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2024-01-15

NEA newsletter-202401

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

UK Revises Legislation on POP Chemicals
In 2023, the United Kingdom government issued two pieces of legislationUK S. I.2023/729 and 2023/1217to revise its retained Regulation (EU) 2019/1021 on persistent organic pollutants (POP).

  • The Persistent Organic Pollutants (Amendment) Regulations 2023(UK S.I. 2023/729)
    Permits the manufacture, placing on the market and use of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in textiles for oil- and water-repellancy for the protection of workers from dangerous liquids until December 3, 2025. This revision became effective in July 2023.
  • The Persistent Organic Pollutants (Amendment) (No.2) Regulations 2023 (UK S.I.2023/1217)
    Adds perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds and their unintentional trace contaminant (UTC) values. The limit is 0.025 mg/kg for PFHxS and its salts and 1 mg/kg for the sum of PFHxS-related substances.The effective date was November 16, 2023.

European Commission to lower limit for HBCDD in POPs regulation
On November 28, 2023, the European Commission has proposed an amendment to the bloc's regulation on persistent organic pollutants (POPs) to lower the trace limit of brominated flame retardant hexabromocyclododecane (HBCDD) in substances, mixtures or articles or as constituents in flame-retarded articles. The draft delegated regulation cuts the limit from 100mg/kg to 75mg/kg.
Except for the use of HBCDD in recycled polystyrene in the production of expanded polystyrene (EPS) and extruded polystyrene (XPS) insulation material for use in buildings or civil engineering works, for which the limit is maintained at 100mg/kg.
Both values need to be reviewed by 1 January 2026 based on the available technical and scientific information. The consultation feedback period is from 28 November 2023 to 26 December 2023.

The REACH authorisation application deadline for the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices is extended
On November 13, 2023, the amending Regulation (EC) No 1907/2006 is published in the Official Journal of the European Union. The latest application date and sunset date for the use of bis (2-ethylhexyl) phthalate (DEHP) in medical devices are extended. This amending Regulation shall enter into force on November 14, 2023. Annex XIV is amended as follows: The latest application date for the use of DEHP in medical devices is extended from November 27, 2023 to January 1, 2029. The sunset date is extended from May 27, 2025 to July 1, 2030. After that companies are not allowed to sell or use DEHP without authorization.

U.S. Environmental Protection Agency prohibits bans PFAS from the fluorination process of plastics
On December 1, 2023, U.S. Environmental Protection Agency (EPA) issued unilateral orders to enhance technologies under the Toxic Substances Control Act (TSCA) Section 5(f). EPA banned the company's unintentional production of three PFAS substances (PFOA, PFNA, and PFDA) in the fluorination process of plastic containers. In addition, EPA required the company to cease manufacture of other six PFAS substances (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA) under the TSCA Section 5(e). The company need to perform additional tests if it intends to restart production. The company said the move would threaten its "survival" and affect thousands of downstream businesses.

Three chemicals as known to cause cancer are added to CP65
Effective November 17, 2023, the Office of Environmental Health Hazard Assessment (OEHHA) is adding coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers to the list of chemicals known to the State of California to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65.The International Agency for Research on Cancer (IARC) concluded that coal-tar pitch and fluoro-edenite fibrous amphibole are classified in Group 1 ("carcinogenic to humans") and that silicon carbide whiskers are classified in Group 2A ("probably carcinogenic to humans").

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