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I. New EU REACH Regulation Restrictions on Microplastics
(I) Core Content of the New Regulation
On September 27, 2023, the European Commission issued an amendment to the REACH Regulation ((EC) No 1907/2006), adding entry 78 to Annex XVII to impose restrictions on intentionally added microplastics. Meanwhile, new Appendices 15 and 16 were added to clarify the rules for proving the degradability and solubility of these microplastics.
The restricted objects are synthetic polymer microparticles that are organic, insoluble, resistant to degradation, and have a particle size of less than 5 millimeters. The core requirements include:
Affected products include perfumes, cosmetics, detergents, fabric softeners, glitter, toys, pharmaceuticals and medical devices, fertilizers, granular filling materials for artificial sports fields, etc.
The amendment entered into force on October 17, 2023, and does not apply to synthetic polymer microparticles (in separate or mixed forms) placed on the market before October 17, 2023. However, products for specific uses are not subject to this date restriction.
(II) Transition Period Arrangements
1. Transition Period for Specific Uses
| Date | Product Category |
|---|---|
| October 17, 2027 | Rinse-off products (excluding products covered by other entries and products containing "microbeads" used for abrasion) |
| October 17, 2028 | Detergents, waxes, polishes and air care products (excluding the aforementioned rinse-off products and products containing microbeads) |
| October 17, 2028 | Fertilizer products not covered by EU Regulation (EU) 2019/1009 |
| October 17, 2028 | Agricultural and horticultural products not covered by the preceding entries |
| October 17, 2029 | Synthetic polymer microparticles used for encapsulating fragrances |
| October 17, 2029 | Leave-on products (excluding products covered by the preceding entries) |
| October 17, 2029 | Medical devices (covered by EU Regulation (EU) 2017/745, excluding products containing microbeads) |
| October 17, 2031 | Plant protection products, seeds treated with such products, and biocidal products |
| October 17, 2031 | Granular filling materials used in synthetic sports fields |
| October 17, 2035 | Lip, nail and color cosmetic products (excluding products covered by the preceding entries and products containing microbeads) |
2. Transition Period for Supplier Information and Labeling Requirements
| Date | Product Category and Requirements |
|---|---|
| October 17, 2025 | Suppliers of synthetic polymer microparticles used in industrial premises: Provide instructions for use and disposal, compliance statements, information on the quantity/concentration of microparticles, and general identification of polymers |
| October 17, 2025 | Suppliers of relevant microparticles such as food additives: Provide instructions for use and disposal to prevent release to users |
| October 17, 2026 | Suppliers of in vitro diagnostic device products: Provide instructions for use and disposal to prevent release to users |
| October 17, 2031 - October 16, 2035 | Suppliers of lip, nail and color cosmetic products: Label "This product contains microplastics" (products launched before October 17, 2031 may be labeled by December 17, 2031) |
Note: Information shall be presented in legible, easily readable and indelible text or pictograms on labels, packaging, etc., and may be supplemented with electronic versions; text descriptions shall use the official language of the member state where the product is placed on the market (unless otherwise specified).
(III) ECHA Information Submission Requirements
| Year | Operator Type | Information Content |
|---|---|---|
| 2026 | Manufacturers and downstream industrial users of synthetic polymer microparticles used as raw materials for plastic manufacturing in industrial premises | Description of usage, general identification of polymers, estimation of environmental release, and explanation of exemption clauses |
| 2027 | Other manufacturers of synthetic polymer microparticles and other downstream industrial users using them in industrial premises | Description of end uses of products placed on the market, general identification of polymers, estimation of environmental release, and explanation of exemption clauses |
| 2027 | Suppliers of synthetic polymer microparticles in specific products such as medical devices | Description of end uses of products placed on the market, general identification of polymers, estimation of environmental release, and explanation of exemption clauses |
II. 35 New Notifiable Substances Added to the EU PIC Procedure
On August 25, 2023, the European Commission issued Regulation (EU) 2023/1656, amending Regulation (EU) No 649/2012 on the Prior Informed Consent (PIC) Procedure, adding 35 hazardous chemicals (including 27 pesticides and 8 industrial chemicals) to Annex I.
Currently, the list contains 295 entries, specifying chemicals that require export notification and consent from importing countries. The regulation aims to regulate the trade of hazardous chemicals prohibited or strictly restricted by the EU and entered into force on September 14, 2023.
III. Other Recent Updates to the EU REACH Regulation (August 30, 2023)
| Topic | Core Content |
|---|---|
| Withdrawal of Proposal for Restrictions on Bisphenols | German authorities withdrew the proposal for environmental restrictions on bisphenols with endocrine-disrupting properties and plan to submit an updated version |
| Update of Regulatory Information in the CLP Regulation Database | Covers information related to multiple regulations such as plant protection products, eco-labels, and construction products |
| Update of Legislative Overview | Involves inland dangerous goods transport, pesticide residues, RoHS Directive, etc. |
| Update of OECD eChemPortal | REACH registration database (covering over 1.3 million endpoints for 27,000 substances) is searchable |
| Proposal for Six Substances of Very High Concern (SVHC) | Including 2,4,6-tri-tert-butylphenol, benzotriazole, dibutyl phthalate, etc. |
| Progress in Nanomaterial Safety Research | New breakthroughs in integrating microbiota into nanomaterial safety research |
| Opening of Chapters in the European Nanoregister | Introduces the establishment of national nano-inventories and cosmetic notification portals, etc. |
| Update of Relevant Links | New links for restriction intention registration, SVHC intention registration, etc. under REACH and CLP Regulations |
IV. New Regulations on Hazardous Substances and Waste Management in France
On September 14, 2023, the French Minister for Ecological Transition and Territorial Cohesion announced a decree on waste generated by hazardous substances in products (issued on August 30, 2023), which entered into force on September 15, 2023.
(I) Supplementary List of Hazardous Substances
Based on the 2021 opinions of the French National Agency for Food, Environmental and Occupational Health Safety (ANSES), the first list of substances equivalent to SVHCs was formulated, including:
(II) Information Access Method
The alternative method Scan4Chem was designated, allowing consumers to scan product barcodes to obtain information on hazardous substances. This requirement stems from the provisions of the Anti-Waste for a Circular Economy Act (AGEC Act) on expanding product information obligations.
V. Update on POPs Regulation in Japan
At the 11th Conference of the Parties to the Stockholm Convention in May 2023, parties agreed to add 3 new persistent organic pollutants (POPs) to Annex A for elimination. On August 10, 2023, Japan's Ministry of Economy, Trade and Industry announced that these substances would be included in the list of Class I Specified Chemical Substances under the Chemical Substances Control Act. Specific measures (including import bans and exemption reviews) are expected to be implemented in the autumn of 2024.
| Chemical | CAS Number |
|---|---|
| Methoxychlor | 72-43-5 |
| Dechlorane Plus | 13560-89-9 |
| UV-328 | 25973-55-1 |
VI. Global Dynamics of Sustainable Development and Environment-Related Regulations
| Authority | Date | Publication/Regulation Content |
|---|---|---|
| Secretariat of Environment and Natural Resources of Mexico | July 24, 2023 | Standard NOM-152-SEMARNAT-2023: Specifies standards for sustainable forest management plans for forest resources |
| European Commission | August 18, 2023 | Opinion of the European Economic and Social Committee on the proposal for rules on product repair |
| European Commission | August 18, 2023 | Opinion of the European Economic and Social Committee on the proposal for the Green Claims Directive |
| French Ministry for Ecological Transition and Territorial Cohesion | August 31, 2023 | Decree amending the certification and control provisions for EU eco-labels |
| European Commission | August 24, 2023 | Consultation on energy labels for electronic displays (including eco-design) |
| European Commission | September 4, 2023 | Evaluation report on the EU Consumer Programme |
| UK Department for Environment, Food and Rural Affairs | September 4, 2023 | The Fluorinated Greenhouse Gases (Amendment) Regulations 2023 and guidance documents |
| European Parliament | September 20, 2023 | Eco-design requirements for sustainable products under the European Green Deal |
| UK Government | September 13, 2023 | The Greenhouse Gas Emissions Trading Scheme Auction (Amendment) Regulations 2023 |
| French Ministry for Ecological Transition and Territorial Cohesion | September 14, 2023 | Relevant decree of August 30, 2023 (specific content not specified) |
