CA-May13-Doc.8.3
Review programme of active substances: Establishment of a work programme to meet the 2024 deadline
1. Purpose of the document
During the 50th CA meeting of February 2013, the Commission services presented a document in order to discuss the progression of the review programme of existing active substances, proposed some priorities and a way forward.
Discussions took also place during the 1st Meeting of the Biocidal Product Committee (BPC), and it was asked to Member States to submit their current plans concerning the submission of the draft competent authority reports on each substance / product type combination for which they are nominated as rapporteur.
Taking into account these discussions, received comments as well as current plans of Member States (see Appendix 1 to this document), the Commission intends to adopt the following way forward.
2. Organisation of the review programme of active substances
As presented at the last CA meeting, around 430 dossiers are still under examination under the review programme. The overall objective is to finish this review programme by the end of 2024.
Taking into account this objective, the workload that can realistically be handled by the BPC, and other elements that needs to be taken into account in setting priorities (see Point 3 of the document "CA-Feb13-Doc.8.3 - Review programme of AS.doc"), the Commission services proposes to organise the review of existing active substances by establishing legally binding deadlines for the submission of draft CARs in function of their product types, as well as deadlines for ECHA to deliver its opinions in relation to these products types.
The following deadlines are therefore proposed:
Priority / Existing active substances for product types / Deadline for submission of all draft CARs to ECHA / Deadline for ECHA to deliver its opinions1st priority list / 8, 14, 16, 18, 19, 21 / 31/12/2014 / 30/09/2015
2nd priority list / 3, 4, 5 / 31/12/2016 / 30/09/2017
3rd priority list / 1, 2 / 31/12/2018 / 30/09/2019
4th priority list / 6, 13 / 31/12/2019 / 30/09/2020
5th priority list / 7, 9, 10 / 31/12/2020 / 30/09/2021
6th priority list / 11 / 31/12/2022 / 30/09/2023
7th priority list / 12,15,17, 22, 23 (new PT20 under BPR) / 31/12/2023 / 30/09/2024
The choice of this work programme, as well as setting priorities on some PTs compared to other PTs, has been made on the basis of the following justifications:
(1) in relation with the financial programme of ECHA, and the objective to finish the review programme by the end of 2024, a minimum of 50 opinions per year must be taken by the BPC each year on existing active substances.
(2) around 150 to 200 draft CARs will be available and will have to be processed by the BPC as from 1st January 2014, as a "backlog". Draft CARs are still expected to be submitted by Member States over the next years according to their own plans (see Appendix 1). As the BPC is not expected to be able to deliver 150 to 200 opinions in 2014, nor be able to cope with the remaining backlog at each beginning of the year (as this backlog would still be above 50 draft CARs at each beginning of the year), priorities need to be set.
(3) it is appropriate to discuss at same time all active substances supported for the same PT, in order to ensure efficient and consistent discussions in the BPC, as well as decisions in the Standing Committee.
(4) it is necessary to ensure that products placed on the market for the same PT will be subject to the authorisation scheme in the same time window, which will also ensure a better competition on the market as well as improving the possibility to prepare consistent comparative assessments according to article 23 of the BPR, when needed.
(5) this PTs phasing reflects the phasing set for the submission of existing active substance dossiers according to article 9(2) of regulation 1451/2007, and the possibility given progressively to companies to apply for Union authorisation according to article 42(1) of the BPR.
(6) PTs were grouped together in function of a technical relevance, in order that discussions on a PT can be beneficial to the other PTs of the same list. For instance, active substances supported for PT 1, 2, 3, 4, 5 are often the same; AS for PT7,9,10 are often the same and have often similar issues and borderlines between each other etc….
(7) PTs were also grouped taking into account the workload for the BPC, which is directly linked to the number of CARs and opinions that will have to be processed for these PTs by the BPC. For instance, around 129 opinions need to be delivered on active substances supported for PT3,4 and 5, which would correspond to around 2 year of work of the BPC assuming a minimum of 50 opinions on existing active substances delivered per year by the BPC (see Appendix 2 of this document).
These timings will be set in the new review regulation that will replace Regulation (EC) No 1451/2007.
It is important to note that these dates are deadlines: MS shall continue to submit their draft CARs as they progress on them taking into account these priorities and the general principles presented in section 3. These deadlines shall therefore not prevent MS to send their CAR, nor the BPC to deliver its opinions before: if the majority of CARs are submitted just before the specified deadline, it would indeed create a workload impossible to manage for the BPC.
This system would have the benefit to leave some flexibility for the adjustment of the organisation of the BPC (ie. if the BPC can process more opinions per year, if the BPC finalises discussions on substances for a PT well before the deadline etc…), while setting some priorities in the review programme and ensuring that decisions would have been taken on all substances for a PT by a certain date, and that the review programme is finished by the end of 2024.
It shall also be noted that the efficiency of the BPC will to a great extent rely on the work that can be achieved by the members of the BPC, and resources allocated to that work.
In addition, every effort shall be made by Rapporteur Member States in order to finalise the discussions on their CARs which are already available and present in the "backlog". This is particularly important for substances supported for the "1st priority list"(PT8/18/19/21) on which the BPC shall work in 2014-2015.
Finally, new active substances shall be processed as a priority, whatever the product-type(s) for which the substance is supported. The BPC will have 9 months to deliver an opinion as from the date of submission of the draft CARs by the Rapporteur Member State.
3. general principles for the review of existing and new active substances
The Commission proposes that the following general principles shall now apply:
(1) Deadlines in the various procedures shall be applied more strictly by each party. In particular, appropriate deadlines shall be given to applicants when they are requested to submit additional information, and in case no good justification is given concerning delays of submission, the RMS shall continue the evaluation on the basis of the current data, or apply more strictly the provisions of article 14(3) 2nd subparagraph of Regulation (EC) n°1451/2007[1], which might eventually lead to a non-approval of the active substance. More flexibility could be given by Member States on new active substances, as such substance cannot access the EU market until a decision has been taken on its approval.
(2) As from today, draft CARs on existing active substances shall from now on only be submitted if the harmonised C&L, and/or PBT/vPvB (including whether 2 out of 3 of the PBT criteria are met) status have been established by ECHA's Risk Assessment Committee, and or PBT Expert Group, when needed. It will be requested that ECHA refuses any new draft CAR if this condition has not been fulfilled. Such strict approach would ensure that sensitive discussions on properties that can take time and have consequences on the decision making (ex: exclusion, substitution etc.) have been sorted out in order to ensure that ECHA can indeed deliver an opinion in its timeframe. In addition, taking into account the proposed work plan, Member States should have sufficient time to fulfil that condition before delivering draft CARs. ECHA will ensure coordination with the RAC and the PBT Expert Group to achieve the progress of the work programme.
(3) For draft CARs on existing active substances already submitted to ECHA (around 150 draft CARs), Member States shall send as soon as possible to ECHA the appropriate dossiers in order to establish the harmonised classifications and the PBT status where relevant. Contrary to new draft CARs, this will nevertheless not delay the review of the concerned substances by the BPC.
(4) On new active substances, Rapporteur Member States shall send the harmonised C&L dossier or the P/B/T dossiers (including whether 2 out of 3 of the PBT criteria are met) to ECHA as soon as possible after they have finalised their hazard evaluation, and at the latest when they submit their draft CAR to ECHA. Contrary to new draft CARs on existing active substances, this will nevertheless not delay the review of the concerned substances by the BPC. ECHA secretariat, Member States, ECHA's RAC or PBT Expert Group shall nevertheless make every effort to coordinate the progression of the review on the substance in the biocides framework and these other frameworks.
(5) On multiple dossiers[2], only combined draft CARs shall from now on be submitted by RMSs, in order to avoid several discussions on the same AS/PT, and in order for ECHA's BPC to deliver an opinion on an assessment taking into consideration all data available. In case separate CARs are submitted, no discussion would take on an AS/PT combination if all related CARs are not available.
(6) Once the BPC starts to work on a draft CAR, the BPC will have 9 months to deliver its opinion.
In the 50th CA meeting, other proposals were made, for instance concerning the format the assessment report or the obligation to have a validation of the BPC before asking for further information in a dossier : the discussions on these proposals are left to the BPC.
4. Work programme for 2013, 2014, 2015 and 2016
For 2013:
For 2013, a work programme has been established considering dossiers that could be finalised this year in discussion with Rapporteur Member States (see Appendix III). Discussions on active substances will take place in the CA meetings.
After 1st January 2014:
A detailed work programme should be established by the BPC with at least a rolling 2-year visibility, and frequently reviewed by the BPC secretariat every 3-6 months in order to adjust it with regards to the priorities and new draft CARs that are submitted on a day-to-day basis.
Taking into account the priorities and phasing presented in section 2, an example of provisional work programme is presented in Appendix 3 to this document considering the draft CARs that are already available today.
Such work programme will be discussed and set up in the BPC, taking into account that other draft CARs for PTs set as priorities (ie. PT 08, 18, 19, 21) will be submitted by Rapporteur Member States before end of 2014, and therefore have to be processed by the BPC before end of 2015.
5. Conclusion
The Commission services would like to endorse the way forward presented in the document.
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APPENDIX 1
A- Plan provided by Rapporteur Member States concerning the number of draft CARs on EXISTING AS/PT that they intend to submit each year (information on 03/05/2013)
Plan provided / 2013 / 2014 / 2015 / 2016 / CommentsAT / yes / 2 to 5 / 3 to 10 / 0 to 4
BE / yes / 1 / Provided information do not concern all substances
CY / (not concerned)
CZ
DE / yes / 9 / 10 / 12
DK / yes / 6
EE / (not concerned)
EL / yes / 3 / Provided information do not concern all substances
ES / yes / 26 / 8 / 3
FI / yes / 12
FR / yes / 14 / 12 / 6
HU / yes / 2
IE / yes / 3
IT
LT
LV / (not concerned)
MT / yes / Not possible to give estimations for the moment
N / yes / 2 / 4 / 3
NL
PL / yes / 8 / 1 / 11
PT
SE / yes / 11 / 24 / 6
SI
SK / yes / 5
UK / yes / 2 / 3 / 6
TOTAL / - / 64 to 67 / 94 to 99 / 45 to 47 / 17
B- Plan provided by Rapporteur Member States concerning the number of draft CARs on NEW AS/PT that they intend to submit each year (information on 03/05/2013)
Plan provided / 2013 / 2014 / 2015 / 2016 / CommentsAT / (not concerned)
BE / (not concerned)
CY / (not concerned)
CZ
DE / (not concerned)
DK / (not concerned)
EE / (not concerned)
EL / (not concerned)
ES / yes / 1
FI / (not concerned)
FR / yes / 1
HU / (not concerned)
IE / (not concerned)
IT
LT / (not concerned)
LV / (not concerned)
MT / (not concerned)
N / (not concerned)
NL
PL / yes / 2
PT / (not concerned)
SE / yes / 8 / 1
SI / (not concerned)
SK / yes
UK / yes / 5 / 1
TOTAL / - / 15 / 3 / 1 / 0
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APPENDIX 2
A - Progression of the review programme of existing active substances per PT (the figures might be subject to minor corrections – based on data on 24/04/2013)
Total number of Active substance (AS) in the review programme / Number of AS still under evaluation by the RMS, (the draft Competent Authority Report (CAR) has not been submitted yet) / Percentage of AS still under evaluation / Number of AS currently under peer review (the draft CAR has been sent, and discussions are on-going at TM or CA level) / Percentage of AS currently under peer review / Total in still in review (draft CAR not available + CAR under peer review) / Percentage still in review (draft CAR not available + CAR under peer review) / Number of AS for which a decision has been or is ready to be taken (voted in SCB, or inclusion or non-inclusion decision adopted after peer review) / Percentage of AS with a decision taken or ready to be taken