I. Bisphenols and Their Hazards
Bisphenols are a class of chemical compounds containing two phenolic hydroxyl functional groups. Representative substances include Bisphenol A (BPA), Bisphenol S (BPS), Bisphenol B (BPB), and Bisphenol F (BPF). These compounds are used as production intermediates and are widely applied in the manufacture of polymeric materials such as polycarbonates and epoxy resins.
The most controversial aspect of bisphenols is their endocrine-disrupting effects. Long-term exposure can disrupt human hormone levels, increasing health risks such as diabetes, heart disease, cancer, and obesity. The impact on fetuses and infants is particularly significant, with studies indicating associations with fetal malformations, low birth weight, and abnormal brain development in children.
As awareness of the hazards of BPA has deepened and related control measures have strengthened, producers have begun using substitutes with similar structures and properties, such as BPS and BPF. However, these alternatives may possess hormonal interference activity similar to BPA. Therefore, it is necessary to expand the scope and intensify the strength of controls.
II. EU Regulatory Trends: Escalation from Specific to Broad Control
1. New EU Regulations Targeting Bisphenols in Food Contact Materials:
- On December 31, 2024, the EU formally issued a ban on Bisphenol A and related specific hazard category bisphenols (Regulation EU 2024/3190), further strengthening controls on the use of BPA and its related substances in food contact materials and articles.
- Swiss legislation effective July 1, 2025, goes further by prohibiting the use of Bisphenol A and other bisphenols in varnishes and coatings intended for food contact.
- Substance No. 151 (CAS No. 80-05-7, Bisphenol A) and Substance No. 154 (CAS No. 80-09-1, Bisphenol S) have been deleted from the positive list of EU 10/2011. A partial exemption for Article 5 has been added under Article 6 “Non-included exemptions from the Union list,” stipulating that BPA (CAS: 80-05-7) and other harmful bisphenols or bisphenol derivatives defined in Regulation (EU) 2024/3190 may only be used under the conditions specified in that regulation.
2. The EU's control over bisphenols shows three clear trends:
- Expanding Scope of Controlled Substances: The focus has gradually expanded from the initial Bisphenol A (BPA) to include more bisphenols such as Bisphenol S (BPS), Bisphenol B (BPB), and Bisphenol F (BPF).
- Stricter Detection Limit Requirements: Migration limits or release thresholds continue to be lowered. For example, for paper and board intended for infants and young children, the specific migration limit for BPA is required as “non-detect,” with a detection limit as low as 1 μg/kg (1 ppb).
- Broadening Range of Controlled Products: The scope has progressively expanded from children’s feeding products to include various products such as thermal paper, food contact materials, varnishes, and coatings.
3. Summary of EU Migration Limits for Bisphenols by Product Category
- Migration limits for Bisphenol A differ across product categories:
- Food Contact Materials (EU General): Governed by the new regulation (EU) 2024/3190, use is prohibited.
- Paper and Board for Infants and Young Children (EDQM Technical Guide): Non-detect (Detection limit ≤01 mg/kg).
- Paper and Board Not for Infants and Young Children (EDQM Technical Guide): 0.05 mg/kg.
- Children’s Feeding Equipment (EN 14372:2004): ≤03 μg/mL.
- Soothers (EN 1400-2013+A2:2018): ≤01 mg/L.
- Soother Holders (EN 12586:2025): ≤04 mg/L.
- Children’s Toys (2009/48/EC): ≤04 mg/L (for toys intended for children under 36 months and likely to be placed in the mouth).
In response to the increasingly stringent EU regulations, PFI Fareast Laboratory has specifically established a high-precision testing program for bisphenols. Leveraging advanced analytical technologies, we can perform rigorous tests for the release and migration levels of substances like BPA, BPS, BPB, and BPF in various products, including infant care items and food contact materials. With a detection limit as low as 1 ppb, we ensure our test results fully comply with, or even exceed, the most stringent EU regulatory limits.
