Directives and Ordinances

Plastics / food contact

Kindly refer to the following list for the polycarbonates which comply with the recommendations of the BfR and the provisions of the EU or the USA.

Product	German		English
	EU	USA	EU	USA
Makrolon®

Plastics for food contact applications

The most important requirements for materials for food contact applications are defined e.g. in Art. 31 of the German Foods and Commodities Act (LMBG):

"Commodities must be of such a nature that they cannot cause damage to health when used for the intended purpose or in a foreseeable manner. Moreover, it is forbidden to use ... commodities ... commercially, or to put them into circulation, for applications in which substances can pass from them to foods or the surfaces thereof, excluding components which are harmless in terms of health, taste and odour and which are technically unavoidable."

These requirements are also included in similar form in the food law provisions of all other EU countries, the USA, etc. Only the requirement "technically unavoidable" is expressed differently there, using terms such as Good Manufacturing Practice.

The provisions of food law include so-called positive lists as essential elements. These list the permissible starting materials, either in the form of overall lists or broken down according to polymer classes.

The starting materials, e.g. monomer units, auxiliaries or additives, may be regulated by limit values, such as the quantity used, or the residual content in the article, or specific migration limits.
If unlisted monomer units, auxiliaries or additives are to be used in the production of commodities, applications involving extensive data (material properties, technical application, complete data on migration, toxicological data) have to be submitted for inclusion in the positive lists.

Except in France and the USA, this so far does not apply to coloured materials. In view of the vast number of colours and the wide variety of requirements, you are requested to contact BMS-HSEQ-Application and Product Support if, for example, you intend to use a particular colour shade.

EU Member States

In connection with the establishment of the single European market in the EU, there was a need to create uniform assessment criteria for plastics intended for food contact applications. EU Directives were elaborated to this end.

The provisions of the EU Member States concerning plastics for food contact applications will remain highly complex and confusing for the time being.

The monomer units of plastics as well as a growing number of additives are regulated by EU Directives and their implementations in national regulations, e.g. the Commodities Regulation in Germany.

In contrast, there are not yet any definitive EU regulations for all further components of plastics (further additives, polymerisation aids, colorants, etc.). Consequently, these have to comply with the occasionally differing national provisions/positive lists, insofar as these are defined in detail. In Germany, additives, etc. thus still have to comply with the "BfR" (Bundesinstitut für Risikobewertung, former . BGA resp. BgVV -)- recommendations.

Kindly refer to the a/m list for the polycarbonates which comply with the recommendations of the BfR and the provisions of the EU.

USA

The structure of food legislation in the USA is similar to that in Germany. The FDA regulations, the "Code of Federal Regulations of the Food and Drug Administration", have the same basic structure, but with slight differences and some special features, particularly as regards coloured plastics.