Analysis of the migration from elastomers used for food contact materials

Project

Project code: BfR-CPS-08-1322-497
Contract period: 01.03.2011 - 01.12.2016
Purpose of research: Experimental development

Elastomers are used for the production of a number of food contact materials. Art. 3 Paragraph 1 of the Framework Regulation (EC) 1935/2004 (L338/4) states that food contact materials shall be safe and that they shall not transfer their components into the food in quantities that could endanger human health. In order to verify if the legal principles concerning the release of additives, impurities as well as reaction products from food contact materials made of elastomers is respected, it is important to study the status quo, in which the transfer of these components into foodstuff occurs. Based on the scientific data, the need for risk management measures shall be considered. 2016: Natural and synthetic rubbers known as elastomers are used by the rubber manufacturers to produce a series of materials such as seals and tubes which are intended to come into direct contact with food. Art. 3 Paragraph 1 of the Framework Regulation (EC) 1935/2004 (L338/4) states that food contact materials shall be safe and that they shall not transfer their components into the food in quantities that could endanger human health. For groups of materials and articles listed in Annex I, specific measures may be adopted. Silicone and rubber are listed in Annex I but specific measures have not yet been adopted. As a consequence, these materials are regulated at national level, in Germany by the BfR recommendation XXI. Currently, recommendation XXI is revised, leading partly to a re-assessment of substances. Rubber materials contain additives used to change the physical and chemical properties and to optimize specific polymer properties. Common additives are vulcanizing agents, antioxidants, accelerators, retardants, stabilizers and plasticizers. These are generally present at low levels but may migrate into the food and then be ingested by the consumer. However there is currently limited information on the nature and level of the transfer of these substances. In order to verify if the legal principles concerning the release of additives, impurities as well as reaction products from food contact materials made of elastomers is respected, it is important to study the status quo of the levels at which the transfer of these components into foodstuff occurs. Knowledge on the release is necessary for the risk assessment of these substances and to define the need for action with regard to risk management. According to the available data, this knowledge may be incorporated into BfR recommendation XXI.

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