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Database BfR Recommendations on Food Contact Materials (formerly "Plastics Recommendations")

"Recommendations on the health assessment of plastics and other high polymers" such as paper and rubber (“Plastics Recommendations”) 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 (formerly "Plastics Recommandations).

BfR Recommendations on Food Contact Materials are not legal norms

The BfR Recommendations on Food Contact Materials (formerly “Plastics Recommendations”) 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 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.

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 have been adjusted several times to conform to current laws.

Since 2011 Regulation (EU) No 10/2011 is in force. As a European regulation it is directly legally valid and contains a binding positive list with monomers and additives for the manufacture of materials and articles from plastics which may come into contact with food.

The BfR Recommendations on Food Contact Materials (formerly “Plastics 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. The database also includes recommendations for other materials than plastics (e.g. paper).

The Database

The recommendations are provided online by BfR as Database BfR Recommendations on Food Contact Materials (formerly “Plastics Recommendations”). Access via the BfR website is free of charge. The recommendations can be downloaded. Furthermore, 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.

If an acid, phenol or alcohol or at least one of the aluminium, ammonium, calcium, iron, potassium, magnesium, sodium or zinc salts of the acid, phenol or alcohol is listed in a recommendation, then the other salts of the acid, phenol or alcohol of the salts listed there can also be used (including double salts and acid salts). Any limits established - bearing in mind the different molecular masses - also apply to the other salts included.

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. Additionally petitioners are requested to complete the substance overview (25.5 KB) and add it to the respective documents of the petition. Further information 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 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
  • additionally the non-toxicological part of the dossier as a hardcopy
  • two electronical versions of the complete dossier (both 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.

Given the current situation regarding the European harmonisation of the provisions for plastics intended to come into contact with food pursuant to § 2 No. 3 of the Consumer Goods Ordinance, it is no longer possible to submit applications for the inclusion of additives used in the production of these plastics to BfR. For the corresponding recommendations, applications may henceforth only be submitted for polymerisation production aids and aids to polymerisation.

Questions and comments

Questions and comments can be sent to the following e-mail address: karla.pfaff@bfr.bund.de.

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

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