15TH AMENDMENT OF REGULATION No.10/2011
The 15th amendment of Regulation no.10/2011 has entered into force. The amendment adds new substances to the positive list in Annex I, in addition to introducing several substantive changes to the Plastics Regulation.
In accordance with the transitional provision, plastic materials and articles that were placed on the EU market before March 23, 2021, and that comply with the Plastics Regulation as applicable before the entry into force of this amendment may continue to be placed on the EU market until September 23, 2022 and remain on the market until the exhaustion of stocks.
Some of the significant changes are listed below.
- The following substances are added to the Plastic Regulation’s positive list subject to specific restrictions:
- montmorillonite clay modified with hexadecyltrimethylammonium bromide;
- phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)],C10-16 alkyl ester; and
- titanium dioxide surface-treated with fluoride-modified alumina, including the nano form
- The non-detect limit for the specific migration limit (SML) of the primary aromatic amine (PAA) 1,3-phenylenediamine is reduced from 0.01 mg/kg to 0.002 mg/kg food or food simulant. Otherwise, the limit applicable to the migration of individual PAAs needs to be considered on a case by case basis taking into consideration the criteria set out in the Regulation and may be as low as a non-detect limit of 0.002 mg/kg.
- The table in Annex II (Restrictions on materials and articles) listing elements/metals subject to specific migration limits is considerably expanded based on recent scientific opinions issued by the European Food Safety Authority (EFSA). New metals listed include arsenic, cadmium, chromium, mercury and lead.
- The four lanthanides (lanthanum, europium, gadolinium and terbium) are also included in Annex II as permitted salts of authorized phenols, alcohols and acids subject to restrictions.
- Annex IV (Declaration of Compliance), point 6, has been updated to state that the following information shall be included in the Declaration of Compliance:
“(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.
- At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,
- that are subject to restrictions in Annex II, or
- for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant.”
- Certain changes to compliance testing requirements in Annex V are made for food processing equipment/appliances, as well as to the overall migration testing requirements.
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