16th amendment: updates to EU Regulation 10/2011

16th amendment: updates to EU Regulation 10/2011

Our regulatory expert discusses a possible amendment to the Plastics Regulation (EU) No 10/2011 and its impact on food contact materials.

The 16th amendment

The European Commission has circulated a preliminary draft text for what would be, if adopted in its draft scope, a significant 16th amendment to Regulation (EU) No 10/2011. This comes at a time when some members of the food packaging industry in Europe are seeking progress in areas of non-harmonized legislation such as paper and inks, rather than more detail on materials that already have detailed specific measures. It is interesting to note therefore, that the focus of the Commission appears to be on a detailed review of Regulation (EU) 10/2011. In a previously published opinion of April 2020, EFSA reviewed 451 compounds listed in 10/2011 without specific migration limits (SMLs) and generated a list of 284 substances requiring further review.

These have been classified into three groups as follows:

  1.  Low priority: 179 substances
  2.  Medium priority: 102 substances
  3.  High priority: styrene, lauric acid vinyl ester and salicylic acid  

The draft 16th amendment deletes the listing for two of the three substances in the high priority category from Annex 1 of the Regulation and adds a procedure to allow for their continued use, subject to a valid application. In addition, the amendment revokes the listing for wood flour following an EFSA opinion of 24 October 2019 that wood species cannot be assumed to be risk-free.

A new approach to transitional provisions is included, intended to avoid disruption to the supply chain. In summary, the draft amendment addresses the following:

  • Limits for phthalates.
  • Deletes entry 96 “Wood flour and fibres untreated” from Annexe 1, but allows wood species upon a valid application on a case-by-case basis.
  • The use of substances subject to the biocidal product regulation. The draft amendment authorises the use of substances not on the Union list, or Provisional List, subject to compliance with the EU Biocidal Product Regulations, Regulation No 528/2012 (BPR). That would mean that biocidal additives and production aids would be controlled under the BPR. The Provisional List would then be deleted (as there now only remain biocides on that list) together with Article 7 of EU 10/2011.
  • It removes lauric acid vinyl ester and salicylic acid from Annex I subject to specific transitional provisions
  • Allows the use of certain microbial manufactured substances without specific authorisation
  • Defines rules for the processing of in-process recycled polymer off-cuts and scraps
  • Sets out explicit labelling requirements to communicate restrictions listed in column 10 of Annex I
  • Corrects and clarifies some text ambiguities.

Finally, the 16th amendment, if published in its present draft scope, will provide an interesting opportunity to observe how the UK government will update Great Britain food contact legislation and how this will be adopted in the devolved nations. As significant changes are made to EU legislation, the extent to which Great Britain remains aligned will become clear.

How Smithers can support

With over 30 years’ experience helping clients comply with ever-changing food contact legislation around the globe, Smithers provides advice, analytical testing and training to help you understand what you need to do to ensure regulatory compliance for your food contact materials.
While the above amendments are still in draft status, our expert team can help you be prepared for any upcoming changes and show compliance with proposed guidelines with support offerings such as:

 For more information, please get in touch with an expert and check out our food contact testing services.

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