Recommendations: (Text With EEA Relevance)
Recommendations: (Text With EEA Relevance)
Recommendations: (Text With EEA Relevance)
RECOMMENDATIONS
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
Whereas:
(1) Mineral oil hydrocarbons (MOH) are chemical compounds derived mainly from crude oil, but also produced
synthetically from coal, natural gas and biomass. MOH can be present in food through environmental contamina
tion, lubricants for machinery used during harvesting and food production, processing aids, food additives and
food contact materials. Food grade MOH products are treated in a way that the mineral oil aromatic
hydrocarbons (MOAH) content is minimised.
(2) In 2012 the Scientific Panel on Contaminants in the Food Chain (CONTAM Panel) of the European Food Safety
Authority (EFSA) concluded (1) that the potential human health impact of groups of substances among the MOH
vary widely. MOAH may act as genotoxic carcinogens, while some mineral oil saturated hydrocarbons (MOSH)
can accumulate in human tissue and may cause adverse effects in the liver. As some MOAH are considered
mutagenic and carcinogenic, it is important to organise monitoring of MOH to better understand the relative
presence of MOSH and MOAH in food commodities that are major contributors to dietary exposure.
(3) As migration from food contact materials such as paper and board packaging is suspected to contribute signifi
cantly to the total exposure, monitoring should include pre-packaged food, the packaging material and the
presence of functional barriers, and equipment used for storage and processing. Certain parameters may increase
the migration of MOH from packaging into food, such as storage time and storage conditions. As MOH are easier
to detect in high quantities, the sampling strategy should take account of such parameters when their migration
is highest.
(4) To ensure reliability of the obtained analytical data, Member States should ensure the availability of suitable
analytical equipment and gain sufficient experience in the analysis of MOH both in food and in food contact
materials before generating analytical results.
(5) To ensure the uniform application of this recommendation, the European Union Reference Laboratory for Food
Contact Materials (EU-RL) should provide further guidance to the competent authorities of the Member States
and other interested parties, including guidance on information that could be collected during investigations as
well as methods of sampling and analysis,
1. Member States should, with the active involvement of food business operators as well as manufacturers, processors
and distributors of food contact materials and other interested parties, monitor the presence of MOH in food during
2017 and 2018. The monitoring should cover animal fat, bread and rolls, fine bakery ware, breakfast cereals, confec
tionery (including chocolate) and cocoa, fish meat, fish products (canned fish), grains for human consumption, ices
and desserts, oilseeds, pasta, products derived from cereals, pulses, sausages, tree nuts, vegetable oils, as well as food
contact materials used for those products.
(1) EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Mineral Oil Hydrocarbons in Food. EFSA Journal
2012;10(6):2704. p. 185 pp., doi:10.2903/j.efsa.2012.2704.
L 12/96 EN Official Journal of the European Union 17.1.2017
2. To ensure uniform application of this recommendation and in order to generate reliable and comparable results of
the monitoring, specific guidance developed by the EU-RL in the context of this Recommendation (the guidance)
should be followed. As such guidance does not exist yet, the Member States should collaborate with the EU-RL to
jointly develop that guidance in accordance with their needs for developing analytical capabilities.
3. Member States should perform food sampling in accordance with the provisions laid down in Commission
Regulation (EC) No 333/2007 (1). Sampling should include a proportionate number of pre-packaged foods. Sampling
of food contact materials should be carried out in accordance with the best practices appropriate for specific
materials or articles as reflected in the guidance. Further possible sources of MOH related to the use of other food
contact materials in the supply chain, such as during storage or processing, should be investigated where there is
a clear indication that these are contributing to the presence of MOH. The sampling of pre-packaged food should
focus on commodities that are closer to the end of the minimum date of durability, and where storage or processing
takes place at relatively warm conditions.
4. The samples should be analysed as marketed. For pre-packaged food, the level of mineral oil hydrocarbons should be
determined both in the food and in the food contact material if that is the suspected source of detected MOH.
Particular attention should be paid to the differences between MOSH and MOAH and to the interpretation of the
analytical results to ensure that the generated data are reliable and comparable. Member States which intend to
analyse the presence of MOSH and MOAH in foods and food contact materials may request technical assistance of
the EU-RL for Food Contact Materials.
5. Where MOH are detected in food, Member States should carry out further investigations in the food business
establishments in order to determine the possible source or sources. The investigations should, wherever possible,
cover the systems operated by the food business operator that could affect or control contamination (e.g. production
and processing methods, Hazard Analysis and Critical Control Points (HACCP) or similar systems or measures
implemented to prevent such presence).
6. Where MOH are detected in or originate from food contact materials, Member States should collect data on the food
contact material (e.g. type and composition of the packaging material, presence of functional barrier, shelf life of the
packaged food) and carry out further investigations in the establishments of the manufacturers, processors and
distributors of food contact materials to establish the systems operated by the businesses concerned (e.g. production
and processing methods of food contact material, and documentation required under Commission Regulation (EC)
No 2023/2006 (2) on good manufacturing practices) as indicated in the guidance.
7. Member States, food business operators, manufacturers, processors and distributors of food contact materials and
other interested parties should provide to EFSA the monitoring data expressed on whole mass basis with the
information and in the electronic reporting format as set out by EFSA for compilation into a single database. They
should preferably provide the monitoring data by 1 October 2017 and subsequently by 1 October 2018. The last
results should be provided by 28 February 2019. Potentially available occurrence data from 2016 that has not yet
been provided should be transmitted in accordance with the same modalities at the earliest opportunity.
(1) Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control
of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs (OJ L 88, 29.3.2007, p. 29).
(2) Commission Regulation (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).