The Biocidal Products Directive.

ECB INFODAYS, Zagreb11-12th December, 2006

Sharon MunnEuropean Commission DG JRC

Institute for Health and Consumer Protection, European Chemicals Bureau

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

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.

Legal frame - Definitions

A biocidal product is defined as (art. 2(1)(a)):

(a) Biocidal productsActive 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.

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.

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 RequirementsMicro-organisms incl. viruses and fungi• Directive 50/2006/EC amending Annexes IVA &

IVB

Legal frame – review of Existing substances

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.

Article 16 (2) of Directive 98/8/ECThe 10 years review programme

Legal frame – Review RegulationsImplementation of Art. 16 (2) of the BPD:

1. 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

Legal frame – Review RegulationsImplementation 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.

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.

Legal frame – Second Review Regulation (2032/2003)

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

Legal frame – Second Review Regulation (2032/2003)

Active substances listed in Annex II to 2nd RR:shall 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 RR:to 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.

Legal frame – Second Review Regulation (2032/2003)

Member States

• shall cancel all existing authorisations/registrations 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

Legal frame – Second Review Regulation (2032/2003)

Part A. 28.03.2004 08 Wood preservatives14 Rodenticides

Part B. 30.04.2006 16 Molluscicides18 Insecticides, acaricides and products

to control other arthropods19 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)

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

Legal frame – Allocation of Rapporteur Member States

Legal framePossibilities 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.)

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,…)

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

Doc. IV-B: Test and Study Reports b.p.(s)

Doc. IV-A: Test and Study Reports a.s.

Doc II-AEffects and

Exposure3) Assess.Active Substance2)

Doc II-BEffects and

Exposure Assess.Biocidal Prod.(s)2)

Doc. II-C Risk Characterisationfor Use of A.S. in B.P.(s)

Doc. II Risk Assessment

Doc. IOverall

Summary and Assessment1)

Document III-BStudy Summaries

Biocidal Product(s)2)

Document III-AStudy SummariesActive Substance2)

1) To append: List of end points 2) To append: Reference listsList of abbreviationsCheck for completeness

Summary Dossier

Complete Dossier

Overview of the composition of a biocides dossier

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 ExposureTGD on Risk Assessment http://ecb.jrc.it/

To ensure transparancy and harmonise the implementation

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.

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.

Within 1 month after the acceptance of the dossier the participant forwards the summary dossier to COM and to the other MSs.

Evaluation of dossiers by the RMS

The CA of the RMS shall carry out the evaluation and prepare an evaluation report

Additional information from the participant (or third parties) shall only be taken into account, if1. the participant informed the RMS at dossier submission2. the data is submitted at latest 3 month before the end of

evaluation3. the data is more reliable4. the result changes the outcome of the recommendation

12 months

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

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

30.04.200628.03.2004 31.07.2007 31.10.2008

Completeness check

Evaluation

Comment phase

Decision phase

Timescale for the reviewprogramme

Results of Completeness check and beyond

PT 08 Wood preservativesNo. of substances in 2032/2003: 81No. of substances for which a dossier was submitted: 37No. of substances with multiple dossiers: 4No. 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: 8Substances in Annex I 1Delayed reports (add. data needed or other): 18

Results of Completeness check and beyond

PT 14 Rodenticides

No. of substances in 2032/2003: 17No. of substances for which a dossier was submitted: 14No. of substances with multiple dossiers:

3No. of substances withdrawn during completeness:

1 Prolonged completeness

0

Finalised CA reports:11

Discussed CA reports: 6Delayed reports (add. data needed or other): 2

Results of Completeness check and beyond

PT 16 Moulluscicides : No dossiers were submitted

PT 18 Insecticides: No. of substances in 2032/2003: 81No. of substances for which a dossier was submitted: 64No. of substances with multiple dossiers:

8No. of substances withdrawn during completeness:

0Prolonged completeness

7Complete dossiers 50Incomplete dossiers

2+5

Results of Completeness check and beyond

PT 19 Attractants and repellents

No. of substances in 2032/2003: 42No. of substances for which a dossier was submitted: 16No. of substances with multiple dossiers:

1No. of substances withdrawn during completeness:

1Prolonged completeness

2Complete dossiers 11Incomplete dossiers

2

Results of Completeness check and beyond

PT 21 Antifoulants

No. of substances in 2032/2003: 46No. of substances for which a dossier was submitted: 10No. of substances with multiple dossiers:

2No. of substances withdrawn during completeness:

0Prolonged completeness:

4Complete dossiers:

6

Doc. IV-B: Test and Study Reports b.p.(s)

Doc. IV-A: Test and Study Reports a.s.

Doc II-AEffects and

Exposure3) Assess.Active Substance2)

Doc II-BEffects and

Exposure Assess.Biocidal Prod.(s)2)

Doc. II-C Risk Characterisationfor Use of A.S. in B.P.(s)

Doc. II Risk Assessment

Doc. IOverall

Summary and Assessment1)

Document III-BStudy Summaries

Biocidal Product(s)2)

Document III-AStudy SummariesActive Substance2)

1) To append: List of end points 2) To append: Reference listsList of abbreviationsCheck for completeness

Summary Dossier

Complete Dossier

Evaluation: Which discussion will come up?

PT 14 RodenticidesANTICOAGULANTS

Early discussion on the long term tests (CMR studies) Avian toxicity testingSubstance identity (corn cob) Classification and Labelling

ALLCompatibility with PPP dossiers

Evaluation: Which discussions will come up?

PT 08 Wood preservativesCurrent ESD conservative => overestimate emissionLeaching testingAssessment of Metal ions, already a discussion item for

other chemicals’ programmesPassing the biodegradation criteria

Substance identity (quats)Read across between substancesCompatibility with PPP dossiers

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.

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

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

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

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

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

Discussions at TM and CA levelsC&L

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

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.

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

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.

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.

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

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

Further information on the Review Process

ECB web page: http://ecb.jrc.it/Biocides• Technical Notes for Guidance on Annex I inclusion

TNsG 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/biocides/index.htm• Basic Principles• Scope/Borderline documents, manual of decisions• Public version of the draft CA reports• Withdrawn substances