Evaluation process for union authorisation
Once the evaluating competent authority has validated the application for the Union authorisation of a biocidal product (or a biocidal product family), the evaluation process starts. The evaluating competent authority has 365 days to assess the application and provide its assessment report and conclusions to ECHA.
This graph shows an overview of the dossier evaluation process
If the evaluating competent authority considers that additional information is necessary to carry out the evaluation, it can request this from the applicant. The applicant has to provide the requested information within 180 days unless a delay is justified by the nature of the data requested or by exceptional circumstances.
Union authorisation process has the following steps:
The evaluating competent authority carries out the dossier evaluation.
The evaluating competent authority finalises the draft assessment report and the conclusions of its evaluation.
The draft assessment report is sent to the applicant through R4BP 3. The applicant has 30 days to provide written comments.
The assessment report and the summary of product characteristics are transmitted through R4BP 3 to ECHA for peer review in the Biocidal Products Committee (BPC).
The Biocidal Product Committee has 180 days to deliver an opinion through a peer review assessment and to submit this opinion to the Commission.
The Commission takes a decision on the authorisation of a biocidal product at Union level.
For those biocidal products containing one or more active substances that are candidates for substitution, the Biocidal Products Regulation foresees a comparative assessment being performed as part of the evaluation process.
As a result of the comparative assessment, the Commission should prohibit or restrict a biocidal product containing active substances identified as candidates for substitution. This applies when it is demonstrated that other authorised biocidal products (or non-chemical control or prevention methods) that present a significantly lower overall risk for human health, animal health and the environment, are sufficiently effective and present no other significant economic or practical disadvantages. An authorisation for biocidal products containing candidates for substitution can be granted for a maximum period of five years.
The main actors in the evaluation process are:
Applicants are responsible for providing all necessary information in their dossiers. They should pay attention to the various deadlines throughout the process. Applicants have the possibility to comment the draft assessment report on their dossier during the process.
Applicants also need to provide a translation of the summary of biocidal product characteristics in the 22 official EU languages.
The ECHA Secretariat facilitates the Biocidal Products Committee's (BPC) work by providing technical and scientific support. ECHA submits the summary of biocidal product characteristics to the Commission in all official EU languages 30 days after the submission of the opinion.
Biocidal Products Committee (BPC)
The BPC delivers an opinion on the authorisation of the biocidal product within 180 days.
Evaluating competent authority
The evaluating competent authority is responsible for carrying out the evaluation of the dossiers submitted by the applicants. The evaluating competent authority has 365 days to evaluate a dossier. It can, however request additional information from the applicant who has a defined number of days to provide it, normally 180 days. The time given to the applicant for providing the additional information extends the 365-day evaluation period.
The European Commission, assisted by the Standing Committee on Biocidal Products, takes the opinion issued by the BPC into consideration and decides whether to grant a Union authorisation or not. The Standing Committee on Biocidal Products consists of representatives of the Member States.