ECHA

The biocides deadline to get included in the list of active substances and suppliers on 1 September 2015 is closer than you think. If you need to be on the list but have not yet submitted your application, this is the last moment to act. ECHA Newsletter spoke with Janssen PMP, one of the companies on the list. Read their last minute tips to help you prepare your application.

Janssen PMP is a supplier of active substances, including Propiconazole which is used in the wood preservation industry. To continue supplying this active substance, the company needed to get on the list of active substances and suppliers, also known as the Article 95 list, before 1 September 2015.

"For the sustainability of our long term business we decided that it would be in our best interest to be listed as a substance supplier under Article 95. Since our decision would directly impact our customers, it was key to keep them informed throughout the whole process," Dr Adrian Gray, European Regulatory Manager says.

Dr Adrian Gray. Image: Janssen PMP.

It takes time to prepare a dossier

According to Dr Gray, submitting the application itself is quite simple but preparing the active substance dossier takes time and should be prioritised. "The first step for us was to understand the active substance data requirements and where waivers could be used. For this, the available guidance on data requirements and information published in the assessment report of the active substance proved to be helpful." However, he adds that for many active substances currently in the review programme, the assessment reports are not yet available.

Whether your company is large or small, help may be needed when preparing your application. For example, to confirm the data requirements Janssen PMP decided to get support from consultants but they also asked ECHA for answers to some of their questions. "Using consultants in areas where they had more expertise, for example with IUCLID, helped us tremendously," Dr Gray says and continues, "on the other hand, since we already had an R4BP 3 account, it was not too complicated to submit the actual application."

He reminds companies to keep an eye on their R4BP 3 account also after submitting their application to follow-up its status and to make sure that they pay the related fee in time. "After the application was submitted, we occasionally contacted the dossier manager at ECHA to get reassurance and further information on likely timelines for the application," Dr Gray explains.

Check if you need to apply – and act now!

If you use a biocidal active substance in your biocidal product but you are not on the list of active substances and suppliers, ask yourself if you need to be.

Formulators making biocidal products available on the EU market could be covered by their supplier. "If it is clear in your supply chain that your active substance supplier (the importer or manufacturer) is already listed for the relevant product type, fine. But if your supplier is not listed and they cannot convince you that they will be listed by the September 2015 deadline, it could be worthwhile checking with a substance supplier that is included in the list if they could supply your needs. This way you may not need to be on the Article 95 list yourself," Dr Gray advises.

Negotiate for a letter of access

If you come to the conclusion that you need to be on the list, you have to act immediately. This, however, does not mean that you necessarily need to produce your own data for the dossier. In many cases, you can buy a letter of access from a supplier who is already listed.

The first step is to contact the data owner. "Since time is now short, negotiating for a letter of access is potentially the quickest route to the Article 95 list, but like many commercial negotiations, it can still take some time. From what we have learned of the overall Article 95 process, it is already rather late to do this, unless your data access negotiations go smoothly," Dr Gray points out.

According to Dr Gray, submitting a dossier based entirely on a letter of access would result in a quicker and more straightforward evaluation of the application. "If the letter of access from the data owner does not cover all the required data, you need to conduct a data gap analysis. To be honest, it is a good idea to do this in advance in any case. It will give you an idea of what other data may be needed and the implications regarding costs and timelines," he emphasises.

He recommends companies to have a look at the published list of active substances and suppliers on ECHA's website to find the possible data owner. Another helpful source of information is ECHA's Guidance documents on active substance suppliers and data sharing. They can help you to understand the obligations of the different parties and give you useful tips for the data negotiations.

Assessment of the application

The process is not over when the application is submitted. ECHA needs to evaluate it before you can get on to the Article 95 list. "I would recommend contacting ECHA to understand the likely timelines for the evaluation of the application. The timeline can vary depending upon the type of your application – whether it is a letter of access only, a mixed application with a letter of access and other data, or a dossier based on your own data," Dr Gray concludes.

Further information:

• Biocides 1 September 2015 – Apply now to stay on the market
• List of active substances and suppliers
• Guidance on biocides legislation
• R4BP 3 – Register for Biocidal Products
• ECHA Helpdesk contact form
• Terminology – in 23 languages

Janssen PMP   Janssen Preservation & Material Protection (PMP) is a division of Janssen Pharmaceutica NV. They develop and formulate active substances and end-use products for the protection of materials and produce, for example, for wood protection, antifouling and microbial control. The company acts as an active substance, technical concentrate and biocidal product supplier. Janssen PMP are established in Belgium, the United States, Argentina, Singapore and Japan.   www.janssenpmp.com

Interview by Päivi Jokiniemi

Top image: Fotolia

If you liked this article, you may also like: ECHA Helpdesk's top tips for biocides applicants, Newsletter 5/2014 Make sure you are included in the list of biocidal active substances and suppliers, Newsletter 4/2014 Want to stay on the market with your biocidal product after 1 September 2015, Newsletter 5/2013