Authorisation of Biocidal Products

Successful achievement of authorisations for your biocidal products

The Biocidal Products Regulation (EU) No 528/2012 replaced the previous Directive 98/8/EC on 1 September 2013. There are several important amendments, in particular concerning the authorisation of biocidal products.

Biocidal products are generally formulations of one or more active substances together with other components. The intention of the biocidal product is to destroy, deter, render harmless, preventing the action of, or otherwise control harmful organisms by any means other than mere physical or mechanical action.

The Biocidal Products Regulation foresees different methods for authorisation of biocidal products. One criteria is its hazard potential. Biocidal products containing non-hazardous active substances and co-formulants may be authorised by a simplified procedure. On the contrary, biocidal products that fulfil specific criteria of concern may be authorised only for reduced periods of time and shall be substituted over time. Several biocidal products containing very same specifications may be authorised as a biocidal product family. An authorisation is possible in principle at national and European level, latter though not for all product-types and now.

Important for formulators of biocidal products is the status of the active substance. Are so called new active substances used, i.e. those that were not already placed on the market before 14 May 2000, they must be approved first and then the biocidal product shall be authorised before placing it on the market.

Existing active substances have to be notified, that is, they must have been included in Annex II to Regulation (EC) No 1451/2007. These active substances are currently being evaluated by the competent authorities as part of an existing active substance review program. During this time, biocidal products containing these active substances may be marketed without approval. After the decision on the approval of an active substance, two years remain until the inclusion in the Union list of approved active substances and until the complete biocidal product dossier should be submitted. A large uncertainty results here from an extension of the review program expected to last until 2024. On the approval or non-approval of an active substance may be decided at any time during this period and in addition in case of approval two years is a rather limited time for the creation of a product dossier.

By changing the definition of biocidal products in-situ active substances are now subject to the Biocidal Products Regulation, which were not previously covered by the Biocides Directive. Both, substances that are generated in-situ from corresponding devices, as well as precursors that generate in-situ agents are considered as biocidal products and require therefore an authorisation. Thus, users of these systems are now subject to obligation under the new regulation, which were previously excluded.

The range of our services in order to achieve the successful authorisation of your biocidal products can be found here.

We at Prosacon support you with:

  • Development of suitable and efficient implementation strategies
  • Portfolio analysis
  • Dossier creation for your application for a biocidal product authorisation
  • Dossier creation for your application of approval of an active substance
  • Support in the communication with competent authorities within your piocidal products authorisation
Target groups:

  • Manufacturers / importers of biocidal active substances
  • Manufacturers / formulators of biocidal products
  • Users of biocidal products
  • Purchasers of drugs or other substances fully formulated biocidal
  • Producers to process the drugs or other substances to produce biocidal
  • Seller of biocidal products
  • Users of biocidal products
  • The product safety experts, the regulatory issues have been discussed and implemented for biocidal function called carrier