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Regulation on Food Contact Materials Amended and Corrected by Means of Several Provisions

On 14 September 2016, new Commission Regulation 2016/1416, published in the EU’s Official Journal, entered into force. This new Regulation amends and corrects Commission Regulation 10/2011 on plastic materials and articles intended to come into contact with food. The latter-mentioned law which was adopted in 2011, and which is now amended, is important as it updated and consolidated the rules related to plastics coming into contact with foodstuffs.

Indeed, the 2011 Regulation sets out rules on the composition of plastic food contact materials, and is particularly noteworthy for its Union List of substances that are permitted for use in the manufacture of plastic food contact materials. The 2011 Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.

Hong Kong’s economic operators exporting foodstuffs and plastic containers or materials intended for food storage, should familiarise themselves with the new amendments of which there are several. The text notes that, since the Regulation’s adoption, the European Food Safety Authority has published further reports on particular substances that may be used in food contact materials as well as on the permitted use of substances that have been authorised previously. In addition, certain textual errors and ambiguities were identified. In order to ensure that the 2011 Regulation reflects the most recent findings of the Authority and in order to remove any doubt as regards its correct application, Regulation 10/2011 needs to be amended and corrected.

While there are dozens of such amendments and corrections, listed below are a few that might interest Hong Kong’s economic operators:

  • The definition of ‘non-fatty foods’ in point (16) of Article 3 of the 2011 Regulation contains a reference to food simulants laid down in an annex to that Regulation. As the definition was intended to refer to food simulants listed in Table 2 of Annex III, the reference has to be corrected accordingly.
  • Regulation 10/2011 uses the term ‘hot-fill’ in the context of setting restrictions on the use of certain authorised monomers in materials and articles intended to act as a receptacle for hot food. In order to clarify the scope of such restrictions, the Commission deems it appropriate to provide a definition of the term specifying the temperatures at which such restrictions apply.
  • As specific migration limits are expressed in mg/kg food, the same measurement unit should also be used for the verification of compliance of a cap or closure, as a consistent approach avoids the potential for conflicting results. It is therefore deemed appropriate to remove the option to express the migration from caps or closures in mg/dm2.
  • The European Food Safety Authority has adopted a scientific opinion on the safety of aluminium from dietary intake, which establishes a tolerable weekly intake of 1 mg aluminium per kg body weight per week. Applying the conventional exposure assumptions for food contact materials, the migration limit would have to be set at 8.6 mg/kg food. The opinion, however, notes that the current dietary exposure of a significant part of the Union's population likely exceeds this level. Therefore, it is now deemed appropriate to limit the contribution from exposure by food contact materials to the overall exposure. Therefore, a migration limit for aluminium of 1 mg/kg food is now considered appropriate for food contact materials, and the 2011 Regulation must be amended accordingly.
  • Similarly, that Authority has adopted a scientific opinion on dietary reference values for zinc. This confirms the opinion expressed by the Scientific Committee on Foods (SCF) in 2002 which sets the tolerable upper level of zinc for adults to 25 mg per day. In Annex II to Regulation 10/2011, the migration limit for zinc is set at 25 mg/kg food. As dietary exposure from other sources significantly contributes to the total exposure, it is now deemed appropriate to amend the migration limit specified in Annex II to the Regulation to 5 mg/kg food.


While new Regulation 2016/1416 entered into force on 14 September 2016, the provisions on (among others) the specific migration limits for aluminium and zinc will only have to apply as from 14 September 2018.

Please click on the following to view:
Commission Regulation 2016/1416 amending and correcting Regulation 10/2011.
Commission Regulation 10/2011 on plastic materials and articles.

Content provided by Picture: HKTDC Research
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