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Your regular update for technical and industry information

EU: Proposed amendments on Regulation (EU) No 10/2011 on plastic materials and articles for food contact

march 2018 - Relevant for: hardlines INDUSTRY

On 22 February 2018, the European Commission notified the WTO on the proposed amendments1 to Regulation (EU) No 10/20112 on plastic materials and articles intended to come into contact with food.

This amendment3 authorises two new substances, extends the authorized use of an existing authorised substance, and decreases the specific migration limits for another existing authorised substance on the basis of new scientific evidence.

According to the timeline submitted to the WTO, the proposal is expected to be adopted by the end of May 2018.

Details4 of these proposed changes are summarized in the following tables.

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

 FCM Substance No.

Cas No.

Substance Name


Restrictions and Specifications



1,2,3,4-tetrahydronaphtalene-2,6-dicarboxylic acid, dimethylester


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).



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


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

FCM substance No.


Substance Name





Perchloric acid, salts

- 0.05 mg/kg

- 0.002 mg/kg



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

- 5 mg/kg

- 10 mg/kg

[1] WTO Notification - G/SPS/N/EU/233
[2] Regulation (EU) No 10/2011 (consolidated)
[3] The proposed regulation
[4] Annex to the proposed regulation

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