EN    EN  EUROPEAN COMMISSION 
Brussels,  
C(2010) final 
Draft 
COMMISSION DIRECTIVE ../…/EU 
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 ../…/EU 
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 materi als and articles intended to co me into contact with food 
and repealing Directives 80/590/EEC and 89/109/EEC
1, and in particul ar 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 (hereinafter "BPA"), as 
monomer for the manufacture of plastic materi als and articles intended to come into 
contact with foodstuffs in accordance 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 plas tics. 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 Government informed the Commission and the 
Member States that it has decided to appl y 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 Technical 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 a nd the behaviour in ne w-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 aske d the EFSA to give its opinion on 
the grounds adduced by Denmark for conc luding 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 measures 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 th e 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 BPA
7. 
(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 daily intake (hereina fter "TDI") of 0.05 
mg/kg bodyweight per day. This TDI is base d on the no adverse effect level of 5 
mg/kg bodyweight per day from a multi-gener ation 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 toxicity 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 conclude d that the effects observed in certain 
studies raised uncertainties which may not  be covered by the current TDI which 
should therefore be considered temporary unt il more robust data becomes available in 
the areas of uncertainty. 
(10) The Panel noted that some animal studi es conducted on developing animals have 
suggested other BPA-related effects of possibl e toxicological relevance, in particular 
biochemical changes in brain, immune-modulat ory effects and enhanced 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 s ource 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 wo rst 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 re aches the adult capacity during the first 6 
months. 
(13) The potential toxicological effects may have 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 e ffects, 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 toxicological relevance. 
These effects in particular those on the bi ochemical changes in the brain, which may 
affect neurodevelopment and on immune modulation are reflecting 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 pol ycarbonate 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, ha s not yet 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 the toxicological relevance of some observed effects of BPA, in particular as regards biochemical changes in brain, 
immune-modulatory effects and enhanced  susceptibility 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 th e Council of 28 January 2002 laying down the 
general principles and requirements of food law, establishing the European Food 
Safety Authority and laying down pro cedures in matters of food safety
10 allows the 
Union to provisionally adopt measures on the basis of available 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 regarding 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 a ppropriate for the achievement  of the basic objective of 
ensuring a high level of hu man health protection to obv iate 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 biochemical  changes in brain, 
immune-modulatory effects and enhanced susc eptibility 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 a nd economic feasibility to implement the 
proposed measure it is concluded that the meas ure is no more restri ctive of trade than 
is required to achieve the high level of  health protection chosen in the Union. 
(22) The measures provided for in this Directiv e 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 te xt in column 4 under the refe rence 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 Di rective 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 n ecessary 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 impor tation into the 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 the tw entieth day following that  of its publication in 
the Official Journal of  the European Union . EN 7   EN Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President