EU releases the latest revision of Food Contact Articles (EU) 2018/79
On January 19, 2018, The European Commission has published Regulation (EU) 2018/79 to approve amending Regulation (EU) No 10/2011 on plastic food contact materials and articles. The EU food-grade plastic regulations have been revised nine times since its release (EU) 10/2011. the list of authorizations for Annex I of (EU) 10/2011 was ｕｐｄａｔｅd with the addition of the monomer 2,4,4′-trifluorobenzophenone (FCM substance No 1061 and CAS No 80512-44-3), the monomer 2,3,3,4,4,5,5-heptafluoro-1- pentene (FCM substance No 1063 and CAS No 1547-26-8), tungsten oxide (WOn (n = 2,72-2,90)) (FCM substance No 1064 and CAS No 39318-18-8), the mixture of methyl-branched and linear C14-C18 alkanamides , derived from fatty acids (FCM substance No 1065 and CAS No 85711-28-0), and expanded the list of (Butadiene, Styrene , Methyl methacrylate, butyl acrylate) and divinylbenzene or 1,3-butylene glycol dimethacrylate.
1. Implementation time and transitional period
1. (EU) 2018/79 will come into effect on February 9, 2018.
2. Products complying with Regulation No 10/2011 before enactment of this amendment may be placed on the market until 8 February 2019 and may remain on the market until stock exhaustion.
2. Revision summary
(EU) 10/2011 Appendix 1 be amended, as follows:
(1) Point 1 in Table 1 be amended as follows:
(a) FCM No. 856 is replaced by the following:
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Substance No
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CAS No
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Substance name
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Change in restrictions
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856
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25101-28-4
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(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate
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Adding authorised use in blends of styrene acrylonitrile copolymer (SAN) / poly(methyl methacrylate) (PMMA) under certain conditions at up to 40% w/w.
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(b) Proposed addition of substances:
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Substance No
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CAS No
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Substance name
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Restrictions and specifications
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1061
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80512-44-3
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2,4,4-trifluorobenzophenone
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Co-monomer in polyether ether ketone plastics up to 0.3% w/w of the final material.
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1063
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1547-26-8
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2,3,3,4,4,5,5-heptafluoro-1-pentene
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Polymer processing aid of tetrafluoroethylene and/or ethylene co-monomers to manufacture certain fluorocopolymers at up to 0.2% w/w of the food contact material.
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1064
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39318-18-8
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tungsten oxide
(WOn, n = 2.72-2.90)
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Specific migration limit:
≤ 0.05 mg tungsten/kg food
[This does not apply when used as reheat agent in polyethylene terephthalate (PET).]
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1065
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85711-28-0
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mixture of methyl-branched and linear C14-C18 alkanamides, derived from fatty acids
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Manufacture of articles made of polyolefins for certain foods.
Specific migration limit: ≤ 5 mg/kg
[This does not include migration of stearamide (Substance No 306).]
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(2) in Table 3, the following entries are added:
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Number
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Instructions for verifying compliance
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（25）
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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
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（26）
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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.’
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