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Editor-in-chief: Maurizio Roncaccia

Editors: Paul Trouth and Päivi Jokiniemi

Article related to: Biocides

Your experience of Article 95

Art 95 list

1 September 2015 marked a deadline for companies to be included on the list of active substances and suppliers, known as the Article 95 list. By that date, ECHA had received 158 applications to be included on the list. We asked some of our stakeholders about their experience of dealing with the Article 95 requirements.

Ms Flore Cognat of the European Chemical Industry Council, Cefic, says that information on the Article 95 requirements only started spreading in late 2014.

"We still get many enquiries from companies, so I'm sure applications for inclusion on the list will continue to come. For example, the legal clarification for in situ active substances came quite late for the data owners and the third parties to adapt and understand what they needed to do," she says.

Dr Thomas Leopold, a consultant at Ecomundo, says that small and medium-sized companies (SMEs) have especially had problems with the complexity of the process, the cost of data and with the IT tool R4BP 3.

"There are also strategic issues relating to the trade of the products. If a company chooses to apply to be on the list and buys a letter of access (LoA) to get access to the data, it cannot go back anymore. You cannot resell the LoA. Companies have needed help in figuring out what is the right strategy for them."

He says his consultancy is still dealing with various Article 95 dossiers. "Some companies came to us very late. We tell them that there is no need to panic, but that they should really speed up. The European Commission has recommended that the enforcing Member States give the companies ‘a period of grace' of six months to comply with the requirements."

Sharing data and its cost

The sharing of data between those companies already on the list and the alternative suppliers has raised a lot of questions. "Companies are asking me what is my role, what do I need to do, how can I be compliant? Some of them are not quite sure what they need – the obligations are different depending on their role. But in general, from what I've seen, the intentions from both sides to come to an agreement on data sharing are good," Ms Cognat explains.

Stefaan Verschaeve from Sopura – an SME offering hygiene and water treatment solutions – says his company, which is already on the list, received a lot of requests for sharing data. "The discussions, even with our competitors, have been very constructive. The data sharing really works. Of course, I admit that we are dealing mainly with big companies," he says.

On the other side of the coin, the room for negotiation might be almost non-existent. "There are three parts that make up the price: the cost of studies, the evaluation of the active substance dossier by the Member State, and the cost of the dossier management. For the first two, we are able to ask for details, but as for the cost for managing the dossier, we have no say. We cannot really argue to lower this cost," Dr Leopold says.

Determining the overall costs of sharing data is not always straightforward. This is the case especially if the data owner has supported the active substance for several years as a participant of the review programme. "The aim is equitable compensation. An alternative supplier may only now be interested in the data that the review programme participant has been collecting for the past 10 years. That work needs to be compensated," Ms Cognat points out.

Ecomundo has seen some very interesting cases with companies aiming to cut down on the cost of compliance with the Biocidal Products Regulation (BPR). "Companies have formed partnerships to be able to share the cost for inclusion in the Article 95 list. For example, a European shoe retailer may want to have anti-mould paper to protect the shoes they are selling. The supplier of this paper is a small non-EU company who cannot afford the cost of the LoA. The shoe retailer and the supplier of the anti-mould paper form a partnership where they share the costs of the LoA and sign a commercial exclusivity contract. Afterwards, the shoe retailer can resell the antimould paper to other suppliers to get income to cover the costs of the LoA," Dr Leopold explains.

Other management options

Altogether, half of Ecomundo's clients have stopped marketing certain products because of the Article 95 requirements. "Unfortunately, these are small companies, who have tried to do their best with limited resources. They have engaged in research and development to develop their products and afterwards have had to discontinue. I also worry that if the number of active substances decreases, we may see more resistance from targeted microorganisms and parasites."

One fifth of Ecomundo's customers chose to change their products or to reduce their product range to focus on other legislation. 30% chose to apply for the Article 95 list.

"We have worked with companies who chose to target borderline products. One example is about the commercialisation of a hydroalcoholic gel. The company could not afford the LoA so they changed their product. It became a sanitiser instead of a disinfectant and therefore required compliance with the Cosmetics Regulation and not the BPR. Another example is a company that decided to focus only on the medical device market," Dr Leopold concludes.

Further information:

Article 95

Companies that have submitted a dossier for an active substance under the Biocidal Products Directive (BPD) or the Biocidal Products Regulation (BPR) that has been validated by a Member State are on the list of active substances and suppliers – as are companies with an approved Article 95 application.

To be able to make a biocidal product available on the market, the company needs to be listed or buy the active substance from somebody who is listed.

ECHA will continue updating the Article 95 list each month to include suppliers whose applications are decided upon after 1 September 2015. These cases include late applicants, new market entrants and new relevant substances.

ECHA also publishes a list of the pending applications, which tells industry and other stakeholders who has applied but who has not yet received a final decision.

Text by Hanna-Kaisa Torkkeli
Top image: Fotolia