Smithers Pira food contact expert Dr Alistair Irvine outlines the changes in the recent 7th amendment to EU Regulation 10/2011.
Regulation 752/2017, for the most part, contains some relatively minor tweaks to the legislation for food contact plastics and has introduced six new substances to the positive list contained in Annex I of EU Regulation 10/2011. From the substances which have been newly approved, the most notable addition is for a clay based additive which is also permitted for use in its nanoform.
The European Food Safety Authority, who risk assess food contact substances on behalf of the European Commission, have historically been cautious about materials in nanoform, so this is an interesting development.
Whilst there are no substances that have been deleted from the positive list of approved plastics ingredients, there is a new specific migration limit of 0.02mg/kg introduced for nickel and which will take effect from May 2019. This is not to say that all food contact plastics would need to be tested for the migration of nickel as of this date, however whenever a substance containing nickel is used in plastics it might require testing.
EU Regulation 752/2017 also contains a new version of the table detailing the food simulants that are to be used when testing compliance with the overall migration requirements of the legislation.
Perhaps the most significant change introduced by this regulation is a requirement which relates to the food contact Declaration of Compliance. In many cases, there will now be a requirement to state the maximum ratio of surface area to volume for which compliance with overall and specific migration limits has been demonstrated in line with the requirements of Articles 17 and 18 of EU Regulation 10/2011.
It should be noted though that Article 17 still lists a significant number of situations where the assessment should be carried out on the basis of 6dm2 of packaging per kg of food.
For advice on how this new regulation might impact your food contact materials, please contact Alistair.
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