EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/XXXX […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION REGULATION (EU) No …/.. 
amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact with food 
 
Ref. Ares(2015)1748520 - 24/04/2015EN 2   EN ANNEX  
 
Regulation (EU) No 10/2011 is amended as follows: (1) In Article 3(16) the words  'Table 2 of A nnex V' are replaced by 'Table 2 of Annex 
III' 
(2) In Article 3 the following point s (19) and (20) are added: 
'(19) 'rubber' means a polymeric material, of which:  
(a) the main structural component under goes vulcanisation during or after its 
final polymerisation step; or 
(b) at least one polymeric compone nt is vulcanised during the last 
polymerisation step of a mixture that contains several polymeric components; 
(20) 'vulcanisation' means the crosslinking of polymeric chains with a specific type 
of covalent bonds, using sulphur and/or  chemically equivalent curatives.' 
(3) In Article 6(3) point (a) is repl aced with the following wording: 
'(a) salts (including multiple salts, acid  salts, and salt hydrates) of aluminium, 
ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, 
manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols;' 
(4) In Article 9, the following paragraph 3 is added: 
'3. Substances listed in Annex I for wh ich a restriction on the migration of 
oligomers is laid down in that Annex sha ll only be used if a suitable method of 
analysis for determining the migration of oligomers is published by the European Union reference laboratory for material intended to come into contact with foodstuffs, established as  laid down in Regulation (EC) No 
882/2004, in accordance with the rule s set out in Article 18a.' 
(5) In Article 13(3) the first senten ce is replaced by the following: 
'The migration of the substances unde r paragraph 2(b) into food or food 
simulant shall not be detectable measur ed by a method of analysis set out in 
Article 11 of Regulation (EC) No 882/ 2004 with a limit of detection of 0,01 
mg/kg, taking into account measurement uncertainty.' 
(6) In Article 17(3)(a) the phra se 'in mg/dm2'is deleted: 
(7) In Article 18(4) the words 'A, B, C, D1, and D2 as' are deleted 
(8) The following Article 18a is inserted: 
'Article 18a Publication of methods of analysis by the European Union reference laboratory 
1. When this Regulation requires the pub lication of one or more methods by 
the European Union reference laboratory for materials intended to come into contact with foodstuffs ('th e reference laboratory') be fore a substance can be 
placed on the market, and not all necessary methods have been published for that substance, any busine ss operator wishing to use the substance can submit a 
suitable method to the reference laboratory. EN 3   EN Any calibrants required for the use of  the submitted method shall be made 
available to that reference laboratory along with the method. 
The reference laboratory shall publish the method without delay on its web-
site, taking account of any relevant pr evious withdrawal notices it published. 
2.  The European Union reference laborat ory for materials intended to come 
into contact with foodstuffs shall re view all methods it publishes for their 
technical and practical suita bility. It may amend or withdraw methods which it 
considers not suitable, replace them, or include them in other methods. 
3. The European Union reference laborat ory for materials intended to come 
into contact with foodstuffs  shall only withdraw a me thod when an alternative 
method is made available or eight months  after the publication of a withdrawal 
notice on its website. This notice shall give detailed reas ons justifying the 
withdrawal and providing information to the improvement of the method.' 
(9) In Article 19 the first paragr aph is replaced by the following: 
'Compliance with Article 3 of Regu lation (EC) No 1935/2004 of substances 
referred to in Articles 6(1), 6(2), 6(4), 6(5), 13( 2)(b) and 14(2) of this 
Regulation which are not covered by an in clusion in Annex I to this Regulation 
shall be assessed in accordance with internationally rec ognised scientific 
principles on risk assessment.' 
(10) In Article 22 paragraph 4 is replaced by: 
'Until 31 December 2016 constituents of gla ss fibre sizing agents for glass fibre 
reinforced plastics which are not listed in Annex I have to comply with the risk assessment provisions set out in Article 19.' 
(11) In Article 23 the fourth paragraph is replaced by: 
'The provision of Article 5 as regards the use of constituents of glass fibre 
sizing agents for glass fibre reinforced  plastics, shall apply from 31 December 
2016.' 
(12) The word 'should' is replaced by 'shall' in the following locations in Annex I: 
(a) In table 1, substance 72, column 10 
(b) In table 1, substance 642, column 10 
(c) In table 1, substance 672, column 10 
(d) In table 1, substance 776, column 10 
(e) In table 1, substance 782, column 10 
(f) In table 1, substance 923, column 10 
(g) In table 1, substance 974, column 10 
(h) In table 3, Note No (4), column 2 
(i) In table 3, Note No (5), column 2 
(13) In column (10) of table 1 of Annex I the phrase 'simulant D' is replaced by 'simulant 
D1 and/or D2' in the entries for the substances with Nos. 93, 199, 262, 326, 637, 768, 803, 810, 815, 819, and 889. 
(14) Table 1 of Annex I is amended as follows: EN 4   EN (a) the entry concerning FCM substances Nos. 87, is replaced by the following:  
'87 86285  Silicon dioxide, 
silanated Yes No No   When produced 
from particles 
smaller than 100 
nm, no particles of less than 100 
nm shall remain 
in the final material  
_______________________ 
* Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food 
additives listed in Annexes II and III to Regulatio n (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: 
'871  0287916-
86-3 dodecanoic acid, 12-
amino-, polymer with 
ethene, 2,5-furandione, 
α-hydro-ω-
hydroxypoly (oxy-1,2-
ethanediyl) and 1-
propene yes no no   Only to be used in 
polyolefins at 
levels of up to 20 
weight %. These polyolefins shall 
only be used in 
contact with foods
 
for which Table 2 
of Annex III 
assigns simulant E, at ambient 
temperature or 
below, and when migration of the 
total oligomeric 
fraction of less 
than 1000 Da 
does not exceed 50 μg/kg food  
1031  3238-40-
2 furan-2,5-dicarboxylic 
acid no yes no 5  Only to be used as 
a monomer in the production of 
polyethylene 
furanoate. The migration of the 
oligomeric 
fraction of less than 1000 Da 
shall not exceed 
50 μg/kg food 
(expressed as 
furan-2,5-
dicarboxylic acid) (22) 
1034  3710-30-
3 1,7-octadiene no yes no 0.05  Only to be used as 
a crosslinking co-monomer in the 
manufacture of 
polyolefins for contact with any 
type of foods for  EN 5   EN long term storage 
at room 
temperature, 
including hot fill conditions 
1045  1190931-
27-1 perfluoro{acetic acid, 
2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, 
ammonium salt yes no no   Only to be used as 
a polymer production aid 
during the 
manufacture of fluoropolymers 
under high 
temperature 
conditions of at 
least 370 °C  
1048  624-03-3 ethylene glycol 
dipalmitate yes no no  (2) Only to be used 
when produced from a fatty acid precursor that is 
obtained from 
edible fats or oils  
1051  42774-
15-2 N,N'-bis(2,2,6,6-
tetramethyl-4-piperidinyl) 
isophthalamide yes no no 5    
1052  1455-42-
1 2,4,8,10-
tetraoxaspiro[5.5]undecane-3,9-diethanol, β3,β3,β9,β9-
tetramethyl- ('SPG') no yes no 5  Only to be used as 
a monomer in the production of polyesters. The 
migration of 
oligomers of less 
than 1000 Da 
shall not exceed 50 μg/kg food 
(expressed as 
SPG) (22) 
1053   fatty acids, C16–18 
saturated, esters with dipentaerythritol
 yes no no   Only to be used 
when produced from a fatty acid precursor that is 
obtained from 
edible fats or oils  
(c) The entry concerning FCM substance No 725 is deleted. 
(15) In Table 2 of Annex I, the entries concerning group restri ctions Nos. 2 and xx are 
replaced by the following:  
'2 89 
227 
263 
1048 30 expressed as ethyleneglycol  EN 6   EN (16) In Table 3 of Annex I, the following entry is added: 
'(22) When used in contact with non-alcoholic f oods for which Table 2 of Annex 3 assigns food 
simulant D1, food simulant C shall be used for verification of compliance instead of food 
simulant D1'  
(17) Point 1 of Annex II is replaced by the following: 
'1. Plastic materials and articles shall not release the following substances in 
quantities exceeding the specific migration limits below: 
Aluminium = 1 mg/kg food or food simulant. Barium = 1 mg/kg food or food simulant. Cobalt = 0,05 mg/kg food or food simulant. Copper = 5 mg/kg food or food simulant. Iron = 48 mg/kg food or food simulant. Lithium = 0,6 mg/kg food or food simulant. Manganese = 0,6 mg/kg food or food simulant. Nickel = 0,02 mg/kg food or simulant. Zinc = 5 mg/kg food or food simulant.' 
(18) The note below Table 1 of Annex III is replaced by the following: 
'(*) This may be any vegetable oil that contains less than 1% of unsaponifiable 
matter' 
The table contained in the cu rrent note is hereby deleted. 
(19) In point 3 of Annex III the eight pa ragraph is replaced by the following: 
'For food categories where in sub-column D2 or E the cross is followed by an 
oblique stroke and a figure, the migrati on test result shall be corrected in 
accordance with point 4.2. of Annex V to this Regulation by applying the 
figure as the correction factor referred to in this point' 
(20) In table 2 of Annex III the entries 04.01 and 04.04 are replaced by the following 
entries 04.01 and 04.04: 
' 
04.01 Fruit, fresh or chilled:       
 A. unpeeled and uncut      X/10 
 B. peeled and/or cut X X(*)       
04.04 Vegetables, fresh or 
chilled:       
 A. unpeeled and uncut      X/10 
 B. peeled and/or cut X        
' EN 7   EN (21) In table 2 of Annex III the entry 04.05.B. ('Fres h vegetables, peeled or cut') is deleted 
(22) To Annex III the following point 5 is added: 
'5. General derogation to the assignment of food simulants In derogation to the assignments for food simulants in point 1 to 4 of this 
Annex, only a single food simulant suffi ces if on the basis of scientific 
evidence it is established that this food simulant is the most severe for the particular material being tested under the applicable time temperature 
conditions.  
The scientific basis on which basis this derogation is used shall in such case be 
part of the documentation required u nder Article 16 of this Regulation.' 
(23) In the beginning of Annex V the section 'c ompliance testing' is replaced by the 
following: 
'Compliance Testing
 
For testing compliance of migration fr om plastic food contact materials and 
articles the general rules set out in  chapter 1-4 of this Annex apply. 
When applying these rules, any speci fied temperature shall always be 
determined at the contact surface betw een the food contact material and the 
food or food simulant. If measuring at th e contact surface is not practicable the 
test temperature shall be adjusted to en sure the real temperature at the contact 
surface corresponds to the specified temperatures.' 
(24) The word 'should' is replaced by 'shall' in the following locations in Annex V: 
(a) In paragraph 1.1., last sentence 
(b) In paragraph 2.1.5, first sentence 
(c) In paragraph 2.1.6, last sentence 
(d) In paragraph 4.2, last sentence 
(25) In the second paragraph of point 2.1.3 the phrase 'in which these physical or other 
changes do not take place' at the end of the paragraph is deleted. 
(26) To point 2.1.3 the following paragraph is added at the end: 
'If under real worst foreseeable conditions of use it is not tec hnical feasible to 
perform the test in food simulant D 2, migration tests sh all be done using 
ethanol 95% and isooctane. In addition a test shall be done using food simulant 
E in case the worst foreseeable conditions of use exceed 100°C. The test that results in the highest specific migration shall be used to establish compliance 
with this regulation.'  
(27) In Table 1 of Annex V the header of column 2 is replaced by the following: 
'Contact time during testing' 
(28) Table 2 of Annex V is replaced with the following table: 
' 
Conditions of contact in worst 
foreseeable use Test conditions EN 8   EN Contact temperature Test temperature 
T ≤ 5 °C 5 °C 
5 °C < T ≤ 20 °C  20 °C 
20 °C < T ≤ 40 °C 40 °C 
40 °C < T ≤ 70 °C 70 °C 
70 °C < T ≤ 100 °C 100 °C or reflux temperature 
100 °C < T ≤ 121 °C 121 °C(*) 
121 °C < T ≤ 130 °C 130 °C (*) 
130 °C < T ≤ 150 °C 150 °C (*) 
150 °C < T < 175 °C 175 °C (**) 
175°C < T ≤ 200°C 200° C(**) 
T>200°C   225° C(**) 
(*) This temperature shall be used only for food simulants D2 and E. For 
applications heated under pressure migration testi ng under pressure at the 
relevant temperature may be performed. For food simulants A, B, C or D1 the 
test may be replaced by a test at 100 °C or at reflux temperature for duration of 
four times the time selected according to the conditions in Table 1. 
(**) Materials and articles used at contact temperatur es exceeding 175°C shall be 
tested using only simulant E. 
' 
(29) Point 2.1.4 of Annex V is replaced  with the following point 2.1.4: 
' 2.1.4 Specific conditions for contact times above 30 days at room temperature and 
below 
For contact times above 30 days at room temperature and below the specimen shall 
be tested at accelerated test conditions at  elevated temperature for a maximum of 10 
days at 60 °C(*):  
• Testing for 10 days at 20 °C shall cove r all storage times at frozen condition.  
• Testing for 10 days at 40 °C  shall cover all storage times at refrigerated and 
frozen conditions including hot-fill cond itions and/or heating up to 100 C for 
up to 15 minutes.  
• Testing for 10 days at 50 °C shall cover all storage times of up to 6 months at 
room temperature  EN 9   EN • Testing for 10 days at 60 °C shall cove r long term storage above 6 months at 
room temperature and below including hot -fill conditions an d/or heating up 
to 100 °C for up to 15 minutes.  
For storage at room temperature testing ti me can be reduced to 10 days at 40 °C 
if there is scientific evidence that migr ation of the respective substance in the 
polymer has reached equilibration under this test condition.   
• For worst foreseeable cond itions of use not covered by above test conditions, 
the testing time and temperature cond itions shall be base d on the following 
formula: 
t2 = t1 * Exp (9627 *(1/T2-1/T 1))  (‘Arrhen ius equation’) 
t1 is the contact time  
t2 is the testing time  
T1 is the contact temperature in Kelvin. For room temperature storage 
this is set at 298 K (25 °C). For refrigerated and frozen conditions it is set at 278 K (5 °C).  
T2 is the testing temperature in Kelvin.  
 (*)When testing at these accelerated test conditions the test specimen shall not 
undergo any physical or other changes comp ared to the real conditions of use, 
including a phase transition of the material. 
' 
(30) In point 2.1.6 of Annex V the third pa ragraph is replaced by the following: 
'The material or article shall respect th e specific migration limit already in the 
first test for all substances for which the specific migration limit is set as non-
detectable and for non-listed substances used behind a plastic  functional barrier 
covered by the rules of point (b) of Ar ticles 13(2) which should not migrate in 
detectable amounts.' 
(31) In points 2.2 and 3.4 of Annex V the phrase 'more severe than' is replaced with the 
phrase 'at least as severe as'. 
(32) In point 2.2.3 of Annex V the word 'overestimat e' is replaced by 'at least as severe as' 
(33) In point 2.2.4 of Annex V the first pa ragraph is replaced by the following: 
‘To screen for specific migration, food simulants can be replaced by substitute 
food simulants if it is ba sed on scientific evidence that the substitute food 
simulants result in migration that is as  severe as migration that would be 
obtained using the food simulant s specified in section 2.1.’ 
(34) At the end of point 2.2 of Annex V the following point 2.2.5 is added: 
‘2.2.5 Single test for successive comb inations of time and temperature 
If the material or article is intended for a food contact appl ication where it is 
successively subject to two or more time and temperatures combinations, a 
single migration contact test time can be  defined based on the highest contact 
test temperature from section 2. 1.3 and/or 2.1.4 by using the Arrhenius 
equation as described in section 2.1.4. The reasoning jus tifying that the 
resulting single test is at least as seve re as the combined time and temperature 
combinations shall be documented.’  EN 10   EN (35) In table 3 of Annex V the entry for OM6 is replaced by the following: 
' 
OM6 4 h at 100°C or at reflux Any food contact conditions 
with food simulants A, B, C or D1, at temperature exceeding 40°C. 
' 
and paragraph 4 of point 3.1 is replaced by the following: 
' Test OM 6 covers also food contact  conditions described for OM1, OM2, 
OM3, OM4 and OM5. It represents worst case conditions for food simulants A, 
B, C and D1 in contact with non-polyolefins' 
(36) In point  3.1 of Annex V paragraph 3 is replaced by the following: 
‘Test OM 7 covers also food contact  conditions described for OM1, OM2, 
OM3, OM4, OM5. It represents the worst case conditions for food simulant D2 
in contact with non-polyolefins. In case it is technically not f easible to perform 
OM 7 with food simulant D2 the test can  be replaced as set out in paragraph 
3.2.' 
(37) Point 3.2 of Annex V is replaced by the following point 3.2: 
‘3.2 Alternative overall migration te sts for tests with simulant D2’ 
‘If under real worst foreseeable conditions of use it is not technical feasible to 
perform one or more of the tests OM1 to OM6 in food simulant D2, migration 
tests shall be done using 95% ethanol 95% and isooctane. In addition a test shall be done using simulant E in case the worst foreseeabl e conditions of use 
exceed 100°C. The test that results in th e highest specific migration shall be 
used to establish compliance with this regulation. 
In case it is technically not  feasible to perform OM7 with food simulant D2 the 
test can be replaced by either test OM 8 or test OM9 as appropriate given the 
intended or foreseeable use. Both tests involve testing at two tests conditions 
for each of which a new test sample sh all be used. The test condition that 
results in the highest over all migration shall be used to establish compliance 
with this regulation 
Test number Test conditions Intended food 
contact conditions Covers the intended 
food contact 
conditions described 
in 
OM 8 Food simulant E for 2 
hours at 175°C and Food simulant D2 for  
2 hours at 100°C High temperature 
applications only OM1, OM3, OM4, 
OM5, and OM6 EN 11   EN OM 9 Food simulant E for 2 
hours at 175°C and Food simulant D2 for  
10 days at 40°C High temperature 
applications including long term storage at room temperature OM1, OM2, OM3, 
OM4, OM5 and OM6 
’ 
(38) Point 3.3 of Annex V is replaced by the following point 3.3: 
‘3.3 Repeated use articles If the material or article is intended to come into re peated contact with foods, 
the overall migration test(s) shall be car ried out three times on a single sample 
using another portion of food simulant  on each occasion. Compliance shall be 
checked on the basis of the level of the overall migration found in the third test.  
If it is not technically feasible to use the same sample three times, such as when 
testing in oil, the overall migration test  described in the first paragraph can be 
carried out by testing different sample s one, two and three times the contact 
test time and by calculating the overall migration of each migration as a difference of two successive test results.  
In derogation to the first paragraph, if on the basis of scientific evidence it is 
known that for the material being tested the overall migration does not increase in the second and third tests and if th e overall migration limit is not exceeded 
in the first test, only the first test is necessary.’ 
(39) In point 3.4.2 of Annex V the first pa ragraph is replaced by the following: 
‘To screen for overall migration food si mulants can be replaced if based on 
scientific evidence that the substitute food simulants resu lt in migration that is 
as severe as migration that would be obtained using the food simulants 
specified in section 2.1.’ 
(40) In point 4.1 of Annex V the last pa ragraph is replaced by the following: 
‘The specific migration in food shall not  exceed the generic specific migration 
limit before application of the FRF’  
(41) Point 4.2. of Annex V is replaced by the following: 
'4.2. Correction of migration into food simulant D2 or E The migration test results  shall be divided by the correction factor before 
comparing with the migration limits. 
The correction is not applicable to the sp ecific migration for all substances for 
which the specific migration limit is ‘not detectable’ and for non-listed substances used behind a plastic func tional barrier covered by the rules of 
Article 13(2)(b) which should not mi grate in detectable amounts.' 
(42)