ECHA

What is the role of the European Commission under the new Biocidal Products Regulation? ECHA Newsletter spoke with Mr Pierre Choraine, the Biocides Team Leader in the Commission, to find out more about the upcoming changes, improvements and challenges brought by the regulation.

The role of the European Commission will not change radically when the Biocidal Products Regulation enters into operation. Some of the most important tasks of the Commission, according to Mr Choraine, are to guarantee the successful implementation of the regulation and to anticipate and respond to the concerns of industry.

The European Commission aims to guarantee the the successful implementation of the new biocides regulation. The Commission's Pierre Choraine spoke at ECHA's Biocides Stakeholders' Day.

The Commission also has an important role to play in encouraging discussion and debate around the regulation. "Our role in the meetings with the Member States is to promote new ideas and to steer the debate until the discussion comes to a conclusion that could be supported by the majority of the Member States." The role of the Commission's Joint Research Centre, which managed the former Biocidal Products Directive, is taken over by ECHA.

In more practical terms, the Commission is involved in the ECHA Management Board and will continue to chair meetings with the competent authorities where the implementation of the regulation is discussed. "We will provide support to the coordination group, which is responsible for making sure that the mutual recognition of authorisation between Member States is working as smoothly as possible. We also participate as an observer in the meetings of the Biocidal Products Committee to ensure that the opinions that come out from the Committee can be directly processed in the Commission without a need to re-discuss with the Member States," he explains.

In the context of the review programme and active substance approval, Mr Choraine reminds that it is a task of the Commission to provide ECHA with the necessary budget and resources to carry out its tasks. "The review programme should be completed by 2024, which means that ECHA will have to adopt around 50 opinions per year on the active substances under assessment. Once these substances have been approved, within two years, the products containing them have to be authorised. This means that companies that choose Union authorisation or mutual recognition need to submit applications for product authorisation to ECHA."

The Commission will be monitoring the implementation of the regulation and take action if needed. "The regulation has given the Commission the power to adopt implementing rules and that is what we will do if any changes are needed."

Challenges ahead

As with much other European legislation, small and medium-sized companies also need special attention when the biocides regulation becomes operational. "We understand that this is a very complex piece of legislation and therefore it is important that companies, especially SMEs, know what they are expected to do and what rules they need to follow." According to Mr Choraine, SMEs need support in accessing data to make sure that they are not forced to accept unfavourable agreements.

The sustainable use of the biocidal products is an issue that the Commission hopes to address in the coming years. "We are thinking of ideas and tools on how to provide incentives for products that have the best profiles for the environment and human health. One of the ideas is to enable products with better profiles to be recognised in the market, for example, by giving them a specific eco-label," he says.

Another challenge Mr Choraine refers to are treated articles and the new requirements that the Biocidal Products Regulation introduces for articles that have been treated with a biocidal product. "Many companies are not yet aware of the obligations they are facing and, therefore, it is critical to spread the information and educate industry on these new requirements."

Benefits of the new regulation

The new regulation lays down clear timelines for the different processes and actors which Mr Choraine sees as a positive development.

"With set timelines, we can guarantee that the active substance approvals and product authorisations are processed in a given timeframe and, consequently, that safer products will be placed on the market faster than before."

Union authorisation, which is one of the new ways of getting biocidal products authorised, is another good development worth flagging. "Once the Commission has granted the Union authorisation, the company is allowed to place their product on the entire EU market the next day. In terms of harmonisation of the internal market, this is the best thing we can offer," he says and continues, "this will be especially interesting for companies who are marketing for a large number of countries or for the entire EU market".

Companies who have taken their responsibilities seriously under the Biocidal Products Directive, will benefit from the introduction of Article 95 that responds to industry's concerns about sharing of costs.

"The BPR will provide a level playing field because all substance suppliers have to contribute to the costs that have been incurred by companies in bringing an active substance to the review programme," Mr Choraine explains.

Learning from other legislation

The REACH Regulation has been said to be a forerunner in the world of chemicals legislation. The Biocidal Products Regulation may not quite fill the boots of REACH when it comes to having global impact, but the regulation certainly addresses many issues that have not been taken into consideration before.

"We are covering the nanoforms of active substances, have introduced the concept of exclusion and substitution, we will assess substances that have endocrine disruptive properties, and we have some new provisions on treated articles. We are at the forefront of what has been done and we have looked at the best practice from other legislation when developing this legislation," Mr Choraine concludes.

Interview by Päivi Jokiniemi and Hanna-Kaisa Torkkeli