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2024-11-26

NEA newsletter-202411

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

Japan proposes to ban 138 PFOA-related compounds
On September 9, 2024, the Japanese Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry, and Ministry of Environment jointly published a proposal to ban 138 perfluorooctanoic acid (PFOA)-related compounds by designating them as class I specified chemical substances. This will fall under the Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture. The move by Japan to ban PFOA is aimed at aligning the country's approach with global PFOA restrictions under the Stockholm Convention on persistent organic pollutants (POPs). The consultation ended on 9 October. Promulgation is expected in November and enforcement will begin on January 10, 2025. This measure marks an important progress in Japan's environmental protection and public health efforts, aimed at controlling and reducing the distribution of persistent organic pollutants in the environment.

POPs ban on methoxychlor and reduction of HBCDD Limits 
On September 27, 2024, the European Commission published amendments to the EU Persistent Organic Pollutants Regulation (EU) 2019/1021 in its Official Journal as Regulations (EU) 2024/2555 and (EU) 2024/2570. These amendments include reducing the unintentional trace contaminant (UTC) limit for hexa-bromocyclododecane (HBCDD) from 100 mg/kg to 75 mg/kg and adding the new substance methoxychlor to Annex I of the EU POPs Regulation, thereby increasing the list of banned substances from 29 to 30. The regulations will come into force 20 days after their publication in the Official Journal.
Amendment of HBCDD Limit The revision in Annex I, Part A, concerning hexabromocyclododecane (HBCDD), replaces Point 1 in column 4 ("Specific exemptions for intermediate uses or other specifications") with the following:

  • For the purposes of this entry, Article 4(1)(b) applies to substances, mixtures, articles containing or consisting of HBCDD at concentrations ≤75 mg/kg (by weight, equivalent to 0.0075%)
  • For recycled polystyrene used in the production of EPS and XPS insulation materials for buildings or civil engineering, Point (b) should apply to HBCDD concentrations ≤ 100 mg/kg (by weight, 0.01%). The exemption specified in Point 1 shall be re-viewed and assessed by the Commission before January 1, 2026
  • Addition of Methoxychlor Requirements "Methoxychlor" refers to any possible isomer or combination thereof of dimethoxydiphenyltrichloroethane. According to Article 4(1)(b), the concentration of methoxychlor in substances, mixtures, or articles must not exceed 0.01 mg/kg (0.000001%)

SVHC adds one substance to intentional items
On October 10, 2024, the European Chemicals Agency (ECHA) announced the addition of Reactive Brown 51 as the intentional item to the Candidate List of Substances of Very High Concern (SVHC). This substance is primarily used in textile processing products and dyes and has been proposed due to its reproductive toxicity (Article 57c). It is currently in the "Registrant prepares dossier for the substance" phase, with a submission deadline set for February 3, 2025. Following this, ECHA will initiate a public consultation on the candidate substance, during which all stakeholders can submit feed-back to ECHA. If the feedback is approved through evaluation, the substance will be officially added to the SVHC Candidate List.
The information for this substance is as follows:
Substance Name: Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-[(2-[(4-fluoro-6-[(4-(vinylsulfonyl)phenyl)amino]-1,3,5-triazin-2-yl)amino]propan-1-yl)amino]-1,3,5-triazin-2-yl]amino}-5-sulfo-1-naphthyl)azo]-5-methoxyphenyl}azo]-1,3,6-naphthalenetrisulfonic acid salt (Reactive Brown 51)
EC No. /CAS No.: 466-490-7 / -

SVHC proposal list for H2 Y2024
On August 30, 2024, the European Chemicals Agency (ECHA) has launched a consultation over following 6 chemicals as substance of very high concern (SVHC). The public consultation ended on October 14, 2024. ECHA will evaluate the comments, and after evaluation, these substances will be identified as SVHC and will add to SVHC candidate list.
Name EC No. CAS No. Proposing authority Reason for proposing
6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid 701-118-1 2156592-54-8 Austria Toxic for reproduction
O,O,O-triphenyl phosphorothioate 209-909-9 597-82-0 Netherlands PBT
Octamethyltrisiloxane 203-497-4 107-51-7 Norway vPvB
Perfluamine 206-420-2 338-83-0 Belgium vPvB
Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives 421-820-9 192268-65-8 Netherlands PBT
Tris(4-nonylphenyl, branched and linear) phosphite - - France Endocrine disrupting properties

EU regulates PFHxA and PFHxA-related substances under REACH
On September 20, 2024, the European Union published an official journal (EU) 2024/2462, adding restrictions on perfluorohexanoic acid (PFHxA), its salts, and related substances to Annex XVII of the REACH regulation. The proposal for this amendment was approved in February of this year. As of now, the Annex XVII of the EU REACH Regulation has been updated to its 79th entry, and the regulation will take effect 20 days after its publication in the official journal. The regulation contains several important provisions as follows: 
  • Defines PFHxA, its salts, and related substances as:
    • Having a linear or branched C5F11- group directly attached to another carbon atom;
    • Having a linear or branched C6F13- group;
    • Excludes several substance names, including: C6F14, C6F13-C(=O)OH, C6F13-C(=O)O-X′, or C6F13-CF2-X′ (where X′= any radical, including salts), and any substance containing a C6F13- group with a non-terminal carbon atom directly attached to an oxygen atom
  • Requirement:
    In homogeneous materials:
    • The sum of PFHxA and its salts: <0.025 mg/kg
    • The total of PFHxA-related substances: <1 mg/kg
  • Specifies the scope of control:
    • Firefighting foams and firefighting foam concentrates used for public firefighting, training, and testing, effective from April 10, 2026
    • Cosmetics, food contact paper, and cardboard have effective dates not specified in the document
    • Textiles, leather, fur, footwear, and mixtures in articles intended for public use other than clothing and accessories, effective from October 10, 2026
    • Textiles, leather, fur in products intended for public use other than clothing and accessories, effective from October 10, 2027
    • Civil aviation firefighting foams and firefighting foam concentrates, effective from October 10, 2029

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