From the Sector

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 transition towards safer and more sustainable chemicals is progressing in some areas, while in others, it is just beginning. This is the finding of a first, joint Europe-wide assessment of the drivers and impact of chemical pollution by the European Environment Agency (EEA) and the European Chemicals Agency (ECHA). The benchmarking found that more work is still needed to reduce the impact of harmful substances on human health and the environment.

The number of industrial chemicals scrutinised under the EU’s chemicals legislation to determine their safety has increased substantially. Authorities now have much better knowledge about the hazardous properties of chemicals that are used across the EU, resulting in many actions to minimise and control the risks of several groups of substances.

According to the joint EEA-ECHA synthesis report on the EU indicator framework for chemicals, the overall use of the most harmful chemicals (in particular those that are carcinogenic, mutagenic and reprotoxic) is still growing but more slowly than the overall chemicals market growth. Pressure is increasing to avoid the use of so-called substances of concern and to implement the principles of the safe and sustainable by design framework.

There is a need to more effectively ensure that consumer products do not contain the most harmful substances, for example chemicals that are endocrine disrupting, that negatively affect the hormone system, or substances that are persistent, bioaccumulative and toxic, which present a risk for years to come even after their use has ceased.

More data and information are needed to better understand human and environmental exposure to those most harmful chemicals and their impacts. Still, the indicators show clearly that the shift to safe and sustainable chemicals must continue and should even be accelerated.

The report is based on a set of 25 key indicators, which monitor the drivers and impacts of chemical pollution in Europe.

Key findings

• Transition towards safer and more sustainable chemicals is progressing in some areas while in others it is just getting started.
• Action by authorities and industry has supported minimising and controlling the risks from several groups of hazardous chemicals. Efforts are ongoing to increase knowledge on chemical hazards and support risk management action where needed.
• Available data suggest that there is little evidence of progress towards eliminating substances of concern from waste and secondary materials. This is a barrier to the transition towards a more circular economy.
• Emissions of certain chemicals to water and air have fallen following specific EU regulations (e.g., on industrial emissions) and international actions, but further measures are needed to reach concentration levels that are not harmful for human health and the environment.
• Emissions from industry still lead to major costs in terms of damages to human and ecosystem health.
• Human biomonitoring offers the opportunity to understand human exposure to chemicals from multiple sources and thus health risks associated with chemical pollution. As such, biomonitoring forms a key tool to measure the effectiveness of chemicals legislation in protecting human health and the environment.

The European Chemicals Agency (ECHA) has published its Strategy Statement 2024-2028. The strategy details the agency’s goals and priorities over the next five years to protect health and the environment through its work for chemical safety.

Main elements of the Strategy – Goals and Priorities

Be a trusted chemicals agency – ECHA aims to achieve this by delivering its legal mandate using independent expertise and robust data. The Agency, to support this, will:

• Deliver transparent, independent, and high-quality scientific advice, opinions, and decisions;
• Enhance decision and policy making through optimal use of data, knowledge, and competence; and
• Facilitate the prioritisation and co-ordination of regulatory actions on substances and groups of substances with the European Commission (EC), EU agencies and Member State Authorities.

 
Respond to emerging challenges and changes in their legal landscape – ECHA will prepare for new tasks and inform EU chemical and environmental policy. To support this goal, it will focus on the following priorities:

• Implement new legal requirements using existing and new synergies and experience;
• Work with relevant EU agencies and bodies to deliver Chemical Strategy for Sustainability (CSS) actions and objectives; and
• Provide scientific and technical advice on chemicals to EU policy makers.

 
Communicate and Engage – by collaborating with stakeholders and partners, ECHA will strengthen public confidence in chemicals regulation. In support of this goal, the Agency will:

• Deepen their network of engagement with EU institutions and agencies and Member States;
• Collaborate and provide tools, advice, and support to industry; and
• Promote awareness and understanding of ECHA's work to stakeholders representing workers, the public and the environment.

 
Lead on chemical knowledge and expertise – the Agency will advance knowledge and understanding on chemical safety. To achieve this, it will:

• Contribute proactively to expanding scientific and technical competence and knowledge on chemical safety;
• Promote the development and use of alternative methods for the assessment of hazards and risks of chemicals; and
• Support the EC to enhance engagement and synergies at international level.

 
Invest in people and organisational excellence – ECHA is committed to working together to achieve their vision. In order to achieve this they will:

• Develop and empower their people for success;
• Create optimal ways of working for the Agency, its bodies, its people, and the environment; and
• Adopt an IT delivery model that is cost-effective, streamlined, modular, interoperable, cloud based and centralised.

The European Chemicals Agency (ECHA) has added five new chemicals to the Candidate List. One of them is toxic for reproduction, three are very persistent and very bioaccumulative and one is toxic for reproduction and persistent, bioaccumulative and toxic. 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.

ECHA’s Member State Committee has confirmed the addition of these substances to the Candidate List. The list now contains 240 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.

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.

The European Chemicals Agency invites interested parties to send in scientific and technical information on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) by 25 September 2023.

The six-month consultation on the restriction proposal, prepared by the Danish, German, Dutch, Norwegian and Swedish authorities, opens on 22 March 2023 and closes on 25 September 2023 (23:59 Helsinki time).

The consultation is to give anyone with information on PFAS the opportunity to have their say. Of particular interest is information relevant to the risks, socio-economic aspects and alternative substances.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the consultation input to evaluate the proposed restriction and form an opinion on it.

An online information session will be held on 5 April. During the session, experts from ECHA and the five national authorities will explain the restriction process, the content of the proposal and how to participate in the consultation. They will also respond to questions from the participants.

The five national authorities submitted the universal proposal to restrict PFAS to ECHA on 13 January. The European Commission, together with the EU Member States, will eventually decide on the potential restriction based on the proposal and the committees’ opinion.

ECHA has added nine chemicals to the Candidate List because of their hazardous properties. They are used for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers and in the manufacture of textile, leather or fur and paper.

Entries added to the Candidate List on 17 January 2023:

• 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]
• 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol
• 4,4'-sulphonyldiphenol
• Barium diboron tetraoxide
• Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
• Isobutyl 4-hydroxybenzoate
• Melamine
• Perfluoroheptanoic acid and its salts
• reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine

Information on these substances' uses and reasons for inclusion on the Candidate List is available here.

The Committees for Risk Assessment and Socio-Economic Analysis support Germany’s proposal to restrict the use of undecafluorohexanoic acid (PFHxA) and related substances. The potential restriction is expected to reduce further environmental and human exposure to these chemicals resulting mainly from uses in food contact materials, textiles and fire-fighting foams.

The Committee for Socio-Economic Analysis (SEAC) has adopted its final opinion on Germany’s proposal to restrict undecafluorohexanoic acid (PFHxA), its salts and related substances. This follows an earlier opinion by the Committee for Risk Assessment (RAC) in June 2021 to restrict these substances that are very persistent and mobile in the environment and can damage the human reproductive system.

RAC supported the proposed restriction for uses where it is not possible to minimise emissions through other means, especially for consumer uses in food contact materials and textiles as well as for fire-fighting foams used by municipal fire departments and at home.

SEAC considers that a restriction of PFHxA is, in general, an appropriate measure to address the identified risks and to ensure a consistent level of protection for people and the environment across the EU. However, while SEAC concluded that a restriction on certain uses was likely to be proportionate (e.g. textiles in consumer apparel, paper and cardboard in food contact materials and cosmetic products), uncertainties in the available information prevented SEAC from concluding that the proposed restriction as a whole was the most appropriate means to address the identified risk.

During their meetings, SEAC also adopted its opinion on the French proposal to restrict substances in single-use baby diapers, and RAC adopted 11 opinions on harmonised classification and labelling. In addition, RAC and SEAC adopted an opinion on an application for authorisation on the use of chromium trioxide and sodium dichromate for passivation of electrolytic tinplate, and RAC agreed on six and SEAC on five draft opinions on applications for authorisation mostly on electroplating uses of chromium (VI) substances. More about these and other topics can be found in the annex.