http://www.legislation.gov.uk/id/eur/2015/174

ANNEX

Annex I to Regulation (EU) No 10/2011 is amended as follows:

(1)

Table 1 is amended as follows:

(a)

the entries concerning FCM substances Nos 161, 241, 344, 364, 410, 713, 784, 799, 880 and 881 are replaced by the following:

‘161
92160
000087-69-4
L-(+)-tartaric acid
yes
no
no
241
22960
0000108-95-2
phenol
no
yes
no
3
344
13810
0000505-65-7
1,4-butanediol formal
no
yes
no
0,05
15
30
(21)
21821
364
15404
0000652-67-5
1,4:3,6-dianhydrosorbitol
no
yes
no
5
Only to be used as:
(a)
a co-monomer in poly(ethylene-co-isosorbide terephthalate);
(b)
a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters.
Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
410
62720
0001332-58-7
kaolin
yes
no
no
Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.
713
43480
0064365-11-3
charcoal, activated
yes
no
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/201217 with exception of ash content which can be up to 10 % (w/w).
0007440-44-0
784
95420
0745070-61-5
1,3,5-tris (2,2-di-methylpropanamido) benzene
yes
no
no
5
799
77708
polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C₈-C₂₂) alcohols
yes
no
no
1,8
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
880
31348
acids, fatty (C₈-C₂₂), esters with pentaerythritol'
yes
no
no
881
25187
0003010-96-6
2,2,4,4-tetramethylcyclobutane-1,3-diol
no
yes
no
5
Only for:
(a)
repeated use articles for long term storage at room temperature or below and hotfill;
(b)
single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’

(b)

the following entries are inserted in numerical order of the FCM substance numbers:

859
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform
yes
no
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.
When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
903
37486-69-4
2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]
yes
no
no
Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:
(a)
repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times;
(b)
repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
969
24937-78-8
ethylene-vinyl acetate copolymer wax
yes
no
no
Only to be used as a polymeric additive up to 2 % w/w in polyolefins.
The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
998
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform
yes
no
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
1017
25618-55-7
polyglycerol
yes
no
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
1043
(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform
yes
no
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.

(2)
In Table 2, the entries concerning group restrictions Nos 15 and 30 are replaced by the following:
15
98
196
344
15
expressed as formaldehyde
30
254
344
672
5
expressed as 1,4-butanediol

(3)

In Table 3, the following entry is added:

(21)
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.

‘161	92160	000087-69-4	L-(+)-tartaric acid	yes	no	no
241	22960	0000108-95-2	phenol	no	yes	no	3
344	13810	0000505-65-7	1,4-butanediol formal	no	yes	no	0,05	15 30		(21)
344	21821	0000505-65-7	1,4-butanediol formal	no	yes	no	0,05	15 30		(21)
364	15404	0000652-67-5	1,4:3,6-dianhydrosorbitol	no	yes	no	5		Only to be used as: (a) a co-monomer in poly(ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
410	62720	0001332-58-7	kaolin	yes	no	no			Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.
713	43480	0064365-11-3	charcoal, activated	yes	no	no			Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/201217 with exception of ash content which can be up to 10 % (w/w).
713	43480	0007440-44-0	charcoal, activated	yes	no	no
784	95420	0745070-61-5	1,3,5-tris (2,2-di-methylpropanamido) benzene	yes	no	no	5
799	77708		polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C₈-C₂₂) alcohols	yes	no	no	1,8		In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
880	31348		acids, fatty (C₈-C₂₂), esters with pentaerythritol'	yes	no	no
881	25187	0003010-96-6	2,2,4,4-tetramethylcyclobutane-1,3-diol	no	yes	no	5		Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’

859		(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform	yes	no	no	Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
903	37486-69-4	2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]	yes	no	no	Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
969	24937-78-8	ethylene-vinyl acetate copolymer wax	yes	no	no	Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
998		(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform	yes	no	no	Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
1017	25618-55-7	polyglycerol	yes	no	no	To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
1043		(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform	yes	no	no	Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.