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Article related to: biocides
ECHA Helpdesk's top tips for biocides applicants
A little over a year has passed since the entry into operation of the Biocidal Products Regulation. The ECHA Helpdesk, however, started to offer support for companies with biocides questions in April 2013 and since then they have received over 1 300 enquiries. Find out what some of the most common questions are and where to find further information and support.
Many of the companies who contact the ECHA Helpdesk, especially small and medium-sized companies, find it difficult to understand what all the aspects of the Biocidal Products Regulation and its implementing regulations mean for them. Therefore, the job of the ECHA Helpdesk is to translate the legal texts into language that is easy to understand even by inexperienced companies and to refer them to the right sources of information.
Many of the questions received are specific to the needs of a particular company but some are recurring.
How can I find data?
During recent months, many questions have been about accessing and sharing data. This is because the Biocidal Products Regulation requires companies to share data from tests and studies on biocidal active substances and products. Many companies are contacting ECHA to ask for contact details of data owners.
To find out which tests and studies are already available and to get the contact information of the data owner, prospective applicants can submit a data-sharing inquiry to ECHA through the IT tool, R4BP 3. If, later on, there is a need to bring a data-sharing dispute to ECHA, the inquiry must have been made.
It can also be helpful to look for a potential data owner from the list of active substances and suppliers that is available on ECHA's website.
What's the difference between chemical similarity and technical equivalence?
The technical equivalence check can only be carried out for already approved substances. It is needed when an authorisation is sought for a biocidal product whose active substance is from a different source than the one already approved. The different source might be a different manufacturing process, location or manufacturer.
The chemical similarity check, on the other hand, is an optional service that can be useful when the active substance has not yet been approved. This could be the case when the active substance is part of the review programme or when an application for approval of the active substance has not yet been made.
Applications for technical equivalence or chemical similarity checks are sent to ECHA through R4BP 3. ECHA's website contains information on both of these processes.
How do I get on the Article 95 list?
ECHA's Helpdesk is the contact point for questions related to R4BP 3, IUCLID and issues related to dossier submission. Image: ECHA.
Companies often think that they have to submit a full dossier to be included in the list of active substances and suppliers (the Article 95 list). However, most of the time, this is not required. It is sufficient to submit a ‘letter of access' which shows that the company is sharing the costs of the data. As no new dossier has to be evaluated, the processing of the application is quicker and the fee charged is significantly lower than in cases where a full alternative dossier is submitted.
In general, it is enough that one supplier within a particular supply chain is listed on the Article 95 list.
More information about the requirements under Article 95 can be found in the draft guidance on active substances and suppliers.
Where can I read more?
ECHA's website contains a lot of information related to the biocides legislation and its requirements as well as practical information on biocides submissions.
To start with, some of the frequently asked questions received by the ECHA Helpdesk and the national helpdesks have been collected under the support section. These include answers to questions related to active substance suppliers, data sharing and treated articles.
The guidance documents describe good practice on how to fulfil the obligations under the Biocidal Products Regulation and the Biocides Submission Manuals provide technical assistance, for example, on building a IUCLID dossier and submitting applications through R4BP 3.
The support section on R4BP 3 lists all the different application types and gives practical advice on the steps that need to be taken when preparing a submission.
Which Helpdesk should I contact?
The national biocides helpdesks are the first point of contact for companies who need to know more about their obligations under the Biocidal Products Regulation. The national helpdesks offer support in local languages and have a good understanding of national conditions.
The ECHA Helpdesk, on the other hand, gives advice on the approval of active substances and Union authorisation. It is the contact point for companies when they have questions related to R4BP 3 or IUCLID or issues related to dossier submission. The ECHA Helpdesk also advises on questions related to other processes carried out by ECHA.
- Biocides guidance
- Practical guides on Biocidal Products Regulation
- Biocides submission manuals
- Questions and Answers
- R4BP 3 support
Presentations from the Biocides Stakeholders' Day
Many of the topics introduced in this article were also discussed during the Biocides Stakeholders' Day in September. All presentations and a video recording of the event are available on the event page of ECHA's website.
Text by Päivi Jokiniemi
Top image: Fotolia
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: