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2023-01-16

NEA newsletter-202301

Latest Progress in Environmental Protection Laws and Regulations, Product Recall Case, and Experts Q&A

Resorcinol identified as SVHC due to its endocrine disrupting properties
Recently, the EU executive published the revised draft implementing regulation for discussion in the REACH Committee meeting on Dec 13-14, 2022. In the revised proposal, resorcinol is identified as an SVHC for its endocrine disrupting properties. Resorcinol was proposed to add in SVHC list in 2020. A majority of EU member states concluded there is scientific evidence of probable serious effects to humans under REACH Article 57(f) due to hypothyroidism and potential neurodevelopmental effects during pregnancy. However, three member states objected, and eight others abstained. Resorcinol is widely used to make tyres, rubber products, adhesives, and industrial resins, as well as some cosmetics and medical products.

Next EU-wide REACH enforcement project to focus on imported products
During the meeting on Nov 16, 2022, the Enforcement Forum of ECHA agreed that the next REACH enforcement project will investigate how companies fulfil the registration, authorisation and restriction obligations for products and chemicals they import from outside the EU. This subject was triggered by high levels of non-compliance in imported goods detected in previous forum projects, including a recent pilot project. The pilot found that 23 % of inspected products were non-compliant with requirements set by EU law and further controls are necessary. The project will be done in 2023-2025 and will require close cooperation between REACH enforcement and national customs authorities in the Member States.

EU amends the limit of hexachlorobenzene under Annex I to Regulation (EU) 2019/1021
On November 23, 2022, the EU released (EU) 2022/2291, amending Annex I to Regulation (EU) 2019/1021 of the Europe-an Parliament and of the Council on persistent organic pollutants regarding hexachlorobenzene (HCB). In order to clarify the legal situation and facilitate enforcement on the use of sub-stances, mixtures or articles containing HCB as an unintentional trace contaminant (UTC), with a limit of 10 mg/kg (0,001 % by weight) should be set for HCB. The possible applications of HCB are fungicide, production of fireworks, as fireworks coloring agent, and as the raw material of pentachlorophenol and sodium pentachlorophenate. The limit for HCB was empty in Annex I to Regulation (EU) 2019/1021.  According to (EU) 2022/2291. the concentrations of HCB shall equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances, mixtures or articles. (EU) 2022/2291 enters into force on Dec 13, 2022.

California Bill 65 proposes to add 3 new carcinogens
The Office of Environmental Health Hazard Assessment (OEHHA) is announcing its intention to list 1-bromo-3-chloropropane, 1-butyl glycidyl ether, and glycidyl methacrylate as carcinogens under Proposition 65. This action is being pro-posed pursuant to the "Labor Code" listing mechanism. OEHHA is providing an opportunity to comment by Monday, Jan 9, 2023. 
International Agency for Research on Cancer (IARC)has published on its website "IARC Monographs on the Identification of Carcinogenic Hazards to Humans, Volume 125 -Some Industrial Chemical Intermediates and Solvents" (IARC, 2020).  IARC concluded that 1-bromo-3-chloropropane and 1 butyl glycidyl ether are "possibly carcinogenic to humans" (Group 2B) based on sufficient evidence of carcinogenicity in animals and strong evidence in experimental systems that they each exhibit key characteristics of carcinogens (IARC, 2020).  IARC concluded that glycidyl methacrylate is "probably carcinogenic to humans" (Group 2A) based on sufficient evidence of carcinogenicity in animals, strong evidence that the chemical belongs, on the basis of mechanistic considerations, to a class of reactive glycidyl epoxides, and strong evidence in human primary cells that the chemical exhibits key characteristics of carcinogens (IARC, 2020).

CEN published two standards for food contact plastics
In Q3 of 2022, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published two standards for the latest overall migration test methods in simulants for food contact plastics.  These are:

  • EN 1186-2:2022 'Materials and articles in contact with food-stuffs – Plastics – Part 2: Test methods for overall migration in vegetable oils
  • EN 1186-3:2022 'Materials and articles in contact with food-stuffs – Plastics – Part 3: Test methods for overall migration in evaporable simulants
EN 1186-2:2022 supersedes EN 1186:2002 Parts 2, 4, 6, 8, 10 and 12, while EN 1186-3:2022 supersedes EN 1186:2002 Parts 3, 5, 7, 9, 14 and 15. Standards conflicting to the latest version shall be withdrawn by January 2023 and February 2023 respectively.

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