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Article related to: Biocides
Union authorisation: pros and cons from an industry perspective
The Biocidal Products Regulation (BPR) enables companies to get authorisation for their biocidal products in all Member States with just one application. This ‘Union authorisation' allows companies to place their product on the entire European market without the need to apply for specific national authorisations. ECHA Newsletter spoke with Mr Ludger Grunwald, Director of Regulatory Affairs in Europe, Africa and the Middle East for Ecolab, a company that is preparing their first application for Union authorisation.
Where biocidal products have similar conditions of use across the European Union, Union authorisation grants them the same rights and obligations. It is possible to apply for Union authorisation both for a single biocidal product and for a biocidal product family.
Union authorisation is not possible for all products however. For products that contain active substances fulfilling the exclusion criteria (for example, substances classified as carcinogenic, mutagenic or toxic for reproduction) Union authorisation can not be granted. Additionally, those that belong to product-types 14, 15, 17, 20 and 21, which cover, for example, products to control rodents, birds and fish, and antifouling products, are also excluded from Union authorisation.
Mr Grunwald thinks that Union authorisation is a good alternative for companies who wish to place their biocidal product on the entire European market. Image: ECHA.
Mr Grunwald believes that Union authorisation is a good alternative for Ecolab because it gives its product access to the whole EU market with one application. "With Union authorisation we need to prepare one application instead of potentially 28 and it will be evaluated by one Member State. We expect that this will make the process more straightforward and the time needed by authorities to review a dossier will be shorter". He also appreciates that there are clear deadlines for each step of the application process which improves the predictability. This, together with ECHA's involvement in the process is very much welcomed by Ecolab.
Mr Grunwald finds that there is enough information available for applicants to get started with their Union authorisation. "It is easy to find information on ECHA's website because it has a very good structure. The webinars offered for applicants and the meetings with ECHA have been very helpful. We have also received support from the ECHA Helpdesk," he says.
Although Mr Grunwald hopes that Union authorisation will streamline the steps to authorisation, he sees that both industry and authorities will face some challenges when applying this new procedure.
The first challenge he mentions is the overall cost of Union authorisation. When applying for Union authorisation, companies need to pay fees both to ECHA and to the evaluating Member State competent authority. In Mr Grunwald's opinion, ECHA has high administrative fees, covering both the authorisation and also annual fees, but these are clearly stated and can therefore be planned. However, it is not yet known whether some Member States will decide to charge additional annual fees. Therefore, at this point, the overall cost is impossible to estimate and could potentially jeopardise the attraction of Union Authorisation. Mr Grunwald would like the European Commission and ECHA to reflect on the fees when the Fee regulation is reviewed.
The new concept of biocidal product families also brings challenges. "It is important that the authorities clearly define the boundaries of the product family so that applicants can take advantage of the concept," Mr Grunwald emphasises. He welcomes the work already done to clarify some of the issues related to biocidal product families but he stresses how important it is to get the guidance published by the European Commission as soon as possible.
The final challenge relates to the workload of the Member States. In Mr Grunwald's view, it is not certain yet how Union authorisation will work in practice and if all the deadlines can be kept. "ECHA's deadlines are clear and predictable, but the Member States are usually overloaded with work or don't have the resources. Therefore, we are not 100 % sure if this will negatively impact on the overall timeline. For the moment, it is working well, with the pre-submission meetings offered by ECHA as there are only a handful of companies asking for Union authorisation. In the future though we may run into problems if there are too many applications," he explains.
Need for an alert system
Although Mr Grunwald is satisfied with the support they have received, he identifies some additional tools that could help industry.
"It would be really helpful to have a fee calculation tool or fees database available on ECHA's website. Currently, the Member States have various fees for the evaluation work they carry out and it makes it very difficult to decide whether it is more advisable to go down the mutual recognition or the Union authorisation path," Mr Grunwald reflects.
"Additionally, some alerts to inform potential applicants when the different applications reach the next step of the evaluation process would be useful," he adds and continues, "whenever the Biocidal Products Committee gives an opinion on an active substance, you usually have to wait for the minutes of the meeting, which are often published a month later. It would be much easier for industry to keep up-to-date on the applications if there was a system that would allow you to sign up for dossiers of interest and that would alert you every time progress is made. This should also include alerts on draft opinions that are adopted on active substances. Currently, this information may be missed," Mr Grunwald emphasises.
Start preparing now!
The main advice Mr Grunwald gives to other companies who are considering Union authorisation is to start their preparations well in advance. It is also essential to have a good overview of the portfolio of the company. "It is better to start very early. As one of the first steps, I would recommend everyone to ask for a pre-submission meeting with ECHA. The best scenario would be to meet in parallel with ECHA and the evaluating authority," Mr Grunwald advises.
All in all, Union authorisation can be a good option but Mr Grunwald reminds that it is not suitable for everyone. "Considering the high fees, you need to know that you want to place your product in many countries. The product must also have similar conditions of use across Europe, otherwise Union authorisation is not even an option," he concludes.
Ecolab is a global provider of water, hygiene and energy technologies and services.
Ecolab's global headquarters are in St Paul, Minnesota, United States and its European headquarters are in Wallisellen, Switzerland.
Interview by Julia Sierra
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Committee for Risk Assessment:
Committee for Socio-Economic
Biocidal Products Committee:
Member State Committee:
4-8 February (tentative)
Management Board meeting: