ISO 13073-1:2012

Ships and marine technology - Risk assessment on anti-fouling systems on ships - Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling systems on ships

ISO 13073-1.2012 specifies a risk assessment method that protects the marine environment from the potential negative impacts of biocidally active substances that are intentionally used in the anti-fouling system applied to a ship during its service life. This method can also be modified for use in freshwater environments. ISO 13073-1.2012 does not provide a specific test method for evaluating the hazard and toxicity or usage restrictions of certain substances. This also does not provide an efficacy-evaluation method for an anti-fouling system using a specific substance. The following are not covered by ISO 13073-1.2012: the risk assessment of biocidally active substances in anti-fouling systems during their application and removal during vessel maintenance and repair, new building or ship recycling; the use of anti-fouling systems intended to control harmful aquatic organisms and pathogens in ships' ballast water and sediments according to the International Convention for The Control and Management of Ships' Ballast Water and Sediments, 2004; anti-fouling systems applied to fishing gear, buoys and floats used for the purpose of fishing, and to equipment used in fisheries and aquaculture (nets/cages etc); test patches of anti-fouling systems on ships for the purpose of research and development of anti-fouling products; and the assessment of risk of biocidally active substances in cases of accidental releases, such as spillage during ocean transport or releases into the sea from rivers and/or coastal facilities.

Navires et technologie maritime — Évaluation des risques pour les systèmes antisalissure sur les navires — Partie 1: Méthode d'évaluation des risques environnementaux maritimes des substances actives biocides utilisées pour les systèmes antisalissure sur les navires

General Information

• Status: Published
• Publication Date: 23-Jul-2012
• ICS: 13.020.99 - Other standards related to environmental protection
• ICS: 47.020.99 - Other standards related to shipbuilding and marine structures
• Technical Committee: ISO/TC 8/SC 2 - Marine environment protection
• Drafting Committee: ISO/TC 8/SC 2 - Marine environment protection
• Current Stage: 9093 - International Standard confirmed
• Start Date: 11-Oct-2023
• Completion Date: 13-Dec-2025

Overview

ISO 13073-1:2012 - Ships and marine technology - Part 1 - defines a marine environmental risk assessment method for biocidally active substances used in anti-fouling systems on ships. The standard provides a structured, pragmatic approach to evaluate potential impacts of substances intentionally released from anti-fouling coatings during a ship’s service life. It is adaptable for freshwater environments but does not prescribe specific toxicity test methods or efficacy tests for anti-fouling products.

Key topics and technical requirements

• Scope and exclusions: Focuses on in-service releases from anti-fouling systems; excludes application/removal during maintenance, shipbuilding/recycling, test patches, fisheries equipment, ballast-water treatment systems, and accidental spills.
• Exposure assessment: Selection of representative products, quantification of release rates, preparation of emission scenarios, and estimation of predicted environmental concentration (PEC).
• Hazard assessment: Compilation of ecotoxicity data and derivation of predicted no-effect concentration (PNEC) using appropriate assessment factors and data quality considerations.
• Risk characterization: Comparison of PEC/PNEC ratios to determine environmental risk, treatment of organic vs. inorganic biocides, and handling of bioaccumulative or persistent substances.
• Reporting and documentation: Minimum information for a risk assessment report and structured presentation of results.
• Supporting annexes: Guidance on release-rate estimation methods, risk characterisation details for organic and inorganic substances, data quality examples, testing method references, and validated models for PEC prediction.

Practical applications and users

ISO 13073-1:2012 is intended for stakeholders who need to evaluate environmental risks from anti-fouling biocides, including:

• Shipowners and shipyards assessing hull coating options
• Paint and biocide manufacturers preparing dossiers for approvals or stewardship
• Environmental consultants conducting marine risk assessments
• Regulatory agencies and approval systems implementing national or regional controls
• IMO contracting parties and organizations harmonizing assessments under the AFS Convention

Typical uses include product approval workflows, environmental permitting, comparative assessment of anti-fouling options, and supporting compliance with international guidance on harmful anti-fouling systems.

Related standards and guidance

• ISO 13073 series (Part 2: system-level assessment; Part 3: human health assessment - under development)
• IMO International Convention on the Control of Harmful Anti-fouling Systems on Ships (AFS Convention)
• References to validated models and recognized ecotoxicity test guidelines (listed in the standard’s annexes)

ISO 13073-1:2012 provides a consistent, transparent framework for marine environmental risk assessment of anti-fouling biocides, helping regulators and industry manage environmental impact while supporting compliant product development and use.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13073-1
First edition
2012-08-01
Ships and marine technology — Risk
assessment on anti-fouling systems on
ships —
Part 1:
Marine environmental risk assessment
method of biocidally active substances
used for anti-fouling systems on ships
Navires et technologie maritime — Évaluation des risques pour les
systèmes antisalissure sur les navires —
Partie 1: Méthode d’évaluation des risques environnementaux
maritimes des substances actives biocides utilisées pour les systèmes
antisalissure sur les navires
Reference number
©
ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Terms and definitions . 1
3 Application . 4
3.1 General . 4
3.2 Application considerations . 4
4 Structure and procedure of environmental risk assessment . 5
5 Exposure assessment . 5
5.1 Selection of representative product . 5
5.2 Quantification of release rate . 6
5.3 Preparing the emission scenario . 6
5.4 Determination of PEC . 8
6 Hazard assessment . 8
6.1 Setting of PNEC . 8
6.2 Consideration of assessment factors .10
6.3 Determination of PNEC used for risk characterization .10
7 Risk characterization . 11
7.1 General . 11
7.2 Data and information . 11
7.3 Assessment results .12
7.4 Additional information obtained after last risk characterization .13
8 Risk assessment report .13
Annex A (informative) Systems for estimation of release rates of biocidally active substances from anti-
fouling paints .14
Annex B (normative) Details of risk characterization process of an environmental risk assessment for
organic biocidally active substances used in anti-fouling systems on ships .17
Annex C (normative) Issues to be considered for risk characterization for inorganic biocidally active
substances used in anti-fouling systems on ships .24
Annex D (informative) Examples of guidance for determining data quality .28
Annex E (informative) Examples of testing methods.29
Annex F (informative) Setting of assessment factors (AF) .34
Annex G (normative) Minimum information required for the risk assessment report .40
Annex H (informative) Previously validated models for predicting environmental concentrations .44
Bibliography .46
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13073-1 was prepared by Technical Committee ISO/TC 8, Ships and marine technology, Subcommittee
SC 2, Marine environment protection
ISO 13073 consists of the following parts, under the general title Ships and marine technology — Risk
assessment on anti-fouling systems on ships:
— Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling
systems on ships
— Part 2: Marine environmental risk assessment method for anti-fouling systems on ships using biocidally
active substances
— Part 3: Human health risk assessment for the application and removal of anti-fouling systems (under development)
iv © ISO 2012 – All rights reserved

Introduction
The attachment of fouling organisms, such as barnacles and algae, on the submerged parts of a ship’s hull
increases the propulsive resistance of the hull against water, leading to increased fuel consumption and
accidental introduction of non-indigenous species to a foreign marine environment, which may possibly cause
significant and harmful changes. As a means of preventing such circumstances, an anti-fouling system that
relies on biocidally active substances (e.g. anti-fouling paint) to prevent attachment of fouling organisms can
be applied onto the hull of the ship. The harmful effects of organotin compounds used as biocides (historically
used in anti-fouling paint) on marine organisms and human health have been of global concern. To prevent
the continued use of these compounds, a legally-binding international framework regulating the use of anti-
fouling systems containing harmful substances was enacted by the International Maritime Organization (IMO).
Consequently, the International Convention on the Control of Harmful Anti-fouling Systems on Ships (the AFS
Convention) was adopted at the IMO diplomatic conference held in London in October 2001, and entered into
force in September 2008.
The Convention envisages handling various harmful anti-fouling systems within its framework and lays out a
process by which anti-fouling systems can be risk assessed. Annexes 2 and 3 of the Convention include the
list of information needed to determine whether an anti-fouling system is harmful to the environment and should
be restricted from use on ships, but a marine environmental risk assessment method for making this decision
is not provided. Furthermore, Resolution 3, adopted by IMO along with the AFS Convention, recommends that
contracting Parties continue to work in appropriate international fora for harmonization of test methods and
assessment methodologies, and performance standards for anti-fouling systems containing biocidally active
substance(s).
Based on this, there is a global need for an international method for conducting scientific environmental risk
assessments of biocidally active substances for use in anti-fouling systems. This part of ISO 13073 provides a
pragmatic approach to introducing systems (i.e., self-regulation or approval systems) in countries where either
no system exists, or a less developed system is in place and would help such countries improve protection of
the aquatic environment.
This part of ISO 13073 is intended to be used for the positive evaluation of biocidally active substances for
use in anti-fouling systems. For an evaluation of a biocidally active substance’s entry onto Annex 1 of the AFS
Convention, which is a negative listing, the methodology can be used but the evaluation should include an
extensive assessment supported by the full data requirements established in the AFS Convention.
INTERNATIONAL STANDARD ISO 13073-1:2012(E)
Ships and marine technology — Risk assessment on anti-
fouling systems on ships —
Part 1:
Marine environmental risk assessment method of biocidally
active substances used for anti-fouling systems on ships
1 Scope
This part of ISO 13073 specifies a risk assessment method that protects the marine environment from the
potential negative impacts of biocidally active substances that are intentionally used in the anti-fouling system
applied to a ship during its service life. This method can also be modified for use in freshwater environments.
This part of ISO 13073 does not provide a specific test method for evaluating the hazard and toxicity or usage
restrictions of certain substances. This also does not provide an efficacy-evaluation method for an anti-fouling
system using a specific substance.
The following are not covered by this part of ISO 13073:
— the risk assessment of biocidally active substances in anti-fouling systems during their application and
removal during vessel maintenance and repair, new building or ship recycling;
— use of anti-fouling systems intended to control harmful aquatic organisms and pathogens in ships’ ballast
water and sediments according to the International Convention for The Control and Management of Ships’
Ballast Water and Sediments, 2004;
— anti-fouling systems applied to fishing gear, buoys and floats used for the purpose of fishing, and to
equipment used in fisheries and aquaculture (nets/cages etc);
— test patches of anti-fouling systems on ships for the purpose of research and development of anti-
fouling products;
— the assessment of risk of biocidally active substances in cases of accidental releases, such as spillage
during ocean transport or releases into the sea from rivers and/or coastal facilities.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
acute test
exposure test on an aquatic species conducted for a short period (mostly for several dozen hours, although it
varies among species), in order to obtain an LC or EC for fish fatality, abnormal behaviour of invertebrates,
50 50
or inhibition of algal growth as the end point
2.2
anti-fouling system(s)
coating, paint, surface treatment, surface, or device that is used on a ship to control or prevent attachment of
unwanted organisms
2.3
assessment factor(s)
numerical factor that accounts for the uncertainty of extrapolating an effect concentration based upon
experimentally derived hazard end points (for example, dose-dependent measures such as NOEC) to Predicted
No-Effect Concentrations for use in environmental risk assessment
NOTE The hazard end point derived using a particular data point is divided by the assessment factor to define the
PNEC for that particular biocidally active substance. It is equivalent to the “uncertainty factor” used in risk assessment for
human health effects.
2.4
biocidally active substance(s)
substance having general or specific action such as mortality, growth inhibition, or repellence, on unwanted
fouling organisms, used in anti-fouling systems, for the prevention of attachment of sessile organisms
2.5
chemical substance(s)
chemical element and its compounds in the natural state or obtained by any manufacturing process
2.6
chronic test
exposure test on an aquatic species conducted through most of its lifecycle, during its sensitive period (for
fish, from fertilized eggs to the early life stage such as larvae and juveniles that take food), or for several
generations, in order to obtain a NOEC for mortality, growth or reproduction as the end point
NOTE OECD Guidelines for Testing of Chemicals, Test Nos. 212 and 215 are not chronic tests.
2.7
correction factor
numerical factor that accounts for the difference between the estimated release rate using a given method and
the expected release rate from an anti-fouling system in-service; the estimated release rate using a particular
method is divided by the correction factor to allow a more accurate and representative estimate to be made of
the release rate to the marine environment
2.8
emission scenario
set of parameters that define the sources, pathways and use patterns with the aim of quantifying the releases
of a chemical or biocidally active substance into the environment
NOTE Emission scenarios are used in the risk assessment to establish the conditions on use and releases of the
chemicals that are the bases for estimating the predicted concentrations of chemicals in the environment.
2.9
exposure assessment
procedure for evaluating the exposure of an organism, system or (sub)population to a biocidally active substance
(and its degradants and/or metabolites), accounting for the exposure path, exposure amount, and concentration
2.10
harmful organism
any organism that has an unwanted presence or a detrimental effect on human activities, products they use or
produce, animals or the environment
2.11
hazard assessment
process designed to determine the possible adverse effects of a biocidally active substance to which an
organism, system or (sub)population could be exposed
2 © ISO 2012 – All rights reserved

2.12
lowest-observed effect concentration
LOEC
lowest tested concentration of a test substance at which the substance is observed to have a significant effect
when compared with the control
NOTE All test concentrations above the LOEC must have an effect equal to or greater than those observed at the LOEC.
2.13
marine environment
physical, chemical and biological features surrounding marine organisms, affecting the viability and bio-
function of the organisms
NOTE Seawater and estuarine regions are included.
2.14
no-observed-effect concentration
NOEC
highest tested concentration of a test substance at which no statistically significant lethal or other effect is
observed when compared with the control
2.15
predicted environment concentration
PEC
estimated concentration of a substance in a defined environment as quantified using exposure assessment
NOTE The substance is a biocidally active substance, a chemical substance, metabolite or any other relevant substance.
2.16
predicted no-effect concentration
PNEC
concentration of a substance determined from hazard assessment by applying a suitable assessment factor,
below which no adverse effect to a defined environment is anticipated
2.17
release rate
representative value of the mass of biocidally active substance released in a day from the unit surface area of
an anti-fouling system to water
−2 −1
NOTE Release rate is expressed in µg cm day .
2.18
risk
combination of the probability and the severity of an adverse effect due to a substance under certain conditions
2.19
risk assessment
process intended to quantitatively estimate the risk posed by exposure to a substance
NOTE 1 A quantitative assessment of environmental risk is defined as “environmental risk assessment”.
NOTE 2 In the case of low degradability and significantly high bioaccumulation, risk assessment is conducted without
calculating PEC/PNEC ratio.
2.20
risk characterization
procedure to determine the risk level from the PEC/PNEC ratio calculated based on PEC calculated from
exposure assessment and PNEC calculated from hazard assessment
2.21
ships
vessels of any type whatsoever operating in the marine environment including hydrofoil boats, air-cushion
vehicles, submersibles, floating craft, fixed or floating platforms, floating storage units (FSUs) and floating
production storage and off-loading units (FPSOs)
2.22
worst-case scenario
realistic scenario in which organisms living in marine environment are expected to be most exposed to the
biocidally active substance
2.23
50 % effective concentration
EC
concentration at which an effect is observed in 50 % of test organisms
2.24
50 % lethal concentration
LC
concentration at which 50 % of test organisms would die in an experiment
3 Application
3.1 General
Risk assessment, as defined in this part of ISO 13073, is conducted for the protection of the marine environment.
The risk assessment shall be conducted for any degradates where there is evidence that they will be present
in the environment at levels greater than 10 % mass of the parent compound from which they were formed.
This part of ISO 13073 could be modified for assessing risk to freshwater environments such as rivers and
lakes. Special attention should be given to defining the emission scenarios required for freshwater areas, and
particular care should be taken to consider effects on the species found in those environments.
This part of ISO 13073 provides a minimum guideline for the following uses:
— regulation of anti-fouling systems by government organizations;
— self-regulation or approval system for industry or industrial organizations;
— evaluations conducted for product development by the industry.
This part of ISO 13073 will enable quantitative characterization of the environmental risk posed by a biocidally
active substance on the marine environment, and will determine whether the environmental risk of the substance
is acceptable.
3.2 Application considerations
The following shall be taken into account when this part of ISO 13073 is used:
a) This part of ISO 13073 provides a method for quantifying the marine (and freshwater, where necessary)
environmental risk posed by a biocidally active substance, but does not directly regulate or approve the
use or commercialization of the substance. Classification of a substance into the category of “risk of high
concern” does not directly mean prohibition of its use. It may be accepted for use under certain conditions
such as under continuous monitoring of the substance or its metabolites in the environment.
b) This part of ISO 13073 does not include a method for a general risk assessment of industrial chemical
substances. This is based on the assumption that it has already been accomplished by other methods.
4 © ISO 2012 – All rights reserved

c) For regulatory systems with approval or evaluation procedures developed according to this part of
ISO 13073 and with restriction of a substance classified as “tentatively low risk” under Level 1 of Tier 2,
an appropriate sale period or quantity should be specified taking into account the severity of the potential
effects on the exposed environment.
All data submitted by an applicant is, and shall remain, the property of the applicant under this part of ISO 13073.
These data shall not be made available to other applicants without prior written approval from the owner of the data.
4 Structure and procedure of environmental risk assessment
Environmental risk assessment consists of three procedures: exposure assessment, hazard assessment and
risk characterization. Exposure assessment is a procedure used to obtain the PEC, and hazard assessment
is used to obtain the PNEC. The ratio of the PEC to the PNEC (PEC/PNEC) is used as a quantitative index for
the risk assessment. This procedure is summarized in Figure 1.
The risk characterization processes of the environmental risk assessment for organic and inorganic biocidally
active substances used for anti-fouling systems on ships are provided in Annexes B and C, respectively.
NOTE * An organic biocidally active substance is considered to be very bioaccumulative and with “risk of high
concern” when its bioconcentration factor (BCF) is more than 2 000.
Figure 1 — Composition and schematic procedure of environmental risk assessment
5 Exposure assessment
5.1 Selection of representative product
A representative product (for example, an anti-fouling paint) for the exposure assessment shall be chosen
from anti-fouling systems containing the biocidally active substance to be assessed. This product shall have
a release rate as quantified according to 5.2.1. The risk assessment process can lead to a determination of
the maximum release rate of that biocidally active substance which can be used in real products to maintain
protection of the environment.
5.2 Quantification of release rate
There are three approaches to determining release rates: calculation, laboratory testing and field measurement.
5.2.1 Quantification method
The release rate of biocidally active substances into seawater from the anti-fouling system applied onto the
ship shall be estimated.
There are several methods to estimate the release rate for the anti-fouling system. Examples of the existing
calculation, laboratory and field methods are described in Table A.1.
It is preferable to select one of the methods in Annex A, but this part of ISO 13073 does not preclude the
development and/or use of other quantification methods.
Appropriate correction factors should be applied to laboratory and calculated release rate data to enable the
most reliable estimate of environmental release rates to be made.
NOTE The results of laboratory test methods described in Table A.1 do not generally reflect the environmental
release rates for anti-fouling products in use, and they are not necessarily suitable for direct use in the environmental risk
assessment. The mass-balance calculation method described in Table A.1 generally provides more realistic environmental
release rates, which are more suitable for use in the environmental risk assessments than the results of the laboratory test
methods. A suitable method is selected on a case-by-case basis.
5.2.2 Test laboratory
When the release rate is estimated through measurements in testing laboratories, tests should be conducted
at a laboratory that complies with ISO 17025 or at establishments with equivalent qualifications.
5.3 Preparing the emission scenario
The emission scenario is a set of parameters that define the sources and pathways of exposure, as well as use
patterns of the biocidally active substance in the anti-fouling system. The scenario enables the quantification
of the distributions of the release to the environment by taking into account the physico-chemical parameters
of both the substance and the exposed environment.
Examples of existing emission scenarios for anti-fouling products can be found in the OECD EMISSION
SCENARIO DOCUMENT (OECD, 2005).
5.3.1 Types of marine environments to be considered
With regard to the service life of an anti-fouling system used on ships, the characterization should be conducted
for a marine environment where the biocidally active substance is to be released. Types of marine environments
to be considered may be as follows:
— open sea;
— shipping lane;
— harbour;
— marina.
It may also be necessary to consider other bodies of water (e.g. a larger expanse of water).
Depending on the usage of products or receiving waters, it may not be necessary to consider all the environment
types cited above.
6 © ISO 2012 – All rights reserved

5.3.2 Defining the emission scenario
Following the selection of the type(s) of marine environments under consideration, a representative scenario
should be proposed that gives typical dimensions of the exposed environment. For example, the length, width
and depth of a typical harbour should be defined. The emission scenario should provide enough information to
enable the predicted environmental concentrations to be calculated taking into account the relevant physico-
chemical and hydrodynamic parameters of the defined scenario. The typical parameters to be considered
when a scenario for modelling the PEC is defined are given below.
a) the release rate of the biocidally active substance:
— release rate of biocidally active substance (the mass of biocidally active substance per unit area
and unit time).
b) parameters relating to emission:
— total number of ships at berth and total number of ships moving;
— proportion of ships moving;
— proportion of ships at berth;
— submerged surface area of ships (surface area per length class of ships);
— percentages of the ships painted with the product.
c) the layout of the target sea area:
— the length and the width (or surface area), and depth of the target sea area;
— the width and depth of the boundary between the target sea area and non-target sea area (e.g.
exchange area, harbour mouth below mean sea level, depth in harbour entrance).
d) water quality:
— temperature;
— salinity;
— pH;
— silt concentration (silt fraction < 63 µm in mg/L);
— fraction of organic carbon [organic carbon content (dry mass) of sediment];
— POC and DOC concentration [particulate and dissolved organic carbon (OC) concentration in mg OC/L)];
— suspended particulate matter in the water column.
e) hydrology:
— tidal exchange rate (in-flow and out-flow rate of water per unit time and unit cross-section);
— flow rate of rivers and streams connected to the target sea area (in-flow and out-flow rate of water per
unit time and unit cross-section).
f) environmental media:
— depth of mixed sediment layer;
— dissolved organic carbon.
NOTE This list is not exclusive.
5.3.3 Requirements for setting parameters
All the parameters shall be set to give a realistic worst-case scenario. Examples of such scenarios are given in
the OECD EMISSION SCENARIO DOCUMENT (OECD, 2005). When a scenario is produced, it is important to
ensure that a realistic worst-case scenario is developed. For example, when risk to harbours is assessed, one
would survey the dimensions of a suitable sub-set of harbours from the country of interest. Typical dimensions can
then be defined based upon this sub-set of harbours for the country. Depending upon the size of the sub-set, an
appropriate statistical measure should be chosen (e.g. average length, or 95th percentile length of the data set).
5.4 Determination of PEC
The PEC for each emission scenario and each relevant environmental compartment should be determined
using the parameters determined in 5.3.2 and 5.3.3 and the properties relevant to each specific substance
under consideration. Typical parameters may include the following:
— degradation rate of the biocidally active substance (abiotic and/or biological);
— particle adsorption rate (or ratio of the biocidally active substance bound to particulates compared to this
substance dissolved in seawater);
— organic-carbon partitioning coefficient (K );
oc
— bioaccumulation factor of the biocidally active substance.
In calculating the PEC, a suitable mathematical model should be chosen which can determine the environmental
loading by taking into account all the parameters defined in the scenario. Typically this is handled by a suitable
computer program such as MAMPEC (Marine Antifoulant Model to Predict Environmental Concentrations).
Annex H describes a number of validated models which should be used.
The organic-carbon partitioning coefficient (K ) in suspended matter can be determined by adsorption studies
oc
(OECD TG 106) or measured by the HPLC-method (OECD TG 121).
Examples of average or typical values of the volume fraction of seawater in suspended solids, the volume
fraction of solids in suspended matter, the density of the solid phase, and the mass fraction of organic carbon
in suspended matter are listed in the Technical Guidance Document (European Commission, 2003).
Where necessary, the PEC for predators and mammals (PEC ) should be determined using the parameters
pred
such as BCF, mean fish consumption rate, and the PEC for seawater (PEC ).
SW
It is important that any models used to determine the PEC are themselves appropriately validated. The validation
report for the model should be made available as a part of the risk assessment report. Validated models for
PEC determination are described in Annex H.
6 Hazard assessment
6.1 Setting of PNEC
6.1.1 Setting of PNEC in seawater (PNEC )
sw
6.1.1.1 PNEC estimation from chronic test results
sw
When chronic test results are used, PNEC is calculated with the formula below.
sw
NOEC
c
PNEC = (1)
SW
AF
where
PNEC is the PNEC in seawater (mg/L);
SW
8 © ISO 2012 – All rights reserved

NOEC is the lowest NOEC obtained through chronic testing (mg/L);
c
AF is the assessment factor (see 6.2).
The lowest NOEC obtained through each chronic test is used for the calculation of the PNEC . The AF is
c SW
determined based on the factors cited in 6.2.
According to many OECD Test Guidelines, test concentrations should be arranged in a geometric series unless
otherwise stated in the relevant test guidelines. For example, a constant factor not exceeding 3,2 is required
in OECD 210. In certain studies, the ratio between test concentrations may exceed the factor specified under
the validated test methods. In this case, the average value of NOEC and LOEC (maximum allowable toxicant
concentration, MATC) may be used as the NOEC.
6.1.1.2 PNEC estimation from acute test results
sw
When acute test data are used, PNEC is calculated with the formula below:
SW
L(E)C
PNEC = (2)
SW
AF
where
PNEC is the PNEC for seawater (mg/L);
SW
L(E)C is the 50 % Lethal Concentration (LC ) or the 50 % Effective Concentration (EC )
50 50 50
(mg/L);
AF is the assessment factor.
The lowest L(E)C obtained from the acute test data is used for the calculation of the PNEC . The AF is
50 SW
determined based on the factors cited in 6.2.
6.1.1.3 Considerations for data-rich substances
Many substances, particularly metals, are very data-rich with many and repeated studies being available both in
the public domain and in protected data systems. Thus, evaluation of such a wide collection of data requires a
complex screening and assessment of the studies using, for example, probabilistic techniques (6.1.1.4) to allow
them to be used to establish a robust evaluation of the environmental risk posed by the use of such substances.
6.1.1.4 Typical statistical extrapolation techniques to be used
The method of choice for statistical extrapolation is the model that assumes a parametric distribution for
the different chronic ecotoxicity data (no observed effect concentrations: NOEC’s) observed on a number of
species, belonging to an ecosystem. In order to estimate the uncertainty associated with the use of limited
data sets, 95 % and 50 % confidence limits can be calculated for 5 % hazardous concentrations (HC5) value.
The PNECs are usually set at the level of the 50 % lower confidence value of the HC5. These statistical
extrapolation techniques are explained in the existing guidance such as the Technical Guidance Document
(European Commission, 2003).
6.1.2 Setting of PNEC for sediment-dwelling organisms (PNEC )
sed
6.1.2.1 PNEC estimation from chronic test results
sed
When chronic test results are used, PNEC is calculated with the formula below
sed
Chronic
sed
PNEC = (3)
sed
AF
where
PNEC is the PNEC for sediment-dwelling organisms (mg/kg);
sed
Chronic is the lowest NOEC obtained through the chronic test, the 10 % Lethal Concentration
sed
(LC ) or the 10 % Effective Concentration (EC ) (mg/kg);
10 10
AF is the assessment factor.
The lowest NOEC obtained through each chronic test or the lowest LC or EC obtained through each
sed 10 10
acute test is used for the calculation of the PNEC . The AF is determined based on the factors cited in 6.2.
sed
6.1.2.2 PNEC estimation from acute test results
sed
When acute test data are used, PNEC is calculated with the formula below:
sed
L(E)C
PNEC = (4)
sed
AF
where
PNEC is the PNEC for sediment-dwelling organisms (mg/kg);
sed
L(E)C is the 50 % Lethal Concentration (LC ) or the 50 % Effective Concentration (EC )
50 50 50
(mg/kg);
AF is the assessment factor.
The lowest L(E)C obtained from the acute test data is used for the calculation of the PNEC . The AF is
50 sed
determined based on the factors cited in 6.2.
6.1.3 Setting of PNEC for avian and mammalian species (PNEC )
pred
The PNEC for organisms in trophic levels higher than fish is calculated with the following formula:
Tox
pred
PNEC = (5)
pred
AF
where
PNEC is the PNEC for an organism of higher trophic level (mg/kg);
pred
Tox is the toxicity value for an organism of higher trophic level (mg/kg);
pred
AF is the assessment factor.
The lowest value of either LC or NOEC for avian species or NOEC for mammals is set as Tox and used
50 pred
to calculate the PNEC. The AF is determined based on the factors cited in 6.2.
6.2 Consideration of assessment factors
In order to adjust the uncertainty in calculating the PNEC that results from testing on a limited set of potential
aquatic organisms, an assessment factor is incorporated into the PNEC based on the test type, number of
tested species, and number of trophic levels covered by the test species.
Some examples of setting the assessment factor are described in Annex F; a combination of these
methods/perspectives may be appropriate.
6.3 Determination of PNEC used for risk characterization
The PNEC to be used in a risk characterization calculation will be derived from the lowest experimentally
determined value, either NOEC from chronic test data or L(E)C from acute test data. This NOEC or L(E)C
50 50
is used in conjunction with the appropriate assessment factor derived from the entire ecotoxicology data set.
10 © ISO 2012 – All rights reserved

7 Risk characterization
7.1 General
Risk characterization for organic substances shall be conducted according to the tiered process described in
Annex B. Risk characterization for inorganic substances shall be conducted under Annex C. The PNEC for
organic substances is calculated using the toxicity data developed for each tier/level of the process. The risk
level should be determined by calculating the ratio of PEC to PNEC (PEC/PNEC ratio). Both systems use a
step-by-step approach to risk characterization utilizing the common approach described below.
Metallic complexes of organic compounds should undergo risk characterization to both Annexes B and C.
7.2 Data and information
7.2.1 Collection and acquisition of data and information
In order to conduct the assessment appropriately, data and information concerning the physico-chemical
characteristics, environmental behaviour and hazardous properties of the biocidally active substances are
required. Appropriate tests are described in Annexes B and C.
7.2.2 Reliability assessment of the collected data
7.2.2.1 Reliability assessment of data
Standard methodologies already exist for determining a reliability score to assess the data. One of such
systems is the Klimisch scoring system (see D.4). Within this approach, consideration should also be given to
a “weight-of-evidence” analysis.
7.2.3 Determination of any data gaps
If necessary, data gaps should be closed using as much information as possible from existing studies by
applying the examples mentioned in OECD (2009). These include the following.
— Quantitative Structure-Activity Relationship (QSAR): a quantitative (mathematical) relationship between
a numerical measure of chemical structure, and/or a physico-chemical property, and an effect/activity.
QSARs often take the form of regression equations, and can make predictions of effects/activities that are
either on a continuous scale or on a categorical scale. Thus, in the term “QSAR”, the qualifier “quantitative”
refers to the nature of the relationship, not the nature of the end point being predicted. Caution should be
used that only those QSAR techniques appropriate to class of the substances (e.g. organic or inorganic)
are employed.
— Read-across argumentation: the technique for filling data gaps, where end point information for an untested
chemical is predicted by using data on the same end point for a tested chemical, which is considered to
be “similar” for some aspect (e.g. activity, property or structure). A read-across argumentation is feasible,
where studies exist for an analogous substance to the one under consideration. If such an argument is
substantiated, then the studies on one salt of an inorganic substance may be used for other salts of the
same substance.
— Grouping approaches: the use of properties across a group of substances which show substantial
similarities for the group as a whole.
Only valid studies should be used, and the most conservative value from these studies should be used to derive
the PNEC. Data evaluated as “not reliable” or “of very low reliability” shall not be used for the risk assessment.
Examples of guidance on data quality evaluation methods are provided in Annex D.
7.2.4 Test requirements
7.2.4.1 Testing methods
Tests shall be conducted according to internationally recognized test methods, or test methods equivalent to
such methods (see Annex E), by an organization or a laboratory meeting Good Laboratory Practice (GLP)
requirements or with the equivalent qualification.
7.2.4.2 Selection of test species
Test species relevant to the environmental compartment under evaluation should be chosen. For example,
where a product is intended for use primarily in marine water, the use of marine species is preferable, however
this does not rule out the use of freshwater species specified in the test methods shown in Annex E as long as
this is taken into account when determining the assessment factor to be applied to the derived NOEC or L(E)
C for determining the PNEC. For freshwater assessment, preference should be given to freshwater species.
7.2.4.3 Test omission
In certain circumstances, it may be acceptable to omit or replace some tests with other test results or
methodologies. In all cases, scientifically justified reasons should be given for not conducting the test(s).
Examples include the following:
— The study has been conducted on a chemically similar substance.
— It is impractical to test the target substance.
7.2.5 Data or information to be submitted
The applicant may submit the data or information evaluated as “not reliable” or “not assignable” according to the
reliability assessment described in Annex D for ‘weight of evidence’ arguments or test omission justifications on
the condition that the reliability assessment document on the data or information is attached.
The applicant shall submit any data indicating adverse effects or information that is of high significance to
the protection of the marine environment, regardless of the reliability of the data (for example information on
endocrine disrupting properties).
7.2.6 Consideration of animal protection
When an implementation plan is established for an additional test, consideration shall be given to animal
protection, i.e. using the minimum number of vertebrate test animals. When considering whether a new test
shall be conducted, it should be determined if such a test will significantly improve NOEC accuracy, before its
implementation. The test shall not be conducted if the possibility is low.
7.3 Assessment results
The following terms are used to characterize the apparent risk of using the biocidally active substance.
7.3.1 Low risk
If the substance is assessed as “low risk”, the application of the anti-fouling system using the biocidally active
substance on ships is regarded as having a risk to the marine environment which is considered negligible.
7.3.2 Risk of high concern
If the substance is assessed as “risk of high concern”, the ecological risk to the marine environment is
considered to be high (more than negligible) and there is concern regarding the application of an anti-fouling
system using that biocidally active substance.
12 © ISO 2012 – All rights reserved

7.3.3 Relatively low risk
If the biocidally active substance is assessed as “relatively low risk”, it means that ecological risk of the anti-
fouling system using this substance on ships is not considered to be negligible in the marine environment, but
it is deemed to be within an acceptable range.
7.4 Additional information obtained after last risk characterization
In cases where additional information has been made available after last risk characterization for a biocidally
active substance assessed as “low risk”, “relatively low risk” or “risk of high concern” in a marine environment,
a revised risk characterization shall be developed.
8 Risk assessment report
Regarding the risk assessment conduc
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