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NEA newsletter-202304

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

Restriction of PFCAs under the REACH regulation came into force
On February 25, 2023, certain restrictions on C9-C14 PFCAs, their salts and related substances in entry 68 of REACH Annex XVII had come into effect. The requirements are as follows:

  • Shall not be manufactured, or placed on the market as substances on their own from 25 February 2023
  • Shall not, from 25 February 2023, be used in, or placed on the market in:
    (a)  another substance, as a constituent;
    (b)  a mixture;
    (c)  an article,
except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances.
Other restrictions under this entry will come into force later in this year or in coming years.

Notice of intent to list two new substances under Proposition 65
The Office of Environmental Health Hazard Assessment (OEHHA) announced its intention to list 1,1,1-trichloroethane and leuco-malachite green as carcinogens under Proposition 65. The collection of public comments has been closed close on April 3, 2023. Common uses of these two chemicals are as follows:
  • 1,1,1-trichloroethane (CAS RN 71-55-6)
    (a)  1,1,1-Trichloroethane is used as a cleaning solvent for cleaning metals and plastic molds

    (b)  Solvent for cleaning precision instruments, metal degreasing, pesticide, textile processing
  • Leucomalachite green (CAS RN 129-73-7)
It can be used as a biological stain to stain cells or cell tissues in blue-green, which is convenient for research under a microscope. It is also used as dye for silk, leather and paper.

EU proposal for restrictions on BPA
Germany sets out three options with varying limits and conditions in the proposal on Bisphenol A(BPA) in November 2022. As required by the proposal, BPA shall not be placed on the market in a mixture or an article if its concentrations equal to or higher than 10 ppm (0.001% by weight).
ECHA is giving interested parties six months to submit comments. Dozens of stakeholders responded to an early deadline of 25 January following a request from ECHA’s committees for socio-economic analysis (Seac) and risk assessment (Rac) to help them with their initial discussions. Stakeholders can continue to submit comments to the consultation until 22 June.

ECHA identifies certain brominated flame retardants as candidates for restriction
On 15 March 2023, ECHA has released its Regulatory Strategy for Flame Retardants, identifying aromatic brominated flame retardants as candidates for an EU-wide restriction. Aromatic brominated flame retardants are generally persistent in the environment. Many are also known or suspected to be toxic and accumulate in people and animals. The restriction scope could cover all aromatic brominated flame retardants that are con-firmed or will be confirmed to be persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) through harmonised classification or identification as substances of very high concern (SVHCs). For many aliphatic brominated and some organophosphorus-based flame retardants, more data is needed to determine if a restriction is necessary. These data are expected to be available from 2024 on-wards, and ECHA suggests reassessing the situation for those groups in 2025. No regulatory action is recommended for several non-halogenated subgroups of flame retardants, including certain organophosphorus-based flame retardants, since no or low hazard was identified at this time. For chlorinated flame retardants, regulatory measures are already in place or initiated.

China issues an announcement of Approved New Food-Related Products
On March 3, 2023, the Department of Food Safety Standards and Monitoring and Evaluation of the National Health Commission of the People's Republic of China (NHC) issued the "Announcement on 28 Types of 'Three Novel Food' such as Leuconostoc pseudomesenteroides" (No. 1 of 2023). It includes 1 new food ingredients, 16 varieties of food additives such as potassium polyaspartate, and 11 new varieties of food-related products such as Cyclohexane, 1,1'-methylenebis [4-isocyanato-, homopolymer, cyclohexylamine-terminate. Please refer to the official announcement for more details.

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