HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
Pesticides and Biocides
Note for Guidance
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with all or a majority of the Member States' Competent Authorities for biocidal products. Please note,however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:Provisions of Article 55(2) of the BPR on provisional authorisations
1.- Background and purpose of the document
(1)ECHA helpdesk received several questions regarding the provisions of Article 55(2)[1] of the BPR on provisional authorisations, in particular whether mutual recognition of provisional national authorisationswould bepossible.
(2)How to convert a provisional authorisation to a definitive one upon formal approval of the new active substance (AS) has also been raised in that context.
(3)This paper addresses thesequestions.
2.- Discussion points and agreed way forward
2.1.- Submission of applications
(4)The provisions of Article 55(2) are silent with regard toapplication routesand data requirements. Hence, theseshall be the same as for any other biocidal product, the only notable difference being that the newAS is not yet approved.
(5)The application for product authorisation - which may result in a provisional authorisation - can therefore be submitted:
a)at any time after - including in parallel to - the submission of the application for approval of the new AS;
b)by any person – and not only the one that submitted the application for the new active substance approval – provided that the relevant data or LoA is submitted within the application[2];
c)for the authorisation of any biocidal products containing such a new AS, and not only for the reference product accompanying the new AS dossier;
d)and in accordance with:
- Article 29, when the product is to be initially placed on only one Member State market[3]; otherwise in accordance with
- Article 43, where the conditions in Article 42(1) concerning the eligible PTs and similar conditions of use across the Union are met; or with
- Article 34 (MR in parallel), when the products is to be initially placed on more than one Member State market[4].
Regarding the later, it is important to note that, if this option was not open to applicant, this would lead to a situation where several CAs would evaluate applications relating to the same biocidal product, which would be in contradiction with both Articles 29(2)(b) and (4).
(6)Whatever application route is chosen by the applicant, where the application is submitted to:
(a)the same evaluating CA (eCA) responsible for the assessment of the new AS dossier[5], it can be submitted in parallel to the submission of the application for approval of the new AS.
(b)Another receiving CA, it can be only submitted once the eCA responsible for the assessment of the new AS dossierhas submitted to ECHA a recommendation for approval of the new AS.
(7)It has to be noted that the wording in Article 55(2) does not exclude that the provisional authorisation can be granted to a biocidal product containing, in addition to a new AS, one or more approved[6] existing ASs. However, Article 55(2) is not applicable to a biocidal product containing, in addition to a new AS, one or more existing ASsstill under evaluation in the review programme. In this case, once the new AS is approved and until the last of the existing AS contained in the product is approved, the provisions in Article 89(2)(b) of the BPR would apply andthe product can be placed on the market in accordance with MSs national rules[7].
(8)Finally, it is also important to recall that where the new AS is suspected to meet the exclusion criteria as laid down in Article 5(1), the eCA will not be in the position to recommend the approval of the AS. As a consequence, products containing a new AS that is expected to meet the exclusion criteria would not be eligible for a provisional authorisation under Article 55(2).
2.2.- Assessment of applications
(9)As applications, which may result in provisional authorisations, will have been submitted in accordance with Article 29, 34 or 43, and should have complied with the requirements laid down in Article 20, the eCA would be expected to carry out an assessment of the applicationin accordance with Annex VI. This assessment shall be conclusive enough to confirm that the product fulfils the conditions laid down in Article 19, but the formal approval of the new AS.
(10)Where the new AS (or where relevant, any approved existing substances contained in the product)meets the substitution criteria other than criterion (a) in Article 10(1), the eCA would have to consider whether a comparative assessment in accordance with Article 23 of the BPRmight have to be carried out.
(11)Taking into account that the product to be provisionally authorised contains a new AS and that experience should be acquired first through using that product in practice, as an exceptional case,the product could be authorised without comparative assessment in accordance with Article 23(4) for a period of 3 years only.
2.3- Extension of a provisional authorisation
(12)In accordancewith Article 55(2), subparagraph 4 of the BPR, where a decision on the approval of the new AS has not yet been adopted by the Commission when the 3-year period expires, CAshaving granted a provisional authorisation, or the Commission, may extend such anauthorisation for a period not exceeding one year.
(13)For the purpose of such an extension, the authorising MSs or where relevant, the Commission,willamend on its own initiative the expiry date of the provisional authorisation decision and the R4BP asset accordingly (i.e. without requiring any specific application from the authorisation holder).
(14)It has to be noted that the product authorisation resulting from such an extension will still be considered as provisional, as it cannot be converted into a definitive one until the new AS is approved.
2.4- Conversion from provisional to definitive authorisations
(15)Upon formal approval of the new ASand, where possible,at least 550 days before the expiry date of the provisional authorisation, the authorisation holder will have to submit to those MSs having provisionally authorised the productor where relevant, to the Agency, an application for renewal in accordance with:
(a)Article 31of the BPR, for purely national authorisations,
(b)Regulation EU No 492/2014, for authorisations subject to MRthat are eligible for such a procedure,
(c)Article 45 of the BPR, for authorisations granted by the Commission.
(16)In the context of the renewal procedure, the eCA will be able to:
(a)assess any relevant data required under Article 20 of the BPR that might have been generated since the provisional authorisation, in particular to address any specific condition included in the approval of the new AS,
(b)where relevant, carry out a comparative assessment in accordance with Article 23 of the BPR.
(17)Unless otherwise indicated by the assessment to be carried out under paragraph 16, the eCA should in principle decide that a full evaluation of the application is not necessary. In so doing, a conclusion on the renewal of the provisional authorisation, as definitive, could be reached within shorter timelines.
(18)The authorising MSs or where relevant the Commission,shallrenew theauthorisation for a period upto 10 years from the date of renewal, unless the product contains an AS meeting the substitution criteria listed in Article 10(1)[8].
Annex 1. Relevant legal provisions in the BPR
Article 55(2)
By way of derogation from point (a) of Article 19(1) and until an active substance is approved, competent authorities and the Commission may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.
Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for approval of the new active substance and the competent authorities which received the application for the provisional authorisation or, in the case of a provisional Union authorisation, the Agency, consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).
If the Commission decides not to approve the new active substance, the competent authorities which granted the provisional authorisation or the Commission shall cancel that authorisation.
Where a decision on the approval of the new active substance has not yet been adopted by the Commission when the period of three years expires, the competent authorities which granted the provisional authorisation, or the Commission, may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2). Competent authorities which extend the provisional authorisation shall inform the other competent authorities and the Commission of such action.
Article 29
[…]
2. Within 30 days of acceptance, the receiving competent authority shall validate the application if it complies with the following requirements:
(a) the relevant information referred to in Article 20 has been submitted; and
(b) the applicant states that it has not applied to any other competent authority for a national authorisation for the same biocidal product for the same use(s).
In the context of the validation referred to in the first subparagraph, the receiving competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
[…]
4. Where the Register for Biocidal Products referred to in Article 71 shows that a competent authority other than the receiving competent authority is examining an application relating to the same biocidal product or has already authorised the same biocidal product, the receiving competent authority shall decline to evaluate the application. In that event, the receiving competent authority shall inform the applicant of the possibility of seeking mutual recognition in accordance with Article 33 or 34.
1/6
[1]See the relevant legal provisions in the BPR in Annex I to this document.
[2]Where anapplicant submits a LoA or his own data for a different source of the new AS, astechnical equivalence cannot be established against an approved reference source, chemical similarity should be established beforehand by ECHA and confirmation of it is included in the application for product authorisation.
[3]An application for national authorisation in one single MS followed by a MR in sequence would be also possible where the spread to other markets is decided at a later stage.
[4]Where relevant, articles 35, 36 and 37 of the BPR will apply.
[5]In case of mutual recognition,the application has to be submitted to the eCA as the reference Member State.
[6]With the exception of a silent AS (e.g. in-can preservatives), as per document CA-Sept13-Doc.6.2.b Rev.1 on Authorisation under the BPR of products containing more than one existing active substance or belonging to more than one product-type.
[7]MSs should ensure that the national rules have been adapted to this new provision resulting from the BPR amendment.
[8]Where the product contains an AS meeting the substitution criteria, the renewal of the authorisation shall be limited to 5 yearsin accordance with Article 23(6).