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Migration of bisphenol A from commercially available pacifiers: HPLC-FLD analysis and exposure assessment in infants
Lena Herwanger1, Katharina Sternecker2, Jan Kühnisch1
1Department of Conservative Dentistry, Periodontology and Digital Dentistry, LMU University Hospital, LMU Munich, Goethestrasse 70, 80336, Munich, Germany.
Insights
Bisphenol A (BPA) can migrate from pacifiers, even those labeled "BPA-free." Even the lowest migration levels exceed new safety limits, posing a risk to infants and toddlers.
Area of Science:
- Environmental Health
- Toxicology
- Pediatric Health
Background:
- Bisphenol A (BPA) is an endocrine-disrupting chemical found in plastics, linked to various health issues.
- Infants and toddlers are highly susceptible to BPA due to immature detoxification systems and critical developmental stages.
- While BPA is restricted in infant bottles in the EU, its presence in pacifiers remains unregulated, despite misleading 'BPA-free' labels.
Purpose of the Study:
- To quantify BPA migration from commercially available pacifiers.
- To assess infant exposure to BPA from pacifiers relative to the European Food Safety Authority (EFSA) tolerable daily intake (TDI).
Main Methods:
- Pacifiers were dissected into components (shield, teat) and cut into fragments.
- BPA migration was analyzed using high-performance liquid chromatography with fluorescence detection (HPLC-FLD).
- Extrapolated total BPA release per pacifier was calculated and compared to EFSA TDI.
Main Results:
- BPA concentrations in eluates ranged up to 288 µg/L.
- Total BPA release per pacifier varied from 33 to 26,536 ng.
- The highest BPA migration was detected in a product labeled 'BPA-free'.
- Even the lowest BPA migration exceeded the 2023 EFSA TDI (0.2 ng/kg bw/day).
Conclusions:
- Pacifiers can be a significant source of early-life BPA exposure.
- Voluntary 'BPA-free' claims on pacifiers are unreliable.
- Harmonized EU regulation for BPA in pacifiers is needed, similar to restrictions on feeding bottles and toys.
Abstract:
Bisphenol A (BPA) is an endocrine-disrupting compound widely used in plastics and resins and associated with metabolic, reproductive, and neurodevelopmental disorders. Infants and toddlers are particularly vulnerable because detoxification capacity is immature and exposure occurs during sensitive developmental stages. While BPA is banned in infant feeding bottles within the European Union, its use in pacifiers remains unregulated despite frequent "BPA-free" labeling. This study quantified BPA migration from seven commercially available pacifiers and assessed potential exposure relative to the newly revised European Food Safety Authority (EFSA) tolerable daily intake (TDI; 0.2 ng kg⁻1 bw day⁻1) in a worst-case exposure scenario. Pacifiers were dissected into shield and teat components, cut into fragments, and analyzed separately using validated high-performance liquid chromatography with fluorescence detection (HPLC-FLD). Measured BPA concentrations in the eluates (c(BPA,HPLC)) ranged from below the limit of quantification (LOQ) up to 288 µg/L. Based on these measured values, the extrapolated total BPA release per pacifier was 33 to 26,536 ng, with the highest migration observed in a "BPA-free" labeled product. Even the lowest total migration exceeded the 2023 EFSA TDI, whereas exposures would have been negligible under the former 2015 t-TDI (4 µg kg⁻1 bw day⁻1). These findings demonstrate that pacifiers can constitute a relevant early-life source of BPA exposure and contribute to already critical background levels. The results underline the unreliability of voluntary "BPA-free" claims and emphasize the need for harmonized EU regulation analogous to existing restrictions for feeding bottles and toys.
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