Recently, Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food is amended by (EU) 2015/174. This Regulation shall enter into force on 26 February, 2015.
Plastic materials and articles complying with the requirements of Regulation (EU) No 10/2011 as applicable before 26 February 2015 may be placed on the market until 26 February 2016. Those plastic materials and articles may remain on the market after that date until exhaustion of stocks.
Annex I to (EU) No 10/2011 are amended and corrected as follows:
1.The entries concerning FCM substances Nos 161, 241, 344, 364, 410, 713, 784, 799, 880 and 881 are replaced by the following. The specific migration of phenol is amended from 60 mg/kg to 3 mg/kg;
| FCM Substance No | CAS No | Substance Name | Use as additive or polymer production aid (yes/no) | Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no) | SML (mg/kg) | SML(T) (mg/kg) (Group restriction No) | Change |
| 161 | 000087-69-4 | L-(+)-tartaric acid | Yes | No | / | / | ChangeSubstance Name |
| 241 | 0000108-95-2 | phenol | No | Yes | 3 | / | Change SML from 60→3 |
| 344 | 0000505-65-7 | 1,4-butanediol formal | No | Yes | 0.05 | 15 30 | Change SML from N.D.→0.05, add group restriction No |
| 364 | 0000652-67-5 | 1,4:3,6-dianhydrosorbitol | No | Yes | 5 | / | Add restrictions and specifications |
| 410 | 0001332-58-7 | kaolin | Yes | No | / | / | Do. |
| 713 | 0064365-11-3 0007440-44-0 | charcoal, activated | Yes | No | / | / | Change restrictions and specifications |
| 784 | 0745070-61-5 | 1,3,5-tris (2,2-di- methylpropanamido) benzene | Yes | No | 5 | / | Change SML from 0.05→5 |
| 799 | / | polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols | Yes | No | 1.8 | / | Change restrictions and specifications |
| 880 | / | acids, fatty (C8-C22), esters with pentaerythritol' | Yes | No | / | / | Delete CAS No |
| 881 | 0003010-96-6 | 2,2,4,4-tetramethylcyclobutane-1,3- diol | No | Yes | 5 | / | Add restrictions and specifications |
2.The following entries are inserted in numerical order of the FCM substance numbers:
| FCM Substance No | CAS No | Substance Name | Use as additive or polymer production aid (yes/no) | Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no) | SML (mg/kg) | SML(T) (mg/kg) (Group restriction No) |
| 859 | / | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform | Yes | No | / | / |
| 903 | 37486-69-4 | 2H-perfluoro- [(5,8,11,14- tetramethyl)- tetraethyleneglycol ethyl propyl ether] | Yes | No | / | / |
| 969 | 24937-78-8 | ethylene-vinyl acetate copolymer wax | Yes | No | / | / |
| 998 | / | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform | Yes | No | / | / |
| 1017 | 25618-55-7 | polyglycerol | Yes | No | / | / |
| 1043 | / | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform | Yes | No | / | / |
3.The entry concerning FCM substance No 725 is deleted.
4.In Table 2, the entries concerning group restrictions Nos 15 and 30 are added No 344 FCM substances separately.
5.In Table 3, the following entry is added: “In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.”
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