Regulation of antifouling paints in Sweden Regulation of antifouling paints in Sweden

and in the EUand in the EUGothenburg 20 Nov 2009Gothenburg 20 Nov 2009

Kurt Haglund

www.kemi.se

EU legislation

• 1998. Adoption of the Biocidal

Products Directive 98/8/EC (BPD).Effective from May 2000. The BPD is implemented in Swedish legislation via the Biocidal Products Ordinance (2000:338).

• A review programme for existing biocides is presently going on, planned to be finished in May 2010 (now

postponed).

• As result of this programme, biocides will be included or not included in Annex I, IA or IB of the directive.

Article 2(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.

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EU legislation cont.

• At latest 2010, all products that are put on the EU market

and belong to any of the 23 product types need to be approved according to the requirements of the directive.

• This date (14 May 2010) will be postponed to 14 May 2013 (not finally decided).

• Until then (a transition period) the different member states

are allowed to use their national legislation.

• Active substances in biocidal products need to be

included in Annex I, IA or IB of the BPD or be part of the ongoing review programme for existing biocidal active

substances.

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EU legislation cont.

• Thus, both new and existing biocidal active substances need to be scrutinised in the same evaluation process,

involving a comprehensive evaluation of the effects on

health and environment, before they can be included in biocidal products.

• Presently, active substances in antifouling products (PT 21) are evaluated in the review programme. The first

draft CA reports are expected early next year.

This is how the BPD is meant to work

Active substance evaluated in the EU

A company

applies for

approval of a

BP in an EU MS

And, finally, applies for mutual recognition of approval in other MS

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Doc II-AEffects and Exposure3)

AssessmentActive 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. I

EvaluationReport1)

Document III-BStudy Summaries

Biocidal Product(s) 2)

Document III-AStudy Summaries

Active Substance2)

1) To include: I.1 Subject Matter 2) To append: Reference lists

I.2 Overall Summary and Conclusions

I.3 Proposal for Decision Re. Annex I, IA , IB Inclusion

Appendix: List of end points.; Appendix: List of abbreviations

Initial check for completeness of dossiers

CAs' Report

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

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

Doc II-AEffects and Exposure3)

AssessmentActive 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 Summaries

Active Substance2)

1) To append: List of end points 2) To append:

Reference lists

List of abbreviations

Check for completeness

Summary Dossier

Complete Dossier

Antifouling biocides examined in the EU

Existing

• Copper [Cu(I)O, CuSCN, Cu(s)]

• Cybutryne (Irgarol)

• DCOIT (Sea-Nine)

• Dichlofluanid

• Tolylfluanid

• Copper pyrithione

• Zinc pyrithione

• Zineb

New

• Tralopyril (Echonea)

• Medetomidine

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Data requirementsAccording to Annex IIA of the BPD

I. Applicant

II. Identity of the active substance

III. Physical and chemical properties of the active substance

IV. Methods of detection and identification

V. Effectiveness against target organisms and intended uses

VI. Toxicological profile for man and animals including

metabolism

VII. Ecotoxicological profile including environmental fate

and behaviour

VIII. Measures necessary to protect man, animals and the

environment

IX. Classification and labelling

Possibilities for waiving of data requirements

• There is a minimum amount of data which always need to be submitted. Data requirements shall reflect technical progress.

• Data which may be considered not necessary on the basis of the properties of the biocidal product or the suggested area of use does not need to be submitted. Neither does data which are unnecessary for scientific reasons or technically impossible or very difficult to produce. In all such cases a justification must be submitted, which has to be approved by the competent authority (Rapporteur Member State).

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PARTICULAR REQUIREMENTS FOR ANTIFOULING BIOCIDES, PT 21

(TNsG on Data Requirements Part C)

The biodegradation tests have to be performed using saltwater.

The aquatic toxicity tests need to be performed additionally with marine/brackish species: 7.4.1.1 Acute toxicity to fish 7.4.1.2 Acute toxicity to invertebrates 7.4.1.3 Growth inhibition test on algae (if no NOEC is available from the core data set) Several additional tests with marine/brackish species are required to accurately assess the risks for these substances: 7.4.3.2 Effects on reproduction and the growth rate on an appropriate species of fish 7.4.3.3.1 Bioaccumulation in an appropriate species of fish 7.4.3.3.2 Bioaccumulation in an appropriate invertebrate species 7.4.3.4 Effects on reproduction and growth rate with an appropriate invertebrate species 7.4.3.5.1 Effects on sediment dwelling organisms 7.4.3.5.2 Aquatic plant toxicity

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Estimation of environmental exposureAntifouling products (Product type 21)

Harmonisation of Environmental

Emission Scenarios:An Emission Scenario Document (ESD) for Antifouling Products in OECD countries.

European Commission

Directorate-General Environment (2004)

MAMPEC – Marine Antifoulant Model to

Predict Environmental Concentrations

Deltares|Delft Hydraulics, IVM (2008)

History of AFP regulation in Sweden

• 1985. Antifouling products regulated for the first time.

• 1989. Antifouling paints with organic tin compounds (TBT) were forbidden on boats < 25m.

• 1992. The first approval process of antifouling products.

• 1998. New, in-depth evaluation of antifouling paints –stricter regulations for pleasure boats.

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General risk assessment of pesticides in Sweden

• KemI risk assessment: hazard assessment (chem/phys, tox, ecotox, e-fate)exposure assessment risk assessment (MOE, PEC/PNEC)

• Risk/benefit analysis:does benefit outweigh risk?

• Decision: denial orapproval with conditionslimited time period

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Varför?

• Intensive shipping to ports at the west coast and in the

Baltic Sea

• More than 700 000 pleasure boats in Sweden (2004)

• Ca 2 million Swedes use pleasure boats each year

• A high-volume biocidal product

Why antifouling?

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Environmental risk assessment

� Calculate PEC- Leaching rate estimation- Emission Scenario Document PT 21 (service life in harbour, marina,

shipping lane, application, removal)- MAMPEC (specific scenarios for Swedish conditions)

� Calculate PNEC- Appropriate studies for obtaining a NOEC- Extra assessment factor for the Baltic Sea- Special discussion regarding copper

� PEC/PNEC > 1 = unacceptable risk

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Leaching rate

• ASTM/ISO standard test 45 d– overestimates the leaching rate

• CEPE mass balance calculation method– based on the service life of the product

– considered as an overstimation for anchored pleasure boats

• US Navy Dome method– in situ-test on ships (very expensive)

– used to calculate correction factors for the above methods which are

used in the EU

• Prolonged ASTM/ISO test 120 d (Norden report 2008)– better estimation of steady state leaching rate

– rises questions regarding the relevance of using correction factors

Alternatives to biocidal paints – other coatings

• Physically acting polishing paints – zinc oxide

• Silicone elastomer based paints

• Fluorinated polymer based paints

• Oxygen depleted surfaces

• Oily or fat surfaces (e.g. wool grease)

• Epoxy paints (”ice-breaker paints”)

• Ceramic based paints

• Glass flakes in vinyl ester

• Textured surfaces (microstructures, nanostructures)

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Function of zinc oxide

Formulator

• Pigment. Enhances different colours.

• Provides self polishing properties. According to paint manufacturers zinc oxide has unique solubility properties that can make the paint erode in a controlled fashion.

How much?

• 25% ZnO in the paint is common. Over 50% in some paints.

Biocide or not?

• Until 2003 it was notified, but it was withdrawn 2004.

• Still debated. Action mechanism chemical/biological or not?

Alternatives to biocidal paints – mechanical

• Boatwashers

• Cleaning robots

• High-pressure water hosing

• Dark plastic foils suspended

under the anchored boat

• Inflatable anchoring pool

• Boat lifts

• We anticipate a change of mentality among pleasure

boat owners towards more of individual efforts, e.g.

cleaning your boat!

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Where are we today?

• Improved tool for estimation of environmental exposure (PEC)

• Updated scenarios for the Baltic and the west coast

• Strong focus on the evaluation of copper in the EU

• Phasing-out of Irgarol in pleasure boat paints

• Funding for marine research available (SE EPA)

• Better alternative coatings available

• Boatwashers increase in number

• The Swedish Government provides funding to installation of mechanical cleaning devices

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Thank youThank you

Thanks to colleagues that Thanks to colleagues that

have contributed to the have contributed to the

presentationpresentation