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EU - Proposed regulations on the use of BPA and other bisphenols in food contact materials and articles

The European Commission proposed a Commission Regulation (EU) on the use of bisphenol A (BPA) and other bisphenols and their derivatives in food contact materials and articles.

It is prohibited to use 4,4'-isopropylidenediphenol (BPA) (CAS No 80-05-7) at any at any manufacturing stage of food contact varnishes and coatings, printing inks, adhesives, ion-exchange resins and rubbers and the placing on the market of final food contact articles composed partly or wholly of these materials.

The use of BPA as a precursor in the synthesis of BADGE and its derivatives to be used as monomers for the manufacture and placing on the market of BADGE-based heavy-duty varnishes and coatings is permitted subject to the following restrictions:

  1. liquid epoxy BADGE-based heavy-duty varnishes and coatings shall be obtained in separate identifiable batches before subsequent manufacturing steps;
  2. the migration of BPA from materials and articles on which BADGE-based heavy-duty varnishes and coatings is applied shall not be detectable with a limit of detection (LOD) of 0.01 mg/kg;
  3. the use of BADGE-based heavy-duty varnishes and coatings in the manufacture of food contact materials and articles shall not lead to its hydrolysis or any other reaction either during manufacturing or when in contact with food that results in the presence of BPA in those materials and articles or in the food.

The use of bisphenols and bisphenol derivatives listed in Regulation (EC) No 1272/2008 in the manufacture of food contact varnishes and coatings, printing inks, adhesives, ion-exchange resins and rubbers is prohibited unless it is authorized.

Business operators shall ensure that materials and articles are accompanied at all stages of marketing by a written declaration of compliance.

Besides, this proposed regulation also amend Regulation (EC) No 1985/2005 and Regulation (EU) No 10/2011 regarding BPA.

In Regulation (EC) No 1985/2005, the use of BADGE in the manufacture of materials and articles with a capacity of less than 250 litres is prohibited. Materials and articles with a capacity between 250 litres and 10 000 litres shall not release the substances listed in Annex I in a quantity exceeding the limits.

Besides, the union list of authorized substance in Regulation (EU) No 10/2011 is amended. 2,2-bis(4-hydroxyphenyl)propane (entry 151 in the union list) is deleted. Disodium 4,4'-isopropylidene diphenolate (CAS No 2444-90-8) is newly added in the union list. 

Regulation (EU) 2018/213 shall be repealed.

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