New amendments to the EU Regulation on Food Contact Materials

The new EU Regulation  2018/79  entered into force on 8 February 2018, adding conditions and restrictions regarding certain plastics, uses and substances for food packaging. It amends Regulation 2011/10 on plastic materials and articles intended to come into contact with food (the food contact materials or ‘FCM’ Regulation).

The new amending Regulation extends the use of one substance and inserts further substances onto the Union List, specifying their uses and concentration limits. The new Regulation notes that the European Food Safety Authority (EFSA) has published further scientific opinions on particular substances that may be used in FCMs as well as on the permitted use of authorized substances. The new text aims to ensure that the FCM Regulation reflects EFSA’s most recent findings.

The amendments concern the following substances and mixtures:

  • CAS No 25101-28-4: (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate: The current authorization of this substance is extended to include the use as a polymeric additive at up to 40% w/w in blends of styrene acrylonitrile copolymer repeat-use articles intended for contact at room temperature with aqueous, acidic and/or low alcoholic (< 20%) foodstuffs for less than 1 day and with dry foodstuffs for any duration of contact including long-term storage.
  • CAS No 80512-44-3: 2,4,4′-trifluorobenzophenone: This monomer is inserted onto the Union List for use as a co-monomer in the manufacture of polyether ether ketone plastics up to 0.3% w/w based on the final material.
  • CAS No 1547-26-8: 2,3,3,4,4,5,5-heptafluoro-1-pentene: This monomer is inserted onto the Union List for use as a co-monomer together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers that are only intended to be applied as polymer processing aids at up to 0.2 % w/w of the FCM, and when the low molecular mass fraction below 1,500 Da in the fluorocopolymer does not exceed 30 mg/kg food.
  • CAS No 39318-18-8: tungsten oxide: This substance is included in the Union List for use as a reheat agent in polyethylene terephthalate (PET) without setting out a verification requirement for migration limits since the substance is insoluble. For other technical functions or use in other polymers, the specific migration limit is set at 0.05 mg/kg food.
  • CAS No 85711-28-0: methyl-branched and linear C14-C18 alkanamides, derived from fatty acids: This mixture is included in the Union List for use in the manufacture of polyolefin articles intended for contact with all foodstuffs other than fatty foods and when its migration does not exceed 5 mg/kg food.

Plastic materials and articles complying with the FCM Regulation as applicable before the entry into force of the amending Regulation, may be placed on the market until 8 February 2019 and may remain on the market until exhaustion of stocks.

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