DIRECTIVES  
COMMISSION DIRECTIVE 2011/8/EU  
of 28 January 2011  
amending Directive 2002/72/EC as regards the 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 August 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 Bisphenol A (hereinafter ‘BPA’), as monomer for the 
manufacture of plastic materials and articles intended to 
come into contact with foodstuffs in accordance with the 
opinions of the Scientific Committee on Food (here ­
inafter ‘SCF’) (  3 ) and the European Food Safety 
Authority (hereinafter ‘the EFSA’) (  4 ). 
(2) BPA is used as monomer in the manufacture of poly ­
carbonate plastics. Polycarbonate plastics are used 
amongst others in the manufacture 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.  (3) On 29 March 2010 the Danish Government informed 
the Commission and the Member States that it has 
decided to apply the safeguard measures provided for 
in Article 18 of Regulation (EC) No 1935/2004 and 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 exposed to BPA in low 
doses monitoring the development of the nervous 
system and the behaviour in newborn rats. DTU Food 
has also evaluated whether the new data changes its 
previous evaluation of the toxic effects on the devel ­
opment of the nervous system and behaviour possibly 
caused by BPA.  
(5) In accordance with the procedure provided for 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 measures 
provided for in Article 18 of Regulation (EC) No 
1935/2004 and to temporarily ban the manufacture, 
import, export and placing on the market of feeding 
bottles containing BPA (  6 ). 
(7) The French Government substantiated its safeguard 
measure with two opinions issued by the French Food 
Safety Authority (AFSSA) on 29 January and 7 June 
2010 and the report published on 3 June 2010 by the 
National Institute of Health and Medical Research 
(INSERM).EN 29.1.2011 Official Journal of the European Union L 26/11  
( 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.p df  
( 4 ) Opinion of the Scientific Panel on Food Additives, Flavourings, 
Processing Aids and Materials in Contact with Food on a request 
from the Commission related to 2,2-BIS(4-HYDRO ­
XYPHENYL)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.  ( 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  o 2010-729 du 30 juin 2010 tendant à suspendre la commer ­
cialisation de biberons produits à base de bisphénol A, JORF n  o 
0150 du 1 juillet 2010, page 11857.(8) On 23 September 2010 the EFSA adopted the opinion of 
its Panel on food contact materials, enzymes, flavourings 
and processing 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 evaluated in the Danish risk 
assessment and the review and evaluation of other 
recently published studies on BPA (  1 ). 
(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 (hereinafter ‘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-generation 
reproductive toxicity study in rats, and the application 
of an uncertainty factor of 100, which is considered as 
conservative based on all information on BPA toxi ­
cokinetics. However, in a minority opinion one 
Member of the Panel concluded that the effects 
observed in certain studies raised uncertainties which 
may not be covered 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 
developing animals have suggested other BPA-related 
effects of possible toxicological relevance, in particular 
biochemical changes in brain, immune-modulatory 
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 future, 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 add- 
itional 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 level 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 system 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 have a higher 
impact in the developing organism. According to the 
opinions of the Scientific Committee on Food of 
1997 (  2 ) and 1998 (  3 ) certain effects, in particular 
endocrine and reproductive effects, effects on the 
immune system and the neurodevelopment are of 
particular relevance to infants. Reproductive effects and 
neurodevelopmental effects of BPA have been studied 
extensively in standard multigeneration toxicological 
tests and in other studies, which took account of the 
developing organism and did 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 effects of possible 
toxicological relevance. These effects, in particular those 
on the biochemical 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 later 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.  
(14) According to the EFSA opinion of 2006 polycarbonate 
feeding bottles is the main source of exposure to BPA for 
infants. Alternative materials to polycarbonate that do 
not contain BPA exist on the EU market, in particular 
glass and other plastic infant feeding bottles. These alter ­
native materials have to comply with the strict safety 
requirements set out for food contact materials. 
Therefore, it is not necessary to continue the use of 
BPA-containing polycarbonate for infant feeding bottles.EN L 26/12 Official Journal of the European Union 29.1.2011  
( 1 ) Scientific Opinion on Bisphenol A: evaluation of a study investi ­
gating 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.  ( 2 ) 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 19 September 1997).  
( 3 ) Further advice on the opinion of the Scientific Committee for Food 
expressed on 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).(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 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 toxi ­
cological 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 
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 (  1 ) 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 uncertainties in the 
present state of scientific research with regard to the 
harmfulness of BPA exposure to infants (  2 ) through poly ­
carbonate 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 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.  
(18) Thus, it is necessary and appropriate for the achievement 
of the basic objective of ensuring a high level of human 
health protection 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 action 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 feeding 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 suscep ­
tibility 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 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 measure 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  
In Annex II, Section A of Directive 2002/72/EC, 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 the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive. They shall 
forthwith communicate to the Commission 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. Member States shall determine how 
such reference is to be made.  
2. Member States shall apply the provisions referred 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 the Union of, plastic materials and 
articles intended to come into contact with foodstuffs 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.EN 29.1.2011 Official Journal of the European Union L 26/13  
( 1 ) OJ L 31, 1.2.2002, p. 1.  
( 2 ) As defined in Commission Directive 2006/141/EC (OJ L 401, 
30.12.2006, p. 1).Article 3  
This Directive shall enter into force on 1 February 2011.  
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 28 January 2011.  
For the Commission  
The President  
José Manuel BARROSOEN L 26/14 Official Journal of the European Union 29.1.2011