- The big push towards 2013
- Following the lead to Helsinki: ECHA welcomed lead registrants back for a second workshop
- Smaller companies taking the lead
- Make every effort to share data within your SIEF
- How can I find my co-registrants?
- Candidate List – the way ahead
- ECHA finds over 2 000 potentially non-compliant dossiers
- Reaching the nano scale
- ECHA holds a scientific discussion session on in vivo mutagenicity tests
- The world is watching: ECHA at ICCM-3
- ECHA audited for the management of conflicts of interest: Taking an interest in interest management
- Airing new strategies for REACH implementation
- Executive Director visits authorities in Romania and Bulgaria: "More resources needed for chemicals management"
- Chair of the Risk Assessment Committee appointed
- Highlights of the 27th Management Board meeting
- Substitution of chemicals on the Candidate List for authorisation is already happening
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Article related to: REACH
Smaller companies taking the lead
At the Lead Registrants Workshop, ECHA Newsletter interviewed few of the participants on their experience with REACH registration, managing substance information exchange forums (SIEFs) and the challenges for smaller companies of being a lead registrant.
Mariano Alessio Verni from SILC Fertilizzanti Srl, is the co-ordinator of the Potassium Phosphites Consortium. His company has experience as a member registrant from the 2010 deadline and recently stepped in to become a lead registrant for 2013. He is quick to point out that there is a substantial change in communication within the SIEFs from two years ago. "It is not like in 2010 registration, when we had a couple of big companies with enough people to work on REACH inside the company itself. Smaller companies usually have to outsource this work. It is not profitable to train people internally if you have to register only a couple of substances." He explains that usually the lead registrants call on an external consultant and the companies that are members also call on consultants. "The dialogue is between the consultants themselves and not between companies, so it is an indirect communication. Moreover, different consultants have different approaches on how to make the gap analysis. This makes it very hard to manage the consortium."
To address this challenge, Mariano Alessio Verni considers that the lead registrant's company or a core group of companies should have sufficient expertise to guide the consultants. "I have enough expertise in the sector, so I can help our consultant not only with the chemical issues, but also with the technical, marketing and commercial issues." He is convinced that good knowledge of the market is also important. "I already know other SIEF members from my past commercial of our members in congresses or trade exhibitions in and outside Europe and that helps a lot in the communication." He advises that it is not good to forget the commercial aspects when dealing with REACH, especially when the consortium involves SMEs.
Attending ECHA's Lead Registrants' workshop provided the opportunity to have a one-to-one session and to clarify the sameness of the substances that will be registered. Following this, he is planning a meeting with the consortium to do final preparations before submitting the lead dossier before the end of February 2013.
Stéarinerie Dubois, a French medium-sized company manufacturing fatty esters, is registering for the first time in 2013 as lead registrant for several substances. Regulatory Affairs Manager Laetitia Halbeisen says that her company became a member of a consortium several years ago to be able to manage the registration process. The consortium is managed by an external consultant. "We don't have the internal resources especially for the eco-toxicological and toxicological parts, so the support of the consultant is very important. It is still somewhat difficult to decide strategies since it requires a lot of background in these fields, but we are learning" Ms Halbeisen says.
Stéarinerie Dubois is exporting products all over the world and has to comply with many different legislations. "Our products have to conform to legislations in Europe, Asia, America… and we need to adjust to the changes they introduce. For example, we might have to register a substance under REACH and commission tests according to certain methods. To export the same substance to China, we would have to do other tests which are applicable to their legislation. The overall context is complex," Ms Halbeisen explains.
From ECHA, Ms Halbeisen would also like to receive positive, reassuring feedback, to know that her company is on the right track. "For example, when you put in a confidentiality claim, which requires a detailed argumentation, it would be good to know that it is being assessed and what the result is. At present, there is a waiting period during which you may receive messages in REACH-IT if there are comments or problems. It is the same with dossier updates. It would be great to receive some proactive signals from ECHA," she concludes.
Darren Abrahams is an environmental lawyer working with REACH and related legislation at Steptoe & Johnson LLP in Brussels. He helps his clients interpret the REACH Regulation and guides them on strategies. "But we are also an Only Representative. We are actually registering for a large number of non-EU manufacturers; companies, which are exporting chemicals subject to REACH onto the European market. So I get to see everything from pre-registration right through to registration, which will be leading us to 2018", he mentions.
Although many of Mr Abrahams' clients are large companies, he also helps clients who are engaging with REACH for the first time in 2013. According to him, the 2013 deadline is not – and should not be – a repetition of the 2010 deadline. "We are dealing with a very different audience. These are people who have made sincere efforts to try and prepare properly for REACH but may not have the resources nor time that are required to really do this properly", Mr Abrahams explains.As specific problematic issues for all registrants, Mr Abrahams mentions supply chain management and communication within the SIEF. Supply chain problems occur both upstream and downstream. "Our clients need the information on the substances they register. A lot of these suppliers are not based in the EU and do not have a legal obligation to provide that information. We spend a lot of time trying to help our clients to extract that information and also provide a way to give reassurance to their customers downstream without disclosing commercially sensitive information." Although there are supply chain requirements within REACH, a lot of the practical elements are not directly addressed by the legislator. "All of these issues, where there is a legal requirement but not very much explanation from the legislator create issues for our clients. ECHA is of course doing its best trying to fill the gaps", he says.
Mr Abrahams says that communication within SIEFs is now very different compared to the past deadline. "We are actually not just educating our lead registrant clients but everyone they need to engage with. Joint registration is a collective process. There is no magic formula for SIEFs really. You need to be transparent and treat everyone fairly. You also need to repeat the same thing over and over again. It is a drip-drip effect and eventually you get through", he explains. Darren Abrahams advises lead registrants to keep a paper trail of all their actions showing that they have done everything required to bring the SIEF together.
Interviews by Virginia Mercouri & Hanna-Kaisa Torkkeli
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Committee for Risk Assessment:
Committee for Socio-Economic
Biocidal Products Committee:
Member State Committee:
4-8 February (tentative)
Management Board meeting: