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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 (Plastic 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. These are announced in the Bundesgesundheitsblatt - Gesundheitsforschung – Gesundheitsschutz (monthly federal publication on health, health research and health protection) as notices. BfR publishes updated recommendations in the Database BfR Recommendations on Food Contact Materials (formerly “Plastics Recommendations”)

BfR Recommendations on Food Contact Materials are not legal norms

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 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. If consumer goods are produced or used in a manner that deviates from the provisions of the recommendations, the manufacturer or user may receive complaints based on food law provisions (§§ 30, 31 para 1 LFGB).

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:

In 2000 the Plastics Recommendations were revised completely. The recommendations for those plastics that are categorised under the term for plastics according to § 2, No. 3 of the German Consumer Goods Ordinance no longer lists those monomers and additives which are already regulated by this Ordinance. The details describing the polymer matrix in the corresponding recommendations, to which the assessment of the polymerisation production aids and additives not yet regulated by the Consumer Goods Ordinance refers, are merely provided by way of information. They are no longer part of the BfR recommendations.

In August 2006, the Recommendations were once again revised in order to accommodate the necessary changes that resulted when the Act on Foods and Commodities (LMBG) was replaced by the Food and Feed Code (LFGB).

Further changes were necessary as a result of the fifth amendment of the “Plastics Directive” (Commission Directive 2002/72/EC). The Directive specifies that as from 1 January 2010 only those additives included in the “Community list of additives” may be used for the manufacture of plastic materials and articles. Exceptions to this are listed in the “Provisional List of Additives”. Substances in this list have already been evaluated by the European Food Safety Authority (EFSA).

In 2011 the COMMISSION DIRECTIVE 2002/72/EC relating to plastic materials was replaced by the COMMISSION REGULATION (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

As of 2010, the BfR Recommendations on Food Contact Materials therefore only contain substances for which there are no harmonised EU regulations, i.e. constituents of catalytic systems (catalysts and initiators, aids to polymerisation) as well as polymerisation production aids (PPA). The recommendations XVIII “Melamine Resin Compression Moulding Materials” and XXVI “Cellulose Acetate and Cellulose Propionate” solely contained substances that are within the scope of the Consumer Goods Ordinance. Both recommendations were therefore withdrawn as of 31 December 2009.

Those recommendations that are concerned with materials that are regulated by the Consumer Goods Ordinance (e.g. silicone, latexes, hard paraffins, microcrystalline waxes, rubber, paper and cardboard) are not subject to any changes.

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 and add it to the respective documents of the petition.

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 foods 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 components of the catalytic system (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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