- Tomorrow’s Europe needs flexibility
- Registration update deadlines clarified
- Restriction: covering imports of articles not subject to authorisation
- REACH authorisation aims for substitution
- Removing obstacles to successful poison centre notifications
- Battling COVID-19 with biocides
- Chemicals strategy: backing companies on the path to sustainability
- Improved cooperation helps to keep imported products containing harmful chemicals out of the EU market
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REACH authorisation aims for substitution
Substances of very high concern (SVHCs) have been controlled under the REACH authorisation system for over a decade, with 340 SVHC uses scrutinised. In 2019, the General Court clarified when applications need to contain a substitution plan. We spoke to Matti Vainio, Head of the Risk Management Unit responsible for applications for authorisation at ECHA, to hear where authorisation is headed.
The aim of the authorisation process is multidimensional. It has three objectives, which need to be balanced for optimal risk management: reducing risks for EU citizens and the environment, promoting the eventual substitution of SVHCs with safer alternatives, and ensuring that European companies remain competitive and continue to contribute to the welfare of the EU.
“Meeting these objectives has been a challenge for the applicants and for the system itself. The most recent development is the 2019 General Court’s judgment on when applicants need to prepare a substitution plan. Implementing authorisation has involved a lot of learning by doing, so the court judgment gives direction to applicants,” Mr Vainio says.
The ruling of the General Court changed the interpretation concerning suitability of alternatives. Applicants now need to prepare substitution plans and include them in their applications if there are suitable alternatives available for their uses in general – although these alternatives might not be technically or economically feasible for the applicant.
|Matti Vainio. |
|“The reduction of risks as a result of the authorisation requirement has been significant. When companies apply for authorisation, they need to show they have done a good job at reducing emissions and exposure of people.” |
In practice, this means that some of the applications, which the European Commission has not yet decided on, need to be re-assessed by ECHA’s Committee for Socio-economic Analysis (SEAC). “The Commission has asked 12 applicants to submit substitution plans of which we have received four. These concern the use of hexavalent chromium in surface treatments and a curing agent MOCA from ‘upstream’ applicants. The rest consist of an ‘upstream’ application on the plasticiser DEHP as well as a ‘downstream’ application of hexavalent chromium in surface treatment and sodium dichromate in wool dying. The last ones will arrive by early December,” Mr Vainio explains.
SEAC will evaluate the credibility and completeness of the plans from a scientific viewpoint and give its opinions to the Commission to help them decide whether to grant or refuse these authorisations. “We want to run this in a transparent manner. The substitution plans are published when they arrive and subject to consultations in two batches in mid-October and December before SEAC starts its work,” Mr Vainio says.
ECHA has also promoted substitution in other ways. For example, the Agency has published an 18-hour long online training on analyses of alternatives and supported Member States and industry to organise ‘supply chain workshops’ to find alternatives to substances of concern. ECHA has also contributed to the work of the OECD on a guidance on safer alternatives.
A recent report on the impacts of REACH restrictions and authorisation on substitution in the EU indicated that restriction and authorisation are the main regulatory drivers of substitution. While 19 % of the respondents indicated that restriction is their main reason for replacing hazardous chemicals with safer alternatives, 15 % signalled that adding a substance to the Candidate List or Authorisation List was their trigger.
“Some companies already substitute while the regulatory management option analysis (RMOA) is ongoing, but especially when the outcome of the RMOA indicates a further action such as identification as a substance of very high concern. So, companies seem to substitute very proactively when feasible alternatives exist,” Mr Vainio says.
Legacy spare parts and ‘upstream’ applications
As part of the second review of REACH in 2018, the Commission called for simplification of the application process for SVHCs in legacy spare parts and improvements in the ‘upstream’ applications.
Legacy spare parts are used in old equipment, such as cars or aeroplanes, that are no longer manufactured. The Commission is currently preparing an implementing regulation concerning these parts. “Once this simplification has taken effect, we are interested in seeing the extent to which it will be used in practice,” Mr Vainio explains.
‘Upstream’ applications are made by the manufacturers and importers of chemicals covering their downstream uses and sometimes their own use. The logic of ‘upstream’ applications is similar to registration where manufacturers are responsible for registering the substance and knowing its uses. However, experience has shown that ‘upstream’ applicants often do not know the uses down the supply chain well enough. In particular, they seem to have difficulties in figuring out what the alternatives are and how easily the substance could be substituted by the end users.
“For the manufacturers of the substance, the analysis of alternatives has proven to be challenging. As a consequence, the ‘upstream’ applications have been going back and forth during opinion and decision-making with EU authorities asking for more information from the applicants and their downstream users,” Mr Vainio says.
ECHA has made a proposal for a two-level strategy for managing ‘upstream’ applications in its guide for applicants (page 19). “Making the ‘upstream’ applications workable still requires consideration. Covering the whole supply chain with one application is the largest challenge in the application process. The fact that the companies using the substance are competitors does not make things any more simple,” Mr Vainio notes.
As of August 2020, ECHA has handled over 200 applications for authorisation for 340 uses of SVHCs. For about a third of the substances on the Authorisation List, ECHA has received no applications, which could mean that European companies have either found alternatives or stopped using them. Furthermore, in many cases – such as for the flame retardant HBCDD and lead chromate pigments – ECHA has not received review reports after the expiry of the review period. In practice, this means that the companies will not apply to renew their authorisation.
“We know that the uses of several substances, for example DEHP and trichloroethylene, have been substituted in a significant manner after the Commission added them to the Authorisation List,” Mr Vainio explains.
When companies apply for authorisation, they need to go through their manufacturing process. This alone often leads to improvements that reduce environmental pollution and negative impacts on people’s health, for example by limiting workers’ exposure. “For instance, the exposure of hexavalent chromium in most authorisation applications is around 2 μg/m3, which is well below the current occupational exposure limit (OEL) value of 10 μg/m3. We are very pleased to see that, thanks to the authorisation requirement, companies are reducing this exposure considerably to reduce cancer risk in workplaces,” Mr Vainio states.
“The reduction of risks as a result of the authorisation requirement has been significant. When companies apply for authorisation, they need to show they have done a good job at reducing emissions and exposure of people,” he continues.
Moreover, granting authorisations has been important for the competitiveness of EU industry. ECHA is currently preparing a report where the monetised societal benefits and the remaining risks to human health of SVHCs as well as emissions are being estimated. This report is planned to be published in November 2020.
“It’s good to keep in mind that authorisation is not a ban and that usually a certain level of risk remains. Companies that have niche uses can apply, and if their application is justified, they can get an authorisation. At the same time, the overall use of the substance of concern declines considerably as many companies start to use feasible substitutes,” Mr Vainio concludes.
From our stakeholders
“There is no denying that authorisation has contributed to the phase-out of hazardous chemicals. As a matter of fact, a recent ECHA study clearly shows that strong EU regulation is key to reducing the use of hazardous chemicals.
However, REACH could have protected the health of EU citizens and the environment more efficiently had it been implemented in a stricter way. Industry should have been given clear-cut directions already from the start. Unfortunately, ECHA has not been clear enough in saying that industry would need to phase out harmful chemicals to comply with the legislation. This has led to many companies not starting their phase-out work in time. When a chemical is added to the Candidate List, it should be clearly communicated that it will need to be phased out.
Authorisation has great potential to efficiently phase out hazardous chemicals, it just needs some minor but very important tweaks to function properly. Now, finally, the assessment of alternatives, and which of them are available in general, is being discussed. We are pleased to see that there is an ongoing process to come to terms with this.”
Frida Hök, International Chemical Secretariat, ChemSec
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“The assessment of chemicals through authorisation is a dynamic process that keeps evolving. It has been improved step-by-step already, but we see room for improvement in the process for applying, assessing and granting authorisation.
For industry, authorisation is complex, costly, temporary and unpredictable – it tends to be a ‘last resort’ option. Before deciding to apply for authorisation, companies typically assess internally if they have alternatives and for which uses. Where no technically or socio-economically satisfactory alternative has been found, authorisation is the way to go.
If we want the authorisation process to work in the way it was meant to and be a thrust for an in-depth review of applied risk management measures, we suggest the following:
- Secure at an early stage a coordinated approach seeking to identify the most effective regulatory measures.
- Call for more dialogue between the applicant and the authorities during the opinion-making process – in addition to the already existing one-off trialogue.
- Determine proportionate information requirements for specific cases, such as low volumes, industrial chemical processes and the review report.
- Explore how to ensure more effective and efficient communication in the supply chain.
- Integrate elements like sustainability and circularity into discussions on alternatives.”
Sylvie Lemoine, European Chemical Industry Council, Cefic
To further advance authorisation, ECHA is keen to work with its stakeholders. One channel for collaboration is the Network of REACH socio-economic and analysis of alternatives practitioners (NeRSAP). This is a network of experts set up to discuss and exchange methods and experiences on the practical aspects of socio-economic analysis and analysis of alternatives with participants from industry, Member State authorities and NGOs.
ECHA will host web-based meetings for the network on 20 October and 5 November 2020. As part of the meetings, the Agency hopes to collect practical suggestions from participants as well as feedback on what has been working well and what needs to improve. The feedback, together with the analysis of the applications and the experience on the practical implementation of the authorisation process, will feed into ECHA’s report on the operation of REACH and CLP, which is due in May 2021.
Interview by Hanna-Kaisa Torkkeli
Published on: 29 September 2020
Updated on 12 October to reflect that the substitution plan for the curing agent MOCA is among the four received.
Top image: Unsplash/Bill Oxford
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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: