Monthly Report on Chemical and Environmental Regulatory Developments in the Consumer Goods Sector - November 2023

I. Core Developments in EU Chemical Regulation

(I) New Restrictions on Plastic Glitter and Other Microplastics

On October 17, 2023, the European Commission published updated considerations regarding the scope of application of microplastic restrictions (Entry 78 of Annex XVII to the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)), explicitly including plastic glitter both individually and in products within the regulatory scope. The core rules are as follows:

1. Core Content of the Ban: Starting from the same day, the sale of products containing plastic glitter (except biodegradable or dissolvable ones) either individually or intentionally added is prohibited. Uses without a transition period, such as craft kits, toys, and Christmas decorations, are directly subject to this ban.

2. Definition of Exemptions:

• Plastic glitter fixed in solid matrices (e.g., glitter glue), solid films (e.g., paints, inks), solid objects (e.g., inside jewelry), or fully encapsulated (e.g., in snow globes) is not subject to the ban.

• Glitter-containing items where the decorative function is secondary (e.g., textiles for clothing, footwear, curtains, etc.) are exempt as the glitter is considered an integral part of the item.

• Glitter can only be deemed an integral part of an item and thus exempt if it does not detach during normal use (including storage).

3. Supplementary Implementation Notes: Currently, there is no standard test method to verify whether glitter detaches. An official Q&A guide is scheduled to be released by the end of 2023. Imported products that do not comply with the transition period provisions must arrive at EU customs by October 17, 2023, to be eligible for derogation provisions.

(II) Advancement of Per- and Polyfluoroalkyl Substances (PFAS) Restrictions

The consultation phase for the PFAS restriction proposal concluded on September 25, 2023, receiving over 5,600 comments from more than 4,400 organizations, companies, and individuals. The subsequent process will proceed as follows:

1. Comments will be reviewed by five initiating countries (Denmark, Germany, the Netherlands, Norway, and Sweden) and the European Chemicals Agency (ECHA)’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC);

2. RAC and SEAC will formulate scientific opinions for ECHA to submit final recommendations;

3. The European Commission, together with EU member states, will decide whether to implement the restrictions.

(III) Launch of Hexavalent Chromium Restriction Proposal

On October 11, 2023, ECHA was authorized by the European Commission to initiate the preparation of an Annex XV report, proposing restrictions on hexavalent chromium substances listed in Entries 16 and 17 of the REACH Authorization List (Annex XIV). The process will follow standard REACH procedures: after evaluation by RAC and SEAC, the European Commission will adopt restriction measures. If implemented, this will mark the first time in REACH history that substances are removed from the Authorization List.

(IV) Relevant Regulatory Resource Links

1. REACH-related: Register of Intentions for Restrictions, Register of Intentions for Substances of Very High Concern (SVHC), Community Rolling Action Plan (CoRAP), Adopted Opinions and Past Authorization Application Consultations, etc. (all available on the ECHA website);

2. CLP-related: Register of Intentions for Classification and Labeling Inventory (CLH), Harmonized Classification and Labeling Consultations (all available on the ECHA website).

II. New Regulations on Endocrine-Disrupting Substances in France

On October 12, 2023, the French Minister for Ecological Transition and Territorial Cohesion published several decrees related to endocrine-disrupting substances (drafted on September 28, 2023), which officially took effect on October 13, 2023. The core content is as follows:

1. Decree No. 13:

• Identifies three categories of substances/products: commercial substances with proven or suspected endocrine-disrupting properties, substances suspected of having endocrine-disrupting properties, and product categories with specific exposure risks;

• Regulatory Objective: In accordance with the "Anti-Waste for a Circular Economy Act" (AGEC Act), requires providing the public with information on relevant substances in ingredients, mixtures, articles, and food in an electronic open format. The French National Agency for Food, Environmental and Occupational Health Safety (ANSES) is responsible for classifying these properties.

2. Decree No. 14: Designates "Scan4Chem" as an alternative method for providing the public with information on relevant substances.

III. Key U.S. Chemical Regulatory Initiatives

(I) Finalization of PFAS Data Reporting Rule

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized one-time reporting requirements for PFAS under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The rule took effect on November 13, 2023, with the following core details:

1. Reporting Entities and Scope: Any person who manufactured, imported, or has ever manufactured or imported PFAS or PFAS-containing articles in any year since January 1, 2011, must report relevant activities for each calendar year from 2011 to 2022, with no minimum threshold.

2. Definition of PFAS: Adopts a broad structural definition covering three specific chemical structures. The EPA confirmed that at least 1,462 PFAS known to be manufactured or used in the U.S. meet this definition, and the list will be published on the "CompTox Chemicals Dashboard".

3. Reporting Process and Timelines:

• Companies must collect information within one year of the effective date and submit reports within the subsequent six months;

• The reporting deadline for most companies is May 8, 2025, with submissions opening on November 12, 2024;

• The deadline for "small manufacturers" importing only PFAS-containing articles is November 10, 2025;

• Submissions must be made through EPA’s CDX portal.

4. Reporting Content and Record-Keeping:

• Those manufacturing/importing PFAS substances or mixtures must use standard forms, while those importing PFAS-containing articles may use simplified forms (including company information, chemical information, use categories, import volumes, etc.);

• Records must be retained for 5 years from the last day of the submission period.

5. Small Manufacturer Criteria: Eligible if meeting either condition: annual total sales below $120 million (except if annual production/import volume of a specific substance at a single site exceeds 45,400 kg); annual total sales below $12 million (no volume restrictions). Sales thresholds will be adjusted every five years based on the Producer Price Index for chemicals and related products (when changes exceed 20%).

(II) Proposed Revisions to California Proposition 65 Warning Requirements

On October 27, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking (NPR) to revise the "clear and reasonable warning" provisions of Proposition 65. The public comment period closes on December 20, 2023. Key changes and comparisons between current and proposed requirements are as follows:

1. Major Revisions:

• Requires short-form warnings to identify specific chemicals;

• Clarifies that short-form warnings can be used for food product safe harbor warnings;

• Refines warning requirements for products sold online and via catalogs;

• Adds signal word options for food warnings;

• Creates new customized warning methods for chemical exposure from passenger vehicle, off-highway vehicle, and recreational vessel components.

2. Comparison of Current and Proposed Warning Requirements:| Substance of Exposure | Current Warning | Proposed Warning ||------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|| Carcinogens | WARNING : Cancer – www.P65Warnings.ca.gov | WARNING or CA WARNING or CALIFORNIA WARNING: Cancer risk from exposure to [chemical name]. or Can expose you to [chemical name], a carcinogen. See www.P65Warnings.ca.gov || Reproductive Toxicants | WARNING: Reproductive Harm – www.P65Warnings.ca.gov | WARNING or CA WARNING or CALIFORNIA WARNING: Risk of reproductive harm from exposure to [chemical name]. or Can expose you to [chemical name], a reproductive toxicant. See www.P65Warnings.ca.gov || Both Carcinogens and Reproductive Toxicants | WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov | WARNING or CA WARNING or CALIFORNIA WARNING: Risk of cancer from exposure to [chemical name] and reproductive harm from exposure to [chemical name]. or Can expose you to [chemical name], a carcinogen, and [chemical name], a reproductive toxicant. See www.P65Warnings.ca.gov || Substances Listed as Both Carcinogens and Reproductive Toxicants | WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov | WARNING or CA WARNING or CALIFORNIA WARNING: Risk of cancer and reproductive harm from exposure to [chemical name]. or Can expose you to [chemical name], a carcinogen and reproductive toxicant. See www.P65Warnings.ca.gov |

IV. Latest Developments in Environment and Sustainability

Summary of Key International and EU Publications

V. Regulatory Updates for Cosmetics and Personal Care Products

California enacted new legislation in 2023, banning 26 high-risk ingredients in cosmetics and personal care products. These ingredients, which may increase risks of burns, cancer, birth defects, reproductive issues, etc., are among the 1,600 ingredients already banned globally. Some typical ingredients and their uses are as follows:

• Vinyl Acetate: Used in nail polish to enhance adhesion;

• Anthraquinone: Used in hair dye products;

• Lilial: Used in perfumes, shampoos, body washes, etc.

The law will take effect on January 1, 2027, allowing companies time to complete ingredient substitution and product adjustments.