ECHA: 50% more REACH dossiers checked for compliance in 2019

In 2019 ECHA increased the checks carried out on companies’ chemical safety data by 50%. Important safety data has been requested to clarify long-term effects of chemicals on human health and the environment, including those affecting reproduction and causing genetic mutations. Our interview to ECHA’s managers.

The European Chemicals Agency (ECHA) is an Agency of the European Union implementing EU chemical regulations. Together with our partners, ECHA works for the safe use of chemicals. Last year, ECHA conducted 301 in-depth checks on almost 3,000 dossiers, covering 274 unique chemicals.

Decisions to make the registration compliant were sent to all registrants of the chemical - a change to the earlier practice where only the lead registrant was contacted. This contributed to a better collaboration among co-registrants. More checks were also done on dossiers from companies that registered their chemicals separately from joint submissions. This is to ensure that the reason registrants submitted their dossiers separately was legally justified and data-sharing obligations are met.

The focus has continued to be on information needed to clarify the long-term effects on human health or the environment. Information was requested in 245 of the 301 checks, with most asking to clarify long-term effects on the development of unborn children, genetic mutations, and aquatic toxicity. ECHA also examined close to 100 testing proposals submitted by industry.

Overall, in the last decade, ECHA has carried out an in-depth check of more than 1 000 chemicals across all tonnage bands. Over 20 % of the large volume chemicals with the highest potential exposure have been checked in depth. More than 10 % of the checked chemicals have been proposed as candidates for harmonised classification at EU/EEA level.

 

A crucial work about chemical safety

Bjorn Hansen, ECHA’s Executive Director says: “Chemical safety impacts citizens’ health. We know that European consumers are more worried about impacts of chemicals than ever before. To make sure companies follow the law and ensure the safety of the chemicals they sell, we have stepped up our efforts to check more registrations. This work is crucial to prevent harmful chemicals entering the EU market and ultimately minimising chemical pollution in Europe.”

With regards to substance evaluation done at the Member State level, 264 chemicals were evaluated between 2012 and 2019. For 181 chemicals, further information was needed to clarify suspected concerns. For around one-third of the 181 chemicals, risk management was needed. for example, four were flagged for restriction, nine were identified as substances of very high concern and 41 needed harmonised classification.

A full breakdown of the numbers is published in ECHA’s annual evaluation statistics overview along with recommendations for registrants on how they can improve their dossiers.

We asked some questions to Christel Musset, Director of Hazard Assessment, and Wim de Coen, Head of Unit for Hazard Assessment.

 

We asked some questions to Christel Musset, Director of Hazard Assessment, and Wim de Coen, Head of Unit for Hazard Assessment.

 

Why did ECHA decide to get a new approach in evaluating the dossiers?

Ensuring compliance of chemicals safety data submitted in registration dossiers to ECHA remains a key priority for 2020 and the years ahead. It has been our priority for some time now as it’s an area where urgent improvement is needed. In October 2019, Member States approved the REACH Evaluation Joint Action Plan for ECHA and the European Commission to increase the minimum percentage of registration dossiers that undergo compliance checks in each tonnage band from 5% to 20%. This will mean, that overall, around 30 % of all registered substances will be checked.

Also, by checking all affected members of the joint submission with non-compliant dossiers, we require all recipients to comply with their respective information requirements and to provide data missing for compliance.

More background information can be found here in our Newsletter article.

Which are the most important critical aspects that ECHA finds in evaluating the compliance of the dossiers?

Compliance check focuses on eight key endpoints which are most relevant for the safe use of substances: genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. These are the key endpoints for identification of substances of concern.

As an example, outcome of 301 compliance checks conducted in 2019 demonstrated that in the assessed dossiers, there was not enough data on long-term effects of chemicals, such as their effect on the development of unborn children, genetic mutations, or aquatic toxicity. More information on tests requested in 2019 can be found at echa.europa.eu/further-information-requests-2019

As REACH provides for a legal obligation on manufacturer and importer to provide tonnage dependent minimum information requirements on the intrinsic properties of their substances, and also inform on their volumes, uses and exposure it should be in the particular interest of operators to ensure compliant and up to date information in the registration dossiers irrespective of any evaluation activity being carried out.

All REACH registrants are encouraged to proactively update and review their information so as to improve the quality of their registration dossiers. Based on its findings in the dossiers, ECHA has published and keeps updating recommendations to registrants on echa.europa.eu/recommendations-to-registrants

 

Why did ECHA decide to collaborate with Cefic for the application of “best practices” on defining testing strategies for substances?

As outlined in the Joint Action Plan, compliance of the individual dossier is a matter of each individual registrant. However, organisation of information in joint submissions, efficiency of capturing groups of substances either through similarities in hazard or due to common uses, exposure information etc. speak for the organisation of the dossier review and update in a more systematic manner. Companies with a large portfolio or business associations are in position to launch programmes capturing many substances and update the information as necessary to identify current weaknesses, introduce new knowledge and where necessary propose optimised testing strategies.

The Joint Action Plan calls for industry to review their registrations and update them as needed, including by generating new information. In 2019, we continued to support industry associations in their initiatives to develop programmes for helping registrants review their registrations. In this context, CEFIC Action plan can be mentioned as a good example.

 

The dossiers often need to clarify suspected concerns or do not have enough information about risk management. In this case, what ECHA has to do?

As outlined above, in 2019, ECHA has prepared with the Commission the REACH Evaluation Joint Action Plan which sets out a new and more ambitious approach to scrutinise all registered substances, identify those that should be regulated and obtain compliance within a timeline of nine years. ECHA therefore continues performing compliance checks to ensure that the legally required information on the intrinsic properties of substances is available, allowing to conclude on the need for further risk management and with a focus on substances and groups of substances that matter most for risk management.

With the support to Member States the Agency enables all actors in the evaluation process to provide their contribution to clarify concerns of importance for risk management.

 

The dossiers about nanomaterials are still not enough, at the moment. Why is it more difficult for these materials?

Updated REACH information requirements for nanoforms of substances have applied since 1 January 2020. Beyond this date, companies must have a REACH registration compliant with these requirements to manufacture or import nanoforms of substances. The purpose of the new requirements is to make sure companies provide adequate data to show the safe use of their nanoforms for human health and the environment. As you have seen from ECHA’s communications, the updates received on substances in the nanoform are lower than expected. We are currently in contact with industry stakeholder organisations to probe further into the reasons behind the low numbers.

We understand from these discussions that there are multiple reasons currently at play. For example, some of the registrants who are aware of their registration obligations face difficulties in creating their submission jointly i.e. due to confidentiality issues linked to the specific aspects of their forms. Some consortia have set up a ‘trustee’ system which tries to alleviate such hurdles, however, this could also create some complication in terms of communication. It also seems that some registrants are currently still in the process of characterising their forms and are awaiting the outcome of the test laboratories. Overall, it is unclear how much of the current situation is due to a lack of awareness or due to perceived difficulties in registration. ECHA will be discussing this with the competent authorities at the CARACAL meeting as well as with the national enforcement bodies at the next Forum meeting.

Also, we have no view on how the lack of certain test methods impacts the registration process. For those endpoints at REACH Annex VII and VIII, where there is currently no internationally agreed test method available but where registrants have done all efforts to generate compliant information and engage themselves to test in the future once the test method becomes available, we have generated a temporary approach here.

For Annex IX and X endpoints, we have foreseen to receive testing proposals for nanoforms. However, up to now, ECHA has not received any such proposals, even for those endpoints where such internationally agreed test methods are lacking. Whether this means that registrants are currently mainly focusing on their specific nanoform characterisation and not (yet) on the hazard information, remains to be seen.

 

Do you think that Cefic’s Action Plan on REACH dossier improvement can be a positive thing to improve dossiers?

Yes. Compliance of dossiers, their systematic review and updates of registrations based on new information remains industry’s responsibility. We welcome all actions from industry to proactively improve and update their dossiers and continue to support industry associations’ initiatives to develop programmes for helping registrants review chemicals safety data.

However, it would be yet too early to conclude whether the voluntary industry programmes already led to further improvement of the data in registration dossiers and safe use and better management of hazardous chemicals. A positive trend is expected to be seen in the next years, especially if the voluntary industry programmes bring the necessary improvements and additional information before ECHA issues compliance check decisions.

 

Which will be the role of ECHA in this phase of transition?

As part of implementing ECHA’s Integrated Regulatory Strategy and in line with the REACH evaluation joint action plan, we will continue compliance checks addressing relevant higher-tier hazard endpoints for substances or groups of substances of potential concern mainly in the higher tonnage bands (over 1000 tonnes dossiers and 100-1000 tonnes dossiers). In addition, a strategy is in preparation to check the compliance of dossiers in lower tonnage bands (1-10 and 10-100 tonnes).

By carrying out this work, the Agency addresses the findings of the REACH Review with the aim to ensure that REACH works effectively to ensure safe use of chemicals and contributes to the 2030 World Summit on Sustainable Development (WSSD) goals.

Therefore, in 2020 ECHA will maintain most of its resources dedicated to the key processes under REACH. Evaluation is one of those key processes for which a high workload is foreseen in 2020. ECHA will re-allocate staff from other functions to evaluation tasks. Other actions include simplifying compliance check decisions, cooperating closely with the Member States Competent Authorities, increasing enforcement, interaction with industry associations to make sure registrants step up their compliance efforts, and establishing a transparent monitoring system of the progress made.

You may consult a relevant background article on the compliance topic:

https://newsletter.echa.europa.eu/home/-/newsletter/entry/why-compliance-matters

echa.europa.eu

 

 

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