BfR Recommendations on Food Contact Materials
Recommendations on the health assessment of food contact materials have been issued by BfR and its predecessors since 1958. The inclusion of new substances as well as alignment with current regulations require that the recommendations are adjusted on a regular basis. The respective amendments are announced in the Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz (monthly federal publication on health, health research and health protection).
BfR publishes updated recommendations in the Database BfR Recommendations on Food Contact Materials.
The BfR Recommendations on Food Contact Materials are not legal norms. They do, however, represent the current state of the scientific and technical knowledge for the conditions under which consumer goods made of high polymer substances such as silicones, paper, and rubber meet the requirements of § 31, para 1, German Food and Feed Code (Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch, LFGB) as well as those of Article 3, para 1 a of the Regulation (EC) No 1935/2004 in respect to their health safety.
According to these provisions, materials and articles that come into contact with food shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health.
The BfR Recommendations on Food Contact Materials are based on European law and its transposition into national law. In order to take this into account, the recommendations are continuously adjusted to conform to current laws.
The focus of the BfR Recommendations on Food Contact Materials was originally on plastic food contact materials. For plastics a mandatory European regulation (Regulation (EU) No 10/2011) has entered into force. Therefore, the BfR Recommendations only contain those substances for which there are no harmonised EU regulations: In the field of plastics these are aids to polymerisation, e.g. constituents of the catalytic system (catalysts and initiators), as well as polymerisation production aids like e.g. emulsifiers, which are needed in the manufacturing process. For the assessment of other not specifically regulated food contact materials such as silicones, paper, and rubber the Recommendations can still be used.
The recommendations are provided online by BfR as Database BfR Recommendations on Food Contact Materials. Access via the BfR website is free of charge. The recommendations can be downloaded.
CAS numbers were assigned to the listed substances as far as possible. This enables database searches using both the substance name as well as the CAS number.
All salts of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols can be used. Any limits established - bearing in mind the different molecular masses - also apply to the other salts included. The specific migration limits set out in Regulation (EU) No 10/2011, Annex II (1) shall be complied with. If deviating limits are specified in the individual recommendations, these deviating limits apply specifically to the material.
Unless otherwise indicated the listing is based on the risk assessment of the substances in conventional particle size and does not cover engineered nanoparticles.
New substances are included in the BfR Recommendations on Food Contact Materials upon application by the manufacturer to BfR. The application must be submitted on the basis of the EFSA Note for Guidance.
Until further notice, new poly- or perfluorinated substances (PFAS) will not be included in the BfR recommendations. Prior to a final decision questions concerning mobility and persistence in the environment (via production processes, waste disposal and recycling) and the contamination of air and drinking water have to be addressed.
If for filling data gaps a read-across approach is used the revised ECHA guidance for grouping substances and read-across shall be used accompanied by a scientific justification for this approach.
Submitting companies are requested to complete the substance overview (PDF file,25.50 KB) and add it to the respective documents of the petition.
Further information (PDF file,44.70 KB) should be observed in case of applications for the addition of substances to recommendations XXXVI, XXXVI/1, and XXXVI/2 (Recommendations on paper and board).
For consideration of the applications at the meeting of the BfR Committee for Consumer Products in April and November, the following data must be submitted to BfR by 1 December of the previous year and 1 July respectively:
- a complete version of the whole dossier as a hardcopy
- an electronical version of the complete dossier (on CD in an easily researchable format, e.g. as PDF- or DOC-file)
- If the application contains confidential data, an additional CD excluding the confidential data is needed. For requests according to the freedom of information act only non-confidential data is forwarded.
- The petitioner confirms to be the rights holder or to be assigned by the rights holder.
Please send the documents to the following address:
German Federal Institute for Risk Assessment (BfR)
D - 10589 Berlin.
For the recommendations concerning plastics, applications may henceforth-only be submitted for polymerisation production aids and aids to polymerisation. Given the current situation regarding the European harmonisation of the provisions for plastics intended to come into contact with food applications for the inclusion of monomers and additives used in the production of these plastics have to be made on European level. Further information on the authorization process can be obtained here.
Questions and comments
Questions and comments can be sent to the following e-mail address: firstname.lastname@example.org.
No commercial use of the Recommendations is permitted without the prior approval of BfR.