EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11824/2019 
(POOL/E2/2019/11824/11824 -EN.docx) 
D066086/02  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
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)   EN 1  EN COMMISSION REGULATION (EU) …/…  
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 mat erials and articles intended to come into contact with food 
and repealing Directives 80/590/EEC and 89/109/EEC1, and in particular points (a), (d), (e), 
(h) and (i) of Article 5(1), Article 11(3) and Article 12(6) thereof,  
Whereas:  
(1) Commission Regulation (E U) No 10/20112 (‘the Regulation’) lays down specific rules 
as regards plastic materials and articles intended to come into contact with foods. In 
particular, Annex I  to the Regulation establishes a Union list of substances  that may be 
used in the manufactu re of plastic food contact materials and articles , while Annex II 
establishes additional restrictions applicable to plastic materials and Articles .  
(2) Since the last amendment to the Regulation, the European Food Safety Authority (‘the 
Authority’) has publis hed further scientific opinions on particular substances that may 
be used in food contact materials (‘FCM’) as well as on the use of already authorised 
substances. In addition, certain ambiguities to the application of the Regulation were 
identified. In or der to ensure that the Regulation takes account of the most recent 
findings of the Authority and in order to remove any doubt as regards its correct 
application, the Regulation should be amended and corrected.  
(3) The Authority adopted a favourable scientific opinion3 on the use of isostructural salt 
complexes of terephthalic acid (generically described as 1,4 -benzene dicarboxylic 
acid, FCM substance No 785) with the following lanthanides:  lanthanum (La), 
europ ium (Eu), gadolinium (Gd) and terbium (Tb) used alone or in combination and in 
varying proportions, as additives in plastics intended to come into contact with foods. 
The Authority concluded that th ose salts are not of a safety concern for the consumer 
if used as additives in polyethylene, polypropylene  or polybutene plastic materials and 
articles intended to come into contact with all food  types  under contact conditions of 
up to 4 hours at 100°C or for long -term storage at ambient temperature. This 
conclusion is made on the basis that , if migration from  the plastic food contact 
material to the food or food simulant were to occur, the lanthanides should be present 
in the food or the food simulant in dissociated ionic form and the migration of the sum 
                                                 
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 EFSA Journal 2018;  16(11)5449  EN 2  EN of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should 
not exceed 0,05 mg/kg food.   
(4) The Authority noted that, in light of the chemical characteristics of the isostructural 
lanthanide salts of terephthalic acid and of the four lanthanides (La, Eu, Gd, Tb) 
themselves, it is not necessary to restrict the use of these additives to the three 
polyolefin type of plastics specified in the application  dossier the applicant provided to 
the Authority as no undesirable interactions with plastics (including, but not limited to 
polyolefins) leading to formation and possible migration of undesirable reaction and 
transformation products are to be expected . This conclusion is made on the same basis 
as for the polyolefin plastics that, if migration from the plastic food contact material to 
the fo od or food simulant were to occur, the lanthanides should be present in the food 
or the food simulant in dissociated ionic form and the migration of the sum of the four 
lanthanide ions (La, Eu, Gd, Tb), when used alone or in combination, should not 
exceed 0,05 mg/kg food. Therefore, it is appropriate to authorise the lanthanides for 
use in all types of plastic materials and articles  as salts of already authorised 
substances, provided that these restrictions are met.   
(5) Article 6(3)(a) of the Regulation allows  for the use of salts of certain metals and of 
ammonium of authorised acids, alcohols and phenols , based on the conclusion that 
these salts will dissociate in the human stomach to the corresponding cations and the 
phenols, alcohols and acids4. As the Autho rity concluded that the four lanthanides 
should also dissociate, and for the purpose of simplification, those four lanthanides 
should also be included  in the scope of Article 6(3)(a), in order to authorise their use 
as counter ions of already authorised acids, alcohols and phenols in all types of plastic 
materials and articles. Therefore it is appropriate to amend this Article to include th ose 
four lanthanides.  
(6) Article 10 of the Regulation sets out general restrictions related to plastic materials 
and articles, which are laid down in Annex II  to the Regulation. Specifically, point 1 
of this Annex  restrict s the migration of certain elements from plastic m aterials and 
articles into food or food simulants.  The elements to which these limits apply may be 
present in plastic materials and Articles on the basis of several provisions  set out in 
Chapter II of the Regulation . They may be present in the plastic beca use they are 
intentionally used as an additive or starting substance included in Annex I, or because 
their use is subject to a derogation under Article 6, including if they would be present 
in the plastic as an impurity or other non -intentionally added sub stance. The migration 
limits  set in point 1 of Annex II to the Regulation therefore also  apply  to the metals 
which are present in the plastic material or article on the basis of  Article 6(3)(a) of the 
Regulation . When the four lanthanides are added to the list of metals set out in Article 
6(3)(a)  their limits should therefore also be added to point 1 of Annex II.  
(7) The addition of the four lanthanides to Article 6(3)(a) further lengthens the list of 
substances set out in that provision. For reasons of clarit y and good drafting practice 
such lists should not be set out in the enacting terms of the Regulation but in an 
Annex. As point 1 of Annex II already applies to most metals presently listed in 
Article 6(3)(a) this point can be used to also clarify whether it is permitted to use 
certain salts of these substances in accordance with Article 6(3)(a) without adding 
another list to the Regulation. It is therefore appropriate to clarify and simplify the 
Regulation by removing the names of the metals from Article 6 (3)(a) and by amending 
Annex II to includ e them  in point 1 of  Annex II . For this purpose, i t is appropriate to 
                                                 
4 EFSA Journal 2009; 7(10):1364  EN 3  EN replace the present list of limits in point 1 of Annex II with a table that lists all metals 
presently included in Article 6(3)(a) and those incl uded in point 1  of Annex II  and 
with the specific conditions of use and migration limits  of those metals . As Article 
6(3)(a) also provides  that ammonium salts of authorised acids, alcohols and phenols 
are authorised in the same way as the specified metals,  it is appropriate that 
ammonium is also included in point 1 of Annex II.  
(8) The substance 1,3 phenylenediamine (CAS No 0000 108-45-2, FCM No 236) is a 
Primary Aromatic Amine currently included in Annex I of the Regulation to be used 
as a starting substance in plastic materials and articles intended to come into contact 
with food provided it does not migrate. However to verify compliance with this 
requirement it should not be d etected in the food or the food simulant above the 0,01 
mg/kg food or food simulant detection limit, in accordance with the second 
subparagraph of Article 11(4) of Regulation (EU) 10/2011. The advances in analytical 
capabilities allow the detection of 1,3 phenylenediamine  at 0,002 mg/kg food or food 
simulant. It is therefore appropriate to amend Annex I of the Regulation to set this 
value as a specific detection limit for this substance to reflect this improvement in 
analytical capability and to maximise th e health protection of consumers.  
(9) The Authority adopted a favourable scientific opinion5 on the use of the substance 
montmorillonite clay modified with hexadecyltrimethylammonium bromide (FCM No 
1075),  as an additive in plastic food contact materials. In t hat opinion, the Authority 
concluded that the substance is not of safety concern for the consumer if it is used as 
an additive at up to 4% (w/w) in polylactic  acid plastics intended for storage of water 
at ambient temperature or below.  The Authority noted that once dispersed in the 
polylactic acid plastic, the particles can form platelets that can be in one or two 
dimension s in the nanoparticle range (< 100 nanometres) . These platelets are not 
expected to migrate as they are oriented parallel to the plastic  packaging film surface 
and they are fully embedded in the polymer. Therefore, that additive should be 
included in the Union list of authorised substances with the restriction that those 
specifications should be met . 
(10) The Authority adopted a favourable scie ntific opinion6 on the use of the substance 
phosphorous acid, triphenyl ester, polymer with alpha -hydro -omega -
hydroxypoly[oxy(methyl -1,2-ethanediyl)], C10 -16 alkyl esters (FCM No 1076 and 
CAS No 1227937 -46-3), as an additive in plastic food contact materials. In that 
opinion , the Authority concluded that this substance is not of safety concern for the 
consumer if it is used as an additive at up to 0,2% (w/w) in high impact polystyrene 
(‘HIPS’) materials and articles intended for contact with aqueous,  acidic, low -alcohol 
and fatty foods, for long -term storage at room temperature and below, including hot -
fill and/or heating up to 100°C for up to 2 hours , and if its migration does not exceed 
0,05 mg/kg food. To ensure that the migration levels establishe d by the Authority are 
not exceeded , this substance should not be used in contact with foods for which food 
simulants C and/or D1 is assigned in Annex III to the Regulation. Therefore, that 
additive should be included in the Union list of authorised substa nces with the 
restriction that those specifications should be met.  
(11) The Authority adopted a favourable scientific opinion on the use of the substance 
titanium dioxide surface -treated with fluoride -modified alumina (FCM No 1077) as an 
                                                 
5 EFSA Journal 2019;  17(1):5552  
6 EFSA Journal 2019 ; 17(5):5679  EN 4  EN additive in plastic foo d contact materials7. In that opinion, the Authority noted that the 
substance, which is a defined mixture of particles of which a certain number have a 
diameter  in the nanoparticle range (< 100 nanometres), is embedded in the polymer 
and does not migrate. The Authority concluded that this substance is not of safety 
concern to the consumer if it is used as an additive at up to 25 ,0% (w/w) in all polymer 
types in contact with all food types for any time and temperature conditions. The 
Authority also concluded  that the use of this substance in polar polymers which swell 
when in contact with foods for which food simulant B (3 ,0% w/v acetic acid) is 
assigned in Annex III to the Regulation could exceed the respective specific migration 
limits of 0,15 mg/kg and 1,0  mg/kg food or food simulant  for fluoride and aluminium 
respectively, if used in certain contact conditions. Significant exceedance of those 
limits was shown in contact conditions exceeding 4 hours at 100 °C.  Migration testing 
or modelling should therefore  be used to exclude the possible exceedance of those 
limits under the intended and foreseeable use of a material contain ing this additive. 
This risk should be communicated to users of such materials and control authorities 
via a note on the verification of  compliance.  Therefore, it is appropriate  to include this 
additive in the Union list of authorised substances , allowing  its use as an additive at up 
to 25,0% (w/w) and with a note on the verification of compliance, warning that the 
migration limits can be  exceeded under certain conditions . 
(12) Antimony trioxide (CAS No 001309 -64-4, FCM No 398) is currently included in 
Annex I of Regulation (EU) 10/2011 to be used as an additive or polymer production 
aid in plastic materials and articles intended to come into c ontact with food, with a 
specific migration limit of 0,04 mg/kg food or food simulant established in the  
opinion8 of the Authority on this substance  adopted in 2004 , expressed as antimony , 
and with a note on the verification of compliance in Table 3 of An nex I that this 
specific migration limit may be exceeded at very high temperatures. Migration limit  of 
0,04 mg/kg  is based on the Tolerable Daily Intake (‘TDI’) for antimony and a 10% 
allocation factor to account for the contribution of exposure to antimon y from sources 
other than  plastic materials and articles intended to come into contact with foods. This 
migration limit together with the accompanying note on the verification of compliance 
should therefore apply for the migration of antimony from plastic materials and 
articles intended to come into contact with food. It is therefore appropriate that Annex 
II of Regulation (EU) 10/2011 is amended to include antimony  provided that its 
migration does not exceed 0,04 mg antimony/kg food or food simulant, and t o also 
include the note on the verification of compliance of Table 3 of Annex I of that 
Regulation applicable to the antimony specific migration limit.  
(13) The Authority has adopted opinions on arsenic (As), cadmium (Cd), chromium (Cr), 
lead (Pb), and mercury (Hg). These metals are not included in Annex I of Regulation 
(EU) 10/2011 and therefore are not authorised to be used in plastic materials and 
articles intended to come into contact with food. The adverse health effects of these 
metals are well established  and transfer of these metals from plastics materials and 
articles to food should not occur at levels harmful to human health. While the levels of 
these metals are normally controlled in the subsequent manufacturing stages of plastic 
materials and articles  in accordance with Article 4(d) of th e Regulation, they can 
nevertheless end up being present as impurities in final plastic materials and articles 
based on the derogations set out in Article 6(4)(a), and adversely affect the health of 
the consumer. While  the safety of these metals should principally be controlled in 
                                                 
7 EFSA Journal 2019;  17(6):5737  
8 EFSA Journal 2004; 24 (1 -13):2903  EN 5  EN accordance with  Article 19 of th e Regulation and the documentation provided 
according to the provisions of Articles 15 and 16 of th e Regulation, such work may 
not be implemented uniformly, is burdensome and difficult to verify by competent 
authorities. Therefore it is important to establish clarity  with regard to  the levels that 
should be verified analytically. It is therefore appropri ate to amend Annex II of 
Regulation (EU) 10/2011 to establish limits on the migration of these metals to  ensure 
a uniform approach to verification of compliance, the application of a uniform level of 
health protection, and the proper functioning of the sin gle market.  
(14) Some metals already exert adverse health effects at levels in the food below what can 
be quantified analytically using techniques applied by official control laboratories. In 
such a case, a non -detect limit in accordance with Article 11(4) of the Regulation is 
the appropriate means to verify the level of migration. The European Union Reference 
Laboratory for Food Contact Materials, designated in accordance with Regulation 
(EU) 2017/6259 (‘EURL -FCM’) has conducted work with the national referenc e 
laboratories which shows that analytical methods are already available that are suitable 
to detect the migration of metals from plastic materials at lower  levels  that is presently 
the case  and which can be routinely used by the majority of involved labor atories. 
Even though some of these limits may change because of further analytical 
developments in the future, it is appropriate to assign the detection limits that can be 
achieved now to those metals in order to establish a maximum possible and uniform 
level of safety . Therefore it is appropriate to clarify the detection limits for metals in 
table 1 of Annex II  to the Regulation , and to redraft that table to provide a clearer 
framework for future changes to such limits.  
(15) Specifically, the Authority adopted an opinion on inorganic arsenic in food10 in which 
it identified a range of benchmark dose (‘BMDL 01’) values (at 99% confidence limit) 
between 0,3 and 8 µg of arsenic/kg body weight per day for cancers of the lung, skin 
and bladder as well as skin lesions. The Authority further estimated that dietary 
exposures to inorganic arsenic for average and high level consumers are within the 
range of the BMDL 01 values, and that there is little or no margin for any additional 
exposure, and therefore the possibility of a risk to some consumers cannot be 
excluded. Based on the lower BMDL 01 value, on a 10% allocation factor to account 
for the contribution of exposure to arsenic from sources other than  plastic materials 
and articles intended to come into contact with food , and taking into account 
conventional exposure assumptions for food contact materials, the migration of arsenic 
from plastic materials and articles intended to come into contact with foods that may 
contain arsenic,  should not exceed  the level of 0,002 mg arsenic/kg food or food 
simulant. However, according to the EURL -FCM reliable detection of arsenic in food 
or food simulant has not been tested among National Reference Laboratories below 
the level of detection as laid down in Article 11(4) to the Regulati on. Therefore it 
                                                 
9 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council 
Regulations (EC ) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) 
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608 /EEC, 
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 
92/438/EEC (OJ L 95, 7.4.2017, p. 1).  
10 EFSA Journal 2009; 7(10):1351  EN 6  EN advised to retain the  non-detect (ND) limit for arsenic of 0,01 mg/kg food instead. It is 
therefore appropriate t o amend  Annex II of Regulation (EU) 10/2011 accordingly.  
(16) The Authority furthermore adopted an opinion on cadmium in food11 in w hich it 
identified a Tolerable Weekly Intake (‘TWI’) of 2,5 μg of cadmium/kg body weight 
per week for kidney toxicity. In that opinion, the Authority also noted association of 
cadmium intakes with increased risk of cancers of the lung, endometrium, bladder  and 
breast. The Authority estimated that the mean exposure for adults is close to, or 
slightly exceeding, the TWI and subgroups of consumers such as vegetarians, children, 
smokers and people living in highly contaminated areas may exceed the TWI by about 
twofold. The Authority concluded that although the risk for adverse effects on kidney 
function taking into account dietary exposures across Europe is very low, the current 
exposure to cadmium should be reduced.  Based on the TWI, on a 10% allocation 
factor to account for the contribution of exposure to cadmium from sources other than  
plastic materials and articles intended to come into contact with food,  and taking into 
account conventional exposure assumptions for food contact materials, the migration 
of ca dmium from plastic materials and articles  intended to come into contact with 
food,  should not exceed  the level of 0,002 mg/kg in food or food simulant. Therefore, 
cadmium should not be detected in the food or the food simulant above the 0, 002 
mg/kg food or  food simulan t. It is therefore appropriate t o amend  Annex II of 
Regulation (EU) 10/2011 accordingly.  
(17) The Authority also adopted an opinion on the risks to public health related to the 
presence of chromium in food and drinking water12. In this opinion, the Authority 
acknowledged that there is a lack of data on the presence of hexavalent chromium in 
food and decided to consider that essentially all of chromium analytically identified in 
food is likely to be trivalent chromium as food is, largely, a reducing m edium that 
would not favour oxidation of trivalent chromium to hexavalent chromium. The 
Authority added however that, even if a small proportion of the total chromium in 
food is in the more toxic hexavalent form, it could contribute substantially to 
hexava lent chromium exposure from food. Hexavalent chromium can be present in 
drinking water including bottled drinking water. Although the more advanced 
available analytical techniques can distinguish between the trivalent and hexavalent 
chromium species, this species analytical differentiation can be cumbersome and 
difficult for competent authorities and business operators. It  is therefore appropriate to 
take into account these considerations when ensuring compliance of plastic materials 
and articles , intended to come into contact with food that may contain chromium , with 
the Regulation.  
(18) The Authority established a TDI of 0,3 mg/kg body weight per day for trivalent 
chromium for diffuse duodenal epithelial hyperplasia and haematoxicity. The 
Authority estimated th at the dietary intakes of trivalent chromium for average and high 
level consumers in Europe amount to 5 and 8% of the TDI respectively. Based on the 
TDI and on a 20% allocation factor to account for the contribution of exposure to 
chromium from sources other than  plastic materials and articles intended to come into 
contact with food and taking into account conventional exposure assumptions for food 
contact materials,  a specific migration limit of 3,6 mg trivalent chromium/kg food or 
food simulant is appropr iate. It is therefore appropriate to amend Annex II of 
Regulation (EU) 10/2011 to include trivalent chromium provided that the migration 
                                                 
11 EFSA Journal 2009; 980 (1 -131) 
12 EFSA Journal 2014;12(3):3 595. EN 7  EN from plastic materials and articles intended to come into contact with food does not 
exceed 3,6 mg trivalent chromium/k g food or food simulant .  
(19) In addition, the Authority also established a benchmark dose (at 90% confidence limit) 
(‘BMDL 10’) of 1,0 mg/kg body weight per day for hexavalent chromium. Since this 
species of chromium is genotoxic and carcinogenic , the Authority considered that a 
Margin of Exposure (‘MOE’) above 10  000 is required for the exposure to be of low 
concern.  Taking into account the BMD L10, the MOE of 10.000, a 20% allocation to 
account for the contribution of exposure to hexavalent chromi um from sources other 
than plastic materials and articles intended to come into contact with food , and taking 
into account conventional exposure assumptions for food contact materials, the 
migration of hexavalent chromium from plastic materials and article s intended to come 
into contact with foods should not exceed  the level of 0,0012 mg hexavalent 
chromium/kg food or food simulant  to exclude adverse health effects . However, 
according to the EURL -FCM reliable detection of total chromium in food or food 
simu lant has not been tested among National Reference Laboratories below the level 
of detection as laid down in Article 11(4) to the Regulation . Therefore it advised to 
retain the  non-detect (ND) limit for chromium of 0,01 mg/kg food instead . 
(20) In the light of t he large difference in toxicity between trivalent and hexavalent 
chromium and the difficulty to distinguish between the two chromium species without 
using  burdensome analytical methods, to verify compliance of plastic materials and 
articles , intended to co me into contact with food that may contain chromium, with th e 
Regulation , Annex II of Regulation (EU) 10/2011 should be amended to include the 
detection limit for chromium which was derived on the basis of the toxicity of 
hexavalent chromium as the limit for chromium migration into food or food simulant . 
The migration of all chromium, regardless of its oxidation state,  from plastic materials 
and articles intended to come into contact with foods , should therefore not be 
detectable in food or food simulant a bove the level of 0,01 mg food or food simulant. 
However if the operator placing the material on the market can prove on the basis of 
pre-existing documentary evidence that the presence of hexavalent chromium in the 
material can be excluded because it is n ot used or formed during the entire production 
process, the migrating species should be considered trivalent chromium only and 
therefore a migration limit of 3,6 mg/kg food should apply  in accordance with the 
second subparagraph of Article 11(4) of Regulat ion (EU) 10/2011. It is therefore 
appropriate t o amend  Annex II to Regulation (EU) 10/2011 accordingly.  
(21) The Authority adopted an opinion on the risks to public health related to the presence 
of lead in food13. It determined the 9 5th percentile lower confide nce limit of the 
benchmark dose (BMD) of 1 % extra risk (BMDL 01) of 0,5 μg lead/kg body weight  as 
a reference point for the risk characterisation of lead when assessing the risk of 
intellectual deficits in children measured by the Full Scale IQ score. A 1 % increase of 
systolic blood pressure  annually or on average in the whole population was considered 
a public health issue , corresponding to 1,5 μg lead/ kg body weight per day for effects 
on systolic blood pressure , and a BMDL 10 value (at 90% confidence limit) of 0,63 μg 
lead/ kg body weight per day for  effects on prevalence of chronic kidney disease . The 
Authority concluded that in adults, children, and infants, the margins of exposure were 
such that the possibility of an effect from lead in some consumers, particularly in 
children, cannot be excluded  at any level of exposure , and a health based guidance 
value could not be derived . The Authority also concluded that protection of children 
                                                 
13 EFSA Journal 2010; 8(4):1570  EN 8  EN against the potential risk of neurodevelopm ental effects would be protective for all 
other adverse effects of lead, in all populations.   
(22) Lead should  not be used intentionally to manufacture a plastic material, but it can be 
present as an impurity . As its presence cannot be fully prevented, and it c an cause  
health effects at any  level  of exposure, there should be uniform rules to ensure its 
presence can be controlled. It  is therefore  appropriate to establish a common limit for 
its migration from plastic materials.  In absence of a health based guidanc e value  the 
BMDL 01 value of 0,5 μg lead/ kg body weight per day  is used as basis for that limit. 
Lead exposure however occurs from many sources other than from articles and 
materials intended to come into contact with food . To derive a limit for the migration  
of lead from plastic materials and articles intended to come into contact with food, it is 
therefore appropriate to apply a conventional allocation factor of 10%,  to account for 
the contribution of  lead from materials and articles intended to com e into contact with 
food. Taking into account conventional exposure assumptions for such materials  and 
articles , and assuming an average body weight of 60 kg,  the migration of lead from 
plastic materials and articles intended to come into contact with food  should not 
exceed  0,003 mg/kg food in food or food simulant  in order to reduce the probability of  
adverse health effects  to a minimum . However, according to the EURL -FCM reliable 
detection of lead in food or food simulant has not been tested among Nationa l 
Reference Laboratories below the level of detection as laid down in Article 11(4) to 
the Regulation . Therefore , it advised to assign a non -detect (ND) limit for lead at 0,01 
mg/kg food instead. It is therefore appropriate t o amend  Annex II of Regulation (EU) 
10/2011 accordingly.  
(23) The Authority adopted an opinion on the risks to public health related to the presence 
of mercury and methyl mercury in food14 in which it identified a TWI of 4,0 μg of 
inorganic mercury (expressed as elemental mercury)/kg body weight for kidney 
toxicity. The Authority concluded that the estimated exposure to inorganic mercury in 
Europe from the diet alone does not exceed the TWI.  Based on the TWI, on a 20% 
allocation  factor to account for the contribution of exposure to mercury from sources 
other than  plastic materials and articles intended to come into contact with food, and 
taking into account conventional exposure assumptions for food contact materials, the 
migrati on of mercury from plastic materials and articles intended to come into contact 
with food,  should not exceed  the level of 0,007 mg /kg food or food  simulant. 
However, according to the EURL -FCM reliable detection of mercury in food or food 
simulant has not been tested among National Reference Laboratories below the level 
of detection as laid down in Article 11(4) to the Regulation . Therefore it advised to 
retain the  non-detect (ND) limit for mercury of 0,01 mg/kg food instead.  It is 
therefore appropriate t o amend Annex II of Regulation (EU) 10/2011 accordingly.  
(24) Primary aromatic amines (‘PAAs’) may be used in plastic food contact materials as 
colorants  or may be present as not intentionally added substances in accordance with 
Article 6 of the Regulation. PAA s are a  large  family of compounds, some of which are 
carcinogens, while others are suspected carcinogens. Certain  PAAs may have adverse 
effects at any migration level, therefore they should not migrate into the food. 
However, it is not possible to exclude their migration analytically, as analytical 
methods can only exclude migration up to their limit of detection. For the purpose of 
compliance verification, and to ensure legal certain ty, the migration of PAAs into food 
has been restricted to a specified level that is not detectable in the food or food 
                                                 
14 EFSA Journal 2012;10(12):2985.  EN 9  EN simulant by means of commonly used analytical methods. However, according to the 
EURL -FCM advances in analytical capabilities ensure tha t equipment is now 
commonly available that allows to lower the detection limit of 0,01 mg/kg food or 
food simulant that the Regulation presently assigns to the detection of individual 
PAAs  to a new detection l imit of 0,002 mg/kg food or food simulant . Ther efore  that 
lower detection limit should be defined in the Regulation  as the detection limit for 
individual PAAs .  
(25) At present, the restriction on PAAs in Annex II applies to all PAAs that are not listed 
in Table 1 of Annex I to the Regulation.  Applying the new low detection limit  that is 
now assigned  would require testing  for a large number of substances , and , not all 
PAAs  would adversely affect health above that detection limit. The most problematic 
PAAs are listed in entry 43 of Appendix 8 to Annex XVII to  Regulation (EC) No 
1907/2006, ‘the Azocolourants entry’ . It is  therefore  appropriate to apply the new 
detection limit only to these substances, given their established toxicity . Other PAAs 
for which no limit is laid down in Annex I should be assessed in a ccordance with 
Article 19 of the Regulation. However, to avoid their combined toxicity may cause 
adverse health problems, it is appropriate to limit their total migration to a maximum 
of 0.01 mg/kg in food or food simulant.  
(26) Point 2 of Annex II to the Regu lation  require s that the sum of PAAs does not exceed 
0,01 mg/kg food or food simulant , to avoid that their collective presence can cause 
adverse health effects . As the limit of detection is now lowered to 0, 002 mg/kg food or 
food simulant for all PAAs list ed in the Azocolourants entry, the sum would  not 
require evaluation  if such a PAA is detected  because  the material would not be in 
compliance with the Regulation anyway in this case. However, when it is known or 
suspected that certain PAAs not listed in An nex I or in the Azocolourants entry may 
be present, their presence can be assessed on the basis of migration testing and 
modelling considerations . Therefore , it is appropriate to maintain the provision that the 
sum of those PAAs does not exceed 0,01 mg/kg food or food simulant .  
(27) The new or updated restrictions on substances in Annex II require clear 
communication in the supply chain to ensure  that adequate information on the 
presence of these substances is available to business operators  which use products  
from intermediate stages in the supply chain  or final articles or materials in which 
these substances may be contained . When such  information is not provided they 
cannot be certain on the presence and amount of these  substances and they would need 
to test more frequently  than would be needed if that information was provided.  
However , if the presence and amount of these substances is  known  to these business 
operators , in many cases simple calculation techniques can suffice to establish whether 
a limit could be exceeded, and analytical testing would not be required at all . 
Moreover, communication of the amounts of substances is also required  to 
communicate on the presence of these substances to later stages of the supply chain . 
Therefore, it is appropriate to amend point 6 of Annex IV to the Regulation to clarify 
that the amount of substances subject to limits under Annex II should be included in 
the declaration of compliance.  
(28) Before placing an intermediate or final product on the market, the manufactur er of that 
product needs to assess whether it complies with Article 3 of Regulation (EU) No 
1935/2004, and/or to comply with Article 19 of the Regulation. Various and 
complementary approaches should be used in such assessment. A  common and cost 
efficient t esting approach is to determine only the safety of substances that are present 
above a concentration of 10 ppb by using migration testing with a food simulant. EN 10  EN Substances that do not exceed this limit are then considered safe. However, the 
migration of sub stances at a level of 10 ppb can only be considered safe provided that 
their genotoxicity can be ruled out. Therefore, the use of such a testing technique 
should always be complemented by an assessment of whether substances that could be 
genotoxic are pres ent. Therefore,  it should be communicated to downstream users of 
an intermediate or final  material that it may contain substances  of which the 
genotoxicity has not been ruled out . Producers of intermediate materials know that 
these substances can be presen t in their products as they use preparations that contain 
them, or should  obtain that information from their suppliers. Therefore , point 6 of 
Annex IV should also be clarified to require information on substances present in a 
material or article, of which genotoxicity has not been ruled out.  
(29) Point 2.1.6 of Annex V to the Regulation requires three subsequent tests for articles 
and materials that are placed in repeated contact with food. The results of the third 
migration test should be used to verify complia nce with the migration limits. However, 
if the migration was to  increase between the first, second and third test, the tests would 
not be suitable to verify compliance even in cases where the specific migration limit is 
not exceeded in any of the three tes ts, as they will not adequately predict the final 
migration level after continued contact with food. Thereto the migration should be 
strictly decreasing in subsequent tests. While this principle is already reflected in the 
second subparagraph of point 2.1. 6 on conditions to use the results of the first test, as 
well as in point 3.3.2 on overall migration testing, a requirement that the migration 
should not increase  between subsequent tests was not specified in the first paragraph 
of point 2.1.6. It would therefore  be appropriate to amend the Regulation and add this 
requirement.  However, in some instances, such as when migration is low relative to 
the measurement error, it may be difficult to establish a decreasing trend analytically 
and it would require comp lex rules. Therefore it is appropriate to only require that a 
the migration established in a subsequent test does not exceed that of the previous test, 
to clarify this principle in the Regulation, and to establish that a material that shows 
increasing migr ation over the subsequent tests should never be considered compliant .   
(30) Annex V provides rules for the tests to demonstrate the compliance of migration from 
plastic materials and articles intended to come into contact with food with the 
migration limits re ferred to in Articles 11 and 12 of th e Regulation. Certain types of 
plastic materials and articles are intended to come to contact with food only at cold or 
ambient temperatures and for a short duration (less than 30 minutes). While conditions 
for the spec ific migration testing for such intended contact are available, 
corresponding conditions for the overall migration testing are not assigned in table 3 
of Annex V of the Regulation. The Overall Migration (OM) testing condition 2 
(OM2), which requires testin g at 40 °C for 10 days, and the OM3 , which requires 
testing at 70 °C for two hours, are the two OM test conditions which come close in 
simulating the intended food contact conditions for these types of kitchenware but they 
are significantly more severe tha n the real life conditions which could foreseeably 
occur during actual use of such kitchenware. Therefore it is appropriate to amend table 
3 of Annex V of this Regulation and the relevant text below that table  to introduce 
overall migration conditions of 3 0 minutes at 40 °C designated as OM0 for the overall 
migration testing of plastic kitchenware materials and articles only at cold or ambient 
temperatures and for a short duration.   
(31) Migration testing at 100 °C can be technically difficult in some situations  because of 
high evaporation of water . In order to overcome this difficulty and to ensure that 
migration testing can be properly conducted, a reflux condition may be used as an EN 11  EN alternative to test for  specific and overall migration at 100 °C. Such a reflux  condition 
is provided for as an option in the OM5 and OM6 test conditions in table 3 of Annex 
V of the Regulation which require testing at 100 °C. A reflux alternative testing 
condition is not provided for the OM4  test condition  which  also requires testin g at 100 
°C. It is therefore appropriate to amend the OM4 entry in table 3 of Annex V of th e 
Regulation to provide for the reflux condition as an option when testing at 100 °C is 
technically difficult.  
(32) Migration  testing using the whole food processing and /or food producing equipment 
or appliance is presently not allowed under the Regulation. However, when food 
processing equipment o r appliances are made of multiple plastic parts, or contain 
plastic parts as well as other materials, it may be burdensome and in some cases 
impossible to verify compliance of these plastic parts with the Regulation. It should 
therefore be possible to verif y compliance by conducting migration tests in the food or 
food simulant produced or processed using the whole equipment or appliance, or 
assemblies or modules thereof , in accordance with the operating instructions, instead 
of trying to establish the migrat ion from each individual plastic part or material used in 
the equipment or appliance . If such a migration test is done under the worst 
foreseeable use  conditions in the food, or when appropriate, in a food simulant, which 
can be achieved in accordance with  the operating instructions, and the transfer of 
constituents from the equipment or appliance as a whole does not exceed the specific 
migration limits, the plastic parts of the food processing equipment should be 
considered to comply with the requirements of Article 11(1) of the Regulation if the 
plastic parts comply with the compositional provisions set out in the Regulation. It is 
therefore appropriate to amend Annex V of th e Regulation to introduce provisions that 
will allow for the migration testing wit h the final food processing and/or food 
producing equipment instead of verifying the compliance of each of its individual 
parts.  
(33) Applying the whole equipment or appliance in accordance with its operating 
instructions to prepare the food, or parts thereof m ay not be representative for all of its 
parts. Certain parts will be subject to different contact conditions, in particular those 
parts that are used for storage, in some cases long term, such as containers, reservoirs, 
capsules, and pads. Those parts woul d need to be tested also separately to ensure they 
are safe for those storage conditions as well.  
(34) Migration testing of food processing and/or food producing equipment or appliance 
can only establish the compliance of the equipment with th e Regulation. Howe ver, in 
case a non-compliant migration is observed when testing food processing and/or food 
producing equipment or appliance s, it should be verified that this migration does not 
originate from  materials not subject to th e Regulation. Therefore, it is appro priate to 
require to establish whether the source of the non -compliance is a plastic part of the 
equipment or appliance, or whether it is another material not subject to the Regulation. 
The non -compliance of the equipment with th e Regulation should then only be 
established if that non -compliance is due to a plastic part.   
(35) The first paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions 
for the substitution of food simulant D2 with 95% ethanol and isooctane in the  overall 
migration (OM) tests 1 -6 referred to in table 3 of Annex V, when it is not technically 
feasible to perform one or more of the OM tests 1 -6 with the simulant D2. The third 
sentence of th at paragraph erroneously makes reference to specific migration  rather 
than to overall migration. It is therefore necessary to correct th at sentence.   EN 12  EN (36) The second paragraph of Chapter 3.2 of Annex V of Regulation (EU) No 10/2011 sets 
out conditions for the substitution of the overall migration (OM) test 7 with the OM 
tests 8 or 9 when it is not technically feasible to perform the OM test 7 with simulant 
D2. The wording of that paragraph does not clearly specify by which test OM 7 should 
be substituted, and makes reference to the highest overall migration  in the last 
sentence , which could be erroneously interpreted  in such a way  that more than two 
OM tests  should be conducted. It is therefore appropriate to clarify the paragraph by 
laying down  that one test should be selected and by referring to the higher overall 
migrati on obtained under the two testing conditions required in that test.  
(37) Regulation (EU) No 10/2011 should therefore be amended and corrected accordingly .  
(38) Plastic materials and articles complying with Regulation (EU) No 10/2011, as 
applicable before the date o f the entry into force of this Regulation,  and which were 
also placed on the market before that date should be allowed to be placed on the 
market for two more years and remain on the market until the exhaustion of stocks. 
However, this long period should n ot be used to develop new materials and articles 
which had not yet been placed on the market at the time of entry into force of this 
Regulation, and are not yet compliant with it. Business operators may not be able to 
fully anticipate the entry into force of this Regulation when they would have been 
already planning to place such new materials on the market before the entry into force 
of this Regulation. Therefore it is appropriate to allow such placing on the market of 
new materials and articles based on t he old rules for six months after the entry into 
force of this Regulation .  
(39) The measures  provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plants, Animals, Food and Feed . 
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) No 10/2011 is amended as follows:  
(1) In Article 6(3), point (a) is replaced by the following:  
“(a) all salts of substances for which ‘yes’ is indicated in column 2 in table 1 of 
Annex II  of authorised acids, phenols or alcohols, and subject to  the restrictions 
set out in column 3 and 4 of that table ”. 
(2) Annexes I, II , IV  and V are amended in accordance with the Annex to this 
Regulation.  
Article 2  
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable 
before the ent ry into force of this Regulation, and which were first placed on the market 
before [enter date 6 months after the date of entry into force of this Regulation]  may continue 
to be placed on the market until [enter date 24 months after the date of entry into force of this 
Regulation ] and remain on the market 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.   EN 13  EN This Regulation shall  be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN