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.

Legal relevance

The BfR recommendations on food contact materials are not binding legal standards. However, they represent the current state of science and technology for the conditions under which food contact materials made of highly polymeric substances such as silicones, paper and rubber fulfil the requirements of Article 3(1)(a) of Regulation (EC) No 1935/2004 with regard to their safety to health. In addition, in some cases, the good manufacturing practice recommendations contain corresponding requirements for compliance with the requirements of Article 3(1)(b) and (c) of Regulation (EC) No 1935/2004.

According to Regulation (EC) No 1935/2004, Article 3(1), food contact materials and articles shall be manufactured in accordance with good manufacturing practice in such a way that, under normal or foreseeable conditions of use, they do not transfer to food in quantities likely to

a) endanger human health; or

b) cause an unacceptable change in the composition of the food, or

c) cause an impairment of the organoleptic properties of the food.

According to Section 31 (1) of the German Food, Commodities and Feed Code (LFGB), articles that do not meet these manufacturing requirements may not be used or placed on the market.

Legal basis

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 Database

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.

Listed substances

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

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-Datei, 13,64 KB) and add it to the respective documents of the petition.

To apply for the addition of substances to the BfR recommendations or for the modification of substance entries, the following information (PDF-Datei, 665,92 KB) should be observed. Please also consider the BfR Guideline for "Testing of substance transfers from consumer articles made of paper, cardboard and paperboard" (PDF-Datei, 199,15 KB)

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 electronic version of the complete application in a searchable format, e.g. as a Word document or PDF (to be uploaded to a BfR server or submitted on a data storage medium).
• 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)
FG 74
Max-Dohrn-Str. 8-10
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: 74@bfr.bund.de.

No commercial use of the Recommendations is permitted without the prior approval of BfR.