Substance active existante
The Review Programme is the name commonly used for the work programme for the examination of existing biocidal active substances contained in biocidal products. The programme was set up by the European Commission under the Biocidal Products Directive (BPD) and continues under the Biocidal Products Regulation (BPR).
Existing active substances are those substances which were on the market on 14 May 2000 as an active substance of a biocidal product (for purposes other than scientific or product and process-orientated research and development). The existing active substances which were accepted to be examined in the Review Programme were those which were identified as such and for which a notification was accepted, as set out in Annex II to Commission Regulation (EC) No 1451/2007.
The detailed rules for the Review Programme have been adapted to the provisions of the BPR in the new Review Programme Regulation (EU) No 1062/2014, which repeals and replaces Commission Regulation (EC) No 1451/2007.
The transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012 allow biocidal products containing an active substance included in the Review Programme (for a given product-type) to be made available on the market and used, subject to national rules, until three years after the date of their approval (shorter timeframes apply in case of non-approval).
In Annex II part 1 of the Review Programme Regulation, the active substances which are under evaluation are listed.
In addition, the Review Programme Regulation adapts the processes for the evaluation of a dossier to align them to those described in the BPR for new active substances or in Regulation (EU) No 88/2014 for the amendment of Annex I.
Furthermore, the Review Programme Regulation provides a defined role for ECHA and sets out procedures on how to join or replace a participant in the Review Programme by mutual agreement, how to withdraw as a participant, how to take over the role of participant in certain situations and introduces the possibility to add substance/PT combinations to the Review Programme, under certain conditions.
The Review Programme is foreseen to be completed by 2024.
Changes of elements of the Review Programme
Joining or replacing participants by mutual agreement
A prospective participant in the Review Programme may join or replace an existing participant by mutual agreement, provided that:
- the existing participant agrees, and;
- the prospective participant has the right to refer to all the data that the existing participant referred to or submitted to the evaluating competent authority.
In this respect, an application for joining or replacing of a participant(s) (PA-CHG) must be submitted through R4BP 3.
If the submission is successful, the Agency will update the information in R4BP 3 with respect to the identity of the participant. The new participant(s) will also be added to the Article 95 list.
Participants may withdraw from the Review Programme by informing the Agency through R4BP 4 of their intention to withdraw. Participants will also be considered to have withdrawn where they fail to submit the approval application in time, the application is rejected, they fail to provide requested additional information or fail to pay the applicable fees in time.
A notification for withdrawal of participant(s) must be submitted through R4BP 3 (case type PA-CHG).
Where the withdrawal is made before the evaluating competent authority submits its competent authority report to the applicant for final comments, it is considered as a "timely withdrawal".
Following a "timely withdrawal", the Agency will update the information in R4BP 3 with respect to the identity of the participants and the Article 95 list will be updated accordingly.
Where a biocidal product covered by the scope of the BPR and being placed on the market consists of, contains or generates an existing active substance which is neither approved, nor already included in the Review Programme for the product-type, and is not included in Annex I to the BPR, that substance is eligible for inclusion into the Review Programme if it falls into one of these three groups:
- the person placing the product on the market has relied on guidance published by, or written advice received from the 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 the BPR or that the relevant product-type was one for which the active substance had been notified and that guidance or advice has been subsequently reviewed in a decision adopted pursuant to Article 3(3) of the BPR or in newer authoritative guidance published by the Commission.
- the substance has benefitted under Regulation (EC) No 1451/2007 from the derogation for food and feed;
- under the BPR, the biocidal product belongs to a different product-type than the one it belonged to under the BPD, as a result of a modification of scope of the product-types, and contains a substance included in the Review Programme for the original product-type but not the new one.
If the substance falls into one of the above categories, any person can declare an interest to notify the eligible substance/PT combination with the intention to have the substance included into the Review Programme for this product-type.
For category a) the declaration of interest must contain a substantiated justification showing that the conditions are fulfilled.
The declaration of interest must be submitted within specific deadlines:
For category a):within 12 months of a published Commission Decision or guidance clarifying that the product falls under the scope of the BPR.
For categories for b) and c): by 30 October 2015 (12 months after entry into force of Regulation (EU) No 1062/2014).
For categories a) and c), the substance/product-type combination will be considered as already notified by a participant if 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, and the participant who has submitted that dossier indicates an interest to support the substance/product-type combination.
Any declaration of interest made under Regulation (EU) No 1062/2014 will be checked against these conditions by the Commission, in consultation with the Member States.
A declaration of interest might be submitted through R4BP 3 (case type DI-SUB).
Furthermore, following a successful declaration of interest (i.e. confirmed as meeting the conditions) the substance/product-type combination is to be published on ECHA's website. Within 6 months from the date of this publication any person with an interest to notify the active substance/PT combination must do so through R4BP 3 in IUCLID format.
The transitional measures described in Article 21 of Regulation (EU) No 1062/2014 apply to active substances belonging to this category.
Substances where all the participants withdraw
If all participants supporting the same substance/product-type combination have made a timely withdrawal, and the role of the participant for that combination has not previously been taken over, the Agency will publish an open invitation for taking over the role of the participant for that substance/product-type combination.
This possibility to take over the role of the participant is given only if it was not already given in the past and if ECHA has not already begun working on its opinion.
A prospective participant needs to notify through R4BP 3 in IUCLID format within 12 months from the date of the ECHA publication of the open invitation.
Substances with a redefined identity
Where the evaluation of an active substance demonstrates that it does not exactly match the identity of the substance as included in the Review Programme (Part 1 of Annex II of the Review Programme Regulation) such that the evaluation does not allow conclusions to be drawn relating to the substance identity included in the Review Programme, the substance identity will be redefined by the evaluating competent authority (after consultation with the participant). The substance will continue to be evaluated in the Review Programme (for the relevant product-types) under the newly defined substance identity.
The Agency will publish an open invitation to make a notification to take over the role of the participant for the former substance identity (as included in Part 1 of Annex II of the Review Programme Regulation).
N.B.: The possibility to notify does not cover the new substance identity.
A prospective participant needs to notify through R4BP 3 with a dossier in IUCLID format within 12 months from the date of the ECHA publication of the open invitation.
Active substances redefined to specify the precursor and in situ generation system combinations covered
The Commission in consultation with Member States and participants has redefined the identity of active substances included in the Review Programme which can be generated in situ. This measure has been taken to describe more consistently the precursors and in situ active substance generation combinations covered by the existing entries in the Review Programme. The newly redefined entries will replace the old entries in the list of substances in the Review Programme and consequently, in the list of active substances and suppliers (Article 95 list).
Due to this redefinition exercise, any person (for example, manufacturers of precursors generating the same active substances with different generation methods or precursor systems) will have the possibility to make a notification to take over the role of participant for the active substances corresponding to the formerly included identities.
For this specific situation, the same requirements and timelines apply as mentioned above for the general case: notification within 12 months from the date of the ECHA publication of the open invitation.
Substances which are no longer supported at the date of entry into force of Regulation (EU) 1062/2014 (listed in Annex II part 2)
The substance/product-type combinations listed in Annex II part 2 of Regulation (EU) No 1062/2014 were, at the time of the entry into force of this regulation, not supported by any participant in the Review Programme.
Notifications to support these substance/product-type combinations need to be submitted by 30 October 2015 (i.e. within 12 months from the entry into force of Regulation (EU) No 1062/2014).
Notifications can also be submitted for nanomaterial forms of the substance/product-type combinations listed in Annex II part 2, for nanomaterial forms of the substance/product-type combinations already supported in the Review Programme, and for nanomaterials for approved substance/product-type combinations, unless the original substance name specifically mentions "nanomaterials" as for example silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) and silicon dioxide (as a nanomaterial formed by aggregates and agglomerates).
If no notification is made by 30 October 2015, or if the notification is rejected by the Agency, a non-approval decision will be taken by the European Commission on the active substance/product-type combinations and nanomaterials and the entries will be removed from the Review Programme.
Substances where all the participants have withdrawn
Substances with a redefined identity
The identity of the substances listed in the table below has been redefined and accordingly new notifications for the former identity are invited from potential participants by the applicable deadline.
The identity of active substances originally included in the Review Programme which can be generated in situ have been redefined to specify the active substance/precursor combinations presently covered (active substance x generated from precursor y). The table below (fourth column) is a non-exhaustive list of the active substances included in the Review Programme which can be generated in situ and for which new notifications can be made. Please note that notifications are only possible for precursor combinations not already covered by the new identity.
The information contained in the table derives from Competent Authority Meeting document "substance generated in situ".
- Commissions CA paper [DOC]
Please note that the redefinition of the identity of the active substances which can be generated in situ is not yet reflected in the biocides IT tools R4BP 3 and the SPC editor and on the ECHA dissemination website. The substance identities are foreseen to be updated in R4BP 3 and the SPC editor in due time.
To ensure that no substance is unduly maintained or included in the Review Programme without subsequently being evaluated, interested companies have twelve months to make a notification of essential data regarding the substance. Once the notification is declared compliant by ECHA, a participant has two years to submit an application.
The fee to be paid to the Agency per notification of a substance/product-type(s) combination is 10 000 Euros, according to the Fee Regulation (EU) No 564/2013. This fee will be deducted from the application fee for approval of the active substance/product-type combination.
The following table lists the substance/product-type combinations notified for inclusion in the review programme for which ECHA has issued a declaration of compliance in accordance with Article 17(5) of the Review Programme Regulation (EU) No 1062/2014), together with the name of the notifying company (“participant” in accordance with Article 2(c) of the Review Programme Regulation).
The list includes notifications made for redefined active substances, substance/ product-type combinations in part 2 of Annex II to the Review Programme Regulation, substances where previous participants made a timely withdrawal, substances that previously benefitted from the food & feed derogation, substances where the product-type was modified under the BPR compared to the BPD. The list will be updated regularly.
Companies are encouraged to collaborate to submit the application for approval of the active substance where appropriate, in particular to minimise testing on animals. The active substance approval application must be submitted by the participants within 2 years of the relevant notification compliance decision (in accordance with Article 3(2) of the Review Programme Regulation).
The active substance/product-type combinations will be added to the Article 95 list of relevant substances and suppliers when the complete substance dossier is submitted and validated by the evaluating Competent Authority.