EU - published Regulation (EU) 2018/831 to amend Union List of Authorised Substances to Regulation (EU) No 10/2011 on Plastic Food Contact Materials and Articles
The European Commission has published Regulation (EU) 2018/831 to amend the Union List of authorised substances under Regulation (EU) No 10/2011 for plastic food contact materials and articles. Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation. effective from 26 June 2018
Plastic food contact materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this amendment, may be placed on the market until 26 June 2019 and may remain on the market until exhaustion of stocks.
Annex I to Regulation (EU) No 10/2011 is amended as follows:
(a) the entries concerning FCM substances No 822 and No 974 are 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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SML (mg/kg)
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Restrictions and specifications
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822
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-
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perchloric acid, salts
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0.002
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-
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974
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939402-02-5
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phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters
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10
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SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol. The migration of 2,4-di-tert- amylphenol shall not exceed 1 mg/kg food
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(b) the following entries are added in numerical order of the FCM substance numbers:
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Substance No.
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CAS No.
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Substance name
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SML (mg/kg)
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Restrictions and specifications
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1066
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23985-75-3
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1,2,3,4-tetrahydronaphtalene-2,6-dicarboxylic acid, dimethyl ester
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0.05
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Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
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1068
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2530-83-8
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[3-(2,3-epoxypropoxy)propyl]
trimethoxy silane
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-
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Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs.
In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer)
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