From the Sector

The European Chemicals Agency’s (ECHA) investigation found that use of non-polymeric aromatic brominated flame-retardant additives pollutes the environment due to their persistence, bioaccumulation and toxicity. These substances are released to the environment throughout the product lifecycle, with waste stage being of particular concern.

ECHA has investigated, as requested by the European Commission, the uses and releases of aromatic brominated flame retardants (ABFRs), and their (potential) hazardous properties. It has also considered possible alternatives and aspects related to recycling and waste management.

The investigation focused on 60 ABFRs that are potentially on the EU market. The key findings are:

• Environmental impact
  Of all ABFRs, non-polymeric additives pose the highest environmental risks due to their tendency to leach from the material. ECHA identified five substances with particular concern, confirmed to be either persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). In addition, 37 ABFRs are likely to be PBT. Of these, 17 are non-polymeric additives;
• Uses and releases
  ABFRs are used in many applications. The sectors contributing the most to the overall releases are electronics, construction and textiles. Releases from the waste stage are key contributors, particularly when materials are shredded or end up as landfill;
• Alternatives
  Alternatives to ABFRs are available for many uses. These include organophosphate flame retardants and non-combustible materials. However, some organophosphate flame retardants may have similar hazard properties as ABFRs and are prone to leaching. Polymeric ABFR additives are viable alternatives to non-polymeric ABFR additives in many uses;
• Waste management
  Inefficient recycling and waste management systems may increase environmental releases of ABFRs. To address the challenges, ECHA emphasises the need to eliminate problematic plastic additives early in the value chain; and
• Group approach
  Some non-polymeric additive ABFRs are not registered under REACH. Yet, they have been detected in the environment at high concentrations. This suggests potential issues with REACH registration compliance or uncertainty about the plastic composition in imported articles. Therefore, any regulatory action on ABFRs should consider a group approach.

This investigation will support the European Commission in deciding whether to request ECHA to prepare a restriction proposal and, if so, what its scope should be. A potential restriction on flame retardants is already included in the Commission’s planning document, the Restrictions Roadmap.

An EU-wide project of ECHA’s Enforcement Forum found that 35 % of the checked safety data sheets (SDS) were non-compliant. Compliance has improved compared to earlier enforcement projects, but more efforts are needed to further enhance the quality of information to better protect workers, professional users and the environment from risks posed by hazardous chemicals.

Inspectors in 28 EU-EEA countries checked over 2,500 safety data sheets (SDS) to enforce the new requirements introduced in 2023. The primary goal was to check whether the SDS were complete, up-to-date and included all the required information, especially the new information required. Second objective was to check the quality of the information, its consistency and compliance with the legal requirements.

Inspectors found that 35% of the inspected SDS did not comply with the legislation – either because the content did not meet the requirements or the safety data sheet was not provided at all.

It was also found by inspectors that the flow of SDS in the supply chain works well – suppliers provided the SDS to the recipients when required in 96 % of the cases. Additionally, most of the 2,500 SDS were updated to the new format.

Among the new information requirements, the biggest challenge was the lack of information on nanoforms and on endocrine disrupting properties, missing respectively in 67 % and 48 % of the checked SDS where it was required. Another relevant finding was that some of the SDS (16 %) lacked the information required by the authorisation decisions.

The Forum project also reported deficiencies in data quality for 27 % of the inspected SDS. Common issues included incorrect information on hazard identification, composition or exposure control. Additionally, 18 % of the checked SDSs lacked the required exposure scenarios.

Enforcement actions
To address non-compliance, inspectors primarily issued written advice, but also used administrative orders, fines and, in some cases, filed criminal complaints.

Abdulqadir Suleiman, chair of the Enforcement Forum’s working group, said:
“In recent years, inspectors have observed improvements in the compliance of chemicals suppliers with their obligation to provide up-to-date safety data sheets. These compliance improvements could be attributed to the harmonised requirements of REACH, great efforts by the industry, continued focus by enforcement authorities, but also the dialogue between enforcement and stakeholder organisations about improving the quality of safety data sheets held some years back.

“However, there is still work to be done to enhance the quality of the information to ensure better protection of the European workers who are handling hazardous chemicals in the workplace.”

Background
SDS are used by chemical suppliers to provide their professional and industrial customers with information about the properties and risks of the chemicals and how to handle, store, use and dispose them safely. The SDS are critical to the protection of workers. They should be used by employers, or health and safety professionals of the downstream users, for carrying out chemical risk assessments in the workplace, required under the Occupational Health and Safety legislation.
This project followed an update to the safety data sheet requirements that have been in force since 2023. The SDS must now include information on nanoforms, endocrine disrupting properties, conditions of authorisation, UFI codes, acute toxicity estimates, specific concentration limits and several other parameters that help to handle chemicals safely. This change in legal requirements necessitated an update of all the SDS to include new information.

In addition to checking the data relevant to the new requirements, inspectors also checked the quality and correctness of the information included in many of the safety data sheet sections.

The inspections of this enforcement project were conducted between January and December 2023 in 28 EEA countries.

The Candidate List of substances of very high concern (SVHC) now contains 242 entries for chemicals that can harm people or the environment. Companies are responsible for managing the risks of these chemicals and giving customers and consumers information on their safe use.

ECHA’s Member State Committee confirmed the addition of triphenyl phosphate to the list in its October meeting. The substance has endocrine disrupting properties and is used as a flame retardant and as a plasticiser. The committee’s discussion on including the substance was originally foreseen for June but delayed, exceptionally, due to substantial new information becoming available on its properties.

Entry added to the Candidate List on 7 November 2024:

The list now contains 242 entries – some are groups of chemicals, so the overall number of impacted chemicals is higher.

This substance may be placed on the Authorisation List in the future. If a substance is on this list, companies cannot use it unless they apply for authorisation and the European Commission authorises its continued use.

 
Consequences of inclusion on 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 (07 November 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 must 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).

The European Chemicals Agency (ECHA), between 2009 and 2023, has performed compliance checks of approximately 15 000 registrations, representing 21 % of full registrations.  The Agency has met its legal target for dossier evaluation, which was increased from 5 % to 20 % in 2019. While, for substances registered at quantities of 100 tonnes or more per year, ECHA has checked compliance for around 30% of them.  

In 2023, the Agency conducted 301 compliance checks, covering more than 1 750 registrations and addressing 274 individual substances. These checks focused on registration dossiers that may have data gaps and aim to enhance the safety data of these substances. As a result, 251 adopted decisions were sent to companies, requesting additional data to clarify long-term effects of chemicals on human health or the environment.

ECHA will now put more focus on following up the requests sent to companies. In the follow-up evaluation process, the Agency assesses the incoming information for compliance. The outcome of the incoming data is shared with the Member States and European Commission to enable prioritisation of substances. ECHA will work closer together with the Member States for enforcement of non-compliant dossiers.  

Compliance of registration dossiers will remain a priority for ECHA for the coming years. This year, the Agency will review the impact of the Joint Evaluation Action Plan, aimed at improving REACH registrations compliance, and, together with stakeholders, develop new priority areas to work on.

ECHA CHEM is a new solution for publishing information on chemicals. The first release, available now, includes information from all REACH registrations.

ECHA’s current Information on chemicals platform, launched in 2016, grew rapidly and contains today information on over 360 000 chemicals. In 2022, ECHA announced that it would create a new system for publishing chemicals data. ECHA CHEM allows the Agency to better handle the growing diversity and quantity of data, while taking advantage of technological advancements.

ECHA maintains the largest chemicals database in the European Union (EU), combining industry-submitted data with information generated in the EU’s regulatory processes. ECHA CHEM is the new solution to share with the public the growing amount of information hosted by the Agency.

In the first version of ECHA CHEM, the information from all the over 100 000 REACH registrations are included that companies have submitted to ECHA. Later this year, the database will be expanded with the redesigned Classification and Labelling Inventory, followed by the first set of regulatory lists.

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.

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 where non-compliant products were found, inspectors have taken enforcement measures, with most of them resulting in the withdrawal of such products from the market.

The non-compliance rate was higher in products which originated from outside the European Economic Area (EEA) or whose origin was not known.

The European Chemicals Agency (ECHA) has published a new report on ‘Key areas of regulatory challenge 2023’ that identifies areas where research is needed to protect people and the environment from hazardous chemicals. It also highlights where new methods, that support the shift away from animal testing, are needed.

To further improve chemical safety in the EU, scientific research needs to deliver data that is relevant to regulating chemicals. In order to enhance the regulatory relevance of scientific data, ECHA has identified the following areas as priorities for research:

• Hazard identification for critical biological effects that currently lack specific and sensitive test methods: i.e. developmental and adult neurotoxicity, immunotoxicity and endocrine disruption
• Chemical pollution in the natural environment (bioaccumulation, impact on biodiversity, exposure assessment)
• Shift away from animal testing (read across under REACH, move away from fish testing, mechanistic support to toxicology studies e.g. carcinogenicity)
• New information on chemicals (polymers, nanomaterials, analytical methods in support of enforcement)

Background
The European Partnership for the Assessment of Risks from Chemicals (PARC), is a seven-year EU-wide research and innovation programme under Horizon Europe which aims to advance research, share knowledge and improve skills in chemical risk assessment.

ECHA’s role in PARC is to make sure that the funded scientific research addresses current challenges related to chemical risk assessment and adds value to the EU’s regulatory processes.

The key areas of regulatory challenge report can be seen as an evolving research and development agenda aiming to support and inspire the Partnership for the Assessment of Risks from Chemicals (PARC) and the wider research community. The list of research needs is not exhaustive. The next update to the report is expected in spring 2024.

ECHA’s Enforcement Forum agreed to launch an EU-wide project to check that products sold online comply with REACH restrictions and the requirements of the Classification, Labelling and Packaging (CLP) Regulation. Its subgroup on Biocidal Products Regulation, BPRS, agreed to launch a project on labelling of biocidal products.

The Enforcement Forum including its BPR subgroup (BPRS) is a network of enforcement authorities from the EU and EEA. They are responsible for coordinating the enforcement of the REACH, CLP, PIC, POPs and the Biocidal Product Regulations with the aim of protecting our health and the environment while ensuring a level playing field for companies across the EU market.

Inspections in this REACH-EN-FORCE (REF)-13 project will take place in 2025. The objective is to check that products, such as toys, common household goods or chemicals, sold online comply with REACH restrictions. Inspectors will also check that mixtures are classified, labelled and packaged in line with CLP and that online offers include the required information about the hazards of the mixture. Inspectors may also check compliance with restrictions under the Persistent Organic Pollutants (POPs) Regulation and the Restriction of Hazardous Substances (RoHS) Directive.

The online sale of chemicals is an area of high non-compliance. In a previous Forum project (REF-8), inspectors often found that mixtures and articles sold online contained restricted hazardous substances, including those causing cancer. The project found that 78 % of controlled mixtures or articles did not fulfil the conditions of REACH restrictions.

In the upcoming project, inspectors can rely on stricter rules governing online sales, such as the Digital Services Act and General Product Safety Regulation. These new laws are expected to make enforcement stronger.

The Forum’s subgroup on Biocidal Products Regulation (BPRS), agreed that the next major enforcement project on biocides (BEF-3) will focus on controlling the correctness of product labels for biocidal products. Inspectors will check that the information on the labelling of biocides corresponds to that what has been authorised and included in the Summary of Product Characteristics. Inspectors may also check the presence and quality of information in the Safety Data Sheets, where it is required for biocidal products.

Both REF-13 and BEF-3 projects will be prepared in 2024, inspections are planned for 2025 and reports are expected to be published in 2026.

During the meeting, the Forum members elected a new chair and vice chair. Henrik Hedlund (SE) will start as the Forum chair and Katja vom Hofe (DE) and Maria Orphanou (CY) will be the vice chairs as of 21 June 2023. Its biocides subgroup elected Helmut de Vos (BE) as chair and Jenny Karlsson (SE) and Eugen Anwander (AT) as vice chairs.

The details of the proposed restriction of around 10 000 per- and polyfluoroalkyl substances (PFASs) are now available on ECHA’s website. ECHA’s scientific committees will now start evaluating the proposal in terms of the risks to people and the environment, and the impacts on society.

The proposal was prepared by authorities in Denmark, Germany, the Netherlands, Norway and Sweden and submitted to ECHA on 13 January 2023. It aims to reduce PFAS emissions into the environment and make products and processes safer for people.

All PFASs in the scope of the proposal are very persistent in the environment. If their releases are not minimised, people, plants and animals will be increasingly exposed, and without a restriction, such levels will be reached that have negative effects on people’s health and the environment. The authorities estimate that around 4.4 million tonnes of PFASs would end up in the environment over the next 30 years unless action is taken.

Peter van der Zandt, ECHA’s Director for Risk Assessment said: “This landmark proposal by the five authorities supports the ambitions of the EU’s Chemicals Strategy and the Zero Pollution action plan. Now, our scientific committees will start their evaluation and opinion forming. While the evaluation of such a broad proposal with thousands of substances, and many uses, will be challenging, we are ready.”

Next steps
ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will check that the proposal meets the legal requirements of REACH in their meetings in March 2023. If it does, the committees will begin their scientific evaluation of the proposal. A six-month consultation is planned to start on 22 March 2023.

RAC will form an opinion on whether the proposed restriction is appropriate in reducing the risks to people’s health and the environment, while SEAC’s opinion will be on the socio-economic impacts, i.e. benefits and costs to society, associated with the proposal. Both committees form their opinions based on the information in the restriction proposal and the comments received during consultations. The committees also consider advice from the Enforcement Forum on the enforceability of the proposed restriction. Once the opinions are adopted, they will be sent to the European Commission who, together with the EU Member States, will then decide on the potential restriction.

An online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation.

The Enforcement Forum of ECHA agreed that the next REACH enforcement project will investigate how companies fulfil the registration, authorisation and restriction obligations for products and chemicals they import from outside the EU. The project will be done in 2023-2025 and will require close cooperation between REACH enforcement and national customs authorities in the Member States.
In its November meeting, the Enforcement Forum, responsible for harmonising the enforcement of EU chemicals legislation, agreed to focus its next project on the control of imports of substances, mixtures and articles.

This subject was triggered by high levels of non-compliance in imported goods detected in previous Forum projects, including a recent pilot project. The pilot found that 23 % of inspected products were non-compliant with requirements set by EU law and further controls are necessary.

Control of imports at the point of entry is the most effective means of checking that non-compliant substances, mixtures and articles do not enter the European market. The project will also work on further developing and strengthening existing cooperation between REACH inspectors and customs. By strengthening the control of imports, the project will also contribute to the goals of the EU’s Chemicals Strategy for Sustainability.

The Forum also agreed to publish its future advice on enforceability of new restriction proposals under REACH.

Opportunities for expanding the future role of the Forum, strengthening the control of imports and other areas were on the agenda in an open session where 41 representatives from stakeholder organisations and four candidate countries joined. Among other topics, the open session also addressed the enforceability of REACH restrictions, for example, in textiles or on the use of lead gunshot in wetlands as well as analytical methods relevant for the control of REACH duties.

The Forum’s Biocidal Products Regulation Subgroup (BPRS) re-elected Helmut de Vos (BE) for a second term as a Vice-Chair.