Product Authorisation

Simplified Authorisation

Where certain conditions are met, and the handling of the biocidal product can be established to present a low risk to human health and the environment, the applicant can benefit from a simplified authorisation procedure. Products eligible for this procedure will fulfil the following criteria:

  • all active substances appear in Annex I of the BPR;
  • the biocidal product does not contain any substances of concern*;
  • the biocidal product does not contain any nanomaterials;
  • the biocidal product is sufficiently effective; and
  • the handling of the biocidal product and its intended use do not require personal protective equipment (PPE).

*Substances of concern are those non-active substances which are: classified as hazardous under the DSD or CLP, and lead to the classification of the mixture as hazardous; or meeting the criteria for being a POP, PBT or vPvB substance.

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Annex I lists low-toxicity substances about which sufficient information on inherent hazard is known, for example carbon dioxide or lavender oil. It is not to be confused with Annex I to the previous Biocidal Products Directive which listed approved active substances (low-toxicity substances were listed in Annex IA to the BPD). Whilst there are currently fewer than 20 active substances which, when incorporated into biocidal products, qualify that product for the simplified authorisation procedure; additional substances may be added to Annex I where there is sufficient evidence that they too do not give rise to concern.

Read Annex I >

The key distinction between an application for authorisation of a biocidal product meeting the above criteria, and a standard National or Union authorisation, is that a dossier or letter of access for the biocidal product and active substances is not required. The applicant does, however, still have to submit to ECHA through R4BP:

  • a summary of the biocidal product characteristics in accordance with Article 22;

  • efficacy data; and

  • other data as required to provide evidence of the criteria listed above

Once a simplified authorisation has been granted to an organisation they may make the product available on the market throughout the European Union, without the need for mutual recognition from Member States other than that of the evaluating authority. They must, however, notify via R4BP each Member State 30 days before placing the substance on their market and must label according to the official language of that Member State.