I. Overview of Bisphenol A (BPA)
As a fundamental chemical used in the production of polycarbonate plastics and epoxy resins, Bisphenol A (BPA, CAS No.: 80-05-7) is extensively utilized in plastic additives, coatings, and various other products. However, its endocrine-disrupting properties, reproductive toxicity, and potential immunological and developmental toxicities have raised health concerns. BPA can migrate into the human body through food contact materials and everyday items, posing significant risks, particularly to infants, pregnant women, and immunocompromised groups. Consequently, BPA has been included in the global regulatory focus list for stringent control.
II. Health Risks and Regulatory Background of BPA
▶ Health Hazard Characteristics
- Reproductive toxicity;
- Endocrine-disrupting effects (estrogen-like effects);
- Potential adverse impacts on the immune system; and
- Negative effects on the development of children and infants
▶ Regulatory History (using the EU as an example)
Year | Event | Content |
|---|---|---|
2007 | EFSA Initial Risk Assessment | Preliminary scientific evaluation of potential risks associated with BPA. |
January 2011 | First EU Ban | Prohibition of BPA in the manufacture of polycarbonate (PC) baby bottles. |
September 2018 | Further EU Restrictions | Ban on BPA in plastic bottles and packaging used for food contact with children under 3 years old; reduction of BPA limit in FCM to 0.05 ppm and restrictions on its use in metal can coatings. |
January 2020 | REACH Regulation Restrictions | Prohibition of BPA in thermal paper (limit: ≤0.02%). |
April 2023 | Latest EFSA Scientific Opinion | Significant reduction of the daily tolerable intake (TDI) of BPA to 0.2 ng/kg bw/day, indicating risk at current exposure levels for all consumer age groups. |
July 2023 | European Commission Recommendation | Recommendation for a complete ban on the use of BPA in food contact materials (FCM). |
February 2024 | European Commission Draft Proposal | Formal proposal for a comprehensive BPA ban. |
June 2024 | Agreement by EU Member States | Consensus reached among member states. |
December 19, 2024 | Passed by the European Commission | Official adoption of the new BPA ban (EU) 2024/3190. |
January 20, 2025 | Regulation Comes into Effect | Complete ban on BPA in food contact materials, with an 18-month transition period. |
III. Detailed Explanation of the New EU BPA Ban Regulation — (EU) 2024/3190 (Effective in 2025)
1. Core Prohibition Requirements
a. Complete prohibition of BPA in the manufacture of products related to food contact materials (FCM):
- Prohibition on the use of BPA and its salts in the production of materials used in FCM, including: Adhesives, rubber, ion exchange resins, plastics, printing inks, silicone, varnishes, and coatings.
- Prohibition on placing BPA-containing food contact materials and products on the EU market.
b. Prohibition of other bisphenols and bisphenol derivatives (unless authorized and residue-free):
In principle, other bisphenols or derivatives (such as BPS, BPF, etc.) are also prohibited from being used in the manufacture and sale of FCM, unless specifically authorized and the products are free from BPA residues.
c. Limited exemptions (very restricted):
Material Type | Specific Application | Additional Restrictions |
|---|---|---|
Varnishes and Coatings | As monomers/starters for the production of liquid epoxy resins, used in self-supporting food contact materials/items with a volume >1000 liters | No migration into food; must be cleaned/rinsed before first food contact |
Plastics | As monomers/starters for the manufacture of polysulfone filter membrane components | No additional restrictions specified |
2. Revision of the EU Plastics Regulation (EU) No 10/2011
Addition of Article 6: BPA and harmful bisphenols/derivatives can only be used in the manufacture of specific plastic materials if they comply with the new regulatory requirements (must meet the exemption requirements of Annex II).
Deletion of entries in Annex I Table 1: The entries for BPA (No. 151) and BPS (No. 154, CAS 80-09-1) have been removed, meaning these substances are no longer permitted in plastic food contact materials.
IV. Transition Period Arrangements (Key Timelines)
Product Type | General Sales/Placement Deadline | Extension for Special Cases |
|---|---|---|
Disposable Food Contact Materials and Products | July 20, 2026 | Certain special products (e.g., for fruit/vegetable preservation, seafood-related, metal products only coated with BPA varnish on the exterior) extended to January 20, 2028 |
Reusable Food Contact Materials and Products | July 20, 2026 | Professional equipment for repetitive FCM (if compliant with old regulations) extended to January 20, 2028 |
All Disposable/Reusable FCM (market retention) | - | Latest sale/use by January 20, 2029 |
V. Compliance Declaration Requirements (Essential for Businesses)
Businesses must prepare a compliance declaration, which includes:
- Business Information (name, address, contact details);
- Product Manufacturer/Importer Information;
- Details of Food Contact Materials and Products (including intermediates and final products);
- Date of Declaration;
- List of Bisphenol Substances and Derivatives Used; and
- Compliance Statement with (EU) 2024/3190 and (EC) No 1935/2004
VI. Summary of Bisphenol A (BPA) Regulatory Controls in Major Countries and Regions Worldwide (Including Latest Updates)
🔵 European Union
Regulation/Standard | Scope | Requirements | Notes |
|---|---|---|---|
(EU) 2024/3190 (Effective January 20, 2025) | All food contact materials | Complete ban on BPA, prohibiting BPA-containing FCM products from entering the market, with very few exemptions | ✅ Latest issued in December 2024, effective January 2025, most significant update! |
(EU) No 10/2011 (Revised) | Plastic food contact materials | Original BPA limit was 0.05 mg/kg, now banned | BPA entries removed |
REACH Annex XVII | Thermal paper | BPA ≤ 0.02% (200 mg/kg) | Implemented since January 2020 |
REACH SVHC | - | BPA must be notified/information passed if concentration ≥ 0.1% in articles | Continuously effective |
🟢 China
Regulation/Standard | Scope | Requirements | Notes |
|---|---|---|---|
GB 4806.7-2023 / GB 4806.15-2024 | Infant-specific food contact materials | BPA is banned | ✅ New standards released in 2024, focus on this! |
GB 4806.10-2016 / GB 9685-2016 | Other food contact materials | BPA is banned in infant products; other products must have BPA migration ≤ 0.6 mg/kg | Old standards still in reference |
GB 4806.7-2023 / GB 4806.15-2024 | Other general food contact materials | BPA migration ≤ 0.05 mg/kg | New standards, stricter than previous versions |
🟡 Other Major Countries/Regions
Country/Region | Regulation/Standard | Requirements | Notes |
|---|---|---|---|
USA | FDA | BPA banned in baby bottles, sippy cups, infant formula packaging, etc. | Continuously effective |
USA | CA65 (California Proposition 65) | BPA restrictions in various products: <br>- Phone cases: ≤10 ppm <br>- Thermal paper: ≤10 ppm <br>- Certain socks (containing spandex): No intentional addition, warning label required if detected >1 ppb; must be labeled if >10 ppb | ✅ Updated multiple times in 2023-2024, stringent details, especially in consumer goods |
South Korea | Standards for Food Utensils, Containers, and Packaging | BPA banned in infant products; other products total migration of BPA + phenol + p-tert-butylphenol ≤ 2.5 mg/L, with BPA ≤ 0.6 mg/L | |
Japan | Ministry of Health, Labour and Welfare Notification No. 370 | Total content of BPA + phenol + p-tert-butylphenol ≤ 500 mg/kg, total migration ≤ 2.5 mg/L | |
Mercosur | Positive List for Food Contact Plastics | BPA migration ≤ 0.05 mg/kg | Similar to old EU standards |
VII. Bisphenol Analogues (Require Simultaneous Attention)
In addition to BPA (CAS 80-05-7), the following BPA analogues/derivatives are also under increasingly strict global control, including:
Bisphenol S (BPS, CAS 80-09-1)
Bisphenol F (BPF, CAS 620-92-8)
Bisphenol E (BPE)
Bisphenol B (BPB)
Bisphenol P (BPP)
Bisphenol Z (BPZ)
Bisphenol AF (BPAF)
Bisphenol AP (BPAP)
CIRS Testing Reminder: Many countries have begun risk assessments on BPA substitutes like BPS, and these substances may face similar restrictions to BPA in the future. Companies are advised to plan alternative solutions and compliance strategies in advance.
VIII. CIRS Testing Compliance Recommendations
- Immediately investigate whether your products contain BPA or BPA derivatives, especially in food contact materials, thermal paper, coatings, and plastic products.
- Pay close attention to the EU (EU) 2024/3190 ban effective from January 20, 2025, to ensure compliance with products exported to the EU.
- For major markets such as China, the USA, and South Korea, update product standards in a timely manner, especially for infant products and food contact materials.
- If using BPA substitutes (such as BPS, BPF), keep an eye on the latest regulatory developments to avoid compliance risks from "changing the formula but not the substance."
- Prepare compliance declarations, supply chain traceability, and migration testing reports for market regulation and customer review.
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