- REACHing 2013
- Lead registrants network and share experiences about successfully leading a SIEF
- Lead registrants share their views
- Get organised for joint submission and decide on the chemical safety report
- Communication in the supply chain: Making uses known to registrants well in advance of the registration deadline
- Chesar tool - in support of your safety assessments
- Industry experience with the QSAR Toolbox
- ECHA reporting on nanomaterials to the European Commission
- ECHA and the Member States align views on the joint task of evaluation
- Finnish and Swedish Ministers for Environment show keen interest in ECHA's activities
- New Head of Corporate Services
- ECHA Stakeholders have many important roles
- A REACH story: The tale of a political success
- REACH implementation in Slovenia: Breaking barriers through cooperation
- REACH and CLP enforcement in an Italian context
- Danish EU presidency working towards a green economy
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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
Lead registrants share their views
During the Lead Registrant Workshop, ECHA Newsletter interviewed two representatives of companies that act as lead registrants for the 2013 deadline. These companies have different experience with the REACH Regulation as well as a different operational environment to run their business. What are their thoughts on REACH, expectations for ECHA and how are they going about their preparations for 2013?
Jan Schüller, Director of REACH and Regulatory Affairs at Eastman, is a regular visitor to ECHA events. He represents a big chemical manufacturing company, which already has a lot of experience with REACH and of acting as lead registrant. Eastman is a manufacturer of chemicals, fibres and plastics that are used in consumer products.
In 2010, Eastman submitted around 50 registrations, covering some 45 substances. The company was appointed lead registrant for 18 registrations, which were managed either through consortia or by the company itself through Substance Information Exchange Fora (SIEFs). The same pace will continue for the 2013 deadline. "In 2013 we will submit just below 40 registrations, and will be lead registrant for half of the cases. This reflects the character of our speciality chemicals portfolio: we have a leadership, second or third market position for most of our products", says Mr Schüller. The last deadline went smoothly for Eastman, and the company prefers to take the role of lead registrant. "When we were co-registrants and dependent on others, we sometimes had to go knocking on the door and ask for information. We would prefer not to be dependent on others preparing the dossier for us whilst keeping us in the dark about the progress of the submission", Mr Schüller explains.
Smaller SIEFs, less data
As for the next deadline, Mr Schüller expects to see much smaller SIEFs. "I don't see a big role for consortia or a growth for SIEF leadership teams. What I do anticipate is that the substances will be less data rich. This poses a challenge because for most substances there is not such a big difference in data requirements for Annex 9 (concerns quantities of 100 tonnes or more) and Annex 10 (concerns quantities of 1000 tonnes or more). In my opinion, this means that we will have more data gaps and fewer experienced people to justify waiving statements or the use of read-across and other non-test methods."
Mr Schüller thinks that the main message to old and new lead registrants is the same as in 2010: start early and make sure you have a solid plan on how to move forward. "Active communication to the members is crucial. At Eastman, we do that via REACH platforms, but also through our website. We give a lot of information to our co-registrants as well as our customers on the status of the different dossiers that we are working on. It's really all about diligent project management," he says.
Dealing with backlog
REACH has now been operational for almost four years and there is more and more information available about the impacts of the regulation. Mr Schüller sees REACH fundamentally as a good approach, but also as an obligation of the industry, which should have been fulfilled a long time ago. "It is right that companies are responsible for managing the safe use of their products. I'd rather let the companies do that than the governmental organisations.
But basically, what we have in our hands is an enormous backlog. We are trying to catch up on what we should have done in the past", he explains. Mr Schüller sees some opportunities for innovation in replacing substances on the authorisation list. "But I think those same substances would have been under suspicion also without REACH. I struggle to see how REACH really helps innovation and the competitiveness of European industry", he adds.
Mr Schüller appreciates ECHA's initiatives for organising meetings such as the Lead Registrant workshop. "These events are perfect opportunities for companies to interact and develop more informal contacts with ECHA staff." From ECHA, he would like to see clarity on how to make best use of non-test methods: "A lot of companies have used read-across or the category approach to fill in their data requirements. It would be helpful to know how to bring the reality of industry in line with the expectations that ECHA has for information produced with non-test methods. Using these methods is one of the aims of REACH but in reality, I feel that ECHA often takes a more conservative approach", he concludes.
Benjamin Noel, REACH coordinator at Stéarinerie Dubois – a French fatty ester manufacturing company – has been working with REACH for many years. His company is registering for the first time in 2013 and is a lead registrant for several substances. Stéarinerie Dubois falls under the SME status and benefits from the advantages for SMEs under REACH.
To manage the registration process, Stéarinerie Dubois became a member of a consortium already years ago. "As an SME we cannot do everything by ourselves. The consortium is managed by a consultant; decisions are taken jointly with all the members during our annual meeting", Mr Noel says.
According to Mr Noel, SMEs face a lot of challenges with resources and the fact that they have to multi-task. "We can participate in the consortium discussions, follow the SIEF communication and work on our dossiers in IUCLID on the same day. We also have to deal with cost-sharing, data evaluation and with the cost of the studies. We have kept track of the changing guidelines and meet with the national authorities to know what is going on at the national level. We constantly take stock of all the substances in our portfolio and see how things evolve", he says.
Mr Noel says that it is not always easy to understand what ECHA can and cannot do. Coming to the workshop brought clarity on ECHA's role. "Being here at the workshop helps us to see how ECHA works. You can talk with ECHA staff and get answers from the one-to-one sessions. I now better understand the goals of ECHA and how the work is managed", Mr Noel explains.
From ECHA, Mr Noel expects clear and stabilised guidance, which would illustrate a step-by-step approach for preparing a registration. "I personally would appreciate having a full overview of the obligations for different players for 2013 in the form of guidance. Something concise that would explain all the different steps in the process depending on your role, whether you are a lead registrant or a member in a joint submission", he concludes.
The presentations and a video recording of the workshop are available on ECHA's website.
Interviews by Hanna-Kaisa Torkkeli
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