Risk Assessment of Biocides Biocides - people

Chemical residues in food and water; challenges for a future sustainable agriculture

MGPR 2008 - Piacenza (Italy), 13 and 14 November 1

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Risk Assessment of BiocidesRisk Assessment of Biocides

Chaido LENTZA-RIZOS

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Biocides• Formerly known as non-agricultural pesticides • Regulated with “Directive 98/8/EC of the

European Parliament and of the Council concerning the placing on the market of biocidal products”(BPD)

• Biocidal products definition: 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 action (article 2 of BPD)



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ANNEX V OF 98/8/EC DIRECTIVE

BIOCIDAL PRODUCT TYPES23 Product Types (PT) divided over 4 Groups:

• I DISINFECTANTS & GENERAL BIOCIDES

• II PRESERVATIVES• III PEST CONTROL PRODUCTS• IV OTHER BIOCIDES

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Product-type 1:: Human hygiene biocidal productsProduct-type 2: Private area and public health area disinfectants

and other biocidal productsProduct-type 3: Veterinary hygiene biocidal productsProduct-type 4: Food and feed area disinfectantsProduct-type 5: Drinking water disinfectantsProduct-type 6: In-can preservativesProduct-type 7: Film preservativesProduct-type 8: Wood preservativesProduct-type 9: Fibre, leather, rubber and polymerised materials

preservatives.Product-type 10: Masonry preservativesProduct-type 11: Preservatives for liquid-cooling and processing

systemsProduct-type 12: SlimicidesProduct-type 13: Metalworking-fluid preservativesProduct-type 14: RodenticidesProduct-type 15: Avicides



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Product-type 16: Molluscicides.

Product-type 17: Piscicides

Product-type 18: Insecticides, acaricides and products to control other arthropods

Product-type 19: Repellents and attractants

Product-type 20: Preservatives for food or feed stocks

Product-type 21: Antifouling products

Product-type 22: Embalming and taxidermist fluids

Product-type 23: Control of other vertebrates

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Conditions for issue of an authorisationto a biocidal product (article 5.1. (b) (iii and iv)

It has no unacceptable effects itself or as a result of its residues

On human or animal health directly or indirectly (e.g. through drinking water, food or feed) On the environment, having particular regard to fate and distribution and its impact on non-target organisms

RISK ASSESSEMENT



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RISK ASSESSMENT

• The comparison of a predicted human dose from undertaking a task or tasks with appropriate toxicological endpoints values or NOAELS (TNsGon Human Exposure)

• A process intended to calculate or estimate the risk to a given target organism, system or (sub)population, including the identification of attendant uncertainties, following exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system (joint OECD/IPCS survey)

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Risk Assessment:

Comparison of exposure

with

effects

Final outcome: Risk characterization



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Hazard Characterization

(Effects Assessmentor

Dose-Response Assessment)

Risk Characterization

RISK ASSESSEMENT(fist componentin a risk analysis

process)

Hazard Identification

Exposure Assessment

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HAZARD IDENTIFICATION

Hazard: the inherent property of an agent or situation having the

potential to cause adverse effects when an organism is exposed to

that agent

(neurotoxicity, carcinogenicity, etc)



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High hazard

High hazard

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Risk• The probability of an adverse effect

in an organism, system or (sub) population caused under specified circumstances by exposure to an agent



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High hazard, … low risk

High hazard

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Set of datafor a Biocide (dossier)

Hazard identified

Hazard Characterization (Effects assessment

Dose/responseAssessment)

(NOAEL*)

Exposure Assessment

(TDI* mg/kg bw day)

Risk CharacterizationIncidence and severity

TDI< NOAELTDI> NOAEL

*NOAEL=No Observed Adverse Effect Level

* TDI =total daily intake

Risk assessment



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Part I: Risk Assessment for Human Health

Part II: Environmental Risk Assessment

Part III: (Q)SARs/Use Categories/RA Report Format

Part IV: Emission Scenario Documents

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Technical Notes for Guidance (TNsG)

Five Technical Notes for Guidance (TNsG) have specifically been developed for biocides:

1. TNsG on Data Requirements:This document provides guidance on the data requirements and waiving arguments that are required for biocidal active substances and products.2. TNsG on Annex I Inclusion:This document identifies criteria for unacceptable/acceptable effects and associated conditions for inclusion of active substances onto Annex I (or IA or IB).3. TNsG on Product EvaluationThis document provides guidance on how to perform the administrative and scientific evaluation of applications for authorisation and registration.4. TNsG on Human Exposure:This document provides guidance on the estimation of Human Exposure to biocidal products for all Product Types.5. TNsG on Dossier Preparation and Study Evaluation:This guidance focuses primarily on applications for the inclusion of active substances onto Annex I (or IA or IB). It is intended to give guidance on how the documentation to be submitted by the applicant should be prepared and presented.



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Assessment of Human Exposure

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Human Exposure • Occupational (at workplace) (professional

users, workers) (industrial workers are covered by other EU legislation) (primary exposure)

• Non-professional users (consumers/users of any consumer product purchased from retail outlets) (primary exposure)

• Bystanders and others indirectly exposed via the environment (general public) (secondary

exposure)



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HUMAN EXPOSURE

PRIMARY(direct)

SECONDARY(indirect)

Occupational (Professional

users)

Non-professionaluses

(consumers)

•Bystanders•General public

Indirectly exposedvia environment

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ROUTES of EXPOSURE/PATHWAYS OF EXPOSURE

Inconsistent use of terms in the TGD and TNsG

EFSA adopted in 2008 the EPA terminology• Source of exposure: manner of use or intended

purpose (PPP, biocide, veterinary, etc)• Pathway: food, drinking water, residential,

occupational)• Route: Inhalation, dermal, ingestion (oral??)



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Human exposure

NON-PRO

FESSIONAL

(consu

mer)

Via Environment

air water food soil

oral dermalinhalation

professional

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Pathways of Exposure (USDA)Food

ResidentialWater



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Human indirect (secondary) Human indirect (secondary) exposure exposure routesroutes (from TGD Part I)(from TGD Part I)

Are they Are they routesroutes or pathways?or pathways?Air

fish

meat

dairy products

crops

drinking water

HUMANS

cattle

Soil

Groundwater

Surfacewater

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Exposure Scenarios(assessment through

modelling)



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Assessment of occupational (professional)

exposure(TGD)

• EASE model (Estimation and Assessment of Substance Exposure): inhalation and dermal exposure from normal use (UK HSE)

• Other models developed by USA EPA

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Assessment of non-professional (consumer) exposure

(TGD scenarios)• Inhalation (aerosols, gases, evaporation of

dusts, etc)• Dermal (from a substance contained in the

product or from migration of a non-volatile substance from an article, i.e. newsprint from paper)

• Oral (ingestion) (from unintentional swallowing during normal use of a product or from migration

of a substance into food or drink from an article, i.e. cups, plates)



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Assessment of non-professional (consumer) exposure

(several computer models )• EUSES (screening)• CONSEXPO • EPA • CEM (Consumer exposure model of the USA Office of Pollution

Prevention and Toxics)• MCCEM• SHEDS• Calendex• Lifeline• Notitia/CARES• BEAT

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Assessing risks fromAssessing risks from migration of a substance into migration of a substance into food or drink from an food or drink from an article, i.e. cups, plates)article, i.e. cups, plates)

HERA HERA Human and Environmental Risk AssessmentsHuman and Environmental Risk Assessmentson ingredients of household cleaning productson ingredients of household cleaning products

A voluntary European industry programme



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Assessment of indirect exposure via the environment

Fish(BCF) Drinking water

(TNG)

Estimating exposure through

FOOD

Products of Plant Origin (PLANTX model)

Products of Animal Origin (Travis and Arms 1988)

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ENVIRONMENTAL EXPOSURE

COMPARTMENTS ORGANISMS

Terrestrial(Soil)

Acquatic(GroundSurface Water/

Sediment)

Aquatic organismsTerrestrial vertebratesSoil microfloraEarthwormsNon-target arthropodsHoneybeesNon-target higher plants

Atmo-sphere

Non compartment

-specificexposurerelevant

to food chain(secondary poisoning)



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European Union Biocides Environment Emission Scenarios

(Gathering, review and development of Environment Emission Scenarios for Biocides)

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Applicability of estimation models

• Theoretical background is OK• All underlying assumptions together

drastically reduce the applicability of the models



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European Chemical Bureau

Joint Research CentreIspra Italy

http://ecb.jrc.it

DG Environment(http://ec.europa.eu/environment/biocides)