Challenges of REACH – Interview with Geert Dancet

Challenges of REACH – Interview with Geert Dancet

Author: Vera Köster (Photos: © ECHA)

Geert Dancet became the first Executive Director of the European Chemicals Agency (ECHA), Helsinki, Finland, in January 2008.

He talks to Dr. Vera Köster for ChemViews magazine about the challenges ECHA had in meeting the first deadline, the work for meeting the second deadline, and about the agency’s and his personal future plans.

You studied economics, econometrics, and philosophy, but now have been involved in chemical regulation for a long time. Has that somehow changed your view of chemistry or chemicals?

Of course it has. I wasn’t too focused on chemicals before I came to this field in 2004, which is almost ten years ago. That makes you not really an expert, but a knowledgeable person on all these aspects. I think it’s a very challenging area, but what also immediately strikes me is that people don’t have a very good view about chemicals.

Chemicals are basically everywhere, even in nature, as e.g., metals are chemicals. And many of these need to be not only registered when they are entered into the market as a substance, but we also need to follow them up during their whole life cycle. This brings in the entire manufacturing industry. That’s why ECHA has more than 60 EU stakeholders, as basically the entire manufacturing industry is interested in REACH. Compared to other agencies in the EU, we have by far the highest number of stakeholders.
This makes it quite an interesting and complicated challenge. It is much more than chemistry, it’s also manufacturing and manufacturing has been much more part of my past work. So in that way my work at ECHA is a very interesting topic and I’ve always enjoyed it.

The pre-registration process of REACH started five years ago. What highlights do you look back on?

We are not the largest agency, I think we are number four in the list of EU agencies, but we are the one that has had the fastest growth. We basically have added 100 people per year until last year, which is an impressive record for an organization to be able to grow so fast. Absorbing this fast increase of staff has been a huge challenge. Another great challenge was to be up and running with the agency for pre-registration within less than a year and immediately thereafter take the online registration for new substances into operation.

One of the things that we have always wished to ensure was that everything works well from the industry point of view. If there were aspects to suffer, because a tool, for example, was not ready in time, it was for us, not for the industry to take on this extra work. That is, of course, within the organization not so easy to absorb. It required enormous flexibility of the staff, moving people around within the organization, sometimes letting them do simple work, almost like on a conveyor belt. Registration in the beginning, for example, literally had to pass 20 offices. We passed the registration – not in a physical, but in a computerized way – from one employee to the next, and divided the work into little specializations until finally everything was automated in one process.

So this was the secret of how you managed to stick to the legal requirements and also to the short timeframe.

Yes, and also bringing in lots of interims … If you break the task in a Tayloristic way, then you can bring in interim people, train them within a week, and they can then do that small task. That was, partly, what was the success of keeping the first deadline of registration. It was only after the registration that we managed to completely automate all these little processes necessary for registration.

On the other side, we also need to be creative in identifying how to make the scientific requirements of the dossiers understandable. As you probably know, a dossier has many different elements, asking for a lot of information. We had to create something fitting for the purpose so that scientists, who have the tendency to question everything, are going to focus on the essentials. You also have to bring order into the dossiers. And we had to think of the steps that we follow for evaluating the dossier.

That has been an enormous challenge. We understood that this is better done not only by putting the questions in the right order, but also by structuring these with an additional IT tool. So we have another IT tool that no one sees, working in the background. In the beginning we needed to train people for more than a year to deal with this program to evaluate dossiers. Now we’ve managed to bring that down to several months. That again is allowing us to become more efficient.

What is different for the 2013 deadline? You are still waiting for 4,000 registrations?

Perhaps more than 4,000! We never know the right numbers. However, that number is a more manageable number than in 2010. So we have far fewer people involved in registration than in 2010. We don’t see any challenge in processing the dossiers this time; we see a challenge in industry meeting the deadline.

We have the national authorities and national helpdesks to assist companies in their own language, especially if they are smaller, because we don’t manage all the languages fluently. If companies have a more IT related issue, then they can still come to us like during the Stakeholder’s Day we regularly offer here, where they can bring their own dossier with them to discuss. But also we can do that offline by speaking on the phone. So there are ways, we have learned in 2010, how to help companies to register.

However, for us an important task is to make sure that we don’t have an enormous part of our organization involved in the registration, because we have so many other tasks in the meantime that must continue while the registration is ongoing. We have evaluation, authorization, restrictions, and lots of other tasks that must continue. We only have very few people that we can redeploy to registration if there are peaks.

And what are the plans for the final registration deadline in May 2018? 

That is a different challenge again. There are two important elements; on the one hand, the number of substances is much, much higher. So that’s a different challenge as there will be many more lead registrations than we have now. So we are not talking about hundreds of leads, we were talking about thousands. On the other hand, we have many more SMEs. For the 2010 deadline, we are not aware of any SME that took the lead for a registration. For 2013, we have a handful of SMEs doing this. We know them to a very large extent. There may be further challenges that we’re not yet totally aware of, so we want to interact with these SMEs individually, so that we can learn about their challenges. Also the language problems have to be overcome better.

For the third deadline, registration cannot be a sprint at the end for many companies. There are companies that have simply hundreds of substances to register. They must spread the work, they can’t do it all at once because otherwise they would have to multiply their REACH teams, which probably they can’t. They will need to phase-in their efforts early, start maybe in 2015, and register in 2016 or 2017, and not just in 2018.

ECHA is building this huge database with information currently on nearly 8,000 chemical substances. What is the plan to do with that?

I don’t know if you are aware of this, but we already did a study where the contractor collected input from the public on what they want this database to include and how to improve it. In the past two months they have been visiting our stakeholders to get their input on that as well.

The final report will have very clear, very precise recommendations on how we need to improve our dissemination to make it more user-friendly and more interesting on the one hand and how we can link it up to other information databases on the other hand. From that we will draw up a plan on how to rework our IT tool for dissemination.

How do you share or exchange your data with authorities in other regions or countries in the world, for example, the US?

We are talking to them very much about this to get an understanding of how we can best share information. In the first place we are discussing how to share our public information, because our public information in the eChemPortal (OECD) is more searchable than our database accessible from externally. As I said, we need to improve our tool which will take some time.

In the long run, it would be better if we would be able to come to a full sharing of not only public data but also confidential data. However, as you may know, TSCA, the Toxic Substances Control Act that regulates the examination of new or already existing chemicals in the US, is not permitting an exchange of confidential information. The EU would need to establish formal agreements and not just a memorandum of understanding to change this situation. The Canadian legislation is permitting that, so the EU could theoretically do faster business with Canada than with the US.

Companies then wouldn’t have to redo the hazard part of their registration work for other regulatory instances, because the information would be stored in IUCLID, the International Uniform ChemicaL Information Database, which is based on OECD standards for hazards, and thereby would be exchangeable.
What is not exchangeable is the risk assessment, the methodologies are not harmonized and that’s why I’m pleading very much that the OECD should work more on harmonizing also the risk assessment.

So ECHA already is internationally in a strong position there?

Yeah, we are able to play a strong role. I mean we are, in reality, the newest kid on the block. But in practice, everybody looks at us because we have a) developed the most modern administration, b) have in the meantime collected the most information, and c) have recruited and trained the highest number of real experts in the field. But we don’t want agencies to enter into competition. The objective or grand plan in the long run is to share data and burdens, but it will take time, years, to achieve all of this.

How justifiable is the fear especially of smaller companies, that a competitor can find out how they do or produce something?

I think in a large company this is impossible as they registered so many products, but in a smaller company, that maybe only has two products, I guess it’s very easy by looking at what kind of intermediates and products they have registered.

At the moment the data are protected by the confidentiality aspects of REACH. For twelve years all the confidential information remains confidential. Of course, this is far less time than in other parts of the world. That means that, yes, there are companies, for example, in the East, eager to collect confidential information on the composition of chemicals in order to copy what has been done. However, for most aspects of REACH, we basically talk about existing chemicals not about new chemicals.

What is perhaps not known is the specific technical use. Therefore, one of the elements that is most protected under the REACH regulation is the specifics on the use. An SME may have a very important use that is not done by anyone else, it uses a chemical in a totally different way, and that will be always protected. We cannot make this public, even if an authorization is needed for that type of use. It may be too complicated to patent the manufacturing use, so we need to protect this business secret.

You’ve said a lot about what you want to achieve for ECHA in the future. What do you personally want to achieve in maybe five or ten years?

In five years I will no longer be in this organization. My time is limited here to the end of 2017 so then I will have to find a new job. I haven’t reflected on this too much yet.

So there’s a limited time where you can work for ECHA?

Yes. The Executive Director can stay for a maximum of two terms of five years and my second term has just started in January. So that’s definitely the end, but that’s fine. I already started during the interim period, so I will have had more than ten and a half years in this organization. If I manage to make it to the end of 2017, physically, and also keep the motivation high, I will be happy.

That’s interesting that you have to leave shortly before the final deadline.

Yes, that’s true. But basically, the final deadline is organized like now, there is a moratorium for at least six months before the deadline so I still need to prepare all activity for the final deadline before then. Then, someone else comes in and follows the roadmap and can reflect about what comes after this last deadline, what is going to happen then, do we still need the same organization, … By that time perhaps the REACH regulation will be reviewed or be still under review. So let’s wait and see.

Thank you very much for the interview, Mr. Dancet.

Geert Dance
t studied economics, econometrics and philosophy at the University of Louvain, Belgium. He was a project manager for the United Nations Industrial Development Organization (UNIDO) in Colombia, before joining the European Commission in Belgium in 1986 in the competition policy field. From 2004–2007 he was the Head of the REACH Unit in the European Commission’s Directorate General for Enterprise and Industry, Brussels, Belgium.

He was responsible for taking the REACH proposal through the regulatory process in the Council and the European Parliament as well as for developing and coordinating the REACH implementation strategy, which included the preparations for the new Chemicals Agency.
In 2007 he became interim Executive Director of the European Chemicals Agency (ECHA), Helsinki, Finland, and in 2008 the first Executive Director.

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