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 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.

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 found about 60 active substances that are not allowed in these products. All products that lacked authorisation or contained non-allowed active substances were withdrawn from the market. In some cases, criminal complaints or fines were issued.

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.

The European Chemicals Agency (ECHA) has found that substances causing cancer, genetic mutations or harming reproduction are present in childcare products, such as car seats, bibs and baby changing mats. Its investigation will help the European Commission to prepare an EU-wide restriction to limit these chemicals, with the aim of safeguarding children.

ECHA’s investigation, drawing on information from 48 different sources, shows that substances which are carcinogenic, mutagenic or toxic for reproduction (CMR) may be present in childcare products (articles). Metals like cobalt and lead, along with phthalates like DEHP, are the most common CMR substances found in childcare products.

CMRs were most often found in items like car seats, bibs, products related to toiletries, and bedding and mattresses. Children may be exposed to these hazardous substances during use, for example through skin or oral contact, and are particularly vulnerable to the harm caused by chemical substances because of their small size, developing physiology and behaviour.

ECHA’s report provides elements to support the European Commission in the preparation of a potential future restriction. These include information on how childcare articles are defined, what the restriction could cover, potential derogations, recommended concentration limits and timeframes for implementation. The report also includes views from ECHA’s Enforcement Forum on how feasible it would be to enforce such a restriction.

The report will now be sent to the European Commission, who will use it to prepare a draft restriction proposal under REACH Article 68(2). This procedure allows the Commission to prepare a restriction proposal without involvement of ECHA’s scientific committees.

Background
The purpose of ECHA’s investigation is to support the European Commission in preparing a restriction under the REACH Regulation to protect children from exposure to CMR substances in childcare articles. It focused on substances that have a harmonised classification under the Classification, Labelling and Packaging (CLP) Regulation as a CMR in category 1A (known human carcinogen, mutagen or reproductive toxicant) or 1B (presumed human carcinogen, mutagen or reproductive toxicant).

During the investigation, ECHA organised two public calls for evidence and a consultation on the draft report. The Agency contacted 233 different stakeholders to inform about the work and considered their feedback.

"Viele Unternehmen sitzen bereits auf gepackten Koffern und haben ihre Investitionsentscheidungen sind getroffen." Deutschland sei gerade erneut dabei, sich in multiple internationale Abhängigkeiten zu begeben und seinen Abschied aus dem Kreis der Industrienationen vorzubereiten. So beurteilen der Geschäftsführer der Industrievereinigung Chemiefaser e.V. (IVC), Dr. Wilhelm Rauch, und der Ressortleiter Umwelt-& Chemikalienpolitik des Zentralverbands Oberflächentechnik e.V. (ZVO), Dr. Malte M. Zimmer gemeinsam mit verschiedenen Unternehmen die Konsequenzen aus dem Plan der European Chemicals Agency (ECHA), rund 10.000 Alkylsubstanzen zu verbieten.

Die EU lasse dabei die Folgen auf Schlüsseltechnologien wie beispielsweise die grüne Energiewende komplett außer Acht. Lithiumbatterien, Windräder, Brennstoffzellen, Computerchips - für PFAS existierten aktuell zumindest in Hightech-Anwendungen keine Alternativen. Bis auf wenige längere Ausnahmeregelungen seien aktuell 18 Monate als Übergangsfristen vorgesehen. Das sei ein ausreichendes Zeitfenster, um die Produktion in Europa abzuwickeln und nach neuen Standorten zu suchen, beispielsweise in den USA. Dort werde die Fluorchemie als Schlüsseltechnologie massiv aufgebaut und als kostbares Gut mit Exportverboten belegt.

IVC und ZVO monierten, dass das Innovationsvermögen der europäischen Industrie hergeschenkt werde und man anderen Ländern den Markt mit allen preislichen und wettbewerblichen Konsequenzen überlasse. Als besonders betroffene Branchen führten die Verbände die Medizintechnik, Schutzausrüstung, Flugzeugbau und Automobilelektronik, den Textilmaschinenbau und Industrietextilien an. Abluftfilter mit PTFE-Membranen oder aus PTFE-Fasern stellten in der Müllverbrennung und in Zementwerken den Umweltschutz sicher, so dass keine Schadstoffe in die Atmosphäre gelangten. Membranen für Wasserstoff-Brennstoffzellen, Wasserstoffelektrolyseure, Lithium-Ionen-Batterien aus Karbonfaservliesen und der fluorchemischen Protonenaustauscher Nafion-Membran würden in Zukunft verboten und damit die die Pläne für eine Wasserstoffenergiewende dauerhaft nicht umsetzbar.

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.