BPA is used as monomer in the manufacture of polycarbonate 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.

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 development of the nervous system and behaviour possibly caused by BPA.

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.

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).

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 toxicokinetics. 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.

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.

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 level of exposure to BPA decreases once feeding from polycarbonate bottles is phased out and other sources of nutrition become dominant.

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.

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 alternative 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.

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 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.

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.

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.

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 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 amended accordingly. The Authority has a mandate to monitor new studies to clarify these endpoints.

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.

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,