Christel Musset is Director of Registration at the European Chemicals Agency (ECHA), Helsinki, Finland. She coordinates all activities related to the registration of chemical substances under the European Chemicals Regulation (REACH). This also comprises publication of chemical information on ECHA’s website and coordination of the IT systems to support these activities.
Dr. Vera Köster spoke to her for ChemViews magazine about the approaching REACH deadline on May 31, 2013 and the benefits and challenges of REACH.
You are right in front of the 2nd deadline of REACH. What has changed since the deadline in 2010?
The first deadline was quite an experience for all of us. I think we have learned from the lessons of 2010, not only the ECHA, but also industry and the European Commission. Before the first deadline, industry associations had some concerns about the ability of companies to register and to prepare dossiers on time. Therefore, the so-called Director Contact Group was formed with participants from the Commission, ECHA, and industry associations on it. We identified things that could prevent a smooth registration and found solutions for these problems.
One problem, for example, was what happens if the test lab cannot provide the hazard and safety data in time for the submission of the dossier. Without these data, it would be difficult to do the risk assessment of the substance needed in the dossier. So we have put what we call exceptional circumstances in as well as how to cope with them together. Very often this has been a case by case discussion with the companies.
We also did a recap of what has happened, what went well, what can be improved, and, by this, we took our lessons from 2010. So from that perspective it is much smoother for this deadline. However, I am still worried, because sometimes, when it seems too easy, it may go wrong in the end. So I will closely monitor what is going to happen during the last month.
What is the status of registration at the moment?
We have direct feedback from the ten largest companies in Europe. In general, the large companies are a bit late compared to their plan. Dossiers were supposed to arrive much earlier but they will be submitted in April.
For us it is very important that the dossiers of the big companies come early, because they are very often the lead registrants. The lead registrants normally know very well what to do, they’ve experiences from the 2010 deadline. The other members very often are smaller companies who may lack experience. So the more time they have, the better for everybody.
We are in contact with the industry associations every two weeks, but they have not alerted us about any difficulties. So, so far, so good, but we will see by the end of May how it turns out.
How difficult is the registration process for small companies?
I would be surprised if they knew what all their obligations are. In 2010 there were mainly large companies involved as substances above 1,000 t had to be registered. I think most SMEs will instead be involved in the last deadline in 2018 when substances from 1 to 100 t have to be registered.
However, the main difficulty for us with SMEs is how to reach them. They are not always speaking with the big industry associations we are in close contact with. We work together with the national authorities and other national associations to reach these small companies.
Starting in early 2014 we will begin to prepare for 2018. Here we have to think about what kind of guidance SMEs need. What is clear from the REACH review recommendations is that our guidance is too extensive. Probably we also need to simplify the tools.
Do you know of any difficulties companies outside of Europe that want to trade in Europe, have?
Before the first deadline there were rumors from outside Europe that REACH would be a great burden for trade into Europe. As a matter of fact, 20 % of all registrations for the first deadline were coming from non-EU companies. The big players, of course, have subsidiaries in Europe so they are totally aware of their obligations. But again, for the deadline in 2018 things might look different.
We hear from associations and from distributors/importers that difficulties for the last deadline, where substances of 1 to 100 t have to be registered, will include the question of whether it is worth trading a substance in Europe. That is something we really have to pay attention to. The European Commission is looking into this to make sure that we don’t have substances disappearing from the market in Europe nor hinder innovation.
You are collecting a huge amount of information on chemicals, partly publically available. Who is taking advantage of these data at the moment?
We are convinced that a lot of these data, like physical and chemical properties, are used for safety data sheets everywhere in the world. We have a lot of NGOs looking at our data to see what is going on with a substance, if it is safe, and if it is properly registered. We are also aware that other Authorities such as the American, Canadian, and Australian are looking at our data to verify a number of aspects.
What are the future plans for these data?
Our first goal is to publish the data from the 2013 dossiers before the end of this year. Then we plan to move away from the very scientific and technical way of presentation to allow consumers and other non-scientists to understand the relevant information as well.
Do you exchange data with other authorities, for example those of the US?
No. The data don’t belong to ECHA, they belong to the companies. However, the US can look at what is publically available, but we don’t give them a copy of our database.
Do you profit from data collected by other countries?
Yes, we fill in a lot of gaps with data coming from everywhere in the world. We also use their published data for prioritization of substances, for finding if there is any concern about a substance, or for crosschecking with our data to see if there are inconsistencies. But we don’t use them to update registration dossiers that have gaps. Authorities in the US, Canada, Australia, etc. are doing the same.
I’ve heard from NGOs that the system of compliance monitoring is not working as the completeness check of the registration dossiers is not sufficient to ensure substances can continue to be legally on the market. Is that an issue?
NGOs are coming regularly with this comment. In certain countries or organizations there is the tendency to have ECHA verify everything. But that is not what REACH is about. It has never been foreseen that ECHA would verify every single dossier. Responsibility is with industry for their dossiers and their data. REACH requires that they change their mindset.
In the completeness check we verify that the dossier is complete from our point of view. Meaning that either the company has submitted the data, or that they have submitted justification for not submitting the data. Legislation foresees many possibilities to waive the data. This would, for example, be because a registrant is using alternative methods or is using a QSAR model, an estimation of the result. It could also be that a registrant is doing what is called a read across. This means that their substance is so similar to another substance that the data of this substance can be used. So REACH includes many possibilities to allow you to not submit the data. What we verify at the completeness check is that either we have the data or we have justification for not needing to provide the data. This is where there is some discussion with the NGOs, who would like us to verify the justification and determine at that stage if the justification is valid. For us this is done at the compliance check.
So what we try to explain is that we have tried to find strategies that include a mix of measures between education and between light and heavy checking procedures. To give you an example: To register an intermediate, very little data is required. We use a screening method to identify possible deficiencies or shortcomings in dossiers. By this we found about 2,500 inconsistencies among 5,500 submitted intermediate registrations. We send one letter per identified dossier to the relevant company. If a company had 500 dossiers with issues, they received 500 letters. This has been a wake-up call for many companies to realize that ECHA is already looking at their dossiers. So far, for about 160 dossiers, companies have recognized that their substance was not an intermediate and they are transferring their intermediates dossier to a full dossier. For us this is an extremely good result. It would have taken us much more time to do this by the procedure of compliance checks.
You said responsibility lies with the industry. Has their perception changed since the start of REACH five years ago?
The big companies have certainly taken on this responsibility. There also have been changes in their portfolio of substances, because of having to register so many substances and maybe because of substitution. Another aspect is that when we put a substance on the candidate list, this often triggers substitution, although it is not its main purpose. However, it is seen as a “black list” for many users of these substances and their suppliers are often asked to substitute these substances. I am pretty sure the companies, at least the big and the medium ones, are taking it seriously.
Something the companies had not realized in the beginning is that registration is not the end of the story. The dossiers have to be updated when new information is available. This realization is coming now, but a bit slower than the registration part.
Is your job at ECHA the perfect combination of your knowledge from your studies in physics, computational sciences, and business administration?
Actually, it is my best job ever. I gained these various degrees because my husband and I moved around the world a lot. I did my business degree, for example, because I had stopped working for several years when we were in Brazil. When we came back to Europe, this was a good chance to start working again.
It is correct, that my work here combines everything that I have been doing. I have good understanding of chemistry, sufficient to understand the scientific people working with me, but I also have the business and the IT degree, so it is the perfect combination. This certainly is my most interesting and challenging job.
Thank you very much for the interview.
Christel Musset received her master’s in physics and chemistry from Lyon University, France, where she also studied Computer Science. She received a Master of Business and Administration (MBA) in 1993. She held several positions in the private sector, first managing large-scale IT projects and then as a director of Sales and Marketing. She coordinated the development of IT systems for REACH at the European Commission, European Chemicals Bureau of the JRC, Ispra, Italy. In 2007 Musset joined the European Chemicals Agency (ECHA), Helsinki, Finland. Currently she is Director of Registration and responsible for all activities related to the registration process under REACH. This also comprises data sharing and dissemination and the coordination of IT systems to support these activities, in particular REACH-IT and IUCLID.
Also of interest:
- REACH – An Overview,
ChemViews magazine 2012.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the European Union chemicals regulation
- News: REACH Registration Statistics,
European Chemicals Agency (ECHA) published statistics on the origin and types of REACH registration dossiers and registered substances
- J. de Bruijn on the Impact and Future of REACH,
ChemViews magazine 2012.
Jack de Bruijn, European Chemicals Agency (ECHA), talks about REACH, its international impact, its future and public perception
- New Biocides Legislation – Interview with Jukka Malm,
ChemViews magazine 2012.
Jukka Malm, European Chemicals Agency (ECHA), talks about the upcoming changes to the biocides legislation