DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A–Green economy
ENV.A.3 - Chemicals
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 forbiocidal 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:Harmonised approach to the consideration of the expiry dates of new product authorisations linked to other authorisations through certain authorisation procedures
1.-Background and purpose of the document
(1)At CG-5a member of the Coordination Group raised the issue of harmonising the expiry dates when authorisations are granted in accordance with different authorisation procedures (e.g. mutual recognition in sequence, the same biocidal product, etc.)[1].
(2)This paper addresses this issue by setting a harmonised approach between Member States (MSs) with a view to facilitate the renewal procedure of product authorisations.
2.- Relevant provisions in the BPR and implementing legislation
(3)Article 17(4) of the BPR mentions that an authorisation shall be granted for a maximum period of 10 years.
(4)Article 19(1)(a) of the BPR establishes that for biocidal products - other than those eligible for the simplified authorisation procedure in accordance with Article 25 - shall be authorised provided that the active substances are approved for the relevant product-type and any conditions specified for those active substances are met.
(5)Article 23(6) of the BPR sets that notwithstanding Article 17(4), and without prejudice to Article23(4), an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years.
(6)Article 23(4) of the BPR mentions that, by way of derogation from Article 23(1), a biocidal product containing an active substance that is a candidate for substitution may be authorised for a period of up to four years without comparative assessment in exceptional cases where it is necessary to acquire experience first through using that product in practice.
(7)Article 91 of the BPR sets that, where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 10 is met, the biocidal product shall be authorised in accordance with Article 23.
(8)Article 7 of Regulation 414/2013 (the SBP Regulation) establishes that:
(a)A SBP shall have a different authorisation number than that of the related reference product, but on all other aspects (e.g. expiry date), the content of the authorisation of a same product shall be identical with that of the related reference product except in terms of the information in respect of which the products differ.
(b)Authorisations of a same product or of a related reference product may be changed or cancelled independently of each other. However, the receiving competent authority or, where relevant, the Agency in the evaluation of a proposed change of a same product or of a related reference product, shall consider the appropriateness of cancelling or amending the authorisation of other products to which the product is linked in the Register for Biocidal Products.
(9)Regulation 492/2014 (the MR renewal Regulation) establishes the principle that in order to avoid unnecessary duplication of work and to ensure consistency, renewal of authorisations having been subject to mutual recognition having, apart from limited exceptions, the same terms and conditions in all the MSs at the time of the application for renewal, shall follow the procedure set by that Regulation.
3.- Agreed way forward[2]
3.1.- First authorisations:
(10)For first authorisations granted under the BPR regime, the validity of product authorisations can be up to a maximum of ten years from the date when the authorisation is delivered in accordance with Article 17(4) of the BPR, except wherethe product contains a substance that fulfils the substitution criteria[3].
(11)It has to be noted that under the BPR, the validity of first authorisations are no longer linked to the expiry date of the active substance approval as under the BPD. Hence the maximum period of 10 years can go beyond the original validity of the active substance approval.
(12)However, in accordance with Article 19(1)(a) of the BPR, the product authorisation will only be valid provided that the active substance approval remains valid (e.g. renewed in due time or extended by the Commission in accordance with Article 14(5) of the BPR). Should the approval of the substance cease to be valid or be more restrictive, CAs shall cancel or amend the authorisation in accordance with Article 48(1)(a) of the BPR.
(13)Where the product contains a substance fulfilling the substitution criteria, the product can be authorised up to a maximum of 5 years in accordance with Article 23(6) of the BPR, unless the product is authorised in accordance with Article 23(4) of the BPR for a maximum period of 4 years.
3.2.-Authorisations granted through mutual recognition:
(14)3.2.1.- Mutual recognition of first authorisations granted under the BPR:
(15)Authorisations granted by the CMSs should have the same expiry date that the authorisation which is mutually recognised with a view to facilitate the renewal procedure in accordance with the MR renewal Regulation.
(16)3.2.2.- Mutual recognition in sequence of first authorisations granted under the BPD:
(17)Authorisations granted by the CMSs should have the same expiry date that the authorisation which is mutually recognised[4],[5].
(18)Where the product contains a substance fulfilling the substitution criteria, the product can be authorised up to a maximum of 5 years in accordance with Article 23(6) of the BPR, unless the product is authorised in accordance with Article 23(4) of the BPR for a maximum period of 4 years.
(19)For a given product containing a substance meeting the substitution criteria and in order to enable the renewal process in accordance with the MR renewal Regulationboth in those MSs having authorised the product through MR in sequence under the BPR (e.g. only for 4/5 years) and those having authorised the product under the BPD until the expiry date of the active substance approval, authorisation holders(AH) are invited to apply for renewal of the product authorisations in all the MSs 550 day before the earliest expiry date in the CMSshaving authorised the product under the BPR[6].By following this approach, work duplication both for MSs and Industry would be avoided and there would be a harmonised renewal date for the future in all the MSswhere the product is authorised.
(20)Specific case: anticoagulant rodenticides authorised after 1st September 2013 would however benefit of the specific provisions agreed under document CA-July13-Doc.11.3 – Final, provided that the first authorisation granted by the RefMSremains valid (i.e. either by renewal in due time or by extension of the initial authorisation in accordance with Article 31(7) of the BPR).
3.3.- Same biocidal product authorisations granted by MSs:
(21)3.3.1.- SBP authorisations of reference products authorised under the BPR:
(22)SBP authorisationsshall have the same expiry date that the authorisation of the reference product.
(23)The coincidence in time of the renewal of the reference product and of the SBP would significantlyfacilitate the assessment of the application for renewal of the latest[7].
(24)3.3.2.- SBP authorisations of reference products authorised under the BPD:
(25)SBP authorisations shall have the same expiry date that the reference product[8],[9].
(26)Where the SBP contains a substance fulfilling the substitution criteria, the product can be authorised up to a maximum of 5 years in accordance with Article 23(6) of the BPR, unless the product is authorised in accordance with Article 23(4) of the BPR for a maximum period of 4 years.
(27)For products containing a substance meeting the substitution criteriaand in line with the provisions in Article 7(2) of the SBP Regulation on changes of same products, where the renewal of the SBP authorisation takes place before the renewal of the reference product and it raises any significant issue, the receiving CA shall consider the appropriateness of cancelling or amending the authorisation of the linked reference product before its renewal in accordance with Article 48 of the BPR.
3.4.- Changes to existingnational authorisations:
(28)Product authorisations for which an application for a change has been agreed by the receiving CA should maintain the same expiry date of the authorisation subject to that change.
Annex 1
Section 3.1.- First authorisations (to be) granted under the BPR
Normal case: maximum 10 years
Article 23(6): maximum 5 years
Article 23(4): max. 4 years
Section 3.2.- Authorisations granted through mutual recognition:
3.2.1.- Mutual recognition of first authorisations granted under the BPR:
Normal case:
RefMS: maximum 10 years
CMSs - MR in parallel
CMSs - MR in sequence
Application for renewal
Where the active substance is a candidate for substitution:
Article 23(6): RefMS: maximum 5 years
CMSs – MR in parallel
CMSs – MR in sequence
Application for renewal
Article 23(4): RefMS maximum 4 years
CMSs – MR in parallel
CMSs – MR in sequence
Application for renewal
3.2.2.- Mutual recognition in sequence of first authorisations granted under the BPD:
Normal case:
RefMS' validity date
CMSs
Application for renewal
Where the active substance is a candidate for substitution:
RefMS' validity date
Article 23(6): CMSs: maximum 5 years
Article 23(4): CMSs: maximum 4 years
Application for renewal
Section3.3.- Same biocidal product authorisations granted by MSs:
3.3.1.- SBP authorisations of reference products authorised under the BPR:
Normal case:
Reference product: maximum 10 years
SBP-1
SBP-2
Application for renewal
Where the active substance is a candidate for substitution:
Article 23(6): Reference product: maximum 5 years
SBP-1
SBP-2
Application for renewal
Article 23(4): Reference product: maximum 4 years
SBP-1
SBP-2
Application for renewal
3.3.2.- SBP authorisations of reference products authorised under the BPD:
Normal case:
Reference product's validity date
SBP-1
SBP-2
SBP-3
Application for renewal
Where the active substance is a candidate for substitution:
Reference product's validity date
Article 23(6): SBP maximum 5 years
Article 23(4): SBP maximum 4 years
Application for renewal
1/9
[1]Document CG-5-2014-4.
[2]See explanatory scheme in Annex 1.
[3]This applies both to new applications for product authorisation submitted under the BPR and to applications subject to Article 91 of the BPR already submitted under the BPD.
[4]It has to be noted that late applications for MR in sequence with regard to the expiry date of the first authorisation will be confronted to an early application for renewal soon after the authorisation in the CMS or even immediately after where the authorisation is granted after the date triggering the application for renewal of the first authorisation in the RefMS(i.e. 550 days before the expiry date).
[5]As a particular case, authorisations of anticoagulant rodenticides to be granted through MR in sequence would however benefit of the specific provisions agreed under document CA-July13-Doc.11.3 – Final (e.g. authorised for 4 years, even if the 4 years go beyond the current expiry date of the first authorisation. In any case, future renewals will be harmonised with regard to 31/08/2020).
[6]Where an applicant decides to only apply for renewal in the MS where the product was just authorised for 4/5 years, the application will be based on Article 31 of the BPR and not on the MR renewal Regulation. In that case, the receiving CA has not the responsibility of checking the status of the application for renewal in the other MSs.It should be also noted that, where the outcome of the renewal in that MS leads to some restrictions in the authorisation or to a non-renewal decision, the AH shall notify this without delay to the other MSs where the product is authorised and ECHA in accordance with article 47(1) of the BPR. In accordance with Article 47(3) second paragraph, those MSs shall examine whether the authorisation needs to be amended or cancelled in accordance with article 48 of the BPR.
[7]It has to be noted that the renewal of SBP authorisations issubject to provisions in Articles 31 and 45 of the BPR, for thosegranted by MSs and the Commission, respectively.
[8]It has to be noted that late applications for SBP with regard to the expiry date of the reference product will be confronted to an early application for renewal soon after the authorisation of the SBPor even immediately after if the SBP authorisation is granted after the date triggering the application for renewal of the reference product (i.e. 550 days before the expiry date).
[9]As a particular case, SBP authorisations of anticoagulant rodenticides would however benefit of the specific provisions agreed under document CA-July13-Doc.11.3 – Final (e.g. authorised for 4 years, even if the 4 years go beyond the expiry date of the reference product. In any case, future renewals will be harmonised with regard to 31/08/2020).