Active substance eligible for inclusion in the biocides active substance review programme
Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
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).
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:
- due to incorrect advice from the EU Commission or Competent Authority;
- it benefited from a food and feed derogation in the Fifth Review Regulation; and/or
- due to change of the scope of the product type.
The UK CAs understanding of the declaration and notification process under Articles 15 to 19 of the EU Review Regulation are explained below.
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:
- the person placing the product on the market has relied on guidance published by, or written advice received from, the EU Commission or a Competent Authority, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of the BPD or of the EU BPR, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of EU BPR or in new guidance published by the Commission;
- the active substance benefited from the derogation for food and feed provided for by Article 6 of the BPD Fifth Review Regulation (Regulation (EC) No 1451/2007);
- the biocidal product belongs under a different EU BPR product-type than the one it belonged to under BPD, as a result of a modification of scope of those product-types, and contains a substance included in the review programme for the original BPD product-type but not for the new one under the EU BPR.
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
- 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;
- of Article 15 at the latest 30 October 2015;
- 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:
- the relevant active substance is already included in the review programme;
- one of the dossiers submitted to the evaluating Member State for the relevant active substance already contains all the data required for the evaluation of the product-type;
- the participant which has submitted that dossier indicates an interest to support the substance/product-type combination.
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.
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.
- evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of EU BPR i.e. the substance’ were on the market on 14 May 2000 as an active substance in a biocidal product;
- an indication of the product-type(s) concerned by the notification;
- information on any studies that have been commissioned for the purpose of application for Approval under EU BPR or for inclusion in Annex I to EU BPR, as well as the expected date of completion;
- the information referred to in Sections
- 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to EU BPR for chemical substances;
- 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to EU BPR for micro-organisms;
- where the notification has been made in a case referred to in point (a) of Article 15 of the Review Regulation, evidence that the substance was on the market as an active substance of a biocidal product falling under the relevant product-type on the date of notification or publication of the decision or guidance referred to in that point.
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.
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
- made available on the UK market for 12 months; and
- existing stocks of the biocidal product may used in the UK for 18 months after the date of publication that the notification wasn’t received or the notification has been rejected.