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EU: Regulation (EU) 2018/831- Amendment on Regulation (EU) No 10/2011 published

june 2018 - Relevant for: hardlines INDUSTRY

We brought to your attention1 in March 2018 that Regulation (EU) No 10/20112 would be amended. On 6 June 2018, the European Commission (EC) published Regulation (EU) 2018/8313 (‘the Regulation’) in the Official Journal of the European Union (OJEU), amending Regulation (EU) No 10/2011 on plastics materials and articles intended to come into contact with food.

The Regulation will enter into force on 26 June 2018. Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of the Regulation may be placed on the market until 26 June 2019 and may remain on the market until exhaustion of stocks.

The details of the amendments are identical to the proposal and are summarized in the following tables.

Table 1. New substances that are added to Table 1, Annex I of Regulation (EU) No 10/2011.

FCM substance No.

CAS No.

Substance Name

SML (mg/kg)

Restrictions and specifications

1066

23985-75-3

1,2,3,4-tetrahydronaphtalene-2,6-dicarboxylic acid, dimethyl ester

0.05

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).

1068

2530-83-8

[3-(2,3-epoxypropoxy) propyl]trimethoxy silane

N/A

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).

Table 2. Amendments to two SMLs in Table 1, Annex I of Regulation (EU) No 10/2011.

FCM substance No.

CAS No.

Substance Name

Previous

Proposed

822

-

Perchloric acid, salts

SML
- 0.05 mg/kg

SML
- 0.002 mg/kg

974

939402-02-5

phosphorous acid, mixed 2,4-bis(1,1- dimethylpropyl)phenyl and 4-(1,1- dimethylpropyl)phenyl triesters

SML
- 5 mg/kg

SML
- 10 mg/k

g

[1] The proposed amendment as previously published in E-ssentials Vol. 6 (2018)
[2] Regulation (EU) No 10/2011 (consolidated)
[3] Regulation (EU) 2018/831

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