In January 2011, the European Union published Regulation 10/2011 that established specific requirements for plastic materials and articles which are intended or could reasonably be expected to come into contact with food, or are already in contact with food.
This regulation applied to:
- materials and articles, and parts thereof, consisting exclusively of plastics;
- plastic multi-layer materials and articles held together by adhesives or by other means;
- materials and articles referred to above that are printed and/or covered by a coating;
- plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
- plastic layers in multi-layer materials and articles.
and it specified the list of substances that are allowed for use in the manufacture of plastic food contact materials, restrictions on the use of these substances and rules to determine the compliance of plastic materials and articles.
In particular, the Regulation was concerned about health risks deriving from certain substances which are used in the manufacture of plastics and which can be transferred into food via migration from the plastic food contact materials. Only substances included in Annex I to Regulation 10/2011 were allowed to be used.
Regulation 10/2011 has now been reviewed eight times since it was issued in 2011. The initial seven amendments were concentrated on the authorized substances contained in Annex I while the latest, the Regulation 2017/752 published on 29 April 2017, amends Annexes I, II, III and IV to Regulation 10/2011. The new Regulation contains a number of significant changes, such as:
- Inserting six new substances to the authorized list of substances;
- A new entry for the specific migration of nickel, restricting it to no more than 0.02 mg/kg in point 1 to Annex II;
- Editorial changes to Table 3 in point 4 to Annex III;
- Replacing the residual content requirement for 10 substances with specific migration limits.
Regulation 2017/752 entered into force on 19 May 2017, but it allows food contact plastics which complied with Regulation 10/2011 and further amendments to be placed on the market until 19 May 2019.
The Regulation 2017/52 can be downloaded at the following link.