EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10578/2017 Rev. 2 CIS 
(POOL/E2/2017/10578/10578R2 -EN 
CIS.doc)  
[…](2017) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
on the use of bisphenol A in varnishes and coatings intended to come into contact with 
food and amending Regulation (EU) No 10/2011 as regards the use of that substance in 
plastic food contact materials  
(Text with EEA relevance)   
Ref. Ares(2017)4140854 - 23/08/2017 
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
on the use of bisphenol A in varnishes and coatings intended to come into contact with 
food and amending Regulation (EU) No 10/2011 as regards the use of that substance in 
plastic food contact materials  
(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 materials and articles intended to come into contact with food 
and repealing Directives 80/590/EEC and 89/109/EEC1, and in par ticular points (d), (e), (h), 
(i) and ( j) of Article 5(1) thereof,  
Whereas:  
(1) The substance  2,2-bis(4 -hydroxyphenyl)propane  (CAS 0000080 -05-7), commonly 
known as bisphenol A ( BPA ) is used in the manufacture of certain  materials and 
articles intended to come into contact with food , such as polycarbonate plastic and 
epoxy resins used in varnishes and coatings. BPA can migrate into food from the 
material 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 materials and articles  is 
authorised by Commission Regulation (EU) No 10/20112. The authorisation is subject 
to a specific migration l imit (SML) of 0 .6 mg of BPA per kg  of food ( mg/kg ) based on 
a previous evaluation by the Scientific Committee on Food3. The European Food 
Safety Authority (the Authority)  has reviewed scientific information and updated its 
opinion on BPA in 20064, 20085, 20106 and 20117. A prohibition  is in place on its use 
in the manufacture of polycarbonate infant feeding bottles  on the basis of the 
precautionary principle .  
(3) After the publication of its scientific advice on BPA  in 2011 , the Authority noted that 
its exposure assessment which dated bac k to its 2006 opinion needed to be updated in 
light of new data  and that the relevance of dietary exposure in the context of other 
routes of exposure should also be investigated. The Authority decided  to undertake a 
full re -evaluation of BPA based on the m ost recent scientific evidence.  In 2012, in 
                                                 
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 Opinion of the Scientific Committee on Food on Bisphenol A (SCF/CS/PM/3936 Final ).  
4 The EFSA Journal (2006 ) 428, 1 . 
5 The EFSA Journal (2008) 759, 1. 
6 The EFSA Journal 2010 ;8(9):1829 . 
7 The EFSA Journal 2011;9(12):2475 .  
EN 3   EN accordance with Article 29(1) (b) of Regulation  (EC) No  178/2002  of the European 
Parliament and of the Council8, the Authority asked its scientific Panel on Food 
Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a 
scientific opinion on the risks to public health related to the presence of BPA in 
foodstuffs.  
(4) The Authority adopted an opinio n on 11 December 20149, having reviewed the 
available data and scientific studies published from  2006  to 2012  as well as some 
studies available in 2013 . In th at opinion, t he Authority established changes in mean 
relative kidney weight in a t wo-generation s tudy in mice as the  critical endpoint and 
calculated a Benchmark Dose (Lower Confidence Limit)  (BMDL 10) of 8960 µg/kg bw 
per day . It was able to a pply 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 Authority applied an uncertainty 
factor of 2. 5 for inter -species differences and  10 for intra -species differences . It 
applied  an additional factor of 6 to take into account u ncertainties surrounding 
potential health effects of BPA on the mammary gland, reproductive, metabolic, 
neurobehavi oural and immune systems . As a result, a n overall uncertainty factor of 
150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 µg/kg bw per 
day. However, t he Authority  designated the TDI as temporary (t -TDI) pending  the 
anticipated  outcome of a long -term toxicity study o n BPA in rodents being undertaken 
by the National Toxicology Program/  Food and Drug Administration (NTP/ FDA) in 
the United States of America  (USA ). 
(6) The Authority noted that dietary exposure to BPA is below the t -TDI and conclud ed 
that there is no health concern at the estimated levels of exposure. In its opinion 
adopted on  11 December 2014 the Authority  also estimated  non-dietary sources of 
exposure as well as those from the diet . Non-dietary sources include exposure  through  
air, ingestion of dust and uptake through the skin as a result of contact with thermal 
paper and cosmetics . The Panel concluded that the central estimates for aggregated 
exposure to BPA through dietary and non -dietary sources for the highest expos ed 
groups including infants, children and adolescents, are below the t -TDI and that the 
health concern for BPA is low at the estimated levels of aggregated  exposure.  
(7) Following the opinion published  by the Authority  in 2014 , the current SML for plastic 
materials and articles  should be updated to take account of the new t -TDI. The setting 
of the SML uses a conventional exposure assumption that 1 kg of food is consumed 
daily by a person of 60 kg body weight  and that all exposure comes from food contact 
materials . Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific 
limits on the migration of certain constituents into or on to food should take due 
account of other possible sources of exposure to those constituents.  The Authority 
noted tha t exposure from non -dietary sources of BPA may contribute a significant 
proportion of overall exposure for some population groups and that in addition to these 
non-dietary sources, non -canned meat and meat products were found to be a major 
                                                 
8 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ). 
9 The EFSA Journal 2015;13(1):3978.   
EN 4   EN contributor to B PA exposure for several population groups. In such cases where 
sources other than food contact materials may contribute sign ificant ly to the potential 
overall exposure of a substance, it is not appropriate to allocate the full TDI to food 
contact materials  and a lower value should be used .  
(8) Taking into account conventional assumptions on the use of allocation factors for food 
contact materials, including that the overall exposure does not exceed the t -TDI and 
the uncertainty factor of 150 in the derivation of the t -TDI,  as well as the data in the 
Authority's opinion on sources of BPA other than food contact materials, an allocation 
factor of 20% is considered appropriate when  setting the SML.  Therefore, on the basis 
of the t-TDI, the allocation factor and th e exposure assumption , an SML of 0,05 mg of 
BPA per kg of food ( mg/kg ) should be set for plastic materials and articles  to ensure 
that exposure to BPA remains below the t -TDI and does not endanger human health . 
(9) While the SML established , which takes into account the  opinion , serve s as a basis for 
the overall management of risks  posed by  BPA from food contact materials , there are  
still uncertainties , which are identified  in that opinion . With respect to two new studies  
on the developmental immunotoxic ity of BPA, the Authority stated in  201610 that the 
new evidence presented by th ose studies adds to the indications of developmental 
immunotoxicity of BPA.  Taking into account the extent of the scientific uncerta inties 
and the nature of the potential advers e effects, in particular developmental effects , 
further precautionary 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 -time.  
(10) The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 
authorises the adopt ion of provisional  measures on the basis of available pertinent 
information, pending results related to continued uncertainties, to an additional 
assessment of risk and a review of the measure within a reasonable period of time.  
(11) The Commission is authorised to take preventive me asure s as regard s the use of BPA  
on the basis of the precautionary principle which is applicable in a situation in which 
there is scientific uncertainty, even if the risk, notably to human health, has not yet 
been fully demonstrated.  In order to do so, BPA should not migrate from plastic 
materials and articles  specifically intended to come into contact with  food intended for 
infants and young children as referred to  in Regulation (EU) No 609/2013 of the 
European Parliament and of the Council11, namely infant formula , follow -on formula , 
processed cereal -based food , baby food or food for special medical purposes 
developed to satis fy the nutritional requirements of infants and young children . 
(12) In addition to its use in plastic food contact materials, BPA is used extensively in 
epoxy resins for varnishes and coatings, particularly for application on the interior of 
food cans. While  specific measures provided for in Article 5 of Regulation (EC) No 
1935/2004 have been adopted as regards  BPA in plastic materials and articles , such 
measures have not been adopted as regards  BPA in varnishes and coatings at the 
Union level. Therefore, in accordance with Article 6 of th at Regulation, Member 
                                                 
10 EFSA Journal 2016;14(10):4580 . 
11 Regulation (EU) No 609/2013 of the European Par liament 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/E C, 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 ).  
EN 5   EN States have been able to maintain or adopt national provisions on BPA in varnishes 
and coatings provided th ose measures comply with the rules laid down in the Treat ies. 
(13) In light of the introduction by Me mber States of divergent national measures 
applicable to BPA  in food contact materials  and the resulting technical and practical 
burdens reported by industry,  and having regard to the  contribution to dietary exposure 
of BPA from  canned food  identified in t he Authority's opinion of 2014 and the 
extensive use of BPA in epoxy resins for varnishes and coatings applied to food cans , 
it is a lso appropriate to establish restrictions  for BPA  used in  varnishes and coatings .  
(14) The same assumption concerning exposure t o BPA from plastic materials and articles 
applies to varnishes and coatings.  In order to ensure the effective functioning of the 
internal market and to ensure a  high level of protection for human health, the SML 
established for BPA from plastic materials and articles  should also apply to varnishe s 
and coatings applied to  materials and articles , where that varnish or coating has been 
produced using BPA . Similarly, BPA should not migrate from varnishes and coatings 
applied to  materials or articles specifical ly intended to come into contact with food 
intended for infants and young children . 
(15) In conjunction with the establishment of restrictions  for varnishes and coatings , it is 
also necessary to define rules for verification of compliance with the restriction s. In 
particular, rules for migration testing and rules for expression of migration testing 
results should be established . Therefore it is appropriate to establish such rules for 
checking compliance with the restriction s for varnishe s and coatings applied to  
materials and articles where th ose varnish es or coating s have been produced using 
BPA .  
(16) Regulation (EU) No 10/2011  establishes a comprehensive framework for verifying 
compliance of plastic food contact materials with defined restrictions , including rules 
on the expression of migration test results. As the varnishes and coatings applied to 
materials and articles do not have specific characteristics that would require the 
establishment of different or more specific provisions, it is appropr iate to extend the 
application of the rules laid down in Regulation (EU) No 10/2011  to the verification of 
compliance of varnishes and coatings with  the established restriction s. 
(17) Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and art icles 
covered by specific measures be accompanied by a written declaration of compliance  
stating that they comply  with the rules applicable to them. On production of the 
varnished or coated material or article, the responsible business operator  should 
docu ment compliance with the applicable rules in a declaration of compliance which is 
made available to their customers . In order to ensure that the declaration provides 
sufficient information to enable verification of compliance, it is appropriate to specify 
the information  that must be included in the declaration . In addition, competent 
authorities should be able to verify compliance with the applicable rules . Business 
operators should therefore be required to make  available for the competent authorities 
appropriate supporting documentation , substantiating the declaration of compliance .  
(18) In order to ensure that the  business operators have  sufficient time to adjust their 
manufacturing processes to comply with th e restriction s and to reduce the 
administrative and financial burden that such adjustment may entail, it is appropriate 
to defer the application of this Regulation and to permit materials and articles which 
have been lawfully placed on the market before  the date of application of this 
Regulation  to remain on the market until the exhaustion of stocks.   
EN 6   EN (19) Regulation (EU) No 10/2011 should therefore be amended accordingly.  
(20) 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  
For the purpose s of this Regulation, the following definitions shall apply:  
(1) 'specific migration limit' (SML) means the maximum permitted amount of a given 
substance released from a material or art icle into food  or food simulants ; 
(2) 'materials and articles' means any materials or articles which fall within one of the 
categories laid down in Article 1(2) of Regulation (EC) No 1935/2004;  
(3) 'varnish es' or 'coating s' means one or more non-self-supporting layer or layers 
composed of substances including 2,2-bis(4 -hydroxyphenyl)propane ('BPA') applied 
on a material or article  in order to impart special properties  on it  or to improve its 
technical performance . 
Article 2 
1. The migration into or onto food of 2,2 -bis(4 -hydroxyphenyl)propane ('BPA') (CAS 
No 0000080 -05-7) from varnish es or coating s applied to materials and articles  shall 
not exceed a specific migration limit of 0,05 mg of BPA per kg of food (mg/kg).  
2. By derogation from paragraph 1,  no migration of BPA shall be permitted from 
varnishes or coatings applied to  materials and  articles specifically intended to come 
into contact with  infant formula, follow -on formula, processed cereal -based food, 
baby food or food for special medical purposes developed to satisfy the nutritional 
requirements of infants and young children , as referred to in Regulation (EU) No 
609/2013 .  
Article 3 
1. In order to verify compliance  with A rticle 2  of this Regulation , rules laid down in  
Article 11(4), in paragr aphs 1, 2, 3, 6 and 7 of Article 18 in Annex III and in 
Chapter s 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 referred to in paragraph 1 
shall be expressed in accordance with t he 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 
operators shall ensure that varnished or coated materials and articles are 
accompanied by  a written declaration  of compliance containing  the information laid 
down in Annex I to th is Regulation . The declaration  shall be available at  all stages of 
manufacture, processing and distribution  other than the retail stage.  
2. The written declaration shall permit an easy identification of the varnished or coated 
materials and article s to which it applies . It shall be renewed to reflect any changes in  
EN 7   EN migration levels from the varnish or coating  that has been applied to materials and  
article s.  
3. Business operators shall, upon request of a national competent authority, make 
available a ppropriate supporting documentation to demonstrate compliance  with the 
written declaration  referred to in paragraph 1 . Such supporting documentation shall 
be provided without delay and in any event not later than 10 days following receipt 
of the request. The documentation shall contain the conditions and results of the 
testing, calculations, including modelling, other anal ysis and evidence on the safety 
or reasoning demonstrating compliance.   
Article 5 
Annex I to Regulation (EU) No 10/2011 is amended in accordance with Annex  II to this 
Regulation .  
Article 6  
Varnished or c oated materials and articles and plastic materials and articles that were lawfully 
placed on the market before [enter the date of application of this Regulation as referred to in 
Article 7 ] may remain on the market until exhaustion of stocks.  
Article  7 
This Regulation shall enter into  force on the  twentieth  day following that of its publication in 
the Official Journal of the European Union .  
It shall apply from [ 6 months after entry into force of this Regulation ]. 
This Regulation shall be binding in its entirety and directly applicable  in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER