Chemicals | Monthly bulletin | November 2024

Eurofins newsflash Chemical

Europe

New update to Candidate List of Substances of Very High Concern (SVHCs)

On 7^th November 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs with the addition of one new substance. The current list of SVHCs now contains 242 substances.

New limits for HBCDD under POP Regulation

On the 27^th of September 2024, the European Commission published the Commission Delegated Regulation (EU) 2024/2555 which amends the table of Part A of Annex I in the Regulation (EU) 2019/1021 (POP Regulation).

The entry Hexabromocyclododecane and its main diastereoisomers was amended in the fourth column, point 1. This amendment affects the “Specific exemption on intermediate use or other specification” of these substances and the limit values. The new limits are:

For substances, mixtures, articles or as constituents of the flame-retarded articles.	For recycled polystyrene in the production of EPS and XPS insulation material for use in buildings or civil engineering works.
≤ 75 mg/kg (0,0075 % by weight)	≤ 100 mg/kg (0,01 % by weight)
Note: The exemptions laid down in this point 1 shall be reviewed and assessed by the Commission by the 1^st of January 2026

This Regulation enters into force on the 17^th of October 2024.

New entry in POP Regulation: Methoxychlor

On the 27^th of September 2024, the European Commission published the Delegated Regulation (EU) 2024/2570 which amends the table of Part A of Annex I in the Regulation (EU) 2019/1021 (POP Regulation).

This amendment adds the entry Methoxychlor and isomer of dimethoxydiphenyltrichloroethane or any combination thereof. The specific exemption on intermediate use or other specification is the limit equal to or below 0.01 mg/kg (0,000001 % by weight) where they are present in substances, mixtures or articles.

Amendment about harmonised classification and labelling of substances

On the 30^th of September 2024, the European Commission published the Delegated Regulation (EU) 2024/2564 which amends Part 3, Table 3 of Annex VI in the Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances.

This amendment inserts 27 entries, replaces 16 entries, and deletes 7 entries.

For more information, consult the complete list in the official publication on the European Commission website here.

The end of the transition period for poison centre notifications

The transition period of poison centre notifications is finnishing. From the 1^st of January 2025, notifications for hazardous mixtures placed on the EU market must be in the harmonised format according to Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation and include the unique formula identifier (UFI) on the label. The non-harmonised national requirements will not be valid.

For more information and support, consult the poison centre website here.

Status of European initiatives related to chemicals

Below is a table that summarises the status of these initiatives:

Published initiative	Status
Export and import of hazardous chemicals – review of the list of chemicals subject to international trade rules. The aim is to support non-EU countries in preventing unwanted imports, and to ensure that information on hazards, risks and safe handling is exchanged when these chemicals are exported. Once a chemical has been put on the list, it can only be exported if certain conditions are met.	It was adopted on 15^th October 2024 by the European Commission
Chemicals regulation – update of EU rules for test methods This initiative will add a number of new/updated methods to that list. These methods could: reduce the number of animals needed to test for chemical hazards refine certain tests to obtain more reliable/precise results on chemical hazards.	It was adopted on 23^rd September 2024 by the European Commission
Electrical equipment – cadmium in oxygen sensors (RoHS exemption) The exemption under assessment concerns cadmium used in electrochemical oxygen sensors in industrial monitoring and control instruments.	In preparation
Electrical equipment – mercury in optical components (RoHS exemption) The exemption under assessment concerns mercury in mercurous chloride monocrystals (calomel), which are used for optical components in electrical and electronic equipment (EEE) such as polarisation optical or acousto-optical applications.	In preparation

Interesting resources on the REACH Regulation on ECHA’s website

Interesting resources on the CLP Regulation on ECHA’s website

Spain

Draft Order about certain substances and articles as by-products

On the 23^rd of September 2024, the Ministry for the Ecological Transition and the Demographic Challenge notified the European Commission about the Draft Order declaring certain substances and articles as by-products under Law 7/2022 of 8 April 2022 on contaminated waste and soil for a circular economy.

This Order establishes the requirements to declare certain substances and articles of a different nature (production of aluminium, electrolytic copper, synthesis of oxalic acid, agri-food industries and others) as by-products, in accordance with Law 7/2022. The Order provides as follows:

Requirements for substances and articles to be declared as by-products.
Obligations of producers of substances and articles.
User obligations.
Monitoring by the Autonomous Communities.
Potential shipments of the by-product within the European Union.

For more information, consult the TRIS notification 2024/0536/ES.

PFAS regulations

California Assembly Bill 347 (AB 347), signed into law by Governor Gavin Newsom on the 29^th of September 2024, represents a significant legislative step in regulating perfluoroalkyl and polyfluoroalkyl substances (PFAS) in consumer products.

Often referred to as "forever chemicals" due to their persistence in the environment and the human body, PFAS are synthetic substances found in a wide range of products, including juvenile products, textiles, and food packaging. Although they offer benefits such as water and stain resistance, their potential health risks, including cancer and liver damage, have prompted regulatory action.

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 approach for implementation, requiring manufacturers to register their products, certify compliance, and adhere to testing and reporting standards. Additionally, the DTSC will be tasked with enforcing these regulations, conducting product tests, and issuing penalties for non-compliance. Notices of violation will be published on the DTSC’s website to ensure transparency and public accountability.

The law's primary objective is to reduce consumer exposure to harmful PFAS while establishing a clear and enforceable framework for manufacturers. AB 347’s phased timeline allows companies time to comply, but failure to do so will result in significant penalties. This document provides a detailed analysis of the key provisions of the law, its timeline, and its implications for manufacturers and consumers.

Key Provisions of AB 347

Extension of Existing PFAS Laws

AB 347 extends existing laws regulating PFAS in juvenile products, textiles, and food packaging by placing these categories under the jurisdiction of the DTSC. This ensures consistency in the application of restrictions and enforcement measures across all product types.

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.

Requirements

Regulations for Enforcement (by 01/01/2029)

The DTSC is required to adopt regulations to implement and enforce PFAS restrictions by January 1^st , 2029. These regulations will provide the framework for manufacturers to ensure compliance with the law.

Manufacturer Registration (by 07/01/2029)

By July 1^st , 2029, manufacturers must register their products with the DTSC, and the registration process will include the following:

The name and a description of each covered product it manufactures.
Paying registration fees.
Providing a Statement of Compliance certifying adherence to PFAS prohibitions.

Compliance and Enforcement (from 07/01/2030)

Beginning July 1^st , 2030, the DTSC will enforce compliance with the PFAS restrictions through product testing, random sampling, and other regulatory measures.

Legislative Reporting (by 07/01/2033)

By July 1^st , 2033, the DTSC will submit a report to the Legislature detailing its compliance and enforcement activities under AB 347, including summaries of products tested, violations issued, and penalties enforced.

Manufacturer Compliance

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. The DTSC will publish a list of accepted testing methods and accredited third-party laboratories by January 1^st , 2029, to standardize testing procedures across industries.

Notice of Violation Publication

In cases of non-compliance, the DTSC may issue a Notice of Violation as per 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, ensuring transparency.
Receive and verify reports of alleged PFAS violations from consumers, businesses, and other entities, and assess administrative penalties based on verified findings.

Testing Disclosures and Compliance Verification

While AB 347 does not mandate product testing as a blanket requirement, it grants the Department of Toxic Substances Control (DTSC) the authority to request technical documentation from manufacturers to verify compliance with PFAS restrictions. This includes the submission of test results performed using analytical methods approved by the DTSC. Manufacturers are expected to maintain records demonstrating that their products meet the applicable PFAS laws and be prepared to provide these results, if requested.

The DTSC will publish a list of approved testing methods and accredited laboratories, which manufacturers should consult to ensure they are following the appropriate procedures.

Existing PFAS Laws Now Under DTSC Jurisdiction

AB 1200 (2021) - PFAS in Food Packaging and Cookware
- Prohibition: As of January 1^st , 2023, PFAS in food packaging is prohibited. Starting January 1^st , 2024, cookware containing PFAS must include clear labeling with additional disclosure on product websites.
- Key Compliance: PFAS in food packaging must be replaced with the least toxic alternatives.
AB 652 (2021) - PFAS in Juvenile Products
- Prohibition: As of July 1^st , 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.
- Key Compliance: Manufacturers are required to eliminate PFAS from juvenile products and use the least toxic alternatives.
AB 1817 (2022) - PFAS in Textiles
- Prohibition: Beginning January 1^st , 2025, textile articles containing regulated PFAS are prohibited. Outdoor apparel for severe wet conditions is exempt until January 1^st , 2028. However, from January 1^st , 2025, such apparel containing PFAS must include a label stating "Made with PFAS chemicals," both on physical products and online listings.
- TOF 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.

Enforcement and Penalties

Enforcement

The enforcement of AB 347 will be conducted by the California Attorney General or the DTSC. Enforcement actions can be initiated by the DTSC based on reports submitted by consumers, businesses, research institutions, and not-for-profit entities. The DTSC will independently test, verify, or inspect the reports to determine violations.

Penalties

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.
Whether the violation was willful or accidental.

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 Department of Toxic Substances Control (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 harm, particularly as violations will be publicly posted on the DTSC’s website. It is crucial for companies to review their product lines for PFAS content and take the necessary steps to meet the compliance deadlines set by the law.

Conclusion

California AB 347 sets a new standard in PFAS regulation, providing clear guidelines for manufacturers and establishing strong 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 the enforcement deadlines approach, manufacturers must act now to align their products and processes with the law.

Sustainability, circular economy and environment

Miscellaneous technical publications relating to environmental, plastics, packaging and waste

The table below summarises the most recent publications regarding sustainability, the Circular economy, and the environment (non-exhaustive):

Entity	Date	Publication
Ley Chile	12/08/2024	Law 21691 Electronic signature modifies law no. 21,368, which regulates the delivery of single-use plastics and plastic bottles, and modifies the legal bodies that it indicates, in terms of the entry into force periods of its obligations. The purpose of this law is to postpone the entry into force of the obligations established in articles 3, 4 and 5 of law 21.368. In particular, it extends to 54 months, that is, until February 2026, the deadline for compliance with the provisions on the delivery of single-use products. Likewise, the deadline for the disposal of the percentage of returnable bottles in the display case, provided for in article 8 of the law, is extended to 54 months. Finally, it extends the period from 18 to 40 months from the publication of law 21.368, for the Ministry of the Environment to issue the regulation referred to in the second transitory article of the aforementioned law.
World trade Organization	29/08/2024	G/TBT/N/PER/164 Draft Technical Regulation on reusable plastic tableware and/or flatware. The notified draft Technical Regulation establishes the technical and labelling requirements to be met in the manufacture of reusable plastic tableware and/or flatware for food and beverages for human consumption, to ensure that no microplastic pollution occurs or hazardous substances are produced.
European Commission	18/09/2024	C/2024/5583 Special report 16/2024: EU revenue based on non recycled plastic packaging waste – A challenging start hindered by data that is not sufficiently comparable or reliable.
European Commission	19/09/2024	2024/0527/PL Draft Act amending the Act on Packaging Management and Packaging Waste and certain other Acts. The planned implementation of deposit and return systems and the coordination and supervision of their operation.
European Commission	27/09/2024	Commission Implementing Regulation (EU) 2024/2493 of 23 September 2024 amending Implementing Regulation (EU) 2018/2066 as regards updating the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council.
European Commission	02/10/2024	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2023/1115 as regards provisions relating to the date of application. The Council agreed to the Commission’s proposal to postpone the application date of the regulation by one year. The obligations stemming from this regulation will be binding from: 30 December 2025, for large operators and traders 30 June 2026, for micro- and small enterprises
European Commission	04/10/2024	Ordinance on Strengthening the Management of Commercial Municipal Waste and Construction and Demolition Waste (2024/0558/DE). The amendments to the Trade Waste Ordinance (GewAbfV). Key content includes: a) Improvement of separate collection b) More stringent pre-treatment obligations c) Format requirements for documentation obligations d) Requirements for pre-treatment plants e) Inclusion of energy recovery plants A definition of non-hazardous asbestos-containing waste is inserted.
European Council	10/10/2024	EU brings product liability rules in line with the digital age and the circular economy. The European Council adopted a directive to update the EU’s civil liability law. It will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Member states have two years to transpose the directive into national law.
European Commission	11/10/2024	Rules on single-use plastics and fishing gear (evaluation) The Single-Use Plastics Directive aims to prevent this waste and reduce its impact on the marine environment. This initiative will evaluate the impact of the Directive’s measures, informing any possible future updates or amendments.
European Commission	11/10/2024	Waste treatment – Amendment to the European List of Waste to address waste batteries and wastes from treating them. This European initiative revises this list to take account of new battery chemistries and fast-changing manufacturing and recycling processes. Its aim in doing so is to improve the identification, monitoring and traceability of the different waste streams and clarify their status as hazardous/non-hazardous waste. The feedback period is opened until the 8^th November 2024.
European Council	14/10//2024	Air quality: Council gives final green light to strengthen standards in the EU. By 2030, the European Commission will review the air quality standards and every five years thereafter, in line with latest scientific evidence. The new rules will contribute to the EU's objective on zero pollution by 2050 and will help prevent premature deaths due to air pollution.
European Commission	18/10/2024	Trade in e-waste (1) – amendments to the Basel Convention annexes. This European initiative was adopted by the European Commission on the 18^th October 2024. The fifteenth Conference of the Parties to the Basel Convention amended the Basel Convention's Annexes II, III and VIII to bring all imports and exports of electrical and electronic waste under the scope of that Convention. This initiative incorporates these changes into EU law (EU Waste Shipment Regulation), which is due for publication in April 2024.
European Commission	18/10/2024	Trade in e-waste (2) – amendments to the Basel Convention annexes. This European initiative was adopted by the European Commission on the 18^th October 2024. The fifteenth Conference of the Parties to the Basel Convention amended the Basel Convention's Annexes II, III and VIII to bring all imports and exports of electrical and electronic waste under the scope of that Convention. This initiative incorporates these changes into EU law (EU Waste Shipment Regulation), which is due for publication in April 2024.
French Ministry of Ecological Transition, Energy, Climate and Risk Prevention	20/10/2024	Order of 8 October 2024 amending the order of 12 December 2022 on data on the extended producer responsibility (EPR) sectors. This decree amends the cross-cutting provisions applicable to EPR sectors of the decree of 12 December 2022, as amended. In particular, it relaxes the schedule for transmitting certain data, specifies the methods for recording flat-rate declarations, introduces a new obligation to transmit the quantity of unsold products, adapts for certain sectors the methods for declaring data relating to waste management and modifies the methods for transmitting regional data to the competent authority for the preparation and monitoring of the SRADDET or PRPGD. The decree enters into force the day after its publication, with the exception of Annex X, which enters into force on the 1^st January 2026.