Overview "Databases"

Database Plastics Recommendations

"Recommendations on the health assessment of plastics and other high polymers" like paper and rubber (Plastic Recommendations) were first issued in 1958. Initially the Federal Health Office (BGA) was responsible for the Plastics Recommendations, and this task was then transferred to BgVV in 1994. In November 2002 BfR was put in charge. For the elaboration of the recommendations, BfR is advised by its Committee for Consumer Products.

The recommendations were elaborated within the framework of the Act on Foods and Commodities (Lebensmittel- und Bedarfsgegenständegesetz - LMBG) that has been replaced by the Food and Feed Act (Lebensmittel - und Futtermittelgesetzbuch - LFGB. Regarding the migration of substances to foods from consumer goods that come into contact with food, the LFGB refers to Article 3, para 1 of the EC Regulation 1935/2004 on materials and articles intended to come into contact with food.

Plastics Recommendations are not legal norms

The Plastics Recommendations are not legal norms. They do, however, represent the current state of science and technology for the conditions under which consumer goods made of high polymer substances meet the requirements of § 31, Para. 1, LFGB (Article 3, Para. 1 a Reg. (EC) No.1935/2004) in respect to their health safety. According to these provisions, materials and articles that come into contact with food are to be produced in compliance with good manufacturing practice in such a way that, under normal or foreseeable conditions of use, they do not transfer their constituents to foods in quantities which could endanger human health. If consumer goods are produced or used in a manner that deviates from the provisions in these recommendations, responsibility for any complaints based on food law provisions (§§ 30, 31 Para. 1 LFGB) lies solely with the manufacturer or user, respectively.

Considerations of statutory provisions

The Plastics Recommendations are aimed at the European legal position and its transposition into national legislation. To reflect the situation in terms of legal enforcement, a fundamental review of the recommendations was undertaken in 2000. For those plastics which fall under the plastics definition in § 2 No. 3 of the Consumer Goods Ordinance, the monomers and additives regulated in this Ordinance were no longer listed in the respective recommendations. 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.

Another revision of the recommendations, made available in August 2006, allowed the implementation of changes required due to the replacement of the LMBG with the LFGB.

The fifth amendment of the “Plastics Directive” (Commission Directive 2002/72/EC) determines that as of 1 January 2010 only additives listed in the “Community list of additives” are permitted for the manufacture of materials and articles that come into contact with food. Notwithstanding, additives listed in the EU Commissions’ “Provisional List of Additives” are still permitted for use according to national set provisions. The list can be found below under “External Links”:

For substances in the provisional list the required documentation has been provided to EFSA, however the assessment has not yet been completed. Once the assessment has been concluded, the substances are either included in the community list or deleted from the provisional list if the EU Commission has decided not to include the substance in the community list.

For the Plastics Recommendations only substances that are listed in the provisional list are intended to be considered. The revised recommendations are expected to be published by 2009. Additional information on this can be found in the minutes of the 122nd Plastics Committee meeting. The minutes can be found below.

Amendments to the database version of the Plastics Recommendations will be published in the Bundesgesundheitsblatt (Federal Health Gazette) (Springer Publishing House, Heidelberg.

The database Plastic Recommendations

The recommendations were published on the Internet by BfR as “Database Plastic 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.

Please note the following: 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 here can also be used (including double salts and acidic salts). Any limits established - bearing in mind the different molecular masses - also apply to the other included salts.

New substances

New substances are included in the recommendations through application by the manufacturer to BfR. The application must be submitted on the basis of the European Commission’s Note for Guidance which can be downloaded from the link below. Additionally petitioners are requested to complete the substance overview and add it to the respective documents of the petition. A template can be found below.

For the deliberations of the applications at the meetings of the Committee for Consumer Products in April and November, the data must be submitted to BfR by 15 January and 15 August respectively. Two full copies plus one further copy without the data on toxicology are to be submitted. In addition, the data are to be submitted on a CD in an easily researchable format, e.g. as PDF-files). 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 according 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 plastics to the BfR. For the corresponding recommendations, applications may only be submitted henceforth for polymer production aids and components of the catalytic system (aids to polymerisation).

However, there are no changes to the recommendations concerning materials other than those regulated in Directive 2002/72/EC (silicones, dispersions, hard paraffins and microcrystalline waxes, rubber, paper, carton and paperboard).

Questions and comments

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

Without approval of the BfR, further commercial use of the recommendations is prohibited.