REGUL ATIONS 
COMMISSION REGUL ATION (EU) 2015/174 
of 5 Febr uary 2015 
amending and correcting Regulation (EU) No 10/2011 on plastic mater ials and articles intended to 
come into contact with food 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
mate rials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), 
and in particular points (a), (c), (d) and (e) of Article 5(1), Article 11(3) and Article 12(6) thereof, 
Whereas: 
(1)  Annex I to Commission Regulation (EU) No 10/2011 (2) establishes a Union list of author ised substances 
(‘the Union list’) whic h may be used in the manufacture of plastic mater ials and articles. 
(2)  Tartaric acid (food contact mat erial (FCM) substance No 161) was assessed by the Scientifi c Committ ee for Foods 
(SCF) in 1991 (3). The SCF gave a favourable opinion only to the natural occur ring form of tartaric acid 
(L-(+)-tar taric acid). It explicitly excl uded the DL form of tartaric acid. It followed from the SCF assessment that 
only L-(+)-tar taric acid does not endanger human health, while this has not been shown for all other forms of 
that substance. Theref ore, it should be clear from the name of the substance as included in Table 1 of Annex I to 
Regulation (EU) No 10/2011 that it refers only to L-(+)-tar taric acid. Theref ore, the name of FCM substance 
No 161 should be amended according ly. 
(3)  The European Food Safety Author ity (the Auth ority) adop ted an opinion re-evaluating the tolerable daily intake 
(TDI) of phenol (4). Phenol (FCM No 241) is included as a starting substance in Table 1 of Annex I to Regulation 
(EU) No 10/2011. The gener ic specifi c migration limit (SML) of 60 mg/kg set out in Article 11(2) of Regulation 
(EU) No 10/2011 applies to that substance. In the re-evaluation of phenol, the Authority reduced the TDI from 
1,5 mg/kg body weight (‘bw’)/da y to 0,5 mg/kg bw/da y. The Auth ority noted that the exposure from all sources 
was above the TDI, while exposure from food contact mater ials was likely to be in the range of the TDI. In 
addition to the TDI, an allocation factor of 10 % for the exposure from food contact mater ials should be used to 
achi eve a suffi cient reduction in phenol exposure. The setting of the migration limit take s into account a 
conven tional exposure assump tion that 1 kg of food is consumed daily by a person of 60 kg body weight. 
Theref ore, on the basis of the TDI, the allocation factor and the exposure assump tion a specifi c migration limit of 
3 mg/kg for phenol should be set to ensure that phenol does not endanger human health. 
(4)  1,4-Butanediol formal (FCM No 344) was evaluated by the SCF in 2000 (5). The SCF concluded that a SML of 
0,05 mg/kg should be set for that substance. Column 8 of Table 1 of Annex I to Regulation (EU) No 10/2011 
incor rectly states that migration of the substance shall be non-det ectable and should theref ore be corrected. 
(5)  The SCF proposed to determine the residual conte nt of the substance 1,4-butanediol formal (FCM No 344) in the 
mate rial inste ad of verifying compl iance against the SML, because no suitable method to determine the substance 
in a food or simulant was available. Suitable methods to determine the substance in a food or simulant 6.2.2015 L 30/2 Official Jour nal of the European Union EN     
(1)OJ L 338, 13.11.2004, p. 4. 
(2)Commission Regulation (EU) No 10/2011 of 14 Januar y 2011 on plastic mat erials and articles intended to come into contact with food 
(OJ L 12, 15.1.2011, p. 1). 
(3)Repor t of the Scientific Committee for foods, 25th series, EUR 13416, 1991. 
(4)EFSA Jour nal 2013; 11(4):3189. 
(5)Opinion of the Scientific Committee on Food on the 11th additional list of monomers and additives for food contact mat erials, 
SCF/CS/PM/GEN/M8313, November 2000. are available now. Theref ore, verifying compl iance by determining the residual should be replaced by migration 
testing. 1,4-butanediol formal may hydrolyse in contact with foods or simulants to form 1,4-butanediol (FCM 
No 254) and formaldeh yde (FCM No 98). Theref ore the total specific migration limits set for these substances 
should not be exceed ed. As a result 1,4-butanediol formal should be added to group restr ictions 15 and 30. As 
hydrolysis occurs only in certain cases, rules which indicate when verification of compliance to these group 
restr ictions is needed should be added to Table 3. 
(6)  The Author ity adopt ed a favour able scientific opinion (1) on a possible exte nsion of the use of starting substance 
1,4:3,6-dianh ydrosorbitol (FCM No 364) to the use as a co-monomer for the production of polyest ers, if used at 
levels of up to 40 mol % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydr oxy­
meth yl)cy clohexane, and if polyes ters made using 1,4:3,6-dianhydr osorbitol together with 1,4-bis(hydro xymethyl) 
cyclohexane are not used in contact with foods containing more than 15 % alcohol. The extension of the use of 
the substance to the new specifi cations does not endange r human health if those conditions are met. Theref ore, 
the author isation of FCM substance No 364 should be amended to include the additional specifications. 
(7)  The Auth ority adop ted a favourable scientific opinion (2) on a possible extensi on of the use of the substance 
kaolin (FCM No 410) to include particles in the nanof orm with a thickness less than 100 nm and incor porat ed 
up to 12 % in ethylene vinyl alcohol (EVOH) copolymer . The extension of the use of the substance to the new 
specification does not endange r human health if those conditions are met. Theref ore, the author isation of FCM 
substance No 410 should be amended to include a specific ation and restr iction on particle size. 
(8)  The Union list includes a substance identif ied as ‘charcoal, activated’ (FCM No 713, CAS No 64365-11-3). 
Another substance is also used on the mark et, identif ied as ‘activated carbon’ (CA S No 7440-44-0). In practice 
the two substances are the same, and their names are used inter chang eably and are synon ymous. Theref ore, it 
should be made clear that FCM substance No 713 covers the substance under the name ‘charcoal, activat ed’ and 
applies to both CAS numbers. The author isation of FCM substance No 713 should theref ore be amended by 
adding the CAS No for activated carbon. 
(9)  On the basis of new toxicological data the Author ity adop ted a favourable scientific opinion (3) whic h allows 
increasing the migration limit for the additive 1,3,5-tr is(2,2-dimethylpropanamido)benzene (FCM No 784). to 
5 mg/kg food. Theref ore, the author isation of substance FCM No 784 should be amended according ly. 
(10)  The restr iction whic h is defined for polyeth yleneg lycol (EO = 1-50) ethers of linear and branched primar y 
(C8-C22) alcohols (FCM No 799) refers to the purity criteria for ethylene oxide laid down in Commission Directive 
2008/84/EC (4). That Directive has been repealed by Commission Regulation (EU) No 231/2012 (5) whic h 
specifies the purity criteria for certain food additives setting out a maximum ethylene oxide cont ent for those 
additives. That maximum should also apply to substances with FCM No 799. 
(11)  The group of substances ‘acids, fatty (C8-C22), esters with pentaer ythr itol’ (FCM No 880) is listed in Table 1 of 
Annex I to Regulation (EU) No 10/2011 with CAS No 85116-93-4. This CAS number refers only to a subgroup 
of FCM No 880, and is theref ore inappropr iate. For the group with FCM No 880 no CAS number is defined. 
Theref ore, the listing of FCM substance No 880 in Table 1 of Annex I should be amended by deleting the 
CAS number . 
(12)  The Author ity adop ted a favourable scientifi c opinion (6) on the possible exte nsion of the use of the substance 
2,2,4,4-t etramethylcy clobutane-1,3-diol (FCM No 881) to sing le use applications. The opinion concluded that for 
sing le use applications, the substance does not raise a safety concer n if used as co-monomer in the production of 
polye sters at use levels up to 35 mol % of the diol component, in contact with all food types other than spirits 
and highly fatty foods to be simulat ed by food simulant D2 (vegeta ble oil) for long time storage at room 
temperature or belo w and hot fill. In its evaluation the author ity only considered migration tests with 
10 % ethanol and 3 % acetic acid as basis for full evaluation. Theref ore, the extension of use should also not 
include foods with an alcohol cont ent over 10 %. Theref ore, if the permitte d use of this substance is extende d 
according ly and includes the new specifi cations, the use of this substance does not endanger human health. 
Theref ore, the author isation of FCM substance No 881 should be amended according ly. 6.2.2015 L 30/3 Official Jour nal of the European Union EN     
(1)EFSA Jour nal 2013; 11(6):3244. 
(2)EFSA Jour nal 2014; 12(4):3637. 
(3)EFSA Jour nal 2013; 11(7):3306. 
(4)Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and 
sweet eners (OJ L 253, 20.9.2008, p. 1). 
(5)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificatio ns for 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). 
(6)EFSA Jour nal 2013; 11(10):3388. (13)  The Author ity adopt ed a scientifi c opinion (1) on the use of three new substances in nanof orm, (butadiene, ethyl 
acrylate, methyl methacr ylate, styrene) copolymer cross-linked with divin ylbenzene (FCM No 859), (butadiene, 
ethyl acrylate, methyl methacr ylate, styrene) copolymer not cross-link ed (FCM No 998) and (butadiene, ethyl 
acrylate, meth yl methacr ylate, styrene) copolymer cross-linke d with 1,3-butanediol dimethacr ylate (FCM 
No 1043). The Author ity has no safety concer n in case those substances are used at a maximum combined 
weight percentage of 10 % w/w in non-plasticised polyviny l chlor ide in contact with all food types at ambient 
temperature or belo w, including long-t erm storag e, and when used individually or in combination as additives, 
and when the diamete r of the particles is larger than 20 nm, and for at least 95 % by number the diamet er is 
larger than 40 nm. Theref ore, the use of those substances does not endanger human health when used in 
accordance with those specif ications, and these substances should be inser ted according ly in Table 1 of Annex I 
to Regulation (EU) No 10/2011. 
(14)  The Author ity adop ted a favourable scientifi c opinion (2) on the use of the new polymer production aid 
2H-perf luoro-[(5,8,11,14-t etrameth yl)-tetraeth yleneg lycol ethyl prop yl ether] (FCM No 903). That substance 
should only be used as a polymer production aid in the polymer isation process of fluoropolymers. Dur ing that 
process the sinter ing or processing conditions set out in the opinion should be applied. The use of this substance 
does not endanger human health when used in accordance with those specif ications and it should be added to 
Table 1 of Annex I to Regulation (EU) No 10/2011. 
(15)  The Author ity adopt ed a favour able scientifi c opinion (3) on the use of the new additive ethylen e-vinyl acetate 
copolymer wax (FCM No 969), provided that the substance is used as an additive up to 2 % w/w in only 
poly olefin mate rials and articles and the migration of low molecular weight oligomer ic fraction belo w 1 000 Da 
does not exceed 5 mg/kg food. The use of this substance does not endang er human health when used in 
accordance with those specifi cations and it should be added to Table 1 of Annex I to Regulation (EU) 
No 10/2011. 
(16)  The Author ity adopt ed a favourable scientifi c opinion (4) on the use of the new additive polyg lycerol (FCM 
No 1017). The opinion concluded that the substance does not raise a safety concer n if it is used as plasticiser at a 
maximum use level of 6,5 % w/w in polymer blends of aliphatic-aromatic poly esters. As the opinion states that 
the substance is a naturally occur ring hydrolysis product of an author ised food additive (E475) with author ised 
use levels up to 10 g/kg food, it can be concluded that the substance would be of no safet y concer n when 
migration is above the gener ic specifi c migration limit refer red to Article 11(2) of Regulation (EU) No 10/2011. 
The Author ity reached its conclusion also on the basis that the substance would not decompose during its 
processing in plastic mate rial. Theref ore, the use of the substance would not endang er human health if the 
gener ic specific migration limit is respected and decom position of the substance during processing is avoided. 
Theref ore, this additive should be added to Table 1 of Annex I to Regulation (EU) No 10/2011, with an additional 
specification preventing its decomp osition during processing. 
(17)  The mixture ‘polyeth yleneg lycol (EO = 2-6) monoalkyl (C16-C18) ether ’ (FCM No 725) is a subgroup of the 
mixture, ‘polyeth yleneg lycol (EO = 1-50) ethers of linear and branched primar y (C8-C22) alcohols’ (FCM No 799.) 
The SML and other restr ictions for FCM No 799 are based on a more recent scientifi c evaluation (5). The entr y 
for FCM No 725 is covered by the entr y for FCM No 799 and should theref ore be remo ved from Table 1 of 
Annex I to Regulation (EU) No 10/2011. 
(18)  To limit the administrative burden to business operat ors, plastic mater ials and articles whic h have been lawfully 
placed on the market based on the requirements set out in Regulation (EU) No 10/2011 before the entr y into 
force of this Regulation and whic h do not compl y with this Regulation should be able to be placed on the 
mark et until 26 Febr uary 2016. They should be able to remain on the market until exhaustion of stoc ks. 
(19)  Regulation (EU) No 10/2011 should theref ore be amended according ly. 
(20)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 6.2.2015 L 30/4 Official Jour nal of the European Union EN     
(1)EFSA Jour nal 2014; 12(4):3635. 
(2)EFSA Jour nal 2012; 10(12):2978. 
(3)EFSA Jour nal 2014; 12(2):3555. 
(4)EFSA Jour nal 2013; 11(10):3389. 
(5)FCM 725 was evaluated by the SCF, http://europa.eu.int/comm/f ood/fs/sc/scf/out20_en.pdf. FCM 799 was evaluated by EFSA, 
EFSA Jour nal (2008) 698-699. HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation. 
Article 2 
Plastic mater ials and articles complying with the requirements of Regulation (EU) No 10/2011 as applicable before 
26 Febr uary 2015 may be placed on the mark et until 26 Febr uary 2016. Those plastic mater ials and articles may 
remain on the mark et after that date until exhaustion of stoc ks. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 5 Febr uary 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  6.2.2015 L 30/5 Official Jour nal of the European Union EN     ANNEX 
Annex I to Regulation (EU) No 10/2011 is amended as follows: 
(1)  Table 1 is amended as follows: 
(a)  the entr ies concer ning 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-(+)-tar taric 
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-dia ­
nhydrosorbi ­
tol 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 compo nent in combi ­
nation with ethylene gly­
col and/or 1,4-bis(hydr o­
xymeth yl)cy clohexane, for 
the production of polye ­
sters. 
Polyest ers made using dia­
nhydrosorbitol together 
with 1,4-bis(hydro xy­
meth yl)cy clohexane 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 incor porated 
at a quantity of less than 
12 % w/w in an ethylen e vi­
nyl 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.  6.2.2015 L 30/6 Official Jour nal of the European Union EN     713 43480 0064365-11-3 charcoal, 
activated yes no no   Only for use in PET at maxi ­
mum 10 mg/kg of polymer . 
Same purity requirements as 
for Vegetable Carbon (E 153) 
set out by Commission Regu ­
lation (EU) No 231/2012 (*) 
with excep tion of ash cont ent 
which can be up to 10 %  
(w/w).  0007440-44-0 
784 95420 0745070-61-5 1,3,5-tr is 
(2,2-di- 
methylpropa ­
namido) 
benzene yes no no 5    
799 77708  polyeth ylene ­
glycol 
(EO = 1-50) 
ethers of lin­
ear and 
branched pri­
mar y (C8-C22) 
alcohols yes no no 1,8  In compl iance with the maxi ­
mum ethylene oxide content 
as laid down in the purity cri­
teria for food additives in 
Commission Regulation (EU) 
No 231/2012.  
880 31348  acids, fatty 
(C8-C22), esters 
with pentaer ­
ythr itol' yes no no     
881 25187 0003010-96-6 2,2,4,4-tetra ­
methylcy clo­
butane-1,3- 
diol no yes no 5  Only for: 
(a)  repeate d use articles for 
long term storag e at 
room temperature or be­
low and hotf ill; 
(b)  sing le use mater ials and 
articles as a co-monomer 
at a maximum use level 
of 35 mole % of the diol 
compo nent of poly esters, 
and if such mat erials and 
articles are for long term 
storage at room tempera ­
ture or belo w of food 
types which have an alco ­
hol content of up to 10 % 
and for which Table 2 of 
Annex III does not assign 
simulant D2. Hot fill con­
ditions are allowed for 
such sing le use mater ials 
and articles.  
(*)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificat ions 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).’  6.2.2015 L 30/7 Official Jour nal of the European Union EN     (b)  the following entr ies are inser ted in numer ical order of the FCM substance numbers: 
‘859   (butadiene, 
ethyl acrylate, 
methyl 
methacr ylate, 
styrene) copo ­
lymer cross ­
linked with 
divinylben ­
zene, in nano ­
form 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 tempera ­
ture or belo w including long- 
term storag e. 
When used together with the 
substance with FCM No 998 
and/or the substance with 
FCM No 1043, the restr iction 
of 10 % w/w applies to the 
sum of those substances. 
The diamete r of particles shall 
be > 20 nm, and for at least 
95 % by number it shall be 
> 40 nm.  
903  37486-69-4 2H-perf luoro- 
[(5,8,11,14- 
tetrameth yl)- 
tetraeth ylene ­
glycol ethyl 
prop yl ether] yes no no   Only to be used as a polymer 
production aid in the poly ­
mer isation of fluoropolymers 
intended for: 
(a)  repeate d and sing le use 
mat erials and articles 
when sintered or pro­
cessed (non-sintered) at 
temperatures at or above 
360 °C for at least 10 min ­
utes or at higher tempera ­
tures for equivalent 
shor ter times; 
(b)  repeate d use mat erials 
and articles when pro­
cessed (non-sintered) at 
temperatures from 300 °C 
and up to 360 °C for at 
least 10 minutes.  
969  24937-78-8 ethylene-vin yl 
acetate copo ­
lymer wax yes no no   Only to be used as a poly ­
mer ic additive up to 2 % w/w 
in poly olefi ns. 
The migration of low molecu ­
lar weight oligomer ic fraction 
belo w 1 000 Da shall not ex­
ceed 5 mg/kg food.  
998   (butadiene, 
ethyl acrylate, 
methyl 
methacr ylate, 
styrene) copo ­
lymer not 
cross-linked, 
in nanof orm 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 tempera ­
ture or belo w including long- 
term storag e.   6.2.2015 L 30/8 Official Jour nal of the European Union EN     When used together with the 
substance with FCM No 859 
and/or the substance with 
FCM No 1043, the restr iction 
of 10 % w/w applies to the 
sum of those substances. 
The diamete r of particles shall 
be > 20 nm, and for at least 
95 % by number it shall be 
> 40 nm.  
1017  25618-55-7 polyg lycerol yes no no   To be processed under condi ­
tions preventing the decom ­
position of the substance and 
up to a maximum tempera ­
ture of 275 °C.  
1043   (butadiene, 
ethyl acrylate, 
methyl 
methacr ylate, 
styrene) copo ­
lymer cross ­
linked with 
1,3-butanediol 
dimethacr y­
late, in nano ­
form 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 tempera ­
ture or belo w including long- 
term storag e. 
When used together with the 
substance with FCM No 859 
and/or the substance with 
FCM No 998, the restr iction 
of 10 % w/w applies to the 
sum of those substances. 
The diamete r of particles shall 
be > 20 nm, and for at least 
95 % by number it shall be 
> 40 nm.’   
(c)  The entr y concer ning FCM substance No 725 is delet ed. 
(2)  In Table 2, the entr ies concer ning group restr ictions 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 entr y is added: 
‘(21) In case of reaction with foods or simulants verification of compl iance shall include verification that the mi­
gration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.’   6.2.2015 L 30/9 Official Jour nal of the European Union EN