- Getting ready for the Biocidal Products Regulation
- World of biocides brought up to date
- Steering the work to make the new biocides regulation a success
- From our stakeholders: "Support for small enterprises is crucial"
- Setting up national biocides helpdesks
- New online tools for biocides applications
- Raising awareness on the new Biocidal Products Regulation
- Working together for better communication on the safe use of chemicals
- What to do when receiving an extended safety data sheet?
- Working towards the REACH dossier evaluation goal
- Setting the scene for applications for authorisation
- Board of Appeal members' term in office prolonged
- Guest column: Reflections on the review of REACH
- Making use of derived no-effect levels generated under REACH
- Call for creative ideas to overcome REACH challenges
- Croatia joins the EU chemicals management framework
- Debating chemicals policy
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Article related to: biocides
World of biocides brought up to date
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. The application date, 1 September 2013, is the first of many important milestones of the regulation.
"The new Biocidal Products Regulation brings the world of biocides up to date and brings it into line with the regulations for chemicals," says Hugues Kenigswald, the Head of Biocides Unit in ECHA.
"One of the most concrete changes for the applicants is the shift to a completely online submission system," says Hugues Kenigswald.
As an example of important changes, he mentions mandatory data sharing, a principle familiar from the REACH Regulation. The goal of this principle is to reduce the amount of testing on vertebrate animals by avoiding the duplication of studies. Another important element in the new regulation is the exclusion and substitution criteria for the most hazardous active substances, which in turn will lead to safer biocidal products.
With these and other changes, the regulation intends to cover the limitations of the Biocidal Products Directive, which was the predecessor of the Biocidal Products Regulation.
One of the advantages of the regulation, according to Mr Kenigswald, is the fact that the regulation is directly applicable across the EU, which will make the biocides market more harmonised.
"For the applicant, one of the most concrete changes is the shift to a completely online submission system. All applications will be prepared using IUCLID 5.5 and they will be submitted to the authorities through the Register for Biocidal Products (R4BP 3).
Cooperation between many players
The new approval and authorisation processes under the regulation involve input and cooperation from many actors. The applicants of course have the key role, as they will provide all the required information to the authorities and possibly take action in different phases during the process.
ECHA is involved in most of the processes, for example by validating the incoming applications, developing the online tools and maintaining the list of active substance suppliers as well as supporting the work of the Biocidal Products Committee.
The Member State competent authorities play a significant part under the regulation. "The Member States will be responsible for evaluating the applications for approval of active substances or Union authorisation of biocidal products. They will either act in the role of an evaluating competent authority or present their view when the evaluation report prepared by one Member State is assessed by the others," explains Mr Kenigswald. Each Member State can nominate one member to the Biocidal Products Committee.
To ensure that the applicant is able to estimate the required processing time of their application, the regulation gives strict deadlines for each step of the process.
'Be on the list or out of the market'
The regulation also aims to increase the equal treatment of the different active substance suppliers with the obligation that every company on the market must contribute to the costs of the application.
"If you are not on the list of approved active substance suppliers by 1 September 2015 you are out of market," Mr Kenigswald emphasises. This is good news for the companies who have until now taken the economic burden alone for getting an active substance approved while other companies may have been marketing the same substance in Europe without having made any contribution.
New ways to authorise products
After 1 September 2013, a biocidal product can only be sold in the EU after its active substance has been approved and the product itself has been authorised. "For companies interested in more than one national market, the new regulation provides alternatives to the existing process of national authorisation followed by individual national mutual recognitions," says Mr Kenigswald.
Union authorisation opens the whole EU market in one go. On the other hand, for companies only interested in a limited number of national markets, the mutual recognition in parallel gives the possibility to start the authorisation process in all chosen Member States at the same time.
Mr Kenigswald also mentions another new possibility for product authorisation, which supports one of the main goals of the regulation: ensuring a high level of protection for human health and the environment.
"To encourage the applicants to use only the safest active substances in their products, the regulation introduces a simplified authorisation that is faster and requires less supporting data".
1 September 2013
Biocidal Products Regulation enters into operation and the first list of approved suppliers is published
1 September 2013
Union authorisation is available for all products containing a new active substance, as well as for product-types 1, 3, 4, 5, 18 and 19
1 September 2015
All active substance suppliers must be on the list of approved suppliers in order to stay on market
1 January 2017
Union authorisation available for product-types 2, 6 and 13
1 January 2020
Union authorisation available for remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22
The product-types and their descriptions are in Annex V of the Regulation.
Interview by Päivi Jokiniemi
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)