EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11378/2015 Rev. 1 CIS 
(POOL/E2/2015/11378/11378R1 -EN 
CIS.doc)  
[…](2016) 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)   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 Un ion, 
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 particular points (e) , (i) and ( j) 
of Article 5(1) thereof,  
Whereas:  
(1) The substance  2,2-bis(4 -hydroxyphenyl)propane  (CAS 0000080 -05-7), more 
commonly known as bisphenol A (hereinafter '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. Small 
quantities of BPA can migrate into the food from the material or article with which it 
is in contact, resulting in some 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 , as a result of some uncertainty having been expressed in the 
opinion issued by the Authority in 2010. 
(3) After the publication of its scientific advice on BPA  in 2011 , the Authority noted that 
its exposure assessment which dated back 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 most 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 –75. 
5 The EFSA Journal (2008) 759, 1–10. 
6 The EFSA Journal 2010,  8(9):1829 . 
7 The EFSA Journal 2011;  9(12):2475 . EN 3   EN accordance with Art icle 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 opinion  on 11 December 20149, having review ed all of the 
available data and scientific st udies published since 2006  and having used refined 
methodologies . The Authority established changes in mean relative kidney weight in a 
two-generation study 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 
apply 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, 
neurobehavioural 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. The Authority designated  the TDI as temporary (t -TDI) pending the outcome of a 
long-term toxicity study o n BPA in rodents , currently being undertaken by the 
National Toxicology Program/  Food and Drug Administration in the United States of 
America . 
(6) The Authority conclude d that die tary exposure to BPA for the highest exposed groups, 
which include infants , children and ad olescents , is below the t -TDI, indicating that 
there is no health concern at the estimated levels of exposure. Those conclusions also 
apply to  prenatally exposed chi ldren  and to the elderly.  
(7) 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 sk in 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 exposed 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 exposure.  
(8) The Authority noted uncertainty in the exposure estimates for the non -dietary sources  
of BPA , which  may contribute a significant proportion of overall expos ure for some 
population groups.  In addition to the non -dietary sources of exposure  to BPA , non -
canned meat and meat products were found  to be a major contributor to BPA exposure 
for several population groups.  
(9) Following the new evaluation by the Authority,  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 exposur e comes from food contact 
                                                 
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 o f 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 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 constitu ents. 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 .  
(10) 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 the exposure ass umption , an SML of 0,05 mg of 
BPA per kg of food ( mg/kg ) should be set for plastic materials and articles  to fully 
ensure that exposure to BPA remains below the t -TDI and does not endanger human 
health .  
(11) In addition to its use in plastic food contact mater ials, BPA is used extensively in 
epoxy resins for varnishes and coatings, particularly for application on 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  varnishes and coatings at the Union level. Therefore, 
in accordance with Article 6 of th at Regulation, Member States have been able to 
maintain or adopt national provisions on BPA in varnishes and coatings provided 
those measures comply with the rules laid down in the Treat ies. 
(12) In light of the introduction by Member States of divergent national measures 
applicable to BPA  in food contact materials  and the resulting technical and practical 
burdens rep orted by industry,  and having regard to the  contribution to dietary exposure 
of BPA from  canned food  identified in the Authority's opinion and the extensive use of 
BPA in epoxy resins for varnishes and coatings applied to food cans , it is a lso 
appropriate to establish an  SML for BPA  used in  varnishes and coatings .  
(13) The same assumption concerning exposure to 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 . 
(14) In conjunction with the establishment of an SML  for varnishes and coatings , it is also 
necessary to define rules for verification of compliance with that SML. In particular, 
rules for migration testing and rules for expression of migration testing results sho uld 
be established . Therefore it is appropriate to establish such rules for checking 
compliance with the SML for varnishe s and coatings applied to  materials and articles 
where th ose varnish es or coating s have been produced using BPA .  
(15) Regulation (EU) No 10 /2011  establishes a comprehensive framework for verifying 
compliance of plastic food contact materials with defined SMLs, including rules on 
the expression of migration test results. As the varnishes and coatings applied to 
materials and articles do not ha ve specific characteristics that would require the 
establishment of different or more specific provisions, it is appropriate to extend the 
application of the rules laid down in Regulation (EU) No 10/2011  to the verification of 
compliance of varnishes and c oatings with  the established SMLs . EN 5   EN (16) Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles 
covered by specific measures be accompanied by a written declaration of compliance  
stating that they comply  with the rules applicable to t hem. On production of the 
varnished or coated material or article, the responsible business operator  should 
document 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 .  
(17) In order to provide business operato rs with sufficient opportunity to adjust their 
manufacturing processes in order to comply with the established  SML and to reduce 
the administrative and financial burden that such adjustment may entail, it is 
appropriate to permit materials and articles whi ch 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.  
(18) Regulation (EU) No 10/2011 should therefore be amended accordingly.  
(19) The measures provided for in this Regul ation 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 ; 
(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 p erformance . 
Article 2 
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).  
Article 3 
1. In order to verify compliance  with the specific migration limit established  in Article 
2 of this Regulation , the rules laid down in , Article 18(1), (2), (3), (6) and (7) , Annex 
III and 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 the rules laid down in Article 17 (1) to (3) of 
Regulation (EU) No 10/2011 . EN 6   EN 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 
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 docu mentation to demonstrate compliance  with the 
written declaration  referred to in paragraph 1 . That documentation shall contain the 
conditions and results of the testing, calculations, including modelling, other analysis 
and evidence on the safety or reasoni ng 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