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Is testing for specific migration really necessary?

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We are often asked if an overall migration test is sufficient to state compliance with regulation 1935/2004/EC - and the answer to that question is no

An overall migration is a very important part of the documentation needed to prove compliance with regulation 1935/2004/EC - but it is not enough. An overall migration is basically a hygienic precaution to ensure the inertness of the product.

Regulation 1935/2004/EC article 3 states that a product for contact with foodstuff must not

1)     Endanger human health

2)     Bring about an unacceptable change in the composition of the food

3)     Bring about a deterioration in the organoleptic characteristics of the food

-       And this article cannot be complied with on the basis of an overall migration test.

All substances listed in Annex I of Regulation 10/2011/EC have been evaluated and approved for use in the manufacture of food contact materials made of plastic. Some of these substances may change the flavor or the odor of the food - or may have a damaging effect on human health when released to the food. Therefore these substances are restricted by specific migration limits - and a specific migration test is thus a health related / organoleptic related precaution. When a product contains one or more of these substances it must be documented that the limits are complied with. This can be done either by worst case calculations or by testing.

If a manufacturer/importer can obtain sufficient information on the amounts of the substances restricted by specific migration limits from his supplier - he may be able to argue that the limits will not be exceeded even if 100% of the substances migrate. In these cases  tests will not be necessary. If it is not possible to retrieve sufficient information to make such  worst case calculations - or if the calculations show that the limits will be exceeded if all of the substances migrate -  specific migration tests must be conducted. Only by documenting that the specific migration limits in a product are complied with, it can be claimed that the product will not endanger human health and will not bring about a deterioration of the organoleptic characteristics of the food.

Mette Damgaard
M.Sc., Consultancy
+4570224276 / D+4587545711