The regulation n°528/2012 on biocidal products aims at improving the functioning of the market of biocidal products within the European Union, while guaranteeing a high level of protection of the human health and the environment. Thus, all biocidal products destined to be put on the market require an authorisation and the active substances they contain have to be approved beforehand. There are 3 big families of authorisations (transitory, provisional and long-term). EcoMundo details the different types of “long-term” marketing authorisations. 

Les différents types d'AMM biocides

The biocidal marketing authorisation

The authorisation for biocidal products is issued at a national or European level. Marketing authorisation (MA) applications can only be submitted for biocidal products containing active substances on the “positive lists” or those in the process of being assessed.

Companies wishing to apply for marketing authorisation for a product must submit an MA application in the country in which they wish to market the product, using the European Register for Biocidal Products platform (R4BP). The submission of the dossier has to be done before the approval date of the active substance.

The application dossier must include all the information enabling an assessment of the efficacy of the product for all of the intended uses, as well as the risks for humans and the environment linked to its use.

The different types of biocidal Marketing Authorisations

The Union Authorisation

Union authorisation allows applicants to place their biocidal products or family products on the European market, without requiring a specific national authorisation. Union authorisation gives all Member States the same rights and obligations than those received by national authorisations.

This authorisation is applicable to biocidal products containing new Active Substances (ASs) or to biocidal products containing existing ASs, according to the product types (PTs).

National MA and Mutual Recognitions

National Authorisation

The applicant submits his application to the competent authority of the country in which he wishes to sell his product. The Member State (MS) evaluates the application and decides on the authorisation within 365 days.

National authorisation can then be recognised by other Member States via a request for mutual recognition in sequence or in parallel.

Authorisation length:

 
Biocidal product (BP) Max 10 years, according to Article 17, paragraph 4
BP containing ASs which are candidates for substitution Max 5 years
BP containing new ASs Max 3 years, according to Article 55, paragraph 2
 

NB: These lengths are the same ones for both Union MAs and National MAs.

Mutual Recognition
  • In sequence

It can only be requested once the national authorisation is granted in a reference Member State. The applicant then submits a translation of the national authorisation in the official languages requested by the Member States concerned.

  • In parallel (or simultaneaously)

It is the process that consists in submitting a national authorisation application to the reference MS by indicating the list of all MS’ concerned. The reference MS assesses the application at the same time as the concerned MS’ assess the mutual recognition application.

NB: The mutual recognition process will take approximately 5 months from the validation of the application by the evaluating competent authority.

Simplified MA

It is possible to submit an authorisation application via the simplified authorisation process, if the AS meets the criteria stated in Article 25.

Once the authorisation has been granted in one Member State, the biocidal product may be made available on the market, in another Member State, after this one has been notified, at least 30 days before placing the product on the market.

MA of a "same" biocidal product

Marketing authorisation of the same biocidal product is possible only if:

  • the reference biocidal product is authorised in a Member State or in the European Union
  • the reference biocidal product is identical to the product you want to market

Therefore, an application for the same biocidal product may be filed with the Member State or ECHA in order to allow the product you want to place on the market in the Member State or in the European market.

Parallel trade MA

Under section 53 of the BPR, it is understood that: if a Biocidal Product (1) is authorised in the Member State of origin and that if a Biocidal Product (2) which is the reference product is authorised in a MS (2) and if it is determined that the biocidal product 1 is identical to Biocidal Product 2, then a parallel trade authorisation request can be filed at the MS 2 in order to allow the biocidal product 1 there.

The competent authority of MS 2 grants parallel trade authorisation within 60 days after payment of the fees.

Want to know more about MAs?

 

For more information on biocidal products, do not hesitate to contact our expert Mr. Fang Zhou by phone : +33 1 83 64 20 54 for Europe, or +1 (778) 234 1607 if you are calling from North America or by email at [email protected]

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