Food contact materials

In-house documentation
Nordic check lists to industry and trade
Food contact materials
In-house documentation: Nordic check lists to industry and trade

ANP 2008:709
© Nordic Council of Ministers, Copenhagen 2008

ISBN 978-92-893-1645-3
Print: Saloprint, Copenhagen 2008
Design: Par No 1
Copies: 1,300
Printed on environmentally friendly paper
This publication can be ordered on www.norden.org/order.
Other Nordic publications are available at
www.norden.org/publications

Printed in Denmark

Nordic Council of Ministers Nordic Council

Store Strandstræde 18 Store Strandstræde 18
DK-1255 Copenhagen K DK-1255 Copenhagen K
Phone (+45) 3396 0200 Phone (+45) 3396 0400
Fax (+45) 3396 0202 Fax (+45) 3311 1870

www.norden.org

Nordic co-operation
Nordic cooperation is one of the world’s most extensive forms
of regional collaboration, involving Denmark, Finland, Iceland,
Norway, Sweden, and three autonomous areas: the Faroe Islands,
Greenland, and Åland.

Nordic cooperation has firm traditions in politics, the economy,

and culture. It plays an important role in European and international
collaboration, and aims at creating a strong Nordic community in a
strong Europe.

Nordic cooperation seeks to safeguard Nordic and regional

interests and principles in the global community. Common Nordic
values help the region solidify its position as one of the world’s
most innovative and competitive.
Food contact materials
In-house documentation
Nordic check lists1) to industry and trade

Producer
Chemicals/raw materials (starting substances)

Producer
Polymer/intermediates

Producer
FCM

Importer
FCM

Producer
Foodstuffs

Importer/trade
Foodstuffs

Retailer

Consumer

1) Extract
of report; Full text to be found on http://www.norden.org/pub/sk/
Members of this project group consist of the following persons:
Denmark: Bente Fabech, Per Rathmann Hansen and Jan Petersen, Danish Veterinary and Food Administration;
Finland: Pirkko Kostamo, Evira (National Food Administration) and Vesa Tuomaala, Ministry of Industry and Trade;
Iceland: Grimur Olafsson, ­Environmental & Food Agency of Iceland; Norway: Per Fjeldal, Norwegian Food Control
Authority and Sweden: Maria Florin, National Food Administration

3
Food contact materials - In-house documentation: Nordic check lists to industry and trade

A. Introduction
Food contact materials are a potential source of contamination of all types of foods. Foods are
normally in contact with one or several types of food contact materials, like packaging, includ-
ing multilayer materials, process equipment etc.

Food contact materials shall comply with the legislation and in-house control in industry and
trade is a tool to prevent violation of the legislation. Furthermore, in-house control are impor-
tant pre-requisites to limit this contamination, e.g. in-house control based on declaration of
compliance and documentation at the producers and importers.

B. What are food contact materials?

Food contact materials and articles (in the following abbreviated FCM) comprise a broad and
complex area. Many different types of materials are used like plastics, paper, metals, woods,
lacquers, adhesives, printing inks etc. The materials are used either as single materials or
combinations e.g. in complex multilayer materials. Furthermore, many different substances
are used in the materials, as e.g. monomers or additives like plasticizers, stabilisers, solvents
and pigments. An estimation of the total number of chemicals used is 10.000’s and only lower
percent of these chemicals have been assessed by the EU Scientific panels in EFSA2) for the use
in FCM and possible migration and potentials safety effect on consumer health.

C. EU legislation
Regulation no.1935/2004 on materials and articles intended to come into contact with foods
is the framework regulation covering all types of FCM. The general requirements are as follows:

FCM shall – under normal and foreseeable conditions of use – not transfer their constituents
into foodstuffs in quantities, which could:
a. Endanger human health
b. Bring about an unacceptable change in the composition of the foodstuffs or
c. Bring about de­te­ri­o­ration in the organoleptic characteristics thereof.

This regulation applies to FCM, including active and intelligent FCM, which in their finished
state are:

a. Intended to be brought into contact with food; or

b. Already brought into contact with food and are intended for that purpose; or
c. Can reasonably be expected to be brought into contact with food or to transfer their
­constituents to food under normal or foreseeable conditions of use.

The regulation does not apply to FCM which are supplied as antiques, covering or coating
­materials, such as the materials covering cheese rinds, prepared meat products or fruits,
and which form part of the food and may be consumed together with this food nor to fixed
­public or private water supply equipment.

In addition to the general legislation, EU has specific legislation on plastic, ceramics and
regenerated cellulose and on good manufacturing practise at the producers of food contact
materials and the intermediates used for the production of FCM.

The responsibility for observation of the legal requirements is on the producer, user or
­importer of FCM and processed and pre-packed food.

An overview of the EU and Nordic legislation on FCM can be found on the relevant webpages,
please see addresses below.

2) European Food Safety Authority, former Scientific Committee for Food

4
D. In-house control
The starting point for establishing in-house declaration of compliance and documentation is
the legal requirement.

What is in-house control? In-house control is defined as the systematic measures taken by the
business operators to ensure that the requirements set out concerning food contact materials
are fulfilled.

In-house control at the producers and importer of FCM (and food) is the basis for a sustain-
able production or import. The control comprises GMP in the production, and for importers,
knowledge of the GMP at their suppliers. Control on the activities should be based on HACCP
and on declarations of compliance for raw materials and other ingoing materials like FCM from
suppliers.

Who should have in-house control? All links in the production chain from the producers of the
chemicals substances and raw materials over the users in the food industry to the retailers
should have in-house control.

Documentation and declarations of compliance: Compliance shall be documented as part of

the in-house declarations of compliance in industry and trade.

Prerequisites for evaluation of declaration of compliance: The responsible companies in

industry and trade need to have the knowledge of or be acquainting with some specific areas
essential to their assessment of the declaration of compliance.

The responsible companies shall have

a. Relevant knowledge of the types of materials and combinations of materials

b. Relevant knowledge about the legislation, including test conditions3) to be able to
­assess the reliability of the documentation
c. The starting point for the check lists for the establishment of appropriate in-house
documentation is that all links in the chain from the producers of chemicals and other
starting substance are responsible for compliance of the final FCM
d. In-house documentation based on knowledge and trust between trade partners

In general, a declaration of compliance should as a starting point be regarded as adequate

in-house documentation for starting substances, intermediates and the final FCM and their
compliance with the legislation.

In-house control shall ensure that starting materials, including chemicals, intermediates and
final FCM are complying with existing EU legislation and national legislation (if any) and the
minimum requirements in it.

3) The
test conditions for e.g. plastics are included in EU directives, but not discussed in details in the background
report for this brochure.

5
Food contact materials - In-house documentation: Nordic check lists to industry and trade

E. Check lists as guidance for in-house control

The check lists below are meant to be used as guidance with minimum requirements for the
industry and trade in the process of the establishment of in-house documentation in each link
in the chain from the producers of chemicals and other raw materials to the food producers
and the retailer.

General requirements and guidance for in-house control of all types of FCM

a. Legislation: In-house declaration of compliance and documentation is declaration

of compliance with national and EU legislation on FCM, including EU regulation
1935/2004.
b. Updating: The declaration of compliance shall always be updated, when there are
changes such as changes in the legislation or if changes are made in the composition
or production of the FCM (including intermediates). In general, the documentation
shall be revised periodically e.g. once a year.
c. Language: The in-house declaration of compliance and documentation shall be written­
in a language understood by industry and trade and the public food inspection.
In Denmark, Norway and Sweden accepted languages would be the Scandinavian
­languages and English. Finland accepts Finnish, Swedish and English, and Iceland
accept Icelandic and English.
d. Knowledge of suppliers and customers: All links in the chain should have some
­knowledge of the legal frame under which their suppliers and customers work.
A dialog between the stakeholders is needed.
e. GMP requirements are fulfilled and documented, see regulation 2023/2006.
f. Analysis: There are two general points:
• Sampling for analysis shall take place at critical points, like start of production,
after hardening of adhesives etc.
• Analysis should in general follow a standardised method for which the laboratories
have an accreditation.
g. Model calculations: Model calculations of migration from plastics shall follow
­recognized methods for calculation.
h. Documentation availability: In general, detailed information on the FCM should be kept
in each individual link of the chain and not necessary given to customers.

The declaration of compliance and documentation shall be available for authorities on request.

6
 Producers:
Chemicals and raw materials
Chemical substances and other raw materials produced and sold for the production of FCM
shall have documentation for compliance with the requirements set in the EU regulation
1935/2004 and specific measures on the area.

Producers cover the national producers, producers in EU and importers into EU from third
countries. Information given to customers (users – producers of intermediates and FCM):

Minimum requirements in declaration of compliance for chemicals:

a. EFSA opinion of the chemical substances (if available)4)

b. Producers self-assessment and declaration of compliance and documentation on
toxicological testing (in-vitro and in-vivo) in accordance with the EFSA requirements
for FCM5) and
c. Risk assessment of compliance from other countries following guidelines and data
requirements equivalent to the EFSA requirements, like BfR or FDA.
d. Restrictions in other legislation, e.g. if the chemicals are regulated as food additives,
including the requirements for purity and identity.

Please, see also the general requirements.

Minimum requirements in declaration of compliance for raw materials:

a. Wooden fibres, see Nordic report on paper and board

b. Other raw materials: EFSA or other international risk assessments
c. Risk assessment of compliance from other countries following guidelines and data
requirements equivalent to the EFSA requirements, like BfR or FDA.

Please, see also the general requirements.

4) EFSA opinions are available on http://www.efsa.europa.eu/en/science/afc.html. It should be noticed that the

directives and regulations specifically cover several of the chemicals.
5) Such documentation would sometimes be regarded as private property. If such documentation is regarded as

confidential, an abstract with the conclusion of the toxicological risk assessment can be forwarded at the first step.

7
Food contact materials - In-house documentation: Nordic check lists to industry and trade

Producers:
Intermediates like e.g., formulations of printing inks, surface coatings, lacquers,
polymers or master batches
Producers of intermediates like formulations of printing inks etc. have the responsibility of
selecting chemicals, for which a risk assessment is available, and to produce products, which
will comply with the legislation when used in accordance with guidance or instructions of use
given to the user.

Producers cover the national producers, producers in EU and importers into EU from third
countries.

Minimum requirements to suppliers of chemicals and raw materials

a. Name and address of the supplier

b. Traceability
c. Chemical name and CAS-number or for raw materials, generic name e.g. fibres of wood
(species)
d. Declaration of compliance and documentation on risk assessment of the chemical
• Chemicals e.g., monomers and additives on positive lists in the legislation
• EFSA assessment, including report no. (if available)
• Industry risk assessment conducted in accordance with EFSA guidelines
• Risk assessment of compliance from other countries following guidelines and data
requirements equivalent to the EFSA requirements, e.g. BfR or FDA.
e. Risk assessment should include the intended use
f. Information on components subject to specific restrictions, e.g. specific migration
limits or TDIs
g. For dual-use additives, declaration of compliance and documentation on specifica-
tions on purity and identity and quantitative content and information on quantitative
content in the FCM.
h. Information on quantitative content of substances functioning as surface active
­biocide
i. If needed, advice on restrictions in use of the final FCM.

Please, see also the general requirements.

Declaration of compliance and documentation to the customers shall fulfil the demands of the
customer.

8
Producers:
Final food contact materials and articles
Producers of final FCM are producing the FCM from the chemical raw materials and/or from
intermediates. Materials can be suitable for contact with a wide variety of foods under many
different conditions of use, while others would have a limited area of use.

Producers cover the national producers, producers in EU and importers into EU from third
countries.

Minimum requirements to suppliers of chemicals, raw materials and inter­mediates

a. Name and address of the supplier

b. Traceability
c. Declaration of compliance and documentation on risk assessment of the chemical
• Are the chemicals e.g., monomers and additives on positive lists in the legislation
• EFSA assessment, including report no. (if available)
• Industry risk assessment conducted in accordance with EFSA guidelines
• Risk assessment of compliance from other countries following guidelines and data
requirements equivalent to the EFSA requirements, e.g. BfR or FDA.
d. Risk assessment shall include the intended use
e. Information on components subject to specific restrictions, e.g. specific migration
limits or TDIs (e.g., global migration for plastics, specific migration limits in mg/kg to
foods)
f. For dual-use additives, declaration of compliance and documentation on specifica-
tions on purity and identity and quantitative content and information on quantitative
content in the FCM.
g. Information on quantitative content of substances functioning as surface active
­biocide
h. For active or intelligent components, information on maximum (intended) migration,
efficacy and instructions of use shall be requested.
i. If needed, advice on restrictions in use of the final FCM.

Please, see also the general requirements.

Declaration of compliance and documentation to the customers shall fulfil the demands of the
customer.

9
Food contact materials - In-house documentation: Nordic check lists to industry and trade

Producers:
Food industry
The food producing industry is responsible for compliance with the legislation of the FCM they
use for specific uses. Declaration of compliance and documentation in this link shall address
the specific types of food contact and the specific conditions. The food business operator
should have a dialog with the supplier on this.

Producers cover the national producers, producers in EU and importers into EU from third countries.

Minimum requirements to suppliers of final FCM

a. Name and address of the supplier

b. Traceability
c. Declaration of compliance and documentation on risk assessment of the chemical in
the FCM
• Are the chemicals e.g., monomers and additives on positive lists in the legislation
• EFSA assessment, including report no.
• Industry risk assessment conducted in accordance with EFSA guidelines
• Risk assessment of compliance from other countries following guidelines and data
requirements equivalent to the EFSA requirements, like BfR or FDA.
d. Risk assessed includes the intended use, like food types in contact, temperatures,
contact time etc.
e. Information on analysis of migration, including specific test conditions, simulants
used or analysis in foods, duration of the test etc.
f. For dual-use additives, declaration of compliance and documentation on specifica-
tions on purity and identity and quantitative content and information on quantitative
content in the FCM.
g. Information on quantitative content of substances functioning as surface active
­biocide
h. For active and intelligent packaging, information on efficacy
i. For active, emitting packaging, information on minimum and maximum migration.
j. Information on recognised mathematical calculations on migration or other calcula-
tions on other calculations on potential migration where knowledge of the quantitative
content of chemicals in the FCM is used.
k. Advice on conditions and restrictions of use of the final FCM.

Please, see also the general requirements.

Declaration of compliance and documentation to the customers shall fulfil the demands of the
customer.

10
Retailers6)
Retailers are many different types of enterprises. They are handling and/or processing and
storing food at the point of sale or delivery to the final consumer, and includes distribution
terminals, catering operations, factory canteens, institutional catering, restaurants and
other similar food service operations, shops, supermarket distribution centres and wholesale
outlets.

In general,
a. Retailers with production of food are regarded as producers of food and should have the
same declaration of compliance and documentation
b. Retailers with own import of pre-packed food or FCM, are regarded as importers of FCM
and/or packaged food and should have the same declaration of compliance and documen-
tation
c. Retailers with a central trade or production organisation should have access to declaration
of compliance and documentation on request.

The table lists the requirements for documentation at the different retailers:

Type of retailer Requirements for documentation

Produce from na- Remarks
tional or inter-com- Imports for third
munity trade (EU) countries
Retailer type: Food production/sales of pre-packaged food
Production: baker, Same as for food Same as importers Relevant labelling
butcher, restaurant, producers of FCM
take-away etc.
Without production: No documentation** Same as importers
Import of pre-packaged of food
food or sales of pre-
packaged food from
national producer/
importer
Groups of stores with If FCM is used in own Same as importers
central trade or pro- production, same as of food
duction organisation food producers
buying produce from
importers or producers If no production, no
as mentioned above documentation**.
FCM for sales to the final consumer.
From supplier No documenta- Same as importers
tion**, except for of FCM
ceramics
Sales to consumers No documentation** No documentation** Relevant labelling
* Please note, that the labelling requirements have to be fulfilled. The requirements for labelling are found in regula-
tion no. 1935/2004, and include information on whether the FCM is usable in contact with foods, contact time and
temperature and other relevant instructions of use.
Sales of FCM are prohibited, if the labelling is in a language not understood by the consumers.

**It has to be noted, that “No documentation” means that compliance with the legislation must be documented at
the supplier to the retailer, e.g. at food producer who deliver pre-packaged food must have the appropriate docu-
mentation.

6) Trade via Internet is covered by the same requirements as other retailers.

11
Food contact materials - In-house documentation: Nordic check lists to industry and trade

F. EU and Nordic sites with overview on legislation,

guidance etc.:
An overview of the EU and Nordic legislation on FCM can be found on the webpages below7):

EU Commission:
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/legisl_list_en.htm

Danish Veterinary and Food Administration:

www.fvst.dk/fødevaresikkerhed/materialer og genstande.

Finnish Food Safety Authority:

http://www.evira.fi

The Environment and Food Agency of Iceland:

http://english.ust.is

Norwegian Food Safety Authority:

http://www.mattilsynet.no/mat/mattrygghet/emballasje

Sweden National Food Administration:

http://www.slv.se/templates/SLV_Page.aspx?id=8093

7) Other parts of the food legislation are relevant to food contact materials, e.g.,
• Food Law:
Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 on general
principles and requirements in the food law, on establishment of the European Food Authority and procedures
related to food safety.
• Official control:
Regulation (EC) no. 882/2004 of the European Parliament and of the Council of 29. April 2004 on official control
performed to ensure the verification of compliance with (feed and) food law, animal health and animal welfare rules.
• Hygiene: Regulation (EC) No. 852/2004 of the European Parliament and of the Council of 29 April 2004 on
hygiene of foodstuff.
• Food additives:
http://ec.europa.eu/food/food/chemicalsafety/additives/index_en.htm
• Food flavours:
http://ec.europa.eu/food/food/chemicalsafety/flavouring/index_en.htm
• FCM: EU Commission
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm
• FCM/risk assessment: EFSA, AFC-panel (risk assessors for FCM):
http://www.efsa.europa.eu/science/afc/afc_guidance/722_en.html

12
Decision tree for requirements for declaration of compliance and documentation

Step The material Requirement to be fulfilled Nordic guidance Supplemen-

consist of from the tary informa-
homepages tion
1 One layer? If a)
Several lay-  Requirements at steps 3 a-s
ers? (type of material)
Does the ma-
terial contain If b)
chemicals  Requirements at step 3-a-s
regulated in (for the individual layers8).
other parts
of the EU When information is available on
legislation? contents of chemicals under point
c), see also  step 2
2 Food addi- Overview of the EU requirements Food ad-
tives, flavour- are found on ditives are
ings or other regulated
chemicals Food additives in positive
covered http://ec.europa.eu/food/food/ lists and
by specific chemicalsafety/additives/index_ permitted
regulation en.htm to be used
in specific
Flavourings foods within
http://ec.europa.eu/food/food/ specific
chemicalsafety/flavouring/index_ restrictions
en.htm in the food
and labelling
require-
ments.
3-a Adhesives Regulation 1935/2004 Assessment of the Additives,
individual compo- solvents etc.
nents

3-b Cellulose Regulation 1935/2004 This sets a posi- Polymers,

regenerates Commission Directive 93/10/EEC tive list of author- additives
as amended by Directive 93/111/ ised substances
EC and Commission Directive and the conditions
2004/14/EC under which they
can be used.
3-c Ceramics. Regulation 1935/2004 Maximum levels Clay, silicium
Council Directive 84/500/EEC as on lead and cad- oxide, addi-
amended by Directive 2005/31/EC mium tives, surface
+ Assessment coating
of the individual
components
3-d Cork Regulation 1935/2004 Assessment of the Bark of Quer-
individual compo- qus suber,
nents possibly
additives
and surface
coatings

8) A multilayer material can consist of layers of e.g. plastics, metal, printing inks, adhesives and surface coating.

13
Food contact materials - In-house documentation: Nordic check lists to industry and trade

Step The material Requirement to be fulfilled Nordic guidance Supplemen-

consist of from the tary informa-
homepages tion
3-e Glass Regulation 1935/2004 DK: Maximum
levels on lead and
cadmium
+ Assessment
of the individual
components
3-g Leather Regulation 1935/2004 Assessment of the Hide, possi-
individual compo- bly additives
nents
3-h Metals and Regulation 1935/2004 Assessment of the Metals, pos-
alloys individual compo- sibly surface
nents + Council of coatings and
Europe Guideline printing inks
3-i Paper and Regulation 1935/2004 Only for contact Fibres, ad-
board, recy- with foodstuff ditives, con-
cled that are shelled taminants
or peeled before like chemi-
ingestion cals and
microbes
3-j Paper and Regulation 1935/2004 Nordic guideline Fibres, addi-
board, virgin tives
3-k Plastics Regulation 1935/2004 Positive list Polymers,
Commission Directive 2002/72/ for monomers, additives
EC amendments (Directives 92/39/ incomplete list of
EEC, amended by Directive 2004/1/ additives +
EC, Directive 2004/19/EC and Direc- Assessment of the
tive 2005/79/EC. individual compo-
nents
Basic rules for migration tests
are supplied in Council Directive
82/711/EEC and amendments
93/8/EEC and 97/48/EC, Council
Directive 85/572/EEC gives a list of
food simulants to be used in migra-
tion tests for the various types of
foodstuffs.
3-l Printing inks Regulation 1935/2004 Assessment of the Colours,
individual compo- pigments,
nents additives,
solvents
processing
aids
3-m Rubber Regulation 1935/2004 Assessment of Polymers,
the individual additives
components +
maximum level on
nitrosamines in
soothers.
3-n Silicones Regulation 1935/2004 Assessment of the Polymers,
individual compo- additives
nents

14
Step The material Requirement to be fulfilled Nordic guidance Supplemen-
consist of from the tary informa-
homepages tion
3-o Stone Regulation 1935/2004 Assessment of the Different
individual compo- stones,
nents possibly
with surface
coatings
3-p Surface Regulation 1935/2004 Assessment of the Additives,
coatings, individual compo- solvents etc.
including nents
lacquers and
heavy duty
coatings
3-q Textiles Regulation 1935/2004 Assessment of the Cotton,
individual compo- linen, wool,
nents possibly with
additives
3-s Wood Regulation 1935/2004 Genuine Nordic Differ-
species like pine, ent wood
beech, oak and species,
birch can be used, possibly
for other species with surface
assessment of the coatings and
individual species. printing inks

15
St. Strandstræde 18
DK-1255 Copenhagen K
www.norden.org

ANP 2008:709
ISBN 978-92-893-1645-3