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Publication 9th Amendment

9th amendment to 2018/79

picOn January 18, 2018, Commission Regulation (EU) 2018/79 on plastic materials and articles intended to come into contact with food was published in the EU’s Official Journal.

This 9th amendment was originally proposed as the 8th, but the EC had to change the numbering due to administrative reasons.

Official Journal of the European Union

The proposal contains a list of new substances to be included into the Union list of authorised substances with the restriction that those must be used according to given specification:

  • (FCM 1061) 2,4,4′-tri-fluorobenzophenone
  • (FCM 1063) 2,3,3,4,4,5,5-hepta-fluoro-1-pentene
  • (FCM 1064) tungsten oxide
  • (FCM 1065) mixture of methyl-branched and linear C14-C18 alkanamides, derived from fatty acids

Also, there has been an update of existing entry FCM 856.. The following new information has been added:

  • Cas number 25101-28-4
  • Additional use in column 10:

“Only to be used in: _at up to 40% w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeat- use articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (<20%) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.”

The following entries are added to the Table 3 of the Annex to Regulation (EU) No 10/2011:

  • (25) When used as reheat agent in polyethylene terephthalate (PET) verification of compliance with the specific migration limit is not required; in all other cases compliance with the specific migration limit shall be verified in accordance with Article 18; the specific migration limit is expressed as mg tungsten / kg food.
  • (26) Migration of stearamide, listed in Table 1 under FCM substance No 306 to which no specific migration limit applies, shall be excluded from verification of the compliance of the migration of the mixture with the specific migration limit laid down for the mixture.

Unlike the draft version, the final version now contains a transition period for the supply chain to adapt to the changes.
“Article 2. Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 8 February 2019 and may remain on the market until exhaustion of stocks.”

This amendement will be processed and added to FOCOS® as soon as possible.
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