CA-Feb13-Doc.8.3
Review programme of active substances: Establishment of a work programme to meet the 2024 deadline
1. Purpose of the document
The purpose of this document is to discuss the progression of the review programme of existing active substances, and to some extend the evaluation of new active substances. It presents an overview of the current situation, and provides some proposals to set priorities.
The objective is to streamline the progression of the review programme of active substances to finish it before the new deadline of 2024, taking into account that its progress has a direct consequence on the overall implementation of the authorisation scheme of biocidal products.
The Commission would like to receive the views of the Member States and stakeholders on these various proposals. However, in view of the seriousness and urgency of the matter for the year 2013, the Commission services would aim at agreeing on the measures proposed in section 4.3.1 at the 50th CA meeting.
2. Current situation and facts
The review programme of existing active substances was set up almost 10 years ago with the adoption of Regulation (EC) 2032/2003, fixing the organisation of the review of existing active substances. Participants had to submit their applications to request inclusion of their active substances in Annex I/IA of the BPD in relation to product types that they intended to support:
- 1st list of the review programme: submission before 28 March 2004 for product-types (PT) 08 and 14;
- 2nd list of the review programme: submission from 1 November 2005 until 30 April 2006 for PT 16, 18, 19, 21;
- 3rd list of the review programme: submission from 1 February 2007 until 31 July 2007 for PT 1, 2, 3, 4, 5, 6 and 13;
- 4th list of the review programme: submission from 1 May 2008 until 31 October 2008 for the rest of the PTs
Most applications were submitted within those deadlines, and only a few other dossiers were submitted later, in cases where an original participant withdrew its participation or where an application was rejected, and then taken-over by a new participant. Today, only a few dossiers on existing active substances are still expected to be submitted[1].
Since 2006, decisions have progressively been taken on the inclusion or non-inclusion of active substances into Annex I/IA of the BPD. Originally set to end before 14th May 2010, the review programme has been extended first to 14th May 2014 and is now about to be extended to the end of 2024, assuming that 50 decisions per year will be taken as from 2013.
An overview of the progress of the review programme is presented in the following two tables.
The 1st table presents the progress of the review of active substances for each product type, presenting the number of substances still under assessment by the Rapporteur Member States (RMS), the number of substances under peer review in TM or CA meetings, and the number of substances for which a decision has now been taken.
Table 1: Progression of the review programme of existing active substances per PT (the figures might be subject to minor corrections)
Total number of Active Substances (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 / Number of AS for which a decision has been or is ready to be taken (voted in SCBP, or inclusion or non-inclusion decision adopted after peer review) / Percentage of AS with a decision taken or ready to be taken1st list / PT8 / 41 / 0 / 0% / 13 / 32% / 28 / 68%
PT14 / 14 / 0 / 0% / 0 / 0% / 14 / 100%
2nd list / PT18 / 57 / 11 / 19% / 24 / 42% / 22 / 39%
PT19 / 15 / 4 / 27% / 6 / 40% / 5 / 33%
PT21 / 10 / 5 / 50% / 5 / 50% / 0 / 0%
3rd list / PT1 / 37 / 30 / 81% / 7 / 19% / 0 / 0%
PT2 / 85 / 60 / 71% / 23 / 27% / 2 / 2%
PT3 / 55 / 43 / 78% / 12 / 22% / 0 / 0%
PT4 / 55 / 40 / 73% / 15 / 27% / 0 / 0%
PT5 / 19 / 14 / 74% / 5 / 26% / 0 / 0%
PT6 / 49 / 36 / 73% / 13 / 27% / 0 / 0%
PT13 / 30 / 20 / 67% / 10 / 33% / 0 / 0%
4th list / PT7 / 27 / 23 / 85% / 4 / 15% / 0 / 0%
PT9 / 38 / 34 / 89% / 4 / 11% / 0 / 0%
PT10 / 28 / 26 / 93% / 2 / 7% / 0 / 0%
PT11 / 50 / 47 / 94% / 3 / 6% / 0 / 0%
PT12 / 39 / 33 / 85% / 6 / 15% / 0 / 0%
PT17 / 1 / 1 / 100% / 0 / 0% / 0 / 0%
PT20 / 1 / 0 / 0% / 0 / 0% / 1 / 100%
PT22 / 8 / 7 / 88% / 1 / 13% / 0 / 0%
PT23 / 1 / 0 / 0% / 1 / 100% / 0 / 0%
Total / 660 / 434 / 66% / 154 / 23% / 72 / 11%
The 2nd table presents the number of decisions adopted on existing or new active substances per year since the beginning of the review programme (inclusion directives into Annex I/IA or decision of non-inclusion adopted after full evaluation of an application).
Table 2: Number of decisions adopted on existing or new active substances and published since the beginning of the review programme
Year / PT2 / PT8 / PT12 / PT14 / PT18 / PT19 / Total2006 / 1 / 1
2007 / 2 / 1 / 3
2008 / 8 / 2 / 10
2009 / 7 / 6 / 3 / 16
2010 / 1 / 1 / 3 / 5 / 1 / 11
2011 / 4 / 6 / 2 / 12
2012 / 2 / 4 / 1 / 6 / 2 / 15
Total / 2 / 27 / 1 / 13 / 20 / 5 / 68
For these substances, the peer review of the draft CAR - from submission of the draft CAR to the vote in the Standing Committee - took around 2.5 years on average[2]. It includes 3 months for the discussion in CA meetings at the end of the process, which corresponds to discussions in 2 CA meetings.
The limitation in the progress of the review programme can be attributed to different possible reasons: dossiers suspended to require additional data to applicants, delays in their submission, need to have discussions on a harmonised way to assess active substances, lack of experience assessing biocidal uses, lack of resources etc.
In addition, managing the different documents of a Competent Authority Report (Doc I, Doc IIA, Doc IIB, Doc IIC, and confidential information) has shown to be time-consuming due to the formalism requested for making comments and updates of all these documents during the peer review, in order to come to a finalised CAR[3].
Over the past 3 years, the pace of transmission of draft CARs has nevertheless increased (see the Appendix 1 to this document), mainly due to the fact that most of the dossiers were submitted several years ago, that missing data on an active substance can be useful for several PTs under assessment and their submission can therefore unlock several dossiers (ex : most substances of the 3rd and 4th list of the review are the same, and are supported for several PTs), that progress on methodology for their assessment was made. For the same reasons, it could also be expected that the number of draft CARs submitted could continue to increase in the next-coming months/years, at least for dossiers for which no particular technical difficulty remains (ex: lack of methodology for the assessment).
On the contrary, the pace of progression of the peer review in Technical meetings as well as agreements reached in CA meetings / Standing Committee has not improved so much over the past 3 years.
It shall furthermore be noted that Member States started to receive applications for product authorisations in 2008, and the more active substances are included, the more applications for product authorisation are submitted too, which also increases the general workload of Member States.
According to Article 90(1) and subparagraph 5 Article 90(2) of the BPR, ECHA is responsible for coordinating the process of evaluation of applications submitted after 1st September 2012, and of applications under evaluation in the current review programme as from 1st January 2014.
The revised financial statement presented in August 2011 together with the Commission communication concerning the position of the Council on the adoption of the BPR was assuming that 50 active substance/product-type decisions would be adopted in 2013.
If no measure of urgency is taken, it is likely that, at the current pace, only around 13 decisions will be adopted in 2013. This would then have dramatic consequences for ECHA’s budget in 2015, as the expected number of applications for product authorisations would then drop, representing a loss of income of 4 MEUR out of 11 MEUR budget.
From information available, 36 draft final CARs are however due, some of them since a very long time.
Substance / RMS / Due date / PTBardap 26 / IT / 5/12/09 / 8
TMAC / IT / 5/12/09 / 8
BTI strain SA3A / IT / 14/08/10 / 18
Bacillus sphaericus strain 2362 / IT / 6/08/11 / 18
Silicon dioxide – amorphous / FR / 1/12/11 / 18
Cyfluthrin / DE / 3/01/12 / 18
DCOIT / NO / 3/01/12 / 21
IR3535 / BE / 1/02/12 / 19
Benzoic acid / DE / 12/02/12 / 3 and 4
Bromoacetic acid / ES / 12/02/12 / 4
Copper sulphate / FR / 14/03/12 / 2
Cybutryne / NL / 21/06/12 / 21
Transfluthrin / NL / 1/09/12 / 18
BCDMH / Bromochlorodimethylhydantoin / NL / 18/09/12 / 2
Cyromazine / EL / 18/09/12 / 18
Iodine / SE / 18/09/12 / 1, 3 and 22
Triflumuron / IT / 18/09/12 / 18
Cu-HDO / AT / 15/11/12 / 8
Etofenprox / AT / 1/01/13 / 18
IPBC / DK / 1/01/13 / 6
Pythium oligandrum, Chromista – Stramenopila / CZ / 1/01/13 / 10
Zineb / IE / 31/01/13 / 21
Tralopyril / UK / 12/02/13 / 21
Aluminium phosphide / DE / 1/03/13 / 23
Lauric acid / DE / 1/03/13 / 19
Nonanoic acid / AT / 1/03/13 / 10
Perestane / HU / 1/03/13 / 2
Tebuconazole / DK / 1/03/13 / 7 and 10
Clothianidin / DE / 1/05/13 / 18
Decanoic acid / AT / 1/05/13 / 18
Octanoic acid / AT / 1/05/13 / 18
Octanoic acid / AT / 1/09/13 / 4
The Commission services, following consultation with the MS, recognise that this is due, in many cases, to the fact that one or a few issues remain to be addressed and data is expected from the participant in the review programme.
In most cases, the TM has however already reached its conclusions and these substances can be included in Annex I provided the outstanding issues are addressed.
In view of the lack of progress and of the almost complete stand-still of the review programme, the Commission services are questioning the interest of the current approach, where matters linger and no progress achieved, to the effect that substances remain in the meantime unregulated on the market with no benefit whatsoever for public health or the environment.
Taking into account the current situation, there is a need to define additional rules to organise the review, and set some priorities on both the assessment by MSs and the peer review at EU level.
3. Elements to be taken into account in the organisation of the review of active substances
Taking into account the overall objective of improving harmonisation while ensuring a high level of protection of human, animal health and environment, the Commission intends to organise the review with the following objectives in mind:
- ensure that the review programme of existing active substances will be completed as fast as reasonably possible, and by any event by 2024.
- streamline the review of active substances in order to ensure the transition to the authorisation scheme for biocidal products containing them, and by this way, ensure fair competition on the market for products placed on the market for the same product types/uses.
- ensure that the current review will respect the upcoming provisions of the BPR, regarding for instance the harmonised classification, the PBT/vPvB status or the endocrine disruption properties (as far as possible), which are important for the decision making (i.e. exclusion/substitution criteria, comparative assessment of biocidal products, possible inclusion into Annex I of the BPR…).
- deal as a priority with the specific needs of new active substances, which cannot access the market until a decision is taken on their inclusion/approval.
- ensure that the Agency is financed through fees received from applications, and in particular from applications for mutual recognition and Union authorisations.
- ensure a realistic workload for all parties, in particular for the ECHA's Biocidal Product Committee, which will have to deliver opinions on the approval of active substances / inclusion into Annex I of the BPR. The BPR currently foresees a period of 9 months for ECHA to deliver its opinion to the EU commission once the assessment report is submitted.
Some elements of context need also to be pointed out in order to achieve these objectives, and set priorities:
- some AS/PT combinations may have been supported by several participants who submitted separate applications.
- most substances supported under the 3rd list of the review programme are also supported under the 4th list of the review programme (i.e. AS with disinfecting properties).
- a product is subject to the authorisation scheme when all its active substances are approved[4], and most biocidal products are placed on the market for only one PT. This argues to have close approvals in time for all active substances supported for the same PT, as far as possible.
- a better competition on the market, at both EU and national levels, will be ensured if all companies supplying products for the same product types/uses (ex: wood preservatives, insecticides) are subject to the same rules. This also argues to have close approvals in time for all active substances supported for the same PT, as far as possible.