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it's all about biocides
Things to know about the authorisation of biocidal products within the EU / EEA :
All biocidal products have to be approved before placing them on the market in Europe or in the European Economic Area, as also the active substances of these products.
The european regulation on biocidal products ( BPR, Regulation (EU) No. 528/2012 ) regulates the authorization processes, placing on the market and the use of biocidal products which are used to protect humans, animals and materials from harmful organisms such as bacteria and pests.
The aim of the BPR is to harmonize the authorization of active substances and the approval processes, placing on the market and use of biocidal products, as well as seting deadlines for evaluations, the preparation of opinions and uniform decision-making by the member states. In addition, the mandatory data sharing and the use of alternative test methods laid down in the regulation are intended should help to reduce the number of animal experiments.
What types of authorisations are available?
This kind of authorisation is valid for a biocidal product or a biocidal product family in the Member State in which the authorisation was applied for.
If marketability in other Member States should be given, an application for mutual recognition can be submitted. A simplified approval procedure is available for this, in which the detailed evaluation of the product / product family by the Member State that issued the previous national approval is taken into account.
A valid authorisation of a biocidal product or a biocidal product family in all EU countries will be given after successfull evaulation of the dossier.
Products whose active ingredients are listed in Annex I of the BPR regulation can be approved by using simplified procedure. This process applies to products i.e. which do not contain any substances of concern.
Approval of product families:
A biocidal product family is a group of biocidal products that are used for the same purpose and contain active substances with the same classifications. The formulations of the products in a biocidal product family can have specified deviations which however, must neither increase the risk potential nor reduce the effectiveness of the products. All products of a biocidal product family are covered by a single authorisation process according to the BPR.
Approval of the same biocidal product / product family:
Regulation 414/2013 (amended by Regulation 2016/1802) enables simplified authorization instead of extensive authorization. It is possible to apply for approval for a single product that is identical to another allready approved product ("reference product") or for which the application has already been submitted.
The reference product can be an individual product or a product from a biocidal product family.
It is possible to apply for a national authorisation with a reference product that has been authorised by union authorisation process or for which a union authorisation process is running.
An application for authorisation for the same biocidal product family (Union authorisation, national or simplified authorisation) is also possible.
The authorisation procedure for a same biocidal product leads to an independent authorisation with the same expiry date as the reference product (or the reference product family).
The approval is given under its own approval number and can be changed or deleted independently of the reference product.
Sounds complicated, but it is not!
We offer you a knowledge-oriented organizational management through the necessary approval processes so that you can become competitive and marketable withyour products.
“Knowledge” is one of the key terms in the world today.
Everyone wants it, everyone needs it and everyone thinks they have it.
Especially in the area of biocidal product approval under the BPR, knowledge and experience are important core issues.
Together we will coordinate the scope, costs and kind of authorisation, of the required measures individually for your company and your products because your approvals should be as unique as your company and your goals.
With DESICON step by step ..... up to product authorisation.
