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Why compliance matters
To be sustainable, you need reliable information. The data collected under REACH is the backbone upon which successful EU chemicals management is built. It allows us to see the properties of chemicals, to decide which are safe and which are hazardous, and to find effective routes for phasing harmful chemicals out from the market. This is why compliance matters.
A push towards a circular economy
If we want to move towards circularity, we need reliable information on chemicals. ECHA’s chemicals database is the largest in the world, bringing a wealth of information to users. The non-compliance of many REACH registrations has been a concern for the Agency ever since the first compliance checks were carried out in 2009. Since then, ECHA’s evaluation reports have consistently highlighted the need for registrants to keep their dossiers up to date so that the information requirements are fulfilled.
“We have good information on short-term, acute effects of substances on human health and the environment. But we are lacking data for long-term effects, such as endocrine disruption, carcinogenicity or bioaccumulation, which are extremely important. We can’t be complacent in retrieving this information. It is vital for building a comprehensive and accurate knowledgebase that will allow manufacturers to make the right choices on materials and help in moving towards a circular economy,” says Christel Musset, ECHA’s Director for Hazard Assessment.
|“We have a responsibility to Europe’s citizens and to our stakeholders to make sure that the data provided by industry complies with the REACH information requirements.”|
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 percent to 20 percent. This will mean, that overall, around 30 percent of all registered substances will be checked.
Self-reflection to boost compliance
Even before the percentage increase was given the stamp of approval by Member States, ECHA has taken action to improve compliance. From the start of the year until the end of October 2019, more than 200 substances had been checked for compliance – which corresponds to more than 2 100 registrations. By the end of 2019, ECHA estimates that 50 percent more substances will have been checked compared to 2018.
“We have a responsibility to Europe’s citizens and to our stakeholders to make sure that the data provided by industry complies with the REACH information requirements. But, we also need to get the data as quickly as possible so we can make sensible risk management decisions,” Ms Musset tells.
The Agency has looked at how it carries out evaluation work and has launched a series of projects throughout 2019 to increase the number of decisions that are generated.
“We now involve our legal department much earlier in discussions with our scientists to decide on the best strategy for requesting information from companies. We have also standardised the texts we use for our compliance checks in an effort to generate more consistent decisions at a faster rate,” she explains.
Speed is of the essence… but science is key
The pace at which the Agency checks dossiers has already begun to accelerate, but speed is not the only important factor. The work carried out on checking registration dossiers for compliance should not be underestimated. This is not just an administrative exercise, but involves complex scientific work that is often cross-disciplinary and may impact many processes under REACH.
“The quality of information we collect under REACH has to be reliable to reduce the chance that harmful effects might go undetected. This reliability is also important for other pieces of downstream legislation, for example, those involving cosmetics or toys. If the EU is to move towards safer and more sustainable chemicals, data is the key. Making sure the data is compliant requires many actors to work together including ECHA, the Member States, the European Commission and industry,” Ms Musset says.
When amendments to ECHA’s draft evaluation decisions are proposed by Member States, the Member State Committee will discuss the cases and seek a unanimous agreement. These discussions can often be lengthy. “We should reflect whether these extended discussions improve the final decisions. If improvements are possible, then we should continue to discuss these amendments in detail. But, if the decisions are unlikely to change, we should do all we can to avoid wasting time,” she highlights.
The Agency has also discussed the possibility of simplifying the wording and clarifying the REACH annexes with the Commission. “We believe that changes to the annexes will help industry to better understand the information requirements and how to conduct their testing,” she adds.
Grouping and prioritising
ECHA’s work to map the chemical universe aims to have full clarity on all registered substances above one tonne by 2027. The Agency’s approach is to first, based on the information available, group the substances into pools depending on whether they are high priority for risk management, high priority for data generation, or currently low priority for further action.
“The groups of chemicals are not only being looked at from a hazard assessment point of view but also with risk management in mind. It’s really about having a holistic view on all chemicals in the group. In this way, we can identify those substances where we need more data to conclude on their effects on human health and the environment and those where risk management measures could be immediately pursued at EU level,” Ms Musset explains.
Ultimate responsibility lies with industry
ECHA has put in place a number of agreements with Cefic and other industry associations to engage with them and better understand the obstacles preventing compliance.
“We think it is important that we work together and give support to industry to improve their registrations. But, the biggest responsibility still lies with companies. They have to show they are committed to updating their dossiers and that they take their social responsibilities seriously,” Ms Musset concludes.
Interview by Paul Trouth
Published on: 14 November 2019
Top image: © Pexels/Matthias Zomer
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: