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ECHA:

ECHA Unveils New Chemical Information Database: ECHA CHEM

The European Chemicals Agency (ECHA) has introduced a groundbreaking database, ECHA CHEM, marking a significant enhancement in the accessibility and transparency of chemical information in the European Union (EU). This initiative represents the latest effort by ECHA to provide comprehensive data on chemicals to the public, consolidating industry-submitted data with insights from EU regulatory processes.

ECHA, known for maintaining the EU’s largest chemicals database, has launched the first release of ECHA CHEM. This initial version offers details from all 100,000+ REACH registrations submitted by companies, with plans for future expansions. Upcoming updates will include a revamped Classification and Labelling Inventory and the introduction of regulatory lists.

Mercedes Viñas, ECHA’s Director of Submissions and Interaction, emphasized the importance of ECHA CHEM in improving the agency’s data-sharing capabilities. She highlighted its role in making vast amounts of chemical information readily accessible online in a stable and user-friendly format.

Kai Taka-aho, Director of Information Systems, noted the technical flexibility and future-proof design of ECHA CHEM. The platform is built to accommodate large datasets and adapt to varying needs, including potential new tasks for ECHA, leveraging the latest technological advancements.

ECHA’s journey in providing chemical information began in earnest with the launch of its Information on chemicals platform in 2016. As the platform expanded to include information on over 360,000 chemicals, the need for an advanced system became apparent. In response, ECHA announced its intention in 2022 to develop ECHA CHEM. This new system not only accommodates the increasing diversity and volume of chemical data but also capitalizes on technological progress to enhance data management and accessibility.

 

EU Sets New Standards to Reduce Harmful Substances in Drinking Water

The European Commission has recently established new minimum hygiene standards for materials and products in contact with drinking water. This initiative aims to mitigate the risk of harmful substances, such as PFAS (per- and polyfluoroalkyl substances) and microplastics, leaching into drinking water systems. These standards are part of a broader effort to ensure the safety and quality of drinking water across the EU.

Applicable from 31 December 2026, these standards will cover a wide range of materials and products used in water supply systems, including those for the abstraction, treatment, storage, or distribution of water, as well as for repair works. Items such as supply pipes, valves, pumps, water meters, fittings, and taps will need to comply. Products meeting these standards will be granted an EU declaration of conformity and a unique EU marking, facilitating their unrestricted sale within the single market.

This move is in line with the objectives of the revised Drinking Water Directive (DWD), effective since 2021, which focuses on improving water access and safeguarding both public health and the environment from contamination risks.

In support of the European Commission, the European Chemicals Agency (ECHA) has been instrumental in:

  • Developing European positive lists of substances approved for use in manufacturing materials in contact with drinking water.
  • Creating risk assessment methodologies and information requirements for the review and potential addition of substances to the positive lists.
  • Establishing administrative procedures for regularly updating these lists.

With the first European positive lists adopted on 12 January, the Commission plans to review the DWD’s implementation in January 2032. Meanwhile, the European Parliament and the Council of Ministers have a two-month period to raise objections to the adopted legislative acts.

Further efforts include refining methodologies and guidelines for detecting microplastics and PFAS in drinking water. Additionally, recent EU legislative negotiations have aimed to enhance the Urban Waste Water Treatment Directive (UWWTD), introducing stricter treatment requirements to eliminate micropollutants, showcasing the EU’s commitment to combating water contamination and protecting public health and the environment.

 

EU Parliament Committee Endorses Stricter Toy Safety Standards

The European Parliament’s Environment Committee (ENVI) has cast a significant vote to tighten restrictions on the use of nitrosamines and bisphenols in toys, a move that has sparked concerns among EU toy manufacturers. During a meeting held on 24 January 2024, ENVI voted overwhelmingly in favor of amending the European Commission’s proposed toy safety regulations, adopting stricter limits without exceptions and potentially impacting the availability of ‘safe’ toys in the market.

Key Amendments and Industry Reactions:

  • ENVI proposes stringent migration limits for nitrosamines (0.01mg/kg) and nitrosable substances (0.1mg/kg) in all toys, eliminating the prior exemptions for toys intended for children under 36 months and certain other toys.
  • The Toy Industries of Europe (TIE) warns that such restrictions could render the production of latex balloons, which naturally contain nitrosamines, unfeasible. TIE argues that existing standards already ensure safety and that the new restrictions may unjustly penalize conscientious manufacturers.
  • Additionally, ENVI seeks to lower the allowable trace levels for banned fragrance allergens in toys from 100mg/kg to 10mg/kg, challenging manufacturers to maintain undetectable levels in products like crayons and paints that rely on natural elements.
  • A notable amendment includes a comprehensive ban on all bisphenols in toys, expanding beyond the initial proposal that targeted only bisphenol A. This move has been praised by consumer rights groups as a vital step towards eliminating harmful chemicals from children’s environments.

The ENVI’s stance reflects growing concerns over children’s exposure to carcinogenic and harmful chemicals through toys, aiming for a safer, toxin-free future. However, the toy industry expresses apprehension over the feasibility of these new standards and calls for a more extended transition period to adapt.

With the toy safety regulation proposal now fast-tracked for a plenary vote on 11 March, the debate underscores the tension between advancing public health objectives and addressing industry challenges in ensuring product safety.

 

PCN:

New EU Poison Centre Notification Requirements Now Effective

As of 1 January 2024, companies involved in notifying EU poison centres about mixtures intended for industrial use are now required to follow a harmonized format, as outlined in Annex VIII of the Classification, Labelling and Packaging (CLP) regulation. This new rule mandates that the unique formula identifier (UFI) code must be included on the product’s label, aiming to streamline and enhance the efficiency of hazardous mixture notifications.

ECHA has provided a grace period for companies that had completed their notifications prior to the enforcement date, allowing them a 12-month transition period until 1 January 2025. This period is designed to facilitate the update of notifications and relabeling efforts for products whose composition, identifiers, hazard classification, or toxicological information change.

The implementation of these requirements comes amidst increased scrutiny by national enforcement authorities across the EU. An initiative led by the ECHA Enforcement Forum focused on verifying the compliance of poison centre notifications for hazardous mixtures such as paints, detergents, and adhesives. The operation, which concluded in mid-2023, highlighted the critical need for compliance, with a comprehensive report anticipated early this year.

Moreover, recent inspections in four member states have uncovered significant irregularities in the application of UFI codes, underscoring the importance of adherence to the new regulations.

These developments signify a concerted effort to ensure the safety of industrial mixtures and protect public health through better information management and compliance. Companies eligible for the transition period are encouraged to review their notification status and prepare for the necessary updates to align with the EU’s harmonized standards.

A new year has just begun, and the one we have just left behind has been eventful for those working in the chemical regulatory field; therefore, it is only fitting that we summarize the past 12 months.

Let’s take a look together at what were the most important updates of 2023, a year that was full of news and in some cases a watershed between old and new legislation.

We will proceed by dividing the updates into  two major thematic groups: REACH and CLP.

 

REACH 

Microplastics

The restriction on synthetic polymer microparticles, so called microplastics (entry n. 78 of Annex XVII, REACH Regulation), entered into force on the 17th October 2023.

The restriction arises from the European Commission’s intention to reduce “microplastic pollution”, caused by the presence of tiny fragments of synthetic or chemically modified natural polymers, which are insoluble in water, degrade very slowly and are widespread in the environment.

 

Formaldehyde 

The European Commission restricted formaldehyde and formaldehyde-releasing substances (entry n. 77 of Annex XVII, REACH Regulation).

 

PFAS

ECHA received 5 642 contributions from the public consultation regarding the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the EEA.

 

Bis(2-ethylhexyl) phthalate (DEHP)

The European Commission has extended the deadline for applications to use DEHP in medical devices to 1 January 2029. The sunset date has been extended to 1 July 2030.

 

1,4-dioxane 

The submission of the Restriction report on 1,4-dioxane was postponed to October 2025.

 

Bisphenols

German CA have momentarily withdrawn their restriction proposal on bisphenols that have ED properties to the environment and their salts. The restriction proposal will be updated and re-submitted.

 

Lead in PVC

The European Commission introduced a restriction (entry 63, Annex XVII, REACH) to the use and placing on the market of lead in polyvinyl chloride (PVC) articles.

 

Candidate List

ECHA has updated the Candidate List adding 9 hazardous chemicals in January () and 2 hazardous chemicals in June (Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, Bis(4-chlorophenyl) sulphone).

 

Authorisation List

ECHA has recommended adding 8 substances (ethylenediamine; 2-(4-tertbutylbenzyl)propionaldehyde and its stereoisomers; lead; glutaral; 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone; diisohexyl phthalate and orthoboric acid, sodium salt) to the Authorisation List. Once substances are added to the list, companies will need to apply for authorisation to continue using them.

 

CLP 

Regolamento delegato (UE) 2023/707

On 03/31/2023, the European Commission published in the Official Journal Delegated Regulation (EU) 2023/707, which amends the CLP Regulation by establishing new hazard classes and new criteria for the classification, labelling, and packaging of substances and mixtures.

This legislation is binding on manufacturers, importers, downstream users and distributors placing substances on the EU market and applies from April 20, 2023. There are transition periods from the entry into force of the delegated regulation:

– For new substances on the market, companies will have to comply with the new rules from May 1, 2025, while for substances already on the EU market, they will have until November 1, 2026.

– For mixtures, separate transition periods apply. The new hazard classes will apply from May 1, 2026, to new mixtures, while companies will have until May 1, 2028, to update the classification and labelling of existing mixtures.

  • Delegated Regulations (UE) 2023/1434 e and 2023/143 

On July 11, 2023, the European Union published Delegated Regulations (EU) 2023/1434 and 2023/143, known as ATP 19 and ATP 20 respectively (ATP = adaptation to technical and scientific progress) of CLP, which make interrelated changes:

Commission Delegated Regulation (EU) 2023/1434 amends Annex VI, Part 1 of Regulation (EC) No. 1272/2008 by adding the following notes: Note X (to Section 1.1.3.1), Note 11 and Note 12 (to Section 1.1.3.2), to clarify that:

– the classification of a group of substances under the same heading is based solely on the hazardous properties of that part of the substance common to all substances under that heading;

– in classifying mixtures containing boric acid and its salts and other boric acid/borate releasing compounds as toxic to reproduction, the principle of additivity applies: “Classification of mixtures as toxic to reproduction is required if the sum of the concentrations of the individual boron compounds classified as toxic to reproduction in the mixture placed on the market is ≥ 0.3 %.”

– in classifying mixtures containing certain substances listed in a group entry (such as, for example, 2-ethylhexanoic acid and its salts) as toxic to reproduction, the principle of additivity applies: “Classification of mixtures as substances toxic to reproduction is required if the sum of the concentrations of the individual substances listed in this entry in the mixture placed on the market is equal to or greater than the applicable generic concentration limit for the assigned category or a specific concentration limit specified in this entry.”

Commission Delegated Regulation (EU) 2023/1435 amends Annex VI, Part 3 of Regulation (EC) No. 1272/2008 by updating the harmonized classification and labelling for the following entries:

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

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

– No. Index 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.

Both regulations took effect on July 31, 2023.  To give suppliers an adjustment period, Reg. (EU) 2023/1435 will be mandatorily applicable as of February 1, 2025.

 

  • PCN Notification:

As a reminder, by the CLP Regulation, importers and downstream users who have submitted information on hazardous mixtures to a body designated under Article 45(1) (e.g., Istituto Superiore di Sanità for Italy), before the expiration dates of:

– January 1, 2021, for products intended for consumption;

– January 1, 2021, for products intended for professional use;

– January 1, 2024, for products intended for industrial use.

are required to comply with the provisions of Annex VIII of the CLP reg. for such mixtures as of January 1, 2025.

In simpler words, the transitional period under Annex VIII has ended for all products that were placed on the market and notified before the above deadlines (notified under the old non-harmonized format). As of January 1, 2025, all products subject to notification are required to be notified according to the new harmonized format (PCN notification) by Annex VIII of the CLP reg.

 

  • In addition:

In the CLP regulatory sphere, activity has already begun in the new year as well. Opening the dance is the publication on January 5th of this year of the 21st ATP of the CLP reg. (i.e., Reg. (EU) 2024/197), which will enter into force on January 25th, 2024, and will apply mandatorily as of September 1, 2025. This regulation amends Annex VI of the CLP reg. by introducing or updating the harmonized classification and labelling of several substances, including lead, for which the current aquatic toxicity classification for lead dust has been modified with the M-factor and a different aquatic toxicity classification has been introduced for massive lead.