What is the Transitional Period?

Biocidal Products (BP) containing Active Substance (AS) under evaluation in the review program are all in Transitional Period. Their marketing is governed by the Directive 98/8, previous national laws, which is now replaced by Biocide Regulation 528/2012. Once the date of approval of the AS/PT (Product Type) couple is approved, the Transitional Period is over and the Long-term Period begins, during which authorisations must match the Regulation's requirements. If the AS/PT couple is not approved at an European level the biocidal product must be withdrawn after the date specified in the decision of non inclusion.

 
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Transitional Authorisation Application

Marketing procedures, costs and evaluation time in Transitional Period are specific to each country and may be different depending on the product types.

Marketing a product during Transitional Period may be automatic, after a simple notification to the country. The authorisation issue may be refused or it may depend on costs and time.

Keep in mind that complementary notifications specific to each country may be required for the biocidal product marketing, such as a declaration to anti-poison centers. Overall, these are also required during Long-term period.

What do I do when the Transitional Period expires?

The marketing Transitional Authorisation, allows a biocidal product to be placed on a market until the AS/PT approval. After this time, a Long-term Authorisation is necessary, otherwise the product must be withdrawn from the market.

To obtain a Long-term Authorisation, a new authorisation matching the regulation requirements is needed to keep marketing your product. The Authorisation Dossier is then run by the regulation 528/2012 requirements, and is harmonised to every European states.

NB: The regulation is a community law that is applied to every European state member. The regulation enables to have a harmonised procedure for all European countries. This is regulation spirit, coming with application guidelines. However, the directive must be implemented by the state itself. The state is then free to choose the means to implement it within a prescribed time. To obtain a transitional Authorisation the dossier is more or less big according to different countries. It depends on if the country asks for an authorisation dossier or a notification (like in France). Items to be supplied within the dossier are imposed by each country.

Careful: a product authorised or notified during the transitional period should be subject to another authorisation dossier to be marketed in the Long-term Period.