II 
(Non-legislative acts) 
REGUL ATIONS 
COMMI SSION REGUL ATION (EU) 2020/1245 
of 2 September 2020 
amending and correcting Regulation (EU) No 10/2011 on plast ic mater ials and articles intended to 
come into contact with food 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
mater ials and articles intende d to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), 
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 (EU) No 10/2011 (2) (‘the Regulation’) lays down specifi c rules as regar ds plastic mate rials 
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 manufacture of plastic food contact mat erials and articles, while Annex II 
establishes additional restr ictions applicable to plastic mater ials and articles. 
(2) Since the last amendment to the Regulation, the European Food Safety Author ity (‘the Author ity’) has published 
further scientific opinions on particular substances that may be used in food contact mat erials (‘FCM’) as well as on 
the use of already author ised substances. In addition, certain ambiguities to the application of the Regulation were 
identif ied. In order to ensure that the Regulation takes account of the most recent findings of the Auth ority and in 
order to remove any doubt as regar ds its correct application, the Regulation should be amended and corrected. 
(3) The Author ity adopt ed a favourable scientific opinion (3) on the use of isostr uctural salt compl exes of terephthalic 
acid (generically descr ibed as 1,4-benzene dicarbo xylic acid, FCM substance No 785) with the followi ng lanthanides: 
lanthanum (La), europium (Eu), gadolinium (Gd) and terbium (Tb) used alone or in combination and in varying 
propor tions, as additives in plastics intended to come into contact with foods. The Author ity concluded that those 
salts are not of a safety concer n for the consumer if used as additives in polyeth ylene, polyprop ylene or polybut ene 
plastic mat erials 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-t erm storage at ambient temperature. This conclusion is made on the basis that, if 
migration from the plastic food contact mate rial 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 of the four 
lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food. 
(1)OJ L 338, 13.11.2004, p. 4. 
(2)Commission Regulation (EU) No 10/2011 of 14 Januar y 2011 on plastic mat erials 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 Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                            L 288/1   (4) The Author ity noted that, in light of the chemical charact eristics of the isostr uctural lanthanide salts of terephthalic 
acid and of the four lanthanides (La, Eu, Gd, Tb) themselves, it is not necessar y to restr ict the use of these additives 
to the three poly olefin types of plastics specified in the application dossier that the applicant provided to the 
Authority. The Author ity reasoned that no undesirable inter actions with plastics (including, but not limited to 
poly olefi ns) leading to formation and possible migration of undesirable reaction and transf ormation products are to 
be expected. Like poly olefins, if migration from any plastic food contact mater ial to the food or food simulant were 
to occur , the lanthanides should be present in the food or the food simulant in dissociat ed 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, and no further restr ictions should be necessar y. Theref ore, it is appropr iate to author ise 
the lanthanides for use in all types of plastic mater ials and articles as salts of already author ised substances, 
provid ed that these restr ictions are met. 
(5) Article 6(3)(a) of the Regulation allows for the use of salts of certain metals and of ammonium of author ised acids, 
alcohols and phenols, based on the conclusion that these salts will dissociat e in the human stomac h to the 
corresponding cations and the phenols, alcohols and acids (4). This Regulation requires that the four lanthanides 
should also be present in the dissociated ionic form. Theref ore, in order to author ise their use as count er ions of 
already author ised acids, alcohols and phenols in all types of plastic mater ials and articles, and for the purpose of 
simplification, those four lanthanides should also be included in the scope of Article 6(3)(a). Theref ore it is 
appropr iate to amend this Article to include those four lanthanides. 
(6) Article 10 of the Regulation sets out general restr ictions related to plastic mater ials and articles, which are laid down 
in Annex II to the Regulation. Specifically , point 1 of this Annex restr icts the migration of certain chemical elements 
from plastic mat erials and articles into food or food simulants. The chemical elements to which these limits apply 
may be present in plastic mater ials and Articles on the basis of several provisions set out in Chapt er II of the 
Regulation. They may be present in the plastic because they are intenti onally 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 impur ity or other non-inten tionally added substance. The migration limits set 
in point 1 of Annex II to the Regulation theref ore also apply to the metals which are present in the plastic mat erial 
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 theref ore 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 clarity and good draf ting practice such lists should not be set out in the enacting term s 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 theref ore appropr iate to clarify 
and simplify the Regulation by removi ng the names of the metals from Article 6(3)(a) and by amending Annex II to 
include them in point 1 of Annex II. For this purpose, it is appropr iate to 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 included 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 
provid es that ammonium salts of author ised acids, alcohols and phenols are author ised in the same way as the 
specifi ed metals, it is appropr iate that ammonium is also included in point 1 of Annex II. 
(8) The substance 1,3 pheny lenediamine (CA S No 0000108-45-2, FCM No 236) is a Primar y Aromatic Amine currently 
included in Annex I of the Regulation to be used as a starting substance in plastic mater ials and articles intended to 
come into contact with food provided it does not migrate. However to verify compl iance with this requirement it 
should not be detect ed in the food or the food simulant abov e the 0,01 mg/kg food or food simulant detection 
limit, in accordance with the second subparagraph of Article 11(4) of the Regulation. The advances in analytical 
capabilities allow the detection of 1,3 pheny lenediamine at 0,002 mg/kg food or food simulant. It is theref ore 
appropr iate to amend Annex I of the Regulation to set this value as a specifi c detection limit for this substance to 
reflect this impro vement in analytical capability and to maximise the health prote ction of consumers. 
(4)EFSA Journal 2009; 7(10):1364. EN Offi cial Jour nal of the European Union L 288/2                                                                                                                                             3.9.2020   (9) The Author ity adop ted a favour able scientific opinion (5) on the use of the substance montmor illonite clay modifi ed 
with hexadecyltr imethyl ammonium bromide (FCM No 1075), as an additive in plastic food contact mater ials. In that 
opinion, the Authority concluded that the substance is not of safety concer n for the consumer if it is used as an 
additive at up to 4 % w/w in polylactic acid plastics intended for storag e of water at ambient temperature or below . 
The Author ity noted that once dispersed in the polylactic acid plastic, the particles can form platelets that can be in 
one or two dimensions in the nanopar ticle rang e (< 100 nanometres). These platelets are not expecte d to migrat e as 
they are oriente d parallel to the plastic surface and they are fully embedded in the polymer . Theref ore, that additive 
should be included in the Union list of author ised substances with the restr iction that those specifi cations should be 
met. 
(10) The Author ity adop ted a favourable scientific opinion (6) on the use of the substance phosphorous acid, triphenyl 
ester, polymer with alpha-hydro-omeg a-hydro xypoly[o xy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (FCM 
No 1076 and CAS No 1227937-46-3), as an additive in plastic food contact mate rials. In that opinion, the 
Authority concluded that this substance is not of safety concer n for the consumer if it is used as an additive at up to 
0,2 % w/w in high imp act polystyrene (‘HIPS’) mater ials 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 established by the Auth ority are not exceed ed, 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. Theref ore, that additive should be 
included in the Union list of author ised substances with the restr iction that those specifi cations should be met. 
(11) The Authority adopt ed a favour able scientific opinion on the use of the substance titanium dioxide surface-treat ed 
with fluor ide-modifi ed alumina (FCM No 1077) as an additive in plastic food contact mater ials (7). In that opinion, 
the Author ity note d that the substance, whic h is a defined mixture of particles of which a certain number have a 
diamete r in the nanopar ticle range (< 100 nanometres), is embedded in the polymer and does not migrat e. The 
Authority concluded that this substance is not of safety concer n 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 whic h swell when in contact with foods 
for whic h 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 fluor ide and aluminium 
respectively , if these polar polymers are used in certain contact conditions. Significant exceed ance of those limits was 
shown in contact conditions excee ding 4 hours at 100 °C. This risk should be communicated to users of such 
mater ials and control author ities via a note on the verification of compl iance. Theref ore, it is appropr iate to include 
this additive in the Union list of author ised substances, allowing its use as an additive at up to 25,0 % w/w and with a 
note on the verification of compl iance, warning that the migration limits can be exce eded under certain conditions. 
(12) Antimony trioxide (CAS No 001309-64-4, FCM No 398) is currently included in Annex I of the Regulation to be 
used as an additive or polymer production aid in plastic mate rials and articles intended to come into contact with 
food, with a specif ic migration limit of 0,04 mg/kg food or food simulant established in the opinion (8) of the 
Authority on this substance adopt ed in 2004, expressed as antimony , and with a note on the verification of 
compl iance in Table 3 of Annex I that this specifi c migration limit may be exceeded at very high temperature. 
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 contr ibution of exposure to antimony from sources other than plastic mat erials and 
articles intended to come into contact with foods. This migration limit together with the accompan ying note on the 
verification of compl iance should theref ore apply for the migration of antimony from plastic mater ials and articles 
(5)EFSA Journal 2019; 17(1):5552. 
(6)EFSA Journal 2019; 17(5):5679. 
(7)EFSA Journal 2019; 17(6):5737. 
(8)EFSA Jour nal 2004; 24 (1-13):2903. EN Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                            L 288/3   intended to come into contact with food. It is theref ore appropr iate that Annex II of the Regulation is amended to 
include antimony provided that its migration does not exceed 0,04 mg antimony/kg food or food simulant, and to 
also include the note on the verification of compl iance of Table 3 of Annex I of that Regulation applicable to the 
antimony specifi c migration limit. 
(13) The Author ity has adop ted opinions on arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and mercur y (Hg). 
These metals are not included in Annex I of the Regulation and theref ore are not author ised to be used in plastic 
mater ials 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 mat erials and articles to food should not occur at levels 
harmful to human health. While the levels of these metals are normally brought under control during the 
subsequent manufactur ing stages of plastic mater ials and articles in accordance with Article 4(d) of the Regulation, 
these metals can never theless end up being present as impurities in final plastic mate rials and articles based on the 
derogat ions set out in Article 6(4)(a), and adversely affect the health of the consumer . While the safet y of these 
metals should principally be controlled in accordance with Article 19 of the Regulation and the documentation 
provid ed according to the provis ions of Articles 15 and 16 of the Regulation, such work may not be implemented 
unif ormly, and is burdensome and difficult to verify by compet ent author ities. Clearly defined migration limits 
based on opinions of the Author ity would allow unif orm analytical verification of compl iance. It is theref ore 
appropr iate to amend Annex II of the Regulation to establish limits on the migration of these metals to ensure a 
unif orm approach to verification of compl iance, the application of a unif orm level of health prote ction, and the 
proper functioning of the sing le mark et. 
(14) Some metals already exer t adverse health effects at levels in the food below what can be quantifi ed analytically using 
techniques applied by official control laboratori es. In such a case, a method with a limit of detection in accordance 
with Article 11(4) of the Regulation is the appropr iate means to verify the level of migration. The European Union 
Reference Laboratory for Food Contact Mate rials, designate d in accordance with Regulation (EU) 2017/625 of the 
European Parliament and of the Council (9) (‘EURL-FCM’) has conducted work with the national reference 
laboratories which shows that analytical methods are already available that are suitable to detect the migration of 
metals from plastic mat erials at lower levels that is presently the case and which can be routinely used by the 
majority of involved laboratories. Even though some of these limits may change because of further analytical 
developments in the future, it is appropr iate to assign the detection limits that can be achi eved now to those metals 
in order to establish a maximum possible and unif orm level of safet y. Theref ore it is appropr iate to clarify the 
detection limits for metals in the list of limits in point 1 of Annex II to the Regulation, and to redraf t that list as a 
table to provid e a clearer framework for future changes to such limits. 
(15) Specifi cally , the Author ity adopt ed an opinion on inorganic arsenic in food (10) in whic h it identif ied a rang e of 
benc hmark dose (‘BMDL 01’) values (at 99 % conf idence 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 Author ity further estimate d that dietar y 
exposures to inorg anic 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 theref ore the possibility of a risk to some consumers 
cannot be excl uded. Based on the lower BMDL 01 value, on a 10 % allocation factor to account for the contr ibution of 
exposure to arsenic from sources other than plastic mate rials and articles intende d to come into contact with food, 
and taking into account conventional exposure assump tions for food contact mat erials, the migration of arsenic 
from plastic mater ials 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 
(9)Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official 
activities perfor med to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant 
prot ection 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 Offi cial Jour nal of the European Union L 288/4                                                                                                                                             3.9.2020   detection of arsenic in food or food simulant has not been tested among National Reference Laboratori es below the 
limit of detection as laid down in Article 11(4) to the Regulation. Theref ore, it advised to retain the detection limit 
for arsenic of 0,01 mg/kg food inste ad. It is theref ore appropr iate to amend Annex II of the Regulation according ly. 
(16) The Author ity further more adopt ed an opinion on cadmium in food (11) in which it identif ied a Tolerable Weekly 
Intake (‘TWI’) of 2,5 μg of cadmium/kg body weight per week for kidne y toxicity . In that opinion, the Author ity 
also note d association of cadmium intak es with increased risk of cancers of the lung, endometr ium, bladder and 
breast. The Author ity estimated that the mean exposure for adults is close to, or slightly exceed ing, the TWI and 
subgroups of consumers such as vegetarians, children, smoke rs and people living in highly contaminated areas may 
exceed the TWI by about twof old. The Author ity concluded that although the risk for adverse effects on kidney 
function taking into account dietar y 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 contr ibution of exposure to cadmium 
from sources other than plastic mat erials and articles intended to come into contact with food, and taking into 
account conventional exposure assum ptions for food contact mater ials, the migration of cadmium from plastic 
mater ials and articles intende d to come into contact with food, should not exceed the level of 0,002 mg/kg in food 
or food simulant. Theref ore, cadmium should not be detected in the food or the food simulant abov e the 
0,002 mg/kg food or food simulant. It is theref ore appropr iate to amend Annex II of the Regulation according ly. 
(17) The Auth ority also adop ted an opinion on the risks to public health related to the presence of chromium in food and 
drinking water (12). In this opinion, the Auth ority ackno wledged that there is a lack of data on the presence of 
hexavalen t chromium in food and decided to consider that essentially all of chromium analytically identif ied in food 
is likely to be trivalent chromium as food is, largely, a reducing medium that would not favour oxidation of trivalent 
chromium to hexa valent chromium. The Author ity added however that, even if a small propor tion of the total 
chromium in food is in the more toxic hexavalen t form, it could contr ibute substantially to hexavalen t chromium 
exposure. Hexa valent chromium can be present in drinking water including bottled drinking wate r. Although the 
more advanced available analytical techniques can distinguish between the trivalent and hexavalent chromium 
species, this species analytical differ entiation can be cumbersome and difficult for compet ent author ities and 
business operators. It is theref ore appropr iate to take into account these considerations when ensur ing compl iance 
of plastic mat erials and articles, intended to come into contact with food that may contain chromium, with the 
Regulation. 
(18) The Auth ority established a TDI of 0,3 mg/kg body weight per day for trivalent chromium for diffuse duodenal 
epithelial hyperplasia and haemato toxicity . The Author ity estimat ed that the dietar y intakes of trivalent chromium 
for averag e 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 contr ibution of exposure to chromium from sources other than plastic 
mater ials and articles intended to come into contact with food and taking into account conventional exposure 
assump tions for food contact mater ials, a specifi c migration limit of 3,6 mg trivalent chromium/kg food or food 
simulant is appropr iate. It is theref ore appropr iate to amend Annex II of the Regulation to include trivalent 
chromium provid ed that the migration from plastic mater ials and articles intende d to come into contact with food 
does not exceed 3,6 mg trivalent chromium/kg food or food simulant. 
(19) In addition, the Author ity also established a benc hmark dose (at 90 % conf idence limit) (‘BMDL 10’) of 1,0 mg/kg 
body weight per day for hexavalen t chromium. Since this species of chromium is genoto xic and carcinog enic, the 
Authority considered that a Margin of Exposure (‘MOE’) above 10 000 is required for the exposure to be of low 
concer n. Taking into account the BMDL 10, the minimum MOE of 10 000, a 20 % allocation to account for the 
contr ibution of exposure to hexa valent chromium from sources other than plastic mat erials and articles intende d to 
come into contact with food, and taking into account conventional exposure assump tions for food contact mater ials, 
(11)EFSA Journal 2009; 980 (1-131). 
(12)EFSA Journal 2014;12(3):3595. EN Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                            L 288/5   the migration of hexa valent chromium from plastic mate rials and articles intended to come into contact with foods 
should not exce ed the level of 0,0012 mg hexavalent chromium/kg food or food simulant to excl ude adverse health 
effects. However , according to the EURL-FCM reliable detection of total chromium in food or food simulant has not 
been tested among National Reference Laboratori es below the limit of detection as laid down in Article 11(4) to the 
Regulation. Theref ore it advised to retain the detection limit for chromium of 0,01 mg/kg food inste ad. 
(20) There is a large differ ence in toxicity between trivalent and hexavalen t chromium and it is difficult to distinguish 
between the two chromium species without using burdensome analytical methods. Theref ore, verifying compl iance 
with the Regulation of plastic mat erials and articles that may contain chromium should be done on the basis of 
hexavalen t Chromium as this is the most toxic species. Annex II of the Regulation should theref ore be amended to 
include the detection limit as the limit for chromium migration into food or food simulant. The migration of all 
chromium, rega rdless of its oxidation state, from plastic mat erials and articles intended to come into contact with 
foods, should theref ore not be detectable in food or food simulant above the level of 0,01 mg/kg food or food 
simulant. However , if the business operat or placing the mat erial on the mark et can prove on the basis of pre- 
existing documentar y evidence that the presence of hexa valent chromium in the mater ial can be excl uded because it 
is not used or formed during the entire production process, the migrating species should be considered trivalent 
chromium only and theref ore a migration limit of 3,6 mg/kg food should apply in accordance with the second 
subparagraph of Article 11(4) of the Regulation. It is theref ore appropr iate to amend Annex II to the Regulation. 
(21) The Author ity adopt ed an opinion on the risks to public health related to the presence of lead in food (13). It 
determined the 95th percentile lowe r conf idence limit of the benchmark dose (BMD) of 1 % extra risk (BMDL01) of 
0,5 μg lead/kg body weight as a reference point for the risk charact erisation 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 (SBP) 
annually or on averag e in the whole population was considered a public health issue. On this basis the Author ity 
calculat ed a mean BMDL 01 for SBP of 36 μg/L, corresponding to 1,5 μg lead/kg body weight per day for effects on 
systol ic blood pressure. It also calculat ed a BMDL 10 value (at 90 % conf idence limit) of 0,63 μg lead/kg body weight 
per day for effects on prevalence of chronic kidne y disease. The Author ity 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 excl uded at any level of exposure, and a health based guidance value could 
theref ore not be derived. The Author ity also concluded that prote ction of children against the potential risk of 
neurodevelopmental effects would be prot ective for all other adverse effects of lead, in all populations. 
(22) Lead should not be used intentionally to manufacture a plastic mat erial, but it can be present as an impur ity. As its 
presence cannot be fully prevented, and it can cause health effects at any level of exposure, there should be unif orm 
rules to ensure its presence can be controlled. It is theref ore appropr iate to establish a common limit for its 
migration from plastic mat erials. In absence of a health based guidance 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 man y sources other than 
from articles and mate rials intended to come into contact with food. To derive a limit for the migration of lead 
from plastic mate rials and articles intended to come into contact with food, it is theref ore appropr iate to apply a 
conven tional allocation factor of 10 %, to account for the contr ibution of lead from mat erials and articles intended 
to come into contact with food to the total lead exposure. Taking into account conven tional exposure assump tions 
for such mat erials and articles, and assuming an average body weight of 60 kg, the migration of lead from plastic 
mater ials and articles intended to come into contact with food should not excee d 0,003 mg/kg food in food or food 
(13)EFSA Journal 2010; 8(4):1570. EN Offi cial Jour nal of the European Union L 288/6                                                                                                                                             3.9.2020   simulant in order to reduce the probability of adverse health effects to a minimum. Howe ver, according to the EURL- 
FCM reliable detection of lead in food or food simulant has not been tested among National Reference Laboratories 
below the limit of detection as laid down in Article 11(4) to the Regulation. Theref ore, it advised to assign a 
detection limit for lead at 0,01 mg/kg food instead. It is theref ore appropr iate to amend Annex II of the Regulation 
according ly. 
(23) The Auth ority adop ted an opinion on the risks to public health related to the presence of mercur y and meth yl 
mercur y in food (14) in which it identif ied a TWI of 4,0 μg of inorg anic mercur y (expressed as elemental mercur y)/ 
kg body weight for kidney toxicity . The Author ity concluded that the estimate d exposure to inorg anic mercur y in 
Europe from the diet alone does not excee d the TWI. Based on the TWI, on a 20 % allocation factor to account for 
the contr ibution of exposure to mercur y from sources other than plastic mater ials and articles intended to come 
into contact with food, and taking into account convention al exposure assum ptions for food contact mate rials, the 
migration of mercur y from plastic mater ials 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 
mercur y in food or food simulant has not been tested among National Reference Laboratori es below the limit of 
detection as laid down in Article 11(4) to the Regulation. Theref ore, it advised to retain the detection limit for 
mercur y of 0,01 mg/kg food inste ad. It is theref ore appropr iate to amend Annex II of the Regulation according ly. 
(24) Primar y aromatic amines (‘PAAs ’) may be used in plastic food contact mater ials as colorants or may be present as not 
intenti onally added substances in accordance with Article 6 of the Regulation. PAAs are a large family of 
compo unds, some of whic h are carcinog ens, while others are suspect ed carcinog ens. Certain PAAs may have 
adverse effects at any migration level, theref ore they should not migrate into the food. However , it is not possible to 
excl ude their migration analytically , as analytical methods can only excl ude migration above their limit of detec tion. 
For the purpose of compliance verification, and to ensure legal certainty , the migration of PAAs into food has been 
restr icted to a specifi ed level that is not detectable in the food or food simulant by means of commonly used 
analytical methods. Howe ver, according to the EURL-FCM advances in analytical capabilities ensure that 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 detec tion of individual PAAs to a new detection limit of 0,002 mg/kg food or 
food simulant. Theref ore that lower detection limit should be defined in the Regulation as the detection limit for 
individual PAAs. 
(25) At present, the restr iction 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 this Regulation now assigns would require testing for a large 
number of substances, and, not all PAAs would adversely affect health abov e that detection limit. The most 
problematic PAAs are listed in entr y 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council (15), ‘the Azocolourants entr y’. It is theref ore appropr iate to apply the new 
detection limit only to these substances, given their established toxicity . Other PAAs for whic h no limit is laid down 
in Annex I should be assessed in accordance with Article 19 of the Regulation. However , to avoid their combined 
toxicity may cause adverse health problems, it is appropr iate to limit their total migration to a maximum of 
0,01 mg/kg food or food simulant. 
(26) Point 2 of Annex II to the Regulation requires that the sum of PAAs does not excee d 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 listed in the Azocolourants entr y, the sum would not 
require evaluation if such a PAA is detec ted because the mate rial would not be in compl iance with the Regulation 
anywa y in this case. However , when it is known or suspecte d that certain PAAs not listed in Annex I or in the 
(14)EFSA Journal 2012;10(12):2985. 
(15)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning the Registration, 
Evaluation, Authorisatio n and Restr iction of Chemicals (REA CH), establishing a European Chemicals Agency , amending Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
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 Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                            L 288/7   Azocolourants entr y may be present, their presence can be assessed on the basis of migration testing and modelling 
considerations. Theref ore, it is appropr iate to maintain the provision that the sum of those PAAs does not exce ed 
0,01 mg/kg food or food simulant. 
(27) The new or update d restr ictions 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 operat ors whic h use 
products from interm ediate stages in the supply chain or final articles or mater ials in whic h 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 kno wn to these business operat ors, in man y cases 
simple calculation techniques can suffice to establish whether a limit could be excee ded, 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. Theref ore, it is appropr iate 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 compl iance. 
(28) Before placing an interm ediat e or final product on the market, the manufacturer of that product needs to assess 
whether it compl ies with Article 3 of Regulation (EC) No 1935/2004, and/or complies with Article 19 of the 
Regulation. Various and compl ementar y approaches should be used in such assessment. A common and cost 
efficient testing approach is to determine only the safety of substances that are present abov e a concentration of 10 
ppb by using migration testing with a food simulant. Substances that do not exceed this limit are then considered 
safe. Howe ver, the migration of substances at a level of 10 ppb can only be considered safe provid ed that their 
genoto xicity can be ruled out. Theref ore, the use of such a testing technique should alwa ys be compl emented by an 
assessment of whether substances that could be genoto xic are present. Theref ore, it should be communicat ed to 
down stream users of an intermediate or final mater ial that it may contain substances of which the genot oxicity has 
not been ruled out. Producers of interm ediate mater ials kno w that these substances can be present in their products 
as they use preparations that contain them, or should obtain that information from their suppliers. Theref ore, point 
6 of Annex IV should also be clarified to require information on substances present in a mater ial or article, of whic h 
genoto xicity has not been ruled out. 
(29) Point 2.1.6 of Annex V to the Regulation requires three subsequent tests for articles and mater ials that are placed in 
repeated contact with food. The results of the third migration test should be used to verify compl iance with the 
migration limits. Howe ver, if the migration was to increase between the first, second and third test, the tests would 
not be suitable to verify compl iance even in cases where the specifi c migration limit is not exce eded in any of the 
three tests, as they will not adequately predict the final migration level after continued contact with food. Theret o 
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 
specifi ed in the first paragraph of point 2.1.6. It would theref ore be appropr iate 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 compl ex rules. Theref ore it is 
appropr iate 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 mater ial that shows increasing 
migration over the subsequent tests should never be considered compl iant. 
(30) Annex V provid es rules for the tests to demonstrate the compl iance of migration from plastic mater ials and articles 
intended to come into contact with food with the migration limits referred to in Articles 11 and 12 of the 
Regulation. Certain types of plastic mater ials and articles are intended to come to contact with food only at cold or 
ambient temperatures and for a shor t duration (less than 30 minutes). While conditions for the specific 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 testing at 40 °C for 10 days, and the OM3, whic h requires testing at 70 °C for two hours, are the two OM 
test conditions whic h come close in simulating the intended food contact conditions for these types of kitchenware 
but they are significantly more severe than the real life conditions which could foreseeably occur during actual use EN Offi cial Jour nal of the European Union L 288/8                                                                                                                                             3.9.2020   of such kitchen ware. Theref ore it is appropr iate to amend Table 3 of Annex V of the Regulation and the relevant text 
below that table to introduce overall migration conditions of 30 minute s at 40 °C designat ed as OM0 for the overall 
migration testing of plastic kitchenware mate rials and articles only at cold or ambient temperatures and for a shor t 
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 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 whic h require testing 
at 100 °C. A reflux alternative testing condition is not provid ed for the OM4 test condition which also requires 
testing at 100 °C. It is theref ore appropr iate to amend the OM4 entr y in Table 3 of Annex V of the Regulation to 
provid e for the reflux condition as an option when testing at 100 °C is technically difficult. 
(32) Migration testing using the whole equipment or appliance for food processing and/or food production is presently 
not allowed under the Regulation. However , when food processing equipment or appliances are made of multiple 
plastic parts, or contain plastic parts as well as other mater ials, it may be burdensome and in some cases impossible 
to verify compl iance of these plastic parts with the Regulation. It should theref ore be possible to verify compl iance 
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 instr uctions, instead of trying to 
establish the migration from each individual plastic part or mater ial used in the equipment or appliance. If such a 
migration test is done under the worst foreseeable use conditions in the food, or when appropr iate, in a food 
simulant, which can be achieved in accordance with the operating instr uctions, and the transfe r of constituents 
from the equipment or appliance as a whole does not exceed the specifi c migration limits, the plastic parts of the 
food processing equipment should be considered to compl y with the requirements of Article 11(1) of the 
Regulation if the plastic parts comply with the compo sitional provi sions set out in the Regulation. It is theref ore 
appropr iate to amend Annex V of the Regulation to introduce provisions that will allow for the migration testin g 
with the whole equipment or appliance for food processing and/or food production, instead of verifying the 
compl iance of each of its individual parts. 
(33) Applying the whole equipment or appliance in accordance with its operating instr uctions to prepare the food, or 
parts thereof may 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, 
reser voirs, capsules, and pads. Those parts would need to be tested also separately to ensure they are safe for those 
storag e conditions as well. 
(34) Migration testing of food processing and/or food producing equipment or appliance can only establish the 
compl iance of the equipment with the Regulation. However , in case a non-com pliant migration is obser ved when 
testing food processing and/or food producing equipment or appliances, it should be verified that this migration 
does not originate from mate rials not subject to the Regulation. Theref ore, it is appropr iate to require to establish 
whether the source of the non-com pliance is a plastic part of the equipment or appliance, or whether it is another 
mater ial not subject to the Regulation. The non-com pliance of the equipment with the Regulation should then only 
be established if that non-com pliance is due to a plastic part. 
(35) The first paragraph of Chapt er 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 refer red to in Table 3 of 
Annex V, when it is not technically feasible to perf orm one or more of the OM tests 1-6 with the simulant D2. The 
third sente nce of that paragraph erroneously make s reference to specifi c migration rather than to overall migration. 
It is theref ore necessar y to correct that senten ce. 
(36) The second paragraph of Chapt er 3.2 of Annex V of the Regulation 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 perf orm 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 sente nce, which could be erroneously 
interpreted in such a way that more than two OM tests should be conducted. It is theref ore appropr iate to clarify 
the paragraph by laying down that one test should be select ed and by refer ring to the higher overall migration 
obtained under the two testing conditions required in that test. EN Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                            L 288/9   (37) Regulation (EU) No 10/2011 should theref ore be amended and corrected according ly. 
(38) Plastic mater ials and articles compl ying with Regulation (EU) No 10/2011, as applicable before the date of the entr y 
into force of this Regulation, and whic h 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 stoc ks. Howe ver, this 
long period should not be used to develop new mate rials and articles whic h had not yet been placed on the mark et 
at the time of entr y into force of this Regulation, and are not yet compl iant with it. Business operat ors may not be 
able to fully anticipate the entr y into force of this Regulation when they would have been already planning to place 
such new mater ials on the market before the entr y into force of this Regulation. Theref ore it is appropr iate to allow 
such placing on the mark et of new mat erials and articles based on the old rules for six months after the entr y into 
force of this Regulation. 
(39) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Regulation (EU) No 10/2011 is amended as follows: 
(1) in Article 6(3), point (a) is replaced by the followi ng: 
‘(a) all salts of substances for whic h “yes” is indicated in column 2 in Table 1 of Annex II of author ised acids, phenols or 
alcohols, and subject to the restr ictions set out in column 3 and 4 of that table’ ; 
(2) Annex es I, II, IV and V are amended in accordance with the Annex to this Regulation. 
Article 2 
Plastic mater ials and articles compl ying with Regulation (EU) No 10/2011 as applicable before the entr y into force of this 
Regulation, and which were first placed on the mark et before 23 March 2021 may continue to be placed on the mark et 
until 23 September 2022 and remain on the mark et until the exhaustion of stoc ks. 
Article 3 
This Regulation shall enter into force on the twentieth day followi ng 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, 2 Sept ember 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 288/10                                                                                                                                           3.9.2020   ANNEX 
Annex es 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) entr y 236 on 1,3-phenylenediamine is replaced by the follo wing: 
‘236 23050 00001­
08-45-2 1,3-pheny le­
nediamine no yes no ND   (28)’   
(ii) entr y 398 on antimony trioxide is replaced by the following: 
‘398 35760 00013­
09-64-4 antimony tri­
oxide yes no no    (6)’   
(iii) the follo wing entr ies are inser ted in numer ical order: 
‘1075   Montmor il­
lonit e clay 
modified 
with hexade­
cyltr imethy­
lammonium 
bromide yes no no   Only to be used as additive 
at up to 4,0 % w/w in poly­
lactic acid plastics in­
tended for long-term sto­
rage of water at ambient 
temperature or below . 
Can form platelets in the 
nanof orm that are in one 
or two dimensions thin­
ner than 100 nm. Such 
platel ets shall be oriente d 
parallel to the polymer 
surface and shall be fully 
embedded in the polymer .  
1076  12279­
37-46-3 Phosphorous 
acid, triphe­
nyl ester , 
polymer with 
alpha-hy dro- 
omega -hy­
droxypoly 
[oxy(meth yl- 
1,2-ethane­
diyl)], 
C10-16 alkyl 
ester yes no no 0,05  Only to be used as an ad­
ditive at up to 0,2 % w/w in 
high impact polystyrene 
materials and articles in­
tended contact with food 
at room temperature and 
below , including hot-fi ll 
and/or heating up to 100 ° 
C for up to 2 hours. It shall 
not be used in contact 
with foods for whic h si­
mulant C and/or D1 is 
assigned in Annex III.  
1077   Titanium di­
oxide surface- 
treated with 
fluor ide- 
modified alu­
mina yes no no   Only to be used at up to 
25,0 % w/w , including in 
the nanof orm. 29’   EN Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                          L 288/11   (b) in point 3 of Table 3, the following entr ies are 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 
fluor ide are excee ded. Under contact conditions above 4 hours at 100 °C this excee dance can 
be high.’   
(2) Annex II is replaced in its entirety by the followi ng: 
‘ANNEX II 
Rest rictions on plastic mater ials and articles 
The followi ng restr ictions on plastic mater ials and articles apply: 
1. Plastic mater ials and articles shall not release the substances in Table 1 below in quantities exceed ing the specific 
migration limits expressed in mg/kg food or simulant 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 compo sitional requirements set out in Chapt er 
II. If Chapt er II does not provid e a basis for the author ised use of such a substance, that substance may only be 
present as an impurity subject to the restr ictions specified in Table 1. 
Table 1 
General list of mig ration limits for subst ances mig rating from plas tic mater ials and articles 
(1) (2) (3) (4) 
Name Salts allo wed in accordance 
with Article 6(3)(a) SML [mg/kg food or food 
simulant] Remark 
Aluminium yes 1  
Ammonium yes - (1) 
Antimon y no 0,04 (2) 
Arsenic no ND  
Barium yes 1  
Cadmium no ND (LOD 0,002)  
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) EN Offi cial Jour nal of the European Union L 288/12                                                                                                                                           3.9.2020   Lead no ND  
Lithium yes 0,6  
Magnesium yes - (1) 
Manga nese yes 0,6  
Mercur y no ND  
Nickel no 0,02  
Potassium yes - (1) 
Sodium yes - (1) 
Terbium yes 0,05 (4) 
Zinc yes 5  
ND: Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: 
specified 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 excee ded at very high temperature 
(3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. 
However if the operat or that placed the mater ial on the mark et can prove on the basis of pre-existing 
documentar y evidence that the presence of hexavalent chromium in the mater ial is excluded 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 specif ic 
migration limit of 0,05 mg/kg; and 
(b) analytical evidence using a well descr ibed methodology demonstrating that the lanthanide substance(s) 
used are present in dissociat ed ionic form in the food or the food simulant, forms part of the 
documentation referred to in Article 16.   
2. Primar y aromatic amines (“PAAs”) liste d in entr y 43 to Appendix 8 of Annex XVII to Regulation (EC) 
No 1907/2006 of the European Parliament and of the Council (*) and for whic h no migration limit is specified in 
Table 1 of Annex I shall not migrat e or shall not other wise be released from plastic mat erials and articles into food 
or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg 
food or food simulant applied to each individual primar y 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 whic h no specif ic 
migration limit is specif ied in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in 
accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.’ 
_____________ 
(*) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning 
the Registration, Evaluation, Author isation and Restr iction of Chemicals (REA CH), establishing a European 
Chemicals Agen cy, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and 
Commission Regulation (EC) No 1488/94 as well as Council 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 Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                          L 288/13   (3) in Annex IV, point 6 is replaced by the followi ng: 
‘(6) adequate information relative to the substances used or products of degradation thereof for which restr ictions 
and/or specific ations are set out in Annex I and II to the Regulation to allow the downs tream business operat ors 
to ensure compl iance with the Regulation. 
At interm ediate stages , this information shall include the identif ication and amount of substances in the 
intermediate mat erial, 
— that are subject to restr ictions in Annex II, or 
— for which genoto xicity has not been ruled out, and whic h originate from an intentional use during a 
manuf actur ing stage of that interm ediate mate rial and which could be present in an amount that foreseeably 
gives rise to a migration from the final mater ial excee ding 0,00015 mg/kg food or food simulant.’; 
(4) Annex V is amended as follows : 
(a) Chapt er 2 is amended as follo ws: 
(i) in the second paragraph of point 2.1.3, the following subparagraph is added: 
‘(iv) if the plastic mater ial or article intended to come into contact with food of whic h the compl iance 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 deter mining the specific migration into the food or 
food simulant produced or processed by the whole equipment or appliance, or the part thereof, as 
appropr iate, subject to the followi ng 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 operat ed in 
accordance with its operating instr uctions, and 
— the migration from parts used for storage such as from reser voirs, containers, 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 representative 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 mate rials 
present in the equipment or appliance shall be considered to compl y with Article 11(1). 
The testing of the parts used for storage or supply such as reser voirs, containers, capsules or pads shall be 
under conditions representative of their use, and shall include the foreseeable storag e conditions of the 
food in these parts. 
The suppor ting documentation refer red to in Article 16 shall clearly document the testing on the whole 
food processing and/or food producing equipment or appliance, or on parts thereof. It shall demonstrate 
that the testing was representative of its foreseeable use, and shall indicate for whic h substances migration 
testin g was carried out and provid e all testing results. The manufa cturer of individual plastic parts shall 
ensure the absence of migration for substances for whic h the Regulation specifies that their migration 
shall not be detectable at a specifi ed level of detection in accordance with Article 11(4). 
Comp liance 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 might be 
exceed ed under the foreseeable use of the supplied part or mate rial. 
When the result is not in compl iance with the Regulation it shall be deter mined whether the source of the 
non-com pliance is a plastic part subject to the Regulation or a part made from another mate rial not 
subject to the Regulation on the basis of documentar y evidence or analytical testing. Without prejudice 
to Article 3 of Regulation (EU) No 1935/2004, non-com pliance to the Regulation shall only be 
established if the migration originates from a plastic part.’; EN Offi cial Jour nal of the European Union L 288/14                                                                                                                                           3.9.2020   (ii) point 2.1.6, is replaced in its entirety by the following: 
‘2.1.6. Repeated use mater ials and articles 
If the mate rial or article is intended to come into repeated contact with foods, the migration test(s) shall 
be carried out three times on a sing le sample using another portion of food simulant on each occasion. 
The specifi c migration in the second test shall not excee d the level obser ved in the first test, and the 
specific migration in the third test shall not excee d the level obser ved in the second test. 
Com pliance 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 mater ial or article from the first to the 
third migration test. The stability of the mater ial shall be considered insuffi cient if migration is 
obser ved abov e the level of detection in any of the three migration tests, and increases from the first 
migration test to the third migration test. In case of insuff icient stability , compliance of the mater ial 
shall not be established even in case the specifi c migration limit is not excee ded 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 exce eded on the first test, no further test is necessar y. 
Irrespective of the above rules, a mate rial or article shall never be considered to compl y with this 
Regulation if in the first test a substance that is prohibited from migrating or from being released in 
detectable quantities under Article 11(4) is detected .’; 
(b) Chapt er 3 is amended as follo ws: 
(i) in point 3.1, Table 3 and the four paragraphs below Table 3 are replaced by the followi ng: 
‘Table 3 
Standardised conditions for testing the overall mig ration 
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 tem­
peratures and for a shor t duration (≤ 30 
minute s). 
OM1 10 d at 20 °C Any food contact at frozen and refrigera ted 
conditions 
OM2 10 d at 40 °C Any long-t erm storage at room temperature 
or below , including when packag ed 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) minute s. 
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, whic h are 
not follo wed by long-ter m room tempera­
ture or refrigerat ed storage. EN Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                          L 288/15   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 
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 alter­
natively 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 tempera­
ture excee ding 40 °C, and with foods for 
whic h point 4 of Annex III assigns simulants 
A, B, C or D1. 
OM7 2 h at 175 °C High temperature applications with fatty 
foods exceed ing the conditions of OM5. 
Test OM 7 covers also food contact conditions descr ibed for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst 
case conditions for fatty food simulants in contact with non-poly olefins. In case it is technically not feasib le to perf orm OM 
7 with food simulant D2 the test can be replaced as set out in paragraph 3.2. 
Test OM 6 covers also food contact conditions descr ibed for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst 
case conditions for food simulants A, B and C in contact with non-poly olefins. 
Test OM 5 covers also food contact conditions descr ibed for OM0, OM1, OM2, OM3, OM4. It represents the worst case 
conditions for all food simulants in contact with poly olefins. 
Test OM 2 covers also food contact conditions descr ibed for OM0, OM1 and OM3.’   
(ii) in point 3.2, the paragraphs before the table are replaced by the follo wing: 
‘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 exce ed 100 °C. The test that results in the highest 
overall migration shall be used to establish compl iance with the Regulation. 
In case it is technically not feasible to perf orm OM7 with food simulant D2, either test OM8 or test OM9 shall 
be selected as a replacement test by selecting the most appropr iate of these two tests on the basis of the 
intende d and the foreseeable use of the mat erial or article that is being tested. Subsequently , a migration test 
shall be done at each of the two test conditions specif ied for the selected test, using a new test sam ple for each 
test condition. The test condition that results in the higher overall migration shall be used to establish 
compl iance with the Regulation.’; 
(iii) point 3.3.2 is replaced in its entirety by the followi ng: 
‘3.3.2. Repeated use articles and mater ials 
The applicable overall migration test shall be carried out three times on a sing le sample using another 
portion of food simulant on each occasion. The migration shall be deter mined using an analytical 
method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the 
European Parliament and of the Council (*). 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. 
Complian ce with the overall migration limit shall be verified on the basis of the level of the overall 
migration found in the third test. EN Offi cial Jour nal of the European Union L 288/16                                                                                                                                           3.9.2020   If it is not technically feasible to test the same samp le three times, such as when testing in vege table oil, 
the overall migration test can be carried out by testing diffe rent samples for three different periods of 
time lasting one, two and three times the applicable contact test time. The diffe rence between the 
third and the second test results shall be considered to represent the overall migration. Com pliance 
shall be verified on the basis of this differ ence, which shall not exceed the overall migration limit. In 
addition, the differ ence between the second and the first test results shall be lower than the first test 
results and the differ ence between the third and the second test results shall be lower than the 
differ ence between the second and the first test results. 
By derog ation from the first paragraph, if, on the basis of scientific evidence, it is established that for 
the mater ial or article being tested the overall migration decreases in the second and third tests and if 
the overall migration limit is not exceed ed in the first test, the first test alone shall be suffi cient. 
_____________ 
(*) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities perf ormed 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 (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).’   EN Offi cial Jour nal of the European Union 3.9.2020                                                                                                                                          L 288/17