Annual Report 2021
Annual Report 2021
Annual Report 2021 - banner
Annual report 2021 intro
Our Annual Report provides the conditions and challenges we faced in 2021, together with the key achievements of the year. These are described for each of our three strategic priorities, as well as the corresponding governance and enablers, framing our work with a view to the Agency's contribution to EU priorities.
Annual report 2021 timeline
Annual report 2021 part 1
In the second year of the pandemic, ECHA achieved its work programme objectives thanks to the agility of staff and investments in our solid infrastructure. It has been encouraging to see how well ECHA’s committees and bodies have adapted to the remote setting and have been able to deliver under these conditions.
Under the umbrella of the EU Green Deal, the Commission’s Chemicals Strategy for Sustainability (CSS) is expected to become a game changer for chemicals management in Europe in the next decades. To support the Commission, we established working methods and agreed where and how ECHA’s expertise best serves them in the reviews of REACH and CLP. In 2021, with the implementation of its Work Programme, ECHA also contributed to the Commission’s preparatory work and many other initiatives under the CSS and Green Deal. For instance, ECHA gave its views on the possible amendment of registration requirements und REACH and discussed with the Commission how CLH dossiers could be prioritised and developed in ECHA under a revised CLP Regulation.
ECHA gained further experience with on-boarding new tasks and identifying how competences and resources can be efficiently allocated across different activities. Our involvement can bring broader regulatory synergies while the impact on resources and other parts of the Agency have to be continuously calibrated. The Agency has to keep on delivering on its core mandate, that is to achieve high quality regulatory outputs, and to invest smartly into getting ready for changes resulting from policy developments.
As an important input to the Commission’s review of the EU’s chemicals legislation, we published our five-year report on the operations of REACH and CLP. This retrospective reflection illustrates the impact that legislation has had on people’s health, the environment, internal market, competitiveness, innovation and promoting alternatives to animal testing. The lessons we have learned will serve to provide more tailor-made input for the ongoing development of possible changes to the legislation and as compass for ourselves to continue working to protect health and the environment from harmful chemicals.
The Management Board of ECHA reviewed the strategic plan 2019-2023. While confirming its validity for the remaining time, it gave steer to the Agency in how the strategic priorities should be understood and translated into action. With this as a guide, ECHA is well prepared to move ahead.
Annual report 2021 - mission
Annual report 2021 - Key achievements
This strategic priority represents an important part of ECHA’s core mandate. The majority of ECHA’s legally mandated operational work in managing chemicals under the REACH, CLP, BPR, PIC and POPs regulations aims to identify substances of concern and manage their risks.
The impact of this work is illustrated by the progress ECHA and Member States have made in identifying new substances of potential concern. We have become more effective and efficient in this by focusing on groups of substances – but inherently assessing groups of substances isa complex task.
We assess groups of substances and assign them to pools for further data generation, risk management and those that currently require no further action. The number of not yet assigned substances decreased from 18 341 to 17 126 in 2021, and as such we have better clarity on which risk management routes (if any) are planned and for which substances further data on properties and hazards is needed. This gives companies better predictability on the regulatory actions that authorities plan to take.
ECHA’s Member State Committee agreed on more than 440 decisions to request further information in 2021. The Agency also obtained hazard data for more than 200 substances on decisions taken earlier, although the 40 % non-compliance rate after these information requests is still high. These cases have been sent to the Member States for further enforcement actions. On average, when Member States enforce ECHA dossier evaluation decisions, the missing information is ultimately submitted to ECHA in around 92 % of cases. Regardless, this is still late and after the legal deadlines.
Furthermore, ECHA published the first assessments of regulatory needs for groups of substances, evidence of the Agency’s continued shift away from assessing individual substances, seeking synergies and increasing efficiencies. Group assessments make it easier for companies to predict what actions regulators are planning and help them to prepare strategies to replace harmful chemicals with safer alternatives, where relevant. The Agency assessed several important groups of substances which have received particular attention over the past years due to their extensive use in consumer products, such as bisphenols and phthalates .
- ECHA assessed the regulatory needs of 1 900 substances and shifted to dealing with them in groups rather than individually. 15 % of the 1 900 were substances registered above 100 tonnes per year. From this, we identified 300 that require further risk management measures, 800 that need more data to be generated and 800 that currently do not require further action. The regulatory needs of 1 300 substances registered above 100 tonnes per year still need to be assessed and have not yet been assigned. But we remain on target to conclude for all registered substances by 2027.
- To increase transparency on the regulatory actions being pursued and the progress made on groups of substances, ECHA published the first assessments of regulatory needs for 19 groups covering more than 450 substances at the end of 2021.
- The results of an EU-wide enforcement project of products sold online shows that three out of four inspected products breach EU chemicals laws.
- The extension of the technical completeness checks carried out for each new and updated registration now includes checking the content of chemical safety reports. This enables substances to be better prioritised for regulatory action by authorities, enhances the dissemination of use information and improves the starting point for appropriate supply chain communication.
- ECHA continued its efforts to phase out animal testing in Europe to the extent possible under the existing regulatory framework and support industry, authorities and institutions in making progress towards this goal. In this respect, ECHA updated its comprehensive guidance for companies on how to reliably combine different sources of non-animal data when assessing skin sensitisation of chemicals. The advice outlines how to use computer simulation tools such as the QSAR Toolbox to assess skin sensitisation and protect people from skin allergies without testing on animals.
- We conducted a total of 371 compliance checks covering more than 2 100 registrations and addressing 341 unique substances. This is a slight increase compared to 2020. For the vast majority of compliance checks, ECHA verified, as a minimum, the relevant higher-tier hazard endpoints for substances or groups of substances of potential concern. From this total, 300 were full compliance checks addressing all relevant endpoints for 288 unique substances of potential concern. 71 were targeted compliance checks. They resulted in 280 draft decisions being sent to companies, requesting more data to clarify long-term effects on human health or the environment.
- For the 363 follow-ups to dossier evaluation performed in 2021, around 40 % of dossiers remained incompliant. These have been sent to the Member States for further enforcement.
- ECHA received 535 registrations covering 143 nanoforms by the end of 2021. The exact number of nanomaterials on the EU market is unknown and there is reason to believe this figure ought to be higher. But there may be differences in tonnage that explain the discrepancy between the number of registered nanoforms, and the number of nanomaterials reported in the EU Observatory for Nanomaterials (EUON).
- In line with actions under the Commission and ECHA REACH evaluation joint action plan, we continued to support industry initiatives that help companies review their chemical safety data, for instance by defining a strategy for filling data gaps when assessing the environmental impact of petroleum substances.
- In preparation for identifying and proposing new persistent organic pollutants, ECHA provided the draft evaluation and the draft risk profile for two substances: methoxychlor is an organochlorine pesticide used as an insecticide, and UV-238 is used as a UV stabiliser found in plastic shrink films and outdoor furniture.
- Under authorisation, ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) adopted 18 opinions for substances that have endocrine-disrupting properties, and another 31 opinions for substances with other properties. 12 substitution plans were also evaluated.
- Regarding harmonised classification and labelling dossiers, RAC processed 54 opinions, and issued opinions on the evaluation of occupational exposure limits (OELs) for asbestos, and for cadmium and its inorganic compounds.
- Work on glyphosate re-commenced in coordination with EFSA where RAC will provide an opinion on the proposal for harmonised classification and labelling, and EFSA will develop its opinion on the authorisation of the use as a pesticide.
- Improvements to applications for authorisation were implemented, with an improved format of opinions on applications that provides clearer input to the Commission on scientific elements. The authorisation application format was also adapted, which should help to get better information into the process.
- Publication of a meta-analysis of the socio-economic impacts of authorisation based on data from 2010 and 2020 indicated that the authorisation system has inbuilt dynamics that inherently promote substitution.
- ECHA collaborated with the REACH exposure expert group (REEG), a community of Member State experts, on the levels of use and exposure information needed to swiftly move hazardous substances beyond screening into various risk management processes.
- Following agreement at the Member State Committee (MSC), 12 substances were added to the Candidate List of substances of very high concern, mostly because they are toxic for reproduction, carcinogenic, respiratory sensitisers or endocrine disruptors.
- A restriction proposal was issued on lead in ammunition for hunting, outdoor sports shooting and fishing.
- Concerning restriction proposals, RAC and SEAC provided two opinions, on PFHxA (a subgroup of PFAS) and on the proposal to restrict formaldehyde, PAHs, dioxins, furans and PCBs in single-use baby diapers.
- Publication of a study on costs and benefits of restrictions that estimated that restricting the manufacture and use of chemicals that pose a risk would result in health benefits amounting to EUR 2.1 billion each year.
- Investment in actions intended to accelerate the review programme under the Biocidal Products Regulation has started to pay off, with 18 competent authority reports evaluating active substances received during the yea r, including Review Programme, new active substances, renewal of approval and backlog cases that re-start a peer-review phase – almost double the amount received in 2020.
- The Biocidal Products Committee (BPC) issued 18 opinions on active substance approvals in 2021, compared to 15 last year. The number of BPC opinions on Union authorisation also increased to 15, compared to 9 in 2020.
The Agency calibrated its engagement on this priority following the decision to prioritise our focus on legally required tasks under strategic priority 1. As a result, we targeted our efforts on supporting companies to carry out their chemical safety assessments and improving Chesar for this purpose.
Functioning communication up and down in the supply chain on hazards and risks, and, first and foremost, appropriate safety assessments are essential elements of risk management by economic operators. ECHA’s support helps them to comply with their legislative obligations that are challenging to achieve through other means such as formal decision making or enforcement.
Due to the priority setting for strategic priority 1 in 2021, the impact remains limited to targeted support.
- Two new versions of Chesar published, upgrading the tool with new functionalities to better support companies in carrying out their chemical safety assessments.
- The obligation to notify hazardous mixtures for professional and consumer use started in 2021. Notifications must be made in a harmonised format defined under CLP, while labels must also include a unique formula identifier (UFI) – a unique code that allows poison centres to precisely identify the composition of the mixture and the product involved in a poisoning incident. ECHA processed a large number of notifications and made them available to the national authorities. This helps poison centres give quick and accurate advice when someone is accidentally poisoned.
- ECHA has collaborated with the European Integrated Pollution Prevention and Control Bureau (EIPPCB), providing REACH data and chemicals management advice to enhance the implementation of the Industrial Emissions Directive.
Implementing strategic priority 3 impacted ECHA in two ways. Firstly, the Agency has gained further experience in onboarding new tasks, supporting the legislator in preparing new or revised legislation, and how to run corresponding processes where ECHA has a role in such new tasks. ECHA staff has a very good understanding, based on concrete experience, of what it takes to integrate new regulatory work into the organisation’s portfolio. Onboarding activities have brought synergies and economies of scale to the Agency in some cases while in other cases it became clear that the intended synergy effect could not materialise.
Secondly, the Agency engaged successfully in implementing new tasks. Here, the main challenge has been to provide the necessary resources during the pre-onboarding phase, when the ultimate scope of the work is not yet defined, and dedicated resources are not yet available. ECHA is able to deploy experienced staff to this conceptualisation work, with the downside that this staff is then missing from initial activities and process work, and then this work needs to be compensated.
With the Commission’s Chemicals Strategy for Sustainability, the demands on ECHA have increased, with the Agency supporting the definition of possible new tasks and performing early analyses on process conceptualisation and resource predictions.
We continued trustful cooperation with other agencies on topics of common interest, such as ‘one substance, one assessment’, the development of IUCLID for the European Food Safety Authority’s (EFSA) evaluation of active substances in plant protection products and exchanging information and data with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in the context of developing an early warning system for new psychoactive substances.
With the launch of the SCIP database collecting notifications on substances of concern in products, ECHA is also providing another tool for economic operators, consumers and authorities to help them understand where harmful substances are used, increasing ambitions to replace them with safer alternatives.
- Ad hoc support to the Commission in the early phase of implementing the Chemicals Strategy for Sustainability and coordination of tasks involving ECHA’s competences and experience.
- Launch of the SCIP database for substances of very high concern (SVHCs) contained in products. This is useful for consumers who want more information about the products they buy and will also help to improve the treatment of waste, particularly recycling processes. Around 6 800 companies across the EU successfully submitted more than 15 million notifications to the database.
- Further development and promotion of IUCLID as a widely accepted format for information on chemicals across the world. Collection and use of data in the same format in the EU and internationally facilitates the recording, storage, maintenance and exchange of digital scientific data on chemicals.
- Supporting Member States and the European Commission under the Prior Informed Consent (PIC) Regulation, which implements the UN Rotterdam Convention in the European Union.
- ECHA contributed to the risk management evaluation of methoxychlor, which has been proposed by the European Union for listing as a persistent organic pollutant under the Stockholm Convention. A consultation was launched for the risk management evaluation of methoxychlor, as well as for the risk profile of UV-328.
- ECHA coordinated the publication of studies assessing the gaps and needs of Montenegro and Serbia in readying themselves to implement EU chemicals legislation on their path towards membership. Following this, ECHA also procured a second study to assess existing situation in Albania, Kosovo, Turkey, North Macedonia and Bosnia Herzegovina to guide the organisation in our future work in support these countries in their harmonisation of EU acquis for chemicals.
- Contacts were established with the European Environmental Agency (EEA) and ECHA participated in the Zero Pollution focus group. This work is a step towards safety and sustainability and will contribute to establishing indicators under the 8th Environmental Action Programme to 2030 and the CSS.
- ECHA began setting up EU-wide positive lists of chemicals that can be safely used in materials that come into contact with drinking water under the respective directive. The aim is to protect people from contaminated drinking water, improve their access to safe drinking water, and ensure that safety and hygiene standards are uniform throughout the EU.
- Provision of informal support to review sectoral best available techniques reference documents (BREFs). For example, in the review of the BREF for the textile sector, ECHA gave input on how chemicals management systems could be structured and described
- The Management Board led the mid-term review of the multiannual strategy and confirmed that ECHA’s strategic direction remains largely valid, while providing guidance to the secretariat for the remaining part of the implementation period. The Board also appointed the new Legally Qualified Member of the Board of Appeal.
- High quality outputs were delivered during the continued COVID-19 pandemic and support was provided to stakeholders as we work in a hybrid setting, with 650 virtual meetings and around 45 000 participants.
- The initial budgeted expenditure of 2021 totalled EUR 113.1 million (including the separately funded ‘Other tasks’) and the final total expenditure figure concluded in the second amending budget in September 2021 was EUR 111.1 million. The decline of the fee income levels of the REACH/CLP part of the budget was managed well by finding savings in meeting and travel costs through virtual meetings. For fees under the Biocidal Products Regulation (BPR), the persistently high volatility and unpredictability continued. The Agency met its budget implementation targets reaching a 98 % commitment rate and an 86 % payment rate (estimates were 95 % and 80 %, respectively).
- A high number of internal mobilities in line with our HR strategy and organisational culture that provides an agile and flexible working environment.
- Continuous investment in a healthy work environment based on collaboration, agility and a well-developed management culture led to the Agency being recognised as one of the most inspiring workplaces in Finland. The turnover of temporary agents remained low at 2 % and 97 % of establishment plan posts were filled.
- ECHA applied for registration to the EU Eco-Management and Audit Scheme (EMAS) as a premium management instrument for organisations to evaluate, report and improve their environmental performance.
- The third Enterprise Architecture Roadmap (2021-2023) has resulted in an increased integration or modularisation of IT to support the increased integration of business processes.