REACh - The European Union chemicals regulation REACh (short for Registration, Evaluation, Authorisation and Restriction of Chemicals) requires all companies manufacturing or importing chemical substances into the EU in quantities of one tonne or more per year to register these with the European Chemicals Agency (ECHA) in Helsinki, Finland.

Dr. Jack de Bruijn, Director of Risk Management at ECHA, is responsible for identifying and implementing the authorization and restrictions processes under REACh, as well as managing the classification-related tasks resulting from the Classification, Labeling and Packaging (CLP) Regulation.

Dr. Vera Köster from Wiley-VCH talked to him for ChemViews magazine about REACh, its international impact, and its future.

CHEManager Europe: Dr. de Bruijn, what is your role within ECHA regarding REACh?

Jack de Bruijn: REACh is what we call a horizontal legislation. It covers all basic chemicals that the industry manufactures, imports, and puts on the European market. REACh sets the framework and basically tells the industry that it is their own responsibility to make sure that these chemicals are safe in terms of their use as well as their customers' use. And, therefore, the industry has to provide basic information, toxicological and eco-toxicological information, and physical chemical properties-depending on the tonnage.

They have to have this information available and to provide it to ECHA. In terms of evaluation we look in detail at the information and figure out if this is in line with the legislation and if there are cases-not only from evaluation, but also from other routes-where we think that there is an authority intervention needed. Then we get to a discussion about introducing risk management measures such as authorization and restrictions. Most of the normal risk management should go via the industry route.

Do you see differences between different countries in this?

Jack de Bruijn: REACh has taken over the previous chemicals legislation and although there were differences, I think for a long time the implementation of the directives was done in a quite similar manner in all European countries. Of course there are different practices in how companies follow the directives, which is very much related to the culture, but also to what extent countries have enforced the rules. And whether they really have gone out and checked what companies were doing.

But a lot of the chemical industry is European or even worldwide oriented and organized. And in particular during this first phase of registration, we are dealing not only, but mostly with bigger companies. Although they are based in one country, they have very often been acting internationally for a long time, so for those companies I don't expect that there will be big differences in how they implement REACh in Europe.

What is the international impact of REACh?

Jack de Bruijn: A lot of the countries outside the EU have been following the REACh developments a lot and a number of countries have since then also implemented new chemicals legislation, some relatively close to what is happening in the EU and REACh, some like South Korea may be somewhat similar but with some differences. But I think it has definitely triggered a worldwide review of each country's own chemicals legislation, to see if they need to adapt to what is happening in Europe. So Europe has been leading the development in that sense.

There have been quite a lot of countries-and this has also been debated a lot during the negotiations-who did not really believe that REACh would work. But I think they have moved away from that. They have started realizing that REACh has actually worked: We have managed the first deadline; industry has done a tremendous job of gathering all the information and collaborating between themselves. So these positive developments have probably provided a big boost for many to actually do something in their own countries.

REACh only deals with chemicals produced in quantities greater than a tonne. Do you think that lower tonnage chemicals also pose a risk which is missed out by REACh?

Jack de Bruijn: This, of course, was debated a lot when the REACh legislation was built because the previous legislation had lower tonnages in terms of notification of new chemicals. We run a certain risk that indeed there might be chemicals of below one tonne, which could be problematic. On the other hand, this is a relatively low mark.

Do you think this is something for a future update of REACh?

Jack de Bruijn: No. I think the only real update that is planned is to look at the information requirements between one and ten tonnes, which are now definitely lower than they were in the previous legislation. The commission will look at what has been put in the legislation again around 2018. I don't know what is going to happen on the lower tonnage. I would be a bit surprised if it would really be changed.

Can you say if there are any other aspects which should be improved?

Jack de Bruijn: This is a difficult question, as our evaluation colleagues are still very much focused on getting the test proposals through their system. They are also looking at compliance check and the contents of the dossiers, but not very many yet.
What we see is that the quality of the information could definitely improve still. This has already been recognized last year in our own report on the first phase of REACh. There are good dossiers and there are also dossiers, which are definitely not of appropriate quality, and we will, of course, do further assessments and compliance checks and come back to these companies.

Do you think REACh has a positive effect on the public perception of chemistry?

Jack de Bruijn: This is a very difficult question because there is definitely a negative perception among the public. One good thing of REACh is that it makes a lot of data available and at least collects everything that is available so we will have, at some point, a much better view of what is actually happening in the market. This includes information on which chemicals are used and also roughly where they are used, and in what way. We disseminate a lot of this information on our website. So in principle it is available. But, of course, it is not easy to understand or to access by the general public.