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Editor-in-chief: Maurizio Roncaccia
Editors: Paul Trouth and Päivi Jokiniemi
Article related to: News from ECHA
Too many companies are not updating their REACH and CLP data
A study looking at companies’ intentions to update their REACH registrations and CLP notifications tells a worrying story: updating data on chemicals is not a priority – unless prompted by ECHA.
Around 64 % of the dossiers submitted to ECHA since 2008 have never been updated. And those that have been, were mostly updated only after a letter from ECHA. Given that reliable data on chemicals is the foundation of safe use and the management of risk from dangerous substances, this is putting the protection of human health and the environment in jeopardy. Without data that reflects the reality, risk management becomes impossible.
Consequently, improving the data is one of ECHA’s priorities. With many actions already underway (e.g. screening dossiers, completeness checks), the results of the study will help ECHA and the European Commission to analyse more closely what is needed to nudge companies into being more proactive in updating their REACH and CLP information.
Four main shortcomings
The study suggests that there are four issues that affect companies’ willingness and readiness to update their data:
Seeing registration as the end of the process Many companies have the perception that receiving their registration number is the end of the REACH registration process and that no further work is needed. This perception is worsened, for example, by the fact that the fees payable (for registering and getting access to data) are one-off payments. It is also difficult for the lead registrant to get contributions from the SIEF members when they are trying to update the dossier.
Lack of clarity on what needs to be done, when and by whom The study respondents were unclear about what needs to be updated according to Article 22 of REACH. It places an obligation on the individual to decide when an update is needed – mentioning that it needs to be done based on ‘new information’ without ‘undue delay’. As REACH is based on the ‘one substance, one registration’ principle, the responsibility for updates is ambiguous. Is it the lead registrant’s task alone or should the other SIEF members support? Or are updates the responsibility of each individual registrant?
Limited resources The costs of updating can be high and the benefits non-existent. In particular, small and medium sized enterprises (SMEs) felt that REACH is just a regulatory burden. The respondents also signalled a 'REACH fatigue' with a great deal of effort and cost already spent on the original registration.
Limited use of the whole set of data The fourth issue has to do with the practical value of the data in the dossier. The respondents felt that the dossier as a whole contains highly technical information better suited for academics and regulators than for downstream users, who benefit more from up-to-date CLP classifications and exposure scenarios. They mentioned that the downstream users want good quality safety data sheets and that the focus should be on those.
The study suggests actions for ECHA, trade associations and policy makers.
Clarity on what needs to be updated ECHA should clarify Article 22 requirements and provide additional guidance for SMEs (e.g. a clear overview of what the lead registrant can ask from the members).
A clear definition of who is responsible for the updates For example, improving ECHA material and guidance on the roles of lead and co-registrants.
Improved understanding of why updates are important Trade associations and ECHA are encouraged to increase awareness of the benefits of updating dossiers and risks of not doing so.
An implementing act to make the update requirement clearer and enforceable The European Commission should consider a new implementing act, which would provide detail on clear circumstances and fixed intervals when dossiers need to be updated.
Why are updates important?
Poor data means poor quality protection of human health and the environment and poor risk management. Registration dossiers are your business asset. Good quality, up-to-date information helps appropriate communication in the supply chain and makes sure that adequate safe use advice is given further down the supply chain, eventually to end users like consumers and workers.
For ECHA and the national authorities, good data enables effective decision making on further risk management measures and leads to better information being published for the general public.
ECHA's chemicals database now shows when the registrant last updated their dossier. The updates are marked with the IUCLID symbol in the database. Image: ECHA.
Did you know?
Updates visible in the chemicals database
Since May 2017, ECHA’s chemicals database shows the year of the latest dossier received by a registrant. You can find that by searching for the chemical and going to the registered dossier data.
Under the section General information – Registrants/Suppliers of the substance, you can see a list of registrants and an indication of the registrants who have updated their dossier and when.
Legal obligation to update
Article 22 of REACH says registrants must update their dossiers ‘without undue delay’ whenever there is a material change or new information comes to light. This includes, for example, new chemical safety reports (CSR), changes in uses and tonnage as well as new toxicity data.
A study to gather insights on the drivers, barriers, costs and benefits of updating dossiers was conducted from April-June 2017. ECHA stakeholders responded to an online questionnaire with volunteers interviewed in depth. The online questionnaire had 322 respondents. Telephone interviews were done with 20 organisations of which 13 were large companies, four SMEs and three trade associations.
The study was commissioned by ECHA and carried out by Amec Foster Wheeler Environment and Infrastructure UK Limited in association with Peter Fisk Associates Limited.