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Release Time:2023-03-29 Recently, European Chemicals Agency (ECHA) has launched a public consultation on the restriction proposal for Bisphenol A and Bisphenols of similar that have endocrine disrupting effects on the environment, which have previously attracted concern, which has previously received attention from all parties. The consultation deadline is June 22, 2023. According to the procedure, once the opinion is adopted by the European Commission, this control may be introduced in the form of REACH Appendix XVII restriction requirements.
Substance Information |
Bisphenols, HO-(R1)-R2-(R3)-OH with R1 and R3 being phenylene groups bearing any substituents at any ring position and R2 being a methylene group being unsubstituted or bearing any substituents or another bridging unit bearing unspecified substituents, which are listed in Appendix X and their salts. Further bisphenols may be added to Appendix X if they fulfil one or more of the following conditions: Ø They have been identified as substances of very high concern due to their endocrine disrupting properties for the environment according to Article 57 and Article 59 of REACH Regulation. Ø They are classified as endocrine disruptors for the environment category 1 in Part 3 of Annex VI to Regulation (EC) No 1272/2008. Ø They have been identified as endocrine disruptors for the environment according to the Biocidal Products Regulation (EU) No 528/2012. Ø They have been identified as endocrine disruptors for the environment according to the Plant Protection Products Regulation (EC) No 1107/2009. |
Appendix X | ||
Substances | EC No | CAS No |
4,4'-isopropylidenediphenol (Bisphenol A) | 201-245-8 | 80-05-7 |
4,4'-(1-methylpropylidene)bisphenol (Bisphenol B) | 201-025-1 | 77-40-7 |
4,4'-sulphonyldiphenol (Bisphenol S) | 201-250-5 | 80-09-1 |
4,4'-methylenediphenol (Bisphenol F) | 210-658-2 | 620-92-8 |
4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol (Bisphenol AF) | 216-036-7 | 1478-61-1 |
Conditions of restriction |
1. Shall not be placed on the market in mixtures and articles in a concentration equal to or greater than 10 ppm (0.001 % by weight). This limit value refers to the sum of all substances subject to this Annex XVII entry which are present in the respective mixtures and articles. 2. Paragraph 1 shall not apply to mixtures and articles where the bisphenols listed in Annex X are either covalently bound to any type of matrix (e.g. via functioning as a crosslinker) or are used as intermediates in the manufacture of polymers, and for which i. contact to aqueous media in any form can be excluded during their reasonable and foreseeable use throughout their service life or ii. the migration limit in the respective mixtures and articles does not exceed 0.04 mg/L over the entire service life. Conditions for migration testing are described in Annex Z below. 3. Paragraphs 1 and 2 shall apply from [EiF + 18 months] for entries 1 to 5 of Appendix X. Specific derogations are listed in Appendix Y. 4. Appendices X and Y shall be amended in accordance with the procedure referred to in Article 133(4). Articles 69 to 73 shall not apply. |
The exemptions proposed in Appendix Y | |
Use | Proposed Derogation |
Recycling of paper | Concentration limit 150 ppm for 78 months |
Fluoroelastomer | Concentration limit 50 ppm for 10 years |
Polycarbonates (PC) and Polycarbonate based mixtures | Concentration limit 150 ppm |
Epoxy resins | Concentration limit 65 ppm for the placing on the market of articles manufactured with solid and semisolid epoxy resins. Concentration limit of 1 ppm for epoxy resin mixtures intended for consumer uses |
Leather articles and mixtures used for the tanning of leather | Concentration limit 500 ppm for 5 years. |
Bisphenols are important organic chemical raw materials, mainly used in the manufacture of various polymer materials, such as polycarbonate, epoxy resin, polyphenylene ether resin, polysulfone resin, and also used in the manufacture of heat stabilizers for PVC, rubber antioxidants, agricultural fungicides, antioxidants, and so on. In the manufacturing process of plastic products, the addition of bisphenols can make them colorless, transparent, durable, lightweight, and outstanding impact resistance. As coatings, they can also prevent acidic vegetables and fruits from corroding metal containers from the inside. Therefore, they are widely used in the packaging of canned foods and beverages, milk bottles, water bottles, sealants for dental fillers, eyeglasses, and hundreds of other daily necessities. Since the 1960s, bisphenols have been used to manufacture hard plastic (milk) bottles, suction cups for young children, inner coatings for food and beverage powder cans, and heat transfer paper. The above materials are high-risk materials containing bisphenols.
AGC reminds relevant enterprises to pay attention to the latest developments of the European Union's bisphenol restriction requirements, actively respond, make preparations in advance, and effectively prevent subsequent risks.
Link: https://echa.europa.eu/documents/10162/450ca46b-493f-fd0c-afec-c3aea39de487
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