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28.02.2024

ECHA: 21% REACH registrations evaluated

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.

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.

 

Source:

European Chemicals Agency

05.02.2024

ECHA: Strategic goals for 2024-2028

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:

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.
Source:

European Chemicals Agency

30.01.2024

ECHA: New chemicals database

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.

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.

More information:
ECHA database REACH chemicals
Source:

European Chemicals Agency

24.01.2024

ECHA: Hazardous chemicals found in coating products and polymers

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 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.

 

Source:

European Chemicals Agency

13.12.2023

ECHA: Hazardous chemicals found in fashion products

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:

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.

More information:
ECHA hazardous chemicals
Source:

European Chemicals Agency

21.11.2023

One in three checked biocidal products found to be non-compliant

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.

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.

More information:
ECHA biocid
Source:

European Chemicals Agency (ECHA)

15.11.2023

ECHA: Research needs for regulating hazardous chemicals

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:

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.

More information:
ECHA chemicals polymers
Source:

The European Chemicals Agency (ECHA)

08.11.2023

ECHA: Toxic chemicals in childcare products

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.

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.

Source:

European Chemicals Agency

26.09.2023

ECHA: More than 5 600 comments on PFAS restriction proposal

More than 4 400 organisations, companies and individuals submitted comments and information on the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the European Economic Area.

At the end of the consultation on 25 September, ECHA had received more than 5 600 comments from more than 4 400 organisations, companies and individuals.

The comments will be checked by ECHA's scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), and those providing relevant evidence-based information will be considered in the opinion making process.

The five countries who prepared the initial proposal will also review the consultation input and may update their initial proposal based on it.

Many comments submitted during the consultation are already published on ECHA’s website. Information indicated as confidential by the consultee is not made public. Comments received very close to the deadline are currently being processed and will be published shortly.

More than 4 400 organisations, companies and individuals submitted comments and information on the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the European Economic Area.

At the end of the consultation on 25 September, ECHA had received more than 5 600 comments from more than 4 400 organisations, companies and individuals.

The comments will be checked by ECHA's scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), and those providing relevant evidence-based information will be considered in the opinion making process.

The five countries who prepared the initial proposal will also review the consultation input and may update their initial proposal based on it.

Many comments submitted during the consultation are already published on ECHA’s website. Information indicated as confidential by the consultee is not made public. Comments received very close to the deadline are currently being processed and will be published shortly.

Next steps
RAC and SEAC are evaluating the proposed restriction and considering the relevant information received through the consultation. The committees develop their independent, scientific opinions over a series of meetings, where draft opinions are discussed. Attention is given to all aspects and impacted sectors.

ECHA will deliver the final opinions to the European Commission in the shortest possible timeframe, while ensuring proper scrutiny by the scientific committees. Once the committees adopt their opinions, they will be communicated to the public.

The Commission, together with the EU Member States, will decide on the restriction.

Background
The restriction proposal was prepared by authorities in Denmark, Germany, the Netherlands, Norway and Sweden. It was submitted to ECHA on 13 January 2023. It aims to reduce PFAS emissions into the environment and make products and processes safer for people. The six-month consultation ran from 22 March to 25 September 2023.

Further information
•    Consultation comments
•    Restriction on the manufacture, placing on the market and use of PFAS
•    Topical page on PFAS
•    REACH restriction process

More information:
ECHA PFAS
Source:

ECHA

Industriebrache Pixabay; Tama66
19.07.2023

IVC und ZVI positionieren sich klar gegen Pauschalverbot von PFAS

"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.

"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.

Source:

Industrievereinigung Chemiefaser e.V., Zentralverband Oberflächentechnik e.V.

22.03.2023

ECHA seeks input on proposed PFAS restriction

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.

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.

More information:
ECHA PFAS
Source:

ECHA

08.02.2023

ECHA publishes PFAS restriction proposal

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.

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.

More information:
ECHA PFAS polyfluoroalkyl
Source:

European Chemicals Agency

17.01.2023

ECHA adds nine hazardous chemicals to Candidate List

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.

 

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.

 

More information:
ECHA chemicals hazardous
Source:

European Chemicals Agency

16.11.2022

Next EU-wide REACH enforcement project to focus on imported products

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.

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.

More information:
ECHA REACH
Source:

European Chemicals Agency

22.06.2022

Dr Sharon McGuinness selected as ECHA’s new Executive Director

The Management Board of the European Chemicals Agency has selected Dr Sharon McGuinness as ECHA’s next Executive Director. As part of the appointment procedure, she will make a statement before the European Parliament and answer questions from its members. This is tentatively scheduled for 4 July 2022.

Dr Sharon McGuinness, an Irish national, is the Chief Executive Officer of the Health and Safety Authority (HSA) in Ireland since 2018. Prior to this, she was the Assistant Chief Executive for the Chemicals and Prevention Division within the Authority, with responsibility for division management, policy provision, advice and enforcement for a wide range of occupational health and safety, chemical and market surveillance legislation aimed at protecting human health and safety for workers and consumers.

She was a member of ECHA’s Management Board between 2014-2020 and Chair of the Board between 2016-2020. She graduated from the University College Dublin with a B.Sc. (Hons) in pharmacology and chemistry, and she holds a PhD in pharmacology, as well as diplomas in Legal Studies and Company Direction.

The Management Board of the European Chemicals Agency has selected Dr Sharon McGuinness as ECHA’s next Executive Director. As part of the appointment procedure, she will make a statement before the European Parliament and answer questions from its members. This is tentatively scheduled for 4 July 2022.

Dr Sharon McGuinness, an Irish national, is the Chief Executive Officer of the Health and Safety Authority (HSA) in Ireland since 2018. Prior to this, she was the Assistant Chief Executive for the Chemicals and Prevention Division within the Authority, with responsibility for division management, policy provision, advice and enforcement for a wide range of occupational health and safety, chemical and market surveillance legislation aimed at protecting human health and safety for workers and consumers.

She was a member of ECHA’s Management Board between 2014-2020 and Chair of the Board between 2016-2020. She graduated from the University College Dublin with a B.Sc. (Hons) in pharmacology and chemistry, and she holds a PhD in pharmacology, as well as diplomas in Legal Studies and Company Direction.

Dr McGuinness was one of the candidates preselected by the European Commission after an open competition and interviewed by the Management Board for the post.

Her selection follows that of Bjorn Hansen who retired in March 2022. Since 1 April 2022, Shay O’Malley has been ECHA’s acting Executive Director.

The term of office of the Executive Director is five years. It may be prolonged by the Management Board once, for a further term of five years.

More information:
ECHA Dr Sharon McGuinness
Source:

ECHA

09.12.2021

ECHA: Scientific committees support further restrictions of PFAS

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.

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.

More information:
ECHA
Source:

ECHA

08.07.2021

ECHA: Candidate List updated with eight hazardous chemicals

Some of the newly added substances are used in consumer products such as cosmetics, scented articles, rubber and textiles. Others are used as solvents, flame retardants or to manufacture plastics products. Most have been added to the Candidate List because they are hazardous to human health as they are toxic for reproduction, carcinogenic, respiratory sensitisers or endocrine disruptors.

Companies must follow their legal obligations and ensure the safe use of these chemicals. They also have to notify ECHA under the Waste Framework Directive if their products contain substances of very high concern. This notification is submitted to ECHA’s SCIP database and the information will later be published on the Agency’s website.

Some of the newly added substances are used in consumer products such as cosmetics, scented articles, rubber and textiles. Others are used as solvents, flame retardants or to manufacture plastics products. Most have been added to the Candidate List because they are hazardous to human health as they are toxic for reproduction, carcinogenic, respiratory sensitisers or endocrine disruptors.

Companies must follow their legal obligations and ensure the safe use of these chemicals. They also have to notify ECHA under the Waste Framework Directive if their products contain substances of very high concern. This notification is submitted to ECHA’s SCIP database and the information will later be published on the Agency’s website.

Background
The Candidate List includes substances of very high concern that may have serious effects on our health or the environment. These substances may be placed on the Authorisation List in the future, which means that companies would need to apply for permission to continue using them. The Candidate List has now 219 entries – some of these cover groups of chemicals so the overall number of impacted chemicals is higher.
 
Under the REACH Regulation, companies may have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List. Any supplier of articles containing a Candidate List substance above a concentration of 0.1 % weight by weight has to give sufficient information to their customers and consumers to allow safe use.
 
Importers and producers of articles containing a Candidate List substance have six months from the date of its inclusion in the list (8 July 2021) to notify ECHA. Suppliers of substances on the Candidate List (supplied either on their own or in mixtures) have to provide their customers with a safety data sheet.
 
As of 5 January 2021, suppliers of articles on the EU market containing Candidate List substances in a concentration above 0.1% weight by weight must notify these articles to ECHA’s SCIP database. This duty comes from the Waste Framework Directive.
 
More information on these obligations and related tools are available here.

Source:

European Chemicals Agency