Jukka Malm, Director Regulatory Affairs, European Chemicals Agency (ECHA), Helsinki, Finland, is responsible for the work of Scientific Committees of ECHA as well as for the Legal Affairs unit. In addition, he is in charge of the overall coordination of regulatory decision and opinion making of the Agency.
He talks to Dr. Vera Koester from ChemViews magazine about current biocides regulations, upcoming changes to the legislations, and how he got involved in chemicals legislation.
There are new regulations coming into force regarding how biocides are regulated in Europe. Can you tell us about how they are currently regulated and the new regulations?
The current European legislation is the Biocides Directive which was adopted in 1998 and has been implemented since then. It was the first piece of European legislation harmonizing the biocides legislation. Before that biocides were only regulated at the national level.
All active substances that are put into biocidal products marketed in Europe have to be approved by the Biocides Directive. Within this framework the biocidal products then have to be authorized at a national level. There is also the possibility for mutual recognition of authorization, so that if a product is authorized in, e.g., Germany there is the possibility of authorizing it in or recognizing the authorization of another member state.
The European Commission regularly reviews the implementation of the European legislation. In 2009 they came up with a proposal for a new biocides regulation, because there were clear signals that the current biocides directive didn’t work as it was supposed to work and deliver as efficiently as it was expected to. The processes were very slow and complicated. So the commission wanted to improve the workability of the biocides legislation by proposing this new regulation.
So the improvement is on the process side, not on the regulation side of the directive?
Yes, it is more about the information requirements and about how the regulatory process of approval and authorization works. It is not so much on the technical side of how the scientific evaluation of biocides is carried out.
The commission’s proposal is now at the final stage of the legislation process. Final adoption is foreseen for this spring, entering into force some time over the summer, and the application date will be in September 2013.
Can you explain some of the main changes of the new directive please?
One key element is that for biocidal products there is a new process called Union Authorization. This means that, apart from the national authorization, companies can now also choose to apply for direct access to all EU member state markets instead of going only for individual member states.
There are also elements to improve the process, like the functioning of the national authorization. For example, new deadlines and an improved settlement system in case there are disagreements regarding mutual recognition of national authorization. Most of these elements are directly related to the procedural aspects of product access to market.
Then there are some changes in more content-related elements. The data requirements for active substances and products have been reviewed and revised and in this regard, the biocides regulation is much closer to REACH than the Biocides Directive was. For example, the possibility of using exposure based waiving, i.e., not carrying out long term studies because the exposure is so minimal, is introduced. Also the possibility of using alternative testing methods and non-testing approaches is much stronger now in order to avoid unnecessary testing on animals. There is also a mandatory sharing of test data among companies marketing the same active substances. This was also introduced in REACH. Furthermore, there is extended scope to cover articles and materials treated with biocides.
Are there similar regulations outside the EU?
The situation is fairly mixed, because the definition of biocides and the scope of related legislations are quite different in different parts of the world. In many instances biocides or parts of biocides are covered by the pesticides legislation. In the EU, we see pesticides as agricultural pesticides or plant protection products, but in many other areas pesticides legislation also covers non-agricultural pesticides. In some instances some of the biocides can be considered as part of the industrial chemicals regime. In that case there is probably no approval system, they are just treated as other industrial chemicals.
But if you look from a more practical level for companies, they can use the same data for an application for biocides here in Europe, and, in most cases, for preparing an application in other countries as well. Even though the borderlines and the definitions can differ, the actual data can be reused.
So on one level, there is a kind of harmonization, but on the other hand, at the level of the scope of the legislation and definitions, there are some quite different systems.
So do you think this will be much more harmonized in the future?
At the moment I don’t see a strong development of clearly harmonizing the biocides legislation. For example, in the Organization for Economic Co-operation and Development (OECD), as part of the their chemicals program, there is cooperation in relation to biocides, but it is much more on a technical level—regarding information requirements, technical tools and the ways of assessing the data—and not so much on the higher legislation level.
Who is testing the data you receive from the industry?
It is always the company that has to generate the data and compile the dossier for the application. Then it is up to the authorities to evaluate the data and to conclude whether or not approval or authorization should be granted and under which conditions.
How do you find out if a company fails?
Part of the evaluation process is also looking at the completeness of the application. So if elements of the legal requirements are clearly missing, that can lead to not being able to evaluate the dossier.
What would you like to see happening in the future in the field of biocides legislation?
Well, of course, this is now a very critical time for ECHA, because we have been given new responsibilities, a considerable amount of new tasks, and also new resources. And, of course, the next few years will be the test of the revised biocides legislation in Europe. Our ambition is to make this work so that we are part of a successful implementation.
We cannot do that alone, of course, we have to work very closely with the member state authorities, which play a very crucial role in the authorization process. And we will also have to work together with the commission and industry, as well as with the other stake holders who would like to make this work well.
So in short term, we want to set up our own systems to run this legislation and then, in the longer term, work together with our partners to make its implementation successful.
How did you get involved with chemicals legislation?
I got involved with chemicals legislation very soon after my graduation. Actually, my first long-term position was in chemicals legislation. I am Finnish and I got involved in the Finnish chemicals legislation when it was revised in the late 1980’s. Fairly soon after that Finland started negotiations about the European Economic Area (EEA) agreement, which also involved chemicals and harmonization of chemicals legislations between European Free Trade Association countries and the European community at that point of time. And then, as Finland became a member of the EU, we got more and more involved in the European legislation.
Then I was strongly involved in the chemicals legislation preceding REACH. As the European Comission started to design REACH, I was closely involved in that process. Later, I was involved in the negotiations between council and parliament as part of the Finnish delegation during the Finnish EU Presidency in 2006. Parallel to the REACH proposal, there was the decision by the heads of states of the EU to locate the European Chemicals Agency (ECHA) in Helsinki. I got involved on behalf of the Finnish government in the preparations of ECHA and then I applied for a position within the agency. I started at ECHA in September 2008 and I have been happy working here ever since.
Thank you very much for this interview!
Jukka Malm gained his Master’s degree in Agriculture and Forestry in the field of Environmental Protection in Finland. He worked as Director of Expert Services at the Finnish Environmental Institute. In 2008, he joined the European Chemicals Agency (ECHA) where he currently is responsible for the new directorate for Regulatory Affairs.
He is responsible for the work of Scientific Committees of ECHA as well as for the Legal Affairs unit. In addition he is in charge of the overall coordination of regulatory decision and opinion making of the Agency.
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