EU: Proposed amendments on Regulation (EU) No 10/2011

september 2018- Relevant for: hardlines

On 25 September, the European Commission notified the World Trade Organisation (WTO) on the proposed amendments¹to Regulation (EU) No 10/2011² on plastic materials and articles intended to come into contact with food.

Details^3,4 of these proposed changes are summarised as follows.

1. The authorisation of 3 new substances.

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	SML (mg/kg)	SML(T) (mg/kg) (group restriction No.)	Restrictions and specifications
1059	147398- 31-0	Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)	N/A	(35)	Only to be used alone or blended with other polymers in contact with foods for which food simulant E is assigned in Table 2 of Annex III to Regulation (EU) No 10/2011.
1067	616-38-6	Dimethyl carbonate	N/A	N/A	Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate prepolymers that are used at up to 30% to manufacture thermoplastic polyurethanes with methylene diphenyl isocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short–term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III to Regulation (EU) No 10/2011; or b) for the production of other polycarbonates and/or other conditions provided that the migration of dimethyl carbonate does not exceed 0.05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1,000 Da together does not exceed 0.05 mg/kg food.
1069	75-28-5	Isobutane	N/A	N/A	Only to be used as a blowing agent

2. The modification of the conditions of use of one substance.

Table 2. Proposed change to the conditions of use of [3-(2,3-epoxypropoxy) propyl] trimethoxy silane in Table 1, Annex I of Regulation (EU) No 10/2011.

FCM Substance No.	CAS No.	Substance Name	SML (mg/kg)	Restrictions and specifications
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).

3. The introduction of a group migration limit.

Table 3. A new group SMLs for crotonic acid proposed to be added to Table 2, Annex I of Regulation (EU) No 10/2011

Group restriction No.

FCM Substance No.

SML (mg/kg)

Restrictions and specifications

467

744

1059

0.05

Expressed as crotonic acid

Table 4. Proposed changes to Substance FCM No. 467 and 744 to Table 1, Annex I of Regulation (EU) 10/2011

FCM Substance No.

CAS No.

Substance Name

SML (mg/kg)

SML(T) (mg/kg) (group restriction No.)

Restrictions and specifications

467

3724-65-0

Crotonic acid

N/A

(35)

N/A

744

080181-31-3

3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

N/A

(35)

The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.

Table 5. Proposed change to the row concerning the restriction of substance FCM No 744 in Table 4, Annex I of Regulation (EU) No 10/2011.

FCM Substance No.	Detailed specification of the substance
744	Restriction
744	Specific migration limit for crotonic acid is 0.05 mg/kg food

4. The clarification of the types of migrants that are to be used in foods with a certain pH.

Table 6. Proposed replacement of the food type of “all aqueous and alcoholic foods and milk products” in Table 3 of point 4, Annex III of Regulation (EU) No 10/2011.

Food covered	Food simulants in which testing shall be performed
All aqueous and alcoholic foods and milk products with a pH ≥ 4.5	Food simulant D1
All aqueous and alcoholic foods and milk products with a pH < 4.5	Food simulant D1 and food simulant B

5. The introduction to the requirements for the migration testing for the migrating oligomers for the newly authorised substance FCM No 1067 when it is used for the production or polycarbonates other than the ones covered by the specific authorisation.

Table 7. New notes for substance FCM No 1067 on verification of compliance proposed to be added to Table 3, Annex I of Regulation (EU) No 10/2011.

Note No.

Notes on verification of compliance

(27)

When a final material or article containing this substance and produced under conditions other than those described in point a) column 10 of Table 1 is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in point b) column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16 of Regulation (EU) No 10/2011. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

6. The correction of a minor typographical error.

Table 8. Proposed changes to substance FCM No. 1066 in 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- Tetrahydronaphthalene-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 to Regulation (EU) No 10/2011. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).

[1] WTO Notification – G/SPS/N/EU/271

[2] Regulation (EU) No 10/2011 (consolidated)

[3] The proposed regulation

[4] Annex to the proposed regulation

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