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EURL-FCM - Research

Migration of bisphenol A and other migrants from baby bottles

Despite the fact that for more than a decade many toxicological studies were carried out worldwide, there is not yet a full understanding of the impact of BPA on human health. This continues to generate discussion and is at the centre of political debate, particularly as BPA may migrate into infant formula preparations from polycarbonate baby bottles, which in turn poses a special concern about its possible effect on the development of infants and young children.

Review of literature data related to release from polycarbonate baby bottles

The release of bisphenol A (BPA) from polycarbonate baby bottles into food and food simulants was reviewed in the perspective of the current intensive discussions on the risks of this substance. It contributes to the exposure assessment of BPA.

This review was used for the preparation of the FAO-WHO Expert Meeting to Review Toxicological and Health Aspects of Bisphenol A in Ottawa on 1-5 November 2010

Our study on the release of BPA from polycarbonate was part of a larger project of JRC's IHCP that reviewed the results of various risk assessment studies carried out on BPA. We note that most of the current uncertainties derive from diverging opinions on the reliability of studies carried out with different methodologies. On this base, we observe that future toxicological studies aimed at reducing these uncertainties will have a higher probability of success if they are agreed preliminarily in a context of international collaboration between academic laboratories and governmental bodies, and if they are carried out under the supervision of an international panel of independent experts.

Considering that some BPA-containing products (particularly polycarbonate baby bottles) are already being banned in some countries and/or are being progressively and voluntarily phased out by the industry, we note that it is likewise important to assess the safety of BPA-free substitute materials.

Validation of quantification of Bisphenol A in the simulant 50% EtOH

The choice for the validation of the method for bisphenol A analysis rose from the implementation of a new milk simulant 50% ethanol (EtOH) in Directive 2007/19/EC. The first specific goal of the exercise on BPA was to validate an extension of the scope of EN13130 Part 13 to include this new food simulant in the range around the legislative specific migration limit of 0.6 mg/kg. In addition it was agreed that a second validation range would also be studied to allow validation data to be generated for exposure purposes. Bisphenol A was chosen as target substance because of its importance as monomer in polycarbonate materials that are historically used as baby bottles and are therefore in contact with milk-type products.

Monitoring study of baby bottles of materials other than polycarbonate

In order to assess the status of the current EU market and anticipate what the effects on the EU market of the decisions in Canada and US, a screening survey is conducted on plastic baby bottles, including import products. The scope is to assess the nature of materials, chemicals, and potential release. This aims to provide the risk management with trends of evolution of the market and potential issues based on experimental data. The work includes the development of methods for the quantification of target migrants from substitutes to polycarbonate bottles.