set out in
Part VII of Annex II.

accordance with Article 54 amending point 1.3 of Part VII of
Annex II by adding further detailed yeast production rules, or by
amending those added rules.
Article 20
Absence of certain production rules for specific livestock species
and species of aquaculture animals
Pending the adoption of:
(a) additional general rules for other livestock species than those
regulated in point 1.9 of Part II of Annex II in accordance with
point (e) of Article 14(2);
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(b) the implementing acts referred to in Article 14(3) for livestock
species; or
(c) the implementing acts referred to in Article 15(3) for species or

group of species of aquaculture animals;
a Member State may apply detailed national production rules for

specific species or groups of species of animals in relation to the
elements to be covered by the measures referred to in points (a), (b)
and (c), provided that those national rules are in accordance with this
Regulation, and provided that they do not prohibit, restrict or impede
the placing on the market of products which have been produced
outside its territory and which comply with this Regulation.
Article 21
Production rules for products not falling within the categories of
products referred to in Articles 12 to 19

accordance with Article 54 amending Annex II by adding detailed
production rules, as well as rules on the obligation to convert, for
products that do not fall within the categories of products referred to
in Articles 12 to 19, or by amending those added rules.
Those delegated acts shall be based on the objectives and principles of

organic production laid down in Chapter II and shall comply with the
general production rules laid down in Articles 9, 10 and 11 as well as
existing detailed production rules laid down for similar products in
Annex II. They shall lay down requirements concerning, in particular,
the treatments, practices and inputs that are allowed or prohibited, or
conversion periods for the products concerned.
2. In the absence of the detailed production rules referred to in

paragraph 1:
(a) operators shall, as regards products referred to in paragraph 1,

comply with the principles laid down in Articles 5 and 6, mutatis
mutandis with the principles laid down in Article 7, and with the
general production rules laid down in Articles 9 to 11;
(b) a Member State may, as regards products referred to in paragraph 1,

apply detailed national production rules, provided that those rules
are in accordance with this Regulation, and provided that they do
not prohibit, restrict or impede the placing on the market of
products which have been produced outside its territory and
which comply with this Regulation.
Article 22
Adoption of exceptional production rules

accordance with Article 54 supplementing this Regulation by laying
down:
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(a) the criteria to determine whether a situation qualifies as catastrophic
circumstances deriving from an ‘adverse climatic event’, ‘animal
diseases’, an ‘environmental incident’, a ‘natural disaster’ or a ‘cata
strophic event’, as defined in points (h), (i), (j), (k) and (l) of
Article 2(1) of Regulation (EU) No 1305/2013, respectively, as
well as any comparable situation;
(b) specific rules, including possible derogations from this Regulation,

on how Member States are to deal with such catastrophic circum
stances if they decide to apply this Article; and
(c) specific rules on monitoring and reporting in such cases.
Those criteria and rules shall be subject to the principles of organic

production laid down in Chapter II.
2. Where a Member State has formally recognised an event as a

natural disaster as referred to in Article 18(3) or Article 24(3) of Regu
lation (EU) No 1305/2013, and that event makes it impossible to
comply with the production rules laid down in this Regulation, that
Member State may grant derogations from the production rules for a
limited period until organic production can be re-established, subject to
the principles laid down in Chapter II and to any delegated act adopted
in accordance with paragraph 1.
3. Member States may adopt measures in accordance with the

delegated act referred to in paragraph 1 to allow organic production
to continue or recommence in the event of catastrophic circumstances.
Article 23
Collection, packaging, transport and storage
1. Operators shall ensure that organic products and in-conversion

products are collected, packaged, transported and stored in accordance
with the rules set out in Annex III.

(a) Section 2 of Annex III;
(b) Sections 3, 4 and 6 of Annex III by adding further special rules for
the transport and reception of the products concerned, or by
amending those added rules.
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Article 24
Authorisation of products and substances for use in organic
production
1. The Commission may authorise certain products and substances

for use in organic production, and shall include any such authorised
products and substances in restrictive lists, for the following purposes:
(a) as active substances to be used in plant protection products;
(b) as fertilisers, soil conditioners and nutrients;
(c) as non-organic feed material of plant, algal, animal or yeast origin

or as feed material of microbial or mineral origin;
(d) as feed additives and processing aids;
(e) as products for the cleaning and disinfection of ponds, cages, tanks,
raceways, buildings or installations used for animal production;
(f) as products for the cleaning and disinfection of buildings and instal
lations used for plant production, including for storage on an agri
cultural holding;
(g) as products for cleaning and disinfection in processing and storage

facilities.
2. In addition to products and substances authorised in accordance

with paragraph 1, the Commission may authorise certain products and
substances for use in the production of processed organic food and of
yeast used as food or feed, and shall include any such authorised
products and substances in restrictive lists, for the following purposes:
(a) as food additives and processing aids;
(b) as non-organic agricultural ingredients to be used for the production

of processed organic food;
(c) as processing aids for the production of yeast and yeast products.
3. The authorisation of the products and substances referred to in

paragraph 1 for use in organic production shall be subject to the prin
ciples laid down in Chapter II and to the following criteria, which shall
be evaluated as a whole:
(a) they are essential for sustained production and for the use for which
they are intended;
(b) all of the products and substances concerned are of plant, algal,
animal, microbial or mineral origin, except in cases where
products or substances from such sources are not available in
sufficient quantities or qualities or where alternatives are not
available;
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(c) in the case of products referred to in point (a) of paragraph 1:
(i) their use is essential for the control of a pest for which other
biological, physical or breeding alternatives, cultivation
practices or other effective management practices are not
available;
(ii) if such products are not of plant, algal, animal, microbial or

mineral origin and are not identical to their natural form, their
conditions for use preclude any direct contact with the edible
parts of the crop;
(d) in the case of products referred to in point (b) of paragraph 1, their

use is essential for building or maintaining the fertility of the soil or
to fulfil specific nutritional requirements of crops, or for specific
soil-conditioning purposes;
(e) in the case of products referred to in points (c) and (d) of

paragraph 1:
(i) their use is necessary to maintain animal health, animal welfare

and vitality and contributes to an appropriate diet fulfilling the
physiological and behavioural needs of the species concerned
or their use is necessary to produce or preserve feed because
the production or preservation of feed is not possible without
having recourse to such substances;
(ii) feed of mineral origin, trace elements, vitamins or provitamins

are of natural origin, except in cases where products or
substances from such sources are not available in sufficient
quantities or qualities or where alternatives are not available;
(iii) the use of non-organic feed material of plant or animal origin is

necessary because feed material of plant or animal origin
produced in accordance with organic production rules is not
available in sufficient quantity;
(iv) the use of non-organic spices, herbs and molasses is necessary

because such products are not available in organic form; they
have to be produced or prepared without chemical solvents and
their use is limited to 1 % of the feed ration for a given
species, calculated annually as a percentage of the dry matter
of feed from agricultural origin.
4. The authorisation of the products and substances referred to in

paragraph 2 for use in the production of processed organic food or
for the production of yeast used as food or feed shall be subject to
the principles laid down in Chapter II and to the following criteria,
which shall be evaluated as a whole:
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(a) alternative products or substances authorised in accordance with this
Article or techniques compliant with this Regulation are not
available;
(b) it would be impossible to produce or preserve the food or to fulfil

given dietary requirements provided for on the basis of Union legis
lation without having recourse to those products and substances;
(c) they are to be found in nature and may only have undergone mech
anical, physical, biological, enzymatic or microbial processes,
except in cases where products or substances from such sources
are not available in sufficient quantities or qualities;
(d) the organic ingredient is not available in sufficient quantity.
5. The authorisation of the use of chemically synthesised products

and substances, in accordance with paragraphs 1 and 2 of this Article,
shall be strictly limited to cases where the use of external inputs referred
to in point (g) of Article 5 would contribute to unacceptable impacts on
the environment.

accordance with Article 54 amending paragraphs 3 and 4 of this
Article by adding further criteria for the authorisation of products and
substances referred to in paragraphs 1 and 2 of this Article for use in
organic production in general, and in the production of processed
organic food in particular, as well as further criteria for the withdrawal
of such authorisations, or by amending those added criteria.
7. Where a Member State considers that a product or substance

should be added to or withdrawn from the lists of authorised products
and substances referred to in paragraphs 1 and 2, or that the specifi
cations of use referred to in the production rules should be amended, it
shall ensure that a dossier giving the reasons for the inclusion, with
drawal or other amendments is officially sent to the Commission and to
the other Member States and is made publicly available, subject to
Union and national legislation on data protection.
The Commission shall publish any requests referred to in this paragraph.
8. The Commission shall regularly review the lists referred to in this

Article.
The list of non-organic ingredients referred to in point (b) of paragraph

2 shall be reviewed at least once a year.
9. The Commission shall adopt implementing acts concerning the

authorisation or withdrawal of authorisation of products and substances
in accordance with paragraphs 1 and 2 that may be used in organic
production in general and in the production of processed organic food in
particular, and establishing the procedures to be followed for such auth
orisations and the lists of such products and substances and, where
appropriate, their description, compositional requirements and
conditions for use.

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Article 25
Authorisation of non-organic agricultural ingredients for processed
organic food by Member States
1. Where it is necessary in order to ensure access to certain agri

cultural ingredients, and where such ingredients are not available in
organic form in sufficient quantity, a Member State may, at the
request of an operator, provisionally authorise the use of non-organic
agricultural ingredients for the production of processed organic food on
its territory for a period of maximum six months. That authorisation
shall apply to all operators in that Member State.
2. The Member State shall immediately notify the Commission and

the other Member States, via a computer system that enables the elec
tronic exchange of documents and information made available by the
Commission, of any authorisation granted for its territory in accordance
with paragraph 1.
3. The Member State may prolong the authorisation provided for in

paragraph 1 two times for a maximum of six months each, provided that
no other Member State has objected by indicating, via the system
referred to in paragraph 2, that such ingredients are available in
organic form in sufficient quantity.
4. A control authority or a control body recognised in accordance

with Article 46(1) may grant a provisional authorisation, as referred to
in paragraph 1 of this Article, for a maximum of six months to operators
in third countries that request such an authorisation and that are subject
to controls by that control authority or control body, provided that the
conditions of that paragraph are fulfilled in the third country concerned.
The authorisation may be prolonged for a maximum of two times six
months each.
5. Where, after two prolongations of a provisional authorisation, a

Member State considers, on the basis of objective information, that the
availability of such ingredients in organic form remains insufficient to
meet the qualitative and quantitative needs of operators, it may make a
request to the Commission in accordance with Article 24(7).
Article 26
Collection of data concerning the availability on the market of
organic and in-conversion plant reproductive material, organic
animals and organic aquaculture juveniles
1. Each Member State shall ensure that a regularly updated database

is established for the listing of the organic and in-conversion plant
reproductive material, excluding seedlings but including seed potatoes,
which is available on its territory.
2. Member States shall have in place systems that allow operators

that market organic or in-conversion plant reproductive material, organic
animals or organic aquaculture juveniles, and that are able to supply
them in sufficient quantities and within a reasonable period, to make
public on a voluntary basis, free of charge, together with their names
and contact details, information on the following:
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(a) the organic and in-conversion plant reproductive material, such as
plant reproductive material of organic heterogeneous material or of
organic varieties suitable for organic production, excluding
seedlings but including seed potatoes, which is available; the
quantity in weight of that material; and the period of the year of
its availability; such material shall be listed using at least the Latin
scientific name;
(b) the organic animals for which derogation may be provided in

accordance with point 1.3.4.4 of Part II of Annex II; the number
of available animals categorised by sex; information, if relevant,
relating to the different species of animals as regards the breeds
and strains available; the races of the animals; the age of the
animals; and any other relevant information;
(c) the organic aquaculture juveniles available on the holding and their
health status in accordance with Council Directive 2006/88/EC (1)
and the production capacity for each aquaculture species.
3. Member States may also set up systems which allow operators that
market breeds and strains adapted to organic production in accordance
with point 1.3.3 of Part II of Annex II or organic pullets and that are
able to supply those animals in sufficient quantities and within a
reasonable period to make public the relevant information on a
voluntary basis, free of charge, together with names and contact details.
4. Operators that opt to include information on plant reproductive

material, animals or aquaculture juveniles in the systems referred to in
paragraphs 2 and 3 shall ensure that the information is updated
regularly, and shall ensure that the information is withdrawn from the
lists once the plant reproductive material, animals or aquaculture
juveniles are no longer available.
5. For the purpose of paragraphs 1, 2 and 3, Member States may

continue to use relevant information systems that are already in
existence.
6. The Commission shall make public the link to each of the national
databases or systems on a dedicated website of the Commission, in
order to allow users to have access to such databases or systems
throughout the Union.
7. The Commission may adopt implementing acts providing:
(a) technical details for establishing and maintaining the databases

referred to in paragraph 1 and the systems referred to in paragraph 2;
(1) Council Directive 2006/88/EC of 24 October 2006 on animal health

requirements for aquaculture animals and products thereof, and on the
prevention and control of certain diseases in aquatic animals (OJ L 328,
24.11.2006, p. 14).
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(b) specifications as regards the collection of information referred to in
paragraph 1 and 2;
(c) specifications as regards the arrangements for participation in the

databases referred to in paragraph 1 and in the systems referred to
in paragraphs 2 and 3; and
(d) details as regards the information to be provided by Member States

in accordance with Article 53(6).

Article 27
Obligations and actions in the event of suspicion of non-compliance
Where an operator suspects that a product it has produced, prepared,

imported or has received from another operator does not comply with
this Regulation, that operator shall, subject to Article 28(2):
(a) identify and separate the product concerned;
(b) check whether the suspicion can be substantiated;
(c) not place the product concerned on the market as an organic or

in-conversion product and not use it in organic production, unless
the suspicion can be eliminated;
(d) where the suspicion has been substantiated or where it cannot be

eliminated, immediately inform the relevant competent authority, or,
where appropriate, the relevant control authority or control body,
and provide it with available elements, where appropriate;
(e) fully cooperate with the relevant competent authority, or, where
appropriate, with the relevant control authority or control body, in
verifying and identifying the reasons for the suspected
non-compliance.
Article 28
Precautionary measures to avoid the presence of non-authorised
products and substances
1. In order to avoid contamination with products or substances that

are not authorised in accordance with the first subparagraph of
Article 9(3) for use in organic production, operators shall take the
following precautionary measures at every stage of production, prep
aration and distribution:
(a) put in place and maintain measures that are proportionate and
appropriate to identify the risks of contamination of organic
production and products with non-authorised products or
substances, including systematic identification of critical procedural
steps;
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(b) put in place and maintain measures that are proportionate and
appropriate to avoid risks of contamination of organic production
and products with non-authorised products or substances;
(c) regularly review and adjust such measures; and
(d) comply with other relevant requirements of this Regulation that

ensure the separation of organic, in-conversion and non-organic
products.
2. Where an operator suspects, due to the presence of a product or

substance that is not authorised pursuant to the first subparagraph of
Article 9(3) for use in organic production in a product that is intended
to be used or marketed as an organic or in-conversion product, that the
latter product does not comply with this Regulation, the operator shall:
(a) identify and separate the product concerned;
(b) check whether the suspicion can be substantiated;
(c) not place the product concerned on the market as an organic or

in-conversion product and not use it in organic production unless
the suspicion can be eliminated;
(d) where the suspicion has been substantiated or where it cannot be

eliminated, immediately inform the relevant competent authority, or,
where appropriate, the relevant control authority or control body,
and provide it with available elements, where appropriate;
(e) fully cooperate with the relevant competent authority, or, where
appropriate, with the relevant control authority or control body, in
identifying and verifying the reasons for the presence of
non-authorised products or substances.
3. The Commission may adopt implementing acts laying down

uniform rules to specify:
(a) the procedural steps to be followed by operators in accordance with

points (a) to (e) of paragraph 2 and the relevant documents to be
provided by them;
(b) the proportionate and appropriate measures to be adopted and

reviewed by operators to identify and avoid risks of contamination
in accordance with points (a), (b) and (c) of paragraph 1.

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Article 29
Measures to be taken in the event of the presence of non-authorised
products or substances
1. Where the competent authority, or, where appropriate, the control

authority or control body, receives substantiated information about the
presence of products or substances that are not authorised pursuant to
the first subparagraph of Article 9(3) for use in organic production, or
has been informed by an operator in accordance with point (d) of
Article 28(2), or detects such products or substances in an organic or
an in-conversion product:
(a) it shall immediately carry out an official investigation in accordance

with Regulation (EU) 2017/625 with a view to determining the
source and the cause in order to verify compliance with the first
subparagraph of Article 9(3) and with Article 28(1); such investi
gation shall be completed as soon as possible, within a reasonable
period, and shall take into account the durability of the product and
the complexity of the case;
(b) it shall provisionally prohibit both the placing on the market of the
products concerned as organic or in-conversion products and their
use in organic production pending the results of the investigation
referred to in point (a).
2. The product concerned shall not be marketed as an organic or

in-conversion product or used in organic production where the
competent authority, or, where appropriate, the control authority or
control body, has established that the operator concerned:
(a) has used products or substances not authorised pursuant to the first
subparagraph of Article 9(3) for use in organic production;
(b) has not taken the precautionary measures referred to in Article 28(1);
or
(c) has not taken measures in response to relevant previous requests

from the competent authorities, control authorities or control bodies.
3. The operator concerned shall be given an opportunity to comment

on the results of the investigation referred to in point (a) of paragraph 1.
The competent authority, or, where appropriate, the control authority or
control body, shall keep records of the investigation it has carried out.
Where required, the operator concerned shall take such corrective

measures as necessary to avoid future contamination.
4. By ►M3 31 December 2025 ◄, the Commission shall present a

report to the European Parliament and the Council on the implemen
tation of this Article, on the presence of products and substances not
authorised pursuant to the first subparagraph of Article 9(3) for use in
organic production and on the assessment of the national rules referred
to in paragraph 5 of this Article. That report may be accompanied,
where appropriate, by a legislative proposal for further harmonisation.
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5. Member States having in place rules providing for products that
contain more than a certain level of products or substances not auth
orised pursuant to the first subparagraph of Article 9(3) for use in
organic production not to be marketed as organic products may
continue to apply those rules, provided that those rules do not
prohibit, restrict or impede the placing on the market of products
produced in other Member States as organic products, where those
products were produced in compliance with this Regulation. Member
States that make use of this paragraph shall inform the Commission
without delay.
6. The competent authorities shall document the results of the inves

tigations referred to in paragraph 1, as well as any measures they have
taken for the purpose of formulating best practices and further measures
to avoid the presence of products and substances not authorised
pursuant to the first subparagraph of Article 9(3) for use in organic
production.
Member States shall make such information available to the other

Member States and to the Commission via a computer system that
enables the electronic exchange of documents and information made
available by the Commission.
7. Member States may take appropriate measures on their territory to

avoid the unintended presence in organic agriculture of products and
substances not authorised pursuant to the first subparagraph of
Article 9(3) for use in organic production. Such measures shall not
prohibit, restrict or impede the placing on the market of products
produced in other Member States as organic or in-conversion
products, where those products were produced in compliance with this
Regulation. Member States that make use of this paragraph shall inform
the Commission and the other Member States without delay.
8. The Commission shall adopt implementing acts laying down

uniform rules to specify:
(a) the methodology to be applied by competent authorities, or, where

appropriate, by control authorities or control bodies, for the
detection and evaluation of the presence of products and substances
not authorised pursuant to the first subparagraph of Article 9(3) for
use in organic production;
(b) the details and format of the information to be made available by

Member States to the Commission and other Member States in
accordance with paragraph 6 of this Article.

9. By 31 March of each year, Member States shall electronically

transmit to the Commission relevant information about cases
involving contamination with non-authorised products or substances in
the previous year, including information collected at border control
posts, concerning the nature of contamination detected, and in particular
the cause, the source and the level of contamination as well as the
volume and nature of products contaminated. This information shall
be collected by the Commission through the computer system made
available by the Commission and shall be used to facilitate the formu
lation of best practices for avoiding contamination.
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CHAPTER IV
LABELLING
Article 30
Use of terms referring to organic production
1. For the purposes of this Regulation, a product shall be regarded as

bearing terms referring to organic production where, in the labelling,
advertising material or commercial documents, such a product, its
ingredients or feed materials used for its production are described in
terms suggesting to the purchaser that the product, ingredients or feed
materials have been produced in accordance with this Regulation. In
particular, the terms listed in Annex IV and their derivatives and
diminutives, such as ‘bio’ and ‘eco’, whether alone or in combination,
may be used throughout the Union and in any language listed in that
Annex for the labelling and advertising of products referred to in
Article 2(1) which comply with this Regulation.
2. For the products referred to in Article 2(1), the terms referred to in

paragraph 1 of this Article shall not be used anywhere in the Union, in
any language listed in Annex IV, for the labelling, advertising material
or commercial documents of a product which does not comply with this
Regulation.
Furthermore, no terms, including terms used in trademarks or company

names, or practices shall be used in labelling or advertising if they are
liable to mislead the consumer or user by suggesting that a product or
its ingredients comply with this Regulation.
3. Products that have been produced during the conversion period

shall not be labelled or advertised as organic products or as
in-conversion products.
However, plant reproductive material, food products of plant origin and

feed products of plant origin that have been produced during the
conversion period, which comply with Article 10(4), may be labelled
and advertised as in-conversion products by using the term ‘in-
conversion’ or a corresponding term, together with the terms referred
to in paragraph 1.
4. The terms referred to in paragraph 1 and 3 shall not be used for a

product for which Union law requires the labelling or advertising to
state that the product contains GMOs, consists of GMOs or is produced
from GMOs.
5. For processed food, the terms referred to in paragraph 1 may be

used:
(a) in the sales description, and in the list of ingredients where such a
list is mandatory pursuant to Union legislation, provided that:
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(i) the processed food complies with the production rules set out
in Part IV of Annex II and with the rules laid down in
accordance with Article 16(3);
(ii) at least 95 % of the agricultural ingredients of the product by

weight are organic; and
(iii) in the case of flavourings, they are only used for natural
flavouring substances and natural flavouring preparations
labelled in accordance with Article 16(2), (3) and (4) of Regu
lation (EC) No 1334/2008 and all of the flavouring
components and carriers of flavouring components in the
flavouring concerned are organic;
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(b) only in the list of ingredients, provided that:
(i) less than 95 % of the agricultural ingredients of the product by

weight are organic, and provided that those ingredients comply
with the production rules set out in this Regulation; and
(ii) the processed food complies with the production rules set out in
points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II, with
the exception of the rules on restricted use of non-organic agri
cultural ingredients set out in point 2.2.1 of Part IV of
Annex II, and with the rules laid down in accordance with
Article 16(3);
(c) in the sales description and in the list of ingredients, provided that:
(i) the main ingredient is a product of hunting or fishing;
(ii) the term referred to in paragraph 1 is clearly related in the sales

description to another ingredient which is organic and different
from the main ingredient;
(iii) all other agricultural ingredients are organic; and
(iv) the processed food complies with the production rules set out
in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II,
with the exception of the rules on restricted use of non-organic
agricultural ingredients set out in point 2.2.1 of Part IV of
Annex II, and with the rules laid down in accordance with
Article 16(3).
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The list of ingredients referred to in points (a), (b) and (c) of the first
subparagraph shall indicate which ingredients are organic. The
references to organic production may only appear in relation to the
organic ingredients.
The list of ingredients referred to in points (b) and (c) of the first
subparagraph shall include an indication of the total percentage of
organic ingredients in proportion to the total quantity of agricultural
ingredients.
The terms referred to in paragraph 1, when used in the list of

ingredients referred to in points (a), (b), and (c) of the first subparagraph
of this paragraph, and the indication of the percentage referred to in the
third subparagraph of this paragraph shall appear in the same colour,
identical size and style of lettering as the other indications in the list of
ingredients.
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6. For processed feed, the terms referred to in paragraph 1 may be
used in the sales description and in the list of ingredients, provided that:
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(a) the processed feed complies with the production rules set out in
Parts II, III and V of Annex II and with the specific rules laid down
in accordance with Article 17(3);
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(b) all of the ingredients of agricultural origin that are contained in the
processed feed are organic; and
(c) at least 95 % of the dry matter of the product are organic.

(a) this Article by adding further rules on the labelling of products

listed in Annex I, or by amending those added rules; and
(b) the list of terms set out in Annex IV, taking into account linguistic
developments within the Member States.
8. The Commission may adopt implementing acts to set detailed

requirements for the application of paragraph 3 of this Article.

Article 31
Labelling of products and substances used in crop production
Notwithstanding the scope of this Regulation as set out in Article 2(1),

products and substances used in plant protection products or as
fertilisers, soil conditioners or nutrients that have been authorised in
accordance with Articles 9 and 24 may bear a reference indicating
that those products or substances have been authorised for use in
organic production in accordance with this Regulation.
Article 32
Compulsory indications
1. Where products bear terms as referred to in Article 30(1),

including products labelled as in-conversion products in accordance
with Article 30(3):
(a) the code number of the control authority or control body to which
the operator that carried out the last production or preparation
operation is subject shall also appear in the labelling; and
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(b) in the case of prepacked food, the organic production logo of the
European Union referred to in Article 33 shall also appear on the
packaging, except in cases referred to in Article 30(3) and points (b)
and (c) of Article 30(5).
2. Where the organic production logo of the European Union is used,

an indication of the place where the agricultural raw materials of which
the product is composed have been farmed shall appear in the same
visual field as the logo and shall take one of the following forms, as
appropriate:
(a) ‘EU Agriculture’, where the agricultural raw material has been
farmed in the Union;
(b) ‘non-EU Agriculture’, where the agricultural raw material has been
farmed in third countries;
(c) ‘EU/non-EU Agriculture’, where a part of the agricultural raw

materials has been farmed in the Union and a part of it has been
farmed in a third country.
For the purposes of the first subparagraph, the word ‘Agriculture’ may
be replaced by ‘Aquaculture’ where appropriate and the words ‘EU’ and
‘non-EU’ may be replaced or supplemented by the name of a country,
or by the name of a country and a region, if all of the agricultural raw
materials of which the product is composed have been farmed in that
country and, if applicable, in that region.
For the indication of the place where the agricultural raw materials of
which the product is composed have been farmed, as referred to in the
first and third subparagraphs, small quantities by weight of ingredients
may be disregarded, provided that the total quantity of the disregarded
ingredients does not exceed 5 % of the total quantity by weight of
agricultural raw materials.
The words ‘EU’ or ‘non-EU’ shall not appear in a colour, size and style
of lettering that is more prominent than the name of the product.
3. The indications referred to in paragraphs 1 and 2 of this Article

and in Article 33(3) shall be marked in a conspicuous place in such a
way as to be easily visible, and shall be clearly legible and indelible.

accordance with Article 54 amending paragraph 2 of this Article and
Article 33(3) by adding further rules on labelling, or by amending those
added rules.
5. The Commission shall adopt implementing acts relating to:
(a) practical arrangements for the use, presentation, composition and

size of the indications referred to in point (a) of paragraph 1 and
in paragraph 2 of this Article and in Article 33(3);
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(b) the assignment of code numbers to control authorities and control
bodies;
(c) the indication of the place where the agricultural raw materials were
farmed, in accordance with paragraph 2 of this Article and with
Article 33(3).

Article 33
Organic production logo of the European Union
1. The organic production logo of the European Union may be used

in the labelling, presentation and advertising of products which comply
with this Regulation.
The organic production logo of the European Union may also be used
for information and educational purposes related to the existence and
advertising of the logo itself, provided that such use is not liable to
mislead the consumer as regards the organic production of specific
products, and provided that the logo is reproduced in accordance with
the rules set out in Annex V. In such case, the requirements of
Article 32(2) and point 1.7 of Annex V shall not apply.
The organic production logo of the European Union shall not be used
for processed food as referred to in points (b) and (c) of Article 30(5)
and for in-conversion products as referred to in Article 30(3).
2. Except where used in accordance with the second subparagraph of

paragraph 1, the organic production logo of the European Union is an
official attestation in accordance with Articles 86 and 91 of
Regulation (EU) 2017/625.
3. The use of the organic production logo of the European Union

shall be optional for products imported from third countries. Where that
logo appears in the labelling of such products, the indication referred to
in Article 32(2) shall also appear in the labelling.
4. The organic production logo of the European Union shall follow

the model set out in Annex V, and shall comply with the rules set out in
that Annex.
5. National logos and private logos may be used in the labelling,

presentation and advertising of products which comply with this Regu
lation.

accordance with Article 54 amending Annex V as regards the organic
production logo of the European Union and the rules relating thereto.
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CHAPTER V
CERTIFICATION
Article 34
Certification system
1. Prior to placing any products on the market as ‘organic’ or as ‘in-

conversion’ or prior to the conversion period, operators and groups of
operators referred to in Article 36 which produce, prepare, distribute or
store organic or in-conversion products, which import such products
from a third country or export such products to a third country, or
which place such products on the market, shall notify their activity to
the competent authorities of the Member State in which it is carried out
and in which their undertaking is subject to the control system.
Where the competent authorities have conferred their responsibilities or

delegated certain official control tasks or certain tasks related to other
official activities to more than one control authority or control body, the
operators or groups of operators shall indicate in the notification
referred to in the first subparagraph which control authority or control
body verifies whether their activity complies with this Regulation and
provides the certificate referred to in Article 35(1).
2. Operators that sell prepacked organic products directly to the final

consumer or user shall be exempted from the notification obligation
referred to in paragraph 1 of this Article and from the obligation to
be in the possession of a certificate referred to in Article 35(2) provided
that they do not produce, prepare, store other than in connection with
the point of sale, or import such products from a third country, or
subcontract such activities to another operator.
3. Where operators or groups of operators subcontract any of their

activities to third parties, both the operators or groups of operators and
the third parties to whom those activities have been subcontracted shall
comply with paragraph 1, unless the operator or group of operators has
declared in the notification referred to in paragraph 1 that it remains
responsible as regards organic production and that it has not transferred
that responsibility to the subcontractor. In such cases, the competent
authority, or, where appropriate, the control authority or control body,
shall verify that the subcontracted activities comply with this Regu
lation, in the context of the control it carries out on the operators or
groups of operators that have subcontracted their activities.
4. Member States may designate an authority or approve a body

which is to receive the notifications referred to in paragraph 1.
5. Operators, groups of operators and subcontractors shall keep

records in accordance with this Regulation on the different activities
they engage in.
6. Member States shall keep updated lists containing the names and
addresses of operators and groups of operators that have notified their
activities in accordance with paragraph 1 and shall make public in an
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appropriate manner, including by means of links to a single internet
website, a comprehensive list of this data, together with the information
relating to the certificates provided to those operators and groups of
operators in accordance with Article 35(1). When doing so, Member
States shall comply with the requirements for the protection of personal
data under Regulation (EU) 2016/679 of the European Parliament and
of the Council (1).
7. Member States shall ensure that any operator or group of operators

that complies with this Regulation and, in cases where a fee is collected
in accordance with Articles 78 and 80 of Regulation (EU) 2017/625,
that pays a reasonable fee covering the cost of controls is entitled to be
covered by the control system. Member States shall ensure that any fees
that may be collected are made public.

accordance with Article 54 amending Annex II as regards the
requirements for keeping records.
9. The Commission may adopt implementing acts to provide details

and specifications regarding:
(a) the format and technical means of the notification referred to in

paragraph 1;
(b) the arrangements for the publication of the lists referred to in

paragraph 6; and
(c) the procedures and the arrangements for publication of the fees
referred to in paragraph 7.

Article 35
Certificate
1. Competent authorities, or, where appropriate, control authorities or

control bodies, shall provide a certificate to any operator or group of
operators that has notified its activity in accordance with Article 34(1)
and complies with this Regulation. The certificate shall:
(a) be issued in electronic form wherever possible;
(b) allow at least the identification of the operator or group of operators

including the list of the members, the category of products covered
by the certificate and its period of validity;
(1) Regulation (EU) 2016/679 of the European Parliament and of the Council of
27 April 2016 on the protection of natural persons with regard to the
processing of personal data and on the free movement of such data, and
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119,
4.5.2016, p. 1).
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(c) certify that the notified activity complies with this Regulation; and
(d) be issued in accordance with the model set out in Annex VI.
2. Without prejudice to paragraph 8 of this Article and to

Article 34(2), operators and groups of operators shall not place
products referred to in Article 2(1) on the market as organic products
or in-conversion products unless they are already in possession of a
certificate as referred to in paragraph 1 of this Article.
3. The certificate referred to in this Article shall be an official cer

tificate within the meaning of point (a) of Article 86(1) of Regu
lation (EU) 2017/625.
4. An operator or a group of operators shall not be entitled to obtain

a certificate from more than one control body in relation to activities
carried out in the same Member State regarding the same category of
products, including cases in which that operator or group of operators
operates at different stages of production, preparation and distribution.
5. Members of a group of operators shall not be entitled to obtain an

individual certificate for any of the activities covered by the certification
of the group of operators to which they belong.
6. Operators shall verify the certificates of those operators that are

their suppliers.
7. For the purposes of paragraphs 1 and 4 of this Article, products

shall be classified in accordance with the following categories:
(a) unprocessed plants and plant products, including seeds and other
plant reproductive material;
(b) livestock and unprocessed livestock products;
(c) algae and unprocessed aquaculture products;
(d) processed agricultural products, including aquaculture products, for

use as food;
(e) feed;
(f) wine;
(g) other products listed in Annex I to this Regulation or not covered

by the previous categories.
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8. Member States may exempt from the obligation to be in the
possession of a certificate, provided for in paragraph 2, operators that
sell unpacked organic products other than feed directly to the final
consumer, provided that those operators do not produce, prepare, store
other than in connection with the point of sale, or import such products
from a third country, or subcontract such activities to a third party, and
provided that:
(a) such sales do not exceed 5 000 kg per year;
(b) such sales do not represent an annual turnover in relation to

unpacked organic products exceeding EUR 20 000; or
(c) the potential certification cost of the operator exceeds 2 % of the

total turnover on unpacked organic products sold by that operator.
If a Member State decides to exempt the operators referred to in the first

subparagraph, it may set stricter limits than those set in the first
subparagraph.
Member States shall inform the Commission and the other Member
States of any decision to exempt operators pursuant to the first subpara
graph and of the limits up to which such operators are exempted.

accordance with Article 54 amending the model of the certificate set
out in Annex VI.
10. The Commission shall adopt implementing acts to provide details

and specifications regarding the form of the certificate referred to in
paragraph 1 and the technical means by which it is issued.

Article 36
Group of operators
1. Each group of operators shall:
(a) only be composed of members who are farmers or operators that

produce algae or aquaculture animals and who in addition may be
engaged in processing, preparation or placing on the market of food
or feed;
(b) only be composed of members:
(i) of which the individual certification cost represents more than

2 % of each member’s turnover or standard output of organic
production and whose annual turnover of organic production is
not more than EUR 25 000 or whose standard output of organic
production is not more than EUR 15 000 per year; or
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(ii) who have each holdings of maximum:
— five hectares,
— 0,5 hectares, in the case of greenhouses, or
— 15 hectares, exclusively in the case of permanent grassland;
(c) be established in a Member State or a third country;
(d) have legal personality;
▼M6
(e) only be composed of members whose production activities or
possible additional activities referred to in point (a) take place in
geographical proximity to each other in the same Member State or
in the same third country;
▼B
(f) set up a joint marketing system for the products produced by the
group; and
(g) establish a system for internal controls comprising a documented set

of control activities and procedures in accordance with which an
identified person or body is responsible for verifying compliance
with this Regulation of each member of the group.
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The system for internal controls (ICS) shall comprise documented
procedures on:
(i) the registration of the members of the group;
(ii) the internal inspections, which include the annual internal

physical on-the-spot inspections of each member of the
group, and any additional risk-based inspections, in any
case scheduled by the ICS manager and conducted by ICS
inspectors, whose roles are defined in point (h);
(iii) the approval of new members in an existing group or, where

appropriate, the approval of new production units or new
activities of existing members upon the approval by the ICS
manager on the basis of the internal inspection report;
(iv) the training of the ICS inspectors, which is to take place at

least annually and to be accompanied by an assessment of the
knowledge acquired by the participants;
(v) the training of members of the group on the ICS procedures

and the requirements of this Regulation;
(vi) the control of documents and records;

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(vii) the measures in cases of non-compliance detected during the
internal inspections, including their follow-up;
(viii) the internal traceability, which shows the origin of the

products delivered in the joint marketing system of the
group and allows the tracing of all products of all members
throughout all stages, such as production, processing, prep
aration or placing on the market, including estimating and
cross-checking the yields of each member of the group;
(h) appoint an ICS manager and one or more ICS inspectors who may
be a member of the group. Their positions shall not be combined.
The number of ICS inspectors shall be adequate and proportional in
particular to the type, structure, size, products, activities and output
of organic production of the group. The ICS inspectors shall be
competent with regard to the products and activities of the group.
The ICS manager shall:
(i) verify the eligibility of each member of the group regarding

the criteria set out in points (a), (b) and (e);
(ii) ensure that there is a written and signed membership

agreement between each member and the group, by which
the members commit themselves to:
— comply with this Regulation,
— participate in the ICS and comply with the ICS

procedures, including the tasks and responsibilities
assigned to them by the ICS manager and the obligation
for records keeping,
— permit access to production units and premises and be

present during the internal inspections carried out by the
ICS inspectors and official controls carried out by the
competent authority or, where appropriate, the control
authority or control body, make available to them all
documents and records and countersign the inspection
reports,
— accept and implement the measures in cases of

non-compliances in accordance with the decision of the
ICS manager or the competent authority or, where appro
priate, the control authority or control body, within the
given time-frame,
— immediately inform the ICS manager on suspected

non-compliance;
(iii) develop the ICS procedures and the relevant documents and
records, keep them up to date and make them readily
available to the ICS inspectors, and where relevant, to the
members of the group;
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(iv) draw up the list of the members of the group and keep it up to
date;
(v) assign tasks and responsibilities to the ICS inspectors;
(vi) be the liaison between the members of the group and the
competent authority or, where appropriate, the control
authority or control body, including requests for derogations;
(vii) verify annually the conflict of interest statements of the ICS

inspectors;
(viii) schedule internal inspections and ensure their adequate im

plementation in accordance with the ICS manager’s
schedule referred to in point (ii) of the second paragraph of
point (g);
(ix) ensure adequate trainings for the ICS inspectors and carry out
an annual assessment of ICS inspectors’ competences and
qualifications;
(x) approve new members or new production units or new

activities of existing members;
(xi) decide on measures in case of non-compliance in line with the

ICS measures established by documented procedures in
accordance with point g and ensure the follow-up of those
measures;
(xii) decide to subcontract activities, including the subcontracting

of the tasks of ICS inspectors, and sign relevant agreements
or contracts.
The ICS inspector shall:
(i) carry out internal inspections of the members of the group

according to the schedule and the procedures provided by the
ICS manager;
(ii) draft internal inspection reports on the basis of a template and

submit it within a reasonable time to the ICS manager;
(iii) submit at appointment a written and signed statement on

conflict of interest and update it annually;
(iv) participate in trainings.
▼B
2. Competent authorities, or, where appropriate, control authorities or
control bodies, shall withdraw the certificate referred to in Article 35 for
the whole group where deficiencies in the set-up or functioning of the
system for internal controls referred to in paragraph 1, in particular as
regards failures to detect or address non-compliance by individual
members of the group of operators, affect the integrity of organic and
in-conversion products.
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At least the following situations shall be considered as deficiencies in
the ICS:
(a) producing, processing, preparing or placing on the market of

products from suspended/withdrawn members or production units;
(b) placing on the market of products for which the ICS manager has
prohibited the use of reference to organic production in their
labelling or advertising;
(c) adding new members to the list of members or changing the

activities of existing members without following the internal
approval procedure;
(d) not carrying out the annual physical on-the-spot inspection of a

member of the group in a given year;
(e) failing to indicate the members which have been suspended or

withdrawn in the list of members;
(f) serious deviations in findings between internal inspections carried

out by the ICS inspectors and official controls carried out by the
competent authority or, where appropriate, the control authority or
control body;
(g) serious deficiencies in imposing appropriate measures or carrying

out the necessary follow-up in response to non-compliance
identified by the ICS inspectors or by the competent authority or,
where appropriate, the control authority of control body;
(h) inadequate number of ICS inspectors or inadequate competences of

ICS inspectors for the type, structure, size, products, activities and
output of organic production of the group.
▼B
accordance with Article 54 amending paragraphs 1 and 2 of this
Article by adding provisions, or by amending those added provisions,
in particular as regards:
(a) the responsibilities of the individual members of a group of

operators;
(b) the criteria to determine the geographical proximity of the members

of the group, such as the sharing of facilities or sites;
(c) the set-up and functioning of the system for internal controls,
including the scope, content and frequency of the controls to be
carried out and the criteria to identify deficiencies in the set-up or
functioning of the system for internal controls.
4. The Commission may adopt implementing acts laying down

specific rules concerning:
(a) the composition and dimension of a group of operators;

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(b) the documents and record-keeping systems, the system for internal
traceability and the list of operators;
(c) the exchange of information between a group of operators and the

competent authority or authorities, control authorities or control
bodies, and between the Member States and the Commission.

CHAPTER VI
OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES
Article 37
Relationship with Regulation (EU) 2017/625 and additional rules for
official controls and other official activities in relation to organic
production and labelling of organic products
The specific rules of this Chapter shall apply, in addition to the rules
laid down in Regulation (EU) 2017/625, save as otherwise provided for
in Article 40(2) of this Regulation, and in addition to Article 29 of this
Regulation, save as otherwise provided for in Article 41(1) of this
Regulation, to the official controls and other official activities
performed to verify throughout the entire process at all stages of
production, preparation and distribution that the products referred to
in Article 2(1) of this Regulation have been produced in compliance
with this Regulation.
Article 38
Additional rules on official controls and on action to be taken by
the competent authorities
1. Official controls performed in accordance with Article 9 of Regu

lation (EU) 2017/625 for the verification of compliance with this Regu
lation shall include, in particular:
(a) the verification of the application by operators of preventive and

precautionary measures, as referred to in Article 9(6) and in
Article 28 of this Regulation, at every stage of production, prep
aration and distribution;
(b) where the holding includes non-organic or in-conversion production

units, the verification of the records and of the measures or
procedures or arrangements in place to ensure the clear and
effective separation between organic, in-conversion and
non-organic production units as well as between the respective
products produced by those units, and of the substances and
products used for organic, in-conversion and non-organic
production units; such verification shall include checks on parcels
for which a previous period was recognised retroactively as part of
the conversion period, and checks on the non-organic production
units;
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(c) where organic, in-conversion and non-organic products are collected
simultaneously by operators, are prepared or stored in the same
preparation unit, area or premises, or are transported to other
operators or units, the verification of the records and of the
measures, procedures or arrangements in place to ensure that
operations are carried out separated by place or time, that suitable
cleaning measures and, where appropriate, measures to prevent
substitution of products are implemented, that organic products
and in-conversion products are identified at all times and that
organic, in-conversion and non-organic products are stored, before
and after the preparation operations, separated by place or time from
each other;
(d) the verification of the set-up and functioning of the internal control
system of groups of operators;
(e) where operators are exempted from the notification obligation in

accordance with Article 34(2) of this Regulation or from the obli
gation to be in the possession of a certificate in accordance with
Article 35(8) of this Regulation, the verification that the
requirements for that exemption have been fulfilled and the verifi
cation of the products sold by those operators.

lation shall be performed throughout the entire process at all stages of
production, preparation and distribution on the basis of the likelihood of
non-compliance as defined in point (57) of Article 3 of this Regulation,
which shall be determined taking into account, in addition to the
elements referred to in Article 9 of Regulation (EU) 2017/625, in
particular the following elements:
(a) the type, size and structure of the operators and groups of operators;
(b) the length of time during which operators and groups of operators
have been involved in organic production, preparation and
distribution;
(c) the results of the controls performed in accordance with this Article;
(d) the point in time relevant for the activities carried out;
(e) the product categories;
(f) the type, quantity and value of products and their development over
time;
(g) the possibility of commingling of products or contamination with

non-authorised products or substances;
(h) the application of derogations or exceptions to the rules by

operators and groups of operators;
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(i) the critical points for non-compliance and the likelihood of
non-compliance at every stage of production, preparation and
distribution;
(j) subcontracting activities.
3. In any case, all operators and groups of operators, with the

exception of those referred to in Articles 34(2) and 35(8), shall be
subject to a verification of compliance at least once a year.
The verification of compliance shall include a physical on-the-spot

inspection, except where the following conditions have been satisfied:
(a) the previous controls of the operator or group of operators

concerned have not revealed any non-compliance affecting the
integrity of organic or in-conversion products during at least three
consecutive years; and
(b) the operator or group of operators concerned has been assessed on

the basis of the elements referred to in paragraph 2 of this Article
and in Article 9 of Regulation (EU) 2017/625 as presenting a low
likelihood of non-compliance.
In this case, the period between two physical on-the-spot inspections

shall not exceed 24 months.

lation shall:
(a) be performed in accordance with Article 9(4) of Regulation (EU)

2017/625 while ensuring that a minimum percentage of all official
controls of operators or groups of operators are carried out without
prior notice;
(b) ensure that a minimum percentage of additional controls to those

referred in paragraph 3 of this Article are carried out;
(c) be carried out by taking a minimum number of the samples that

have been taken in accordance with point (h) of Article 14 of
Regulation (EU) 2017/625;
(d) ensure that a minimum number of operators that are members of a

group of operators are controlled in connection with the verification
of compliance referred to in paragraph 3 of this Article.
5. The delivery or renewal of the certificate referred to in

Article 35(1) shall be based on the results of the verification of
compliance referred to in paragraphs 1 to 4 of this Article.
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6. The written record to be drawn up regarding each official control
that has been performed to verify compliance with this Regulation in
accordance with Article 13(1) of Regulation (EU) 2017/625 shall be
countersigned by the operator or groups of operators as confirmation
of their receipt of that written record.
7. Article 13(1) of Regulation (EU) 2017/625 shall not apply to

audits and inspections carried out by competent authorities in the
context of their supervisory activities over control bodies to which
certain official control tasks or certain tasks related to other official
activities have been delegated.

accordance with Article 54:
(a) supplementing this Regulation by laying down specific criteria and

conditions for the performance of official controls conducted to
ensure the traceability at all stages of production, preparation and
distribution, and compliance with this Regulation, concerning:
(i) checks of documentary accounts;
(ii) controls performed on specific categories of operators;
(iii) where appropriate, the period within which the controls

provided for in this Regulation, including the physical
on-the-spot inspections referred to in paragraph 3 of this
Article, are to be performed and the particular premises in or
area on which they are to be performed;
(b) amending paragraph 2 of this Article by adding further elements

based on practical experience, or by amending those added
elements.
9. The Commission may adopt implementing acts to specify:
(a) the minimum percentage of all official controls of operators or

groups of operators that are to be carried out without prior notice
as referred to in point (a) of paragraph 4;
(b) the minimum percentage of additional controls referred to in

point (b) of paragraph 4;
(c) the minimum number of samples referred to in point (c) of

paragraph 4;
(d) the minimum number of operators that are members of a group of

operators referred to in point (d) of paragraph 4.

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Article 39
Additional rules on actions to be taken by the operators and groups
of operators
1. In addition to the obligations laid down in Article 15 of Regu

lation (EU) 2017/625, operators and groups of operators shall:
(a) keep records to demonstrate their compliance with this Regulation;
(b) make all declarations and other communications that are necessary
for official controls;
(c) take relevant practical measures to ensure compliance with this

Regulation;
(d) provide, in form of a declaration to be signed and updated as

necessary:
(i) the full description of the organic or in-conversion production

unit and of the activities to be performed in accordance with
this Regulation;
(ii) the relevant practical measures to be taken to ensure

compliance with this Regulation;
(iii) an undertaking:
— to inform in writing and without undue delay buyers of the

products and to exchange relevant information with the
competent authority, or, where appropriate, with the
control authority or control body, in the event that a
suspicion of non-compliance has been substantiated, that
a suspicion of non-compliance cannot be eliminated, or
that non-compliance that affects the integrity of the
products in question has been established,
— to accept the transfer of the control file in the case of

change of control authority or control body or, in the
case of withdrawal from organic production, the keeping
of the control file for at least five years by the last control
authority or control body,
— to immediately inform the competent authority or the

authority or body designated in accordance with
Article 34(4) in the event of withdrawal from organic
production, and
— to accept the exchange of information among those auth

orities or bodies in the event that subcontractors are subject
to controls by different control authorities or control bodies.
2. The Commission may adopt implementing acts to provide details

and specifications regarding:
(a) the records for demonstrating compliance with this Regulation;

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(b) the declarations and other communications that are necessary for
official controls;
(c) the relevant practical measures for ensuring compliance with this
Regulation.

Article 40
Additional rules on the delegation of official control tasks and tasks
related to other official activities
1. Competent authorities may delegate to control bodies certain

official control tasks and certain tasks related to other official activities
only if the following conditions, in addition to those set out in Chapter
III of Regulation (EU) 2017/625, are satisfied:
(a) the delegation contains a detailed description of the delegated

official control tasks and tasks related to other official activities,
including reporting obligations and other specific obligations, and
of the conditions under which the control body may carry them out.
In particular, the control body shall have submitted the following to
the competent authorities for prior approval:
(i) its risk assessment procedure, which is to determine, in

particular, the basis for the intensity and frequency of the
verification of compliance of the operators and groups of
operators, which is to be established on the basis of the
elements referred to in Article 9 of Regulation (EU)
2017/625 and of Article 38 of this Regulation, and which is
to be followed for official controls on operators and groups of
operators;
(ii) the standard control procedure, which is to contain a detailed

description of the control measures that the control body
undertakes to apply to the operators and groups of operators
that are subject to its controls;
(iii) a list of measures that are in conformity with the common

catalogue referred to in Article 41(4), and that are to be
applied to operators and groups of operators in cases of
suspected or established non-compliance;
(iv) the arrangements for the effective monitoring of the official

control tasks and tasks related to other official activities
carried out in relation to operators and groups of operators
and the arrangements for reporting on those tasks.
The control body shall notify subsequent amendment of the

elements referred to in points (i) to (iv) to the competent authority;
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(b) those competent authorities have procedures and arrangements in
place to ensure the supervision of control bodies, including to
verify that the delegated tasks are carried out effectively, inde
pendently and objectively, in particular as regards the intensity
and frequency of the verification of compliance.
At least once a year, competent authorities shall, pursuant to point (a) of

Article 33 of Regulation (EU) 2017/625, organise audits of the control
bodies to whom they have delegated official control tasks or tasks
related to other official activities.
2. By way of derogation from Article 31(3) of Regulation (EU)

2017/625, competent authorities may delegate to a control body the
decision concerning the tasks provided for in point (b) of Article 138(1)
and in Article 138(2) and (3) of that Regulation.
3. For the purpose of point (b)(iv) of Article 29 of Regulation (EU)

2017/625, the standard for the delegation of certain official control tasks
and certain tasks related to other official activities to verify compliance
with this Regulation which is relevant in relation to the scope of this
Regulation is the most recently notified version of the international
harmonised standard for ‘Conformity assessment – Requirements for
bodies certifying products, processes and services’, the reference of
which has been published in the Official Journal of the European
Union.
4. Competent authorities shall not delegate the following official

control tasks and tasks related to other official activities to control
bodies:
(a) the supervision and audit of other control authorities or control

bodies;
(b) the power to grant derogations other than derogations for the use of
plant reproductive material not obtained from organic production;
(c) the authority to receive notifications of activities by operators or

groups of operators under Article 34(1) of this Regulation;
(d) the assessment of the likelihood of non-compliance with the

provisions of this Regulation that determine the frequency with
which physical checks are to be performed on organic consignments
prior to their release for free circulation into the Union in
accordance with Article 54 of Regulation (EU) 2017/625;
(e) the establishment of the common catalogue of measures referred to

in Article 41(4) of this Regulation.
5. Competent authorities shall not delegate official control tasks or

tasks related to other official activities to natural persons.
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6. Competent authorities shall ensure that information received from
control bodies pursuant to Article 32 of Regulation (EU) 2017/625 and
information on the measures applied by control bodies in the case of
established or likely non-compliance is collected and used by the
competent authorities in order to supervise the activities of those
controls bodies.
7. Where a competent authority has fully or partially withdrawn the

delegation of certain official control tasks or certain tasks related to
other official activities in accordance with point (b) of Article 33 of
Regulation (EU) 2017/625, it shall decide whether any certificates
issued by the control bodies concerned before the date of that partial
or full withdrawal are to remain valid, and shall inform the operators
concerned of that decision.
8. Without prejudice to point (b) of Article 33 of Regulation (EU)

2017/625, before fully or partly withdrawing the delegation of official
control tasks or tasks related to other official activities in the cases
referred to in that point, competent authorities may fully or partly
suspend that delegation:
(a) for a period that shall not exceed 12 months, during which the
control body is to remedy the shortcomings identified during
audits and inspections or to address the non-compliance about
which information was shared with other control authorities and
control bodies, with competent authorities as well as with the
Commission in accordance with Article 43 of this Regulation; or
(b) for the period during which the accreditation referred to in

point (b)(iv) of Article 29 of Regulation (EU) 2017/625, in
connection with Article 40(3) of this Regulation, is suspended.
Where the delegation of official control tasks or tasks related to other

official activities has been suspended, the control bodies concerned shall
not issue certificates referred to in Article 35 for those parts for which
the delegation has been suspended. Competent authorities shall decide
whether any certificates issued by the control bodies concerned before
the date of that partial or full suspension are to remain valid, and shall
inform the operators concerned of that decision.
Without prejudice to Article 33 of Regulation (EU) 2017/625, the

competent authorities shall lift the suspension of the delegation of
official control tasks or tasks related to other official activities as
soon as possible once the control body has remedied the shortcomings
or non-compliances referred to in point (a) of the first subparagraph or
once the accreditation body has lifted the suspension of the accreditation
referred to in point (b) of the first subparagraph.
9. Where a control body to whom competent authorities have

delegated certain official control tasks or certain tasks related to other
official activities has also been recognised by the Commission in
accordance with Article 46(1) of this Regulation to carry out control
activities in third countries, and the Commission intends to withdraw or
has withdrawn the recognition of that control body, competent auth
orities shall organise audits or inspections on the control body as
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regards its activities in the Member State(s) concerned in accordance
with point (a) of Article 33 of Regulation (EU) 2017/625.
10. The control bodies shall transmit to the competent authorities:
(a) a list of the operators which were subject to their controls on 31

December of the previous year by 31 January of each year; and
(b) information on the official controls and other official activities

carried out in the previous year to support the preparation of the
part on organic production and labelling of organic products of the
annual report referred to in Article 113 of Regulation (EU)
2017/625 by 31 March of each year.

accordance with Article 54 supplementing this Regulation as regards
conditions for the delegation of official control tasks and tasks related
to other official activities to control bodies additional to the conditions
laid down in paragraph 1 of this Article.
Article 41
▼C5
Additional rules on actions in the event of suspected and established
non-compliance, and common catalogue of measures
▼B
1. Subject to Article 29, where a competent authority, or, where
appropriate, a control authority or control body, suspects or receives
substantiated information, including information from other competent
authorities, or, where appropriate, from other control authorities or
control bodies, that an operator intends to use or to place on the
market a product which may not be in compliance with this Regulation
but which bears terms referring to the organic production, or where such
competent authority, control authority or control body has been
informed by an operator of a suspicion of non-compliance in accordance
with Article 27:
(a) it shall immediately carry out an official investigation in accordance

with Regulation (EU) 2017/625 with a view to verifying compliance
with this Regulation; such investigation shall be completed as soon
as possible, within a reasonable period, and shall take into account
the durability of the product and the complexity of the case;
(b) it shall provisionally prohibit both the placing on the market of the
products concerned as organic or in-conversion products and their
use in organic production pending the results of the investigation
referred to in point (a). Before taking such a decision, the competent
authority, or, where appropriate, the control authority or control
body, shall give the operator an opportunity to comment.
2. In the event that the results of the investigation referred to in

point (a) of paragraph 1 do not show any non-compliance affecting
the integrity of organic or in-conversion products, the operator shall
be allowed to use the products concerned or to place them on the
market as organic or in-conversion products.
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3. Member States shall take any measures, and provide for any
necessary sanctions, to prevent fraudulent use of the indications
referred to in Chapter IV of this Regulation.
4. Competent authorities shall provide a common catalogue of

measures for cases of suspected non-compliance and established
non-compliance to be applied in their territory, including by control
authorities and control bodies.
5. The Commission may adopt implementing acts to specify uniform

arrangements for the cases where competent authorities are to take
measures in relation to suspected or established non-compliance.

Article 42
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Additional rules on measures in the event of non-compliance
affecting integrity
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1. In the event of non-compliance affecting the integrity of organic or
in-conversion products throughout any of the stages of production,
preparation and distribution, for example as result of the use of
non-authorised products, substances or techniques, or commingling
with non-organic products, competent authorities, and, where appro
priate, control authorities and control bodies, shall ensure, in addition
to the measures to be taken in accordance with Article 138 of Regu
lation (EU) 2017/625, that no reference is made to organic production in
the labelling and advertising of the entire lot or production run
concerned.
2. In the event of serious, or repetitive or continued non-compliance,

competent authorities, and, where appropriate, control authorities and
control bodies, shall ensure that the operators or the groups of
operators concerned, in addition to the measures laid down in
paragraph 1 and any appropriate measures taken in particular in
accordance with Article 138 of Regulation (EU) 2017/625, are
prohibited from marketing products which refer to organic production
for a given period, and that their certificate referred to in Article 35 be
suspended or withdrawn, as appropriate.
Article 43
Additional rules on the exchange of information
1. In addition to the obligations laid down in Article 105(1) and

Article 106(1) of Regulation (EU) 2017/625, competent authorities
shall immediately share information with other competent authorities,
as well as with the Commission, on any suspicion of non–compliance
that affects the integrity of organic or in-conversion products.
Competent authorities shall share that information with other competent

authorities and the Commission via a computer system that enables the
electronic exchanges of documents and information made available by
the Commission.
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2. In cases where suspected or established non-compliance has been
identified with regard to products under the control of other control
authorities or control bodies, control authorities and control bodies
shall immediately inform those other control authorities or control
bodies.
3. Control authorities and control bodies shall exchange other

relevant information with other control authorities and control bodies.
4. Upon receiving a request for information that is justified by the

need to guarantee that a product has been produced in accordance with
this Regulation, control authorities and control bodies shall exchange
with other competent authorities, as well as with the Commission,
information on the results of their controls.
5. Competent authorities shall exchange information on the super

vision of the control bodies with national accreditation bodies as
defined in point (11) of Article 2 of Regulation (EC) No 765/2008 of
the European Parliament and of the Council (1).
6. Competent authorities shall take appropriate measures and

establish documented procedures in order to ensure that information
about the results of controls is communicated to the paying agency in
accordance with its needs for the purpose of Article 58 of Regu
lation (EU) No 1306/2013 of the European Parliament and of the
Council (2) and the acts adopted on the basis of that Article.
7. The Commission may adopt implementing acts to specify the

information to be provided by the competent authorities, control auth
orities and control bodies in charge of the official controls and other
official activities in accordance with this Article, the relevant recipients
of that information and the procedures in accordance with which this
information is to be provided, including the functionalities of the
computer system referred to in paragraph 1.

CHAPTER VII
TRADE WITH THIRD COUNTRIES
Article 44
Export of organic products
1. A product may be exported from the Union as an organic product

and may bear the organic production logo of the European Union,
provided that it complies with the rules for organic production under
this Regulation.
of 9 July 2008 setting out the requirements for accreditation and market
surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Council of 17 December 2013 on the financing, management and monitoring
of the common agricultural policy and repealing Council Regulations (EEC)
No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC)
No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).
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documents intended for customs authorities in third countries, in
particular as regards the issuing of organic export certificates in elec
tronic form wherever possible and the provision of assurances that
exported organic products comply with this Regulation.
Article 45
Import of organic and in-conversion products
1. A product may be imported from a third country for the purpose

of placing that product on the market within the Union as an organic
product or as an in-conversion product, provided that the following
three conditions are met:
(a) the product is a product as referred to in Article 2(1);
(b) one of the following applies:
(i) the product complies with Chapters II, III and IV of this Regu
lation, and all operators and groups of operators referred to in
Article 36, including exporters in the third country concerned,
have been subject to controls by control authorities or control
bodies recognised in accordance with Article 46, and those
authorities or bodies have provided all such operators, groups
of operators and exporters with a certificate confirming that
they comply with this Regulation;
(ii) in cases where the product comes from a third country which is
recognised in accordance with Article 47, that product
complies with the conditions laid down in the relevant trade
agreement; or
(iii) in cases where the product comes from a third country which is
recognised in accordance with Article 48, that product
complies with the equivalent production and control rules of
that third country and is imported with a certificate of
inspection confirming this compliance that was issued by the
competent authorities, control authorities or control bodies of
that third country; and
(c) the operators in third countries are able at any time to provide the
importers and the national authorities in the Union and in those
third countries with information allowing the identification of the
operators that are their suppliers and the control authorities or
control bodies of those suppliers, with a view to ensuring the tracea
bility of the organic or in-conversion product concerned. That
information shall also be made available to the control authorities
or control bodies of the importers.
2. The Commission may, in accordance with the procedure set out in

Article 24(9), grant specific authorisations for the use of products and
substances in third countries and in the outermost regions of the Union,
taking into account differences in the ecological balance in plant or
animal production, specific climatic conditions, traditions and local
conditions in those areas. Such specific authorisations may be granted
for a renewable period of two years and shall be subject to the prin
ciples laid down in Chapter II and to the criteria set out in Article 24(3)
and (6).
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3. When providing for the criteria for determining whether a situation
qualifies as catastrophic circumstances, and when laying down specific
rules on how to deal with such circumstances in accordance with
Article 22, the Commission shall take into account differences in the
ecological balance, climate and local conditions in third countries and in
the outermost regions of the Union.
4. The Commission shall adopt implementing acts to lay down

specific rules concerning the content of the certificates referred to in
point (b) of paragraph 1, the procedure to be followed for their issuance,
their verification and the technical means by which the certificate is
issued, in particular as regards the role of competent authorities,
control authorities and control bodies, ensuring the traceability and
compliance of imported products intended to be placed on the Union
market as organic products or as in-conversion products as referred to in
paragraph 1.

5. Compliance with the conditions and measures for the import of

organic products and in-conversion products referred to in paragraph 1
into the Union shall be ascertained at border control posts, in
accordance with Article 47(1) of Regulation (EU) 2017/625. The
frequency of the physical checks referred to in Article 49(2) of that
Regulation shall depend on the likelihood of non-compliance as
defined in point (57) of Article 3 of this Regulation.
Article 46
Recognition of control authorities and control bodies
1. The Commission may adopt implementing acts to recognise

control authorities and control bodies that are competent to carry out
controls and to issue organic certificates in third countries, to withdraw
the recognition of such control authorities and control bodies, and to
establish a list of recognised control authorities and control bodies.

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2. Control authorities and control bodies shall be recognised in
accordance with paragraph 1 for the control of the import of the
categories of products listed in Article 35(7) if they fulfil the
following criteria:
(a) they are legally established in one Member State or third country;
(b) they have the capacity to carry out controls to ensure that the
conditions set out in points (a), (b)(i) and (c) of Article 45(1)
and in this Article are met in relation to organic products and
in-conversion products intended for import into the Union,
without delegating control tasks; for the purposes of this point,
control tasks carried out by persons working under an individual
contract or a formal agreement that place them under the
management control and the procedures of the contracting control
authorities or control bodies shall not be considered as delegation,
and the prohibition to delegate control tasks shall not apply to
sampling;
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(c) they offer adequate guarantees of objectivity and impartiality and
are free from any conflict of interest as regards the exercise of their
control tasks; in particular, they have procedures in place ensuring
that the staff performing controls and other actions is free from any
conflict of interest, and that the operators are not inspected by the
same inspectors for more than 3 years consecutively;
(d) in the case of control bodies, they are accredited for the purpose of
their recognition in accordance with this Regulation by only one
accreditation body under the relevant harmonised standard for
‘Conformity assessment – Requirements for bodies certifying
products, processes and services’, the reference of which has
been published in the Official Journal of the European Union;
(e) they have the expertise, equipment and infrastructure required to

carry out control tasks, and have a sufficient number of suitable
qualified and experienced staff;
(f) they have the capacity and the competency to carry out their certifi
cation and control activities in accordance with the requirements of
this Regulation and in particular Commission Delegated
Regulation (EU) 2021/1698 (1) for each type of operator (single
operator or group of operators) in each third country and for
each category of products they want to be recognised for;
(g) they have procedures and arrangements in place to ensure the

impartiality, the quality, the consistency, the effectiveness and the
appropriateness of controls and other actions performed by them;
(h) they have sufficient qualified and experienced staff so that controls
and other actions can be performed effectively and in due time;
(i) they have appropriate and properly maintained facilities and

equipment to ensure that staff can perform controls and other
actions effectively and in due time;
(j) they have procedures in place in order to ensure that their staff
have access to the premises of, and documents kept by operators so
as to be able to accomplish their tasks;
(k) they have internal skills, training and procedures suitable to

perform effective controls, including inspections, on operators as
well as on the internal control system of a group of operators, if
any;
(l) their previous recognition for a specific third country and/or for a
category of products has not been withdrawn in accordance with
paragraph 2a or their accreditation has not been withdrawn or
suspended by any accreditation body in accordance with its
procedures for the suspension or withdrawal established in
accordance with the relevant international standard, in particular
(1) Delegated Regulation (EU) 2021/1698 of 13 July 2021 supplementing Regu

lation (EU) 2018/848 of the European Parliament and of the Council with
procedural requirements for the recognition of control authorities and control
bodies that are competent to carry out controls on operators and groups of
operators certified organic and on organic products in third countries and with
rules on their supervision and the controls and other actions to be performed
by those control authorities and control bodies (OJ L 336, 23.9.2021, p. 7).
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the International Organisation for Standardisation (ISO) standard
17011 – Conformity assessment – general requirements for accred
itation bodies accrediting conformity assessment bodies, during the
24 months preceding:
(i) their request for recognition for the same third country and/or
for the same category of products, except where the previous
recognition was withdrawn in accordance with point (k) of
paragraph 2a;
(ii) their request for an extension of the scope of recognition to an

additional third country in accordance with Article 2 of
Delegated Regulation (EU) 2021/1698, except where the
previous recognition was withdrawn in accordance with
point (k) of paragraph 2a of this Article;
(iii) their request for an extension of the scope of recognition to an

additional category of products in accordance with Article 2 of
Delegated Regulation (EU) 2021/1698;
(m) in the case of control authorities, they are public administrative

organisations in the third country for which they request
recognition;
(n) they meet the procedural requirements laid down in Chapter I of

Delegated Regulation (EU) 2021/1698; and
(o) they meet any additional criteria that may be laid down in a
delegated act adopted pursuant to paragraph 7.
2a. The Commission may withdraw the recognition of a control

authority or control body for a specific third country and/or a
category of products if:
(a) one of the recognition criteria set out in paragraph 2 is no longer

met;
(b) the Commission has not received the annual report referred to in
Article 4 of Delegated Regulation (EU) 2021/1698 by the deadline
specified in that Article or the information included in the annual
report is incomplete, inaccurate or does not comply with the
requirements set out in that Regulation;
(c) the control authority or control body does not make available or
does not communicate all the information related to the technical
dossier referred to in paragraph 4, to the control system applied by
it, or to the up-to-date list of operators or groups of operators or to
the organic products covered by the scope of its recognition;
(d) the control authority or control body does not notify the
Commission within 30 calendar days of changes to its technical
dossier referred to in paragraph 4;
(e) the control authority or control body does not provide information
requested by the Commission or by a Member State within the
deadlines set, or the information is incomplete, inaccurate or does
not comply with the requirements set out in this Regulation, in
Delegated Regulation (EU) 2021/1698 and in an implementing act
to be adopted pursuant to paragraph 8, or does not cooperate with
the Commission, in particular during the investigations of a non-
compliance;
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(f) the control authority or control body does not agree to an on-the-
spot examination or audit initiated by the Commission;
(g) the result of the on-the-spot examination or audit indicates a

systematic malfunctioning of control measures or the control
authority or control body is unable to implement all the recommen
dations made by the Commission after the on-the-spot examination
or audit, in their proposed action plan submitted to the Commission;
(h) the control authority or control body fails to take adequate

corrective measures in response to the non-compliances and
infringements observed within a deadline set by the Commission
according to the severity of the situation, which shall not be shorter
than 30 calendar days;
(i) in case an operator changes its control authority or control body, the
control authority or control body does not communicate to the new
control authority or control body the relevant elements of the
control file, including written records, of the operator within a
maximum of 30 calendar days after having received the request
for transfer from the operator or the new control authority or
control body;
(j) there is a risk for the consumer to be misled about the true nature of
the products covered by the scope of the recognition; or
(k) the control authority or control body has not certified any operator
for 48 consecutive months in the third country for which it is
recognised.
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3. The accreditation referred to in point (d) of paragraph 2 may only
be granted by:
(a) a national accreditation body in the Union in accordance with

Regulation (EC) No 765/2008; or
(b) an accreditation body outside the Union that is a signatory of a

multilateral recognition arrangement under the auspices of the Inter
national Accreditation Forum.
4. Control authorities and control bodies shall submit a request for

recognition to the Commission. Such request shall consist of a technical
dossier containing all information that is necessary to ensure that the
criteria set out in paragraph 2 are met.
The control authorities shall provide the latest assessment report issued
by the competent authority, and the control bodies shall provide the
accreditation certificate issued by the accreditation body. Where appro
priate, control authorities or control bodies shall also provide latest
reports on the regular on-the-spot evaluation, surveillance and multi
annual re-assessment of their activities.
5. Based on the information referred to under paragraph 4 and on

any other relevant information relating to the control authority or control
body, the Commission shall ensure appropriate supervision of the
recognised control authorities and control bodies by regularly
reviewing their performance and recognition. For the purposes of that
supervision, the Commission may request additional information from
the accreditation bodies or the competent authorities, as appropriate.
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6. The nature of the supervision referred to in paragraph 5 shall be
determined on the basis of an assessment of the likelihood of
non-compliance, taking into account, in particular, the activity of the
control authority or control body, the type of products and operators
under its control and the changes in the production rules and control
measures.
The recognition of control authorities or of control bodies referred to in

paragraph 1 shall in particular be withdrawn without delay, in
accordance with the procedure referred to in that paragraph, where
serious or repetitive infringements as regards the certification or the
controls and actions laid down in accordance with paragraph 8 have
been detected and where the control authority or control body concerned
has failed to take appropriate and timely remedial action in reaction to a
request by the Commission within a period determined by the
Commission. Such period shall be determined in accordance with the
severity of the problem and in general shall not be less than 30 days.

accordance with Article 54:
(a) amending paragraph 2 of this Article by adding further criteria to

those laid down therein for the recognition of the control authorities
and control bodies referred to in paragraph 1 of this Article and for
the withdrawal of such recognition, or by amending those added
criteria;
(b) supplementing this Regulation as regards:
(i) the exercise of the supervision of the control authorities and

control bodies recognised by the Commission in accordance
with paragraph 1, including on-the-spot examinations; and
(ii) the controls and other actions to be performed by those control

authorities and control bodies.
8. The Commission may adopt implementing acts to ensure the

application of the measures to be taken in relation to cases of
suspected or established non-compliance, in particular those affecting
the integrity of organic or in-conversion products imported under the
recognition provided for in this Article. Such measures may consist in
particular in the verification of the integrity of organic or in-conversion
products before placing the products on the market within the Union
and, where appropriate, in the suspension of the authorisation for the
placing on the market of such products within the Union as organic
products or in-conversion products.

9. On duly justified imperative grounds of urgency relating to unfair

practices or practices which are incompatible with the principles and
rules on organic production, the protection of consumers’ confidence or
the protection of fair competition between operators, the Commission
shall adopt immediately applicable implementing acts in accordance
with the procedure referred to in Article 55(3) to take the measures
referred to in paragraph 8 of this Article or to decide on the withdrawal
of the recognition of the control authorities and control bodies referred
to in paragraph 1 of this Article.
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Article 47
Equivalence under a trade agreement
A recognised third country referred to in point (b)(ii) of Article 45(1) is

a third country which the Union has recognised under a trade agreement
as having a system of production meeting the same objectives and
principles by applying rules which ensure the same level of assurance
of conformity as those of the Union.
Article 48
Equivalence under Regulation (EC) No 834/2007
1. A recognised third country referred to in point (b)(iii) of

Article 45(1) is a third country which has been recognised for the
purposes of equivalence under Article 33(2) of Regulation (EC)
No 834/2007, including those recognised under the transitional
measure provided for in Article 58 of this Regulation.
That recognition shall expire on ►M3 31 December 2026 ◄.
2. On the basis of annual reports to be sent to the Commission, by 31

March of each year, by the third countries referred to in paragraph 1
regarding the implementation and enforcement of the control measures
established by them, and in the light of any other information received,
the Commission shall ensure appropriate supervision of the recognised
third countries by regularly reviewing their recognition. For this
purpose, the Commission may request the assistance of Member
States. The nature of the supervision shall be determined on the basis
of an assessment of the likelihood of non-compliance, taking into
account in particular the volume of exports to the Union from the
third country concerned, the results of the monitoring and supervisory
activities carried out by the competent authority and the results of
previous controls. The Commission shall regularly report to the
European Parliament and the Council on the outcome of its review.
3. The Commission shall, by means of an implementing act, establish

a list of the third countries referred to in paragraph 1 and may amend
that list by means of implementing acts.


the information to be sent by the third countries listed in accordance
with paragraph 3 of this Article which is necessary for the supervision
of their recognition by the Commission, as well as the exercise of that
supervision by the Commission, including through on-the-spot
examination.
5. The Commission may adopt implementing acts to ensure the

application of measures in relation to cases of suspected or established
non-compliance, in particular those affecting the integrity of organic or
in-conversion products imported from third countries referred to in this
Article. Such measures may consist in particular in the verification of
the integrity of organic or in-conversion products before placing the
products on the market within the Union and, where appropriate, in
the suspension of the authorisation for the placing on the market of
such products within the Union as organic products or in-conversion
products.
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Article 49
Report from the Commission on the application of Articles 47 and
48
By ►M3 31 December 2022 ◄, the Commission shall present a report

to the European Parliament and the Council on the state of application
of Articles 47 and 48, in particular as regards the recognition of third
countries for the purpose of equivalence.
CHAPTER VIII
GENERAL PROVISIONS
SECTION 1
Free movement of organic and in-conversion products
Article 50
Non-prohibition and non-restriction of the marketing of organic
and in-conversion products
Competent authorities, control authorities and control bodies shall not,

on grounds that relate to the production, labelling or presentation of the
products, prohibit or restrict the marketing of organic or in-conversion
products subject to control by another competent authority, control
authority or control body located in another Member State where
those products comply with this Regulation. In particular, no official
controls and other official activities other than those under
Regulation (EU) 2017/625 shall be performed and no fees for official
controls and other official activities other than those provided for in
Chapter VI of that Regulation shall be collected.
SECTION 2
Information, reporting and related derogations
Article 51
Information relating to the organic sector and trade
1. Each year Member States shall transmit to the Commission the

information necessary for the implementation and monitoring of the
application of this Regulation. As far as possible, such information
shall be based on established sources of data. The Commission shall
take into account the data needs and synergies between potential data
sources, in particular their use for statistical purposes where appropriate.
2. The Commission shall adopt implementing acts as regards the

system to be used for transmitting the information referred to in
paragraph 1, the details of information to be transmitted, and the date
by which that information is to be transmitted.

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Article 52
Information relating to the competent authorities, control
authorities and control bodies
1. Members States shall keep a regularly updated list of:
(a) the names and addresses of the competent authorities; and
(b) the names, addresses and code numbers of the control authorities
and control bodies.
Member States shall transmit those lists, and any change thereof, to the
Commission and make them public, except where such transmission and
publication has already taken place in accordance with Article 4(4) of
Regulation (EU) 2017/625.
2. Based on the information provided for under paragraph 1, the

Commission shall regularly publish on the internet an updated list of
control authorities and control bodies referred to in point (b) of
paragraph 1.
Article 53
Derogations, authorisations and report
1. The derogations from the use of organic plant reproductive

material and from the use of organic animals provided in points 1.8.5
of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of
Annex II, with the exception of point 1.3.4.4.2 of Part II of
Annex II, shall expire on ►M3 31 December 2036 ◄.
2. From ►M3 1 January 2029 ◄, based on the conclusions as

regards availability of organic plant reproductive material and animals
presented in the report provided for in paragraph 7 of this Article, the
Commission shall be empowered to adopt delegated acts in accordance
with Article 54 amending this Regulation by:
(a) ending the derogations referred to in point 1.8.5 of Part I of

Annex II and in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II,
with the exception of point 1.3.4.4.2 of Part II of Annex II, at an
earlier date than ►M3 31 December 2036 ◄ or extending them
beyond that date; or
(b) ending the derogation referred to in point 1.3.4.4.2 of Part II of

Annex II.
3. From ►M3 1 January 2027 ◄, the Commission shall be

empowered to adopt delegated acts in accordance with Article 54
amending point (b) of Article 26(2) to extend the scope of the
information system referred to in Article 26(2) to pullets and
point 1.3.4.3 of Part II of Annex II to base the derogations concerning
pullets on the data collected in accordance with this system.
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4. From ►M3 1 January 2026 ◄, the Commission shall be
empowered to adopt delegated acts in accordance with Article 54,
based on the information as regards availability of organic protein
feed for poultry and porcine animals made available by Member
States in accordance with paragraph 6 of this Article or presented in
the report referred to in paragraph 7 of this Article, ending the auth
orisations to use non-organic protein feed in the nutrition of poultry and
porcine animals referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part II
of Annex II at an earlier date than ►M3 31 December 2026 ◄ or
extending them beyond that date.
5. When extending the derogations or authorisations referred to in

paragraphs 2, 3 and 4, the Commission shall do so only for as long as it
has information, in particular information provided by Member States in
accordance with paragraph 6, that confirms the unavailability on the
Union market of the plant reproductive material, animal or feed
concerned.
6. By 30 June of each year, Member States shall make available to

the Commission and to the other Member States:
(a) information provided in the database referred to in Article 26(1) and

in the systems referred to in Article 26(2) and, if relevant, in the
systems referred to in Article 26(3);
(b) information on the derogations granted in accordance with

point 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4
of Part II of Annex II; and
(c) information on the availability on the Union market of organic

protein feed for poultry and porcine animals and on the authoris
ations granted in accordance with points 1.9.3.1(c) and 1.9.4.2(c) of
Part II of Annex II.
7. By ►M3 31 December 2026 ◄, the Commission shall present a

report to the European Parliament and the Council on the availability on
the Union market of and, if relevant, on the causes of limited access to:
(a) organic plant reproductive material;
(b) organic animals covered by the derogations referred to in points

1.3.4.3 and 1.3.4.4 of Part II of Annex II;
(c) organic protein feed intended for the nutrition of poultry and
porcine animals subject to the authorisations referred to in points
1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II.
In drawing up that report, the Commission shall take into account, in

particular, the data collected in accordance with Article 26 and the
information relating to the derogations and the authorisations referred
to in paragraph 6 of this Article.
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CHAPTER IX
PROCEDURAL, TRANSITIONAL AND FINAL PROVISIONS
SECTION 1
Procedural provisions
Article 54
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission

subject to the conditions laid down in this Article.
2. ►C1 The power to adopt delegated acts referred to in Article 2(6),

Article 9(11), Article 10(5), Article 12(2), Article 13(3), Article 14(2),
Article 53(2), (3) and (4), Article 57(3) and Article 58(2) shall be
conferred on the Commission for a period of five years from
17 June 2018. ◄ The Commission shall draw up a report in respect
of the delegation of power no later than nine months before the end of
the five-year period. The delegation of power shall be tacitly extended
for periods of an identical duration, unless the European Parliament or
the Council opposes such extension not later than three months before
the end of each period.
3. The delegation of power referred to in Article 2(6), Article 9(11),

(3) and (4), Article 57(3) and Article 58(2) may be revoked at any time
by the European Parliament or by the Council. A decision to revoke
shall put an end to the delegation of the power specified in that
decision. It shall take effect on the day following the publication of
the decision in the Official Journal of the European Union or at a later
date specified therein. It shall not affect the validity of any delegated
acts already in force.
4. Before adopting a delegated act, the Commission shall consult

experts designated by each Member State in accordance with the prin
ciples laid down in the Interinstitutional Agreement of 13 April 2016 on
Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify

it simultaneously to the European Parliament and to the Council.
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6. A delegated act adopted pursuant to Article 2(6), Article 9(11),
(3) and (4), Article 57(3) and Article 58(2) shall enter into force only if
no objection has been expressed either by the European Parliament or
by the Council within a period of two months of notification of that act
to the European Parliament and the Council or if, before the expiry of
that period, the European Parliament and the Council have both
informed the Commission that they will not object. That period shall
be extended by two months at the initiative of the European Parliament
or of the Council.
Article 55
Committee procedure
1. The Commission shall be assisted by a committee called the

‘Organic Production Committee’. That committee shall be a
committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regu

lation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 8 of Regu

lation (EU) No 182/2011, in conjunction with Article 5 thereof, shall
apply.
4. Where the Committee delivers no opinion, the Commission shall

not adopt the draft implementing act and the third subparagraph of
Article 5(4) of Regulation (EU) No 182/2011 shall apply.
SECTION 2
Repeal and transitional and final provisions
Article 56
Repeal
Regulation (EC) No 834/2007 is repealed.
However, that Regulation shall continue to apply for the purpose of

completing the examination of pending applications from third
countries, as provided for in Article 58 of this Regulation.
References to the repealed Regulation shall be construed as references

to this Regulation.
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Article 57
Transitional measures relating to control authorities and control
bodies recognised under Article 33(3) of Regulation (EC)
No 834/2007
1. The recognition of control authorities and control bodies granted

under Article 33(3) of Regulation (EC) No 834/2007 shall expire by
►M3 31 December 2024 ◄ at the latest.
2. The Commission shall, by means of an implementing act, establish

a list of the control authorities and control bodies recognised under
Article 33(3) of Regulation (EC) No 834/2007, and may amend that
list by means of implementing acts.


the information to be sent by the control authorities and control
bodies referred to in paragraph 2 of this Article which is necessary
for the purpose of the supervision of their recognition by the
Commission, as well as the exercise of that supervision by the
Commission, including through on-the-spot examination.
Article 58
Transitional measures relating to applications from third countries
submitted under Article 33(2) of Regulation (EC) No 834/2007
1. The Commission shall complete the examination of applications

from third countries which have been submitted under Article 33(2) of
Regulation (EC) No 834/2007 and which are pending on 17 June 2018.
That Regulation shall apply to the examination of such applications.

accordance with Article 54 supplementing this Regulation by laying
down the procedural rules necessary for the examination of the appli
cations referred to in paragraph 1 of this Article, including on the
information to be submitted by third countries.
Article 59
Transitional measures relating to the first recognition of control
authorities and control bodies
By way of derogation from the date of application referred to in the

second paragraph of Article 61, Article 46 shall apply from 17 June
2018 insofar as necessary in order to allow a timely recognition of
control authorities and control bodies.
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Article 60
Transitional measures for stocks of organic products produced in
accordance with Regulation (EC) No 834/2007
Products produced in accordance with Regulation (EC) No 834/2007

before ►M3 1 January 2022 ◄ may be placed on the market after that
date until stocks are exhausted.
Article 61
Entry into force and application
This Regulation shall enter into force on the third day following that of
its publication in the Official Journal of the European Union.
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It shall apply from 1 January 2022.
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This Regulation shall be binding in its entirety and directly applicable in
all Member States.
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ANNEX I
OTHER PRODUCTS REFERRED TO IN ARTICLE 2(1)
— Yeasts used as food or feed,
— maté, sweetcorn, vine leaves, palm hearts, hop shoots, and other similar
edible parts of plants and products produced therefrom,
— sea salt and other salts for food and feed,
— silkworm cocoon suitable for reeling,
— natural gums and resins,
— beeswax,
— essential oils,
— cork stoppers of natural cork, not agglomerated, and without any binding
substances,
— cotton, not carded or combed,
— wool, not carded or combed,
— raw hides and untreated skins,
— plant-based traditional herbal preparations.

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ANNEX II
DETAILED PRODUCTION RULES REFERRED TO IN CHAPTER III
Part I: Plant production rules

In addition to the production rules laid down in Articles 9 to 12, the rules set out
in this Part shall apply to organic plant production.
1. General requirements
1.1. Organic crops, except those which are naturally grown in water, shall
be produced in living soil, or in living soil mixed or fertilised with
materials and products allowed in organic production, in connection
with the subsoil and bedrock.
1.2. Hydroponic production, which is a method of growing plants which do

not naturally grow in water with their roots in a nutrient solution only
or in an inert medium to which a nutrient solution is added, is
prohibited.
▼M7
1.3. By way of derogation from point 1.1, the following shall be allowed:
(a) the production of sprouted seeds, which include sprouts, shoots

and cress, solely living on the nutritional reserves available in the
seeds, by moistening them in clear water, provided that the seeds
are organic. The use of growing medium shall be prohibited,
except the use of an inert medium intended solely to keep the
seeds moist when the components of that inert medium are auth
orised in compliance with Article 24;
(b) the obtaining of chicory heads, including by dipping them in clear

water, provided that the plant reproductive material is organic. The
use of a growing medium shall be allowed only when its
components are authorised in compliance with Article 24.
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1.4. By way of derogation from point 1.1, the following practices shall be
allowed:
(a) growing plants for the production of ornamentals and herbs in pots
to be sold together with the pot to the final consumer;
(b) growing seedlings or transplants in containers for further

transplanting.
1.5. By way of derogation from point 1.1, growing crops in demarcated

beds shall only be allowed for the surfaces that have been certified as
organic for that practice before 28 June 2017 in Finland, Sweden and
Denmark. No extension of those surfaces shall be permitted.
That derogation shall expire on ►M3 31 December 2031 ◄.
By ►M3 31 December 2026 ◄, the Commission shall present a

report to the European Parliament and the Council on the use of
demarcated beds in organic agriculture. That report may be accom
panied, where appropriate, by a legislative proposal on the use of
demarcated beds in organic agriculture.
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1.6. All plant production techniques used shall prevent or minimise any
contribution to the contamination of the environment.
1.7. Conversion
1.7.1. For plants and plant products to be considered as organic products, the
production rules laid down in this Regulation shall have been applied
with respect to the parcels during a conversion period of at least two
years before sowing, or, in the case of grassland or perennial forage,
during a period of at least two years before its use as organic feed, or,
in the case of perennial crops other than forage, during a period of at
least three years before the first harvest of organic products.
1.7.2. Where the land or one or more parcels thereof have been contaminated
with products or substances not authorised for use in organic
production, the competent authority may decide to extend the
conversion period for the land or parcels concerned beyond the
period referred to in point 1.7.1.
1.7.3. In the case of treatment with a product or a substance not authorised

for use in organic production, the competent authority shall require a
new conversion period in accordance with point 1.7.1.
That period may be shortened in the following two cases:
(a) treatment with a product or a substance not authorised for use in

organic production as part of a compulsory control measure for
pests or weeds, including quarantine organisms or invasive
species, imposed by the competent authority of the Member
State concerned;
(b) treatment with a product or a substance not authorised for use in

organic production as part of scientific tests approved by the
competent authority of the Member State concerned.
1.7.4. In the cases referred to in points 1.7.2 and 1.7.3, the length of the
conversion period shall be fixed taking into account the following
requirements:
(a) the process of degradation of the product or substance concerned

must guarantee, at the end of the conversion period, an insig
nificant level of residues in the soil and, in the case of a
perennial crop, in the plant;
(b) the harvest following the treatment may not be placed on the
market as organic or in-conversion products.
1.7.4.1. Member States shall inform the Commission and the other Member
States of any decision taken by them which lays down compulsory
measures related to treatment with a product or a substance not auth
orised for use in organic production.
1.7.4.2. In the case of treatment with a product or a substance which is not

authorised for use in organic production, point 1.7.5(b) shall not apply.
1.7.5. In the case of land associated with organic livestock production:
(a) the conversion rules shall apply to the whole area of the
production unit on which animal feed is produced;
(b) notwithstanding point (a), the conversion period may be reduced to

one year for pasturages and open air areas used by non-herbivore
species.
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1.8. Origin of plants including plant reproductive material
1.8.1. For the production of plants and plant products other than plant repro
ductive material, only organic plant reproductive material shall be
used.
1.8.2. To obtain organic plant reproductive material to be used for the

production of products other than plant reproductive material, the
mother plant and, where relevant, other plants intended for plant repro
ductive material production shall have been produced in accordance
with this Regulation for at least one generation, or, in the case of
perennial crops, for at least one generation during two growing
seasons.
1.8.3. When choosing organic plant reproductive material, operators shall

give preference to organic plant reproductive material suitable for
organic agriculture.
1.8.4. For the production of organic varieties suitable for organic production,
the organic breeding activities shall be conducted under organic
conditions and shall focus on enhancement of genetic diversity,
reliance on natural reproductive ability, as well as agronomic
performance, disease resistance and adaptation to diverse local soil
and climate conditions.
All multiplication practices except meristem culture shall be carried

out under certified organic management.
1.8.5. Use of in-conversion and non-organic plant reproductive material.
▼M4
1.8.5.1. ►M11 By way of derogation from point 1.8.1, where the data
collected in the database referred to in Article 26(1) or the systems
referred to in Article 26(2) show that the qualitative or quantitative
needs of the operator regarding relevant organic plant reproductive
material are not met, the operator may use in-conversion plant repro
ductive material in accordance with Article 10(4), second
subparagraph, point (a), or plant reproductive material authorised in
accordance with point 1.8.6. ◄
▼M11
In addition, in case of a lack of availability of organic seedlings, ‘in-
conversion seedlings’, marketed in compliance with Article 10(4),
second subparagraph, point (a), may be used when grown as follows:
(a) through a cultivation cycle from seeds to final seedling lasting at

least 12 months on a land parcel that, during that same period, has
completed a conversion period of at least 12 months; or
(b) on an organic or in-conversion land parcel or in containers if

covered by the derogation referred to in point 1.4, provided that
the seedlings have originated from in-conversion seeds, harvested
from a plant grown on a land parcel that has completed a
conversion period of at least 12 months.
Where organic or in-conversion plant reproductive material or plant

reproductive material authorised in accordance with point 1.8.6 is not
available in sufficient quality or quantity to fulfil the operator’s needs,
competent authorities may authorise the use of non-organic plant
reproductive material subject to points 1.8.5.3 to 1.8.5.8.
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Such individual authorisation shall be issued only in one of the
following situations:
(a) where no variety of the species that the operator wants to obtain is
registered in the database referred to in Article 26(1) or the
systems referred to in Article 26(2);
(b) where no operator who markets plant reproductive material, is able

to deliver the relevant organic or in-conversion plant reproductive
material or plant reproductive material authorised in accordance
with point 1.8.6 in time for sowing or planting in situations
where the user has ordered the plant reproductive material in
reasonable time to allow the preparation and supply of organic
or in-conversion plant reproductive material or of plant repro
ductive material authorised in accordance with point 1.8.6;
(c) where the variety that the operator wants to obtain is not registered
as organic or in-conversion plant reproductive material or as plant
reproductive material authorised in accordance with point 1.8.6 in
the database referred to in Article 26(1) or the systems referred to
Article 26(2) and the operator is able to demonstrate that none of
the registered alternatives of the same species are appropriate in
particular to the agronomic and pedo-climatic conditions and
necessary technological properties for the production to be
obtained;
(d) where it is justified for use in research, test in small-scale field

trials, for variety conservation purposes of for product innovation
and agreed by the competent authorities of the Member State
concerned.
Prior to requesting any such authorisation, operators shall consult the

database referred to in Article 26(1) or the systems referred to in
Article 26(2) in order to verify whether relevant organic or
in-conversion plant reproductive material or plant reproductive
material authorised in accordance with point 1.8.6 is available and
thus whether their request is justified.
▼M4
When in compliance with Article 6 (i) operators may use both organic
and in-conversion plant reproductive material obtained from their own
holding, irrespective of the qualitative and quantitative availability
according to the database referred to in Article 26(1) or the system
referred to in point (a) of Article 26(2).
1.8.5.2. ►M11 By way of derogation from point 1.8.1, operators in third

countries may use in-conversion plant reproductive material in
accordance with Article 10(4), second subparagraph, point (a), or
plant reproductive material authorised in accordance with point 1.8.6
when organic plant reproductive material is justified to be not available
in sufficient quality or quantity in the territory of the third country in
which the operator is located. ◄
Without prejudice to relevant national rules, operators in third

countries may use both organic and in-conversion plant reproductive
material obtained from their own holding.
▼M11
Control authorities or control bodies recognised in accordance with
Article 46(1) may authorise operators in third countries to use
non-organic plant reproductive material in an organic production
unit, when organic or in-conversion plant reproductive material or
plant reproductive material authorised in accordance with point 1.8.6
is not available in sufficient quality or quantity in the territory of the
third country in which the operator is located, under the conditions laid
down in points 1.8.5.3, 1.8.5.4, 1.8.5.5 and 1.8.5.8.
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1.8.5.3. Non-organic plant reproductive material shall not be treated after
harvest with plant protection products other than those authorised for
the treatment of plant reproductive material in accordance with
Article 24(1) of this Regulation, unless chemical treatment has been
prescribed in accordance with Regulation (EU) 2016/2031 for phytos
anitary purposes by the competent authorities of the Member State
concerned for all varieties and heterogeneous material of a given
species in the area in which the plant reproductive material is to be
used.
Where the non-organic plant reproductive material treated with the

prescribed chemical treatment referred to in the first paragraph is
used, the parcel on which the treated plant reproductive material is
growing shall be subject, where appropriate, to a conversion period as
provided in points 1.7.3 and 1.7.4.
1.8.5.4. The authorisation to use non-organic plant reproductive material shall

be obtained before the sowing or planting of the crop.
1.8.5.5. The authorisation to use non-organic plant reproductive material shall

be granted to individual users for one season at a time, and the
competent authorities, control authority or body responsible for auth
orisations shall list the quantities of the authorised plant reproductive
material.
1.8.5.6. The competent authorities of the Member States shall create an official
list of species, subspecies or varieties (grouped if applicable) for which
it is established that organic or in-conversion plant reproductive
material is available in sufficient quantities and for the appropriate
varieties in their territory. No authorisations shall be issued for the
species, subspecies or varieties included in that list in the territory of
the Member State concerned pursuant to point 1.8.5.1 unless these are
justified by one of the purposes referred to in point 1.8.5.1(d). If the
quantity or quality of organic or in-conversion plant reproductive
material available for a species, subspecies or variety on the list
turns out to be insufficient or inappropriate, due to exceptional circum
stances, the competent authorities of the Member States may remove a
species, subspecies or variety from the list.
The competent authorities of the Member States shall keep their list
updated on an annual basis and shall make that list publicly available.
By 30 June each year and for the first time by 30 June 2022, the
competent authorities of the Member States shall transmit to the
Commission and to the other Member States the link to the internet
website where the updated list is made publicly available. The
Commission shall publish the links to the national updated lists on a
dedicated website.
1.8.5.7. By way of derogation from point 1.8.5.5, the competent authorities of

the Member States may annually grant a general authorisation to all
operators concerned for the use of:
(a) a given species or subspecies when and in so far as no variety is

registered in the database referred to in Article 26(1) or the system
referred to in point (a) of Article 26(2);
(b) for a given variety when and in so far as the conditions laid down
in point 1.8.5.1(c) are fulfilled.
When using a general authorisation, operators shall keep records of the

quantity used and competent authority responsible for authorisations shall
list the quantities of authorised non-organic plant reproductive material.
The competent authorities of the Member States shall keep the list of
species, subspecies or varieties for which a general authorisation is
issued updated on an annual basis and shall make that list publicly
available.
By 30 June each year and for the first time by 30 June 2022, the
competent authorities of the Member States shall transmit to the
Commission and to the other Member States the link to the internet
website where the updated list is made publicly available. The
Commission shall publish the links to the national updated lists on a
dedicated website.
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1.8.5.8. Competent authorities shall not authorise the use of non-organic
seedlings in the case of seedlings of species that have a cultivation
cycle completed in one growing season, from the transplantation of the
seedling to the first harvest of product.
1.8.6. Competent authorities or, where appropriate, control authorities or

control bodies recognised in accordance with Article 46(1) may
authorise operators producing plant reproductive material for use in
organic production to use non-organic plant reproductive material,
when mother plants or, where relevant, other plants intended for the
production of plant reproductive material and produced in compliance
with point 1.8.2 are not available in sufficient quantity or quality, and
to place such material on the market for use in organic production
provided that the following conditions are met:
(a) the non-organic plant reproductive material used has not been
treated after harvest with plant protection products other than
those authorised in accordance with Article 24(1) of this Regu
lation, unless chemical treatment has been prescribed in
accordance with Regulation (EU) 2016/2031 for phytosanitary
purposes by the competent authorities of the Member State
concerned for all varieties and heterogeneous material of a given
species in the area in which the plant reproductive material is to be
used. Where non-organic plant reproductive material treated with
such prescribed chemical treatment is used, the land parcel on
which the treated plant reproductive material is growing shall be
subject, where appropriate, to a conversion period as provided in
points 1.7.3 and 1.7.4;
(b) the non-organic plant reproductive material used is not a seedling

of species that have a cultivation cycle completed in one growing
season, from the transplantation of the seedling to the first harvest
of product;
(c) the plant reproductive material is grown in compliance with all

other relevant organic plant production requirements;
(d) the authorisation to use non-organic plant reproductive material

shall be obtained before that material is sown or planted;
(e) the competent authority, control authority or control body

responsible for the authorisation shall grant the authorisation
only to individual users and for one season at a time, and shall
list the quantities of the authorised plant reproductive material;
(f) by way of derogation from point (e), the competent authorities of

the Member States may annually grant a general authorisation for
the use of a given species or subspecies or variety of non-organic
plant reproductive material and make the list of species, subspecies
or varieties publicly available and keep it updated on an annual
basis. In that case, those competent authorities shall list the
quantities of authorised non-organic plant reproductive material;
(g) the authorisations granted in accordance with this paragraph shall

expire on 31 December 2036.
By 30 June of each year, and for the first time by 30 June 2023, the
competent authorities of the Member States shall notify the
Commission and the other Member States of the information on the
authorisations granted in accordance with the first paragraph.
Operators who produce and market the plant reproductive material

produced in accordance with the first paragraph shall be allowed to
make public, on a voluntary basis, the relevant specific information on
the availability of such plant reproductive material in the national
systems established in accordance with Article 26(2). Operators that
opt to include such information shall ensure that the information is
updated regularly, and is withdrawn from the national systems once
the plant reproductive material is no longer available. When relying on
the general authorisation referred to in point (f), operators shall keep
records of the quantity used.
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1.9. Soil management and fertilisation
1.9.1. In organic plant production, tillage and cultivation practices shall be
used that maintain or increase soil organic matter, enhance soil
stability and soil biodiversity, and prevent soil compaction and soil
erosion.
1.9.2. The fertility and biological activity of the soil shall be maintained and
increased:
(a) except in the case of grassland or perennial forage, by the use of

multiannual crop rotation including mandatory leguminous crops
as the main or cover crop for rotating crops and other green
manure crops;
(b) in the case of greenhouses or perennial crops other than forage, by

the use of short-term green manure crops and legumes as well as
the use of plant diversity; and
(c) in all cases, by the application of livestock manure or organic

matter, both preferably composted, from organic production.
1.9.3. Where the nutritional needs of plants cannot be met by the measures
provided for in points 1.9.1 and 1.9.2, only fertilisers and soil condi
tioners that have been authorised pursuant to Article 24 for use in
organic production shall be used, and only to the extent necessary.
►M9 Operators shall keep records of the use of those products,
including the date or dates on which each product was used, the
name of the product, the amount applied and the crop and parcels
concerned. ◄
1.9.4. The total amount of livestock manure, as defined in Directive

91/676/EEC, used in the in-conversion and organic production units
shall not exceed 170 kg of nitrogen per year/hectare of agricultural
area used. That limit shall only apply to the use of farmyard manure,
dried farmyard manure and dehydrated poultry manure, composted
animal excrement, including poultry manure, composted farmyard
manure and liquid animal excrement.
1.9.5. Operators of agricultural holdings may establish written cooperation

agreements exclusively with operators of other agricultural holdings
and undertakings which comply with the organic production rules, for
the purpose of spreading surplus manure from organic production
units. The maximum limit referred to in point 1.9.4 shall be calculated
on the basis of all of the organic production units involved in such
cooperation.
1.9.6. Preparations of micro-organisms may be used to improve the overall

condition of the soil or to improve the availability of nutrients in the
soil or in the crops.
1.9.7. For compost activation, appropriate plant-based preparations and prep

arations of micro-organisms may be used.
1.9.8. Mineral nitrogen fertilisers shall not be used.
1.9.9. Biodynamic preparations may be used.

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1.10. Pest and weed management
1.10.1. The prevention of damage caused by pests and weeds shall rely
primarily on the protection by:
— natural enemies,
— the choice of species, varieties and heterogeneous material,
— crop rotation,
— cultivation techniques such as biofumigation, mechanical and

physical methods, and
— thermal processes such as solarisation and, in the case of protected

crops, shallow steam treatment of the soil (to a maximum depth of
10 cm).
1.10.2. Where plants cannot adequately be protected from pests by measures

provided for in point 1.10.1 or in the case of an established threat to a
crop, only products and substances authorised pursuant to Articles 9
and 24 for use in organic production shall be used, and only to the
extent necessary. ►M9 Operators shall keep records proving the need
for the use of such products, including the date or dates on which each
product was used, the name of the product, its active substances, the
amount applied, the crop and parcels concerned, and the pest or
disease to be controlled. ◄
1.10.3. In relation to products and substances used in traps or in dispensers of

products and substances other than pheromones, the traps or dispensers
shall prevent the products and substances from being released into the
environment and shall prevent contact between the products and
substances and the crops being cultivated. All traps, including
pheromone traps, shall be collected after use and shall be safely
disposed of.
1.11. Products used for cleaning and disinfection

Only those products for cleaning and disinfection in plant production
authorised pursuant to Article 24 for use in organic production shall be
used for that purpose. ►M9 Operators shall keep records of the use of
those products including the date or dates on which each product was
used, the name of the product, its active substances, and the location
of such use. ◄
1.12. Record-keeping obligation

Operators shall keep records regarding the parcels concerned and the
amount of the harvest. ►M9 In particular, operators shall keep
records of any other external input used on each parcel and, where
applicable, keep available documentary evidence on any derogation
from production rules obtained in accordance with point 1.8.5. ◄
1.13. Preparation of unprocessed products

If preparation operations other than processing are carried out on
plants, the general requirements laid down in points 1.2, 1.3, 1.4,
1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such
operations.
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2. Detailed rules for specific plants and plant products
2.1. Rules on mushroom production
For the production of mushrooms, substrates may be used if they are

composed only of the following components:
(a) farmyard manure and animal excrement:
(i) either from organic production units or from in-conversion

units in their second year of conversion; or
(ii) referred to in point 1.9.3, only when the product referred to in

point (i) is not available, provided that that farmyard manure
and animal excrement do not exceed 25 % of the weight of
total components of the substrate, excluding the covering
material and any added water, before composting;
(b) products of agricultural origin, other than those referred to in

point (a), from organic production units;
(c) peat, not treated with chemical products;
(d) wood, not treated with chemical products after felling;
(e) mineral products referred to in point 1.9.3, water and soil.
2.2. Rules concerning the collection of wild plants
The collection of wild plants and parts thereof growing naturally in

natural areas, forests and agricultural areas is considered as organic
production, provided that:
(a) for a period of at least three years before the collection, those areas
were not treated with products or substances other than those
authorised pursuant to Articles 9 and 24 for use in organic
production;
(b) the collection does not affect the stability of the natural habitat or
the maintenance of the species in the collection area.
▼M9
Operators shall keep records of the period and location of the
collection, the species concerned and the quantity of wild plants
collected.
▼B
Part II: Livestock production rules
In addition to the production rules laid down in Articles 9, 10, 11 and 14, the
rules laid down in this Part shall apply to organic livestock production.
1.1. Except in the case of beekeeping, landless livestock production, where
the farmer intending to produce organic livestock does not manage
agricultural land and has not established a written cooperation
agreement with a farmer as regards the use of organic production
units or in-conversion production units for that livestock, shall be
prohibited.
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Operators shall keep available documentary evidence on any dero
gation from livestock production rules obtained in accordance with
points 1.3.4.3, 1.3.4.4, 1.7.5, 1.7.8, 1.9.3.1(c) and 1.9.4.2(c).
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1.2. Conversion
1.2.1. In the case of simultaneous start of conversion of the production unit,
including pasturage or any land used for animal feed, and of the
animals existing on this production unit at the beginning of the
conversion period of this production unit as referred to in points
1.7.1 and 1.7.5(b) of Part I, animals and animal products may be
considered organic at the end of the conversion period of the
production unit, even if the conversion period laid down in
point 1.2.2 of this Part for the type of animal concerned is longer
than the conversion period for the production unit.
By derogation from point 1.4.3.1, in the case of such simultaneous

conversion and during the conversion period of the production unit,
animals present in this production unit since the beginning of the
conversion period may be fed with in-conversion feed produced on
the in-conversion production unit during the first year of conversion
and/or with feed in accordance with point 1.4.3.1 and/or with organic
feed.
Non-organic animals may be introduced into an in-conversion

production unit after the start of the conversion period in accordance
with point 1.3.4.
1.2.2. Conversion periods specific to the type of animal production are set
out as follows:
(a) 12 months in the case of bovine animals and equine animals for
meat production, and in any case no less than three quarters of
their lifetime;
(b) six months in the case of ovine animals, caprine animals and
porcine animals and animals for milk production;
(c) 10 weeks for poultry for meat production, except for Peking
ducks, brought in before they are three days old;
(d) seven weeks for Peking ducks brought in before they are three
days old;
(e) six weeks in the case of poultry for egg production brought in
before they are three days old;
(f) 12 months for bees.
During the conversion period, the wax shall be replaced with wax
coming from organic beekeeping.
However, non-organic beeswax may be used:
(i) where beeswax from organic beekeeping is not available on

the market;
(ii) where it is proven free of contamination with products or

substances not authorised for use in organic production; and
(iii) provided that it comes from the cap;

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(g) three months for rabbits;
(h) 12 months for cervine animals.
1.3. Origin of animals

1.3.1. Without prejudice to the rules on conversion, organic livestock shall
be born or hatched and raised on organic production units.
1.3.2. With regard to the breeding of organic animals:
(a) reproduction shall use natural methods; however, artificial insemi

nation shall be allowed;
(b) reproduction shall not be induced or impeded by treatment with

hormones or other substances with a similar effect, except as a
form of veterinary therapeutic treatment in the case of an indi
vidual animal;
(c) other forms of artificial reproduction, such as cloning and embryo

transfer, shall not be used;
(d) the choice of breeds shall be appropriate to the principles of

organic production, shall ensure a high standard of animal
welfare and shall contribute to the prevention of any suffering
and to avoiding the need for the mutilation of animals.
1.3.3. When choosing breeds or strains, operators shall consider giving pref
erence to breeds or strains with a high degree of genetic diversity, the
capacity of animals to adapt to local conditions, their breeding value,
their longevity, their vitality and their resistance to disease or health
problems, all without impairment of their welfare. In addition, breeds
or strains of animals shall be selected to avoid specific diseases or
health problems associated with some breeds or strains used in
intensive production, such as porcine stress syndrome, possibly
leading to pale-soft-exudative (PSE) meat, sudden death, spontaneous
abortion and difficult births requiring caesarean operations. Preference
shall be given to indigenous breeds and strains.
To choose the breeds and strains in accordance with the first

paragraph, operators shall use the information available in the
systems referred to in Article 26(3).
1.3.4. Use of non-organic animals

1.3.4.1. By way of derogation from point 1.3.1, for breeding purposes,
non-organically raised animals may be brought to an organic
production unit when breeds are in danger of being lost to farming
as referred to in point (b) of Article 28(10) of Regulation (EU)
No 1305/2013 and acts adopted on the basis thereof. In such case,
the animals of those breeds need not necessarily be nulliparous.
1.3.4.2. By way of derogation from point 1.3.1, for the renovation of apiaries,
20 % per year of the queen bees and swarms may be replaced by
non-organic queen bees and swarms in the organic production unit,
provided that the queen bees and swarms are placed in hives with
combs or comb foundations coming from organic production units.
In any case, one swarm or queen bee may be replaced per year by
a non-organic swarm or a queen bee.
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1.3.4.3. By way of derogation from point 1.3.1, where a flock is constituted for
the first time, or is renewed or reconstituted, and where the qualitative
and quantitative needs of farmers cannot be met, the competent
authority may decide that non-organically reared poultry may be
brought into an organic poultry production unit, provided that the
pullets for the production of eggs and poultry for meat production
are less than three days old. Products derived from them may only
be considered as organic if the conversion period specified in point 1.2
has been complied with.
1.3.4.4. By way of derogation from point 1.3.1, where the data collected in the
system referred to in point (b) of Article 26(2) shows that the quali
tative or quantitative needs of the farmer regarding organic animals are
not met, competent authorities may authorise the introduction of
non-organic animals into an organic production unit, subject to the
conditions provided for in points 1.3.4.4.1 to 1.3.4.4.4.
Prior to requesting any such derogation, the farmer shall consult the
data collected in the system referred to in point (b) of Article 26(2) in
order to verify whether his or her request is justified.
For operators in third countries, control authorities and control bodies

recognised in accordance with Article 46(1) may authorise the intro
duction of non-organic animals into an organic production unit where
organic animals are not available in sufficient quality or quantity in the
territory of the country where the operator is located.
1.3.4.4.1. For breeding purposes, non-organic young animals may be introduced

when a herd or flock is constituted for the first time. They shall be
reared in accordance with the organic production rules immediately
after they are weaned. In addition, the following restrictions shall
apply on the date on which those animals enter the herd or flock:
(a) bovine animals, equine animals and cervine animals shall be less
than six months old;
(b) ovine animals and caprine animals shall be less than 60 days old;
(c) porcine animals shall weigh less than 35 kg;
(d) rabbits shall be less than three months old.
1.3.4.4.2. For breeding purposes, non-organic adult male and non-organic nulli
parous female animals may be introduced for the renewal of a herd or
flock. They shall be reared subsequently in accordance with the
organic production rules. In addition, the number of female animals
shall be subject to the following restrictions per year:
(a) up to a maximum of 10 % of adult equine animals or bovine

animals and 20 % of the adult porcine animals, ovine animals,
caprine animals, rabbits or cervine animals may be introduced;
(b) for units with fewer than 10 equine animals, cervine animals or
bovine animals or rabbits, or with fewer than five porcine animals,
ovine animals or caprine animals, any such renewal shall be
limited to a maximum of one animal per year.
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1.3.4.4.3. The percentages set in point 1.3.4.4.2 may be increased up to 40 %,
provided that the competent authority has confirmed that any of
following conditions is fulfilled:
(a) a major extension to the farm has been undertaken;
(b) one breed has been replaced with another;
(c) a new livestock specialisation has been initiated.
1.3.4.4.4. In the cases referred to in points 1.3.4.4.1, 1.3.4.4.2 and 1.3.4.4.3,

non-organic animals may only be considered as organic if the
conversion period specified in point 1.2 has been complied with.
The conversion period laid down in point 1.2.2 shall start, at the
earliest, once the animals are introduced into the in-conversion
production unit.
1.3.4.4.5. In the cases referred to in points 1.3.4.4.1 to 1.3.4.4.4, non-organic

animals shall either be kept separate from other livestock or shall be
kept identifiable until the end of the conversion period referred to in
point 1.3.4.4.4.
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1.3.4.5. Operators shall keep records or documentary evidence of the origin of
animals, identifying the animals in accordance with appropriate
systems (per animal or by batch/flock/hive), of the veterinary
records of the animals introduced in the holding, the date of arrival,
and the conversion period.
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1.4. Nutrition
1.4.1. General nutrition requirements
With regard to nutrition, the following rules shall apply:
(a) feed for livestock shall be obtained primarily from the agricultural
holding where the animals are kept or shall be obtained from
organic or in-conversion production units belonging to other
holdings in the same region;
(b) livestock shall be fed with organic or in-conversion feed that meets
the animal’s nutritional requirements at the various stages of its
development; restricted feeding shall not be permitted in livestock
production unless justified for veterinary reasons;
(c) livestock shall not be kept in conditions or on a diet which may

encourage anaemia;
(d) fattening practices shall always respect the normal nutritional

patterns for each species and the animals’ welfare at each stage
of the rearing process; force-feeding is forbidden;
(e) with the exception of porcine animals, poultry and bees, livestock
shall have permanent access to pasture whenever conditions allow
or shall have permanent access to roughage;
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(f) growth promoters and synthetic amino-acids shall not be used;
(g) suckling animals shall preferably be fed on maternal milk for a

minimum period laid down by the Commission in accordance with
point (a) of Article 14(3); milk replacers containing chemically
synthesised components or components of plant origin shall not
be used during that period;
(h) feed materials of plant, algal, animal or yeast origin shall be

organic;
(i) non-organic feed materials of plant, algal, animal or yeast origin,

feed materials of microbial or of mineral origin, feed additives and
processing aids may be used only if they have been authorised
pursuant to Article 24 for use in organic production.
1.4.2. Grazing
1.4.2.1. Grazing on organic land
Without prejudice to point 1.4.2.2, organic animals shall graze on
organic land. However, non-organic animals may use organic
pasturage for a limited period each year, provided that they have
been raised in an environmental friendly way on land supported
under Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU)
No 1305/2013 and that they are not present on the organic land at
the same time as organic animals.
1.4.2.2. Grazing on common land and transhumance

1.4.2.2.1. Organic animals may graze on common land, provided that:
(a) the common land has not been treated with products or substances
not authorised for use in organic production for at least three
years;
(b) any non-organic animals which use the common land have been
raised in an environmental friendly way on land supported under
Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU)
No 1305/2013;
(c) any livestock products from organic animals that were produced
during the period when those animals grazed on common land are
not considered as organic products unless adequate segregation
from non-organic animals can be proved.
1.4.2.2.2. During the period of transhumance, organic animals may graze on

non-organic land when they are being moved on foot from one
grazing area to another. During that period, organic animals shall be
kept separate from other animals. The uptake of non-organic feed, in
the form of grass and other vegetation on which the animals graze,
shall be allowed:
(a) for a maximum of 35 days covering both the outward and return
journeys; or
(b) for a maximum of 10 % of the total feed ration per year,

calculated as a percentage of the dry matter of feedstuffs of agri
cultural origin.
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1.4.3. In-conversion feed
1.4.3.1. For agricultural holdings that produce organic livestock:
(a) up to 25 % on average of the feed formula of rations may
comprise in-conversion feed from the second year of conversion.
This percentage may be increased to 100 % if this in-conversion
feed comes from the holding where the livestock is kept; and
(b) up to 20 % of the total average amount of feed fed to livestock

may originate from the grazing or harvesting of permanent
pastures, perennial forage parcels or protein crops sown under
organic management on lands in their first year of conversion,
provided that those lands are part of the holding itself.
When both types of in-conversion feed referred to in points (a) and (b)
are being used for feeding, the total combined percentage of such feed
shall not exceed the percentage fixed in point (a).
1.4.3.2. The figures in point 1.4.3.1 shall be calculated annually as a

percentage of the dry matter of feed of plant origin.
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1.4.4. Record-keeping of the feeding regime
Operators shall keep records of the feeding regime and, where
relevant, the grazing period. In particular, they shall keep records of
the name of the feed, including any form of feed used e.g. compound
feed, proportions of various feed materials of rations and proportion of
feed from their own holding or the same region and, where relevant,
periods of access to grazing areas, periods of transhumance where
restrictions apply and documentary evidence of the application of
points 1.4.2 and 1.4.3.
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1.5. Health care
1.5.1. Disease prevention
1.5.1.1. Disease prevention shall be based on breed and strain selection,
husbandry management practices, high-quality feed, exercise, appro
priate stocking density and adequate and appropriate housing main
tained in hygienic conditions.
1.5.1.2. Immunological veterinary medicinal products may be used.
1.5.1.3. Chemically synthesised allopathic veterinary medicinal products,

including antibiotics and boluses of synthesised allopathic chemical
molecules, shall not be used for preventive treatment.
1.5.1.4. Substances to promote growth or production (including antibiotics,

coccidiostatics and other artificial aids for growth promotion
purposes) and hormones and similar substances for the purpose of
controlling reproduction or for other purposes (e.g. induction or
synchronisation of oestrus) shall not be used.
1.5.1.5. Where livestock is obtained from non-organic production units, special

measures such as screening tests or quarantine periods shall apply,
depending on local circumstances.
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1.5.1.6. Only the products for cleaning and disinfection in livestock buildings
and installations authorised pursuant to Article 24 for use in organic
production shall be used for that purpose. ►M9 Operators shall keep
records of the use of those products including the date or dates on
which the product was used, the name of the product, its active
substances, and the location of such use. ◄
1.5.1.7. Housing, pens, equipment and utensils shall be properly cleaned and
disinfected to prevent cross-infection and the build-up of disease
carrying organisms. Faeces, urine and uneaten or spilt feed shall be
removed as often as necessary to minimise smell and to avoid
attracting insects or rodents. Rodenticides, to be used only in traps,
and products and substances authorised pursuant to Articles 9 and 24
for use in organic production may be used for the elimination of
insects and other pests in buildings and other installations where
livestock are kept.
1.5.2. Veterinary treatment

1.5.2.1. Where animals become sick or injured despite preventive measures to
ensure animal health, they shall be treated immediately.
1.5.2.2. Disease shall be treated immediately to avoid suffering of the animal.

Chemically synthesised allopathic veterinary medicinal products,
including antibiotics, may be used where necessary, under strict
conditions and under the responsibility of a veterinarian, when the
use of phytotherapeutic, homeopathic and other products is inappro
priate. In particular, restrictions with respect to courses of treatment
and withdrawal periods shall be defined.
1.5.2.3. Feed materials of mineral origin authorised pursuant to Article 24 for

use in organic production, nutritional additives authorised pursuant to
Article 24 for use in organic production, and phytotherapeutic and
homeopathic products shall be used in preference to treatment with
chemically synthesised allopathic veterinary medicinal products,
including antibiotics, provided that their therapeutic effect is
effective for the species of animal and for the condition for which
the treatment is intended.
1.5.2.4. With the exception of vaccinations, treatments for parasites and

compulsory eradication schemes, where an animal or a group of
animals receives more than three courses of treatments with chemically
synthesised allopathic veterinary medicinal products, including anti
biotics, within 12 months, or more than one course of treatment if
their productive lifecycle is less than one year, neither the livestock
concerned nor produce derived from such livestock shall be sold as
organic products, and the livestock shall be subject to the conversion
periods referred to in point 1.2.
1.5.2.5. The withdrawal period between the last administration to an animal of

a chemically synthesised allopathic veterinary medicinal product,
including of an antibiotic, under normal conditions of use, and the
production of organically produced foodstuffs from that animal shall
be twice the withdrawal period referred to in Article 11 of Directive
2001/82/EC, and shall be at least 48 hours.
1.5.2.6. Treatments related to the protection of human and animal health

imposed on the basis of Union legislation shall be allowed.
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1.5.2.7. Operators shall keep records or documentary evidence of any treatment
applied and, in particular, the identification of the animals treated, the
date of treatment, diagnosis, the posology, the name of the treatment
product and, where applicable, the veterinary prescription for
veterinary care, and the withdrawal period applied before livestock
products can be marketed and labelled as organic.
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1.6. Housing and husbandry practices
1.6.1. Insulation, heating and ventilation of the building shall ensure that air
circulation, dust level, temperature, relative air humidity and gas
concentration are kept within limits which ensure the well-being of
the animals. The building shall permit plentiful natural ventilation and
light to enter.
1.6.2. Housing for livestock shall not be mandatory in areas with appropriate
climatic conditions enabling animals to live outdoors. In such cases,
animals shall have access to shelters or shady areas to protect them
from adverse weather conditions.
1.6.3. The stocking density in buildings shall provide for the comfort,
well-being and species-specific needs of the animals, and shall
depend in particular on the species, the breed and the age of the
animals. It shall also take account of the behavioural needs of the
animals, which depend in particular on the size of the group and the
animals’ sex. The density shall ensure the animals’ welfare by
providing them with sufficient space to stand naturally, to move, to
lie down easily, to turn round, to groom themselves, to assume all
natural postures and to make all natural movements, such as stretching
and wing flapping.
1.6.4. The minimum surface for indoor and outdoor areas, and the technical
details relating to housing, laid down in the implementing acts referred
to in Article 14(3), shall be complied with.
1.6.5. Open air areas may be partially covered. Verandas shall not be
considered as open air areas.
1.6.6. The total stocking density shall not exceed the limit of 170 kg of
organic nitrogen per year and hectare of agricultural area.
1.6.7. To determine the appropriate density of livestock referred to in

point 1.6.6, the competent authority shall set out the livestock units
equivalent to the limit referred to in point 1.6.6, following the figures
laid down in each of the specific requirements per type of animal
production.
1.6.8. Cages, boxes and flat decks to raise livestock shall not be used for any
livestock species.
1.6.9. When livestock is treated individually for veterinary reasons, it shall

be kept in spaces that have a solid floor and shall be provided with
straw or appropriate bedding. The animal must be able to turn around
easily and to lie down comfortably at full length.
1.6.10. Organic livestock may not be reared in a pen on very wet or marshy
soil.
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1.7. Animal welfare
1.7.1. All persons involved in keeping animals and in handling animals
during transport and slaughter shall possess the necessary basic
knowledge and skills as regards the health and the welfare needs of
the animals and shall have followed adequate training, as required in
particular in Council Regulation (EC) No 1/2005 (1) and Council
Regulation No (EC) 1099/2009 (2), to ensure proper application of
the rules set out in this Regulation.
1.7.2. Husbandry practices, including stocking densities and housing

conditions, shall ensure that the developmental, physiological and
ethological needs of the animals are met.
1.7.3. Livestock shall have permanent access to open air areas that allow the
animals to exercise, preferably pasture, whenever weather and seasonal
conditions and the state of the ground allow, except where restrictions
and obligations related to the protection of human and animal health
have been imposed on the basis of Union legislation.
1.7.4. The number of livestock shall be limited with a view to minimising

overgrazing, poaching of soil, erosion, and pollution caused by
animals or by the spreading of their manure.
1.7.5. Tethering or isolation of livestock shall be prohibited, except in

relation to individual animals for a limited period and insofar as this
is justified for veterinary reasons. The isolation of livestock may only
be authorised, and only for a limited period, where workers’ safety is
compromised or for animal welfare reasons. Competent authorities
may authorise the tethering of cattle in farms with a maximum of
50 animals (excluding young stock) where it is not possible to keep
the cattle in groups appropriate to their behaviour requirements,
provided they have access to pastures during the grazing period, and
have access to open air areas at least twice a week when grazing is not
possible.
1.7.6. Duration of transport of livestock shall be minimised.
1.7.7. Any suffering, pain and distress shall be avoided and shall be kept to a
minimum during the entire life of the animal, including at the time of
slaughter.
1.7.8. Without prejudice to developments in Union legislation on animal

welfare, tail-docking of sheep, beak trimming undertaken in the first
three days of life, and dehorning may exceptionally be allowed, but
only on a case-by-case basis and only when those practices improve
the health, welfare or hygiene of the livestock or where workers’
safety would otherwise be compromised. Disbudding may be
allowed only on a case by case basis when it improves the health,
welfare or hygiene of the livestock or where workers’ safety would
otherwise be compromised. The competent authority shall only
authorise such operations where the operator has duly notified and
justified the operations to that competent authority and where the
operation is to be carried out by qualified personnel.
(1) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals
during transport and related operations and amending Directives 64/432/EEC and
93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).
(2) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of
animals at the time of killing (OJ L 303, 18.11.2009, p. 1).
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1.7.9. Any suffering to the animals shall be reduced to a minimum by
applying adequate anaesthesia and/or analgesia and by carrying out
each operation at only the most appropriate age by qualified personnel.
1.7.10. Physical castration shall be allowed in order to maintain the quality of

products and traditional production practices, but only under the
conditions set out in point 1.7.9.
1.7.11. The loading and unloading of animals shall be carried out without the
use of any type of electrical or other painful stimulation to coerce the
animals. The use of allopathic tranquillisers, prior to or during
transport, shall be prohibited.
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1.7.12. Operators shall keep records or documentary evidence of any specific
operation applied and justifications for the application of point 1.7.5,
1.7.8, 1.7.9 or 1.7.10. As regards animals leaving the holding, the
following data shall be recorded, where relevant: age, number of
animals, weight of slaughter animals, appropriate identification (per
animal or by batch/flock/hive) date of departure and destination.
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If preparation operations other than processing are carried out on
livestock, the general requirements laid down in points 1.2, 1.3, 1.4,
1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such
operations.
1.9. Additional general rules

1.9.1. For bovine animals, ovine animals, caprine animals and equine
animals
1.9.1.1. Nutrition
(a) at least 60 % of the feed shall come from the farm itself or, if this
is not feasible or such feed is not available, shall be produced
in cooperation with other organic or in-conversion production
units and feed operators using feed and feed material from the
same region. This percentage shall be raised to 70 % as from
►M3 1 January 2024 ◄;
(b) animals shall have access to pasturage for grazing whenever

conditions allow;
(c) notwithstanding point (b), male bovine animals over one year old
shall have access to pasturage or an open air area;
(d) where animals have access to pasturage during the grazing period
and where the winter housing system allows the animals to move
freely, the obligation to provide open air areas during the winter
months may be waived;
(e) rearing systems shall be based on maximum use of grazing

pasturage, by reference to the availability of pastures in the
different periods of the year;
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(f) at least 60 % of the dry matter in daily rations shall consist of
roughage, fresh or dried fodder, or silage. This percentage may be
reduced to 50 % for animals in dairy production for a maximum
period of three months in early lactation.
1.9.1.2. Housing and husbandry practices
With regard to housing and husbandry practices, the following rules

shall apply:
(a) housing shall have smooth, but not slippery floors;
(b) housing shall be provided with a comfortable, clean and dry laying
or rest area of sufficient size, which shall consist of a solid
construction which is not slatted. Ample dry bedding strewn
with litter material shall be provided in the rest area. The litter
shall comprise straw or other suitable natural material. The litter
may be improved and enriched with any mineral product that is
authorised pursuant to Article 24 as a fertiliser or soil conditioner
for use in organic production;
(c) notwithstanding point (a) of the first subparagraph of Article 3(1)

and the second subparagraph of Article 3(1) of Council Directive
2008/119/EC (1), the housing of calves in individual boxes shall be
forbidden after the age of one week, unless for individual animals
for a limited period, and insofar as this is justified for veterinary
reasons;
(d) when a calf is treated individually for veterinary reasons, it shall

be kept in spaces that have a solid floor and shall be provided with
straw bedding. The calf must be able to turn around easily and to
lie down comfortably at full length.
1.9.2. For cervine animals

1.9.2.1. Nutrition
is not feasible or such feed is not available, shall be produced
in cooperation with other organic or in-conversion production
units and feed operators using feed and feed material from the
same region. This percentage shall be raised to 70 % as from
►M3 1 January 2024 ◄;
(b) animals shall have access to pasturage for grazing whenever

conditions allow;
(c) where animals have access to pasturage during the grazing period
and where the winter housing system allows the animals to move
freely, the obligation to provide open air areas during the winter
months may be waived;
(d) rearing systems shall be based on maximum use of grazing

pasturage by reference to the availability of pastures in the
(1) Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards
for the protection of calves (OJ L 10, 15.1.2009, p. 7).
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(e) at least 60 % of the dry matter in daily rations shall consist of
roughage, fresh or dried fodder, or silage. This percentage may be
reduced to 50 % for female cervine animals in milk production for
a maximum period of three months in early lactation;
(f) natural grazing shall be ensured in a pen during the period of

vegetation. Pens that cannot provide feed by grazing during the
period of vegetation shall not be allowed;
(g) feeding shall only be allowed in the event of a shortage of grazing

due to poor weather conditions;
(h) farmed animals in a pen shall be provided with clean and fresh
water. If a natural source of water that is easily accessible to
animals is not available, watering places shall be provided.

shall apply:
(a) cervine animals shall be provided with hiding places, shelters and
fences that do not harm animals;
(b) in red deer pens, animals must be able to roll in the mud to ensure
skin grooming and body temperature regulation;
(c) any housing shall have smooth, but not slippery floors;
(d) any housing shall be provided with a comfortable, clean and dry
laying or rest area of sufficient size, consisting of a solid
may be improved and enriched with any mineral product auth
orised pursuant to Article 24 as a fertiliser or soil conditioner
(e) feeding places shall be installed in areas protected from the

weather and accessible both to animals and to persons attending
to them. The soil where feeding places are located shall be
consolidated, and the feeding apparatus shall be equipped with a
roof;
(f) if permanent access to feed cannot be ensured, the feeding places

shall be designed so that all animals can feed at the same time.
1.9.3. For porcine animals

1.9.3.1. Nutrition
is not feasible or such feed is not available, shall be produced in
cooperation with other organic or in-conversion production units
and feed operators using feed and feed material from the same
region;
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(b) roughage, fresh or dried fodder, or silage shall be added to the
daily ration;
(c) where farmers are unable to obtain protein feed exclusively from
organic production, and the competent authority has confirmed
that organic protein feed is not available in sufficient quantity,
non-organic protein feed may be used until ►M3 31 December
2026 ◄ provided that the following conditions are fulfilled:
(i) it is not available in organic form;
(ii) it is produced or prepared without chemical solvents;
(iii) its use is limited to the feeding of piglets of up to 35 kg with

specific protein compounds; and
(iv) the maximum percentage authorised per period of 12 months

for those animals does not exceed 5 %. The percentage of the
dry matter of feed from agricultural origin shall be calculated.

shall apply:
(a) the housing shall have smooth, but not slippery floors;
(b) the housing shall be provided with a comfortable, clean and dry
laying or rest area of sufficient size, consisting of a solid
may be improved and enriched with any mineral product auth
orised pursuant to Article 24 as a fertiliser or soil conditioner
(c) there shall always be a bed made of straw or other suitable

material large enough to ensure that all pigs in a pen can lie
down at the same time in the most space-consuming way;
(d) sows shall be kept in groups, except in the last stages of

pregnancy and during the suckling period, during which time the
sow must be able to move freely in her pen and her movement
shall only be restricted for short periods;
(e) without prejudice to any additional requirements for straw, a few

days before expected farrowing, sows shall be provided with a
quantity of straw or other suitable natural material sufficient to
enable them to build nests;
(f) exercise areas shall permit dunging and rooting by porcine

animals. For the purposes of rooting, different substrates may be
used.
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1.9.4. For poultry
1.9.4.1. Origin of animals
To prevent the use of intensive rearing methods, poultry shall either be

reared until they reach a minimum age or else shall come from
slow-growing poultry strains adapted to outdoor rearing.
The competent authority shall define the criteria of slow-growing

strains or draw up a list of those strains and provide this information
to operators, other Member States and the Commission.
Where slow-growing poultry strains are not used by the farmer, the
minimum age at slaughter shall be as follows:
(a) 81 days for chickens;
(b) 150 days for capons;
(c) 49 days for Peking ducks;
(d) 70 days for female Muscovy ducks;
(e) 84 days for male Muscovy ducks;
▼C2
(f) 92 days for Mulard ducks;
▼B
(g) 94 days for guinea fowl;
(h) 140 days for male turkeys and roasting geese; and
(i) 100 days for female turkeys.
1.9.4.2. Nutrition
is not feasible or such feed is not available, be produced in co
operation with other organic or in-conversion production units and
feed operators using feed and feed material from the same region;
(b) roughage, fresh or dried fodder, or silage shall be added to the

daily ration;
(c) where farmers are unable to obtain protein feed exclusively from
organic production for poultry species, and the competent
authority has confirmed that organic protein feed is not available
in sufficient quantity, non-organic protein feed may be used until
►M3 31 December 2026 ◄, provided that the following
conditions are fulfilled:
(i) it is not available in organic form;
(ii) it is produced or prepared without chemical solvents;
(iii) its use is limited to the feeding of young poultry with specific
protein compounds; and
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(iv) the maximum percentage authorised per period of 12 months
for those animals does not exceed 5 %. The percentage of the
dry matter of feed of agricultural origin shall be calculated.
1.9.4.3. Animal welfare

Live plucking of poultry shall be prohibited.

shall apply:
(a) at least one third of the floor area shall be solid, that is, not of
slatted or of grid construction, and shall be covered with a litter
material such as straw, wood shavings, sand or turf;
(b) in poultry houses for laying hens, a sufficiently large part of the
floor area available to the hens shall be available for the collection
of bird droppings;
▼M9
(c) buildings shall be emptied of livestock between each batch of
poultry that has been reared. The buildings and fittings shall be
cleaned and disinfected during this time. In addition, when the
rearing of each batch of poultry has been completed, runs shall be
left empty during a period to be established by the Member States
in order to allow vegetation to grow back. The operator shall keep
records or documentary evidence of the application of such
period. Those requirements shall not apply where poultry are
not reared in batches, are not kept in runs and are free to roam
throughout the day;
▼B
(d) poultry shall have access to an open air area for at least one third
of their life. However, laying hens and finisher poultry shall have
access to an open air area for at least one third of their life, except
where temporary restrictions have been imposed on the basis of
Union legislation;
(e) continuous daytime open air access shall be provided from as

early an age as practically possible and whenever physiological
and physical conditions allow, except where temporary
restrictions have been imposed on the basis of Union legislation;
(f) by way of derogation from point 1.6.5, in the case of breeding

birds and pullets aged under 18 weeks, when the conditions
specified in point 1.7.3 as regards restrictions and obligations
related to the protection of human and animal health imposed
on the basis of Union legislation are met and prevent breeding
birds and pullets aged under 18 weeks from having access to open
air areas, verandas shall be considered as open air areas and, in
such cases, shall have a wire mesh barrier to keep other birds out;
(g) open air areas for poultry shall permit fowl to have easy access to
adequate numbers of drinking troughs;
(h) open air areas for poultry shall be covered mainly with vegetation;
02018R0848 — EN — 21.02.2023 — 003.001 — 100
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(i) under conditions where feed availability from the range area is
limited, for example, due to long term snow cover or arid weather
conditions, supplementary feeding of roughage shall be included
as part of poultry diets;
(j) where poultry are kept indoors due to restrictions or obligations

imposed on the basis of Union legislation, they shall have
permanent access to sufficient quantities of roughage and
suitable material in order to meet their ethological needs;
(k) water fowl shall have access to a stream, pond, lake or a pool
whenever the weather and hygienic conditions permit, in order to
respect their species-specific needs and animal welfare
requirements; when weather conditions do not permit such
access, they shall have access to water which enables them to
dip their head therein so as to clean plumage;
(l) natural light may be supplemented by artificial means to provide a

maximum of 16 hours light per day, with a continuous nocturnal
rest period without artificial light of at least eight hours;
(m) the total usable surface area for fattening poultry in poultry houses
of any production unit shall not exceed 1 600 m2;
(n) not more than 3 000 laying hens shall be allowed in a single
compartment of a poultry house.
1.9.5. For rabbits

1.9.5.1. Nutrition
is not feasible or such feed is not available, shall be produced in
cooperation with other organic or in-conversion production units
and feed operators using feed and feed material from the same
region;
(b) rabbits shall have access to pasturage for grazing whenever

conditions allow;
(c) rearing systems shall be based on maximum use of grazing

pasturage by reference to the availability of pastures in the
(d) fibrous feed such as straw or hay shall be provided when grass is
not sufficient. Forage shall comprise at least 60 % of the diet.

shall apply:
(a) housing shall be provided with a comfortable, clean and dry laying
or rest area of sufficient size, consisting of a solid construction
which is not slatted. Ample dry bedding strewn with litter material
shall be provided in the rest area. The litter shall comprise straw or
other suitable natural material. The litter may be improved and
enriched with any mineral product authorised pursuant to Article 24
as a fertiliser or soil conditioner for use in organic production;
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(b) rabbits shall be kept in groups.
(c) rabbit farms shall use robust breeds adapted to outdoor conditions;
(d) rabbits shall have access to:
(i) covered shelter including dark hiding places;
(ii) an outdoor run with vegetation, preferably pasture;
(iii) a raised platform on which they can sit, either inside or out;
(iv) nesting material for all nursing does.
1.9.6. For bees

1.9.6.1. Origin of animals
For beekeeping, preference shall be given to the use of Apis mellifera
and their local ecotypes.
1.9.6.2. Nutrition
(a) at the end of the production season hives shall be left with
sufficient reserves of honey and pollen for the bees to survive
the winter;
▼M1
(b) bee colonies may only be fed where the survival of the colony is
endangered due to climatic conditions. In such case, bee colonies
shall be fed with organic honey, organic pollen, organic sugar
syrups, or organic sugar.
▼B
1.9.6.3. Health care
With regard to health care, the following rules shall apply:
(a) for the purposes of protecting frames, hives and combs, in

particular from pests, only rodenticides used in traps, and appro
priate products and substances authorised pursuant to Articles 9
and 24 for use in organic production shall be permitted;
(b) physical treatments for disinfection of apiaries such as steam or

direct flame shall be permitted;
(c) the practice of destroying the male brood shall only be permitted
for the purpose of isolating the infestation of Varroa destructor;
(d) if, despite all preventive measures, the colonies become sick or
infested, they shall be treated immediately and, if necessary, may
be placed in isolation apiaries;
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(e) formic acid, lactic acid, acetic acid and oxalic acid, as well as
menthol, thymol, eucalyptol or camphor, may be used in cases
of infestation with Varroa destructor;
(f) if a treatment is applied with chemically synthesised allopathic

products, including antibiotics, other than products and substances
authorised pursuant to Articles 9 and 24 for use in organic
production, for the duration of that treatment, the treated
colonies shall be placed in isolation apiaries and all the wax
shall be replaced with wax coming from organic beekeeping.
Subsequently, the conversion period of 12 months laid down in
point 1.2.2 shall apply to those colonies.
1.9.6.4. Animal welfare
With regard to beekeeping, the following additional general rules shall

apply:
(a) the destruction of bees in the combs as a method associated with

the harvesting of apiculture products shall be prohibited;
(b) mutilation such as clipping the wings of queen bees shall be

prohibited.

shall apply:
(a) apiaries shall be placed in areas which ensure the availability of

nectar and pollen sources consisting essentially of organically
produced crops or, where appropriate, of spontaneous vegetation
or non-organically managed forests or crops that are only treated
with low environmental impact methods;
(b) apiaries shall be kept at sufficient distance from sources that may
lead to the contamination of apiculture products or to the poor
health of the bees;
(c) the siting of the apiaries shall be such that, within a radius of 3 km
from the apiary site, nectar and pollen sources consist essentially
of organically produced crops or spontaneous vegetation or crops
treated with low environmental impact methods equivalent to those
provided for in Articles 28 and 30 of Regulation (EU)
No 1305/2013 which cannot affect the qualification of beekeeping
production as being organic. That requirement does not apply
where flowering is not taking place, or the bee colonies are
dormant;
(d) the hives and materials used in beekeeping shall be made basically
of natural materials presenting no risk of contamination to the
environment or the apiculture products;
(e) the beeswax for new foundations shall come from organic
production units;
(f) only natural products such as propolis, wax and plant oils may be
used in the hives;
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(g) synthetic chemical repellents shall not be used during honey
extraction operations;
(h) brood combs shall not be used for honey extraction;
(i) beekeeping shall not be considered as organic when practiced in

regions or areas designated by Member States as regions or areas
where organic beekeeping is not practicable.
▼M9
1.9.6.6. Record-keeping obligations
Operators shall keep a map on an appropriate scale or geographic
coordinates of the location of hives to be provided to the control
authority or control body demonstrating that the areas accessible to
the colonies meet the requirements of this Regulation.
The following information shall be entered in the register of the apiary
with regard to feeding: name of the product used, dates, quantities and
hives where the product is used.
The zone where the apiary is situated shall be recorded together with
the identification of the hives and the period of moving.
All the measures applied shall be recorded in the register of the apiary,
including the removals of the supers and the honey extraction
operations. The amount and dates of the collection of honey shall
also be recorded.
▼B
Part III: Production rules for algae and aquaculture animals
1.1. Operations shall be situated in locations that are not subject to con
tamination with products or substances not authorised for use in
organic production, or with pollutants that would compromise the
organic nature of the products.
1.2. Organic and non-organic production units shall be adequately

separated in accordance with the minimum separation distances set
by Member States, where applicable. Such separation measures shall
be based on the natural situation, separate water distribution systems,
distances, the tidal flow, and the upstream and the downstream
location of the organic production unit. Algae and aquaculture
production shall not be considered as organic when practiced at
locations or in areas designated by Member State authorities as
locations or areas which are unsuitable for such activities.
1.3. An environmental assessment that is appropriate to the production unit

shall be required for any new operators applying for organic
production and producing more than 20 tonnes of aquaculture
products per year to ascertain the conditions of the production unit
and its immediate environment and likely effects of its operation. The
operator shall provide the environmental assessment to the control
authority or control body. The content of the environmental assessment
shall be based on Annex IV to Directive 2011/92/EU of the European
Parliament and of the Council (1). If the production unit has already
been subject to an equivalent assessment, that assessment may be used
for this purpose.
(1) Directive 2011/92/EU of the European Parliament and of the Council of 13 December
2011 on the assessment of the effects of certain public and private projects on the
environment (OJ L 26, 28.1.2012, p. 1).
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1.4. Mangrove destruction shall not be permitted.
1.5. The operator shall provide a sustainable management plan propor

tionate to the production unit for aquaculture and algae harvesting.
1.6. The plan shall be updated annually and shall detail the environmental
effects of the operation and the environmental monitoring to be
undertaken, and shall list the measures to be taken to minimise
negative impacts on the surrounding aquatic and terrestrial
environments, including, where applicable, nutrient discharge into
the environment per production cycle or per annum. The plan shall
record the surveillance and repair of technical equipment.
1.7. Defensive and preventive measures taken against predators in

accordance with Directive 92/43/EEC and national rules shall be
recorded in the sustainable management plan.
1.8. Where applicable, coordination shall take place with the neighbouring
operators in drawing up the management plan.
1.9. Aquaculture and algae business operators shall draw up as part of the
sustainable management plan a waste reduction schedule to be put in
place at the commencement of operations. Where possible, the use of
residual heat shall be limited to energy from renewable sources.
If preparation operations, other than processing, are carried out on

algae or aquaculture animals, the general requirements laid down in
points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis
mutandis to such operations.
▼M9
1.11. Operators shall keep available documentary evidence on any dero
gation from production rules for aquaculture animals obtained in
accordance with points 3.1.2.1(d) and (e).
▼B
2. Requirements for algae
In addition to the general production rules laid down in Articles 9, 10,
11 and 15, and where relevant in Section 1 of this Part, the rules laid
down in this Section shall apply to the organic collection and
production of algae. Those rules shall apply mutatis mutandis to the
production of phytoplankton.
2.1. Conversion
2.1.1. The conversion period for a production unit for algae collection shall
be six months.
2.1.2. The conversion period for a production unit for algae cultivation shall
be a period of six months or one full production cycle, whichever is
the longer.
2.2. Production rules for algae

2.2.1. The collection of wild algae and parts thereof is considered as organic
production provided that:
(a) the growing areas are suitable from a health point of view and are
of high ecological status as defined by Directive 2000/60/EC, or
are of equivalent quality to:
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— the production zones classed as A and B in Regulation (EC)
No 854/2004 of the European Parliament and of the
Council (1), until 13 December 2019, or
— the corresponding classification areas set out in the implemen

ting acts adopted by the Commission in accordance with
Article 18(8) of Regulation (EU) 2017/625, from 14 December
2019;
(b) the collection does not affect significantly the stability of the
natural ecosystem or the maintenance of the species in the
collection area.
2.2.2. The cultivation of algae shall take place in areas with environmental
and health characteristics at least equivalent to those outlined in
point 2.2.1(a) in order to be considered organic. In addition the
following production rules shall apply:
(a) sustainable practices shall be used in all stages of production, from

the collection of juvenile algae to harvesting;
(b) to ensure that a wide gene-pool is maintained, the collection of

juvenile algae in the wild shall take place on a regular basis so as
to maintain and increase the diversity of indoor culture stock;
(c) fertilisers shall not be used, except in indoor facilities, and only if
they have been authorised pursuant to Article 24 for use in organic
production for this purpose. ►M9 Operators shall keep records of
the use of those products, including the date or dates on which
each product was used, the name of the product, and the amount
applied, with information on the lots/tanks/basins concerned. ◄
2.3. Algae cultivation

2.3.1. Algae culture at sea shall only utilise nutrients naturally occurring in
the environment, or from organic aquaculture animal production,
preferably located nearby as part of a polyculture system.
2.3.2. In facilities on land where external nutrient sources are used, the
nutrient levels in the effluent water shall be verifiably the same, or
lower, than the inflowing water. Only nutrients of plant or mineral
origin authorised pursuant to Article 24 for use in organic production
may be used. ►M9 Operators shall keep records of the use of those
products, including the date or dates on which the product are used,
the name of the product, and the amount applied with information on
the lots/tanks/basins concerned. ◄
2.3.3. Culture density or operational intensity shall be recorded and shall
maintain the integrity of the aquatic environment by ensuring that
the maximum quantity of algae which can be supported without
negative effects on the environment is not exceeded.
(1) Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April
2004 laying down specific rules for the organisation of official controls on products of
animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206).
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2.3.4. Ropes and other equipment used for growing algae shall be re-used or
recycled where possible.
2.4. Sustainable collection of wild algae
2.4.1. A once-off biomass estimate shall be undertaken at the outset of algae
collection.
2.4.2. Documentary accounts shall be maintained in the unit or premises and

shall enable the operator to identify and the control authority or control
body to verify that the collectors have supplied only wild algae
produced in accordance with this Regulation.
2.4.3. Collection shall be carried out in such a way that the amounts
collected do not cause a significant impact on the state of the
aquatic environment. Measures such as collection technique,
minimum sizes, ages, reproductive cycles or size of remaining algae
shall be taken to ensure that algae can regenerate and to ensure that
by-catches are prevented.
2.4.4. If algae are collected from a shared or common collection area, docu
mentary evidence produced by the relevant authority designated by the
Member State concerned shall be available showing that the total
collection complies with this Regulation.
3. Requirements for aquaculture animals

In addition to the general production rules laid down in Article 9, 10,
11 and 15, and where relevant in Section 1 of this Part, the rules laid
down in this Section shall apply to the organic production of species
of fish, crustaceans, echinoderms and molluscs. Those rules also shall
apply mutatis mutandis to the production of zooplankton,
micro-crustaceans, rotifers, worms and other aquatic feed animals.
3.1. General requirements

3.1.1. Conversion
The following conversion periods for aquaculture production units

shall apply for the following types of aquaculture facilities including
the existing aquaculture animals:
(a) for facilities that cannot be drained, cleaned and disinfected, a

conversion period of 24 months;
(b) for facilities that have been drained, or fallowed, a conversion

period of 12 months;
(c) for facilities that have been drained, cleaned and disinfected, a
conversion period of six months;
(d) for open water facilities, including those producing bivalve

molluscs, a conversion period of three months.
3.1.2. Origin of aquaculture animals

3.1.2.1. With regard to the origin of the aquaculture animals, the following
rules shall apply:
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(a) organic aquaculture shall be based on the rearing of young stock
originating from organic broodstock and from organic production
units;
(b) locally grown species shall be used, and breeding shall aim to
produce strains which are better adapted to production conditions,
ensuring good animal health and welfare and good utilisation of
feed resources. Documentary evidence of their origin and
treatment shall be provided for the competent authority, or,
where appropriate, the control authority or control body;
(c) species shall be chosen which are robust and can be produced
without causing significant damage to wild stocks;
(d) for breeding purposes, wild-caught or non-organic aquaculture

animals may be brought into a holding only in duly justified
cases where no organic breed is available or where new genetic
stock for breeding purposes is brought into the production unit
after an authorisation has been granted by the competent
authority with a view to improving the suitability of genetic
stock. Such animals shall be kept under organic management for
at least three months before they may be used for breeding. For
animals that are on the IUCN Red List of endangered species, the
authorisation to use wild-caught specimens may only be granted in
the context of conservation programmes recognised by the relevant
public authority in charge of the conservation effort;
(e) for on-growing purposes, the collection of wild aquaculture

juveniles shall be specifically restricted to the following cases:
(i) natural influx of fish or crustacean larvae and juveniles when

filling ponds, containment systems and enclosures;
(ii) restocking of wild fry or crustacean larvae of species that are

not on the IUCN Red List of endangered species in extensive
aquaculture farming inside wetlands, such as brackish water
ponds, tidal areas and costal lagoons, provided that:
— the restocking is in line with management measures

approved by the relevant authorities to ensure the
sustainable exploitation of the species concerned, and
— the animals are fed exclusively with feed naturally

available in the environment.
By way of derogation from point (a), Member States may

authorise the introduction for on-growing purposes on an organic
production unit of a maximum of 50 % of non-organic juveniles
of species that were not developed as organic in the Union by
►M3 1 January 2022 ◄, provided that at least the latter two
thirds of the duration of the production cycle are managed under
organic management. Such derogation may be granted for a
maximum period of two years and shall not be renewable.
For aquaculture holdings situated outside the Union, such dero

gation may only be granted by control authorities or control bodies
that have been recognised in accordance with Article 46(1) for
species that were not developed as organic in either the territory
of the country in which the holding is located or the Union. Such
derogation may be granted for a maximum period of two years
and shall not be renewable.
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3.1.2.2. With regard to breeding, the following rules shall apply:
(a) hormones and hormone-derivates shall not be used;
(b) the artificial production of monosex strains, except by

hand-sorting, the induction of polyploidy, artificial hybridisation
and cloning shall not be used;
(c) appropriate strains shall be chosen.
▼M1
3.1.2.3. Juvenile production
In the larval rearing of marine fish species, rearing systems (preferably

the ‘mesocosm’ or ‘large volume rearing’) may be used. Those rearing
systems shall meet the following requirements:
(a) the initial stocking density shall be below 20 eggs or larvae per
litre;
(b) the larval rearing tank shall have a volume of minimum 20 m3;
and
(c) the larvae shall feed on the natural plankton developing in the
tank, supplemented as appropriate by externally produced phyto
plankton and zooplankton.
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3.1.2.4. Operators shall keep records of the origin of animals, identifying the
animals/batches of animals, the date of arrival and type of species, the
quantities, the organic or non-organic status, and the conversion
period.
▼B
3.1.3. Nutrition
3.1.3.1. With regard to feed for fish, crustaceans and echinoderms, the
following rules shall apply:
(a) animals shall be fed with feed that meets the animals’ nutritional
requirements at the various stages of its development;
(b) feeding regimes shall be designed with the following priorities:
(i) animal health and welfare;
(ii) high product quality, including the nutritional composition of

the product, which shall ensure high quality of the final edible
product;
(iii) low environmental impact;
(c) the plant fraction of feed shall be organic and the feed fraction
derived from aquatic animals shall originate from organic aqua
culture or from fisheries that have been certified as sustainable
under a scheme recognised by the competent authority in line
with the principles laid down in Regulation (EU) No 1380/2013;
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(d) non-organic feed materials of plant, animal, algal or yeast origin,
feed materials of mineral or microbial origin, feed additives, and
processing aids shall only be used if they have been authorised
under this Regulation for use in organic production;
(e) growth promoters and synthetic amino-acids shall not be used.
3.1.3.2. With regard to bivalve molluscs and other species which are not fed
by man, but instead feed on natural plankton, the following rules shall
apply:
(a) such filter-feeding animals shall receive all their nutritional

requirements from nature, except in the case of juveniles reared
in hatcheries and nurseries;
(b) the growing areas shall be suitable from a health point of view and
shall either be of high ecological status as defined by Directive
2000/60/EC or of good environmental status as defined by
Directive 2008/56/EC or of equivalent quality to:
— the production zones classed as A in Regulation (EC)

No 854/2004, until 13 December 2019, or
— the corresponding classification areas set out in the implemen

ting acts adopted by the Commission in accordance with
Article 18(8) of Regulation (EU) 2017/625, from 14 December
2019.
3.1.3.3. Specific rules on feed for carnivorous aquaculture animals
Feed for carnivorous aquaculture animals shall be sourced with the

following priorities:
(a) organic feed of aquaculture origin;
(b) fish meal and fish oil from organic aquaculture trimmings sourced
from fish, crustaceans or molluscs;
(c) fish meal and fish oil and feed material of fish origin derived from
trimmings of fish, crustaceans or molluscs already caught for
human consumption in sustainable fisheries;
(d) fish meal and fish oil and feed material of fish origin derived from
whole fish, crustaceans or molluscs caught in sustainable fisheries
and not used for human consumption;
▼M1
(e) organic feed materials of plant or animal origin.
▼B
3.1.3.4. Specific rules on feed for certain aquaculture animals
In the grow-out phase, fish in inland waters, penaeid shrimps and

freshwater prawns and tropical freshwater fish shall be fed as follows:
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(a) they shall be fed with feed naturally available in ponds and lakes;
(b) where natural feed referred to in point (a) is not available in

sufficient quantities, organic feed of plant origin, preferably
grown on the farm itself, or algae may be used. Operators shall
keep documentary evidence of the need to use additional feed;
(c) where natural feed is supplemented in accordance with point (b):
(i) the feed ration of penaeid shrimps and freshwater prawns

(Macrobrachium spp.) may consist of a maximum of 25 %
fishmeal and 10 % fish oil derived from sustainable fisheries;
(ii) the feed ration of siamese catfish (Pangasius spp.) may consist
of a maximum of 10 % fishmeal or fish oil derived from
sustainable fisheries.
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In the grow-out phase and in earlier life stages in nurseries and
hatcheries, organic cholesterol may be used to supplement the diets
of penaeid shrimps and freshwater prawns (Macrobrachium spp.), in
order to secure their quantitative dietary need.
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3.1.3.5. Operators shall keep records of specific feeding regimes, in particular,
on the name and quantity of feed and the use of additional feed, and
the respective animals/batches of animals fed.
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3.1.4. Health care
3.1.4.1. Disease prevention
With regard to disease prevention, the following rules shall apply:
(a) disease prevention shall be based on keeping the animals in

optimal conditions by appropriate siting, taking into account,
inter alia, the species’ requirements for good water quality, flow
and exchange rate, the optimal design of the holdings, the appli
cation of good husbandry and management practices, including
regular cleaning and disinfection of premises, high-quality feed,
appropriate stocking density, and breed and strain selection;
(b) immunological veterinary medicines may be used;
(c) an animal health management plan shall detail biosecurity and

disease prevention practices including a written agreement for
health counselling, proportionate to the production unit, with
qualified aquaculture animal health services who shall visit the
farm at a frequency of not less than once per year or, in the
case of bivalve shellfish, not less than once every two years;
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(d) holding systems, equipment and utensils shall be properly cleaned
and disinfected;
(e) bio-fouling organisms shall be removed only by physical means or

by hand and where appropriate returned to the sea at a distance
from the farm;
(f) only substances for cleaning and disinfection of equipment and

facilities authorised pursuant to Article 24 for use in organic
production may be used;
(g) with regard to fallowing, the following rules shall apply:
(i) the competent authority, or, where appropriate, control

authority or control body, shall determine whether fallowing
is necessary and shall determine the appropriate duration
which shall be applied and documented after each production
cycle in open water containment systems at sea;
(ii) it shall not be mandatory for bivalve mollusc cultivation;
(iii) during fallowing the cage or other structure used for aqua
culture animal production is emptied, disinfected and left
empty before being used again;
(h) where appropriate, uneaten fish-feed, faeces and dead animals shall
be removed promptly to avoid any risk of significant environmen
tal damage as regards water status quality, to minimise disease
risks, and to avoid attracting insects or rodents;
(i) ultraviolet light and ozone may only be used in hatcheries and
nurseries;
(j) for biological control of ectoparasites, preference shall be given to

the use of cleaner fish and to the use of freshwater, marine water
and sodium chloride solutions.
3.1.4.2. Veterinary treatments
With regard to veterinary treatments, the following rules shall apply:
(a) disease shall be treated immediately to avoid suffering to the

animal. Chemically synthesised allopathic veterinary medicinal
products, including antibiotics, may be used where necessary,
under strict conditions and under the responsibility of a
veterinarian, where the use of phytotherapeutic, homeopathic and
other products is inappropriate. Where appropriate, restrictions
with respect to courses of treatment and withdrawal periods shall
be defined;
(b) treatments related to the protection of human and animal health

imposed on the basis of Union legislation shall be allowed;
(c) when despite preventive measures to ensure animal health referred

to in point 3.1.4.1 a health problem arises, veterinary treatments
may be used in the following order of preference:
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(i) substances from plants, animals or minerals in a homoeo
pathic dilution;
(ii) plants and their extracts not having anaesthetic effects; and
(iii) substances such as trace elements, metals, natural immunos

timulants or authorised probiotics;
(d) the use of allopathic treatments shall be limited to two courses of

treatment per year, with the exception of vaccinations and
compulsory eradication schemes. However, in the cases of a
production cycle of less than a year, a limit of one allopathic
treatment shall apply. Where the indicated limits for allopathic
treatments are exceeded, the aquaculture animals concerned shall
not be marketed as organic products;
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(e) the use of parasite treatments, other than through compulsory
control schemes operated by Member States, shall be limited as
follows:
(i) for salmon, to maximum two courses of treatment per year, or

to one course of treatment per year where the production
cycle is less than 18 months;
(ii) for all species other than salmon, to two courses of treatment
per year, or to one course of treatment per year where the
production cycle is less than 12 months;
(iii) for all species, to no more than four courses of treatment in

total, regardless of the length of the production cycle of the
species;
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(f) the withdrawal period for allopathic veterinary treatments and
parasite treatments in accordance with point (d), including
treatments under compulsory control and eradication schemes,
shall be twice the withdrawal period referred to in Article 11 of
Directive 2001/82/EC or, where this period is not specified,
48 hours;
(g) any use of veterinary medicinal products shall be declared to the

competent authority, or, where appropriate, to the control authority
or control body, before the animals are marketed as organic
products. Treated stock shall be clearly identifiable.
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3.1.4.3. Record-keeping of disease prevention
Operators shall keep records of the disease prevention measures
applied giving details of fallowing, cleaning and water treatment,
and of any veterinary and other parasite treatment applied and in
particular, the date of treatment, diagnosis, the posology, the name
of the treatment product, and veterinary prescription for veterinary
care, where applicable, and withdrawal periods applied before aqua
culture products can be marketed and labelled as organic.
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3.1.5. Housing and husbandry practices
3.1.5.1. Closed recirculation aquaculture animal production facilities shall be
prohibited, with the exception of hatcheries and nurseries or facilities
for the production of species used for organic feed organisms.
3.1.5.2. Artificial heating or cooling of water shall only be permitted in

hatcheries and nurseries. Natural borehole water may be used to heat
or cool water at all stages of production.
3.1.5.3. The husbandry environment of the aquaculture animals shall be

designed in such a way that, in accordance with their species-specific
needs, the aquaculture animals:
(a) have sufficient space for their welfare and have the relevant
stocking density laid down in the implementing acts referred to
in Article 15(3);
(b) are kept in water of good quality with, inter alia, an adequate flow
and exchange rate, sufficient oxygen levels and keeping a low
level of metabolites;
(c) are kept in temperature and light conditions in accordance with the
requirements of the species and having regard to the geographic
location.
In considering the effects of stocking density on the welfare of

produced fish, the condition of the fish (such as fin damage, other
injuries, growth rate, behaviour expressed and overall health) and the
water quality shall be monitored and taken into account.
In the case of freshwater fish, the bottom type shall be as close as

possible to natural conditions.
In the case of carp and similar species:
— the bottom shall be natural earth,
— organic and mineral fertilisation of the ponds and lakes shall be

carried out only with fertilisers and soil conditioners that have been
authorised pursuant to Article 24 for use in organic production,
with a maximum application of 20 kg nitrogen/ha,
— treatments involving synthetic chemicals for the control of hydro

phytes and plant coverage present in production waters shall be
prohibited.
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Operators shall keep records of monitoring and maintenance measures
concerning animal welfare and water quality. In case of fertilisation of
ponds and lakes, the operators shall keep records of the application of
fertilisers and soil conditioners, including the date of application, the
name of the product, the amount applied, and the location of the
application concerned.
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3.1.5.4. The design and construction of aquatic containment systems shall
provide flow rates and physiochemical parameters that safeguard the
animals’ health and welfare, and that provide for their behavioural
needs.
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The specific characteristics for production systems and containment
systems for species or group of species laid down in the implementing
acts referred to in Article 15(3) shall be complied with.
3.1.5.5. Rearing units on land shall meet the following conditions:
(a) flow-through systems shall allow the monitoring and control of the
flow rate and water quality of both in-flowing and out-flowing
water;
(b) at least 10 % of the perimeter (‘land-water interface’) area shall

have natural vegetation.
3.1.5.6. Containment systems at sea shall meet the following conditions:
(a) they shall be located where water flow, depth and water-body
exchange rates are adequate to minimise the impact on the
seabed and the surrounding water body;
(b) they shall have suitable cage design, construction and maintenance
with regard to their exposure to the operating environment.
3.1.5.7. Containment systems shall be designed, located and operated to

minimise the risk of escape incidents.
3.1.5.8. If fish or crustaceans escape, appropriate action shall be taken to

reduce the impact on the local ecosystem, including recapture where
appropriate. Records shall be kept.
3.1.5.9. For aquaculture animal production in fishponds, tanks or raceways,

farms shall be equipped with either natural-filter beds, settlement
ponds, biological filters or mechanical filters to collect waste
nutrients or use algae or animals (bivalves) which contribute to
improving the quality of the effluent. Effluent monitoring shall be
carried out at regular intervals where appropriate.
3.1.6. Animal welfare

3.1.6.1. All persons involved in keeping aquaculture animals shall possess the
necessary basic knowledge and skills as regards the health and the
welfare needs of those animals.
3.1.6.2. The handling of aquaculture animals shall be minimised, and shall be

undertaken with the greatest care. Proper equipment and protocols
shall be used to avoid stress and physical damage associated with
handling procedures. Broodstock shall be handled in such a manner
as to minimise physical damage and stress, and shall be handled under
anaesthesia where appropriate. Grading operations shall be kept to a
minimum and shall only be used where required to ensure fish welfare.
3.1.6.3. The following restrictions shall apply to the use of artificial light:
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(a) for prolonging natural day length, it shall not exceed a maximum
that respects the ethological needs, geographical conditions and
general health of the animals; this maximum shall not exceed
14 hours per day, except where necessary for reproductive
purposes;
(b) abrupt changes in light intensity shall be avoided at the

changeover time through the use of dimmable lights or back
ground lighting.
3.1.6.4. Aeration shall be permitted to ensure animal welfare and health. Mech
anical aerators shall be preferably powered by renewable energy
sources.
3.1.6.5. Oxygen may only be used for uses linked to animal health and welfare
requirements and for critical periods of production or transport, and
only in the following cases:
(a) exceptional cases of a change in temperature, a drop in atmos

pheric pressure or accidental water pollution;
(b) occasional stock management procedures, such as sampling and

sorting;
(c) in order to assure the survival of the farm stock.
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Operators shall keep records of such uses, indicating whether applied
under point (a) (b) or (c).
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3.1.6.6. Appropriate measures shall be taken to keep the duration of the
transport of aquaculture animals to a minimum.
3.1.6.7. Any suffering shall be kept to a minimum during the entire life of the
animal, including at the time of slaughter.
3.1.6.8. Eyestalk ablation, including all similar practices such as ligation,

incision and pinching, is prohibited.
3.1.6.9. Slaughter techniques shall render fish immediately unconscious and

insensible to pain. Handling prior to slaughter shall be performed in
a way that avoids injuries while keeping suffering and stress at a
minimum. Differences in harvesting sizes, species, and production
sites shall be taken into account when considering optimal slaughtering
methods.
3.2. Detailed rules for molluscs

3.2.1. Origin of seed
With regard to the origin of seed, the following rules shall apply:
(a) wild seed from outside the boundaries of the production unit may
be used in the case of bivalve shellfish, provided that there is no
significant damage to the environment, provided that it is
permitted by local legislation and provided that the wild seed
comes from:
(i) settlement beds which are unlikely to survive winter weather

or are surplus to requirements; or
(ii) natural settlement of shellfish seed on collectors;

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(b) for the cupped oyster (Crassostrea gigas), preference shall be
given to stock which is selectively bred to reduce spawning in
the wild;
(c) records shall be kept of how, where and when wild seed was
collected to allow traceability back to the collection area;
(d) wild seed may only be collected after the competent authority has
granted authorisation to do so.
3.2.2. Housing and husbandry practices

shall apply:
(a) production may be carried out in the same area of water as organic
finfish and algae production, in a polyculture system that shall be
documented in the sustainable management plan. Bivalve molluscs
may also be grown together with gastropod molluscs, such as
periwinkles, in polyculture;
(b) organic bivalve mollusc production shall take place within areas
delimited by posts, floats or other clear markers and shall, where
appropriate, be restrained by net bags, cages or other man made
means;
(c) organic shellfish farms shall minimise risks to species of conser

vation interest. If predator nets are used, their design shall not
permit diving birds to be harmed.
3.2.3. Cultivation
With regard to cultivation, the following rules shall apply:
(a) cultivation on mussel ropes and other methods listed in the im
plementing acts referred to in Article 15(3) may be used in organic
production;
(b) the bottom cultivation of molluscs is only permitted where no

significant environmental impact is caused at the collection and
growing sites. A survey and report supporting the evidence of
minimal environmental impact shall be added as a separate
chapter to the sustainable management plan, and shall be
provided by the operator to the competent authority, or, where
appropriate, to the control authority or control body, before
starting operations.
3.2.4. Management
With regard to management, the following rules shall apply:
(a) production shall use a stocking density not in excess of that used
for non-organic molluscs in the locality. Sorting, thinning and
stocking density adjustments shall be made according to the
biomass and to ensure animal welfare and high product quality;
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(b) biofouling organisms shall be removed by physical means or by
hand and where appropriate returned to the sea away from mollusc
farms. Molluscs may be treated once during the production cycle
with a lime solution to control competing fouling organisms.
3.2.5. Specific cultivation rules for oysters

Cultivation in bags on trestles shall be permitted. Those or other
structures in which the oysters are contained shall be set out so as
to avoid the formation of a total barrier along the shoreline. Stock shall
be positioned carefully on the beds in relation to tidal flow to optimise
production. Production shall meet the requirements set out in the im
plementing acts referred to in Article 15(3).
Part IV: Processed food production rules

In addition to the general production rules laid down in Articles 9, 11 and 16, the
rules laid down in this Part shall apply to the organic production of processed
food.
1. General requirements for the production of processed food

1.1. Food additives, processing aids and other substances and ingredients
used for processing food and any processing practice applied, such as
smoking, shall comply with the principles of good manufacturing
practice (1).
1.2. Operators producing processed food shall establish and update appro
priate procedures based on a systematic identification of critical
processing steps.
1.3. The application of the procedures referred to in point 1.2 shall ensure
that the produced processed products comply with this Regulation at
all times.
1.4. Operators shall comply with and implement the procedures referred to
in point 1.2, and, without prejudice to Article 28, shall in particular,:
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(a) take precautionary measures and keep records of those measures;
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(b) implement suitable cleaning measures, monitor their effectiveness
and keep records of those operations;
(c) guarantee that non-organic products are not placed on the market
with an indication referring to organic production.
1.5. The preparation of processed organic, in-conversion and non-organic

products shall be kept separate from each other in time or space.
Where organic, in-conversion and non-organic products, in any combi
nation, are prepared or stored in the preparation unit concerned, the
operator shall:
(a) inform the competent authority, or, where appropriate, the control
authority or control body, accordingly;
(1) Good manufacturing practices (GMPs) as defined in Article 3(a) of Commission Regu
lation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for
materials and articles intended to come into contact with food (OJ L 384, 29.12.2006,
p. 75).
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(b) carry out the operations continuously until the production run has
been completed, separately in place or time from similar
operations performed on any other kind of product (organic,
in-conversion or non-organic);
(c) store organic, in-conversion and non-organic products, before and

after the operations, separate by place or time from each other;
(d) keep available an updated register of all operations and quantities

processed;
(e) take the necessary measures to ensure identification of lots and to

avoid mixtures or exchanges between organic, in-conversion and
non-organic products;
(f) carry out operations on organic or in-conversion products only

after suitable cleaning of the production equipment.
1.6. Products, substances and techniques that reconstitute properties that are
lost in the processing and storage of organic food, that correct the
results of negligence in the processing of organic food, or that
otherwise may be misleading as to the true nature of products
intended to be marketed as organic food, shall not be used.
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1.7. Operators shall keep available documentary evidence on authorisations
for the use of non-organic agricultural ingredients for the production of
processed organic food in accordance with Article 25 if they have
obtained or used such authorisations.
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2. Detailed requirements for the production of processed food
2.1. The following conditions shall apply to the composition of processed
organic food:
(a) the product shall be produced mainly from agricultural ingredients

or products intended for use as food listed in Annex I; for the
purpose of determining whether a product has been produced
mainly from those products, added water and salt shall not be
taken into account;
(b) an organic ingredient shall not be present together with the same
ingredient in non-organic form;
(c) an in-conversion ingredient shall not be present together with the

same ingredient in organic or non-organic form.
2.2. Use of certain products and substances in processing of food
2.2.1. Only food additives, processing aids and non-organic agricultural

ingredients authorised pursuant to Article 24 or Article 25 for use in
organic production, and the products and substances referred to in
point 2.2.2 may be used in the processing of food, with the
exception of products and substances of the wine sector, for which
point 2 of Part VI shall apply, and with the exception of yeast, for
which point 1.3 of Part VII shall apply.
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2.2.2. In the processing of food, the following products and substances may
be used:
(a) preparations of micro-organisms and food enzymes normally used

in food processing, provided that food enzymes to be used as food
additives have been authorised pursuant to Article 24 for use in
organic production;
(b) substances and products defined in points (c) and (d)(i) of

Article 3(2) of Regulation (EC) No 1334/2008 that have been
labelled as natural flavouring substances or natural flavouring
preparations in accordance with Article 16(2), (3) and (4) of that
Regulation;
(c) colours for stamping meat and eggshells in accordance with

(d) natural colours and natural coating substances for the traditional
decorative colouring of the shell of boiled eggs produced with the
intention of placing them on the market at a given period of the
year;
(e) drinking water and organic or non-organic salt (with sodium

chloride or potassium chloride as basic components) generally
used in food processing;
(f) minerals (trace elements included), vitamins, amino acids and

micronutrients, provided that:
(i) their use in food for normal consumption is ‘directly legally

required’, in the meaning of being directly required by
provisions of Union law or provisions of national law
compatible with Union law, with the consequence that the
food cannot be placed at all on the market as food for
normal consumption if those minerals, vitamins, amino acids
or micronutrients are not added; or
(ii) as regards food placed on the market as having particular

characteristics or effects in relation to health or nutrition or
in relation to needs of specific groups of consumers:
— in products referred to in points (a) and (b) of Article 1(1)

of Regulation (EU) No 609/2013 of the European
Parliament and of the Council (1) their use is authorised
by that Regulation and acts adopted on the basis of
Article 11(1) of that Regulation for the products
concerned, or
— in products regulated by Commission Directive

2006/125/EC (2), their use is authorised by that Directive.
(1) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June
2013 on food intended for infants and young children, food for special medical purposes,
and total diet replacement for weight control and repealing Council Directive 92/52/EEC,
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive
2009/39/EC of the European Parliament and of the Council and Commission
Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
(2) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based
foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).
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2.2.3. Only the products for cleaning and disinfection authorised pursuant to
Article 24 for use in processing shall be used for that purpose.
name of the product, its active substances and the location of such
use. ◄
2.2.4. For the purpose of the calculation referred to in Article 30(5), the
following rules shall apply:
(a) certain food additives authorised pursuant to Article 24 for use in

organic production shall be calculated as agricultural ingredients;
(b) preparations and substances referred to in points (a), (c), (d), (e)
and (f) of point 2.2.2 shall not be calculated as agricultural
ingredients;
(c) yeast and yeast products shall be calculated as agricultural

ingredients.
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2.3. Operators shall keep records of any input used in the food production.
In case of production of composite products, complete recipes/
formulae showing the quantities of input and output shall be kept
available for the competent authority or control body.
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Part V: Processed feed production rules
In addition to the general production rules laid down in Articles 9, 11 and 17, the
rules laid down in this Part shall apply to the organic production of processed
feed.
1. General requirements for the production of processed feed

1.1. Feed additives, processing aids and other substances and ingredients
used for processing feed, and any processing practice used, such as
smoking, shall comply with the principles of good manufacturing
practice.
1.2. Operators that produce processed feed shall establish and update
appropriate procedures based on a systematic identification of the
critical processing steps.
1.3. The application of the procedures referred to in point 1.2 shall ensure
that the produced processed products comply with this Regulation at
all times.
1.4. Operators shall comply with and implement the procedures referred to
in point 1.2, and, without prejudice to Article 28, shall in particular:
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(a) take precautionary measures and keep records of those measures;
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(b) implement suitable cleaning measures, monitor their effectiveness
and keep records of those operations;
(c) guarantee that non-organic products are not placed on the market
with an indication referring to organic production.
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1.5. The preparation of processed organic, in-conversion and non-organic
products shall be kept separate from each other in time or space.
Where organic, in-conversion and non-organic products, in any combi
nation, are prepared or stored in the preparation unit concerned, the
operator shall:
(a) inform the control authority or control body accordingly;
(b) carry out the operations continuously until the production run has
been completed, separately in place or time from similar
operations performed on any other kind of product (organic,
in-conversion or non-organic);
(c) store organic, in-conversion and non-organic products, before and

after the operations, separate by place or time from each other;
(d) keep available an updated register of all operations and quantities

processed;
(e) take the necessary measures to ensure identification of lots and to

avoid mixtures or exchanges between organic, in-conversion and
non-organic products;
(f) carry out operations on organic or in-conversion products only

after suitable cleaning of the production equipment.
2. Detailed requirements for the production of processed feed

2.1. Organic feed materials, or in-conversion feed materials, shall not enter
simultaneously with the same feed materials produced by non-organic
means into the composition of the organic feed product.
2.2. Any feed materials used or processed in organic production shall not
have been processed with the aid of chemically synthesised solvents.
2.3. Only non-organic feed material of plant, algal, animal or yeast origin,
feed material of mineral origin, and feed additives and processing aids
authorised pursuant to Article 24 for use in organic production may be
used in the processing of feed.
2.4. Only the products for cleaning and disinfection authorised pursuant to
name of the product, its active substances, and the location of such
use. ◄
2.5. Operators shall keep records of any input used in the feed production.
In the case of production of composite products, complete recipes/
formulae showing the quantities of input and output shall be kept
available for the competent authority or control body.
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Part VI: Wine
1. Scope
1.1. In addition to the general production rules laid down in Articles 9, 10,
11, 16 and 18, the rules laid down in this Part shall apply to the
organic production of the products of the wine sector as referred to
in point (l) of Article 1(2) of Regulation (EU) No 1308/2013.
1.2. Commission Regulations (EC) No 606/2009 (1) and (EC)

No 607/2009 (2) shall apply, save as explicitly provided otherwise in
this Part.
2. Use of certain products and substances

2.1. Products of the wine sector shall be produced from organic raw
material.
2.2. Only products and substances authorised pursuant to Article 24 for use
in organic production may be used for the making of products of the
wine sector, including during the oenological practices, processes and
treatments, subject to the conditions and restrictions laid down in
Regulation (EU) No 1308/2013 and Regulation (EC) No 606/2009,
and in particular in Annex I A to the latter Regulation.
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2.3. Operators shall keep records of the use of any product and substance
used in the wine production and for cleaning and disinfection,
name of the product, its active substances, and where applicable, the
location of such use.
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3. Oenological practices and restrictions
3.1. Without prejudice to Sections 1 and 2 of this Part and to specific
prohibitions and restrictions provided for in points 3.2, 3.3 and 3.4,
only oenological practices, processes and treatments, including the
restrictions provided for in Article 80 and Article 83(2) of Regu
lation (EU) No 1308/2013, in Article 3, Articles 5 to 9 and Articles
11 to 14 of Regulation (EC) No 606/2009, and in the Annexes to those
Regulations used before 1 August 2010 shall be permitted.
3.2. The use of the following oenological practices, processes and

treatments shall be prohibited:
(a) partial concentration through cooling in accordance with point (c)

of Section B.1 of Part I of Annex VIII to Regulation (EU)
No 1308/2013;
(b) elimination of sulphur dioxide by physical processes in accordance

with point 8 of Annex I A to Regulation (EC) No 606/2009;
(c) electrodialysis treatment to ensure the tartaric stabilisation of the

wine in accordance with point 36 of Annex I A to Regulation (EC)
No 606/2009;
(1) Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed
rules for implementing Council Regulation (EC) No 479/2008 as regards the categories
of grapevine products, oenological practices and the applicable restrictions (OJ L 193,
24.7.2009, p. 1).
( ) Commission Regulation (EC) No 607/2009 of 14 July 2009 laying down certain detailed
2
rules for the implementation of Council Regulation (EC) No 479/2008 as regards

protected designations of origin and geographical indications, traditional terms,
labelling and presentation of certain wine sector products (OJ L 193, 24.7.2009, p. 60).
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(d) partial dealcoholisation of wine in accordance with point 40 of
Annex I A to Regulation (EC) No 606/2009;
(e) treatment with cation exchangers to ensure the tartaric stabilisation

of the wine in accordance with point 43 of Annex I A to
Regulation (EC) No 606/2009.
3.3. The use of the following oenological practices, processes and

treatments is permitted under the following conditions:
(a) heat treatments in accordance with point 2 of Annex I A to

Regulation (EC) No 606/2009, provided that the temperature
does not exceed 75 °C;
(b) centrifuging and filtration with or without an inert filtering agent

in accordance with point 3 of Annex I A to Regulation (EC)
No 606/2009, provided that the size of the pores is not smaller
than 0,2 micrometres.
3.4. Any amendment introduced after 1 August 2010 concerning the oeno
logical practices, processes and treatments provided for in
Regulation (EC) No 1234/2007 or Regulation (EC) No 606/2009
may apply to the organic production of wine only after those
measures have been included as permitted in this Section and, if
required, after an evaluation in accordance with Article 24 of this
Regulation.
Part VII: Yeast used as food or feed

In addition to the general production rules laid down in Articles 9, 11, 16, 17 and
19, the rules laid down in this Part shall apply to the organic production of yeast
used as food or feed.
1.1. For the production of organic yeast, only organically produced
substrates shall be used. However, until ►M3 31 December
2024 ◄, the addition of up to 5 % non-organic yeast extract or
autolysate to the substrate (calculated in weight of dry matter) is
allowed for the production of organic yeast where operators are
unable to obtain yeast extract or autolysate from organic production.
1.2. Organic yeast shall not be present in organic food or feed together
with non-organic yeast.
1.3. The following products and substances may be used in the production,
confection and formulation of organic yeast:
(a) processing aids authorised pursuant to Article 24 for use in organic

production;
(b) products and substances referred to in points (a), (b) and (e) of
point 2.2.2 of Part IV.
▼M9
1.5. Operators shall keep records of any product and substance used for
yeast production and for cleaning and disinfection, including the date
or dates on which each product was used, the name of the product, its
active substances, and the location of such use.
02018R0848 — EN — 21.02.2023 — 003.001 — 124
▼B
ANNEX III
COLLECTION, PACKAGING, TRANSPORT AND STORAGE OF

PRODUCTS
1. Collection of products and transport to preparation units

Operators may carry out the simultaneous collection of organic,
in-conversion and non-organic products only where appropriate measures
have been taken to prevent any possible mixture or exchange between
organic, in-conversion and non-organic products and to ensure the identi
fication of the organic and in-conversion products. The operator shall keep
the information relating to collection days, hours, the circuit and date and
time of the reception of the products available to the control authority or
control body.
2. Packaging and transport of products to other operators or units

▼M5
2.1. Information to be provided
2.1.1. Operators shall ensure that organic products and in-conversion products
are transported to other operators or units, including wholesalers and
retailers, only in appropriate packaging, containers or vehicles closed in
such a manner that alteration, including substitution, of the content cannot
be achieved without manipulation or damage of the seal and provided with
a label stating, without prejudice to any other indications required by
Union law:
(a) the name and address of the operator and, where different, of the
owner or seller of the product;
(b) the name of the product;
(c) the name or the code number of the control authority or control body
to which the operator is subject; and
(d) where relevant, the lot identification mark in accordance with a

marking system either approved at national level or agreed with the
control authority or control body and which permits the linking of the
lot with the records referred to in Article 34(5).
2.1.2. Operators shall ensure that compound feed authorised in organic

production transported to other operators or holdings, including whole
salers and retailers, are provided with a label stating, in addition to any
other indications required by Union law:
(a) the information provided in point 2.1.1;
(b) where relevant, by weight of dry matter:
(i) the total percentage of organic feed materials;
(ii) the total percentage of in-conversion feed materials;
(iii) the total percentage of feed materials not covered by points (i)
and (ii);
(iv) the total percentage of feed of agricultural origin;

02018R0848 — EN — 21.02.2023 — 003.001 — 125
▼M5
(c) where relevant, the names of organic feed materials;
(d) where relevant, the names of in-conversion feed materials; and
(e) for compound feed that cannot be labelled in accordance with

Article 30(6), the indication that such feed may be used in organic
production in accordance with this Regulation.
2.1.3. Without prejudice to Directive 66/401/EEC, operators shall ensure that on

the label of the packaging of a mixture of fodder plant seeds containing
organic and in-conversion or non-organic seeds of certain different plant
species for which an authorisation has been issued under the relevant
conditions laid down in point 1.8.5 of Part I of Annex II to this Regu
lation, information is provided on the exact components of the mixture,
shown by percentage by weight of each component species, and where
appropriate varieties.
In addition to the relevant requirements under Annex IV to Directive

66/401/EEC, that information shall include besides the indications
required in the first paragraph of this point also the list of the
component species of the mixture that are labelled as organic or
in-conversion. The minimum total percentage by weight of organic and
in-conversion seeds in the mixture shall be at least 70 %.
In case the mixture contains non-organic seeds, the label shall also include
the following statement: ‘The use of the mixture is only allowed within
the scope of the authorisation and in the territory of the Member State of
the competent authority which authorised the use of this mixture in
conformity with point 1.8.5 of Annex II to Regulation (EU) 2018/848
on organic production and labelling of organic products.’
The information referred to in points 2.1.1 and 2.1.2 may be presented

solely on an accompanying document, if such a document can be
undeniably linked with the packaging, container or vehicular transport
of the product. This accompanying document shall include information
on the supplier or the transporter.
▼B
2.2. The closing of packaging, containers or vehicles shall not be required
where:
(a) the transport takes place directly between two operators, both of which
are subject to the organic control system;
(b) the transport includes only organic or only in-conversion products;
(c) the products are accompanied by a document giving the information

required under point 2.1; and
(d) both the expediting and the receiving operators keep documentary
records of such transport operations available for the control
authority or control body.
3. Special rules for transporting feed to other production or preparation units

or storage premises
When transporting feed to other production or preparation units or storage

premises, operators shall ensure that the following conditions are met:
02018R0848 — EN — 21.02.2023 — 003.001 — 126
▼B
(a) during transport, organically produced feed, in-conversion feed, and
non-organic feed are effectively physically separated;
(b) vehicles or containers which have transported non-organic products

are only used to transport organic or in-conversion products if:
(i) suitable cleaning measures, the effectiveness of which has been

checked, have been carried out before commencing the transport
of organic or in-conversion products and the operators keep
records of those operations;
(ii) all appropriate measures are implemented, depending on the risks

evaluated in accordance with control arrangements, and where
necessary, operators guarantee that non-organic products cannot
be placed on the market with an indication referring to organic
production;
(iii) the operator keeps documentary records of such transport

operations available for the control authority or control body;
(c) the transport of finished organic or in-conversion feed is separated

physically or in time from the transport of other finished products;
(d) during transport, the quantity of products at the start and each indi
vidual quantity delivered in the course of a delivery round is recorded.
4. Transport of live fish

4.1. Live fish shall be transported in suitable tanks with clean water which
meets their physiological needs in terms of temperature and dissolved
oxygen.
4.2. Before transport of organic fish and fish products, tanks shall be
thoroughly cleaned, disinfected and rinsed.
4.3. Precautions shall be taken to reduce stress. During transport, the density
shall not reach a level which is detrimental to the species.
4.4. Records shall be kept for operations referred to in points 4.1, 4.2 and 4.3.
5. ►C6 Reception of products from other operators or units ◄

On receipt of an organic or in-conversion product, the operator shall check
the closing of the packaging, container or vehicle where it is required and
the presence of the indications provided for in Section 2.
The operator shall cross-check the information on the label referred to in

Section 2 with the information on the accompanying documents. The
result of those verifications shall be explicitly mentioned in the records
referred to in Article 34(5).
6. Special rules for the reception of products from a third country

Where organic or in-conversion products are imported from a third
country, they shall be transported in appropriate packaging or containers,
closed in a manner that prevents the substitution of the content and
bearing the identification of the exporter and any other marks and
numbers that serve to identify the lot, and shall be accompanied by the
certificate of control for import from third countries where appropriate.
02018R0848 — EN — 21.02.2023 — 003.001 — 127
▼B
On receipt of an organic or in-conversion product imported from a third
country, the natural or legal person to whom the imported consignment is
delivered and who receives it for further preparation or marketing shall
check the closing of the packaging or container and, in the case of
products imported in accordance with point (b)(iii) of Article 45(1),
shall check that the certificate of inspection referred to in that Article
covers the type of product contained in the consignment. The result of
this verification shall be explicitly mentioned in the records referred to in
Article 34(5).
7. Storage of products
7.1. Areas for the storage of products shall be managed in such a way as to
ensure identification of lots and to avoid any mixing or contamination
with products or substances not in compliance with the organic production
rules. Organic and in-conversion products shall be clearly identifiable at
all times.
7.2. No input products or substances other than those authorised pursuant to

Articles 9 and 24 for use in organic production shall be stored in organic
or in-conversion plant and livestock production units.
7.3. Allopathic veterinary medicinal products, including antibiotics, may be

stored in agricultural and aquaculture holdings provided that they have
been prescribed by a veterinarian in connection with the treatment referred
to in points 1.5.2.2 of Part II and 3.1.4.2(a) of Part III of Annex II, that
they are stored in a supervised location and that they are entered in the
records referred to in Article 34(5).
7.4. Where operators handle organic, or in-conversion or non-organic products

in any combination and the organic or in-conversion products are stored in
storage facilities in which also other agricultural products or foodstuffs are
stored:
(a) the organic or in-conversion products shall be kept separate from the
other agricultural products or foodstuffs;
(b) every measure shall be taken to ensure identification of consignments

and to avoid mixtures or exchanges between organic, in-conversion
and non-organic products;
(c) suitable cleaning measures, the effectiveness of which has been

checked, shall have been carried out before the storage of organic
or in-conversion products and the operators shall keep records of
those operations.
Article 24 for use in organic production shall be used in storage facilities
for that purpose.
02018R0848 — EN — 21.02.2023 — 003.001 — 128
▼B
ANNEX IV
TERMS REFERRED TO IN ARTICLE 30
BG: биологичен.
ES: ecológico, biológico, orgánico.
CS: ekologické, biologické.
DA: økologisk.
DE: ökologisch, biologisch.
ET: mahe, ökoloogiline.
EL: βιολογικό.
EN: organic.
FR: biologique.
GA: orgánach.
HR: ekološki.
IT: biologico.
LV: bioloģisks, ekoloģisks.
LT: ekologiškas.
LU: biologesch, ökologesch.
HU: ökológiai.
MT: organiku.
NL: biologisch.
PL: ekologiczne.
PT: biológico.
RO: ecologic.
SK: ekologické, biologické.
SL: ekološki.
FI: luonnonmukainen.
SV: ekologisk.
02018R0848 — EN — 21.02.2023 — 003.001 — 129
▼B
ANNEX V
ORGANIC PRODUCTION LOGO OF THE EUROPEAN UNION AND

CODE NUMBERS
1. Logo
1.1. The organic production logo of the European Union shall comply with the
model below:
1.2. The reference colour in Pantone is Green Pantone No 376 and Green (50 %
Cyan + 100 % Yellow), when a four-colour process is used.
1.3. The organic production logo of the European Union may also be used in
black and white as shown, only where it is not practicable to apply it in
colour:
1.4. If the background colour of the packaging or label is dark, the symbols may
be used in negative format, using the background colour of the packaging or
label.
1.5. If a logo is used in colour on a coloured background which makes it

difficult to see, a delimiting outer line around the logo can be used to
improve contrast with the background colours.
1.6. Where there are indications in a single colour on the packaging, the organic
production logo of the European Union may be used in the same colour.
02018R0848 — EN — 21.02.2023 — 003.001 — 130
▼B
1.7. The organic production logo of the European Union shall have a height of at
least 9 mm and a width of at least 13,5 mm; the proportion ratio
height/width shall always be 1:1,5. Exceptionally, the minimum size may
be reduced to a height of 6 mm for very small packages.
1.8. The organic production logo of the European Union may be associated with
graphical or textual elements referring to organic production under the
condition that they do not modify or change the nature of the organic
production logo of the European Union, nor any of the indications
defined in accordance with Article 32. When associated to national or
private logos using a green colour different from the reference colour
provided for in point 1.2, the organic production logo of the European
Union may be used in that non-reference colour.
2. Code numbers
The general format of the code numbers shall be as follows:
AB-CDE-999
where:
(a) ‘AB’ is the ISO code for the country where the controls take place;
(b) ‘CDE’ is a term, indicated in three letters to be decided by the

Commission or each Member State, like ‘bio’ or ‘öko’ or ‘org’ or
‘eko’ establishing a link with organic production; and
(c) ‘999’ is the reference number, indicated in maximum three digits, to be

assigned by:
(i) each Member State’s competent authority to the control authorities

or control bodies to which it has delegated control tasks;
(ii) the Commission, to:
— the control authorities and control bodies recognised by the

Commission pursuant to Article 46,
— to the competent authorities of third countries recognised by the

Commission pursuant to Article 48.
02018R0848 — EN — 21.02.2023 — 003.001 — 131
▼M12
ANNEX VI
MODEL OF THE CERTIFICATE
CERTIFICATE PURSUANT TO ARTICLE 35(1) OF REGULATION (EU) 2018/848 ON ORGANIC

PRODUCTION AND THE LABELLING OF ORGANIC PRODUCTS (1)
Part I: Mandatory elements
1. Document number 2. (choose as appropriate)

— Operator
— Group of operators – see point 9
3. Name and address of the operator or group of 4. Name and address of the competent authority, or,
operators: where appropriate, control authority or control
body of the operator or group of operators and
code number in the case of control authority or
control body:
5. Activity or activities of the operator or group of operators (choose as appropriate)
— Production
— Preparation
— Distribution/ Placing on the market
— Storing
— Import
— Export
6. Category or categories of products as referred to in Article 35(7) of Regulation (EU) 2018/848 of the
European Parliament and of the Council (1) and production methods (choose as appropriate)
(a) unprocessed plants and plant products, including seeds and other plant reproductive material
Production method:
□ organic production excluding during the conversion period
□ production during the conversion period
□ organic production with non-organic production
(b) livestock and unprocessed livestock products

Production method:
(c) algae and unprocessed aquaculture products

Production method:
(d) processed agricultural products, including aquaculture products, for use as food
Production method:
□ production of organic products
□ production of in-conversion products
(1) Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of
organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
02018R0848 — EN — 21.02.2023 — 003.001 — 132
▼M12
(e) feed
Production method:
(f) wine
Production method:
(g) other products listed in Annex I to Regulation (EU) 2018/848 or not covered by the previous categories
Production method:
This document has been issued in accordance with Regulation (EU) 2018/848 to certify that the operator or
group of operators (choose as appropriate) complies with that Regulation.
7. Date, place
Name and signature on behalf of the issuing 8. Certificate valid from ….. [insert date] to …..
competent authority, or, where appropriate, control [insert date]
authority or control body, or qualified electronic seal:
9. List of members of the group of operators as defined in Article 36 of Regulation (EU) 2018/848
Name of member Address or other form of member identification
Part II: Specific optional elements

One or more elements to be completed if so decided by the competent authority or, where appropriate, the
control authority or control body that issues the certificate to the operator or group of operators in accordance
with Article 35 of Regulation (EU) 2018/848.
1. Directory of products
Name of the product and/or Combined Nomenclature (CN) code as

□ Organic
referred to in Council Regulation (EEC) No 2658/87 (1) for products
within the scope of Regulation (EU) 2018/848 □ In-conversion
(1) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common
Customs Tariff (OJ L 256, 7.9.1987, p. 1).
02018R0848 — EN — 21.02.2023 — 003.001 — 133
▼M12
2. Quantity of products
Name of the product and/or CN code as referred □ Organic Quantity estimated in

to in Regulation (EEC) No 2658/87 for products kilograms, litres or, where
within the scope of Regulation (EU) 2018/848 □ In-conversion relevant, in number of units
3. Information on the land
□ Organic
Name of the product □ In-conversion Surface in hectares
□ Non-organic
4. List of premises or units where the activity is performed by the operator or group of operators
Description of the activity or activities as referred to in point 5

Address or geolocation
of part I
5. Information on the activity or activities carried out by the operator or group of operators and whether the
activity is, or the activities are performed for their own purpose or as a subcontractor carrying out the activity or
activities for another operator, while the subcontractor remains responsible for the activity or activities
performed
□ Carrying out activity/activities for own purpose

Description of the activity or activities as □ Carrying out activity/activities as a subcontractor for
referred to in point 5 of part I another operator, while the subcontractor remains
responsible for the activity or activities performed
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▼M12
6. Information on the activity or activities carried out by the subcontracted third party in accordance with
Article 34(3) of Regulation (EU) 2018/848
Description of the activity or activities as □ Operator or group of operators remains responsible

referred to in point 5 of part I □ Subcontracted third party is responsible
7. List of subcontractors carrying out an activity or activities for the operator or group of operators in accordance
with Article 34(3) of Regulation (EU) 2018/848, for which the operator or group of operators remains
responsible as regards organic production and for which it has not transferred that responsibility to the subcon
tractor
Description of the activity or activities as referred to in point 5

Name and address
of part I
8. Information on the accreditation of the control body in accordance with Article 40(3) of Regulation (EU)
2018/848
(a) name of the accreditation body;
(b) hyperlink to the accreditation certificate.
9. Other information

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02018R0848 — EN — 21.02.2023 — 003.

►B REGULATION (EU) 2018/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

►C1 Corrigendum, OJ L 270, 29.10.2018, p. 37 (2018/848)

SUBJECT MATTER, SCOPE AND DEFINITIONS

This Regulation establishes the principles of organic production and

1. This Regulation applies to the following products originating from

(a) live or unprocessed agricultural products, including seeds and other

(b) processed agricultural products for use as food;

This Regulation also applies to certain other products closely linked to

2. This Regulation applies to any operator involved, at any stage of

3. Mass catering operations carried out by a mass caterer as defined

4. Except where otherwise provided, this Regulation applies without

5. This Regulation applies without prejudice to other specific Union

6. The Commission is empowered to adopt delegated acts in

For the purposes of this Regulation, the following definitions apply:

(1) ‘organic production’ means the use, including during the

(2) ‘organic product’ means a product resulting from organic

(3) ‘agricultural raw material’ means an agricultural product that has

(4) ‘preventive measures’ means measures that are to be taken by

(1) Regulation (EU) No 1308/2013 of the European Parliament and of the

(6) ‘conversion’ means the transition from non-organic to organic

(7) ‘in-conversion product’ means a product that is produced during

(9) ‘production unit’ means all assets of a holding, such as primary

(10) ‘organic production unit’ means a production unit, excluding

(11) ‘in-conversion production unit’ means a production unit, during

(12) ‘non-organic production unit’ means a production unit which is not

(13) ‘operator’ means the natural or legal person responsible for

(14) ‘farmer’ means a natural or legal person, or a group of natural or

(16) ‘plants’ means plants as defined in point (5) of Article 3 of Regu­

(18) ‘organic heterogeneous material’ means a plant grouping within a

(a) presents common phenotypic characteristics;

(b) is characterised by a high level of genetic and phenotypic

(c) is not a variety within the meaning of Article 5(2) of Council

(d) is not a mixture of varieties; and

(e) has been produced in accordance with this Regulation;

(19) ‘organic variety suitable for organic production’ means a variety as

(a) is characterised by a high level of genetic and phenotypical

(b) results from organic breeding activities referred to in

(21) ‘generation’ means a group of plants constituting a single step in

(22) ‘plant production’ means production of agricultural crop products

(1) Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant

(24) ‘pest’ means a pest as defined in Article 1(1) of Regulation (EU)

(25) ‘biodynamic preparations’ means mixtures traditionally used in

(26) ‘plant protection products’ means the products referred to in

(27) ‘livestock production’ means the production of domestic or domes­

(28) ‘veranda’ means an additional, roofed, uninsulated, outdoor part of

(31) ‘usable area’ means usable area as defined in point (d) of

(32) ‘aquaculture’ means aquaculture as defined in point (25) of

(33) ‘aquaculture products’ means aquaculture products as defined in

(1) Regulation (EU) 2016/2031 of the European Parliament of the Council of

(35) ‘energy from renewable sources’ means energy from renewable

(37) ‘nursery’ means a place where an intermediate aquaculture

(38) ‘water pollution’ means pollution as defined in point (33) of

(39) ‘polyculture’ means the rearing in aquaculture of two or more

(40) ‘production cycle’ means the lifespan of an aquaculture animal or

(41) ‘locally grown species’ means aquaculture species which are

(42) ‘veterinary treatment’ means all courses of a curative or preventive

(43) ‘veterinary medicinal product’ means a veterinary medicinal

(1) Directive 2008/56/EC of the European Parliament and of the Council of

(45) ‘food’ means food as defined in Article 2 of Regulation (EC)

(16) ‘plants’ means plants as defined in point (5) of Article 3 of Regu

(27) ‘livestock production’ means the production of domestic or domes

(46) ‘feed’ means feed as defined in point (4) of Article 3 of Regu

(69) ‘poultry house’ means a fixed or mobile building for accom

(i) inputs from organic production; in the case of plant repro

(f) in the choosing of plant varieties, having regard to the particu