Evaluation of the potential migration risks of baby bottles used as substitutes for polycarbonate - Poster @ ILSI Europe 2016: Poster S1-63-B

Bisphenol A was frequently used in the manufacturing of polycarbonate baby bottles until it was banned in the European Union in 2011. Furthermore, in a recent opinion, the Superior Health Council of Belgium expressed its concern regarding the possible risks associated with the used alternatives to polycarbonate (No. 8697, 11.03.2010), especially for infants. Consequently, baby bottles made of polycarbonate disappeared from the market and have been replaced by many other materials such as polypropylene, polyamide, polyethersulfone, silicone and glass. While many studies have been conducted to evaluate the release of substances from polycarbonate baby bottles, there is a major lack of data on the release of substances from the substitute materials.
In this project, a chemical and toxicological screening is carried out to identify the potential migration risks related to the alternative materials. First, a market study was conducted to identify the various alternative materials. Next, representative samples were chosen and the migration experiments were performed according to EU Regulation 10/2011, followed by chemical identification of the migrants. In parallel, the toxicity (genotoxicity and endocrine activity) of the identified migrants was evaluated using a battery of in vitro assays. Afterwards, the exposure of the infants to the migrants was determined and the corresponding hazards were identified using relevant information from the database of the European Chemicals Agency (ECHA), in silico prediction tools (e.g. ToxTree) and the in vitro assays. Finally, a risk assessment of the identified substances was carried out. However, a distinction should be made between substances listed in Annex I of Regulation 10/2011 and the unlisted substances (e.g. Non Intentionally Added Substances (NIAS)). While the concentration of the listed substances in the migration solutions were compared to their respective specific migration limits (when applicable), the exposure of the unlisted substances was compared to the thresholds determined by the Threshold of Toxicological Concern (TTC) concept. The results have shown that the concentrations of all listed substances were always below their specific migration limits. However, the exposure of some unlisted substances frequently exceeded the human exposure threshold determined by the TTC-concept. An in-depth risk assessment of these substances needs to be performed.
Finally, it can be concluded that the safety evaluation of baby bottles is challenging due to insufficient analytical data for the identification of NIAS and authorized components. Furthermore, there is also an urgent need in more (public available) toxicological information and exposure data for risk assessment.