- Another successful Stakeholders' Day
- Sixth Stakeholders' Day: Start preparing registrations for 2013 now!
- Still a long way to go for downstream users
- ECHA reports to the Commission on the operation of the RE ACH and CLP Regulations and on non-animal testing
- QSAR Toolbox - increasing confidence in computational assessment
- ECHA Unit for Guidance and Forum Secretariat: Supporting the Forum activities
- Risk Management Interview - Part 2: Authorisation and restriction start to work
- Mr Dan Jørgensen, Vice-Chair of the Environment Committee: Happy with progress but some reason for criticism
- Dr Marion Healy: Non-animal testing methods and the assessment of nanomaterials are examples of special areas of interest
- Mr Benedikt Vogt, Enforcer in Freiburg, Germany: Overall situation is positive
- REACH at Helsinki Chemicals Forum
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Article related to: People and perspectives
Risk Management Interview - Part 2: Authorisation and restriction start to work
In the second part of an interview on risk management, Director Jack de Bruijn and Heads of Unit Elina Karhu and Matti Vainio from ECHA's Risk Management Directorate discuss authorisation and restriction.
Elina Karhu, Jack de Bruijn and Matti Vainio, how would you describe authorisation and restrictions as risk management options?
Jack de Bruijn: Authorisation and restriction are the main risk management instruments for the EU Member State authorities and the European Commission under REACH.
Matti Vainio: We use restriction to control situations where specific risks caused by the use of a substance have been identified. The authorisation process uses the hazardous properties of a substance as a starting point and then requires companies to apply for specific uses, which they would like to continue after the sunset date.
What is the significance of the Candidate List?
Jack de Bruijn: Based on our discussions with the Member States, I would say that there are several reasons for proposing a substance for the Candidate List. First, the list is the first step in the authorisation process. In order to get a substance on the Authorisation List, it first needs to be identified as a Substance of Very High Concern (SVHC) and added to the Candidate List. Secondly, the only way to categorise a substance formally as PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative) under REACH is to identify it as a SVHC and place it on the Candidate List. We have had a few cases already.The link between the Articles 7 and 33 of REACH and the Candidate List is a further reason. Companies that have a Candidate List substance in their articles, above the level of 0.1 percent weight by weight need to provide their customers down the supply chain, or consumers on request, available information to allow the safe use of the articles. In addition, under certain condition, producers or importers of articles need to notify ECHA of the presence of these SVHCs in their articles.
Elina Karhu: An additional goal is to raise awareness and support different actors in taking actions on their own to replace these SVHCs with less dangerous ones.
Jack de Bruijn: Yes, the Candidate List definitely has a strong signal function. The market can start acting or reacting to that event already - which we understand is also happening, at least for some chemicals.
Does the authorisation process aim at stopping the use of substances of very high concern?
Jack de Bruijn: Yes, it aims at replacing these highly hazardous substances with other substances in the long run, if technically suitable and economically viable alternatives are available. That is the clear longer-term perspective. Another issue is that we do not want them to be replaced with equally hazardous ones, so we are thinking of how this could be prevented.
Companies asking for authorisation have the burden of proof and they need to provide the information basis to the authorities. In case of restrictions, it is the authorities who have to prove that a restriction is needed. Of course they also consider information from industry.
Elina Karhu: In future, the registration dossiers might deliver the information basis for restrictions in most cases.
If one use of a substance has been prohibited by a restriction, how do we know that the other uses are ok?
Jack de Bruijn: If one use of a substance is restricted, it means that the authorities have assessed that use. The chemical safety assessments of the registrants cover the other uses and should demonstrate that these are properly managed. Or at least nobody has raised an issue against them, provided the registrants have checked all details. The main thing is that industry is trying to do their job, and that we help them to do it.
Elina Karhu: However, even if every registrant can show that the risks for the environment are controlled for their tonnage and their downstream users, when we consider all the uses together, the combined total emissions can cause a problem and may indicate a need to get more information on the overall risks (e.g. through substance evaluation) for initiating risk management action.
Can all substances be put under authorisation or be restricted?
Matti Vainio: The Authorisation List does not apply to imported articles. Therefore, REACH allows restrictions for substances in imported articles. ECHA actually has a specific task to check, after the sunset date, whether such uses should be restricted for SVHCs.
Jack de Bruijn: This is of course a real end-of-pipe measure which in my view may not be very efficient. However, it was also very difficult to put under authorisation something that is coming to the EU in imported articles.
How are substances selected for authorisation and restriction processes?
Jack de Bruijn: The selection is normally based on a risk assessment resulting from real experience – like in the case of having DMFu in sofas causing severe skin reactions – or as a theoretical activity where a hazard and the potential exposure were assessed and a problem identified.
ECHA prioritises the substances for the Authorisation List. How is it done?
Elina Karhu: REACH provides the basic criteria. First of all, substances with PBT properties should have a higher priority. In addition, higher volumes are given a higher priority than lower volumes, as well as wide dispersive uses. For example, if a high volume substance is used only in a limited number of industrial installations in the EU, a substance used by a large number of small companies, professional users, or consumers should have a higher priority. We also need to examine the regulatory effectiveness of the measure. Certain phases in a life-cycle of a substance are, for instance, not covered by authorisation. So if the concern is related to the manufacture of a substance, or its use as an intermediate, or because the substance is mainly present in imported articles, we should reconsider twice whether a restriction would not be a better option.
What are the reasons to grant an authorisation or decide against it?
Matti Vainio: If you can demonstrate "beyond reasonable doubt" that the risks are adequately controlled and the use is safe, normally you should get an authorisation, provided that it is a "threshold substance". That means that you can establish a level below which the substance is used safely. If the substance has no threshold, like the PBTs, you have to demonstrate – and that is the difficult part – that the benefit for the society of an authorisation is larger than the risks caused by continued use.
Jack de Bruijn: This is also the case for carcinogenic and mutagenic substances, unless they have a threshold, but there are very few of those. The message for industry in preparing applications for authorisation is that the better the quality of the dossier, the better chances you have for a fruitful discussion and a useful outcome.
How about alternatives – is it easy to demonstrate their existence or absence?
Elina Karhu: In the case of the "socio-economic route", industry has to also demonstrate that there is no economically and technically feasible alternative that would also reduce the overall risk.
Jack de Bruijn: The analysis of alternatives will play a very important role in the further discussions, especially in the socio-economic route. It will really be one of the cornerstones of discussions by RAC and SEAC and also the area where people can provide information in the public consultation. The challenge will be to get useful information that can be taken into account and assessed by the Committees. Unfortunately the timelines are terribly short.
How does ECHA tackle new developments?
Jack de Bruijn: As ECHA, we are of course not only focusing on the key legal processes we are responsible for. We are also following scientific developments, discussions both at political and scientific-technical level for instance on nanomaterials, endocrine disruptors and mixture toxicity, in order to be at least informed and somehow prepared and provide input to that discussion. When that leads to specific changes in the legislation which would need to be implemented, we are at least prepared for the points that need to be tackled.
Image: Jack de Bruijn, Matti Vainio and Elina Karhu expect that the registration data will also deliver information for risk management measures in future.
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Biocidal Products Committee:
30 November-4 December (tentative)
Committee for Risk Assessment:
6-8 October (RAC-52B);
30 November-4 December (tentative);
7-11 December (tentative)
Committee for Socio-Economic
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting: