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EU releases draft ban on bisphenol A in food contact materials


Time:

2024-02-22

The European Union has proposed to ban the use of bisphenol A in food contact materials and products, and has also standardized the draft regulation on the use of other bisphenol and its derivatives, aiming to replace Regulation (EU) 2018/213 and update the EU Food Contact Plastic Materials Regulation (EU) No 10/2011.

On February 9, 2024, the European Union issued a proposal to ban the use of bisphenol A in food contact materials and products, as well as a draft regulation to regulate the use of other bisphenol and its derivatives, in order to replace Regulation (EU) 2018/213 and update the EU Food Contact Plastic Materials Regulation (EU) No 10/2011.

 

 

The content to be updated is as follows

1、 Expand the control scope of bisphenol substances

1. BPA used in the production of food contact plastics, varnish and coatings, printing inks, adhesives, ion exchange resins, and rubber;

2. Other bisphenol and bisphenol derivatives used in the production of food contact varnish and coatings, printing inks, adhesives, ion exchange resins, and rubber, listed in Appendix VI, Part 3 of Regulation (EC) No 1272/2008, as they are uniformly classified as "teratogenic", "carcinogenic", "reproductive toxicity" 1A or 1B or Class 1 "endocrine disruption to human health";

3. Monitor the presence or migration of BPA in food contact with BADGE (Bisphenol A Diglycidyl Ether (CAS No 1675-54-3) based heavy-duty anti-corrosion varnish and coatings for filtration membranes and polysulfone resins containing recycled materials in paper and paperboard.

 

2、 Prohibition of the use of bisphenol A

1. It is prohibited to use bisphenol A in any manufacturing stage of food contact paints and coatings, printing inks, adhesives, ion exchange resins, and rubbers, as well as to place on the market final food contact products made partially or entirely of these materials using bisphenol A.

2. It is allowed to use bisphenol A as a precursor in the synthesis of BADGE and its derivatives, and to use it as a monomer for the manufacturing and marketing of BADGE based heavy-duty anti-corrosion varnish and coatings, but with the following limitations:
Liquid epoxy BADGE based heavy-duty anti-corrosion varnish and coatings should have separate identifiable batches before subsequent production steps; 
When the detection limit (LOD) is 0.01 mg/kg, materials and items coated with BADGE based heavy-duty anti-corrosion varnish and coatings shall not detect migrated bisphenol A; 
The use of BADGE based heavy-duty anti-corrosion varnish and coatings in the production of materials and items in contact with food shall not cause hydrolysis or any other reaction during the production process or in contact with food, resulting in the presence of BPA in these materials and items or food.

 

 

3、 Specific usage requirements for other bisphenols and bisphenol derivatives

Bisphenols and bisphenol derivatives listed in Appendix VI, Part 3 of Regulation (EC) No 1272/2008, which are classified as Class 1A or 1B "mutagenic", "carcinogenic", "reproductive toxicity" or Class 1 "endocrine disruption" and are harmful to human health, are prohibited from use in the manufacture of food contact paints and coatings, printing inks, adhesives, ion exchange resins, and rubber, unless the following conditions are met:
(a) The authorization application for bisphenol or its derivatives has been submitted to the competent authority in accordance with Article 9 of Regulation (EC) No 1935/2004
(b) The information provided to the Authority complies with the provisions of Article 9 of Regulation (EC) No 1935/2004 and includes a declaration that the application is submitted in accordance with this Article; 
(c) The competent authority has not deemed the relevant application invalid, and; 
(d) The use of bisphenol or its derivatives is limited to the expected usage conditions described in the application.

 

4、 Testing and reporting results

Manufacturers of the following food contact materials and items placed on the EU market should monitor the presence and migration of BPA:
(a) Materials and items using BADGE based heavy-duty anti-corrosion varnish and coatings; 
(b) Polysulfone resin for filter membranes; 
(c) Paper and cardboard materials and items containing recycled materials.
Operators should monitor 5% of the food contact materials and items they put into the market. Operators should randomly select batches. When a single batch cannot be identified during continuous production, random sampling should be taken within a production cycle that does not exceed 200 times the average residence time of the material in the production system.
If no bisphenol A is detected in any batch or cycle of sampling within 6 months after the start of monitoring or the last detection of bisphenol A according to this clause, and at least 10 batches or cycles of production are monitored, monitoring can be reduced to 1% of the batch or 1000 times the average residence time (if possible).

 

5、 Other

In addition, the proposal also describes the methods for verifying compliance, written documentation of compliance statements and their supporting documents. And transitional periods of varying lengths were provided for different categories of products. The 151st substance in Table 1 of Annex I to Regulation (EU) No 10/2011 has been removed, and a new item - Substance 1091- has been inserted at the end of the table:

 

  

Substance number

CAS number Material name Used as an additive or polymer production assistant

1091

2444-90-8

4,4 '- (Propane-2,2-diyl) Sodium Phenol

no

Used as monomers or other starting substances or macromolecules obtained from microbial fermentation

FRF applicability

SML[mg/kg]

Limitations and Instructions

yes

no

ND

Polysulfone resin only used for manufacturing filtration membranes

 

At present, the EU is providing public feedback on the draft regulation, with a deadline of March 8, 2024.

 

About Bisphenol A

Bisphenol A (BPA) is mainly used in the production of epoxy resins, forming the foundation for varnish and coatings, including those applied to the internal and external surfaces of metal food packaging, such as cans, cans, and bottle caps, as well as certain types of plastics, including polycarbonate and polysulfone food storage and processing equipment. Bisphenol A can also be used in other materials, such as printing inks, adhesives, ion exchange resins, and rubber, which form a part of finished food contact products. Bisphenol A can migrate from materials or items in contact with it to food, causing consumers to come into contact with bisphenol A in these foods.

 
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