Chemicals Monthly Bulletin - November 2024

I. Updates to Chemical Regulations in Europe

(I) New Substance Added to the Candidate List of Substances of Very High Concern (SVHCs)

On November 7, 2024, the European Chemicals Agency (ECHA) released the updated Candidate List of SVHCs, with one new substance added. Currently, the total number of substances on the Candidate List of SVHCs has reached 242.

(II) New Limits under the Persistent Organic Pollutants (POP) Regulation

1. Updated Limits for Hexabromocyclododecane (HBCDD) : On September 27, 2024, the European Commission published Commission Delegated Regulation (EU) 2024/2555, which amends the table in Part A of Annex I to Regulation (EU) 2019/1021 (the POP Regulation). The entry for "Hexabromocyclododecane and its main diastereoisomers" was revised in point 1 of the fourth column. This revision affects the "Specific exemption for intermediate use or other specifications" and limit values of these substances. The new limits are as shown in the table below:|Applicable Objects|Limit Value|| ---- | ---- ||Substances, mixtures, articles, or as components of flame-retarded articles|≤ 75 mg/kg (0.0075% by weight)||Recycled polystyrene used in the production of EPS and XPS insulation materials for buildings or civil engineering works|≤ 100 mg/kg (0.01% by weight)|Note: The European Commission shall review and assess the exemptions specified in this point by January 1, 2026. This Regulation entered into force on October 17, 2024.

2. New Entry for Methoxychlor : On September 27, 2024, the European Commission published Delegated Regulation (EU) 2024/2570, which amends the table in Part A of Annex I to Regulation (EU) 2019/1021 (the POP Regulation). This amendment adds the entry for "Methoxychlor and isomers of dimethoxydiphenyltrichloroethane or any combination thereof". The "Specific exemption for intermediate use or other specifications" is that when these substances are present in substances, mixtures, or articles, the limit value shall be equal to or below 0.01 mg/kg (0.000001% by weight).

(III) Revision of Harmonised Classification and Labelling of Substances

On September 30, 2024, the European Commission published Delegated Regulation (EU) 2024/2564, which amends Part 3, Table 3 of Annex VI to Regulation (EC) No 1272/2008 regarding the harmonised classification and labelling of certain substances. This revision adds 27 entries, replaces 16 entries, and deletes 7 entries.

(IV) End of the Transition Period for Poison Centre Notifications

The transition period for poison centre notifications is coming to an end. From January 1, 2025, notifications for hazardous mixtures placed on the EU market must follow the harmonised format specified in Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation, and the label must include the Unique Formula Identifier (UFI). Non-harmonised national requirements will no longer be valid.

(V) Status of European Initiatives Related to Chemicals

(VI) Relevant Resources on the CLP Regulation on ECHA's Website

Reference can be made to the "Harmonised Classification and Labelling Consultations" on the ECHA website at (europa.eu).

(VII) Draft Regulation in Spain

On September 23, 2024, the Ministry for the Ecological Transition and the Demographic Challenge notified the European Commission of the Draft Order on Declaring Certain Substances and Articles as By-Products in accordance with Law 7/2022 of April 8, 2022, on Contaminated Waste and Soil for a Circular Economy. This Order establishes requirements for declaring certain substances and articles of various natures (such as those from aluminium production, electrolytic copper production, oxalic acid synthesis, agri-food industries, etc.) as by-products, including: requirements for substances and articles to be declared as by-products; obligations of producers of such substances and articles; obligations of users; monitoring by Autonomous Communities; and potential shipments of by-products within the European Union.

II. Updates to Relevant Regulations in the United States - Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Regulations

On September 29, 2024, California Governor Gavin Newsom signed California Assembly Bill 347 (AB 347), which marks a significant legislative step in regulating perfluoroalkyl and polyfluoroalkyl substances (PFAS) in consumer products. PFAS, often referred to as "forever chemicals" due to their persistence in the environment and the human body, are synthetic substances widely present in various products such as juvenile products, textiles, and food packaging. Although they offer properties like water and stain resistance, their potential health risks, including cancer and liver damage, have prompted regulatory action.

(I) Main Content of AB 347

AB 347 brings the existing PFAS regulations covering juvenile products, textiles, and food packaging under the jurisdiction of the Department of Toxic Substances Control (DTSC). The bill outlines a phased implementation plan, requiring manufacturers to register their products, certify compliance, and adhere to testing and reporting standards. Additionally, the DTSC will be responsible for enforcing these regulations, conducting product testing, and imposing penalties for non-compliance. Notices of violation will be published on the DTSC website to ensure transparency and public accountability. The primary objective of this law is to reduce consumer exposure to harmful PFAS while establishing a clear and enforceable framework for manufacturers. The phased timeline of AB 347 provides companies with time to comply, but failure to do so will result in significant penalties.

(II) Key Provisions of AB 347

1. Expansion of Existing PFAS Laws : AB 347 expands the existing laws regulating PFAS in juvenile products, textiles, and food packaging by placing these categories under the jurisdiction of the DTSC, ensuring consistency in the application of restrictions and enforcement measures across all product types.

2. Restricted Definition of Juvenile Products : The bill narrows the definition of juvenile products to those specifically mentioned in the law, such as cribs, mattresses, and play mats. This targeted approach focuses the law on products that are most likely to expose children under 12 years of age to PFAS.

(III) Relevant Requirements

1. Regulations for Enforcement (by January 1, 2029) : The DTSC is required to adopt regulations to implement and enforce PFAS restrictions by January 1, 2029. These regulations will provide a framework for manufacturers to ensure compliance.

2. Manufacturer Registration (by July 1, 2029) : By July 1, 2029, manufacturers must register their products with the DTSC. The registration process includes: providing the name and description of each covered product they manufacture; paying registration fees; and submitting a Statement of Compliance certifying adherence to PFAS prohibitions.

3. Compliance and Enforcement (from July 1, 2030) : Starting from July 1, 2030, the DTSC will enforce PFAS restrictions through product testing, random sampling, and other regulatory measures.

4. Legislative Reporting (by July 1, 2033) : By July 1, 2033, the DTSC must submit a report to the Legislature detailing its compliance and enforcement activities under AB 347, including summaries of tested products, issued violations, and imposed penalties.

(IV) Manufacturer Compliance Requirements

1. Statement of Compliance : Manufacturers must submit a statement certifying that each covered product complies with PFAS restrictions. The DTSC may request analytical test reports to verify compliance. By January 1, 2029, the DTSC will publish a list of accepted testing methods and accredited third-party laboratories to standardize testing procedures across industries.

2. Publication of Notices of Violation : In cases of non-compliance, the DTSC may issue a Notice of Violation in accordance with Section 108083. The department is required to: publish the notice on its website, including relevant product information for each covered product subject to the violation; develop a process to keep interested parties informed of updates to notices of violation to ensure transparency; and receive and verify reports of alleged PFAS violations from consumers, businesses, and other entities, and assess administrative penalties based on verified findings.

3. Testing Disclosures and Compliance Verification : While AB 347 does not mandate blanket product testing, it grants the DTSC the authority to request technical documentation from manufacturers to verify compliance with PFAS restrictions, including the submission of test results conducted using DTSC-approved analytical methods. Manufacturers are expected to maintain records demonstrating that their products meet applicable PFAS laws and be prepared to provide these results upon request. The DTSC will publish a list of approved testing methods and accredited laboratories, which manufacturers should consult to ensure they follow the appropriate procedures.

(V) Existing PFAS Laws Now Under DTSC Jurisdiction

1. AB 1200 (2021) - PFAS in Food Packaging and Cookware : The prohibition stipulates that as of January 1, 2023, PFAS in food packaging is prohibited. Starting from January 1, 2024, cookware containing PFAS must include clear labeling with additional disclosure on product websites. A key compliance requirement is that PFAS in food packaging must be replaced with the least toxic alternatives.

2. AB 652 (2021) - PFAS in Juvenile Products : The prohibition states that as of July 1, 2023, new juvenile products containing regulated PFAS cannot be sold in California. These products include cribs, mattresses, strollers, and other items for children under 12 years of age. A key compliance requirement is that manufacturers must eliminate PFAS from juvenile products and use the least toxic alternatives.

3. AB 1817 (2022) - PFAS in Textiles : The prohibition mandates that starting from January 1, 2025, textile articles containing regulated PFAS are prohibited. Outdoor apparel for severe wet conditions is exempt until January 1, 2028. However, from January 1, 2025, such apparel containing PFAS must include a label stating "Made with PFAS chemicals" on both physical products and online listings. Total Organic Fluorine (TOF) as a Proxy: PFAS in textiles can be measured using Total Organic Fluorine (TOF) as a proxy, with thresholds set at 100 ppm, decreasing to 50 ppm by 2027.

(VI) Enforcement and Penalties

1. Enforcement Entities and Methods : Enforcement of AB 347 will be conducted by the California Attorney General or the DTSC. The DTSC may initiate enforcement actions based on reports submitted by consumers, businesses, research institutions, and non-profit entities. The DTSC will conduct independent testing, verification, or inspection of the reports to determine violations.

2. Penalty Standards : For violations of PFAS restrictions, the department may assess administrative penalties starting at $10,000 for the first offense. Additional penalties may accrue for ongoing violations. Penalties will be determined based on: the severity of the violation; the violator's history of prior offenses and cooperation with authorities; and whether the violation was willful or accidental.

(VII) Implications for Industry

Manufacturers of juvenile products, textiles, and food packaging must comply with the new requirements under AB 347. Compliance involves registering products with the DTSC and submitting a Statement of Compliance certifying that products meet PFAS restrictions. Failure to adhere to these requirements may lead to substantial financial penalties and reputational damage, especially since violations will be publicly posted on the DTSC website. Companies must review their product lines for PFAS content and take necessary steps to meet the compliance deadlines set by the law.

(VIII) Conclusion

California AB 347 sets a new standard in PFAS regulation, providing clear guidelines for manufacturers and establishing robust enforcement mechanisms. The law not only protects consumers from harmful chemicals but also promotes transparency by publishing notices of violation for public access. Companies that comply with AB 347 will demonstrate leadership in environmental responsibility, while those that fail to meet the requirements will face substantial penalties. As enforcement deadlines approach, manufacturers must take immediate action to align their products and processes with the law.

III. Regulations Related to Sustainability, Circular Economy, and the Environment

The table below summarizes some of the latest publications (non-exhaustive) regarding sustainability, the circular economy, and the environment: