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Article related to: Biocides
Why Union authorisation?
Union authorisation was introduced by the EU’s Biocidal Products Regulation in 2013. It allows companies to place their biocidal products on the entire EU market, without needing to get specific national authorisations. The first biocidal products are now expected to be granted access to the EU market. We talked with Isabelle Demoment from Kersia Group and Gosia Oledzka from Ecolab, which were among the first companies to opt for Union authorisation.
Harmonised assessment in all EU countries
While national authorisations are managed by Member States independently, Union authorisation is managed by ECHA and the final decision comes from the EU countries and the European Commission.
According to Ms Oledzka, harmonisation and predictability are the two main reasons why Ecolab applied for Union authorisation.
“We have always been in favour of the harmonisation that Union authorisation brings – since the beginning, when the regulation was being drafted. Not only does it streamline the evaluation of the application, but it also ensures that each Member State can comment on the application and influence the outcome,” says Ms Oledzka.
Ms Demoment agrees: “When you make just one unique application that covers all EU countries, the process is easier to manage,” she says. “My team came to the conclusion that Union authorisation would decrease our workload. It also gave us an opportunity to explain our product to all of the authorities in one go rather than going through the same things with several Member States.”
Having one central contact point can also simplify the coordination. “We believe that bringing ECHA into the process helps keep deadlines on track, which is critical for any biocidal product formulator,” Ms Oledzka tells.
She also believes that Union authorisation helps to bring consistency to customers. “We can now offer veterinary hygiene products evaluated by all EU biocidal experts. The end result is one product label with one clear message for the end user. In our case, a French farmer would see the same product label as a farmer in Spain,” she explains.
More economical for multinational markets
If your product is available in one Member State only, it is clear that a national authorisation is the best way forward. But when you want access to several markets in the EU, it is worth investing some time to decide whether to go for Union authorisation or to expand a national authorisation to other countries (this is called mutual recognition). For this, doing a thorough analysis of the fee costs is crucial.
“As we wanted to market our product in at least 15 EU countries, we thoroughly analysed the costs and concluded that Union authorisation would be less costly for us than the mutual recognition process. Generally speaking, if you are placing your product on the market in 10 or more countries, Union authorisation is likely to be more economical for you,” Ms Demoment says.
“How a company chooses their authorisation path is always an individual decision based on their business strategy. By definition, Union authorisation opens access to the whole EU market. Before pursuing it, consider the number of Member States you wish to market your product in – and also think about whether this may expand in the future,” Ms Oledzka adds.
Close cooperation with authorities
The key to a successful application is close cooperation with authorities. The first step is deciding which Member State authority you want to ask to evaluate your application. “We chose the Netherlands because of their vast experience in evaluating biocides dossiers,” Ms Demoment explains.
“Working very closely with the selected evaluating authority is crucial and therefore it is good to work with one that is active and has a high level of competence in this field,” she expands.
The second step is establishing a dialogue with the evaluating authority to build the foundation of the dossier. “Once you have the base, you start gathering scientific data and arguments to support your case. It’s a long process involving many different disciplines. Besides consultants, we were a team of five or six, representing different fields, from regulatory and research and development to microbiology and marketing,” Ms Oledzka explains.
Ms Demoment stresses the importance of understanding the latest scientific discussions. “Make sure you follow the developments and always have the latest guidance in hand, as guidance is never final but keeps evolving. For example, the EU’s scientific criteria to identify endocrine disruptors under biocides was only adopted in 2017 – just when we were at the end of our authorisation process. We are now preparing for how this might affect us.”
The third step is the first discussion at the working groups of the Biocidal Products Committee (BPC).
“You only know if what you have submitted is sufficient once the working groups have positively concluded on your application,” Ms Oledzka highlights. “The fact that experts from each Member State take part in the discussion makes the evaluation more harmonised. In some cases, though, you may be faced with new or emerging guidance or requirements which were not in place when you started your preparations. It is a continuous learning exercise.”
The fourth step is the final BPC conclusion on the application and whether it is supported by the committee. The final decision is taken by the European Commission and Member States.
Support from ECHA is available throughout each step. “You can contact ECHA and they will remind you about upcoming deadlines. Most of the communication is done through the biocides IT tool R4BP 3,” Ms Oledzka says.
In Kersia Group’s case, the company was assigned a coach from ECHA who supported them throughout the task. “This was extremely helpful to us, as we were all new to the process,” Ms Demoment confirms.
New innovations with a product family
With a product family, products can be grouped into the same Union authorisation application if the difference in their composition is limited.
For example, both Kersia Group and Ecolab applied for Union authorisation for a veterinary hygiene product family where all the products contain the same active substance.
Ms Demoment says that the product family approach can help a company to innovate and launch new products easily. “In one application, you can manage a family of similar products. The products can then be adapted to suit the needs of different markets, for example, you can create different formulations for different markets, or launch a new formulation on one market. In this way, Union authorisation combined with a product family supports new innovations.”
Biggest challenges: timelines and fees
Reaching audiences in different markets also requires reaching them in different languages. Both companies highlight the translation of their product information as a challenging step mainly due to the timelines involved.
“We found the translation of the summary of product characteristics (SPC) to be a big hurdle,” Ms Oledzka says. “After ECHA’s Biocidal Products Committee gave its opinion, we only had five days to provide all the translations in 23 EU languages. This is challenging because, even if all the translations have already been done beforehand, the committee may change some wording. Creating the documents in XML format and correcting them in 23 languages is a time-consuming exercise and extending this deadline would be helpful,” she suggests.
Fees are another issue that both companies highlight as a challenge. “This is a big investment for a company and requires lots of resources,” Ms Demoment stresses.
“I believe that if the fees were lower, Union authorisation would be taken up more by companies,” she concludes.
Kersia Group combines Hypred, Antigerm, Medentech, LCB, G3 and KILCO, which develop products, solutions and services for water purification and biosecurity in farming and food processing.
Ecolab provides water, hygiene and energy technologies and services to customers in over 170 countries.
When to apply
For biocidal products containing new active substances, you can submit your application for Union authorisation at any time.
For biocidal products containing existing active substances, the timelines are the same for all biocidal product authorisations: you can apply once the active substance in your product has been approved. You are usually given two years to do this.
You can check the upcoming deadlines for 2018 and 2019 on ECHA’s website.
Tips for Union authorisation
1. Calculate the costs
If you market your product in several EU countries, see whether Union authorisation is cheaper than applying for authorisation in several countries. Consider the whole production lifecycle – not only the initial application.
The whole process may take up to six years. Preparing your application takes two to three years.
3. Work closely with your evaluating authority
Organise a discussion with your evaluating authority, ECHA and the European Commission at the start to make sure you are eligible and to clarify any specific questions.
4. Ensure the right expertise
Applying requires expertise on the process as well as in specific areas, such as risk evaluation and efficacy.
5. Follow newest guidance
Guidance is updated regularly to reflect the latest knowledge in the field. Always make sure you have the latest advice at hand – even if it is just a draft update.
6. Follow regulatory discussion
Follow ECHA’s news to make sure you are in the know about any new developments in regulatory practice.
7. Consider a product family approach
Products can be grouped in the same Union authorisation if the difference in their composition remains limited. With a Union authorisation, the products can be adapted to suit different EU countries.
8. Launch your product in new markets
Once you have a Union authorisation, you can launch your product in any EU country with a simple notification to ECHA or the European Commission.
Interviews by Veera Saari
Top image: © IStock.com/Lysenko Alexander
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