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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.

 

Weitere Informationen:
ECHA European Chemicals Agency chemicals
Quelle:

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.
Quelle:

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.

Weitere Informationen:
ECHA database REACH chemicals
Quelle:

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.

 

Quelle:

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.

Weitere Informationen:
ECHA hazardous chemicals
Quelle:

European Chemicals Agency

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.

Weitere Informationen:
ECHA chemicals polymers
Quelle:

The European Chemicals Agency (ECHA)

20.06.2023

New EU chemicals enforcement project to focus on products sold online

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.

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.

Weitere Informationen:
European Chemicals Agency chemicals
Quelle:

European Chemicals Agency

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.

Weitere Informationen:
ECHA PFAS polyfluoroalkyl
Quelle:

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.

 

Weitere Informationen:
ECHA chemicals hazardous
Quelle:

European Chemicals Agency

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.

Quelle:

European Chemicals Agency