EU Proposed a Ban on the Use of BPA in FCMs

On Feb 9, 2024, the European Commission proposed a new draft aimed at amending the existing regulations on food contact materials (FCMs), involving a ban on bisphenol A (BPA) and its derivatives. The draft amends (EU) No 10/2011 and (EC) No 1895/2005, and repeals (EU) 2018/213.

What is BPA?

Bisphenol A (BPA), known as 4,4'-dihydroxydiphenylpropane (CAS No: 80-05-7), is a monomer or starting substance widely used in the manufacture of polycarbonate, polysulfone, epoxy resins, and other resins. It is extensively used in plastics, varnish coatings, inks, adhesives, and rubbers. 

The structure of BPA and its derivative

Grounds

• (EC) No. 1895/2005 prohibits the use and/or presence of bisphenol A diglycidyl ether (BADGE) and NOGE in the manufacture of FCMs.
• (EU) No. 2018/213 specifies that there should be no migration of BPA in varnishes and coatings in contact with infant food, and the specific migration limit (SML) of BPA in other food contact varnishes and coatings should not exceed 0.05 mg/kg.
• (EU) 2018/213 reduced the SML for BPA from 0.6 mg/kg to 0.05 mg/kg and stipulated that BPA must not be used in the manufacture of infant PC bottles and sippy cups/water bottles for infants and young children.

On April 19, 2023, the European Food Safety Authority (EFSA) published a scientific opinion updating the Tolerable Daily Intake (TDI) for BPA to 0.2 ng/kg body weight, which is 20,000 times lower than the assessment opinion of 2015. Based on this, the European Commission has drafted a ban on BPA.

Main Contents

Ban on BPA

• BPA should not be used in the manufacture of varnishes and coatings, printing inks, adhesives, ion-exchange resins, and rubbers for FCMs. The placing on the market of FCMs made wholly or partly of the aforementioned materials is also banned;
• Delete substance No. 151 (CAS 80-05-7, Bisphenol A) from the positive list in (EU) No 10/2011;
• Amend the (EC) No 1895/2005 to ban the use of BADGE in the manufacture of food containers with a capacity of less than 250 liters.

Exemptions

• The use of BPA as a starting substance is only allowed for the manufacture of BADGE-based heavy-duty anticorrosive varnishes and coatings for materials and articles with a capacity of above 250 liters, provided that the migration of BPA is not detectable (SML 0.01 mg/kg) and there is no hydrolysis or any other reaction leading to the residual presence or migration of BPA into food.
• Add substance No. 1091, 4,4'-(propane-2,2-diyl) diphenol sodium (CAS 2444-90-8) to Annex I of EU 10/2011. This substance can only be used in the manufacture of polysulfone membranes for filtration, with a SML of ND (Not Detected).
• The use of other bisphenol substances requires risk assessment and authorization.

Additionally, the EU will monitor the BPA on the market, focusing primarily on materials and articles using BADGE-based heavy-duty anticorrosive varnishes and coatings; polysulfone membranes for filtration; paper and board materials, as well as articles containing recycled materials. All FCMs on the market that are under this regulation require a Declaration of Compliance, confirming that intermediate and final FCMs comply with this regulation and Articles 3, 15, and 17 of (EC) No 1935/2004.

The draft is published for public comments, with a deadline of March 8, 2024. The regulation will come into effect 20 days after its publication in the Official Journal of the European Union, and businesses will have a transition period of 18 to 36 months to comply with the new regulations. The draft is expected to be implemented by the end of 2025 or the beginning of 2026.

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