The plastics regulation was adopted in 2011 to apply to all food contact plastics, replacing an existing fragmentary legislative approach to these materials.
Regulation 10/2011 and its amendments are an implementing measure under the framework Regulation 1935/2004, and are consequently commonly referred to as the plastics implementing measure (PIM).
The main feature of the 2011 law is a consolidated Annex I of monomers and additives approved for use in food contact materials, known as the positive list. The European Food Safety Authority (EFSA) has developed guidance on how to submit a dossier for a new substance to be evaluated for inclusion in the annex.
As with previous amendments, Regulation 2016/1416 has added substances to this annex, 10 in total that have already been evaluated by the EFSA. It also makes minor corrections and clarifications to the original text. The most significant changes are to other elements of Regulation 10/2011 though.
About 900 substances are listed in the annex to the PIM. Roughly 60% of these are controlled with specific migration limits (SML), residual limits, or some other type of restriction. The new edition deletes the generic specific migration limit (SML) of 60mg/kg in Article 11.2 – a default value applied to any substance that had no SML or other restrictions.
The removal is explained by the fact that the absence of prescribed limits for the substances reflected a prior-held view. The specifications were deemed unnecessary to ensure compliance with the overarching safety criteria of Regulation 1935/2004.
The sixth amendment also lowers the SML for zinc from 25mg/kg to 5mg/kg food; and introduces a new SML for aluminium of 1mg/kg.
Another significant move arises from the authorisation of three substances: a polymeric antistatic additive in hydrophobic plastics; a monomer with ethylene glycol to produce polyethylene furanoate polymer; and a co-monomer to replace ethylene glycol in polyethylene terephthalate. Their existing approvals restrict the migration of the low-molecular-weight oligomeric fraction less than 1,000 daltons to a total of 50μg/kg food.
The amendments entered into force on 14 September 2016 with one caveat and one exception. Materials and articles complying with the pre-amendment PIM may be placed on the market until 14 September 2017 and remain there until stocks are exhausted. The new provisions on the SMLs for aluminium and zinc apply from 14 September 2018.
This article was first published in Food Contact World, available by subscription.
Smithers Pira offers a range of migration testing and consultancy services to enable you to demonstrate regulatory compliance.
Contact Alistair Irvine, Food Contact Compliance