REACH Restriction on Microplastics

2024 proved to be a year of great ferment in terms of regulatory activity aimed at ensuring the safety and protection of human health and the environment at the community level. Below we would like to list, in chronological order, the most important moments of the year from a regulatory perspective.

CLP:

Delegated Regulation EU 2024/197: published on Jan. 5, 2024, and entered into force on Jan. 25, 2024, the 21st ATP of CLP goes to amend Annex VI of the CLP reg. by introducing or updating the harmonized classification and labeling of a number of substances (such as lead, methyl methacrylate, lithium carbonate, lithium chloride, etc.), after taking into consideration the opinions of the Agency’s Risk Assessment Committee (RAC). The 21st ATP of CLP will apply mandatorily as of September 1, 2025.

New ECHA database: On January 30, 2024, ECHA launches ECHA CHEM, a new chemicals database, accessible at https://chem.echa.europa.eu/

This is ECHA’s new public chemicals database, which contains information from all REACH registrations received by the Agency, thus created to enable better management of the large amount and diversity of data.

The first ECHA CHEM version contains information from more than 100,000 REACh registrations and is being developed incrementally. The information contained in the current “Search for Chemicals” platform, which to date contains information on more than 360,000 chemical substances, will be gradually transferred to “Echa Chem.” In 2025 it is planned to be expanded with the Classification and Labeling Inventory, followed by the first set of regulatory lists.

New Version of IUCLID (8.0.1) is released by ECHA on April 29, 2024, in order to implement the new CLP hazard classes introduced by Reg.(EU) 2023/707.

Delegated Regulation (EU) 2024/2564 (the 22nd ATP of the CLP) published on September 30, 2024, and entered into force on October 20, 2024, this regulation will apply mandatorily as of May 1, 2026. This regulation provides for the inclusion, updating or removal of harmonized classification and labeling for certain substances (such as: acetoxime; peracetic acid … %; silver dust: [particle diameter > 100 nm and < 1 mm]; nano-silver: [particle diameter > 1 nm and < 100 nm]) based on RAC opinions.

Regulation (EU) 2024/2492: published on September 29, 2024, and entered into force on October 20, 2024, amends Regulation (EC) No. 440/2008. In order to reflect technical progress and reduce animal testing, seven new test methods are added to the annex of Regulation (EC) No. 440/2008:

– one new test method for basic physicochemical properties,

– one new and two updated test methods for the determination of human health effects related to in vitro tests for immunotoxicity and skin sensitization,

– three updated test methods for the assessment of ecotoxicity.

Thus, Annex I of Reg. (EC) No. 440/2008 is amended to bring it in line with related legislation (in particular with the CLP reg.) and now contains a reorganized and updated list of relevant test methods for acquiring data on physicochemical, toxicological, and ecotoxicological properties.

Updated Guidelines on the Application of the CLP Regulation Criteria: following the introduction of the new CLP hazard classes, in November 2024 ECHA published the updated guidance for the application of the CLP reg. (version 1.0), which is now revised, reorganized and divided into 5 documents for ease of reference:

Part 1: General Principles for Classification and Labelling

Part 2: Physical Hazards

Part 3: Health Hazards

Part 4: Environmental Hazards

Part 5: Additional Hazards

The technical and scientific guidance contained therein is intended to provide guidance to facilitate the implementation of CLP classification criteria. EFSA provided input in drafting the guidance on endocrine disruptors in Sections 3.11 and 4.2.

Update of CLP Reg. – Reg 2024/2865: published on Nov. 20, 2024, this regulation stems from the need to adapt reg. 1272/2008 (CLP) to technological developments, new sales methods (such as online sales), and the challenges of globalization and digitization. The main changes introduced include:

– New instructions for classification of substances containing more than one constituent (MOCS);

– New instructions for labeling (physical and digital), for folding labels to make them easier, simpler and clearer to read;

– Specific provisions for the sale of bulk chemicals through refill stations to ensure safety and protection of human health;

– Regulations on advertising and distance selling;

– Amendments to Annexes I, II, VI and VIII of the CLP reg.

Reg. 2024/2865 entered into force on December 10, 2024, but as stipulated in Article 2 thereof, its provisions will apply mandatorily thereafter, partly from July 1, 2026, and partly from January 1, 2027, to allow operators to adapt to the new classification, labeling, and packaging rules. There are also exemptions from the application of the new provisions for classification, labeling and packaging of substances and mixtures, applicable partly until June 30, 2026 and partly until December 31, 2026.

We also recall the following very important dates for the current year:

January 1st 2025 – date from which all products placed on the market and subject to CLP notification are required to be notified according to the harmonized format (PCN notification) in accordance with Annex VIII of the CLP reg.

February 1st 2025 – date from which (EU) 2023/1435 (ATP 20 of CLP), which amends Annex VI, Part 3 of Regulation (EC) No. 1272/2008, by updating the harmonized classification and labeling for the following items, applies compulsorily:

– Index No. 005-007-00-2 related to boric acid

– Index No. 005-008-00-8 relating to diboron trioxide

– Index No. 005-011-00-4 relating to tetraboron disodium heptaoxide, hydrate; disodium tetraborate, anhydrous; orthoboric acid, sodium salt; disodium tetraborate decahydrate; disodium tetraborate pentahydrate

– Index No. 607-230-00-6 relating to 2-ethylhexanoic acid and its salts.

May 1st 2025 – date from which for new substances on the EU market the rules in Delegated Regulation (EU) 2023/707, which establishes new hazard classes (ED HH 1 and 2, ED ENV 1 and 2, PBT, vPvB. PMT, vPvM) and new criteria for classification, labeling and packaging of substances and mixtures, apply obligatorily.

November 1, 2026 is the deadline by which companies have time to comply with the requirements of this regulation for substances already on the market before May 1, 2025.

The transition periods provided for mixtures (new and on the market before May 1, 2026) are until May 1, 2026 and May 1, 2028, respectively.

September 1st 2025: date from which the provisions of (EU) 2024/197 (i.e., the 21st ATP CLP) are mandatorily applied.

REACH:

Candidate List 

ECHA has updated the Candidate List adding:

5 hazardous chemicals, and updating 1 existing entry, in January (2,4,6-tri-tert-butylphenol, 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one, Bumetrizole, Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol , Dibutyl phthalate);
1 hazardous chemical in June (Bis(α,α-dimethylbenzyl) peroxide);
1 hazardous chemical in November (Triphenyl Phosphate).

D4, D5, D6

The European Commission published Regulation 1328/2024 that introduces a restriction (Annex XVII) on octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6).

The restriction foresees that D4, D5 and D6 shall not be placed on the market as substances on their own, as a constituent of other substances or in mixtures in a concentration equal to or greater than 0,1 % by weight after 6 June 2026. Furthermore they shall not be used as a solvents for the dry cleaning of textiles, leather and fur after 6 June 2026.

The restriction foresee also some exemptions for specific uses.

Perfluorohexanoic acid, its salts, and related substances (“PFHxA”)

The European Commission published Regulation 2024/2462 that introduces a restriction (Annex XVII) on perfluorohexanoic acid, its salts, and related substances (PFHxA).

Scope of the Restriction: PFHxA shall not be placed on the market, or used, above a specific concentration, in different products such as:

Textiles, leather, and outdoor clothing for consumers.
Food contact materials (FCMs), such as paper and cardboard.
Waterproofing sprays and other mixtures for the general public.
Cosmetic products.
Certain firefighting foams for training and testing purposes.

The restriction foresees some exemptions for specific uses.

Distributor

The Italian Ministry of Health recently released an interpretive note clarifying the definitions of “downstream user” and “distributor” under REACH. This clarification is crucial for businesses to understand their specific obligations under REACH, particularly regarding activities such as repackaging, transferring or handling chemicals.

PFAS

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) have been evaluating the proposal to restrict PFAS in the EU/EEA, longside with the comments received during the public consultation. This evaluation is being carried out in batches, focusing on the different sectors that may be affected by a potential restriction.

Community Rolling Action Plan (CoRAP)

ECHA has published the update of the Community Rolling Action Plan (CoRAP) covering the years 2024, 2025 and 2026.

Purpose of CoRAP: The Community Rolling Action Plan is an initiative where specific substances are selected for evaluation to assess potential risks to human health or the environment. If a substance is listed in CoRAP, it indicates that a Member State has either evaluated it or plans to do so within the next few years.

Details in the CoRAP List: For each substance on the list, the CoRAP table includes the evaluating Member State, the planned year of evaluation, and a brief description of the concerns that led to its inclusion. This information helps in tracking the progress and focus of substance evaluations across the EU.

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