Annual Report 2020
ECHA’s Annual Report presents a summary of operational achievements and a breakdown of the resources used during 2020. It explains how the objectives set in the planning phase have been met and the targets achieved for the year. It also covers information on assurance and compliance with internal control standards.
While adapting to the remote way of working due to the global pandemic, significant steps were taken in the EU to make our lifestyles more sustainable and to protect health and the environment. The European Commission’s Green Deal, was followed by the publication of its Chemicals Strategy for Sustainability, supporting the delivery of a toxic-free environment, a zero-pollution ambition and the eighth Environmental Action Programme. Progress was also made on protecting health with the publication of the Commission’s cancer action plan. There are actions with all these policy initiatives to which ECHA can offer expertise and knowhow.
The Agency reflected in 2020 on its capabilities, role and mandate – carrying out a detailed priority setting exercise in preparation of the EU Multi-annual Financial Framework 2021-2027. The outcome of this is that we have focused on prioritising areas where we can have the maximum impact on protecting human health and the environment. For example, assessing chemicals in groups became a norm, and sustainability and circularity entered the spotlight as we launched the SCIP database of safer chemicals in products. As outlined in our Communications Strategy, we also continued to increase visibility on the impact of our work as a centre of knowledge on chemicals safety.
The competence of ECHA’s staff and the vast amount of data held by the Agency, has allowed us to make significant progress in line with our three strategic priorities, and support progress towards the United Nations’ sustainable development goals.
Under the first priority, ECHA aims to check all registered substances to identify substances of concern and decide whether regulatory actions are needed, and the most appropriate ways to manage their risks. In total there are more than 21 000 substances to be checked and prioritised, out of which around 4 600 are manufactured or imported above 100 tonnes per year in the EU.
ECHA continued to assess if the information on chemicals received from companies meets the legal requirements, and significant progress was recorded in generating needed hazard information. In total, 271 full compliance checks covering 258 unique substances and 76 targeted checks on 44 unique substances were carried out in 2020. The full checks targeted long-term effects of chemicals that may cause genetic mutation and cancer, harm fertility or the unborn child, or are harmful to the environment.
There is tangible progress within the EU to reduce exposure to hazardous chemicals. Firstly, six more substances have been added to the Candidate List of substances of very high concern – five that are reprotoxic and one with endocrine-disrupting properties. As of December 2020, 211 entries containing 393 substances of very high concern were on the Candidate List, out of which 54 need authorisations.
Secondly, there are reasons to believe that authorisation requirements have led to substitution, as no applications for authorisation were received for 24 of the substances of very high concern.
And thirdly, restrictions are providing protection for workers, consumers and the environment as they effectively reduce exposure to harmful substances. In 2020, seven opinions on restriction proposals were adopted by ECHA’s scientific committees.
Classification and labelling are important instruments in ensuring the safe use of chemicals. The number of substances addressed by harmonised classification and labelling has been increasing, bringing the total number of substances classified under harmonised classification in all hazard groups to 379, as of December 2020.
ECHA’s Integrated Regulatory Strategy continues to identify substances for which – based on the data received following an evaluation decision – harmonised classification is considered the most suitable option for risk management.
- Information is more transparent in our chemicals database – users can now see when substances were registered, when registrations have been updated, and when companies cease manufacture or have their registrations revoked. Nano data and related studies were also made available, as well as key lists for persistent organic pollutants. The database makes chemicals data easy to access for its 40 000 daily users.
- Our completeness checks for registration dossiers now also cover nanomaterials and have been improved for key hazard endpoints such as genotoxicity and reproductive toxicity. This provides a better starting point for authorities to prioritise substances for regulatory action. Assessors can also now evaluate possible hazards and risks of 190 registrations for 68 substances covering nanoforms received by the end of 2020.
- ECHA’s Integrated Regulatory Strategy has accelerated the grouping approach and the assignment of registered substances into pools based on their regulatory status. This has formed a more complete picture of the universe of registered substances and how to efficiently address those that require action. In 2020, ECHA and Member States checked around 1 900 substances to identify a need for further assessment, of which around 38 % had been registered above 100 tonnes per year.
- Work continued intensively to tackle non-compliant information on chemicals and significant progress was recorded in generating needed hazard information, with 271 full checks covering 258 unique substances and 76 targeted checks on 44 unique substances.
- RAC processed 50 harmonised classification and labelling dossiers – covering 33 industrial chemicals, 40 proposals for carcinogenic, mutagenic or reprotoxic substances (CMRs) and 17 dossiers for active substances used in biocides and plant protection products. The Commission harmonised the classification and labelling of 22 new substances and revised existing harmonisations for 31 substances.
- RAC and SEAC made 96 opinions on applications for authorisation. With the conditions proposed by ECHA’s committees, the environmental emissions of two endocrine-disrupting substances were projected to reduce by more than 90 %. As ECHA did not receive review reports from two-thirds of authorisation holders, there is growing evidence that authorisation accelerates substitution. The annual benefits of the authorisation system were estimated to be about EUR 15 billion.
- RAC and SEAC adopted seven opinions on restriction proposals – for microplastics, cobalt salts, the siloxanes D4, D5 and D6, formaldehyde, skin-sensitisers, PFHxS, and calcium cyanamide. The Agency also worked on four new restriction proposals, including one concerning substances used in single-use nappies. In addition to preventing 100 000 tonnes of chemicals from polluting the environment each year, the annual health benefits from restrictions were estimated to be at least EUR 708 million.
- Member States and ECHA agreed on the active substance action plan to speed up the implementation of the review programme for biocidal active substances at EU level. The aim is to increase the number of dossiers submitted for peer review by the Member States.
- ECHA joined forces with the Commission to help Member States and companies get more disinfectants on the market as part of the fight against COVID-19. ECHA helped specifically by providing compositional recommendations to combat disinfectant shortages.
- ECHA’s support and tools for companies were adapted to take the regulatory amendments to CLP into account, and to help industry prepare poison centre notifications in the harmonised format ahead of the first applicability date on 1 January 2021. By the end of 2020, almost 350 000 notifications were successfully submitted.
- Efforts in harmonising enforcement with two finalised harmonised enforcement projects and a pilot project on REACH and CLP obligations across the EU focused on ensuring that companies provide missing information following evaluation decisions and imported products which often do not comply with EU law.
- Three major studies under the European Union Observatory for Nanomaterials (EUON) were conducted on the effect of nanomaterials on female fertility and reproduction, skin absorption from consumer products and the public’s perception of nanomaterials provide insights on the safety, innovation, research and uses of nanomaterials.
- ECHA’s report concerning progress on the use of alternatives to testing on animals was published, looking for the first time at low-tonnage registrations after the 2018 deadline. The report shows that adaptations continue to be used more than experimental studies, in particular, read-across.
Effective communication up and down the supply chain is critical for the safe use of chemicals. In 2020, ECHA worked with key stakeholders to identify necessary improvements to the current system for providing fit-for-purpose safety information on hazardous substances and mixtures.
A joint analysis, under the umbrella of REACH Review Action 3, was carried out by ECHA, the Commission and the stakeholder Exchange Network for Exposure Scenarios (ENES), concluding that further efforts are needed particularly from industry. Both industry and Member States acknowledge that improving the workability of (extended) safety data sheets needs to be accompanied with improved content in chemical safety reports, as this is the source of information expected to travel through the supply chain.
To derive meaningful risk management advice, it is crucial for chemical safety assessments (CSAs) to be based on representative conditions of use and for dossiers to be updated with information that is increasingly available from the supply chain.
As an outcome of our discussions on prioritising tasks, it was agreed to pause our work to support supply chain communication after 2020.
- REACH requirements for compiling safety data sheets were amended with the addition of mandatory specifications for nanoforms and endocrine-disrupting properties, and the assignment of unique formula identifiers to the labels of hazardous mixtures.
- Updated guidance for safety data sheets was published giving consumers and industry the most current information on how to use chemicals safely.
- Use map information was updated and published for three important sectors of the European economy: agriculture, solvents and the petroleum industry.
- ECHA continued to collaborate with the Joint Research Centre of the Commission on developing best available technology reference documents for ceramics, textiles, ferrous metals processing, and smitheries and foundries under the Industrial Emissions Directive.
- ECHA worked with Member States, Commission and industry to establish a development plan for REACH Review Action 3. The plan is intended to clarify which further work is needed to establish a more effective system and where further investment is needed. As part of the priority setting for 2021, ECHA’s support to communication in the supply chain, including REACH Review Action 3, was paused.
The knowledge and competence that ECHA possesses has made it possible for the Agency to integrate further tasks. The implementation of REACH, CLP, BPR, PIC and POPs remains the backbone, but leveraging on the experience gained has also allowed ECHA to progress with the SCIP database and facilitating the use of IUCLID by the European Food Safety Authority (EFSA) – an important step towards further harmonising data on chemicals.
ECHA also supports the protection of workers in the EU with its opinions on occupational exposure limits and by proposing conditions for the use of substances that need authorisation. Furthermore, environmental emissions of substances are projected to be reduced thanks to the authorisation requirement.
To improve knowledge and transparency on chemicals, ECHA launched the first version of the EU Chemicals Legislation Finder (EUCLEF), allowing users to see how their substances are regulated across 40 pieces of EU legislation. The EU Observatory on Nanomaterials (EUON) further increased the information available about nanomaterials on the EU market, by commissioning three major studies on topics related to human health and general awareness of the nanomaterials in 2020.
- The SCIP database used to track substances of very high concern in products was launched, facilitating moves towards a more sustainable circular economy.
- To protect workers with limit values from exposure to lead and diisocyanates, RAC recommended occupational exposure levels (OELs) and initiated evaluations of asbestos and cadmium.
- Chemical safety in importing countries was promoted as evidenced by the processing of a record number of 11 971 PIC export notifications.
- The EU Chemicals Legislation Finder (EUCLEF) was unveiled, giving instant access information on chemicals across 40 pieces of legislation to companies, citizens and regulators.
- Substances subject to the POPs Regulation or those proposed as POPs are now flagged accordingly in ECHA’s chemicals database. Users can search to find POPs, with different depths of information available in the substance Infocards and Brief Profiles.
- Preparations were started for new tasks including assessing substances used in materials that may come into contact with drinking water under the revised Drinking Water Directive. First discussions were also held on whether and how to integrate the task of managing the risks of dangerous substances in batteries under the draft Batteries Regulation. Despite facing resource constraints, ECHA prepared to integrate the new tasks efficiently and explored how to create economies of scale by re-using existing IT platforms (such as the Cloud Services platform).
- We partnered with global authorities to maximise the use of existing data and promote IUCLID as the go-to platform for maintaining and exchanging data on chemical properties at an international level.
- The move to ECHA’s new premises in 2020 presented an opportunity to scale-up the environmentally conscious actions updating the three-year environmental work programme to reflect the ambition to become net carbon-neutral by 2030.
- We put the necessary steps in place to continue implementing our Work Programme in a fully remote setting with extended teleworking arrangements for all staff members due to COVID-19.
- ECHA’s outreach activities support sustainable chemicals management on a global level. Through capacity building in third countries, ECHA helps them to develop chemical management systems that can benefit from European chemicals management and risk assessment approaches.
- ECHA’s advice on how to transfer registrations and assets to the EU before the end of the transition period avoided disruptions to the EU market by helping UK-based companies prepare in the lead up to Brexit.
- ECHA’s re-certification against the ISO standards 9001:2015 and 14001:2015 for its quality and environmental management systems are proof of a high-quality work and continuous improvement of how to achieve set objectives.
- The Management Board successfully concluded a critical priority setting exercise, providing steer for the Executive Director and the Secretariat and elected Mr Paul Krajnik as its new Chair.
- ECHA has been chairing the European Union Agencies’ Network (EUAN), including most of its subnetworks. While the year was challenging for everyone with the coronavirus pandemic to contend with, the network and its members adapted rapidly and efficiently under exceptional circumstances. Despite not being able to meet physically, in addition to the regular plenaries and sub-network meetings, several extraordinary meetings of the Heads of Agencies and Heads of Resources were organised to deal, among other things, with COVID-19 and Brexit. The EUAN also set up an Executive Directors Group on Administrative Excellence and an Advisory Group on new ways of working as well as adopting the EUAN Multiannual Strategy 2021-2027, in line with the new EU priorities of digitalisation, greening resilience and recovery.
Reference: ECHA-21-B-02-EN, ISBN: 978-92-9481-872-0, Cat. number: ED-BG-21-001-EN-Q, ISSN: 2362-9967, DOI: 10.2823/9169,Publ. date: April 2021