New Biocidal Products Regulation enters into operation on
1 September 2013
The new Biocidal Products Regulation concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms. The regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans, animals and the environment. ECHA is the focal point for all processes under the new regulation.
New Biocides Regulation improves human health and environmental protection
"This Regulation is another step towards ensuring that only safe, authorised products are made available throughout the EU. The simplification of authorisation procedures will bring significant economic benefits to companies while ensuring a high level of environmental protection for citizens," Environment Commissioner Janez Potočnik said.
Safer biocidal products, less animal testing and equal treatment of the active substance suppliers are some of the changes that the new Biocidal Products Regulation introduces. More
R4BP 3 is the central hub through which all biocides applications will be made. It enables industry and the authorities to comply with the legislative requirements and exchange information. The system will officially open on 1 September at 09:00 (Helsinki time). ECHA invites all companies to create an account in the system and log in to check their existing product authorisations. Due to the ongoing migration from the previous version of R4BP to R4BP 3, not all existing authorisations are yet uploaded into the system. If you cannot find yours, consult the Q&A on data migration. The existing authorisations are visible only after the official launch on 1 September.
ECHA provides manuals, templates and video tutorials for companies using R4BP 3 to successfully complete their applications. Companies have to use IUCLID 5 to collect, organise and store the data on active substances and biocidal products. For an application, companies can create a IUCLID 5 dossier and submit it to ECHA and the national authorities through R4BP 3.
Apart from the exceptional opening on Sunday 1 September, R4BP 3 is open continuously from Monday 10:00 to Friday 21:00 (Helsinki time).
Biocidal products, active substances and active substance suppliers
The biocidal products list contains products which have been authorised in accordance with the Biocidal Products Directive and the new Biocidal Products Regulation. As of 1 September 2013, the list contains 2 617 products.
The active substances list contains those substances approved in accordance with the Biocidal Products Directive and the Biocidal Products Regulation. As biocidal active substances are approved, ECHA has an obligation to make certain non-confidential data available. ECHA does not verify the information before publishing. As of 1 September 2013, the list contains 49 substances.
The active substance supplierslist: The Biocidal Products Regulation aims to ensure that the costs of data on active substances are shared in a fair manner. Therefore, all active substance manufacturers and importers placing active substances on the EU market must contribute to the costs. This provisional list comprises information received from the European Commission.
The new regulation introduces an obligation for existing data owners and prospective applicants to share certain data from tests and studies on biocidal active substances and products submitted to EU authorities. By doing this, the applicants can reduce costs and avoid unnecessary testing.
ECHA has now updated the information on data sharing under the BPR. New questions and answers as well as key messages are available. In addition, a short note clarifying which chapters of the Guidance on data sharing are relevant to biocides applicants can be found online.
ECHA has so far published three new guidance documents on biocides:
Guidance on applications for technical equivalence
Guidance on information requirements
Guidance on active substance suppliers
The documents are available in the Guidance section of ECHA's website.
Emission scenario documents and technical guidance developed for the Biocides Directive now hosted by ECHA
Emission scenario documents (ESDs) are used to estimate the initial release of substances from biocidal products or treated materials to the environment. All finalised emission scenario documents for biocides have now been moved from the Joint Research Centre website to ECHA's website.
In addition, technical guidance documents that were developed for the implementation of the Biocidal Products Directive 98/8/EC are now available on ECHA's website.
To help you fulfil your obligations under the BPR, ECHA publishes a set of questions and answers as well as frequently asked questions related to R4BP 3. The ECHA Helpdesk is ready to help applicants with the different provisions of the legislation, individual submissions and IT tools.
In addition, the Member States have their own helpdesks or competent authorities replying to biocides questions in national languages.
Small and medium-sized enterprises established in the European Union can benefit from reduced fees under the Biocidal Products Regulation, depending on their size and provided that certain conditions are met. In order to do this, companies need to submit the documentary evidence proving their entitlement to such reductions in advance of the actual application.
European Chemicals Agency
P.O.Box 400 FI-00121 Helsinki, Finland echa.europa.eu
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