EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/XXXX 
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact with food 
(Text with EEA relevance) 
 
Ref. Ares(2015)1748520 - 24/04/2015EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending and correcting Regulation (EU) No  10/2011 on plastic 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 points (a), (c), (d) 
and (e) of Article 5(1), Article 11(3) and Article 12(6) thereof, 
Whereas: (1) In the definition of 'non-fatty foods' provi ded for in Article 3( 16) of Commission 
Regulation (EU) No 10/2011
2 ('the Regulation'), a reference to food simulants is made 
to the wrong table. Therefore it is appropriate  to correct the refe rence to Table 2 of 
Annex V, which should read Table 2 of Annex III. 
(2) Rubber food contact materials are excluded fr om the scope of the Regulation. Rubbers 
and plastics are both polymeric material s which may be produced from the same 
starting materials, which may be elastic , which may either be thermoset or 
thermoplastic, which may be cross-linked, and which may be added to each other. 
Conventional definitions of rubbers and plastics are based on these properties and 
therefore do not distinguish unambiguously be tween the two materials. This presently 
causes problems in determining the comp liance of rubber-like materials under the 
Regulation and therefore a clarification by defining 'rubber' under the Regulation is 
appropriate. 
(3) Rubber materials and articles are excluded fr om the Regulation because of differences 
in chemistry for which the Regulation does not  provide. In particul ar, vulcanisation of 
rubbers involves a chemistry based on sulphur  or equivalent curatives, but not based 
on other substances including zinc ch loride and cross linking monomers. 
Vulcanisation is therefore pertinent to di stinguish rubbers from  plastics, and such 
rubber materials should therefore not be in the scope of the Regulation. Already 
vulcanised rubber used as an additive to pl astics should remain in the scope of the 
Regulation as its vulcanisation chemistry is no longer releva nt at that stage. It is 
therefore appropriate that the definition of 'rubber' in the Regulation is based 
accordingly on vulcanisation and that the defini tion of 'vulcanisation' is added to the 
Regulation. 
                                                 
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). EN 3   EN (4) The Regulation provides derogation to the list ing requirement for salts of authorised 
acids, phenols or alcohols. However this der ogation was intended to be also applicable 
to multiple salts and hydrates of salts. This is not clear from the current text. Therefore the Regulation should be amended to extend the derogation to multiple salts and salt 
hydrates. 
(5) This Regulation for the first time restrict s the migration of oligomers containing 
certain substances. Testing for oligomer migration is techni cally challenging. 
Enforcement and other laboratories shoul d have adequate analytical methods 
available. To ensure that compliance of a material to which such oligomer migration 
limits apply can be verified by enforcement laboratories and by the users of such materials, and to ensure the uniformity of such verification of compliance on the 
Union market, testing methods should theref ore be made publically  available via the 
European Union reference laboratory for mate rial intended to come into contact with 
foodstuffs established as laid down in Regulation (EC) No 882/2004 to ensure a 
capability regarding their uniform appli cation by business operators and competent 
authorities before the substances can be placed on the market. 
(6) In Article 13(3) of the Regulation the phrase 'with statistical certainty' appears. This 
phrase is meaningless but is intended to i ndicate that measurement uncertainty should 
be taken into account. Therefore it is ap propriate to include  a statement on 
measurement uncertainty, and to dele te 'with statistical certainty'. 
(7) Specific migration should be expressed in mg/kg food. Curr ently migration from caps 
can also be expressed in mg /dm². Therefore it is appropria te to remove the possibility 
to express the migration from caps in  mg/dm² by amending Article 17(3)(a). 
(8) Article 18(4) defines simulant s that should be used for de termining overall migration. 
It is not appropriate to specify these simulants in Article 18(4) as these are specified in Annex III. Therefore the specifi cation of simulants in Arti cle 18(4) should be deleted 
(9) To ensure a clear procedure and to minimi se the burden, rules should be established 
regarding the publicatio n of methods by the European Union reference laboratory for 
material intended to come into contact with  foodstuffs if the public ation of such rules 
is required before a substance can be pl aced on the market. Therefore such rules 
should be added to the Regulation. 
(10) Table 1 of Annex I to the Regulation establis hes a Union list of authorised substances 
('the Union list') which may be used in the manufacture of plastic materials and 
articles.  
(11) Article 13(2)(b) of the Regulation allows th at plastic materials can be produced with 
layers containing substances that are not included on the Union list, provided that 
these layers are used behind a functional ba rrier. Such substances should be risk 
assessed according to interna tionally recognised sc ientific principles  as is required 
under Article 19 of this Regula tion. Article 19 however does not provide a reference to 
Article 13(2)(b). To ensure that also s ubstances allowed under Article 13(2)(b) are 
subject to risk assessment, the Regulati on should be corrected and a reference to 
Article 13(2)(b) should be added to Article 19. 
(12) The transitional period for applying the provisions of the Regulation to additives used 
in glass fibre sizing will end on 31 Decembe r 2015. Further analysis has established 
that the composition of gla ss fiber sizing agents is more complex than initially 
anticipated and that specific rules under th e Regulation are require d in addition or in 
place of application of Article 5. The Comm ission is currently consulting with the EN 4   EN Authority on such rules. Therefore it is a ppropriate to clarify that the transitional 
provisions apply to all consti tuents of glass fibre sizing for glass fibre reinforced 
plastics and to continue the appl ication of Article 19 for one year. 
(13) The word 'should' is used several times in  the Annex I and Annex V of the Regulation 
for obligatory provisions. Therefore 'should' should be replaced with  'shall' in those 
Annexes to the Regulation. 
(14) In column 10 of the Union list several references are made to simulant D. The present 
Regulation does not specify simulant D any more, but specifies simulant D1 and D2. 
Therefore references to simulant D should be replaced by a reference to simulant D1 
or D2  for all substances in which the referen ce to simulant D is specified as part of the 
restriction in column 10.  
(15) The substance silicon dioxide, silanated (f ood contact material ('FCM') substance No 
87), is authorised for use as an additive in all types of plastics, w ithout restriction. This 
substance is produced on the basis of synthetic amorphous silicon dioxide in 
nanoform. Under Article 9(2) Substances in nanoform should only be used if explicitly 
authorised and mentioned in the specifications in Annex I. Taking account of the 
available scientific information on this subs tance, the European Food Safety Authority 
('the Authority') concluded that the use of  this substance does not raise any safety 
concern when in the final material only a gglomerates larger than 100 nm are present3. 
Therefore, the Union list should be amended to  specify that the substance can be used 
in its nanoform when no particles of  a smaller size than 100 nm remain in the final material. 
(16) The Authority adopted a fa vourable scientific opinion
4 on the use of the additive 
dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-
hydroxypoly (oxy-1,2-ethanediyl) and 1-prope ne, FCM No 871. When used as an 
additive in polyolefins at leve ls of up to 20 weight %, in  contact with dry foods as 
represented by simulant E, at contact conditi ons at ambient temperature or below, and 
when migration of the low molecular wei ght oligomeric fraction less than 1000 Da 
does in total not exceed 50 μg/kg food, the use of this substance does not endanger 
human health. Therefore it shoul d be added to the Union list with th e restriction that 
these specifications should be met. 
(17) The Authority adopted a fa vourable scientific opinion5  on the use of the starting 
substance furan-2,5-dicarboxylic acid (FCM No 1031). When used as a as a monomer 
in the production of polyethylene furanoate  (PEF) polymer this substance does not 
raise a safety concern for the consumer when the migration of the s ubstance itself does 
not exceed 5 mg/kg food, and when migra tion of the oligomers less than 1000 Da does 
not exceed 50 μg/kg food. When compliance is verifi ed for contact w ith non alcoholic 
foods for which Table 2 of A nnex III assigns food simulant D1, there is a risk of an 
interaction between the simulant and the plas tic which would not oc cur in contact with 
such foods. According to the opinion food simulant C would be considered sufficiently conservative for such foods. Theref ore it should be adde d to the Union list 
with the restriction that these specifications should be met, and a note on the 
verification of compliance should be added. 
                                                
 
3  EFSA Journal 2014;12(6):3712. 
4  EFSA Journal 2014;12(11):3909. 
5 EFSA Journal 2014;12(10):3866. EN 5   EN (18) The Authority adopted a fa vourable scien tific opinion6 on the use of the starting 
substance 1,7-octadiene (FCM No 1034). When  used as a crosslinking co-monomer in 
the manufacture of polyolefins for contact wi th any type of foods for long term storage 
at room temperature, including hot fill condi tions, and the migration of the substance 
does not exceed 0.05 mg/kg food, the use of this substance does not endanger human health. Therefore it should be added to the Union list with the restriction that these specifications should be met. 
(19) The Authority adopted a favourable scientific opinion
7 on the use of the polymer 
production aid perfluoro{acetic acid, 2- [(5-methoxy-1,3-dioxolan-4-yl)oxy]}, 
ammonium salt (FCM No 1045). When used  as polymer produc tion aid during the 
manufacture of fluoropolymers which are pr oduced under high temperature conditions 
of at least 370 °C the use of this substa nce does not endanger hum an health. Therefore 
it should be added to the Union list with the restriction that these specifications should 
be met. 
(20) The Authority adopted a fa vourable scientific opinion8 on the use of the additive 
ethylene glycol dipalmitate (FCM No 1048). The Authority concl uded that when the 
substance is produced using an fatty acid  precursor conventionally obtained from 
edible fats or oils and the migration of et hylene glycol is contro lled by including it in 
the group SML(T) for ethylene glycol, the use of this additive does not endanger human health. Therefore this additve shoul d be added to the Union list with the 
restriction that these specifica tions should be met, and entry (2) of table 2 of Annex I 
should be amended to include it. 
(21) The Authority adopted a favour able scientific opinion
9 on the use of the additive N,N'-
bis(2,2,6,6-tetramethyl-4-piperidinyl) isophtha lamide (FCM No 1051). The Authority 
concluded that when its the migration doe s not exceed 5 mg/kg food, the use of this 
additive does not endanger human health. Th erefore it should be added to the Union 
list with a migration limit of 5 mg/kg food. 
(22) The Authority adopted a favourable scientific opinion10 on the use of the starting 
substance 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol, β3,β3,β9,β9-tetramethyl- 
('SPG', FCM No 1052). The Authority conclude d that when used as a monomer in the 
production of polyesters, its migrati on does not exceed 5 mg/kg food, and the 
migration of the oligomers of less than 1000 Da does not exceed 50 μg/kg food 
(expressed as SPG), the use of this ad ditive does not endanger human health. 
Therefore it should be added to the Union list with with the restriction that these 
specifications should be met. 
(23) The Authority adopted a favourable scientific opinion11 on the use of the additive fatty 
acids, C16–18 saturated, hexaesters with dipentaerythritol (FCM No 1053).  
Because any content of lower esters (e.g. penta- , tetra-, etc.) is not of a safety concern, 
the Authority concluded that the use of the substance fatty acids, C16–18 saturated, 
esters with dipentaerythritol does not endanger human health, provided that the 
substance is produced using an fatty acid precu rsor obtained from edible fats or oils. 
                                                 
6  EFSA Journal 2015;13(1):3979. 
7 EFSA Journal 2014;12(6):3718. 
8 EFSA Journal 2015;13(2):4019. 
9 EFSA Journal 2014;12(10):3867. 
10 EFSA Journal 2014;12(10):3863. 
11 EFSA Journal 2015;13(2):4021 EN 6   EN Therefore it should be added to the Union lis t with with the rest riction that this 
specification should be met, and wit hout restricting it to hexaesters. 
(24) The Authority adopted an opinion12 on the safety of aluminium from dietary intake. 
This establishes a tolerably weekly intake of 1 mg al uminium per kg body weight per 
week. Using the conventional exposure a ssumptions for food contact materials, a 
migration limit of 8,6 mg/kg food would fo llow. The opinion also notes that the 
current dietary exposure of a significant pa rt European population likely exceeds this 
level. Therefore it would be appropriate to apply an allocation factor of 10% to the 
conventionally derived migration limit. Ther efore a migration limit for aluminium of 
0,9 mg/kg food is appropriate for food cont act materials. To prevent exaggerated 
analytical precision in view of the uncerta inties in deriving this limit, it should be 
rounded to 1 mg/kg food. This limit should ther efore be specified in  Annex II of the 
Regulation, and the Regulation should be amended accordingly. 
(25) The Authority adopted an opinion on the risks to public health related to the presence 
of nickel in food and drinking water13. This establishes a tolera ble daily intake of 2.8 
μg Ni per kg body weight per day, and indicates that th e mean chronic dietary 
exposure to Ni is close to the TDI or above  it, particularly when considering the young 
population. Therefore it would be appropriate to  apply an allocation factor of 10% to 
the conventionally derived migration limit. Th erefore a migration limit for nickel of 
0,0168 mg/kg food is appropriate for food cont act materials. To prevent exaggerated 
analytical precision in view of the uncerta inties in deriving this limit, it should be 
rounded to 0,02 mg/kg food. This limit should th erefore also be specified in Annex II 
of the Regulation, and the Regulatio n should be amended accordingly. 
(26) The Authority adopted an opinion on dietary reference values for zinc14. This 
reconfirms an opinion expressed by the sc ientific committee on foods (SCF) in 200215 
which sets tolerable upper intake level of  zinc from to 25 mg/kg food. In Annex II of 
the Regulation the migration limit for zinc is  also set at 25 mg/kg food. As dietarty 
exposure from other sources si gnificantly contributes to the total expos ure, the upper 
intake level would be exceeded when migr ation of zinc up to the migration limit 
occurs. Therefore to reduce th e contribution from food cont act material to the total 
exposure to zinc, and taking account that the total dietary exposure to zinc is in the range of the upper limit but ge nerally below, it is appropriate to use an allocation 
factor of 20 % for the exposur e from food contact material, it is therefore approapriate 
to amend the migration limit specified in Annex II to 5 mg/kg food. 
(27) Only a specification of the amount of saponifi able matter in vegeta ble oil to be used 
for simulant D2 is sufficient to specify th is simulant. It is therefore appropriate to 
delete any other specification and to am end the note below Table 1 of Annex III. 
(28) No simulants have been assigned for fresh fr uits and vegetables that are unpeeled and 
uncut. These fruits and vegeta bles are generally dry and th erefore food simulant E is 
appropriate. As materials and articles will only be  in partial contact with these fruits or 
vegetables, or the fruits or vegetables may be washed a nd or peeled by the consumer, 
migration testing with food simulant E woul d give a significant overestimation. As in 
practice many contact situations may occur for instance depending on the type of fruit 
or vegetable, it is not pract icable to describe. Therefor e to reduce the overestimation 
                                                
 
12 The EFSA Journal (2008) 754, 1-34 
13 EFSA Journal 2015;13(2). 
14 EFSA Journal 2014;12(10):3844. 
15 SCF/CS/NUT/UPPLEV/62 Final, http://ec. europa.eu/food/fs/sc/scf/out177_en.pdf EN 7   EN the migration results obtained by conventiona l migration testing with food simulant E 
should be devided by 10. Therefore this c ondition should be a dded to Table 2 of 
Annex III, and an explanation of the notati on should added to point 3 of Annex III and 
to paragraph 4.2 of annex V. 
(29) No simulants have been assigned for fresh fruits that are peeled and or cut. It is 
appropriate that food simulant A and B are sp ecified for this type of fruit. Therefore 
this category should be added to Table 2 of Annex III. 
(30) It is not useful to test in several food simulants if it is sc ientifically ev ident that one 
food simulant is the most severe for a speci fic substance or material. Therefore it is 
appropriate to add a genera l derogation to the assignem ents of food simulants in 
Annex III allow the testing in only one simulant  if appropriate scientific evidence is 
documented showing that this simulant is the most severe. 
(31) The Regulation specifies that certain constituents of plastic materials and articles 
should not migrate at detectab le levels. These materials and articles should always 
comply to this specification in the first migration test when used in repeat use articles. The migration testing rules set out in point s 2.1.6 and 4.2 of Anne x V now specifically 
refer to such specifications set out in Anne x I. These rules should also apply to other 
substances that should only migrate in non-detectable amounts including those 
specified in Annex II. It is therefore appropriate to delete  the specific reference from 
the Regulation and to clarify that  it applies to all substances. 
(32) According to recital 32 of the Regulation methods used  to replace migration testing 
should give results that are at  least as severe as the migr ation testing results. In the 
Regulation the wording 'more severe' is also used in this context. This is not consistent and causes problems in the interpretation of the text. Therefore 'more severe' should be 
replaced with 'at least as severe' in these cases. 
(33) The second paragraph of point 2.1.3 of Anne x V may suggest that migration testing 
conditions can be selected su ch that physical or other ch anges do not take place during 
the testing, but that these ch anges could still take place unde r the real usage conditions 
of the material and article. However the mi gration testing conditions should always be 
at least as severe as the real conditions of use. Therefor e it is appropriate  to clarify the 
second paragraph by deleting the last secti on of the last sentence of the paragraph. 
(34) Certain worst foreseeable conditions of use may occur in practice under which it is not 
technically feasible to use f ood simulant D2 for testing. A ppropriate alternatives food 
simulants and rules for veri fication of compliance shoul d be specified for such 
conditions. Therefore it is appropriate to add such alternatives and rules to the 
Regulation. 
(35) Table 1 of point 2.1.3 of Annex V does not cl early set out that the time specified for 
testing represents the time during which a si mulant or food should be in contact with 
the food contact material during the test. Th erefore the table head for column 2 should 
be amended to ensure correct interpre tation of the specified testing times. 
(36)
 The temperature specified for testing above 175°C is not representative for all 
temperatures therefore appropriate rules for testing above 175°C should be added to 
table 2 of point 2.1.3 of Annex V. 
(37) The Regulation specifies conditions for contact times above 30 days. This 
specification is not clear on whether the specified formula should be used or the standard testing conditions, and on the specification of hot-fill and frozen storage 
conditions. These specifications should ther efore be amended to ensure that the EN 8   EN formula is only used for contact conditions in which the standard  conditions do not 
apply and to clearly specify test conditions  for hot-fill and frozen usage conditions. 
(38) The Regulation uses the word ‘overestimate’ in a context in which this is not always 
clear whilst the text ‘as seve re as’ would be cl ear in such instances. Therefore the 
Regulation should be amended accordingly. 
(39) In some cases it is more efficient and appr opriate to screen whether a material or 
article complies with the Regulation using a single test instead of a series of tests 
representative for time and temperature comb inations that would foreseeably be used 
in the real use of a material or article, provided a justification for this substitution is 
documented. Therefore a rule for allowing such a single screen ing test should be 
specified in the Regulation. 
(40) The Regulation states that te sting condition OM6 re presents the worst case conditions 
for simulants A, B and C. However, it al so represents the worst case condition for 
simulant D1, and this simulant can also be used in this test. Therefore the Regulation 
should be corrected to include references to simulant D1. 
(41) The Regulation states that te sting condition OM7 re presents the worst case conditions 
for ‘fatty food simulants’. However, it repres ents the worst case condition for simulant 
D2 only. Therefore the Regulation should be corrected such that only reference to 
simulant D2 is made. 
(42) It is not always technically feasible to test  overall migration usi ng one of the specified 
tests for overall migration testing. The Regula tion only specifies an alternative test for 
OM7, however, also tests for OM1 to OM6 should be specified. 
(43) It is not always technically feasible to test  overall for repeated use in an oily medium 
using the same sample three times. Therefor e an alternative testing approach should be 
specified in the Regulation. 
(44) The Regulation does not clearly describe th at the application of  the FRF should not 
allow that specific migration would exceed  the generic specific migration limit. 
Therefore it is appropriate to clarif y the text of point 4.1 of Annex V. 
(45) To limit the administrative burden to business operators, plastic materials and articles 
which have been lawfully placed on the ma rket 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 should be  able to be placed on the market until 
[insert a precise date which w ill be 12 months after the entry into force of this 
Regulation ]. They should be able to remain on the market until exhaustion of stocks.  
(46) Regulation (EU) No 10/2011 should therefore be amended accordingly. 
(47) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
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. EN 9   EN Article 2 
Plastic materials and articles complying with  the requirements of Regulation (EU) No 
10/2011 as applicable before [entry into force of  this Regulation] may be  placed on the market 
until [12 months after the entry into force of this Regulation]. Those plastic materials and 
articles may remain on the market after that date until 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  […]