The Biocidal Products Directive.

1
The Biocidal Products Directive.

• ECB INFODAYS, Zagreb
• 11-12th December, 2006
• Sharon Munn
• European Commission DG JRC
• Institute for Health and Consumer Protection,
  European Chemicals Bureau

2
This presentation

• Overview of the Legal frame
• Dossier preparation and submission
• Evaluation of dossiers
• Discussions at TM and CA levels
• Next step Authorisation of products
• Web pages

3
Overview of the Legal frame

• The relevant directive is
• Directive 98/8/EC of the European Parliament and
  of the Council of 16 February 1998 concerning the
  placing of biocidal products on the market.
• The Directive regulates the placing of Biocidal
  products on the market in a two step procedure.
  The first step is evaluation of the active
  substances at EU level (Annex I entry) and the
  second step is product authorisation at member
  state level.

4
Legal frame - Definitions

• A biocidal product is defined as (art. 2(1)(a))
• (a) Biocidal products
• Active substances and preparations containing one
  or more active substances, put up in the form in
  which they are supplied to the user, intended to
  destroy, deter, render harmless, prevent the
  action of, or otherwise exert a controlling
  effect on any harmful organism by chemical or
  biological means.
• An exhaustive list of 23 product types with an
  indicative set of descriptions within each type
  is given in Annex V.

5
Legal frame - definitions

• The substance definition is the same as in
  Directive 67/548/EEC, as amended by 92/32/EEC.
• Substances are divided into new and existing
  active substances, defined by the date of
  implementation (14 May 2000).
• New substances have to be evaluated before they
  can be placed on the market.
• Existing substances go through a review programme
  and can stay on the market.

6
Legal frame data requirements

• An Annex I entry is based on data. Requirements
  are given in the annexes of 98/8/EC and address
  both the substance and a product. Requirements
  are the same for new and existing substances.
• Chemicals
• Annexes IIA and IIB
• Annexes IIIA and IIIB
• Details in TNsG on Data Requirements
• Micro-organisms incl. viruses and fungi
• Directive 50/2006/EC amending Annexes IVA IVB

7
Legal frame review of Existing substances
Article 16 (2) of Directive 98/8/EC The 10 years
review programme
Following the adoption of this Directive, the
Commission shall commence a 10-year programme of
work for the systematic examination of all active
substances already on the market on (14th May
2000, existing active substances) . A Regulation
will provide for all provisions necessary for
the establishment and implementation of the
programme including the setting of priorities for
the evaluation and a timetable.
8
Legal frame Review Regulations

• Implementation of Art. 16 (2) of the BPD
• First Review Regulation (1896/2000 of 7 September
  2000)- Identification of existing active
  substances - Notification (supported by basic
  information)
• - Selection of two Product Types, PT 08 and
  14
• 1a. Regulation EC No 1687/2002 of 25th September
  2002 on an additional notification period for
  certain active substances
• 2. Second Review Regulation (2032/2003 of 4 Nov.
  2003)
• - Allocation of Rapporteurs for 1st and 2nd list

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Legal frame Review Regulations
Implementation of Art. 16 (2) of the BPD 3.
Third Review Regulation (1048/2005 of 13 June
2005) - Allocation of Rapporteurs for 3rd and
4th list 4. Additional Regulations to phase out
the active substances for which no dossier was
submitted, and list substances for which
essential use has been claimed. Identified
substances phased out by 1 Sep. 2006, unless Art.
4b dossier submitted or essential use is claimed.
10
Legal frame Second Review Regulation (2032/2003)

• Art 1 Subject matter
• This Regulation lays down detailed rules for the
  implementation of the second phase of the
  programme of work for the systematic examination
  of all active substances already on the market on
  14 May 2000 as active substances of biocidal
  products, hereinafter the review programme,
  referred to in Article 16(2) of Directive 98/8/EC.

11
Legal frame Second Review Regulation (2032/2003)

• Main objectives
• Lists of identified (Annex III) and notified
  (Annex II) substances (all substances Annex I)
• Phase-out period for substances neither
  identified nor notified
• Time schedule for dossier submission for notified
  substances according to PTs (Annex V)
• Details on dossier submission and the evaluation
  process

12
Legal frame Second Review Regulation (2032/2003)
Active substances listed in Annex II to 2nd
RRshall not be included in Annex I, IA or IB to
Directive 98/8/EC within the framework of the
review programme in relation to any PT not
specified in Annex II. Active substances listed
in Annex III to 2nd RRto be phased out by 1
Sep. 2006 Amended according to 1048/2005 an
identification can be upgraded to a notification
by submission of a complete dossier by 1 March
2006.
13
Legal frame Second Review Regulation (2032/2003)

• Member States
• shall cancel all existing authorisations/registra
  tions for biocidal products, except for those
  containing the substances listed in Annex II
  for the notified PTs by 1 Sep. 2006.
• may apply the derogation referred to in Article
  16(1) of Directive 98/8/EC (i.e. applying the
  former national system) only to substances
  listed in Annex II / PT

14
Legal frame Second Review Regulation (2032/2003)
Part A. 28.03.2004 08 Wood preservatives 14
Rodenticides Part B. 30.04.2006 16
Molluscicides 18 Insecticides, acaricides
and products to control other
arthropods 19 Repellents and
attractants   21 Antifouling products Part
C. 31.07.2007 PTs 1, 2, 3, 4, 5, 6, and 13
(Disinfectants and start of preservatives) Part
D. 31.10.2008 PTs 7, 9, 10, 12, 15, 17, 20,
22 and 23 (Preservatives and other biocidal
products)
15
Legal frame Allocation of Rapporteur Member
States
The Rapporteur Member states have been allocated
for substances on Parts A and B in Reg.
2032/2003, and for Parts C and D in Reg.
1048/2005. Substances will continue with the same
RMS throughout the review programme The 10 new
member states will participate as RMS for Parts C
and D

16
Legal frame Possibilities for withdrawn actives.
RRII, Art 8.
8(1) To replace participant ? producer,
formulator or association (P F A) inform COM
and RMS. 8(2) To discontinue participation?
producer, formulator or association inform COM
and RMS stating the reasons. 8(3) If withdrawal
of all participants? COM inform MS 8(4) 3
months? another P F A or MS take over 8(5) COM
decision non inclusion in Annex I for PTs A
substance can always be submitted according to
Art. 11of the BPD (e.g. withdrawn or only
identified subst.)
17

• Dossier Preparation and Submission

• Information requested
• a dossier for a biocidal product (Art.
  11(1)(a)(ii) BPD covering the use in the PT
  (Exposure to man and environment))
• a summary dossier for all studies and end-points
  (toxicology, ecotoxicology and general issues)
• in case of joint application (a) names of all
  participants (b) a person responsible
• If no joint dossier was prepared explanation why
  not
• Breakdown of costs (dossier, animal testing,)

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Dossier preparation and submission

• A complete dossier has 4 levels
• Level I overall summary and assessment
• Level II risk assessment
• Level III robust study summaries of the test
  reports
• Level IV test reports
• The Rapporteur has all 4 levels the other
  member states have levels 1, 2 and 3

19
Overview of the composition of a biocides dossier
20
Evaluation Guidance documents
Technical Notes for Guidance (TNsG) on data
requirements TNsG on Annex I inclusion TNsG on
dossier preparation and study evaluationTNsG on
product evaluationTNsGs on environmental
emission scenariosTNsGs on Human Exposure TGD on
Risk Assessment http//ecb.jrc.it/ To ensure
transparancy and harmonise the implementation
21
Evaluation Completeness check of dossier by RMS
The Rapporteur MS shall verify the dossier
concerning the acceptability within 3 month.
In difficult cases the period shall be prolonged
up to a maximum of 3 month.
Within 1 month after the acceptance of the
dossier the participant forwards the summary
dossier to COM and to the other MSs.
If a participant fails to submit the data within
the deadline (also fees), he will be excluded
form the programme. A new deadline may be
established only under exceptional
circumstances.
22
Evaluation of dossiers by the RMS
The CA of the RMS shall carry out the evaluation
and prepare an evaluation report
12 months

• Additional information from the participant (or
  third parties)
• shall only be taken into account, if
• the participant informed the RMS at dossier
  submission
• the data is submitted at latest 3 month before
  the end of evaluation
• the data is more reliable
• the result changes the outcome of the
  recommendation

23
Evaluation by the RMS

• The RMS shall submit the competent authority
  report to COM, MSs and the applicant which
  includes a recommendation either
• to include the existing active substance in
  Annex I, IA or IB to Directive 98/8/EC stating
  the conditions for inclusion, or
• not to include the substance in Annex I, IA or
  IB, mentioning the reasons for the
  non-inclusion, or
• in the case RMS request additional information
  deadline is established by RMS ?participants may
  submit updated summary dossiers to COM and MSs

24
Evaluation Commission procedures

• COM gives 90 days to the other Member States and
  the applicant to comment the competent authority
  report.COM shall organise, when necessary,
  meetings with experts.
• COM may consult the appropriate Scientific
  Committee(s).
• After the commenting period? COM prepares
• a draft for decision to include the substances
  in Annex I, IA or IB to Dir. 98/8/EC, setting
  out the conditions, or
• a draft for decision addressed to the MS not to
  include the substance in Annex I, IA or IB,
  mentioning the reasons for non-inclusion,
  requesting MS to cancel existing
  authorisations/registrations for biocidal
  products containing the substance

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Completeness check
Timescale for the reviewprogramme
Comment phase
Decision phase
Evaluation
30.04.2006
28.03.2004
31.07.2007
31.10.2008
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Results of Completeness check and beyond
PT 08 Wood preservatives
No. of substances in 2032/2003 81 No. of
substances for which a dossier was submitted
37 No. of substances with multiple
dossiers 4 No. of substances withdrawn during
completeness 0 Prolonged completeness 2
Art. 4b substances, still awaiting
dossier 2 Finalised CA reports
19 Discussed CA reports at TM
8 Substances in Annex I 1 Delayed reports
(add. data needed or other) 18
27
Results of Completeness check and beyond
PT 14 Rodenticides
No. of substances in 2032/2003 17 No. of
substances for which a dossier was submitted
14 No. of substances with multiple
dossiers 3 No. of substances withdrawn during
completeness 1 Prolonged completeness 0
Finalised CA reports 11 Discussed CA
reports 6 Delayed reports (add. data
needed or other) 2
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Results of Completeness check and beyond
PT 16 Moulluscicides No dossiers were
submitted PT 18 Insecticides No. of
substances in 2032/2003 81 No. of substances
for which a dossier was submitted 64 No. of
substances with multiple dossiers 8 No. of
substances withdrawn during completeness
0 Prolonged completeness 7 Complete
dossiers 50 Incomplete dossiers
25
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Results of Completeness check and beyond
PT 19 Attractants and repellents No. of
substances in 2032/2003 42 No. of substances
for which a dossier was submitted 16 No. of
substances with multiple dossiers 1 No. of
substances withdrawn during completeness
1 Prolonged completeness 2 Complete
dossiers 11 Incomplete dossiers 2
30
Results of Completeness check and beyond
PT 21 Antifoulants No. of substances in
2032/2003 46 No. of substances for which a
dossier was submitted 10 No. of substances with
multiple dossiers 2 No. of substances
withdrawn during completeness 0 Prolonged
completeness 4 Complete dossiers 6
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Evaluation Which discussion will come up?
PT 14 Rodenticides
ANTICOAGULANTS Early discussion on the long term
tests (CMR studies) Avian toxicity
testing Substance identity (corn cob)
Classification and Labelling ALL Compatibility
with PPP dossiers
33
Evaluation Which discussions will come up?
PT 08 Wood preservatives
Current ESD conservative gt overestimate
emission Leaching testing Assessment of Metal
ions, already a discussion item for other
chemicals programmes Passing the biodegradation
criteria Substance identity (quats) Read
across between substances Compatibility with PPP
dossiers
34
Evaluation - Methodology

• The methodology for the evaluation is described
  in the Technical Notes for Guidance (TNsGs) and
  the TGD on Risk Assessment (including Emission
  Scenario Documents)
• There are some gaps and by applying the TNsGs
  changes have been suggested / agreed.

35
Evaluation Methodology developments

• There are difficult areas e.g. chemical
  identity, pheromones (guidance document), natural
  substances (guidance document), read across of
  data, leaching rates for PT08 (workshop) and 21
• Methodology is translated from other areas
  Existing Substances Regulation and Plant
  Protection Products
• Some remaining difficult issues e.g. efficacy
  testing, metabolites

36
Evaluation - Statistics

• Experience from the first list was that most RMS
  took 6 months to check completeness.
• Most dossiers took more than 12 months to
  evaluate in Aug. 2006
• 9 (of 13) reports from RMS under PT 14
• 16 (of 40) reports from RMS for PT08
• stop the clock
• Unclear chemical identity
• Data gaps

37
Evaluation Peer review by the other member states

• Peer review by the other member states
• Documents level I, II and III are circulated
• 90 day commenting period for OMS, applicant and
  other interested parties (only public report).
  Comments should be submitted in writing.
• The Rapporteur prepares a response-to-comments
  table, indicating (dis)agreement with the
  comments and actions.
• Information is circulated via CIRCA

38
Discussions at TM and CA levels Peer review by
the other member states

• Outstanding issues from the response-to-comments
  are discussed at a technical meeting.
• The technical meetings are prepared, chaired and
  followed-up by the ECB
• All member states and the applicants are invited
  to the TMs

39
Discussions at TM and CA levels Peer review by
the other member states

• Provides consistency
• Provides common solutions
• Provides a forum for discussion
• Several meetings may be needed

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Discussions at TM and CA levelsCL

• The Classification and labelling is performed in
  the TC CL (Technical Committee for
  classification and labelling).

41
Discussions at TM and CA levels

• TM reports to the Competent Authorities meeting
  and the minutes of the TMs are distributed.
• Update of the Competent Authority Report
  reflecting outcome of discussions presented for
  the CAs.
• The entry of a substance onto Annex I is done via
  a voting committee.
• The legal text is a directive.

42
Annex I inclusion

• So is it possible at all?
• Large dossier / extensive requirements
• Methodology well described, but gaps are still
  found
• 25 MS plus applicant plus EEA (NO, ICE, CH) to
  discuss and reach a decision

43
Annex I inclusion

• Discussion on Sulfuryl fluoride was finished at
  TMI06, and voted onto Annex I at the 22nd CA
  meeting (Sep. 2006)
• The next substances were up for final discussion
  at TM III 06, and Annex I entry in 2007.

44
Annex I inclusion

• Annex I inclusion is for a maximum of 10 years
  (Art. 10 / BPD)
• Comparative assessment
• Art. 14 / BPD New information
• The work under the BPD does not stop with Annex I
  inclusion.

45
Next step Authorisation of products

• The BPD is a two-step Directive.
• The first step is Annex I inclusion under the
  responsibility of the Commission
• The second step is product authorisation under
  the responsibility of the Member States.
• Products can be authorised when they contain
  active substances listed in Annex I

46
Next step Authorisation of products

• Product authorisation is based on the common
  principles in Annex VI
• Product authorisations will be mutually
  recognised according to Art. 4(1) of the BPD

47
Further information on the Review Process

• ECB web page http//ecb.jrc.it/Biocides
• Technical Notes for Guidance on Annex I
  inclusionTNsG on data requirementsTNsG on
  dossier preparation and study evaluationTNsG on
  product evaluationTNsGs on environmental
  emission scenariosTNsGs on Human Exposure
• TGD on Risk Assessment http//ecb.jrc.it/
• DG ENV http//ec.europa.eu/comm/environment/bioci
  des/index.htm
• Basic Principles
• Scope/Borderline documents, manual of decisions
• Public version of the draft CA reports
• Withdrawn substances