EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11824/2019 ANNEX 
(POOL/E2/2019/11824/11824 -EN 
ANNEX.docx) D066086/02  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact with food   EN 1  EN ANNEX  
“Annexes I, II, IV, and V to Regulation (EU) No 10/2011 are amended as follows:  
(1) Annex I is amended as follows:  
(a) in point 1, Table 1 is amended as follows:  
(i) entry 236 on 1,3-phenylenediamine  is replaced by the following:  
“236  23050  000010
8-45-2 1,3-
phenylenediamine  no yes n
o ND   (28)
” 
(ii) entry 398 on antimony trioxide  is replaced by the following:  
“398 35760  000130
9-64-4 antimony trioxide  yes no n
o    (6)” 
 (iii) the following entr ies are inserted in numerical order:  
“1075    Montmorillonite 
clay modified with 
hexadecyltrimethyl
ammonium 
bromide  yes no n
o   Only to be used as 
additive at up to 
4,0% w/w in 
polylactic acid 
plastics intended 
for long term 
storage of water at 
ambient 
temperature or 
below . 
 
Can form platelets 
in the nanoform 
that are in one or 
two dimension s 
thinner than 100 
nm. Such platelets 
shall be oriented 
parallel to the 
polymer surface 
and shall be fully 
embedded in the 
polymer.    
1076   122793
7-46-3 Phosphorous acid, 
triphenyl ester, 
polymer with 
alpha -hydro -
omega -
hydroxypoly[oxy(
methyl -1,2-
ethanediyl)], C10 -
16 alkyl ester  yes no n
o 0,05  Only to be used as 
an additive at up 
to 0,2% w/w in 
high impact 
polystyrene 
materials and 
articles intended 
contact with food 
at room 
temperature and 
below, inclu ding  EN 2  EN hot-fill and/or 
heating up to 
100°C for up to 2 
hours. It shall not 
be used in contact 
with foods for 
which simulant C 
and/or D1 is 
assigned in Annex 
III. 
1077    Titanium dioxide 
surface -treated 
with fluoride -
modified alumina  yes no n
o   Only to be  used at 
up to 25,0% w/w , 
including in the 
nanoform . 29” 
(b) in point 3  of Table 3, the following entry is added:  
“28 A detection limit of 0,002 mg/kg food or food simulant applies  
29 In polar polymers which swell in contact with foods for which simulant B is assigned in 
Annex III, there is a risk that under severe contact conditions  the migration limits for 
aluminium and fluoride are exceeded.  Under contact conditions above  4 hours at 100 °C  
this exceedance can be high. ” 
 
(2) Annex II  is replaced in its entirety by the following:   
“ANNEX II  
Restrictions on plastic materials and articles  
The following restrictions on plastic materials and articles apply:  
1. Plastic materials and articles shall not release the following substances in 
quantities exceeding the specific migration limits expressed in mg/kg food or 
simulant in Table 1 below specified in column (3), and subject to the remarks 
in Column (4).  
Substances listed in Table 1 shall only  be used in accordance with the 
compositional requirements set out in Chapter II of the Regulation . If Chapter 
II does not provide a basis for the authorised use of such a substance, that 
substance may only be present as an impurity subject to the restrict ions 
specified in Table 1 below.  EN 3  EN  
Table 1  
 
General list of migration limits for substances migrating from plastic 
materials and articles  
 
(1) (2) (3) (4) 
Name  Salts allowed in 
accordance with Article 
6(3)(a)   SML  
[mg/kg food or food 
simulant]  Remark  
Aluminium  yes 1  
Ammonium  yes - (1) 
Antimony   no 0,04 (2) 
Arsenic  no ND    
Barium  yes 1  
Cadmium  no ND 
(LOD 0,00 2)   
Calcium  yes - (1)  
Chromium  no ND  (3)  
Cobalt  yes 0,05  
Copper  yes 5  
Europium  yes 0,05 (4) 
Gadolinium  yes 0,05 (4) 
Iron yes 48  
Lanthanum  yes 0,05 (4) 
Lead  no  ND    
Lithium  yes 0,6  
Magnesium  yes - (1) 
Manganese  yes 0,6  
Mercury  no ND     
Nickel  no 0,02  EN 4  EN Potassium  yes - (1) 
Sodium  yes - (1) 
Terbium  yes 0,05 (4) 
Zinc yes 5  
ND: Not Detected; LOD: Limit of Detection  
Remarks  
(1) The migration is subject to Article 11(3) and Article 12  
(2) The note in Annex I, Table 1, FCM No 398 applies: SML might be 
exceeded at very high temperatures  
(3) To verify compliance with the Regulation , the detection limit of 0,01 
mg/kg shall apply for total chromium. However if the operator that 
placed the material on the market can prove on the basis of pre -existing 
documentary evidence that the presence of hexavalent chromium in the 
material is exclu ded because it is not used or formed or during the entire 
production process, a limit for the total chromium of 3,6 mg/kg food 
shall apply.  
(4) The lanthanide substances, europium, gadolinium, lanthanum, and/or 
terbium can be  used in accordance with Article 6 (3)(a) provided that:  
a) The sum of all lanthanide substances migrating to the food or food 
simulant does not exceed the specific migration limit of 0,05 
mg/kg; and,  
b) analytical evidence using a well described methodology 
demonstrating that the lanthani de substance(s) used are present in 
dissociated ionic form in the food or the food simulant, forms part 
of the documentation referred to in Article 16.  
2. Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex 
XVII to Regulation (EC) No  1907/20061 and for which no migration limit is 
specified in Table 1 of Annex I shall not migrate or shall not otherwise be 
released from plastic materials and articles into food or food simulant. They 
shall not be detectable using analytical equipment wit h a limit of detection of 
0.002 mg/kg food or food simulant applied to each individual primary aromatic 
amine (‘PAA’) , in accordance with Article 11(4) .  
For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation 
(EC) No 1907/2006, but for w hich no specific migration limit is specified in 
Annex I, compliance with Article 3 of Regulation (EC) 1935/2004 shall be 
verified in accordance with Article 19 of the Regulation . The sum of those 
PAAs shall  however  not exceed 0.01 mg/kg in food or food simulant. ” 
                                                 
1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/4 5/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Cou ncil 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).  EN 5  EN (3) In Annex IV, point 6 is replaced by the following:  
“ 
(6) adequate information relative to the substances used or products of degradation 
thereof for which restrictions and/or specifications are set out in A nnex I and II 
to the Regulation  to allow the downstream business operators to ensure 
compliance with the Regulation . 
At intermediate stages, this information shall include the identification and 
amount of substances in the intermediate material,  
– that are s ubject to restrictions in Annex II; or,  
– for which genotoxicity has not been ruled out, and which originate from 
an intentional use during a manufacturing stage of that intermediate 
material and which could be present in an amount that foreseeably gives 
rise to a migration from the final material exceeding 0, 00015 mg/kg food 
or food simulant .” 
(4) Annex V is amended as follows:  
(a) Chapter 2 is amended as follows:  
(i) in the second paragraph of  point 2.1.3 , the following subparagraph is 
added:  
“(iv)  if the plastic material or article intended to come into contact with 
food of which the compliance must be verified becomes in its final 
application part of a food processing equipment or an appliance, or 
a part thereof, the migration tests may be carried out by 
determin ing the specific migration into the food or food simulant 
produced or processed by the final equipment or appliance, or the 
part thereof, as appropriate, subject to the following conditions:  
– the food or food simulant is processed during testing by the 
equipment or part thereof in accordance with the worst 
foreseeable conditions that can be achieved if the equipment 
or its part is operated in accordance with its operating 
instructions, and,  
– the migration from parts used for storage such as from 
reservoirs, c ontainers, or capsules or pads which are part of 
the equipment during the processing of the food, is 
determined using conditions representative for their use, 
unless the applied testing conditions for the whole tested 
equipment or appliance are representat ive also of their use.  
When migration testing is done under the above conditions, and the 
transfer of constituents from the equipment or appliance as a whole 
does not exceed the migration limits, the plastic parts or materials 
present in the equipment or appliance shall be considered to 
comply with Article 11(1) of the Regulation . 
The testing of the parts used for storage or supply such as 
reservoirs, containers, capsules or pads shall be under conditions EN 6  EN representative of their use, and shall include the foreseeable storage 
conditions of the food in these parts.  
The supporting documentation referred to in Article 16 of the 
Regulation shall clearly document the testing on the whole food 
processing and/or food producing equipment or appliance, or on 
parts t hereof. It shall demonstrate that the testing was 
representative of its foreseeable  use, and shall indicate for which 
substances  migration testing was carried out and provide all testing 
results . The manufacturer of individual plastic parts shall ensure th e 
absence of migration for substances for which the Regulation  
specifies that their migration  shall not be detectable  at a specified 
level of detection  in accordance with Article 11(4) of the 
Regulation . 
Compliance documentation supplied in accordance with the 
Regulation  to the producer of the final equipment or appliance, or 
part thereof, shall list all substances subject to migration limits that 
may be exceeded under the foreseeable use of the supplied p art or 
material.  
When the result is not in compliance with the Regulation  it shall be 
determined whether the source of the non -compliance is a plastic 
part subject to th e Regulation or a part made from a nother  material 
not subject to th e Regulation on the basis of documentary evidence 
or analytical testing. Without prejudice to Article 3 of Regulation 
(EU) No 1935/2004, non -compliance to the Regulation  shall only 
be established if the migration originates from a plastic part.”  
(ii) point 2.1.6 , is replaced  in its entirety  by the following:  
“2.1.6.  Repeated use materials and articles  
If the material or article is intended to come into repeated contact 
with foods, the migration test(s) shall be carried out three times on 
a single sample using another portion o f food simulant on each 
occasion. The specific migration in the second test shall not exceed 
the level observed  in the first test, and the specific migration in the 
third test shall not exceed the level observed  in the second test.  
Compliance of the mater ial or article shall than be verified  on the 
basis of the level of the migration found in the third test and on the 
basis of the stability of the material or article from the first to the 
third migration  test. For the latter purpose, i f migration is observ ed 
above the level of detection in any of the three migration tests, and 
increases  from the first migration test to the third migration test, 
compliance of the material shall not  be established even in case the 
specific migration limit is not exceeded  in any of the three tests . 
However, if there is conclusive scientific proof that the level of the 
migration decreases in the second and third tests and if the 
migration limits are not exceeded on the first test, no further test is 
necessary.  
Irrespective of the above rules, a material or article shall  never be 
considered to comply with this Regulation if in  the first test a EN 7  EN substance that is prohibited from migrating or from being released 
in detectable quantities under Article 11(4)  is detected .” 
(b) Chapter 3 is amended as follows:  
(i) in point 3.1, Table 3 and the four paragraphs below Table 3 are replaced 
by the following:  
“Table 3  
Standardised conditions for testing the overall migration  
Column 1  Column 2  Column 3  
Test number  Contact time in days [d] or  
hours [h] at Contact 
temperature in [°C] for testing  
 Intended food contact  conditions  
OM0  30 min at 40 °C  Any food contact at cold or 
ambient temperatures and for a 
short duration ( ≤ 30 minutes).  
OM1  10 d at 20 °C  Any food contact at frozen and 
refrigerated conditions  
OM2  10 d at 40 °C  Any long term storage at room 
temperature or below, including 
when packaged under hot -fill 
conditions, and/ or heating up to a 
temperature T where 70 °C ≤ T ≤ 
100 °C for a maximum of t = 
120/2^((T -70)/10) minutes.   
OM3  2 h at 70 °C  Any food contact conditions that 
include hot -fill and/or heating up 
to a temperature T where 70 °C ≤ 
T ≤ 100 °C for maximum of t = 
120/2^((T -70)/10) minutes, which 
are not followed by long term 
room temperature or refrigerated 
storage.  
OM4  1 h at 100 °C or at reflux  High temperature applications for 
all types of food at temperature up 
to 100 °C.  
OM5  2 h at 100 °C or at reflux or 
alternatively 1 h at 121 °C  High temperature applications up 
to 121 °C.  
OM6  4 h at 100 °C or at reflux  Any food contact conditions at a 
temperature exceeding 40 °C, and 
with foods for which point 4 of 
Annex III assigns simulants A, B, EN 8  EN C or D1.  
OM7  2 h at 175 °C  High temperature applications with 
fatty foods exceeding the 
conditions of OM5.  
Test OM 7 cove rs also food contact conditions described for OM0, OM1, OM2, OM3, 
OM4, OM5. It represents the worst case conditions for fatty food simulants in contact 
with non -polyolefins. In case it is technically not feasible to perform OM 7 with food 
simulant D2 the t est can be replaced as set out in paragraph 3.2.  
 
Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, 
OM4 and OM5. It represents worst case conditions for food simulants A, B and C in 
contact with non -polyolefins.  
 
Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, 
OM4. It represents the worst case conditions for all food simulants in contact with 
polyolefins.  
Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3 .” 
 
(ii) in point 3.2 , the paragraphs before the table  are replaced by the 
following:  
“If it is not technically feasible to perform one or more of the tests OM0 
to OM6 in food simulant D2, migration tests shall 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 overall migration shall be used to establish 
compliance with the Regulation  
In case it is technically not feasible to perform OM7 with food simulant 
D2, either test OM8 or test OM9  shall be selected as a replacement test 
by select ing the  most appropriate  of these two tests  on the basis of the 
intended and the  foreseeable use  of the material or article that is being 
tested. Subsequently,  a migration test shall be done at each of the  two test 
conditions  specified for the selected test , using  a new test sample for each 
test condition . The test cond ition that results in the higher  overall 
migration shall be used to establish compliance with the Regulation .”  
(iii) point 3.3.2 , is replaced in its entirety by the following : 
 “3.3.2.  Repeated use articles and materials  
The applicable overall migration test shall be carried out three 
times on a single sample using another portion of food simulant on 
each occasion. The migration shall be determined using an 
analytical method in accordance with the requirements of Article 
34 of Regulation (E U) No 2017/625 . The overall migration in the 
second test shall be lower than in the first test, and the overall 
migration in the third test shall be lower than in the second test. EN 9  EN Compliance with the overall migration limit shall be verified on the 
basis of the level of the overall migration found in th e third test.  
If it is not technically feasible to test the same sample three times, 
such as when testing in vegetable oil, the overall migration test can 
be carried out by testing different samples for three different 
periods of time lasting one, two and three times the applicable 
contact test time. The difference between the third and the second 
test results shall be considered to represent the overall migration. 
Compliance shall be verified on the basis of this difference, which 
shall not exceed the over all migration limit. In addition, the 
difference between the second and the first test results shall be 
lower than the first test results and the difference between the third 
and the second test results shall be lower than the difference 
between the second  and the first test results.  
By derogation from the first paragraph, if, on the basis of scientific 
evidence, it is established that for the material or article being 
tested the overall migration decreases in the second and third tests 
and if the overall m igration limit is not exceeded in the first test, 
the first test alone shall be sufficient.”