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Taking Echa on the next stage of its journey

Björn Hansen, the new head of the European Chemicals Agency, discusses his priorities and hopes with Chemical Watch

Björn Hansen is stepping into the hot seat at Echa less than six months before the final REACH registration deadline for existing substances. During his tenure as executive director – which could stretch to 2027 – the ‘safety’ of all substances on the EU market can, theoretically, be compared and the agency is free to focus on evaluating chemicals, introducing risk management measures and helping chemical companies improve their dossiers.Here we present an abridged interview with Chemical Watch, in which Mr Hansen puts the next decade in context and sets out his vision.

CW: What were the key trends and fundamental changes in European and global chemical policy over the last ten years?

BH: The fundamental changes were based on the introduction of REACH and CLP. REACH reversed the burden of proof for industrial chemicals, thus aligning the way they are treated with the way biocides, pesticides and pharmaceuticals were already treated. There is a necessity for industry to show that the products it puts on the market can be used safely.The introduction of the classification, labelling and packaging (CLP) Regulation meant that the EU implemented a globally harmonised system of classification and labelling rather than having just an EU system. Ultimately, the classification, and especially the label, for a chemical is a very efficient way to risk-manage it.

There was a significant change in chemical companies’ awareness of safety issues, and their acceptance that they had to take responsibility and build this into their strategies. At first, there was strong resistance to REACH in its final form. Then there was an acceptance that it had been adopted and companies needed to address it.

Some parts of industry said they had learned a lot from it, had mainstreamed chemicals management into their business and even, in some cases, had gained business advantages because they could say that their substances fulfilled the REACH requirements.

There was a similar increase in awareness in downstream companies that they were now covered by chemicals legislation and had obligations.There was also a lot of development in the understanding of toxicity – how a chemical can exert a toxic of health effect or have an environmental impact. You see this in the registration dossiers and in the discussions that take place among the scientists in the various committees, but also in our sister agencies.

With this increase in awareness and information came better risk management decision making, and this willingness to take action, including by the companies themselves, was mirrored internationally, with more countries implementing chemicals legislation.

CW: What will be the key trends in European and global chemical policy over the next ten years?

BH: The trends I just mentioned will accelerate. After this year’s registration deadline, REACH moves from a setting-up stage to total operation. We will have finished the phase-in and have all substances on the European market registered, with certain exemptions. And the same will happen with biocides – the plan is to get through the review programme and then go into operational mode.

So in Europe we’ll get our legislation into full operation in its complete scope. Regulators and industry will have insight into and understanding of all chemicals on the market; all new chemicals must go through an approval or registration system and that will continuously improve health and the environment.

The big competitive advantage Europe has is innovation. Over the next decade, the chemical industry – the motor of all industry in Europe – will continue to innovate and, in a world that’s becoming more connected and faster and faster, the pace of innovation will probably increase. And that will affect REACH and the type of chemicals we get in.

With the completion of the phase-in, all chemicals will be competing on an equal playing field within the European market and safety, because registrations and data are needed for all of them and will become an integral part of the product on the market. So within company decisions about which substances to choose, there will automatically be a tendency to go for less risky, less harmful chemicals if they can.The circular economy package will require a lot on innovation in order to develop ‘circular’ materials which can be recycled over and over again, not like today, where most materials can only be recycled a few times.

CW: Will emerging economies seek inspiration from REACH or go for a different approach?

BH: Whatever a country decides to do to regulate chemicals, Echa’s learnings about REACH and the tools we use – which, by the way, are to a large extent OECD tools – can be used by other countries to implement their legislation.

The way we in Europe have managed to reverse the burden of proof is a mechanism which many other countries will be looking at for inspiration. If you look at the EU and member states’ performance in the international arena, we are having a big impact because we’re very active, we’re very transparent and we’re achieving, at least partially, our objectives, and this inspires others.

CW: Can Echa keep REACH’s momentum going after this year’s final deadline for existing substances and prevent companies taking their feet off the pedal?

BH: The European Commission is just finishing the REACH evaluation and there are quite a lot of places where we need to improve and increase efficiencies. We need to focus our decision making better, whether it’s in Echa or supporting Brussels to make its decisions, and learn to target the important parts of a dossier on which decisions really are dependent.

That will enable industry to focus on these parts, save costs and increase their understanding.On the industry side, I agree that this will be a challenge. Industry is making a huge effort now and many companies are tight on resources, so a natural reaction will be to turn their attention to areas where they need to catch up. But once you complete your dossiers, REACH really starts.

It will be a big task for Echa, together with the member states and the Commission, to remind companies of the advantage of continuously updating their dossiers – not so much in order to change things in them, but to continuously monitor and follow developments on their substances, and then implement the consequences for risk management and document those in their registration update. It’s not the update itself, but all the work that leads to it that is the important thing for industry to do. We are definitely looking into how to do this systematically, but ultimately the onus lies on industry to do it.

CW: A preliminary draft of Echa’s strategy for 2019-2023 said in several places that various bits of REACH, such as completeness checks, evaluation and prioritisation, have been moving too slowly. How can these be speeded up?

BH: Yes, there is a general ambition to speed things up but to use the words ‘too slowly’ sounds a bit like attributing blame. There are many understandable reasons here. One is that we’re not at the point that we wanted to be at when we were drafting REACH in 2003-07.

We’re not as efficient as we had hoped we would be at this point, but there may originally have been too high a level of ambition. We’re behind schedule but the reasons why are complex. For example, how good were the estimates back then? But yes, Echa needs to increase its efficiencies.

We’ve seen from Echa’s communication and heard from industry themselves that there is quite a lot of work we need to do together on compliance on registrations dossiers. So the need for dossier evaluation is higher than originally estimated.

Although REACH goes into operational mode after this registration deadline and we will have less activity on registration, evaluation activity is not going to decrease as was planned originally because we need to maintain or even increase the current activity and do that for a longer time – over the next five to ten years.

CW: Will Europe succeed in getting all relevant substances of very high concern (SVHCs) onto the candidate list by 2020? How many substances might be on the list by then?

BH: I can’t predict how many will be there but if I go by past experience we’ve been putting ten on each year, so if 2020 means 31 December 2020 and not 1 January 2021, then there will be 30 more. Using the definition of ‘relevant’ in the Commission’s SVHCs roadmap, whether or not I’ll be able to say on 31 December 2020 “Now it’s done”, I don’t know, but if we don’t manage to do it by 2020 it will be within a few years thereafter.

CW: How can Echa best contribute towards raising the bar in European and global chemicals management? In particular, what might it do that is different to its actions/achievements up to now? Can Echa continue to function in exactly the same way?

BH: No. Our backbone of competence comes from our scientific and technical support for implementing chemicals legislation and over the last ten years Echa has been entrusted with more and more regulation. The big benefit of this, for citizens, is an increased efficiency and consistency. So the more regulations which are implemented in the same way, using the same concepts of risk assessment and hazard assessment, and the same risk management tools, the more efficiently the machinery runs – which means it runs at a lower cost for more protection and we get a better functioning internal market.

Regulation becomes more predictable and that’s also good for competitiveness and innovation. So it’s more efficient, but it’s also done more consistently. If EU citizens see that consistency between the way we do classification and labelling and the way we do a restriction, for example, they become more confident in the system.It’s clear that the Commission, by continuously giving us more and more legislation to implement, sees Echa as a good place to do this and get more efficiency and consistency. And with our growing competence we can take on further tasks should the Commission and the legislator so decide.

CW: Will you seek to give Echa more of a policy suggesting or inputting role in areas like emerging issues or integrating EU chemicals-related legislation?

BH: Clearly our job is not to develop policy or initiate policy discussions. Our duty is to carry out the scientific and technical implementation of legislation, but through this we gain a competence, and with competence we have a responsibility to communicate scientific and technical issues, as we have been doing. As Echa matures, this might be an area we can develop and when we see specific scientific and technical issues that come from our implementation, we make clear to policy makers what the scientific and technical base is saying.

For example, in the area of test method development, we are building understanding of what current test methods deliver and how this can be used for classification and risk assessments, and where these test methods can be improved in order to give us more or better information to make better assessments. That type of understanding is relevant to policy makers in order for them to say they want to focus further development on test methods in these areas because there’s a necessity identified by Echa.

CW: How might Echa help identify priority articles? Any early thoughts on potential candidates?

BH: Not on potential candidates, but on how it could operate, yes. Echa stores a lot of information from industry on substances and on articles. From this, we can get some idea of where chemicals end up and group substances according to the articles or types of articles where they are used.

When looking at efficiencies in risk assessment, one very work-intensive area is the exposure assessment. If we can identify articles on the EU market which contain a number of substances of potential concern, we can use the same type of exposure assessments to cover all the substances, thereby gaining efficiencies.

It could therefore help with restrictions: if we find a number of very hazardous substances which seem to be presenting a risk; with evaluation, if we see there are a number of other substances being used in these very same products but the registrations are either not compliant or there’s additional data needed; or in classification and labelling, where we see these substances seem to have certain hazardous properties.

CW: How can you get more companies to improve their dossiers and supply chain communication, especially extended safety data sheets (eSDSs)?

BH: We can use our legislative powers on a case-by-case basis to tell registrants where they are not complying with the law and need to do this and this. That is, of course, an after the fact response and so, from a preventative point of view, not the optimal use of resources, but it’s one we have the power to do and will continue to do.

But if we are also able to support industry to ensure that its dossiers are compliant, this has a huge advantage. The chemicals that they put on the market are supported by a chemical safety report (CSR) and an SDS which, in crude terms, ‘ensure safety’ because they are based on compliant data – compared with a chemical on the market with an SDS which is based on a non-compliant dossier. We don’t have a strong legislative power to do this but it is one that some companies and some industry associations are interested in for exactly the reason I just mentioned. Of course, the type of discussion or ‘advice’ would need to remain generic, but giving generic examples of what a compliant registration dossier, or a useful CSR or SDS looks like, helps.

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