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Authorisation - an impetus for substituting harmful chemicals and reducing risks
To continue using hazardous substances included in the Authorisation List, you have to apply for authorisation. To date, ECHA has received 120 applications for authorisation for 22 substances of very high concern. A stocktaking conference held in November 2017 highlighted how authorisation has positively impacted European businesses, workers and the general public by stimulating substitution and reducing the risks of hazardous chemicals.
Based on these opinions, the European Commission has so far granted authorisations to all applicants whose applications have gone through the decision-making process.
With data now available from these authorisation cases, ECHA and the Commission have both taken a closer look at how the REACH authorisation system is working. In September, ECHA published a report concluding that even though it is difficult to quantify the direct impact of the granted authorisations, the benefits of authorisation generally outweigh the remaining risks. Why is that?
Putting additional risk management measures in place?
To reduce the risks from continuing to use substances of very high concern, RAC has recommended additional requirements for more than 70 % of the uses applied for.
These requirements aim to primarily protect workers, but also members of the general public who may be exposed to the substance through the environment.
Stricter conditions of use, and monitoring and reviewing the risk management measures are among these additional requirements. “It is quite typical for authorisation holders to be asked to regularly measure occupational exposure of workers involved in such uses and, in addition, the emissions to the environment. This information is used to review how effective the risk management measures and operational conditions are and will help authorisation holders take action if needed,” says Dr Tim Bowmer, the Chairman of RAC.
In other cases, authorisation holders are required to implement additional risk management measures, such as glove boxes to isolate sensitive materials, automatic sampling systems or local exhaust ventilation to protect their employees from being exposed to the substance of very high concern (SVHC).
Shorter review periods
Each authorisation granted by the European Commission comes with a review period – the time during which the authorisation is valid.
If a company has not found a suitable alternative and needs to continue using the substance after this period, it has to submit a review report to ECHA and to justify an extension of the authorisation.
RAC and SEAC have often recommended shorter review periods than what applicants have proposed. On average, the applicants have provided justifications for the review period to be about 11 years, but the recommended period has been around two and a half years shorter.
The first review periods have already or are soon about to expire and ECHA has so far received two review reports. By contrast, about 20 authorisation holders have not submitted review reports for five substances and 10 uses in total.
But, it is not only the stricter conditions of use and other risk management measures that have led to the safer use of harmful substances on the European market – the authorisation process itself has encouraged companies to look for safer alternatives.
Preliminary findings of an ongoing study on the impacts of authorisation were presented in November at the stocktaking conference of the implementation of REACH authorisation. Based on the study, authorisation is seen as a major, although not the only, driver of substitution of SVHCs.
Most substitution activities seem to be triggered when substances are added to the Candidate List.
This is closely followed by inclusion of substances in the Authorisation List. Many applications for authorisation have also reported promising substitution activities.
“This study has shown that some benefits of authorisation are starting to show: SVHCs are being substituted where their use is not essential and, if they cannot be replaced, companies make an effort to improve the risk management measures and to reduce exposure. I think that the comments heard in the early days of authorisation that it was a burden with no added value, can now be dismissed,” Ms Valentina Bertato, the project manager at the European Commission, explains.
There are several reasons to choose substitution if it is technically possible. Some of them are related to the changes on the market after the substance is added to the Candidate List, others are related more to reputational issues.
For example, companies commonly state that they want to avoid the stigma of using SVHCs, costs of regulation and uncertainty associated with having to apply for authorisation and whether it is granted to them.
Difficult to estimate societal impacts
Although recent findings show authorisation has helped to make the life of workers and the general public safer, there is still room for improvement.
The quality of the applications could be better. To show that the risks are properly managed, each application needs to explain in detail how the substance is used.
Applicants must also analyse possible safer alternatives for the substance and the particular use, and analyse what it would mean in socio-economic terms to switch to such an alternative.
All this sounds straightforward on paper. However, analysing all data and considering all possible impacts – including those on the company, its employees, the general public and society as a whole – soon gets pretty complicated.
Therefore, applicants often find it difficult to quantify the added value of their activity to society as a whole. This is something that ECHA’s committees have scrutinised and pointed out in their opinions.
“Companies are usually well aware of how the authorisation or lack of it would affect their business. They also manage to explain the risks that continued use of the substance may pose to their employees if they are exposed to the substance. But they often fail to present the big picture," says Dr Christoph Rheinberger, ECHA’s coordinator for socio-economic analysis.
"What are the consequences to society if a company stops the use of the substance? How would this impact competitors that provide similar products more safely? What would this mean to customers who rely on the products and services of the applicant? These are the questions that applicants should address,” he concludes.
Substances of very high concern (SVHCs)
The basic principle behind REACH authorisations is that substances of very high concern listed on the Authorisation List are not allowed to be used after a specified sunset date unless a user or their supplier has an authorisation from the European Commission.
Looking closer at REACH authorisation
In September 2017, ECHA published a report analysing the socio-economic impacts of REACH authorisations based on the first 100 applications for authorisation submitted and evaluated by the end of 2016.
The European Commission presented preliminary findings from the study looking into impacts of REACH authorisation in the Stock-taking conference on implementation of REACH authorisation that took place at ECHA on 13-14 November. The report has been prepared by four consultancies:
The final report is expected to be published later this year.
Text by Päivi Jokiniemi
Published on: 16 November 2017
Top image: © iStock.com/stock_colors
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: