Regulation and the use of rubber as a food contact material

At the moment there is no specific EU legislation for rubber food contact materials or articles (other than nitrosamines in babies dummies). All such materials or articles need to comply with the general Eramework Directive 89/109/EEC so that in normal use they will not transfer their constituents to food in quantities that could endanger health or cause unacceptable changes in the composition of food or deterioration in its organoleptic properties (i.e. taste, texture, aroma, or appearance). 

The Council of Europe s Rubber Resolution on food contact elastomers contains an inventory list of additives and a small section that deals with breakdown products - nitrosamines and amines. The inventory list is described as Technical document No. 1 - List of substances to be used in the manufacture of rubber products intended to come into contact with foodstuffs . This and other relevant Council of Europe documents are available on the Internet website of the Partial Agreement Division in the Social and Public Health Field www.coe.int/soc-sp. 

In addition to the Technical Document No 1, there are four other documents in the series of statements concerning rubber products intended to come into contact with foodstuffs  

Resolution APRes (2004) places mbber products into one of three categories  

These three categories take into account the wide variety of applications for which rubber products are used and the fact that migration may vary with the application. The level of migration for rubber products may be estimated by taking into account four factors, Ri, R2, R3 and R4, referring respectively to the relative contact area, contact temperature, contact time and number of times that the article is used. Categories are based on the intended use or on the result of multiplying the four factors (Ri x R2 x R3 x R4 = R-total). The factors R, R2, R3 and R4 can be defined as follows  

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