Evaluation process for the amendment of Annex I

The evaluation process starts when an application for amendment of Annex I to the BPR is considered to be valid by the evaluating competent authority. The evaluating competent authority has 180 days in the case of applications for categories 1, 2, 3, 4 and 5 and 365 days in the case of applications for category 6 to assess the application and provide its conclusion to ECHA.

During the evaluation process, the applicant may be requested to provide additional information if the evaluating competent authority considers that more information is necessary. 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.

If an application concerning the inclusion of an active substance in categories 1, 2, 3, 4 or 5 of Annex I of the BPR following a request for additional information, complies fully with a dossier containing a data package allowing a full risk assessment for the intended use, the applicant can request to be included in category 6 of the Annex I instead and that its dossier be evaluated accordingly.

Steps

The evaluation process has the following steps:

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The evaluating competent authority carries out the dossier evaluation.

 
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The evaluating competent authority prepares the draft assessment report and the conclusions of its evaluation.

 
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The draft assessment report is sent to the applicant through R4BP 3. The applicant has 30 days to provide written comments. The evaluating competent authority takes due account of those comments when finalising its evaluation.

 
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The assessment report is transmitted through R4BP 3 to ECHA for peer review in the Biocidal Products Committee (BPC).

 
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The BPC has 180 days in the case of an application for categories 1, 2, 3, 4 and 5 and 270 days in the case of an application for category 6 to deliver an opinion through a peer review assessment and to submit this opinion to the Commission.

 
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The Commission takes a decision on the applicant's request to amend Annex I to  BPR.

 

Actors

The main actors in the evaluation process are:

Applicants

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 on the draft report of their dossier during the process.

ECHA

ECHA coordinates the inclusion process and provides the necessary tools and support for the applicants. ECHA also provides the Secretariat for the Biocidal Products Committee.

Biocidal Products Committee (BPC)

The Biocidal Products Committee gives a scientific opinion on active substances (approval, renewal, review, inclusion in Annex I), Union authorisation of biocidal products and mutual recognition. The Committee also deals with scientific and technical matters and other questions at the request of the European Commission and the Member States. The Committee consists of members appointed by EU Member States and EEA countries on the basis of their experience.

Evaluating competent authorities

The evaluating competent authority is responsible for carrying out the evaluation of the applications. The evaluating competent authority is chosen by the applicant.

European Commission

Provided that there is evidence that an active substance does not give rise to concern within the meaning of Article 28(1) of the BPR, the European Commission together with the Standing Committee on biocidal products, takes into consideration the opinion issued by the BPC (including opinions concerning existing and new active substances) and decides whether to amend Annex I to the BPR or not. The Standing Committee is chaired by the Commission and has representatives from all Member States. Whenever the Commission amends Annex I it must adopt a separate delegated act in respect of each substance.


 

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