Amendment to EU FCMs Regulation (EU) No 10/2011
Recently, EU Commission has published Regulation (EU) 2019/37 to amend Annex I and III to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The regulation has become effective on 31 January 2019. Here provided the highlights of the amendments:
(1) In Table 1 of Annex I, the entries concerning FCM substances No. 467 (crotonic acid), 744 (3-hydroxybutanoic acid-3- hydroxypentanoic acid, copolymer), 1066 (1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester), and 1068 ([3-(2,3-epoxypropoxy)propyl]trimethoxy silane) are replaced by the following:
|
1059
|
|
147398-
31-0
|
poly((R)-3-hydroxybutyrate-co-
(R)-3-hydroxyhexanoate)
|
No
|
Yes
|
No
|
|
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.’
|
|
|
1067
|
|
616-38-6
|
dimethyl carbonate
|
No
|
Yes
|
No
|
|
|
Only to be used:
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-methylenediphenyldiiwocyanate 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 0,05mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1000 Da together does not exceed 0,05 mg/kg food
|
27
|
|
1069
|
|
75-28-5
|
isobutane
|
Yes
|
No
|
No
|
|
|
Only to be used as a blowing agent.
|
|
(2) In Table 2 of Annex I, the following entry is added:
|
35
|
467
744
1059
|
0,05
|
Expressed as crotonic acid
|
(3) In Table 3 of Annex I, the following entry is added:
|
(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.
|
(4) In Table 4 of Annex I, the row concerning restriction of the entry concerning substance FCM No 744 (3-hydroxybutanoic acid-3- hydroxypentanoic acid, copolymer) is replaced by the following:
|
Restriction
|
Specific migration limit for crotonic acid is 0,05 mg/kg food
|
(5) In Table 3 of Point 4 of Annex III, the third and fourth rows are replaced by the following:
|
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
|
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation may be placed on the market until 31 January 2020 and may remain on the market until exhaustion of stocks.
Please check the below official website for details:
DPI provides a comprehensive range of testing services to ensure your products are safe and compliant. Please do not hesitate to contact us for further information.
