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Active substance eligible for inclusion in the biocides active substance review programme

This page outlines the notification process for an active substance that is eligible for inclusion in the biocides active substance review programme under Article 15 of the Review Regulation (Regulation (EU) No 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR).

Introduction

As the scope of the EU Biocides Regulation 528/2012 (EU BPR) is different in some aspects from the Biocidal Products Directive (BPD), the EU BPR Review Regulation (Regulation (EU) No 1062/2014) allows for an active substance to be included into the review programme.
This process only applies to active substances that weren’t included in the review programme previously for certain specific reasons:

The UK CAs understanding of the declaration and notification process under Articles 15 to 19 of the EU Review Regulation are explained below.

Eligibility criteria

Article 15 of the EU Biocides Regulation (EU BPR) Review Regulation states that an active substance shall be eligible for inclusion in the review programme for the relevant product type on any of the following grounds:

Declaration of interest to notify

If an active substance meets one of the eligibility criteria listed in points (a) to (c) of Article 15 (as outlined above) and someone would like to support it for review they must declare their interest via R4BP. The deadline for declare their interest depends on which eligibility criteria in Article 15 they meet. In case referred to in point

  1. of Article 15 at the latest 12 months after the publication of the decision under Article 3 (3) of the EU BPR or guidance published from the EU Commission;
  2. of Article 15 at the latest 30 October 2015;
  3. of Article 15 at the latest 30 October 2015.

Each declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) of Article 15, the declaration shall provide a substantiated justification showing that all the conditions listed are fulfilled.

In cases referred to in points (a) and (c) of Article 15, an active substance/product-type combination shall be considered as notified by a participant, and shall not be eligible for additional notification where the following conditions apply:

Acceptance and publication of declarations

Declaration submitted via R4BP will be considered by the EU Commission and the European Chemicals Agency (ECHA) and once accepted ECHA shall make that information publicly available by electronic means, mentioning the relevant substance/product-type combination.

Within 6 months from the date of a publication any person with an interest to notify the substance/product-type combination may do so.

Notification

Within 6 months from the date of a publication of the declaration by ECHA any person may submit via R4BP an application to support the active substance/product-type combination they are interested in.

The application must be in IUCLID format and must contain the following information.

Where there isn’t an evaluating competent authority listed in Annex II of the EU BPR Review Regulation for the active substance (e.g. active substance isn’t listed as being evaluated by a competent authority for a different product type) the applicant should include the details of the competent authority they would like to evaluate their dossier and provide evidence that the competent authority agrees to do so.

Fees and ECHA verification

Upon receipt of the application ECHA will inform the notifier of the fees payable to ECHA and these fees must be paid with 30 days. If the ECHA fees aren’t paid, ECHA will reject the notification.

If the ECHA fees are paid, ECHA will verify within 30 days that notification has been submitted in the correct format and contains all the required information.

Where the notification hasn’t been submitted in the correct format and/or doesn’t contains all the required information the notifier will be give 30 days to complete or correct the notification. After the expiry of the 30 days to complete or correct the notification ECHA will declare the notification complete or reject it and inform the EU Commission.

Accepted notification

The EU Commission will include the active substance/product type combination in the review programme upon receipt of the confirmation from ECHA that the notification is complete. The notifier must apply to ECHA for approval under EU BPR or for inclusion in Annex I to EU BPR of the active substance/product type combination within two years of this date. The process for submitting and evaluating these dossier applications can be found in Article 3 to 9 of the Review Regulation. ECHA and the Competent Authority will change the relevant fees for evaluating the dossier.

Rejected notification/notification not submitted

ECHA will publish details of the active substance/product type combinations where no notification is received within the time limit referred to in Article 16 (5) of the Review Regulation, or where a notification has been submitted and subsequently rejected.

Biocidal products containing these active substance/product type combinations can be

Updated 2015-11-19