EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EU) No 10/2011 on plasti c materials and articles intended to come 
into contact with food 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EU) No 10/2011 on plasti c materials and articles intended to come 
into contact with food 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard 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 materials and articles intended to come into  contact with food 
and repealing Directives  80/590/EEC and 89/109/EEC
1, and in particular Article 5(1)(a), (c), 
(d) and (e) Article 11(3) a nd Article 12(6) thereof, 
Whereas: (1) Annex I (hereinafter 'Annex I') to Commission Regulation (EU) No 10/2011
2 
(hereinafter 'the Regulation') establishes a Union list of s ubstances which may be used 
in the manufacture of plastic materials an d articles ('Union list of authorised 
substances').  
(2) The substance tartaric acid, CAS No 87-69-4, FCM No 161, wa s assessed by the 
Scientific Committee for Foods (SCF) in 19913. The favourable opinion of the 
committee only includes the natural occurring form, L-(+)-tartaric acid, whilst it explicitly excludes the DL form of tartar ic acid. It follows from the SCF assessment 
that only L-(+)-tartaric acid does not enda nger human health, while  this has not been 
shown for all other forms of this substance. Therefore it should be clear from the name 
of the substance in table 1 of Annex I that this refers  only L-(+)-tartaric acid. 
Therefore the name of substance No  161 should be amended accordingly.  
(3) On 9 April 2013 the European Food Safety Au thority (hereinafter 'the Authority') 
adopted an opinion re-evalu ating the tolerable daily  intake (TDI) of phenol
4. Phenol, 
CAS No 108-95-2, FCM No. 241, is included as  a starting substance in Table 1 of 
Annex I. To this substance the generic Sp ecific Migration Lim it (SML) of 60 mg/kg 
set out by Article 11(2) applies. In its re -evaluation, the Authority reduced the TDI 
from 1.5 mg/kg body weight (bw)/day to 0.5 mg/kg bw/day. The Authority noted that 
exposure from all sources is above the TD I, while exposure from food contact 
materials is likely to be in the range of th e TDI. In addition to the TDI, an allocation 
factor of 10% for exposure from food contac t materials should ther efore be used to 
achieve a sufficient reduction of the phenol  exposure. The setting of the migration 
limit takes into account a conventional assump tion that 1kg of food is consumed daily 
                                                 
1 OJ L 338, 13.11.2004, p. 4. 
2 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact with food (OJ L 12, 15.1.2011, p. 1). 
3 Report of the Scientific Committee for foods, 25th series, EUR 13416, 1991. 
4 EFSA Journal 2013; 11(4):3189. EN 3   EN by a person of 60 kg bodyweight. Therefore to ensure that phenol does not endanger 
human health a specific migration limit of 3 mg/kg for phenol should be set. 
(4) The substance 1,4-Butandiol formal, CAS No  505-65-7 , FCM No 344 was evaluated 
by the SCF in 20005 which concluded that an SM L of 0,05 mg/kg should be set. 
Column 8 of in table 1 of A nnex I incorrectly states that  migration of the substance 
shall be non-detectable. Table 1 of Annex I should therefore be amended accordingly. 
(5) The SCF proposed to determine the residual content of the subs tance 1,4-butanediol 
formal, CAS No 505-65-7, FCM No 344 in the material (i.e. by 'QMA') instead of 
verifying compliance against the SML, becau se no suitable method to determine the 
substance in a food or simulant was availa ble. Article 3(1) of  Regulation (EC) No 
1935/2004 lays down requirements based on the tr ansfer of the constituents to food. 
Testing by QMA also conflic ts with the approach Re gulation (EU) No 10/2011 to 
verify compliance by migration testing, an d suitable methods are available now. 
Therefore, verifying compliance by QMA is no longer appropriate, and should be 
replaced by migration testing only. As the substance may react with some foods and 
simulants, verification of compliance shoul d include verification that the hydrolysis 
products 1,4-butanediol (FCM No 254) and formaldehyde (FCM No 98) do not exceed 
the limits. The current note on the verifica tion of compliance shoul d be replaced, and 
this substance should be added to the group restrictions 15 and 30 in table 2 of Annex 
I. Tables 1, 2 and 3 of Annex I should be amended accordingly. 
(6) On 15 May 2013, the Authority adopte d a favourable scientific opinion6 on a possible 
extension of the use of starting substa nce 1,4:3,6-dianhydrosorbitol, CAS No 652-67-
5, FCM No 364 to the use as a co-monomer for the production of polyesters, if used at 
levels of up to 40 mole% of the diol com ponent in combination with ethylene glycol 
and/or 1,4-bis(hydroxymethyl)cyclohexane. Po lyesters made using dianhydrosorbitol 
together with 1,4-bis(hydroxymethyl)cyclohexa ne should not be used in contact with 
foods containing more than 15 % alcohol. Th erefore the extension of the use of the 
substance to the new specification doe s not endanger human health, and the 
authorisation of FCM substance No  364 should be amended accordingly. 
(7) On 27 March 2014, the Authority adopted  a favourable scientific opinion7 on a 
possible extension of the authorised use of the substance kaolin, CAS number 1332-
58-7, FCM No 410, to include particles in the nanoform with a thickness less than 100 
nm and incorporated up to 12 % in EVOH c opolymer. Therefore the extension of the 
use of the substance to the new specificat ion does not endanger human health, and the 
authorisation of FCM substance No 410 shoul d be amended to incl ude a specification 
and restriction on particle size. The same opi nion also includes a re-evaluation of the 
substance polyacrylic acid, sodium sa lt, CAS number 9003-04- 7 and FCM No 70. 
However, the opinion does not affect the existing authorisation of this substance, which should therefore not be amended. 
(8) The substance with FCM substance No 713 is identified as 'charcoal, activated' with 
CAS No. 64365-11-3. On the market another su bstance is used whic h is identified as 
'activated carbon' with CAS No. 7440-44-0. In practice these two substances are the 
same and names are used interchangeably and are synonymous. Therefore it should be 
clear that FCM substance No 713 cove rs both names and CAS Nos, and the 
                                                
 
5 Opinion of the Scientific Committee on Food on the 11th additional list of monomers and additives for 
food contact materials, SCF/CS/PM/GEN/M8313, November 2000. 
6 EFSA Journal 2013; 11(6):3244. 
7 EFSA Journal 2014;12(4):3637 EN 4   EN authorisation of FCM substa nce No 713 should be amended by adding the CAS No for 
activated carbon. 
(9) On 4 July 2013 the EFSA adopted a favourable  scientific opinion on a possible higher 
migration limit for the additive 1,3,5-tris( 2,2-dimethylpropanamido)benzene, CAS No. 
745070-61-5, FCM No 784. The application con cerns the use of the substance in 
polyolefins. The new toxicological data estab lishes the safety of the substance up to a 
migration limit of 5 mg / kg food. The conclusion of the opinion limits this to 
polyolefins only. The current entry in table 1 of Annex I does not limit the use of the 
substance to polyolefins however. As the opini on shows that migration in a polyolefin 
is far below the proposed SML, and as polyolefins are normally considered a worst case material for migration, migration in ot her polymers is therefore not expected to 
exceed the limit. Because the substance is thermally stable up to 380 °C and plastic 
materials are processed below that temper ature, an SML of 5 mg/ kg food does not 
endanger human health in all plastic mate rials. Therefore th e authorisation of 
substance No 784 should be amended by changing the SML. 
(10) The restriction which is defined for the gr oup of substances, polyethyleneglycol (EO= 
1-50) ethers of linear and br anched primary (C8-C22) alc ohols, FCM No 799 refers to 
the purity criteria for ethylene oxide sp ecified in Commissi on Directive 2008/84/EC
8. 
This directive however specifi es purity crite ria for certain food a dditives setting out a 
maximum ethylene oxide content for those a dditives. This maximum should also apply 
to this group of substances with FC M substance No 799. The wording of the 
restriction set out for FCM No 799 should be amended accordingly in table 1 of Annex I. 
(11) The group of substances 'acids, fatty (C8-C22 ), esters with pentaerythritol', FCM No 
880, is listed in table 1 of Annex I w ith CAS No 85116-93-4. This CAS number 
belongs to only a subgroup of the listed gr oup, named 'acids, fatty (C16-18), esters 
with pentaerythritol'. For the listed subs tance group no CAS number is established. 
Therefore the listing of FCM substance No  880 in table 1 of Annex I should be 
amended by deleting the CAS number. 
(12) On 25 September 2013, the Authority adopt ed a favourable scientific opinion
9 on the 
possible extension of the us e of the substance 2,2,4,4-tetr amethylcyclobutane-1,3-diol, 
CAS No 3010-96-6, FCM No. 881, to single us e applications. The opinion concludes 
that for single use applications , the substance does not raise a safety concern if used as 
co-monomer in the production of polyesters at  use levels up to 35 mol % of the diol 
component, in contact with all food types othe r than spirits and highly fatty foods to be 
simulated by food simulant D2 (vegetable oil), for long time storage at room temperature or below and hot fill. Therefore if the permitted use of this substance is extended to include these new specifications, the use of this substance does not endanger human health, and the authorisa tion of FCM substance No 881 should be 
amended accordingly. Simulant D1 may cause  changes to the material which would 
not occur in non-alcoholic foods for which D1 is assigned in Annex III to the 
Regulation. Therefore, a material containi ng the substance may fail compliance testing 
for such permitted foods. In such cases the material can be considered safe if supporting documentation shows that the material is produced respecting the 
maximum use level of the diol compone nt on the basis of good manufacturing 
                                                
 
8 Comission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food 
additives other than colours and swee teners (OJ L 253, 20.9.2008, p. 1). 
9 EFSA Journal 2013; 11(10):3388. EN 5   EN practices. To avoid uncertainti es regarding the compliance of  a material containing the 
substance a note for the verifi cation of compliance when simulant D1 is used should 
be added to table 3 of Annex I.   
(13) On 27 March 2014, the Authority adopted  a favourable scientific opinion10 on the use 
of three new substances in nanoform, (butad iene, ethyl acrylate, methyl methacrylate, 
styrene) copolymer cross-linked with divi nylbenzene, FCM No 859, (butadiene, ethyl 
acrylate, methyl methacrylate, styrene) copolymer not cross-linked, FCM No 998, and 
(butadiene, ethyl acrylate, methyl methacr ylate, styrene) cross-linked with 1,3-
butanediol dimethacrylate, FCM No 1043, if th ese substances are us ed individually or 
in combination as an additive at up to 10 % w/w in non-plasticised Polyvinyl Chloride (PVC) used in contact with all food types at ambient temp erature or below including 
long-term storage, and if the di ameter of particles is larger  than 20 nm, and for at least 
95% by number the diameter is larger than  40 nm. Therefore the use of these three 
substances does not endanger human health if used according to these specifications, 
and these should be added accordingly to table 1 of Annex I.  
(14) On 21 November 2012, the Authority adopt ed a favourable scientific opinion
11 on the 
use of the new polymer production aid 2H-perfluoro-[(5,8,11,14-tetramethyl)-
tetraethyleneglycol ethyl propyl  ether], CAS No 37486-69-4. Th is substance is only to 
be used as a polymer production aid in th e polymerisation of fluoropolymers intended 
for repeated and single use materials and arti cles and when the applicable processing 
conditions are respected. Therefore the use of this substance does not endanger human 
health if used according to th ese specifications and it s hould be added accordingly to 
table 1 of Annex I with FCM substance No 903.  
(15) On 18 December 2013, the Authority adopt ed a favourable scientific opinion12 on the 
use of the new additive ethylene-viny l acetate copolymer wax, CAS No 24937-78-8, 
provided that the substance is used as additive up to 2 % w/w in only polyolefin 
materials and articles and the migration of  low molecular weight oligomeric fraction 
below 1 000 Da does not exceed 5 mg/kg foo d. Therefore the use of this substance 
does not endanger human health if used acco rding to these specifications and it should 
be added to table 1 of Anne x I with FCM substance No 969. 
(16) On 25 September 2013 the Authority adopted a favourable scientific opinion on the 
use of the new additive  polyglycerol, CAS No 25618-55-7, FCM No 1017. The 
opinion concludes that the substance does not raise a safety concern if it is used as 
plasticizer at a maximum use level of 6.5 % w/w in polymer bl ends of aliphatic-
aromatic polyesters. As the substance is a naturally occurring hydr olysis product of an 
authorised food additive (E475) with use leve ls up to 10 g/kg it can be concluded that 
the substance would be of no safety con cern even well above the generic migration 
limit of 60 mg / kg food. In addition, the specified maximum use level corresponds to 
a calculated worst case migration of 50 mg/kg food according to the opinion. 
Therefore the substance can be  used on the basis of the ge neric migration limit without 
specifying a maximum use level. The opinion st ates that the substance is stable up to 
275 °C which is above the processing temperat ure of polymer blends of aliphatic-
aromatic polyesters the material that is c overed by the application. When the material 
containing the substance is processed at c onditions that avoid the decomposition of the 
substance restricting the use of the substan ce to polymer blends of aliphatic-aromatic 
                                                 
10 EFSA Journal 2014; 12(4):3635 
11 EFSA Journal 2012; 10(12):2978. 
12 EFSA Journal 2014; 12(2):3555. EN 6   EN polyesters is not necessary. Considering that to reduce the burden of evaluating 
substances Annex I provides for general aut horisations, and the use of the substance 
does not endanger human health if the generi c migration limit is respected and it does 
not decompose during processing, this addi tive should now be a dded to table 1 of 
Annex I with FCM substance No 1017. 
(17) The mixture 'polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18), CAS No 68439-
49-6', FCM No 725, is a subgroup of the mi xture, 'polyethyleneglycol (EO= 1-50) 
ethers of linear and branched primary (C 8-C22) alcohols', FCM No 799. The SML and 
other restrictions for FCM No 799 are based on a more recent scientific evaluation. 
Therefore the listing of FCM No 725 is covered by the listing of FCM No 799 and 
should be removed from table 1 of Annex I. 
(18) In order to limit the admini strative burden to business opera tors, plastic materials and 
articles which have been lawfully placed on the market based on the requirements set 
out in Regulation (EU) No 10/2011 before the entry into force of this Regulation and 
which do not comply with this Regulation s hould be able to be placed on the market 
until [12 months after the entry into force of  this Regulation]. They should be able to 
remain on the market until exhaustion of stocks.  
(19) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex I to Regulation (EU) No 10/2011 is ame nded in accordance with the Annex to this 
Regulation. 
Article 2 
Plastic materials and articles which have been lawfully placed on the market before [date of 
entry into force of this Regulation] and whic h do not comply with this Regulation may be 
placed on the market until [12 months after th e entry into force of this Regulation]. Those 
plastic materials and articles may remain on the ma rket after that date until the exhaustion of 
stocks. 
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 States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO