EN    EN EN 
SANCO/12642/2010 Rev. 1 (POOL/E6/2010/12642/12642R1-EN.doc) EN    EN  EUROPEAN COMMISSION 
Brussels, 
(2010) final 
Draft 
COMMISSION DIRECTIVE 
of 
amending Directive 2002/72/EC as regards th e restriction of use of Bisphenol A in 
plastic infant feeding bottles  
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION DIRECTIVE 
of 
amending Directive 2002/72/EC as regards th e restriction of use of Bisphenol A in 
plastic infant feeding bottles  
(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/EEC
1, and in particular Article 18 (3) 
thereof, 
After consulting the European Food Safety Authority, Whereas: (1) Commission Directive 2002/72/EC of 6 Augus t 2002 relating to plastic materials and 
articles intended to come into contact with foodstuffs
2 authorises the use of 2,2-bis(4-
hydroxyphenyl)propane, commonly known as Bis phenol A (hereinaft er "BPA"), as 
monomer for the manufacture of plastic materi als and articles intended to come into 
contact with foodstuffs in acco rdance with the opinions of the Scientific Committee on 
Food(hereinafter "SCF")3 and the European Food Safety Authority (hereinafter "the 
EFSA")4. 
(2) BPA is used as monomer in the manufactur e of polycarbonate pl astics. Polycarbonate 
plastics are used amongst others in the ma nufacture of infant feeding bottles. When 
heated under certain conditions small amounts of BPA can potentially leach out from 
food containers into foods and beverages and be ingested. 
                                                 
1 OJ L 338, 13.11.2004, p. 4. 
2 OJ L 220, 15.8.2002, p. 18. 
3 Opinion of the Scientific Committee on Food on Bisphenol A, expressed on 17 April 2002. 
SCF/CS/PM/3936 Final 3 May 2002. http://ec.europa.eu/food/fs/sc/scf/out128_en.pdf 
4 Opinion of the Scientific Panel on Food Additiv es, Flavourings, Processing Aids and Materials in 
Contact with Food on a request from the Commission related to 2,2-BIS(4-
HYDROXYPHENYL)PROPANE (Bisphenol A) Question number EFSA-Q-2005-100, Adopted on 
29 November 2006, The EFSA Journal (2006) 428, p. 1. and Toxicokinetics of Bisphenol A, Scientific Opinion of the Panel on Food additives, Flavourings , Processing aids and Materials in Contact with 
Food (AFC) (Question No EFSA-Q-2008-382) Adopted on 9 July 2008, The EFSA Journal (2008) 759, 
p. 1. EN 3   EN (3) On 29 March 2010 the Danish Governme nt informed the Commission and the 
Member States that it has decided to a pply the safeguard measures provided for in 
Article 18 of Regulation (EC) No 1935/2004 an d to temporarily ban the use of BPA 
for the manufacture of plastic materials in contact with food intended for children aged 
0-3.5 
(4) The Danish Government substantiated its safeguard measure with a risk assessment 
provided on 22 March 2010 by the National Food Institute at the Te chnical University 
of Denmark (hereinafter "DTU Food"). The risk assessment covers the evaluation of a 
comprehensive study carried out on animals e xposed to BPA in low doses monitoring 
the development of the nervous system and the behaviour in new- born rats. DTU Food 
has also evaluated whether the new data ch anges its previous evaluation of the toxic 
effects on the development of the nervous system and behaviour possibly caused by 
BPA. 
(5) In accordance with the procedure provided fo r in Article 18 of Regulation (EC) No 
1935/2004 on 30 March 2010 the Commission asked the EFSA to give its opinion on 
the grounds adduced by Denmark for concluding that the use of the material endangers 
human health, although it complies with  the relevant specific measures. 
(6) On 6 July 2010 the French Government informed the Commission and on 9 July 2010 
the Member States that it has decided to apply the safeguard meas ures provided for in 
Article 18 of Regulation (EC) No 1935/2004 an d to temporarily ban the manufacture, 
import, export and placing on the market of feeding bottles containing BPA6  
(7) The French Government substantiated its sa feguard measure with two opinions issued 
by the French Food Safety Authority (AFSSA) on 29 January 2010 and 7 June 2010 
and the report published on 3 June 2010 by the National Institute of Health and 
Medical Research (INSERM). 
(8) On 23 September 2010 the EFSA adopted the opinion of its Panel on food contact 
materials, enzymes, flavourings and processi ng aids (hereinafter "the Panel") on BPA 
responding to the Commission's request of  30 March 2010 as well as covering the 
evaluation of the specific neurobehavioural study evalua ted in the Danish risk 
assessment and the review and evaluation of  other recently published studies on BPA7. 
(9) In its opinion the Panel concludes that based on the comprehensive evaluation of 
recent human and animal toxicity data, no new study could be identified, which would 
call for a revision of the current tolerable da ily intake (hereinaft er "TDI") of 0.05 
mg/kg bodyweight per day. This TDI is based on the no adverse effect level of 5 mg/kg bodyweight per day from a multi-ge neration reproductive toxicity study in 
rats, and the application of an uncertainty factor of 100, which is considered as 
                                                
 
5 Bekendtgørelse om ændring af bekendtgørelse om materialer og genstande bestemt til kontakt med 
fødevarer, Lovtidende A, Nr.286, 27.3.2010. 
6 LOI n° 2010-729 du 30 juin 2010 tendant à suspendre la commercialisation de biberons produits à base 
de bisphénol A, JORF n°0150 du 1 juillet 2010, page 11857. 
7 Scientific Opinion on Bisphenol A: evaluation of a study investigating its neurodevelopmental toxicity, 
review of recent scientific literature on its toxi city and advice on the Danish risk assessment of 
Bisphenol A EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF) 
(Question Nos: EFSA-Q-2009-00864, EFSA-Q-2010-01023 and EFSA-Q-2010-00709) adopted on 
23 September 2010, EFSA Journal 2010; 8(9):1829. EN 4   EN conservative based on all information on BPA toxicokinetics. However, in a minority 
opinion one Member of the Panel concluded th at the effects observe d in certain studies 
raised uncertainties which may not be co vered by the current TDI which should 
therefore be considered temporary until more robust data becomes available in the areas of uncertainty. 
(10) The Panel noted that some animal studies  conducted on devel oping animals have 
suggested other BPA-related effects of possibl e toxicological relevance, in particular 
biochemical changes in brain, immune-modul atory effects and enha nced susceptibility 
to breast tumours. These studies have many shortcomings. The relevance of these findings in relation to human health cannot be assessed at present. In case any new 
relevant data becomes available in the fu ture, the Panel will reconsider its opinion. 
(11) Infant formula or breast milk is the only source of nutrition for infants up to the age of 
4 months, and it remains the major source of nutrition for some additional months. In its opinion of 2006 the EFSA concluded that  infants aged 3 and 6 months fed using 
polycarbonate infant feeding bottles have the highest exposure to BPA, though below 
the TDI. For this group of infants the leve l of exposure to BPA decreases once feeding 
from polycarbonate bottles is phased out and other sources of  nutrition become 
dominant. 
(12) Even if the infant has sufficient capacity to  eliminate BPA at worst case exposure the 
EFSA opinion pointed out that an infant's sy stem to eliminate BPA is not as developed 
as that of an adult and it only gradually reaches the adult capacity during the first 6 
months. 
(13) The potential toxicological effects may ha ve a higher impact in the developing 
organism. According to the opinions of  the Scientific Committee on Food of 1997
8 
and 19989 certain effects, in particular endocri ne and reproductive effects, effects on 
the immune system and the neurodevelopement are of particular re levance to infants. 
Reproductive effects and neurodevelopmenta l effects of BPA have been studied 
extensively in standard multigeneration toxi cological tests and in other studies, which 
took account of the developing organism and di d not reveal effects in doses below the 
TDI. However, studies which could not be  taken into account for setting the TDI due 
to many shortcomings showed BPA related e ffects of possible toxi cological relevance. 
These effects in particular those on the bi ochemical changes in the brain, which may 
affect neurodevelopment and on immune modulation are reflect ing the area of 
particular concern for infants highlighted  in the SCF opinions of 1997 and 1998. In 
addition, the EFSA opinion of 2010 mentions  the enhancing effect of an early 
exposure to BPA on tumour formation late r on in life when exposed to a carcinogen. 
Also in this case the sensitive stage is the developing organism. Thus the infant can be identified as the particular vulnerable part  of the population as regards those findings 
for which the relevance for human health could not yet be fully assessed. 
                                                
 
8 Opinion of the Scientific Committee for Food on: A maximum residue limit (MRL) of 0.01 mg/kg for 
pesticides in foods intended for infants and young children (expressed on the 19th September 1997). 
9 Further advice on the opinion of the Scientific Committee for Food expressed on the 19 September 
1997 on a Maximum Residue Limit (MRL) of 0.01 mg/kg for pesticides in foods intended for infants 
and young children (adopted by the SCF on 4 June 1998). EN 5   EN (14) According to the EFSA opinion of 2006 polyc arbonate feeding bottles is the main 
source of exposure to BPA for infants. Alte rnative materials to polycarbonate that do 
not contain BPA exist on the EU market, in particular glass and other plastic infant 
feeding bottles. These alternative materials have to comply with the strict safety 
requirements set out for food contact materi als. Therefore, it is not necessary to 
continue the use of BPA containing polycarbonate for infant feeding bottles. 
(15) Given that there exists a possible particular vulnerability of infants to potential effects 
of BPA although also the infant is deemed to  be able to eliminate BPA and even where 
the risk, notably to human health, has not ye t been fully demonstrated, it is appropriate 
to reduce their exposure to BPA as much as reasonably achievable, until further scientific data is available to clarify th e toxicological relevance of some observed 
effects of BPA, in particular as rega rds biochemical changes in brain, immune-
modulatory effects and enhanced su sceptibility to breast tumours. 
(16) The precautionary principle referred to in  Article 7 of Regula tion (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 f ood law, establishing the European Food 
Safety Authority and laying down pro cedures in matters of food safety
10 allows the 
Union to provisionally adopt m easures on the basis of ava ilable pertinent information, 
pending an additional assessment of risk and a review of the measure within a 
reasonable period of time. 
(17) Taking into account that there are uncertain ties in the present state of scientific 
research with regard to the harm fulness of BPA exposure to infants11 through 
polycarbonate infant feeding bottles  that would need to be clarified  the Commission is 
entitled to take a preventive measure regard ing the use of BPA in polycarbonate infant 
feeding bottles on the basis of the precautiona ry principle which is applicable in a 
situation in which there is scientific uncer tainty, even if where the risk, notably to 
human health, has not yet been fully demonstrated. 
(18) Thus, it is necessary and appropriate for the achievement of th e basic objective of 
ensuring a high level of human health pr otection to obviate sources of danger to 
physical and mental health that may be caused to infants by BPA exposure through 
feeding bottles. 
(19) The Commission evaluated the infant feeding bottle market and received an indication 
by the relevant producers that voluntary act ion by the industry for replacements on the 
market are ongoing and the economic impact of the proposed measure is limited. 
Therefore, all BPA containing infant feedin g bottles on the EU market should be 
replaced by the middle of 2011. 
(20) Until further scientific data are available to clarify the toxicological relevance of some 
observed effects of BPA, in particular as regards bioc hemical changes in brain, 
immune-modulatory effects and enhanced susceptibility to breast tumours, the use of 
BPA in the manufacture and placing on the market of polycarbonate infant feeding 
bottles should be temporarily banned. Directive 2002/72/EC should therefore be 
                                                 
10 OJ L 31, 1.2.2002, p. 1. 
11 As defined in Commission directive 2006/141/EC, OJ L 401, 30.12.2006, p. 1. EN 6   EN amended accordingly. The Authority has a mandate to monitor new studies to clarify 
these endpoints. 
(21) Following the evaluation of the technical and economic feasibility to implement the 
proposed measure it is concluded that the meas ure is no more restrictive of trade than 
is required to achieve the high level of  health protection chosen in the Union. 
(22) The measures provided for in this Directive are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 2002/72/EC is amended as follows: 
In Annex II, Section A, the text in column  4 under the reference number 13480 as regards the 
monomer 2,2-bis(4-hydroxyphenyl)propane is replaced by the following:  
"SML (T) = 0,6 mg/kg. Not to be used for the manufacture of polycarbonate infant(*) feeding 
bottles." 
(*) infant as defined in Directive 2006/141/EC, OJ L 401, 30.12.2006, p. 1. 
Article 2 
1. Member States shall adopt and publish, by [ 15 February 2011 ] at latest the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Co mmission the text of those provisions. 
When Member States adopt the provisions referred to in paragraph 1, they shall 
contain a reference to this Directive or be accompanied by such a reference on the 
occasion of their official publication. Me mber States shall determine how such 
reference is to be made. 
2. Member States shall apply the provisions re ferred to in paragraph 1 in such a way as 
to prohibit from [ 1 March 2011 ] the manufacture of and from [ 1 June 2011 ] the 
placing on the market and importation into th e Union of plastic materials and articles 
intended to come into contact with foods tuffs and which do not comply with this 
Directive. 
3. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on 1 February 2011. EN 7   EN Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President