BPA REACH RESTRICTION
Proposals for a restriction of BPA under REACH have been published by the German BAUA/UBA. After comprehensive stakeholder consultations BAUA withdrew the proposal in 2023. A new, further tailored restriction proposal is expected to be published in 2025.
EFSA opinion on BPA
The final EFSA opinion on safe daily intake of BPA has been published on 19th of April 2023. EFSA established a TDI of 0.2 nanograms/kg of body weight. EFSA concluded that consumers in all age groups exceed the new TDI. The EFSA opinion is not a regulatory measure per se but can be used to establish regulatory measures. The method used by EFSA has been challenged by several expert bodies like the German BfR, the European Medicines Agency or the US FDA. (Bisphenol A | EFSA (europa.eu)). Despite these diverging opinions, the EFSA working group, decided not to adjust the TDI in alignment with the critical comments of aforementioned authorities.
Ban of BPA and other Bisphenols as monomer or starting substance in Food Contact Materials (FCM)*
The European Directorate for Health and Food safety, DG Sante estabilished a new measure on BPA in food contact. The ministry states that, as a conclusion of the publication of the EFSA Opinion EU, the authorisation of BPA as a monomer in FCM plastic is no longer indicated, and a new, lower SML is not practical.
The new regulation establishes a ban of the use of BPA as a monomer or starting substance of polymers for the manufacturing of food contact materials and articles. It also bans the use of other bisphenols with certain harmonised CLP classification.
As a consequence, BP will be withdrawn from the positive list of Commission regulation (EU) 10/2011 (“Plastics Regulation”). The ban includes a list of known food contact applications including varnishes and coatings, adhesives, plastics and printing inks.
Exempt from this ban are BPA derivatives such as BADGE (bisphenol A-diglycidylether) which can still be used if BPA is not detectable. A specific derogation is included in the regulation.
Unintentional presence of BPA as well as articles already on the market (e.g., existing food processing equipment or cans already in commerce) should not be affected. Fixed transition periods of 18 – 36 months are foreseen for the (first) placing on the market of affected FCM from the date of entry into forces. Monitoring and reporting requirements are intended to supplement the ban on intentional use. A declaration of Compliance becomes mandatory to be provided for the use of e.g. BPA derivatives.
*07/2024: Regulatory measure currently under scrutiny by EP and the MS council. Legal enactment expected by end of 2024.
Methods for BPA and BPF measurement
These standard operating procedures (SOP) developed by Solvias describe quantitative test methods for the determination of Bisphenol-A (BPA) in liquid (1) and solid (2) epoxy resins by liquid chromatography-mass spectometry (LC/MS). The specific mass of Bisphenol A is measured in the selected ion monitoring mode (SIM -mode).
Method 1: SOP C52.S1593_02 ; method used to determine Bisphenol-A in different BPA-epoxy resins (liquid).
Method 2: CSOP-0724_01 ; method for the determination of Bisphenol-A (BPA) in solid epoxy resins by LC/MS.
Method 3: SOP ; method for the determination of Bisphenol-F (BPF) in liquid epoxy resins.
It has to be pointed out, that methods for determination of food contact compliance are/will be published by the European Union Reference Laboratory.