As the world grapples with the impact of coronavirus Covid-19, Echa, the European Commission and member states have had to act fast to ensure that industry can continue to supply much needed disinfectants to the market.
The European chemicals agency, like the majority of employers, has been forced to move to remote working for all its staff except a handful of senior employees in business critical roles that remain at Echa HQ.
One of those figures is executive director Bjorn Hansen. Speaking to Chemical Watch yesterday, Dr Hansen said that for the agency it is very much "business as usual with some adjustments" on two fronts – getting staff adapted to home-working and organising the meetings of its Committees for Risk Assessment and Socio-economic Analysis (Rac and Seac), the Member State Committee (MSC) and management board.
A just-completed survey of Echa staff on remote working showed that in general most people feel they can continue working as normal. "Of course in some areas we are experiencing efficiency losses," Dr Hansen said. "I expect to see by the end of year some impact on our work programme, but I don't see any major disruption or major reductions in efficiency."
As for the meetings, the management board held its meeting virtually on 19-20 March, among the first at Echa to do so. The MSC had had its first remote meeting already in early February. This will be the case for all agency meetings for the time being, with the organisation experiencing "some adjustment in some of the more complex discussions" in its committees.
One example is the Rac and Seac discussions on the microplastics restriction proposal. Rac was due to finalise its opinion and Seac to agree its draft opinion in March. But now the agency is looking at at least a three-month delay; the opinions are due to be sent to the Commission at the end of the year.
BPR
In March, national biocides authorities in the EU began encouraging companies to apply for temporary authorisations of hand sanitisers and other disinfectants because of Covid-19. The biocidal products Regulation (BPR) gives authorities the power to permit marketing and use of products that have not gone through the law’s standard authorisation process in emergencies. Such authorisations – given under the BPR's Article 55(1) – are limited and temporary.
Member states have been applying Article 55 "differently […] but seemingly effectively", Dr Hansen said. "Some countries have made more categorical exemptions, saying any company is responsible for ensuring their own product meets the requirements of the biocides Regulation and then they can use the temporary exemption from getting a direct approval. In other places, the member states are still making an exemption on an individual company basis."
Echa has also "committed to expedite" applications within the regulation outside of this temporary exemption. This has been done, Dr Hansen said, in case a company wants to have fast market access. However, the agency "has not seen much activity on that as most companies seem to be utilising the member state exemptions and it seems to be working".
The agency is supporting member states, the Commission and industry by:
- "refining and accelerating" some of the existing procedures;
- providing advice about applying the exemption; and
- publishing information on its webpages.
REACH
Outside of the BPR, the agency is taking steps on REACH registered chemicals, for instance extending certain deadlines to 60 days from 30 to give industry more time. This has already been applied to requests for REACH evaluation information on 12 substances. The measure could also be applied to timelines around authorisation applications.
"We do clearly see that companies can be in difficulty meeting deadlines and in these cases we are always ready to have a dialogue on a case-by-case basis [to see] if we need to extend a specific deadline for a company."
The other option, Dr Hansen said, could be "looking simply at categorically just extending some of the deadlines if we expect the whole industry to be affected".
Asked whether he anticipated fewer REACH registrations while the pandemic continues, Dr Hansen said he would "expect so if it continues for some time". However, he added, the agency "does not have a clear insight into understanding the lag time that exists with companies from when they start preparing a registration dossier to when they actually submit to Echa." Similarly, the agency is not fully aware where the problems exist – "is it the test laboratories or is it that staff have gone home and don’t have access to registration dossiers?"
In April, Echa was due to start completeness checking registration dossiers in terms of chemical safety reports, but Dr Hansen says it has decided to postpone this to October. "It will put extra burden on industry to learn the new rules and this might not be the best time to present them with this learning curve."
The legal deadlines that the agency has to comply with are still the same, he said. "This means that in general we maintain the normal deadlines in our processes, but these can be reviewed on a case-by-case basis. A more categorical extension would require prior consultation with the European Commission."
Industry queries
Since the beginning of the pandemic, Echa has received about 180 questions largely from industry. Approximately 150 of them have been about how to get disinfectants on the market. Echa has delivered feedback, including advising industry to talk to member state authorities if they do not know that they can apply Article 55 of the BPR to make exceptional exemptions for certain disinfectants.
The agency has also received about 20 queries about Echa deadlines that apply to registrants, in particular in relation to testing and REACH compliance check decisions. Companies have been trying to set up contracts with laboratories, but some have closed or are at reduced capacity or have not yet responded.
Dr Hansen said he wanted to emphasise that the agency hopes member states and companies, where they are able to, will continue working with Echa through these "difficult" times.
"This plea is also very much for if we end up in the extreme scenario – postponing work then it becomes very difficult to catch up. We are working at a high, steady workload. Anything we don’t do now, we have to fit in later and that makes life rather difficult. We are really hoping member states, in particular, will be able to continue working like us from home, knowing well that things might slow down a little."
Get in touch
How is Covid-19 affecting you, your team and your organisation? We would like to hear about your needs, views and experiences during the pandemic, to understand how it's affecting your day-to-day work, and to ensure we are taking the right steps to meet your needs. Please get in touch with us at covid19@chemicalwatch.com.