(EU) 2019/37 amendments on Regulation (EU) No 10/2011| TÜV SÜD

EU: Regulation (EU) 2019/37 amendments on Regulation (EU) No 10/2011 on plastic materials and articles of FCM published

January 2019 - Relevant for: hardlines

We brought to your attention¹ in September 2018 that Regulation (EU) No 10/2011² would be amended. On 11 January 2019, the European Commission (EC) published Regulation (EU) 2019/37³ (‘the Regulation’) in the Official Journal of the European Union (OJEU), amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

The Regulation will enter into force on 31 January 2019. 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 31 January 2020 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. The entries concerning FCM substances No 467, 744, 1066, and 1068 are amended in Table 1, Annex I of Regulation (EU) No 10/2011.

FCM substance No.	CAS No.	Substance Name	Amendments
*467	3724-65-0	Crotonic acid	The new group SML (35) has been added in column 9 of Table 1, Annex I.
*744	080181-31-3	3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer	The new group SML (35) has been added in column 9 of Table 1, Annex I for this substance.
1066	23985-75-3	1,2,3,4- tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester	The correction of a minor typographical error of the substance name. Previous consolidated version: 1,2,3,4-tetrahydronaphtalene-2,6-dicarboxylic acid, dimethyl ester Amendments: 1,2,3,4- tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester.
**1068	2530-83-8	[3-(2,3-epoxypropoxy) propyl] trimethoxy silane	The authorised use for this substance has been changed and amended in column 5 (as an additive or polymer production aid), and column 6 (as monomer or other starting substance or macromolecule obtained from microbial fermentation) of Table 1, Annex I.

Note:

* - Column 9: (SML(T) [mg/kg] (group restriction No.)): contains the identification number of the group of substances for which the group restriction in Column 1 (FCM substance No.) in table 2 of Annex I, Regulation (EU) No 10/2011 applies.

** - Column 5: Use as additive or polymer production aid (PPA) (yes/no).

- Column 6: Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no).

Table 2. New substances have been 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)	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	To be used only: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4’ - methylenediphenyldiisocyanate 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; or b) for the production of other polycarbonates and/or under 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	To be used only as a blowing agent.

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

Group restriction No.

FCM substance No.

SML (mg/kg)

Group restriction specification

467
744
1059

0.05

Expressed as crotonic acid.

Table 4. New notes for substance FCM No 1067 on verification of compliance has been 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. 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.

Table 5. The 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 on the substance
744	Restriction	Specific migration limit for crotonic acid is 0.05 mg/kg food.

Table 6. The 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