Is there a future for biocide-containing antifouling coatings? -...

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©1 BACK TO THE SOURCE

Is there a future for biocide-containing antifouling coatings? A REGULATORY PERSPECTIVE

©2 BACK TO THE SOURCEINTERNATIONAL SYMPOSIUM ON CORROSION AND FOULING,

ANTWERP MARITIME ACADEMY, APRIL 1ST, 2019

Global Biocides Regulation – most comprehensive systems

US - FIFRA - EPA

CAN - PCPA - PMRA

EU - BPR - ECHA

AUS - AgVet - APVMA

NZ- HSNO - EPAhttps://www.epa.govt.nz

https://apvma.gov.au

https://echa.europa.eu

https://www.epa.gov/pesticides

https://www.canada.ca/en/health-canada.html

https://www.epa.govt.nz/https://apvma.gov.au/https://echa.europa.eu/https://www.epa.gov/pesticideshttps://www.canada.ca/en/health-canada.html

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What is (a) biocide?a quick browse on the internet:




biocide

geocideecocide

“The destructionof the earth, its ecosystems, or some part thereof, due to

human activity.” [Wiktionary]

“the destruction oflarge areas of the natural

environment as a consequence of human

activity.” [Merriam Webster]

“any action or substance that can destroy living

organisms” [Word Hippo]

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Solution - productmarket

Danger - hazardrules

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Biocides Regulation

Biocidal Products Directive - before◦ Directive 98/8/EC◦ To establish a harmonized regulatory framework for

the placing of biocidal products on the market

Biocidal Products Regulation – now◦ Regulation (EU) No. No. 582/2012◦ After September 1st, 2013◦ Directly applicable in all EU Member States◦ Main legislative model has not changed, …

◦ … but ‘details’ in the new law have far-reaching effects!

◦ Built on the Precautionary Principle

“The purpose ... to improve the functioning of the internal market through the harmonisation of the rules ..., whilst ensuring a high level of protection of both human and animal health and the environment. ... underpinned by the precautionary principle, the aim ... safeguard the health of humans, the health of animals and the environment. Particular attention ... protection of vulnerable groups.”

◦ Review Programme of Active Substances

in the EU

House of Stairs, M.C. Escher, 1951



Definition – ‘When is BPR relevant?’

This Regulation lays down rules for:◦ (a) the establishment at Union level of a list of

active substances which may be used in biocidal products;

◦ (b) the authorisation of biocidal products;

◦ (c) the mutual recognition of authorisations within the Union;

◦ (d) the making available on the market and the use of biocidal products within one or more Member States or the Union;

◦ (e) the placing on the market of treated articles.

active substances/biocidal products/treated articles

placing/making available on the market and use

European Union

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Definition – ‘When is BPR relevant?’

Art.3.1 (a) "biocidal product" means ◦ any substance or mixture, in the form in which it is

supplied to the user,

◦ consisting of, containing or generating one or more active substances,

◦ with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism

◦ by any means other than mere physical or mechanical action.

Art. 3.1 (c) ‘active substance’ means ◦ a substance or a micro-organism that has an action on or

against harmful organisms;

active substances

intent/claim

action not phys/mech



Biocides Regulationin the EU

Active substances approval◦ EU-level assessment by

Rapporteur Member States (RMS)

◦ BPR: Union List (former Annex I under BPD)

Active substances Product formulations

Product authorisation◦ EU-level (Union Authorisation, UA)

◦ not for AF!

◦ Member State-level

◦ Assessment by Reference Member State (RefMS), Mutual Recognition byConcerned Member States (CMS)

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Regulatory hurdles – the ‘Antifouling Golden League’

https://creativecommons.org/licenses/by/2.0/

BIOCIDES (AS) REVIEW PROGRAMME

AF PRODUCT DOSSIERS

SUBSTITUTION / EXCLUSION

COMPARATIVE ASSESSMENT

“A MOVEABLE SECTION OF LIGHT FENCE” [WIKIPEDIA]



Hurdle I - Impact of the Biocides Review Programme

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Hurdle I - Impact of the Biocides Review ProgrammePT-21

Existing AF actives◦ Dicopper oxide

◦ Copper flakes

◦ Copper powder

◦ Copper thiocyanate

◦ Zineb

◦ DCOIT

◦ Zineb

◦ Copper pyrithione

◦ Zinc pyrithione –under review

◦ Tolylfluanid

◦ Dichlofluanid

◦ Cubutryne –not approved

New AF actives◦ Tralopyril

◦ Medetomidine

Source: Hydrotox 2007

2019:30%

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BP dossier - 4 main information pillars◦ PhysChem◦ Human Health◦ Environment◦ Efficacy

◦ These are often the mainspecialist departmentswithin competent authorities

Related label phrases/classification◦ Summary of Product Characteristics

Product SPC

Risk assessments need to be performed for human health and environment◦ For all applicable scenarios◦ Also for Substances of Concern (examples xylene, zinc oxide)

Hurdle II – The products containing the biocides/actives



Hurdle III - Exclusion/substitution of active substances

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Exclusion... ..and.. ..substitution



Hazard versus risk

Hazard – based on intrinsic properties of a substance

Risk – about exposure versus safe levels – likelihood

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Exclusion criteria BPR art. 5◦ Selection via hazard-based criteria (intrinsic properties)

Consequences AS approval status irrespective of actual risk◦ Substances fulfilling exclusion criteria in principle not approved

◦ Derogations: negligible risk, essential use or disproportional societal impact

◦ AS max. 5 years approved, BP authorised if derogation conditions met

Exclusion criteria◦ Substances classified as CMR cat. 1A or 1B◦ Substances with endocrine disrupting properties◦ Substances meeting PBT or vPvB criteria

Hazard labelling◦ Problematic as not all AF actives yet have harmonised label – ECHA RAC Committee

Rodenticides◦ Substances in exclusion zone approved

Hurdle III – Exclusion/substitution of active substances



Hurdle IV – Comparative Assessment

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Substitution - Comparative assessment - steps

Screening

Mapping of existing alternatives* to the relevant BPScreening phase

◦ Resistance

Tier I-A – comparison at SPC** level

Tier I-B – detailed comparison

Tier II – comparison to non-chemical

alternatives

*Alternatives are other authorised BP

**SPC = group of products in BPFamily



EU Approach for antifoulings – PT21

Way forward for AF - CA-March14-Doc.4.2-Final◦ Because first assessments have shown some unacceptable risks

◦ Risk mitigation measures have raised questions – not addressed in CA reports

◦ Needs to be reconsidered at product authorisation stage

Commission proposal to:◦ Approve all actives for PT21 on basis of same generic conditions◦ Establish same expiry date for all existing PT-21 actives

◦ In order to evaluate the renewal of their approval at the same time

◦ Common expiry date Dec. 31st, 2025

◦ Flag special concerns in CA report

Goosebarnacles,Ecomare, Texel NLM. Buschmann

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Antifouling timeline – EU Commission



The ‘Antifouling Golden League’“AND THE WINNER IS.....”

2 1 3

?? ?

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2 1 3

?? ?




Exclusion, Comparative Assessment, ...

Innovation Workshop on Safer and Sustainable Antifouling – Rotterdam, October 2018 - yachts

◦ “Despite their availability, the new products are not yet as widespread as their more traditional counterparts.”

◦ “Both chemical and non-chemical alternatives to the copper-based products exist, addressing the fouling issue in different ways. Alternative technologies include hard coatings, ultrasonic systems, self-cleaning and repellent surfaces, and surfaces with spines that prevent organisms from attaching themselves to the boat.”

There is a ‘green’ wind blowing in the political arena◦ General aversion against ‘chemical’ options[From recent presentation Ctgb chairman Johan de Leeuw in session @ 25 years of Ctgb – themed “Between brainand underbelly”:]◦ Forming of people’s opinion less based on facts,

‘science is only an opinion’◦ How facts and perceptions affect dialogue

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The winner of the ‘Antifouling Golden League’“IS IT THE ENVIRONMENT?”

biocide?

geocide?ecocide

?“The destruction

of the earth, its ecosystems, or some part thereof, due to







“a substance or a micro-organism that has an action

on or against harmful organisms;

” [BPR]




biocide?

geocide?ecocide

?“The destruction










” [BPR]https://creativecommons.org/licenses/by/3.0/#

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biocide?

geocide?ecocide

?“The destruction








By Inowen - Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=76202224







biocide?

geocide?ecocide

?“The destruction








By Inowen - Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=76202224




AF Systems Convention

Biofouling GuidelinesEnergy Efficiency Design Index

GHG Reduction Strategy

IMO

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What is a Biocide?a quick browse on the internet:

Solution - productmarket

Danger - hazardrules

We are focusingtoo much on the

hazards, ....



Biocides Regulation

Biocidal Products Directive - before◦ Directive 98/8/EC◦ To establish a harmonized regulatory framework for

the placing of biocidal products on the market

Biocidal Products Regulation – now◦ Regulation (EU) No. No. 582/2012◦ After September 1st, 2013◦ Directly applicable in all EU Member States◦ Main legislative model has not changed, …

◦ … but ‘details’ in the new law have far-reaching effects!

◦ Built on the Precautionary Principle

“The purpose ... to improve the functioning of the internal market through the harmonisation of the rules ..., whilst ensuring a high level of protection of both human and animal health and the environment. ... underpinned by the precautionary principle, the aim ... safeguard the health of humans, the health of animals and the environment. Particular attention ... protection of vulnerable groups.”

◦ Review Programme of Active Substances

in the EU

House of Stairs, M.C. Escher, 1951

... and we are forgetting that

antifoulings are a solution!

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Risk Hazard aversion or risk management? The challenge:



Hazard aversion or risk management? Until then:

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Risk aversion or -management? Until then:

Thank you!

Is there a future for biocide-containing antifouling coatings? -...

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