Chemicals | Monthly bulletin | August 2024

Eurofins newsflash Chemical

Europe

Status of European initiatives related to chemicals

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

Published initiative

Status

Persistent organic pollutant - dechlorane plus

This draft regulation to amend Part A of Annex I to the Regulation (EU) 2019/1021 on persistent organic pollutants (POP) which implements the EU’s international commitments under the Stockholm Convention on persistent organic pollutants.

This substance shall be subject to certain restrictions and exemptions.

The Draft act feedback period was closed on the 24^th of July 2024.

The Commission’s adoption is planned for the fourth quarter of 2024

Persistent organic pollutants - Polychlorinated biphenyls (PCB)

This initiative amends the PCB entry in Annex I by specifying an unintentional trace contaminant limit value, which is the maximum concentration at which PCB may be unintentionally present in substances, mixtures or articles.

The European Commission is working on the preparation of the Draft Act.

The Commission’s adoption is planned for the fourth quarter of 2024

Interesting resources on the REACH Regulation on ECHA’s website

Interesting resources on the CLP Regulation on ECHA’s website

Technical publication related to PFAS

The table below outlines recent publications related to perfluoroalkyl and polyfluoroalkyl substances (PFAS):

Date	Entity	Publication
30/05/2024	French National Assembly	Proposition de loi n°2710 On the 30^th of May 2024, the Senate adopted the bill on first reading. The National Assembly must now examine the text on second reading. The bill will implement a ban from the 1^st of January 2026, affecting the following sectors: cosmetics; waxes; clothing, shoes and their waterproofing agents (except protective clothing and shoes, such as those used by the military or firefighters). From 2030, all textiles (e.g. furniture) containing PFAS will be banned in France (with the exception of industrial-use textiles). Products which contain only traces of PFAS, will be excluded from this ban. Residual concentration thresholds will be defined by decree. Another amendment will indicate the specific control and administrative sanctions related to this new ban.
24/06/2024	Republique Française (Vie-publique)	Eternal pollutants: the essentials on PFAS in 5 questions On the 30^th of May 2024, the Senate adopted a bill aimed at restricting the manufacture and sale of products containing PFAS, also known as “perennial pollutants”. Vie-publique addresses five key questions on this public health subject.
07/06/2024	German Federal Institute for Risk Assessment (BfR)	Questions and answers about phthalate plasticisers This German entity published a compilation of relevant questions and answers related to phthalates plasticisers, with the aim of informing consumers about these substances and their hazards.

Great Britain’s mandatory classification and labelling list update

On the 26^th of June 2024, the United Kingdom’s Health and Safety Executive (HSE) published the Ministerial decision on 88 chemical substances from the 14^th and 15^th Adaptations to Technical Progress to Regulation (EC) No. 1272/2008.

Using Article 37 and Article 37A procedures of the GB CLP Regulation, HSE has updated the GB Maximum Concentration Limit (MCL) list, giving legal effect to the GB MCLs for 88 substances, while removing entries for titanium dioxide (in powder form) and granulated copper.

These substances were not retained in GB law at the end of the Implementation Period on the 31^st of December 2020.

It came into force on the 26^th of June 2024.

Rhode Island Regulates PFAS in Various Consumer Products

On June 26, 2024, the State of Rhode Island approved Bill S2152 to regulate Perfluoroalkyl and polyfluoroalkyl substances (PFAS) in various consumer products. PFAS is defined as substances that include any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom. Please see details of the new regulation in Table 1 below:

Table 1:

Product Category	Requirement	Effective Date
Carpets or rugs	Prohibited if PFAS is intentionally added	January 1, 2027
Cookware
Cosmetics
Fabric treatments
Juvenile products
Menstrual products
Ski wax
Textiles articles
Artificial turf	Prohibited if PFAS is intentionally added	January 1, 2029
Outdoor apparel for severe wet conditions	Prohibited if PFAS is intentionally added unless labeled “Made with PFAS chemicals”	January 1, 2029

Canada

Canada Amends Products Containing Mercury Regulations

On June 19, 2024, Canada issued the Regulations Amending the Products Containing Mercury Regulations: SOR/2024-109 (the Amendments) to amend the Products Containing Mercury Regulations (SOR2014-254). The Products Containing Mercury Regulations (the Regulations) came into force on November 8, 2015 to prohibit the manufacture and import of products containing Mercury or any of its compounds, with exemptions for essential products that do not have technically or economically viable alternatives.

In 2017, Canada ratified the Minamata Convention on Mercury (the Convention), an international treaty that is a legally binding agreement under the United Nations Environment Program that aims for the global reduction of anthropogenic mercury pollution. As the Regulations came into force prior to the ratification, it does not fully align with all the requirements of the Convention and its amendments. The Amendments will allow Canada to align its regulations with the Convention and its amendments as well as other recent industry standards and international regulatory initiatives.

The Amendments will prohibit the import and manufacture of various types of lamps for general light purposes, including Screw-base compact fluorescent lamps, Pin-base compact fluorescent lamps, Straight fluorescent lamps, and Non-linear fluorescent lamps on December 31, 2025. High-pressure sodium vapour lamps and metal halide lamps used for general lighting purposes will be prohibited on December 31, 2028.

The Amendments will become effective on June 19, 2025.

Canada Adds 3 Products as Hazards of Concern

On July 10, 2024, Health Canada updated Table 1 of its approach to the General Prohibitions under the Canada Consumer Product Safety Act to include infant bath seats, water beads, and lithium-ion batteries as hazards of concern. Hazards associated with classes of consumer products that are listed on Table 1 have not yet undergone an assessment to determine whether they pose a danger to human health or safety. However, the listing of a hazard on Table 1 indicates that it may pose a danger to human health or safety. Regulated parties are encouraged to take steps to mitigate the identified hazards if they have not already.

Table 1:

Class of Consumer Products	Hazard(s) of Concern	Performance Criteria being Evaluated
Infant bath seats (products that support an infant in a seated position during bathing, excluding products that retain water for bathing)	Drowning	Health Canada has reviewed the performance criteria in the following voluntary safety standards and determined neither standard can sufficiently mitigate the drowning hazard inherent to infant bath seats: ASTM F1967-19 Standard Consumer Safety Specification for Infant Bath Seats EN 17022:2018 Child care articles. Bathing aids. Safety requirements and test methods. Health Canada continues to investigate whether there are other measures that can sufficiently mitigate the drowning hazard.
Water Beads (superabsorbent polymer balls, water-absorbing beads)	Ingestion leading to obstruction of the gastrointestinal tract; insertion into ear or nose; aspiration	Health Canada is monitoring the development of new performance criteria for this class of products, including developments of the ASTM F963 Standard Consumer Safety Specification for Toy Safety. Health Canada is also evaluating other potential requirements, such as prohibiting water beads that fit within a small parts cylinder in their dry state.
Lithium-ion batteries, and consumer products that contain lithium-ion batteries	Burn, fire, or explosion	CSA C22.2 No.62133-2:20 - Secondary cells and batteries containing alkaline or other non-acid electrolytes — Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications — Part 2: Lithium systems (Bi-national standard with UL 62133-2, harmonized with IEC 62133-2); or UL 1642, 6^th edition - Lithium Batteries; or UL 2054, 3^rd edition - Household and Commercial Batteries; or the equivalent; and any requirements for the Battery Management System (BMS) that may be specified within a consumer product's associated safety standard; or the equivalent.

Japan

Japan Adds PFOA as Class I Specified Substances

On July 10, 2024, Japan issued Cabinet Order No. 244 to add Perfluorooctanoic acid (PFOA) isomers and PFOA-related substances as Class I Specified Substances under the Enforcement of the Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances. The Cabinet Order will become effective on January 10, 2025.

The Cabinet Order has made below significant revisions:

Includes PFOA isomers as part of PFOA and its salts as Class I Specified Substances
Prohibits below products containing PFOA-related substances (defined as Perfluorooctyl iodide, 8:2 Fluorotelomer alcohol, and compounds containing a perfluoroalkyl group directly bonded to a carbon atom (limited to those with a carbon number of 7), which, through natural processes, produces PFOA (branched in structure and limited to those with a carbon number of 8)
- Floor wax
- Protective and stain-resistant agents for textile products
- Water- and oil-repellent agents
- Textile products treated with water-repellent and oil-repellent coatings
- Defoaming agents
- Coating agents
- Optical fibers or their surface coating agents
- Fire extinguishers, fire extinguishing agents for fire extinguishers, and foam extinguishing agents

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
French Via Publique entity	12/06/2024	Publication of several news articles related to the Circular economy: Circular economy: a first assessment of the “AGEC law” The Circular economy in four questions
European Commission	18/06/2024	Report from the commission to the European Parliament and the Council on the implementation of Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards the better enforcement and modernisation of Union consumer protection rules.
European Commission	26/06/2024	Opinion of the European Committee of the Regions – Preventing plastic pellet losses to reduce microplastic pollution. This proposal provides recommendations for amendments to the Regulation of the European Parliament and of the Council on preventing plastic pellet losses to reduce microplastic pollution.
Swedish Ministry of Climate and Business	26/06/2024	Ordinance amending the Ordinance (2020:1180) on certain greenhouse gas emissions Greenhouse gases or gases that deplete the ozone layer. The aim of the regulation is to introduce the new EU emissions trading system for fossil fuels, European Technical Standard (ETS) 2, including the requirement to monitor and report emissions from fuel products that are made available in specifically designated sectors, and the requirement to surrender allowances.
European Commission	28/06/2024	Forest protection – information system to support EU rules on ‘deforestation-free’ products The European Commission is working on preparing the Draft Act which provides an information system that will contain due diligence statements submitted by businesses. These statements shall demonstrate that the products that businesses intend to sell in the EU or export comply with the new rules. The Commission’s adoption is planned for the third quarter of 2024.
European Commission	05/07/2024	Directive (EU) 2024/1760 of the European Parliament and of the Council of 13 June 2024 on corporate sustainability due diligence and amending Directive (EU) 2019/1937 and Regulation (EU) 2023/2859Text with EEA relevance. Official publication of the Corporate Sustainability Due Diligence Directive (CSDDD) which protects environmental and human rights in the EU.
Ministry for the Ecological Transition and the Demographic Challenge of Spain	10/07/2024	Draft royal decree amending royal decree 163/2014 of the 14^th of March, which creates a carbon footprint registry, compensation and carbon dioxide absorption projects This project will soon be approved and will introduce several key measures, including the obligation for companies to calculate their carbon footprint and develop an emissions reduction plan, in compliance with Law 7/2021 on Climate Change and Transition. It establishes that the obligations will come into force on the 1^st of January 2025, referring to the carbon footprint for the year 2024. Therefore, all obligated companies must calculate their carbon footprint for the year 2024.
European Commission	10/07/2024	Endangered animal and plant species – suspension of imports from non-EU countries (update) The European Commission is working on a Draft Act which shall update the list of endangered animal and plant species using the criteria set out in the Council Regulation 338/97, and according to the opinion of the Scientific Review Group, thus gathering scientific experts from various EU countries.
European Commission	11/07/2024	Forest protection – electronic interface for sending data on ‘deforestation-free’ products The European Commission is preparing a Draft Act aimed at establishing a regulation for an electronic interface to facilitate data exchange between national customs systems and the information system supporting the new rules under Regulation (EU) 2023/1115.
European Commission	12/07/2024	Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act).
European Commission	19/07/2024	Export and import of hazardous chemicals – review of the list of chemicals subject to international trade rules. This European initiative is open for feedback until the 16^th of August 2024. Its aim is to update the list of internationally traded hazardous chemicals. Once a chemical has been put on the list, it can only be exported if certain conditions are met.