EUROPEAN COMMISSION
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 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:
Application of BPR procedures to applications for product
authorisation submitted under the BPD regime and on which a
decision has not been taken by 1 September 2013
1 - Background and purpose of the document
(1)
Article 91 of the Biocidal Products Regulation (BPR) on transitional measures
concerning applications for biocidal product authorisations submitted under
Directive 98/8/EC, mentions that those applications submitted under the Biocidal
Products Directive (BPD) for which the evaluation has not been completed by
1 September 2013, shall be evaluated in accordance with that Directive.
(2)
Certain elements of Article 91, in particular the meaning of 'evaluation', is a
matter of interpretation. This note proposes an interpretation aimed at providing
Member States, ECHA and the Commission with a workable way forward for the
implementation of BPR, while fully respecting the interests and legitimate
expectations of applicants.
2 - Proposed way forward:
(3)
Firstly, regarding the conditions to be met for the product to be authorised, it is
the Commission services understanding that:

If the product contains a substance meeting the exclusion criteria, the
conditions for authorisation are those laid down in Article 19 and Article
23 of the BPR, and the principles laid down in Annex VI to the BPR
should be taken into account to evaluate the product;
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
If the product contains a substance meeting the substitution criteria but not
the exclusion criteria, the conditions for authorisation are those laid down
in Article 5 of the BPD and Article 23 of the BPR, and the principles laid
down in Annex VI of the BPD should be taken into account to evaluate
the product;

If the product does not contain a substance meeting the substitution or
exclusion criteria, the conditions for authorisation are those laid down in
Article 5 of the BPD, and the principles laid down in Annex VI to the
BPD should be taken into account to evaluate the product.1
(4)
However, concerning the procedures to be followed (e.g. the timelines, the
involvement of the coordination group), Article 91 leaves some room for
interpretation as to whether the procedures should be those laid down in the BPD
or those of the BPR
(5)
Thus, considering that:
(a)
It is a common goal for the Commission services and the Competent
Authorities of MSs to facilitate a smooth transition between the BPD and
BPR;
(b)
In the interest of pragmatism and the best use of the available resources,
operating two different, parallel decision making procedures, one under
BPD and one under BPR would be highly complicated in practice;
(c)
The provisions of Article 91 can be interpreted as referring to the
"evaluation" of the dossier submitted by the applicant and not to the
procedural aspects which are related to the different product authorisation
procedures (Articles 26, 29, 30, 33 and 34 of the BPR);
(d)
The logic of the existing practice under BPD for conflict resolution applies
to the conflict resolution provisions of BPR. A parallel operating system
on the basis of notifications in accordance with Article 4(4) of the BPD
being managed by the Commission and referrals to the Coordination
Group in accordance with Article 35 of the BPR being managed by ECHA
would provide no added value;
(e)
The BPR procedures add no additional constraints for applicants compared
with the existing practices under BPD
the Commission services would interpret 'evaluation' as only referring to the
criteria and principles to be taken into account.
1
For the purposes of facilitating the implementation of this paragraph, a list containing information on
the exclusion and substitution criteria agreed in document CA-March14-Doc.4.1-Final (Principles for
taking decisions on the approval of active substances under the BPR) that are met by actives substances
on which an approval decision has been taken will be made available on Circabc and periodically
updated by ECHA (see document CA-March14-Doc.4.4).
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(6)
Secondly, as the BPD (and in many cases presumably also the national legislation
transposing the BPD) has been repealed, the legal basis to authorise these
products should be Article 19 in combination with Article 91 of the BPR, and the
format of the authorisations to be granted to these products should be the one laid
down in Article 22 of the BPR.
In addition, it is important to note that, without prejudice to Article 23(6) or 23(4)
of the BPR, authorisations should be granted for a maximum period of 10 years,
and should no longer be constrained by the expiry date of the active substance, as
was the case under the BPD.
(7)
Therefore, it is proposed to read Article 91 of the BPR as meaning that the BPR
procedures apply for product authorisation and conflict resolution to applications
for product authorisation submitted under the BPD regime, on which a decision
has not been taken by 1 September 2013.
3 - Practical implementation:
(8)
Considering the different roles that Member States may play in the process and
whether the RefMS has already granted or not the first authorisation, the
following paragraphs detail how this proposal should be implemented.
(9)
The proposed approach aims at achieving a smooth transition to the BPR
procedures whilst minimising the impact for MSs and applicants in terms of
deadlines for product authorisation or handling of the applications through
R4BP2. Thus, overall, no major changes to the current practice are proposed in
order to facilitate that transition.
3.1 - Timelines for all MS
(10)
Under the BPD the deadlines for Member States to grant, amend or cancel
product authorisations were laid down in the inclusion Directives.
(11)
However, as the Directive has been repealed, the new deadline for product
authorisation is the one established by Article 89(3) of the BPR.
(12)
As the Commission has proposed to amend Article 89(3) of the BPR2, the period
available to Member States to grant, amend or cancel product authorisations is
likely to be extended from 2 to 3 years, so that MS would have a more realistic
timeframe to complete the exercise under the BPR.
3.2 - Handling of applications by the RefMS
2
COM(2013) 288 final.
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(13)
The practice under the BPD as well as Article 30 of the BPR foresee that the
evaluation shall be done within 365 days and that, where necessary, the clock
could be stopped for a period of up to 180 days.
(14)
It is therefore proposed that the RefMS should continue to carry out their
evaluations with the objective to come to a conclusion within 365 days of the start
of the evaluation.
(15)
It is also proposed that upon completion of its evaluation, and unless the applicant
objects to it, the RefMS should treat a pending application submitted to several
Member States as one subject to mutual recognition in parallel. In other words,
the RefMS would not directly take a decision on the authorisation, but would
transmit to the other CMSs its assessment report (AR) and SPC3, as per the
provisions of Article 34(4) second paragraph of the BPR.
Where a RefMS has not received any objection from the CMSs within the 90 days
referred to in paragraph 17(c), the RefMS can grant the product authorisation in
its territory.
(16)
By derogation from the above, where the remaining period of time to comply with
the deadline for product authorisation in a RefMS is less than 4 months, the
RefMS can decide to grant the product authorisation in its territory4.
3.3 - Handling of applications by the CMS(s)
(17)
Where the RefMS
1 September 2013:
a.
transmits
its
assessment
report
and
SPC
after
Within 15 days of the making available of the AR and draft SPC by the
RefMS, the CMSs have, where relevant, to inform the applicant of:
i. the fees payable in accordance with the relevant national
legislation. A CMS could reject the application if the applicant
fails to pay the fees within 30 days.
ii. the relevant documents that shall be submitted in accordance with
the so-called "step 2" of the application for MR under the BPD5.
3
See paragraph 24. To support the implementation of this provision, a new procedural step was created
in the R4BP2. In addition, an automatic warning e-mail is now sent to the CMSs to inform them of the
making available of the AR and draft SPC, which triggers the start the 45-day acceptance phase to be
followed by the 90-day period to accept or not the conclusions of the RefMS.
4
In those cases, the pending applications for MR in the CMSs will be treated as a MR in sequence (see
paragraph 18).
5
As referred to in Annex II to "Notes for guidance to applicants for product authorisation and mutual
recognition" (CA-Sept12-Doc.6.2.a –Final.Rev2 -28/01/2013).
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b.
Upon receipt of the fees and the relevant documents mentioned above, the
CMSs shall accept the application, and set a common date of acceptance
by day 45 after the making available of the AR and draft SPC by the
RefMS.
c.
The CMS(s) should send any comment or objection on the AR and draft
SPC6 within 90 days of the date of acceptance.
d.
Those CMSs that can agree on the draft SPC proposed by the RefMS may
authorise the product accordingly, as provided for by Article 34(7) of the
BPR, within 30 days7 of agreeing with the draft SPC.
A more detailed description of the different steps is available in section A of
Annex II.
This approach has to be followed by the CMSs which have received an
incomplete application for mutual recognition, and which had put it on hold until
they would have received the copy of the first authorisation or any other
documents necessary for the acceptance of the application in those CMSs.
Those CMSs which have received an intention to submit an application for
mutual recognition after the first authorisation will have been granted should
decide either to follow this approach or the procedure for the mutual recognition
in sequence (see below).
(18)
Where the RefMS grants the first authorisation after the 1 September without
prior transmission to the CMS(s) in accordance with paragraph 15 above8:
(a)
Upon acceptance of the original application for mutual recognition, the
CMS(s) should send to the RefMS any comment or objection on the
authorisation within 90 days of the date of acceptance.
(b)
For the purpose of the acceptance mentioned above, the CMSs are entitled
to request the applicant to submit the documents that were expected to
submitted in accordance with the so-called "step 2" of the MR application
under the BPD5.
(c)
CMS(s) that can agree on the SPC of the authorisation granted by RefMS
may authorise the product accordingly, as provided for by Article 33(3) of
the BPR, within 309 days of agreeing on the SPC.
6
The draft SPC shall be produced according to the agreed template at EU level (document CA-Feb13Doc.5.1.b.a – Final) and in an editable format allowing further amendments. In accordance with
document CA-Sept13-Doc.6.2.d – Final, the draft SPC can be submitted in English.
7
As a result, the authorisation will be granted within 120 days of the submission of the draft SPC by the
RefMS, which is the same period of time as provided under the BPD.
8
This scenario covers the cases referred to in paragraph 16 and those where the CMS had received an
intention to submit an application for mutual recognition after the first authorisation will have been
granted and that CMS decided to follow the procedure for the mutual recognition in sequence.
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A more detailed description of the different steps is available in in section B
Annex II.
(19)
Where the RefMS has already granted the first authorisation on 1 September
2013:
(a)
All CMSs shall mutually recognise the authorisation within 120 days of
the acceptance of the original application for mutual recognition.
3.4 - Settlement of disagreements
(20)
It is proposed that where a CMS:
(a)
cannot agree with the draft SPC proposed by RefMS as described in
paragraph 17, or
(b)
cannot mutually recognise the authorisation granted by the RefMS as
described in paragraphs 18 or 19,
the points of disagreement shall be referred without delay to the coordination
group in accordance with Article 35(2) of the BPR. Articles 35(3) and 36 of that
Regulation will apply.
It is suggested that, in any event, if a CMS does not react within the 90-day
period, it would still be entitled to refer the matter to the coordination Group in
accordance with Article 35(2) of the BPR at a later stage.
3.5 Derogation from mutual recognition
(21)
Derogations from mutual recognition will be handled in accordance to the
procedure laid down in Article 37 of the BPR.
(22)
However, concerning the substantive grounds for possible derogations, these
would have to be those of the BPD, unless the product contains a substance
meeting the exclusion criteria, in which case the BPR would apply in full.
3.6 -IT tools
9
As a result, the authorisation will be granted within 120 days of the acceptance of the original
application for MR, which is the same period of time as provided under the BPD.
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(23)
R4BP2 will be modified in the short term to introduce the following procedural
step to allow RefMS and CMSs to proceed as per the proposal:
Assessment report and SPC made available by RefMS
(24)
In addition, an email notification will be automatically sent from R4BP2 to all
CMSs whenever the status of an application would be changed in R4BP2 by the
RefMS to 'Assessment report and SPC made available by RefMS', so that no
CMS – following the MR procedure in parallel - misses this change. This
notification will trigger the start of the 45-day acceptance phase followed by the
90-day period to agree on the SPC.
(25)
RefMSs will therefore be expected to post their draft assessment report and draft
SPC on R4BP2 and to update the status of the application to 'Assessment report
and SPC made available by RefMS'. Alternatively, and until R4BP2 has been
modified, documents could be made available by e-mail or other means to the
CMS(s).
(26)
On the other hand, CMSs will be free to inform the RefMS of their concerns or
agreement either by using R4BP2 or by any other means.
(27)
Finally, decisions taken by MSs shall be uploaded in R4BP2. They should include
an SPC in accordance with Article 22(2) of the BPR. Until further notice from
ECHA on the tool that they will use to manage SPCs, the SPC can continue to be
uploaded on R4BP2 in PDF. MSs are therefore no longer expected to file in the
dedicated fields made available in R4BP2, but to instead upload a PDF document.
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Annex I
Decision tree
Did the RefMS already take decision on 1 September 2013?
Yes
No
RefMS to send AR and
draft SPC to CMSs
before taking a decision
CMS to recognise decision
within 120 days of the
acceptance of the original
application for MR
CMS to agree on draft SPC
within 90 days10 of receipt
of documents in accordance
with Article 34(5) of BPR
for MR in parallel
If applicant objects or the deadline for
product authorisation in the RefMS is
less than 4 months, RefMS grants the
authorisation
CMS to agree on SPC within
90 days10 of acceptance of
application in accordance
with Article 33(2) of BPR for
MR in sequence
If, disagreement
No
Yes
No
Yes
Coordination group to agree
within 60 days10
Yes
No
Commission to take a
decision
All MS to take decision
within 30 days in
accordance with Articles
33(3), 34(6) or 36(4) of BPR
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10
For applications covered by Article 91, these deadlines have to be considered as an objective to be met.
Annex II
A.- Handling of applications for MR treated as MR in parallel:
1.- The RefMS makes available the AR and draft BPR-compliant SPC (it could be in
EN) through the R4BP2. The R4BP2 will send an automatic e-mail notification to all
the CMSs informing that:
- the AR and draft SPC have been made available by the RefMS (day 0).
- the notification triggers the start of the 45-day acceptance phase by CMSs,
- followed by the 90-day MR phase referred to in paragraph 17(c).
2.- Within 15 days of the making available of the AR and draft SPC by the RefMS,
the CMSs have to inform the applicant of:
- the fees payable in accordance with the relevant national legislation. A CMS
could reject the application if the applicant fails to pay the fees within 30 days.
- the relevant documents that were expected to be submitted in accordance with
the so-called "step 2" of the MR application under the BPD referred to in Annex
II to "Notes for guidance to applicants for product authorisation and mutual
recognition"11. For example:
o
o
o
o
Summary dossier
LoA(s).
Draft/models of the labels, leaflets, etc.
Product’s SDS
3.- Upon receipt of the fees and the relevant documents mentioned above, the CMSs
shall accept the application.
For CMSs which accept the application, the date of acceptance will be set on day 45
after the making available of the AR and draft SPC by the RefMS to ensure that the
next step is handled in parallel for all CMSs having accepted the application.
For CMSs which cannot accept the application within 45 days but it is not rejected,
the application will have to be handled as a MRS.
4.- Where the application is considered as accepted by day 45, the 90-day period
referred to in paragraph 17(c) will start. Within that period, CMSs should send to the
RefMS any comment or objection on the AR and draft SPC and have to agree with
the draft SPC made available by the RefMS.
5.- Within the 30-day period referred to in paragraph 17(d) applicants will have to
submit the translations of the agreed SPC to CMSs as indicated in document CASept13-Doc.6.2.d – Final and CMSs to grant a BPR type product authorisation with a
BPR-compliant SPC in accordance with paragraph 27.
11
CA-Sept12-Doc.6.2.a –Final.Rev2 -28/01/2013.
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B.- Handling of applications for MR treated as MR in sequence:
1.- For the purpose of the acceptance by CMSs of the original application for MR as
referred to in paragraph 18(a), the following elements have to be provided by the
applicant within two months of the granting of the authorisation by the RefMS in
accordance with the "Notes for guidance to applicants for product authorisation and
mutual recognition"11:
a) The translation of the original authorisation in the RefMS. As this authorisation
has been granted after 1st September 2013, there should be a BPR-compliant SPC in
an editable format (it could be in EN if MRS is applied for several MSs). If not, the
applicant has to generate it as for applications for MRS according to Article 33(1) of
the BPR.
b) The relevant documents for each CMS referred to in Annex II to "Notes for
guidance to applicants for product authorisation and mutual recognition"11. For
example:
- Summary dossier
- LoA(s).
- Draft/models of the labels, leaflets, etc.
- Product’s SDS
Note: As the AR is already available in the R4BP2, no resubmission is needed.
2.- When these documents have been received by the CMSs and the fees payable in
accordance with the relevant national legislation have been paid, the application is
accepted and the 90-day period referred to in paragraph 18(a) starts.
3.- Within that 90-day period, the CMSs have to agree with the BPR-compliant SPC
already included in the RefMS authorisation or provided by the applicant. Where the
BPR-compliant SPC is generated by the applicant, the CMS will have to check the
accuracy of the applicants' proposal with regard to the existing BPD-SPC of the
RefMS and the C&L of the product, which is available in the AR.
4.- Where relevant, applicants will have to submit the translations of the agreed SPC
to CMSs in accordance with document CA-Sept13-Doc.6.2.d - Final.
5.- Within the 30-day period referred to in paragraph 18(c) and in accordance with
paragraph 27, the CMSs have to grant a BPR type product authorisation with a BPRcompliant SPC.
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