CONSUMER PRODUCTS AND RETAIL E-SSENTIALS

 FCM substance No.

 CAS No.

 Substance Name

 SML (mg/kg)

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

Restrictions and specifications

 1059

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

 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).

 Group restriction No.

 FCM Substance No.

 SML (mg/kg)

 Restrictions and specifications

 35

467

744

1059

 0.05

 Expressed as crotonic acid

 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.

 FCM Substance No.

 Detailed specification of the substance

 744

 Restriction

 Specific migration limit for crotonic acid is 0.05 mg/kg food

 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

 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.

 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).