ECHA

The Director for Risk Management at ECHA, Jack de Bruijn; Elina Karhu, Head of ECHA's new Risk Management Identification Unit and Matti Vainio, Head of the new Risk Management Implementation Unit discussed with the ECHA Newsletter questions related to regulatory and industry risk management.

Mr Bruijn, what is vital for good risk management under REACH?

Jack de Bruijn: Risk management un­der REACH includes both the tasks that industry has and regulatory risk management by authorities. The latter should actually serve as a safety net. Industry is responsible for gathering information on their chemicals in a systematic and structured way and for registering them, but also in particu­lar for risk management on their site and providing the right safety advice to downstream users. So they have to demonstrate that they can properly manage their chemicals. A relatively small but important part of our activi­ties are related to that, and our Directo­rate will try to provide further support to industry in the coming years.

How can ECHA support industry risk management?

Exposure scenarios are a major new element of risk management under REACH. They are delivered with the safety data sheets to customers and they describe the correct operational conditions; how to use the chemical; under which conditions and with what kind of risk management measures. If we look at how REACH should be implemented, in my view we could pay more attention to how industry is implementing exposure scenarios be­cause that is what professional users of chemicals will be confronted with.

It is particularly the implementation of the exposure scenarios that industry is struggling with at the moment. This dif­ficulty is partly related to the fact that no standardised mechanism exists yet. ECHA has provided a lot of guidance and information on exposure scenarios, but we will indeed have to engage with industry more to support their imple­mentation. We could think of a series of regular meetings and workshops. Industry has also already started to pre­pare examples of exposure scenarios. One example which we developed last year together with the semiconductor industry is available on our website. Exposure scenarios can have a major impact on how downstream user com­panies handle chemicals, because it is the workers, also within smaller scale industries, who are exposed to chemi­cals. Downstream users take decisions on which substances they include in their formulations and about how and with which substances or formulations they treat the final articles.

This part is very important in terms of risk management, and if that is im­plemented well under REACH, we can potentially have a huge effect on safety down the supply chain and in the wider use of chemicals in Europe.

Matti Vainio: Here is a paradox. We do not see the many changes in order to manage risks that users of chemicals make due to REACH. Such information does not come to the press. These small changes are happening at company level. They are not actually communi­cated anywhere. They just happen as a result of better information. However, if this evolution takes place well, these dispersed risk reductions will result in important environmental and public health improvements in Europe.

Jack de Bruijn: Through REACH we will also have a lot of information on registered substances and the Classi­fication and Labelling Inventory with information about the classification of chemicals. If downstream users would like to replace their substance, they can search for a less hazardous one.

How is the situation with chemical safety assessment?

Jack de Bruijn: Chemical safety assess­ment - risk assessment in the past - can be complicated, but it really depends on the case, the information you have to assess, on the information relating to the use(s) of the substances that is available and on what kind of model­ling you need to do.Under REACH, manufacturers and im­porters with a volume from 10 tonnes upwards must do a chemical safety as­sessment, which means that a lot more companies are probably now involved and need more expertise and data gath­ering. It is definitely an expert task. It is a skill and often needs experienced people to perform it. Also the question related to environmental and human health risk assessments may be differ­ent in nature.

Elina Karhu: On the other hand it is good to remember that there are dif­ferent cases. In some the assessment is really scientifically difficult. We nor­mally concentrate on those cases. But then there are a lot of standard cases where the science may not be so com­plicated. It is more a question of peo­ple understanding the system: How to use the information to identify correct risk management measures and how to document and communicate these measures in a clear way. I would claim that for the majority of the chemicals and uses a standard chemical safety assessment and good quality exposure scenarios can already make a differ­ence to the level of human health and environmental protection.

When is regulatory risk management needed?

Jack de Bruijn: The main part of the activities of our Directorate relate to regulatory risk management activities which implies setting up and imple­menting restriction and authorisation and also classification and labelling processes. They are actions taken by the authorities, either Member States or ECHA on request by the Commission, to actually deal with specific chemicals for which we believe there is regulatory action needed. What we have been particularly pro­moting is that authorities who want to take action to cover a concern for a chemical carefully choose the instru­ment. Should the substance be put on the Candidate List and do they want to have it under authorisation or would they prefer a restriction? Or would Candidate Listing followed by specific restrictions be most effective? Or would there be some other kind of (Commu­nity) regulatory measures which would better achieve the regulatory goals?

Elina Karhu: If authorities identify a concern and start thinking of regulato­ry action, then we are normally past the phase when industry could themselves implement better exposure scenarios in their registration. But REACH gives both a framework and the possibility for industry to systematically docu­ment what risk management measures at company level they are implement­ing and recommending in their supply chain, to document that and to show that the risks are adequately controlled. Compared to the past this information will be an important new source for authorities to identify possible cases where risks are not adequately control­led.An example could be where for one company and their tonnages and iden­tified uses the situation is OK but when looking at all uses across different reg­istrants, there starts to be a problem, for instance for the environment. In such cases there might be a need to start reg­ulatory action by authorities who then need to select the best risk management instrument for the action.

How are the problematic cases found?

Jack de Bruijn: There is always some information here and some ideas and suspicions there, but experience from the past has taught us that very often there is not good coverage of how industry is actually using certain chemicals. The situation is of course improving now we have registration dossiers for a large number of important substances but I expect that we will still not have the full picture of what is happening. We have now at least for quite a number of chemicals the real contact details of all the manufacturing and importing companies. Earlier, it was always a problem getting the right information, getting the context and knowing who was actually doing what. Still we are only talking about manufacturers and importers, not about all the downstream users who directly use the chemicals.

Now REACH risk management is working and there will be reactions to it. How do you react to possible negative reactions?

Jack de Bruijn: It is important that we at ECHA carefully follow the relevant consultation procedures and try to ensure that everyone who potentially has something to say on a specific dossier is being heard. As we deal with issues which in the end have either an economic, public or another kind of effect or interest, there will always be people challenging us. I am not afraid of that at all as I am confident that we will be able to explain properly what we are doing and why we are doing it. The stakeholders are of course very important, and we try to keep everybody informed and involved. However, it is in the end our own decision or opinion making that counts. We need to ensure that this fits the needs and interests of our clients. At least in our work area, the Commission is often our direct client and they have to get results which they can easily use to propose final decisions on regulatory risk management measures.

Matti Vainio: The procedure for formulating opinions on proposed restrictions was developed ex ante, based on the REACH Regulation. We can now start seeing how the regulatory risk management process is working in practice as ECHA's committees are formulating their opinions. We are learning from this process and will adapt so that we can provide a better service to our customers.

In the June issue: Jack de Bruijn, Elina Karhu and Matti Vainio on authorisation, restrictions and new developments. Read the interview here.

Image: Jack de Bruijn, Matti Vainio and Elina Karhu stress the importance of good risk management of chemicals.