ECHA has added five new chemicals to the Candidate List. 

They are found in products such as inks and toners, adhesives and sealants and washing and cleaning products.  

 The Agency has also updated the existing Candidate List entry for dibutyl phthalate to include its endocrine disrupting properties for the environment. 

 Entries added to the Candidate List on 23 January 2024:

Consequences of the Candidate List 

Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.  

If an article contains a Candidate List substance above a concentration of 0.1 % (weight by weight), suppliers have to give their customers and consumers information on how to use it safely. Consumers have the right to ask suppliers if the products they buy contain substances of very high concern. 

Importers and producers of articles have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (23 January 2024).  

EU and EEA suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to update the safety data sheet they provide to their customers. 

Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP). 

Full article ECHA: https://echa.europa.eu/sk/-/echa-adds-five-hazardous-chemicals-to-the-candidate-list 

Ekotox REACH Authorisation webpages: https://ekotox.eu/reach-authorisation/ 

Ekotox Training/Webinars: https://ekotoxtraining.com/ 

The 21st ATP to the EU CLP Regulation was published on Jan. 5, 2024. It contains a new list of harmonized substance classifications.

It shall apply from 1 September 2025. 

However, suppliers may already before that date classify, label and package substances and mixtures in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation. 

New entrie e.g. cover dimethyl propylphosphonate, dibutyltin maleate and dibutyltin oxide…

Lead classification as powder and massive were splitted: 

“Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances.” 

Ekotox CLP webpages: https://ekotox.eu/classification-of-dangerous-chemical-substances/
Ekotoxtraining (webinars and online consultations): https://ekotoxtraining.com/
EUR-LEX link: https://eur-lex.europa.eu/eli/reg_del/2024/197/oj

ECHA/NR/23/33 

An EU-wide enforcement project of the ECHA Forum found excessive levels of hazardous chemicals, such as lead and phthalates, in products that are sold to consumers. In total 18 % of the inspected products breached the EU laws.

Helsinki, 13 December 2023 – The national enforcement authorities in 26 EU countries checked over 2 400 products, most of them intended for consumers, and found more than 400 of them breaching the EU’s chemicals laws. 

The most common product types breaching the laws were: 

• Electrical devices such as electrical toys, chargers, cables, headphones. 52 % of these products were found non-compliant, mostly due to lead found in solders, phthalates in soft plastic parts, or cadmium in circuit boards. 
• Sports equipment like yoga mats, bicycle gloves, balls or rubber handles of sport equipment. 18 % of these products were found to be non-compliant mostly due to SCCPs and phthalates in soft plastic and PAH in rubber. 
• Toys like bathing/aquatic toys, dolls, costumes, play mats, plastic figures, fidget toys, outdoor toys, slime and childcare articles. 16 % of non-electric toys were found to be non-compliant, mostly due to phthalates found in soft plastic parts, but also other restricted substances such as PAHs, nickel, boron or nitrosamines. 
• Fashion products such as bags, jewellery, belts, shoes and clothes. 15 % of these products were found non-compliant due to the phthalates, lead and cadmium they contained. 

In cases of non-compliant products, inspectors took enforcement measures, resulting in the withdrawal of many from the market.

Background

The project covered REACH restrictions and duties applicable to substances in articles under REACH, as well as POPs restrictions. It also addressed restrictions derived from the Toys and the RoHS Directives. The checks were carried out by the national enforcement authorities in 26 countries during 2022. 

In the upcoming years (2024-2025), the Forum and BPRS will focus on harmonizing the enforcement of key EU regulations, including REACH, CLP, POPs, PIC, and BPR. While these are the primary areas of concentration, the Forum retains flexibility to address emerging issues or new priorities. 

Horizontal Enforcement Priorities 

1.Imports and Customs Cooperation: 

Prioritizing control of imports and collaboration with customs, driven by alarming non-compliance rates—ranging from 17% to 64%—for various regulations, as highlighted in recent enforcement projects. 

2.Online sales: 

Addressing the significant non-compliance (over 75%) in online sales of chemicals, leveraging new legislations to strengthen enforcement measures. 

3.Integrated Enforcement: 

Streamlining enforcement of substances, mixtures, or articles regulated by multiple legislations to enhance efficiency and resource utilization. 

4.Cooperation Enhancement: 

Focusing on cross-border cooperation and collaboration with various inspection services to effectively enforce legislation, including initiatives like integrated enforcement. 

Specific Enforcement Priorities: 

1. Regulatory Risk Management Measures: 

Emphasizing the enforcement of measures targeting substances of concern, with a focus on improving compliance levels for REACH Restrictions, Authorisation, CLP Harmonised Classification and Labelling, POPs Restrictions, and BPR product authorisation. 

       2. Information in the Supply Chain: 

Prioritizing harmonized enforcement of duties related to information flow in the supply chain, addressing deficiencies in safety data sheets (SDS) and improving compliance. 

        3. Classification and Labelling: 

Addressing the high non-compliance levels in the classification and labelling of mixtures, with a focus on CLP Regulation duties. 

        4. New Provisions: 

Proactively harmonizing enforcement of new provisions that have fully entered into force, such as hazardous mixture notification and new requirements for online sales. 

Priorities for ways of working in 2024-2025 

The work of the Forum goes beyond coordinating enforcement of specific provisions. In prioritising its work, the Forum will be guided not only by the need to enhance compliance  with specific duties (‘enforcement priorities’), but also by a clear preference on how its objectives should be achieved. This includes the preference for practical enforcement through projects and swiftly addressing political and regulatory developments, such as the need to work closely with customs or advise on enforceability of important new restrictions. Therefore, the Forum will also consider the following overarching priorities during the period of this Work Programme. 

The Forum has dedicated over 15 years to executing synchronized enforcement projects, aligning control practices, consolidating compliance data, and furnishing guidance for inspectors. These projects, the linchpin of EU enforcement, are instrumental in fortifying and harmonizing regulatory compliance. The Forum and BPRS will persist in prioritizing these projects, adapting to evolving mandates for optimal efficiency. Emphasizing enforceability advice for new restrictions, the Forum draws on its extensive experience evaluating the viability of proposals under REACH. As legislative shifts expand restrictions, the Forum anticipates heightened demand for enforceability advice, necessitating procedural enhancements and resource reinforcement. Augmented collaboration with stakeholders remains integral for sustained compliance improvements, with ongoing efforts to engage through open sessions, workshops, and regular communications via ECHA channels. Acknowledging potential changes due to the REACH revision, the Forum commits to flexible adaptation. It scrutinizes new tasks and opportunities to effectively deliver on evolving priorities and practices.

In summary, the enforcement priorities for 2024-2025 aim to enhance compliance, streamline enforcement efforts, and adapt to potential changes in regulations and mandates. 

The 1 January 2024 compliance date for poison centre notifications is not an immediate cut-off. Rather, it mandates that, starting from this date, all new notifications for mixtures intended solely for industrial use (in addition to consumer and professional use) must adhere to the harmonised format detailed in Annex VIII of the CLP Regulation. This also includes a UFI code on the label. 

ECHA reminds companies to assess their notification status and check the timelines for having the information in the required harmonised format. 

This message is particularly important to those companies that have existing notifications submitted according to national requirements. In such cases, it is possible to benefit from the transition period, ending 1 January 2025. However, if changes occur in the product or mixture during this period, then information needs to be submitted in the new format which is possible through the ECHA submission portal. 

Companies that benefit from the transition period can already begin planning how and when to update their notifications and manage their re-labelling plans. 

For more details, watch ECHA webinar on this topic or reach out to the national of yours or ECHA Helpdesk. 

The purpose of assessing regulatory needs for a group of substances is to assist authorities in determining the best course of action for addressing identified concerns. This includes deciding on regulatory risk management instruments and any intermediate steps required for implementation.

An assessment of regulatory needs may determine that EU-level regulatory risk management is necessary for certain substances. This could involve various measures such as harmonized classification and labeling or inclusion in the Candidate List. Conversely, it may be concluded that no additional regulatory action is currently needed at the EU level..  

The assessment of regulatory needs is an important step under ECHA’s Integrated Regulatory Strategy. However, it is voluntary, i.e., it is not part of the processes defined in the legislation but aims to support them. Assessing regulatory needs is an iterative process that can start from a low level of information and certainty on the best way forward to proposing more definitive regulatory management options for the (groups of) substance(s).  

Assessment of regulatory needs – an interative process 

The assessment will be revisited when necessary. For example, after further information is generated, clarifying the hazard, or when new insights on uses and risks emerge. It can be revisited by the same or another authority. 

Before initiating a formal regulatory risk management process under REACH/CLP. Аuthorities can optionally make a further, in-depth analysis of the most appropriate regulatory risk management option (RMOA). 

The responsibility for the content of this assessment rests with the authority that developed it. It is possible that other authorities do not have the same view and may develop a further assessment of regulatory needs for the same (group of) substances. 

Even if an assessment of regulatory needs concludes that regulatory action should be initiated, such an outcome does not have any direct legal implications. 

To gain legal and regulatory relevance, the substances assessed need to successfully pass one or more of the formal regulatory management and decision-making processes under REACH, CLP such as harmonised classification and labelling (CLH), SVHC identification or authorisation, or restriction or other legislations. The intentions of authorities to submit a dossier to REACH/CLP formal processes are notified through the Registry of Intentions. 

The outcome of the assessment of regulatory needs is shared in order to increase transparency and predictability of authorities’ work. 

EU-wide enforcement project found about 60 active substances in biocidal products that are not allowed on the EU, EEA and Swiss markets. One in three of the checked products did not comply with at least one of the checked legal requirements. 

Helsinki, 21 November 2023 – The national enforcement authorities in 29 countries checked over 3 500 biocidal products. Overall, 37 % of the checked biocides were non-compliant with at least one of the checked legal requirements.

18 % of checked products were non-compliant with fundamental requirements that affect their safe use. Most of them either lacked a product authorisation or included non-allowed active substances. Most biocides with such major non-compliance were disinfectants, insecticides, and repellents/attractants. Inspectors discovered approximately 60 active substances prohibited in these products. They withdrew all products lacking authorization or containing unauthorized active substances from the market. In certain instances, they also filed criminal complaints or imposed fines.

The remaining 19 % non-compliant products were found to have minor deficiencies that did not affect safe use such as missing contact information of the supplier. In these cases the national enforcement authorities gave advice or administrative orders.

Much non-compliance was found in disinfectants sold to consumers. 265 disinfectants out of nearly 1 900 that were checked (14 %) were found to be non-compliant. This included serious compliance deficiencies such as lacking authorisation or incorrect labelling that usually led to the withdrawal of the disinfectants from the market.

The inspectors focused on disinfectants because new manufacturers entered the market with biocidal products at the early stages of the COVID-19 pandemic. Many of those disinfectants were not fully compliant with the EU’s Biocidal Products Regulation (BPR) and the related national transitional requirements for biocides.

Background  

This harmonised enforcement project on biocides checked how different types of biocidal products on the EU, EEA and Swiss markets comply with the Biocidal Products Regulation. The inspections focused on:

• non-allowed active substances in biocidal products
• approval of the active substance suppliers (Article 95);
• obligations related to labelling, packaging and advertising of biocidal products.

The national enforcement authorities carried out the inspections during 2022. Where needed, controls also involved chemical analysis of biocidal products.

Full article:

https://echa.europa.eu/sk/-/one-in-three-checked-biocidal-products-found-to-be-non-compliant

More about biocides

On 1 January 2024 Annex VIII to the CLP Regulation will enter into force for industrial use mixtures that are classified as hazardous on the basis of their health or physical effects. From that date, if you place such a mixture on the market in EU, you must notify it for the respective member state market in the harmonised format via the ECHA PCN portal.

The harmonised information requirements include the full chemical composition, the toxicological information, information about the product, and the unique formula identifier (UFI), according to Annex VIII to the CLP Regulation.

However, industrial use mixtures have the option of making a “limited submission”, where compositional information from the Safety Data Sheet can be used. If this option is used, the notification must include a contact person who can provide around the clock rapid access to the complete compositional details in case of an incident.

CLP Regulation Annex VIII webpage: EUR-Lex – 32020R1677 – EN – EUR-Lex (europa.eu)

ECHA Poison Centres portal: https://poisoncentres.echa.europa.eu/

Ekotox SDS webpages: https://ekotox.eu/safety-data-sheet-sds/

Ekotoxtraining: https://ekotoxtraining.com/

European Chemicals Agency has received a mandate from the European Commission to prepare an Annex XV report for possible restriction of at least the chromium (VI) substances that are currently in entries 16 and 17 of the REACH Authorisation List (Annex XIV). ECHA will submit the proposal by 4 October 2024.

Help for companies

The Commission has published a Q&A document clarifying the situation for affected companies. This document also covers the main questions concerning the judgment of the European Court of Justice annulling the authorisation of a consortium covering many chromium trioxide downstream users (Chemservice decision).

European Chemicals Agency News webpage: https://echa.europa.eu/-/echa-to-prepare-restriction-proposal-on-chromium-vi-substances

Q&A document: https://ec.europa.eu/docsroom/documents/56174

Ekotox REACH Authorisation webpages: https://ekotox.eu/reach-authorisation/

Ekotox Training Portal: https://ekotoxtraining.com/

In addition to the export notification, most of these chemicals will also require an explicit consent from the importing country before exports can take place. Furthermore, four chemicals that were previously subject only to an export notification, will now also require an explicit consent.

Commission Delegated Regulation (EU) 2023/1656 of 16 June 2023 amending Regulation (EU) No 649/2012 of the European Parliament and of the Council. This amendment concerns the listing of pesticides and industrial chemicals.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.210.01.0001.01.ENG&toc=OJ%3AL%3A2023%3A210%3ATOC

ECHA webpage: https://echa.europa.eu/-/35-hazardous-chemicals-added-to-the-prior-informed-consent-regulation

Ekotox chemicals management webpage: https://ekotox.eu/chemicals-management/