COMMISSION REGUL ATION (EU) 2018/213 
of 12 Febr uary 2018 
on the use of bisphenol A in varnishes and coatings intended to come into cont act with food and 
amending Regulation (EU) No 10/2011 as regards the use of that subst ance in plast ic food contact 
mater ials 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d 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 
mate rials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), 
and in particular points (d), (e), (h), (i) and (j) of Article 5(1) thereof, 
Whereas: 
(1)  The substance 2,2-bis(4-hy droxyphenyl) propane (CA S 0000080-05-7), commonly kno wn as bisphenol A (BPA) is 
used in the manufacture of certain mate rials and articles intended to come into contact with food, such as 
poly carbonate plastic and epoxy resins used in varnishes and coatings. BPA can migrat e into food from the 
mate rial or article with which it is in contact, resulting in exposure to BPA for consumers of those foods. 
(2)  The use of BPA as a monomer in the production of plastic mater ials and articles is author ised by Commission 
Regulation (EU) No 10/2011 (2). The author isation is subject to a specific migration limit (SML) of 0,6 mg of BPA 
per kg of food (mg/kg) based on a previous evaluation by the Scientific Committ ee on Food (3). The European 
Food Safety Author ity (the Author ity) has reviewed scientific information and update d its opinion on BPA 
in 2006 (4), 2008 (5), 2010 (6) and 2011 (7). A prohibition is in place on its use in the manuf acture of poly car­
bonat e infant feeding bottles on the basis of the precautionar y principle. 
(3)  After the publication of its scientific advice on BPA in 2011, the Author ity noted that its exposure assessment 
whic h dated back to its 2006 opinion needed to be update d in light of new data and that the relevance of dietar y 
exposure in the context of other rout es of exposure should also be inve stigat ed. The Author ity decided to 
under take a full re-evaluation of BPA based on the most recent scientifi c evidence. In 2012, in accordance with 
Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (8), the 
Author ity asked its scientific Panel on Food Contact Mate rials, Enzymes, Flavourings and Processing Aids (CEF) to 
provid e a scientifi c opinion on the risks to public health relat ed to the presence of BPA in foodstuffs. 
(4)  The Author ity adop ted an opinion on 11 December 2014 (9), having reviewed the available data and scientifi c 
studies published from 2006 to 2012 as well as some studies available in 2013. In that opinion, the Author ity 
established changes in mean relative kidney weight in a two-g eneration study in mice as the critical endpoint and 
calculat ed a Benc hmark Dose (Lower Confi dence Limit) (BMDL10) of 8 960 µg/kg bw per day. It was able to apply 14.2.2018 L 41/6 Official Jour nal of the European Union EN     
(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)Opinion of the Scientific Committee on Food on Bisphenol A (SCF/CS/PM/3936 Final). 
(4)The EFSA Jour nal (2006) 428, 1. 
(5)The EFSA Jour nal (2008) 759, 1. 
(6)The EFSA Jour nal 2010;8(9):1829. 
(7)The EFSA Jour nal 2011;9(12):2475. 
(8)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safet y Authority and laying down procedures in matt ers of food safet y  
(OJ L 31, 1.2.2002, p. 1). 
(9)The EFSA Jour nal 2015;13(1):3978. new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans 
and established a human equivalent dose (HED) of 609 µg/kg bw per day. The HED was used as a reference point 
for establishing a health-based guidance value for BPA. 
(5)  To establish this health-based guidance value, the Auth ority applied an uncer tainty factor of 2,5 for inter -species 
diffe rences and 10 for intra-species diffe rences. It applied an additional factor of 6 to take into account 
uncer tainties surrounding potential health effects of BPA on the mammar y gland, reproductive, metabolic, 
neurobeha vioural and immune syste ms. As a result, an overall uncer tainty factor of 150 was applied to establish 
a new Tolerable Daily Intake (TDI) of 4 µg/kg bw per day. Howe ver, the Authority designate d the TDI as 
temporar y (t-TDI) pending the anticipated outcome of a long-t erm toxicity study on BPA in rodents being 
under taken by the National Toxicology Program/Food and Drug Administration (NTP/FD A) in the Unit ed State s 
of Amer ica (USA). 
(6)  The Auth ority noted that dietar y exposure to BPA is below the t-TDI and concluded that there is no health 
concer n at the estimat ed levels of exposure. In its opinion adop ted on 11 December 2014, the Author ity also 
estimat ed non-dietar y sources of exposure as well as those from the diet. Non-dietar y sources include exposure 
through air, ingestion of dust and uptak e through the skin as a result of contact with ther mal paper and 
cosmetics. The Panel concluded that the central estimat es for aggregat ed exposure to BPA through dietar y and 
non-dietar y sources for the highest exposed groups including infants, children and adolescents, are below the 
t-TDI and that the health concer n for BPA is low at the estimated levels of aggregat ed exposure. 
(7)  Followin g the opinion published by the Authority in 2014, the current SML for plastic mater ials and articles 
should be updated to take account of the new t-TDI. The setting of the SML uses a conven tional exposure 
assum ption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes 
from food contact mater ials. Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specifi c limits on 
the migration of certain constituents into or onto food should take due account of other possible sources of 
exposure to those constituents. The Author ity noted that exposure from non-dietar y sources of BPA may 
contr ibute a significant propor tion of overall exposure for some population groups and that in addition to these 
non-dietar y sources, non-canned meat and meat products were found to be a major contr ibutor to BPA exposure 
for several population groups. In such cases where sources other than food contact mat erials may contr ibut e 
significantly to the poten tial overall exposure of a substance, it is not appropr iate to allocat e the full TDI to food 
contact mate rials and a lowe r value should be used. 
(8)  Taking into account conventional assum ptions on the use of allocation factors for food contact mater ials, 
including that the overall exposure does not exceed the t-TDI and the uncer tainty factor of 150 in the derivation 
of the t-TDI, as well as the data in the Author ity's opinion on sources of BPA other than food contact mate rials, 
an allocation factor of 20 % is considered appropr iate when setting the SML. Theref ore, on the basis of the t-TDI, 
the allocation factor and the exposure assump tion, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be 
set for plastic mate rials and articles to ensure that exposure to BPA remains below the t-TDI and does not 
endange r human health. 
(9)  While the SML established, which take s into account the opinion, serves as a basis for the overall management of 
risks posed by BPA from food contact mate rials, there are still uncer tainties, whic h are identif ied in that opinion. 
With respect to two new studies on the developmental immunoto xicity of BPA, the Author ity stated in 2016 (1) 
that the new evidence presented by those studies adds to the indications of developmental immunot oxicity of 
BPA. Taking into account the extent of the scientifi c uncer tainties and the nature of the poten tial adverse effects, 
in particular developmental effects, further precautionar y steps should be taken as regards more vulnerable 
population groups, in particular infants and young children, where developmental effects could be irreversible 
and would last a life-ti me. 
(10)  The precautionar y principle refer red to in Article 7 of Regulation (EC) No 178/2002 author ises the adoptio n of 
provis ional measures on the basis of available pertinent information, pending results relat ed to continued 
uncer tainties, to an additional assessment of risk and a review of the measure within a reasonable period of time. 14.2.2018 L 41/7 Official Jour nal of the European Union EN     
(1)EFSA Jour nal 2016;14(10):4580. (11) The Commission is author ised to take preventive measures as regards the use of BPA on the basis of the precau ­
tionar y principle whic h is applicable in a situation in which there is scientific uncer tainty , even if the risk, 
notably to human health, has not yet been fully demonstrate d. In order to do so, BPA should not be used to 
manuf acture poly carbonate drinking cups or bottles which are intended for infants and young children as defined 
in Regulation (EU) No 609/2013 of the European Parliament and of the Council (1). 
(12)  In addition to its use in plastic food contact mate rials, BPA is used extensi vely in epoxy resins for varnishes and 
coatings, particularly for application on the interi or of food cans. While specific measures provided for in 
Article 5 of Regulation (EC) No 1935/2004 have been adopt ed as regards BPA in plastic mate rials and articles, 
such measures have not been adopt ed as rega rds BPA in varnishes and coatings at the Union level. Theref ore, in 
accordance with Article 6 of that Regulation, Member States have been able to maintain or adopt national 
provis ions on BPA in varnishes and coatings provided those measures compl y with the rules laid down in the 
Treaties. 
(13)  In light of the introduction by Member States of diverg ent national measures applicable to BPA in food contact 
mate rials and the resulting technical and practical burdens repor ted by industr y, and having regard to the 
contr ibution to dietar y exposure of BPA from canned food identif ied in the Author ity's opinion of 2014 and the 
exte nsive use of BPA in epoxy resins for varnishes and coatings applied to food cans, it is also appropr iate to 
establish restr ictions for BPA used in varnishes and coatings. 
(14)  The same assump tion concer ning exposure to BPA from plastic mate rials and articles applies to varnishes and 
coatings. In order to ensure the effective functioning of the intern al mark et and to ensure a high level of 
prot ection for human health, the SML established for BPA from plastic mater ials and articles should also apply to 
varnishes and coatings applied to mate rials and articles, where that varnish or coating has been produced using 
BPA. As BPA may be used in food packag ing containing foods for infants and young children, BPA should not 
migrat e from varnishes and coatings applied to mater ials or articles specifi cally intended to come into contact 
with food intended for infants and young children as referred to in Regulation (EU) No 609/2013, namely infant 
formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed 
to satisfy the nutr itional requirements of infants and young children or milk -based drinks and similar products 
specifical ly intende d for young children. 
(15)  In conjunction with the establishment of restr ictions for varnishes and coatings, it is also necessar y to define 
rules for verification of compl iance with the restr ictions. In particular , rules for migration testing and rules for 
expression of migration testin g results should be established. Theref ore it is appropr iate to establish such rules for 
checking compl iance with the restr ictions for varnishes and coatings applied to mat erials and articles where those 
varnishes or coatings have been produced using BPA. 
(16)  Regulation (EU) No 10/2011 establishes a compre hensive framewor k for verifying compl iance of plastic food 
contact mate rials with defined restr ictions, including rules on the expression of migration test results. As the 
varnishes and coatings applied to mate rials and articles do not have specific charact eristics that would require the 
establishment of differ ent or more specifi c provisions, it is appropr iate to exte nd the application of the rules laid 
down in Regulation (EU) No 10/2011 to the verification of compl iance of varnishes and coatings applied to 
mate rials and articles with the established restr ictions. 
(17)  Article 16(1) of Regulation (EC) No 1935/2004 provides that mate rials and articles covered by specific measures 
be accompanied by a written declaration of compl iance stating that they comply with the rules applicable to 
them. On production of the varnished or coated mater ial or article, the responsible business operator should 
document compl iance with the applicable rules in a declaration of compliance which is made available to their 
custome rs. In order to ensure that the declaration provid es suffi cient information to enable verification of 
compl iance, it is appropr iate to specify the information that must be included in the declaration. In addition, 
compet ent author ities should be able to verify compl iance with the applicable rules. Business operators should 
theref ore be required to make available for the compet ent author ities appropr iate suppor ting documentation, 
substantiating the declaration of compl iance. 14.2.2018 L 41/8 Official Jour nal of the European Union EN     
(1)Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and 
of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). (18)  In order to ensure that the business operators have suffi cient time to adjust their manufactur ing processes to 
compl y with the restr ictions and to reduce the administrative and financial burden that such adjustment may 
entail, it is appropr iate to defer the application of this Regulation and to permit mater ials and articles whic h have 
been lawfully placed on the mark et before the date of application of this Regulation to remain on the mark et 
until the exhaustion of stoc ks. 
(19)  Regulation (EU) No 10/2011 should theref ore be amended according ly. 
(20)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
For the purposes of this Regulation, the followi ng definitions shall apply:  
(1) ‘specif ic migration limit ’ (SML) means the maximum permitted amount of a given substance released from a mat erial 
or article into food or food simulants;  
(2) ‘materi als and articles’ means any mater ials or articles whic h fall within one of the cate gories laid down in 
Article 1(2) of Regulation (EC) No 1935/2004;  
(3) ‘varnishes’ or ‘coatings’ means mat erials or articles compo sed of one or more non-self-suppor ting layer or layers 
manufactured using 2,2-bis(4-hy droxyphenyl)propane (‘BPA’), applied on a mater ial or article in order to impart 
special proper ties on it or to improve its technical perf ormance. 
Article 2 
1. The migration into or onto food of 2,2-bis(4-hydro xyphen yl)propane (‘BPA’) (CA S No 0000080-05-7) from 
varnishes or coatings applied to mater ials and articles shall not exceed a specific migration limit of 0,05 mg of BPA 
per kg of food (mg/kg). 
2. By derogat ion from paragraph 1, no migration of BPA shall be permitted from varnishes or coatings applied to 
mate rials and articles specifi cally intended to come into contact with infant formula, follow-on formula, processed 
cereal-based food, baby food, food for special medical purposes developed to satisfy the nutr itional requirements of 
infants and young children or milk -based drinks and similar products specifically intended for young children, as 
referred to in Regulation (EU) No 609/2013. 
Article 3 
1. In order to verify compl iance with Article 2 of this Regulation, rules laid down in Article 11(4), in paragraphs 1, 
2, 3, 6 and 7 of Article 18, in Annex III and in Chapt ers 1, 2 and 4 of Annex V to Regulation (EU) No 10/2011 shall 
apply . 
2. Test results obtained as part of the verification procedure refer red to in paragraph 1 shall be expressed in 
accordance with the rules laid down in paragraphs 1 to 3 of Article 17 of Regulation (EU) No 10/2011. 
Article 4 
1. In accordance with Article 16(1) of Regulation (EC) No 1935/2004, business operat ors shall ensure that varnished 
or coated mate rials and articles are accompanied by a written declaration of compl iance containing the information laid 
down in Annex I to this Regulation. The declaration shall be available at all stages of manufact ure, processing and 
distr ibution other than the retail stage. 
2. The written declaration shall permit an easy identif ication of the varnished or coated mater ials and articles to 
whic h it applies. It shall be renewed to reflect any chang es in migration levels from the varnish or coating that has been 
applied to mater ials and articles. 14.2.2018 L 41/9 Official Jour nal of the European Union EN     3. Business operat ors shall, upon request of a national compet ent author ity, mak e available appropr iate suppor ting 
documentation to demonstrate compl iance with the written declaration refer red to in paragraph 1. Such suppor ting 
documentation shall be provi ded without dela y and in any event not later than 10 days followi ng receip t of the request. 
The documentation shall contain the conditions and results of the testing, calculations, including modelling, other 
analysis and evidence on the safety or reasoning demonstrating compl iance. 
Article 5 
Annex I to Regulation (EU) No 10/2011 is amended in accordance with Annex II to this Regulation. 
Article 6 
Varnished or coated mate rials and articles and plastic mat erials and articles that were lawfully placed on the mark et 
before 6 Sept ember 2018 may remain on the mark et until exhaustion of stocks. 
Article 7 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 6 Sept ember 2018. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 12 Febr uary 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  14.2.2018 L 41/10 Official Jour nal of the European Union EN     ANNEX I 
The written declaration referred to in Article 4 shall contain the follo wing information:  
(1) the identity and address of the business operator issuing the declaration of compl iance;  
(2) the identity and address of the business operator whic h manuf actures or impor ts the coated mater ial or article;  
(3) the identity of the varnished or coated mater ial or article;  
(4) the date of the declaration;  
(5) conf irmation that the varnish or coating applied to the mate rial or article meets the restr ictions laid down in 
Article 2 of this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) 
No 1935/2004;  
(6) specif ications on the use of the coated mater ial or article, such as: 
(a)  the type or types of food with which it is intended to be put into contact ; 
(b)  the time and temperature of treatment and storag e in contact with food; 
(c)  the highest food contact surface area to volume ratio for whic h compl iance has been verified in accordance with 
Articles 17 and 18 of Regulation (EU) No 10/2011 or equivalent information.  14.2.2018 L 41/11 Official Jour nal of the European Union EN     ANNEX II 
In Table 1 of Annex I to Regulation (EU) No 10/2011, the entr y concer ning substance No 151 is replaced by the followi ng: 
‘151 13480 0000080-05-7 2,2-bis(4-hydro xyphen yl) 
propane no yes no 0,05  Not to be used for the manufact ure 
of poly carbonate infant (1) feeding 
bottles (2). 
Not to be used for the manufact ure 
of poly carbonate drinking cups or 
bottles which, due to their spill proof 
charact eristics, are intended for in­
fants (3) and young children (4).  13607 
(1)  Infant as defin ed in Article 2(2)(a) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food inten ded for infants and young children, food for special medical 
purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of 
the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). 
(2)  This restr iction is applicable from 1 May 2011 as regards the manufact ure and from 1 June 2011 as regar ds the placing on the market and impo rtation into the Union. 
(3)  Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013 
(4)  Young children as defin ed in Article 2(2)(b) of Regulation (EU) No 609/2013.’   14.2.2018 L 41/12 Official Jour nal of the European Union EN