Seventh Amendment to the Plastics Regulation Expands Positive List, Adds New Requirements

The 7th amendment, (EU) 2017/752, to the Plastics Regulation, (EU) No 10/2011, updates the positive list, introduces a new specific migration limit for nickel, amends the Declaration of Compliance requirement, and clarifies the food simulants for demonstrating compliance with the overall migration limit (OML). It was published in the Official Journal of the European Union on April 29, 2017.

Newly added substances to the positive or Union List include one substance in nanoform. (The Plastics Regulation prohibits the use of monomers/starting substances or additives in nanoform that are not specifically authorized in nanoform.) The listings for new substances, which have been positively evaluated by the European Food Safety Authority (EFSA) include increasingly detailed specifications and limitations with respect to end use applications.

The 7th amendment includes a table listing the food simulants that may be used to demonstrate compliance with the OML. In addition, a new limit of 0.02 mg/kg food or food simulant for migration of nickel from plastics food contact materials applies from May 19, 2019. Another significant change in the most recent amendment is the introduction of a new requirement that a Declaration of Compliance (DoC) must include the highest surface to volume ratio for which compliance has been established in accordance with Articles 17 (Expression of migration test results) and 18 (Rules for assessing compliance with migration limits) of the Plastics Regulation, or equivalent information.

The 7th amendment enters into force on May 19, 2017, however products produced before the new requirements take effect can be placed on the market until May 19, 2018, and remain on the market until exhaustion of stocks.