1943-21 Assessment Report

Regulation (EU) No 528/2012
concerning the making available on the

market and use of biocidal products
Evaluation of active substance
Assessment Report
Copper flakes (coated with

aliphatic acid)
Product-type 21
January 2016
France
Copper flakes (coated with Product-type 21 January 2016
aliphatic acid)
TABLE OF CONTENT
1 STATEMENT OF SUBJECT MATTER AND PURPOSE ......................................... 3

1.1 Principle of evaluation and procedure followed ...................................... 3
1.2 Purpose of the assessment ..................................................................... 4
1.3 Applicant ................................................................................................ 4
2 OVERALL SUMMARY AND CONCLUSIONS ........................................................... 5
2.1 Presentation of the active substance and biocidal product ..................... 5
2.1.1 Identity, physico-chemical properties and methods of analysis of active
substance ...................................................................................................... 5
2.1.1.1 Identity........................................................................................ 5
2.1.1.2 Physico-chimical properties ............................................................ 5
2.1.1.3 Analytical methods for determination and identification ...................... 6
2.1.2 Identity, physico-chemical properties and methods of analysis of biocidal
products ........................................................................................................ 6
2.1.2.1 Identity........................................................................................ 6
2.1.2.2 Physico-chemical properties ........................................................... 6
2.1.2.3 Analytical methods for determination and identification ...................... 7
2.2 Intended uses and efficacy .................................................................... 7
2.2.1 Field of use/function ............................................................................ 7
2.2.2 Object to be protected, target organisms ............................................... 8
2.2.3 Efficacy .............................................................................................. 8
2.2.4 Mode of action .................................................................................... 8
2.2.5 Resistance .......................................................................................... 8
2.3 Classification and labelling ..................................................................... 8
2.3.1 Current classification of active substance ............................................... 9
2.3.1.1 Current classification ..................................................................... 9
2.3.1.2 Proposed classification by the RMS .................................................. 9
2.3.2 Classification of biocidal product ............................................................ 9
2.3.2.1 Proposed classification of the representative biocidal product by the
RMS 9
2.4 Summary of the risk assessment .......................................................... 10
2.4.1 Summary of human health risk assessment .......................................... 10
2.4.1.1 Hazard identification of active substance ........................................ 10
2.4.1.2 Hazard identification of product .................................................... 16
2.4.1.3 Summary of exposure assessment and risk characterization ............. 17
2.4.2 Summary of environmental risk assessment ......................................... 25
2.4.2.1 Fate and distribution in the environment ........................................ 25
2.4.2.2 Effects assessment on environmental organisms (active substance) .. 26
2.4.2.3 Environmental effect assessment (product) .................................... 31
2.4.2.4 Environmental exposure assessment and risk characterisation .......... 31
2.5 Overall conclusions .............................................................................. 48
2.6 Requirement for further information related to product ....................... 50
APPENDIX 1: LIST OF ENDPOINTS ......................................................................... 51
APPENDIX 2: LIST(S) OF ABBREVATIONS ............................................................... 69
APPENDIX 3: LIST OF STUDIES ............................................................................. 77
2
aliphatic acid)
1 STATEMENT OF SUBJECT MATTER AND PURPOSE
1.1 Principle of evaluation and procedure followed
This assessment report has been established as a result of the evaluation of the active
substance of copper flakes (coated with aliphatic acid) or copper powder CAS n°. 7440-
50-8, as product-type 21 (Antifouling), carried out in the context of the work programm
for the review of existing active substances provided for in Article 16(2) of Directive
98/8/EC concerning the placing of biocidal products on the market 1, with the original
view to the possible inclusion of this substance into Annex I or IA to that Directive, then
carried out in the context of Regulation (EU) No 528/2012 2, with a view to the possible
approval of this active substance
The evaluation has therefore been conducted to determine whether it may be expected,
in light of the common principles laid down in Annex VI to Directive 98/8/EC, that there
are products in product-type 21 containing copper flakes (coated with aliphatic acid) that
will fulfil the requirements laid down in Article 5(1) b), c) and d) of that Directive.
Copper flakes (coated with aliphatic acid)(CAS-no: 7440-50-8) was notified as an

existing active substance, by the EU Antifouling Copper Task Force (EUACTF) for product-
type 21. Data on the representative product were submitted by the biocidal product
manufacturer International Paint Ltd.
Data submitted were collected to compile a complete dossier on the hazard assessment
of the active substance. Therefore, there will be references to the data submitted by the
manufacturer and the EUACTF in this report.
Commission Regulation (EC) No 1451/2007 of the 4th of December 20073 lays down the
detailed rules for the evaluation of dossiers and for the decision-making process in order
to include or not an existing active substance into the Annex I or IA of the Directive.
In accordance with the provisions of Article 3 paragraph 2 of that Regulation, France was
designated as Reporter Member State to carry out the assessment of copper flakes
(coated with aliphatic acid) on the basis of the dossier submitted by the applicant. The
deadline for submission of a complete dossier for copper flakes (coated with aliphatic
acid) as an active substance in product-type 21 was the 30 th April 2006, in accordance
with Article 9 paragraph 2 of Regulation (EC) No 1451/2007.
The hazard assessment of copper flakes (coated with aliphatic acid) was conducted in line
with the assessment of copper compounds dossiers for PT8 for which the active
substances have already been included into the Annex I of Directive 98/8/EC. It has to
be noted that the EUACTF has a letter of access for the PT8 copper compounds dossiers,
which permit to use several agreed endpoints for PT8 copper compounds in the
assessment of copper flakes (coated with aliphatic acid) as PT21.
On the 28th April 2006, the French competent authority received a dossier from EU
Antifouling Copper Task Force (EUACTF) and from the biocidal product manufacturer
International paint Ltd. The Reporter Member State accepted the dossier as complete for
1
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing
biocidal products on the market, OJ L 123, 24.4.98, p.1
2
Regulation (EU n° 528/2012 of the European Parliament and of the council o 22 May 2012 concerning the
making available on the market and use of biocidal products.
3
Regulation EC n° 1451/2007 of december 2007 on the second phase of 10-year work programme referred
to in article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing
biocidal products on the market OJ L 325, 11.12.2007, p. 3.
3
aliphatic acid)
the purpose of the evaluation, taking into account the supported uses, and confirmed the
acceptance of this dossier on the 9th March 2007.
In order to review the competent authority report and the comments received on it,
consultations of technical experts from all Member States (peer review) were organised
by the Agency. Revisions agreed upon were presented at the Biocidal Products
Committee and its Working Groups meetings and the competent authority report was
amended accordingly.
1.2 Purpose of the assessment
The aim of the assessment report is to support a decision on the approval of copper
flakes (coated with aliphatic acid) for product-type 21, and should it be approved, to
facilitate the authorisation of individual biocidal products in product-type21 that contain
coated copper flake. In the evaluation of applications for product-authorisation, the
provisions of Regulation (EU) No 528/2012 shall be applied, in particular the provisions of
Chapter IV, as well as the common principles laid down in Annex VI.
The conclusions of this report were reached within the framework of the uses that were
proposed and supported by the applicant (see Appendix II). For the implementation of
the common principles of Annex VI, the content and conclusions of this assessment
report shall be taken into account.
However, where conclusions of this assessment report are based on data protected under
the provisions of Regulation (EU) No 528/2012, such conclusions may not be used to the
benefit of another applicant, unless access to these data has been granted
1.3 Applicant
Name: EU Antifouling Copper Task Force
Address:
Regulatory Compliance Limited
Bilston Glen Business Centre
Loanhead
Edinburgh, UK
EH20 9LZ
4
aliphatic acid)
2 OVERALL SUMMARY AND CONCLUSIONS
2.1 Presentation of the active substance and biocidal product
2.1.1 Identity, physico-chemical properties and methods of analysis

of active substance
2.1.1.1 Identity
Table 2.1.1-1: Identification of coated copper flake
CAS-No. 7440-50-8
EINECS-No. 231-159-6
Other No. (CIPAC, ELINCS) None
IUPAC Name Copper

Common name, synonyma Copper flakes (coated with aliphatic acid)
Molecular formula Cu
Structural formula Cu
Molecular weight (g/mol) 63.55
The active substance as manufactured is copper flakes (coated with aliphatic acid) with a
minimum purity of 95.3% (total copper). The active substance reacts on fouling
organisms as cupric ion Cu2+.
The specifications of the active substance copper flakes (coated with aliphatic acid) have
been assessed according to what has been agreed as reference specifications of copper
compounds PT8 already included into annex I of Directive 98/8/EC.
Copper flakes (coated with aliphatic acid) as manufactured contains four relevant
impurities: arsenic, cadmium, nickel and lead.
It was demonstrated that the specifications are covered by the tested substance used in
toxicological and eco toxicological studies.
2.1.1.2 Physico-chimical properties
Copper flakes (coated with aliphatic acid) is a reddish, odorless, inorganic powder with a
flake-shape with a roughly circular shape. The d50 ranges between 9 and 11µm as
measured with the dry dispersion method (laser diffraction). The width ranges between
100nm and 2µm.
Copper flakes (coated with aliphatic acid) has a tap density of 0.47 g/cm3. A vapor
pressure of 1.8x10-8 Pa at 25 °C has been calculated from a vapor pressure curve.
It is not really soluble in water (0.27 mg/L at pH 7 and 20 °C). The solubilization results
of the oxido-reduction reaction of the copper metal into ionic copper. Cu(0) → Cu(I) →
Cu (II). At low pH, these reactions are promoted.
The partition coefficient n-octano/water is not relevant for the ecotoxicological risk
assessment due to the copper specific absorption mechanism.
5
aliphatic acid)
Copper flakes (coated with aliphatic acid)is not highly flammable, not oxidizing and not
explosive. An auto-flammability test should be provided.
The active substance does not fulfil the criteria of article 3.1(z) of the BPR, therefore it is
not a nanomaterial.
2.1.1.3 Analytical methods for determination and identification
A CIPAC method has been provided for the determination of the copper flakes (coated
with aliphatic acid)in the technical active substance.
Complete validation data for the determination of relevant impurities and the validation
data for the analysis of additive and other impurities are missing. These missing data are
required and must be provided as soon as possible but no later than at the date of
approval to the evaluating Competent Authority (FR).
The analyses of copper in environmental matrices and body fluids and tissues are
routinely performed in many laboratories. As these methods were collaborately validated
and are very widely used, limited validation data were accepted. Moreover, the EU
Antifouling Copper Task Force has a letter of access for the PT8 copper dossiers where
the methods are described.
Although no method is required for copper in food and feeding stuff, a method has been
provided for the determination of Copper in fresh fish by ICP-AES.
2.1.2 Identity, physico-chemical properties and methods of analysis

of biocidal products
2.1.2.1 Identity
Table 2.1.2-1: Identification of VC17M Graphite
Trade name VC17M Graphite

Manufacturer’s development YBA662/634
code No(s)
Ingredient of preparation Function Content
Coated copper flake Active substance 17.44%
Other formulants Details of the product composition and
information on the co-formulants are
confidential and are presented in the
confidential part of the dossier IIIB.2
Physical state of preparation Liquid mobile paint
VC17M Graphite is a two pack product comprising of a liquid ‘Binder’ and a powder
contained within a ‘hat’ which is clipped onto the top of the tin. The two components are
sold together as one complete product. The powder contained within the hat is mixed
into the paint prior to use.
2.1.2.2 Physico-chemical properties
VC17M Graphite after mixing is liquid paint with a colour of copper metal and a
characteristic solvent odour. Its pH is is neutral (pH = 6.49). It has a density of 1.065.
6
aliphatic acid)
VC17M Graphite is classified as flammable: R10. It has neither oxidizing nor explosive
properties.
The product is stable 56 days at 40 °C, the shelf-life of the product should be 2 years.
However the long term storage stability study (2 years) has not been provided and no
data has been provided on the effect of light. The study is required at the product
authorization stage to confirm the shelf life of two years and the product should be
stored at max 40°C.
The stability of the product at 0°C and the surface tension of the pure product at 25°C
should be provided at the product authorization stage.
The product contains more than 10% of a formulant classified H304, therefore the
cinematic viscosity at 40°C is required in order to verify the classification of the product.
Due to the limits of the pourability test and as the product is not diluted, a study to
determine true residue level in container after use or a management of the packaging in
a specialized processing dedicated circuit is required.
Data have been provided mainly on the mixed product, however the product consists of
two components which are intended to be mixed prior to use. Therefore physico-chemical
properties on the two separate components and data on the mixing step should be
provided.
2.1.2.3 Analytical methods for determination and identification
The analytical method for the determination of the active substance in the product is not
acceptable and a validated analytical method for the identification and determination of
copper flakes (coated with aliphatic acid) in the product VC17m should be provided at the
product authorization stage.
For residue analysis of copper flakes (coated with aliphatic acid) please refer to data
given in active substance part (see 2.1.1.3 in the document).
2.2 Intended uses and efficacy
The assessment of the biocidal activity of the active substance demonstrates that it has a
sufficient level of efficacy against the target organism(s) and the evaluation of the
summary data provided in support of the efficacy of the accompanying product,
establishes that the product may be expected to be efficacious.
In addition, in order to facilitate the work of Member States in granting or reviewing

authorisations, the intended uses of the substance, as identified during the evaluation
process, are listed in Appendix II.
2.2.1 Field of use/function
Main group: 4 – Other biocidal products

Product type 21–Antifouling products
7
aliphatic acid)
Copper flakes (coated with aliphatic acid) as Cu2+ is used in the control of fouling
organisms in marine and freshwater environments.
2.2.2 Object to be protected, target organisms
Copper flakes (coated with aliphatic acid)is intended to be used for the protection against
fouling of both mobile (including but not limited to marine and freshwater vessels) and
stationary (including but not limited to buoys, aquaculture nets, immersed structures)
objects.
2.2.3 Efficacy
Copper is used on vessels which potentially cover large geographical ranges; they are
potentially exposed to multiple marine biotypes. The number of fouling organisms to
which a vessel may be exposed is therefore large; there are over 4000 fouling species
with representatives from a variety of phyla, for example:
- slime , diatoms species e.g. Achnanthes and Amphora species,
- aquatic plants such as Green and red algae spores e.g. Enteromorpha spp,
Polysiphonia,
- animal, barnacles, mussels, tubeworms e.g Serpulids, sponges.
Efficacy of the product VC17M Graphite (17.44 % w/w Cu) has been proved in European
sea waters during 8 months, with a dry film thickness of 20 µm.
No efficacy data has been provided neither for freshwater nor for static objects.
2.2.4 Mode of action
When copper from metallic copper, copper thiocyanate or cuprous oxide leaches into
marine water in presence of oxygen, the predominant form of the copper is the active
substance, the cupric ion, Cu2+.The cupric ion acts to retard settlement of the
microscopic larvae of fouling organisms within a microlayer of water at the paint surface
via two mechanisms:
(1) the ion retards organism’s vital processes by inactivating enzymes,
(2) the ion acts more directly by precipitating cytoplasmic proteins as metallic
proteinates.
2.2.5 Resistance
There have never been any recorded cases of resistance in populations of fouling
organisms through the use of Copper based anti-fouling paints in the literature up to
now.
However, some studies, in the literature, showed some impacts of copper pollution on
marine life and indicate that some hull-fouling species have copper tolerance.
2.3 Classification and labelling
8
Copper flakes ( coated with Product-type 21 January 2016
aliphatic acid)
2.3.1 Current classification of active substance
2 .3.1.1 Current classification
None
2 .3.1.2 Proposed classification by the RMS
No harmonised classification according to Regu lation (EC) No 1272/ 2008 ( CLP

Regulation) of active substance is avai lable. However the RAC opinion4 adopted in
December 2014 contains the following classification:
Ta ble 2.3.1-1: proposed classification according to r egulation 1272/ 2008
Classification accordina to the CLP Re aulation

Hazard Class and Aquatic Acute 1, H400
Category Codes Aquatic chronic 1, H4 10
Acute Tox 4 , H302
Acute Tox . 3, H331
Eve Irrit. 2, H319
La bellina
Pictograms GHS06, GHS09
Signal Word Danger

Hazard Statement Codes H302 : Harmfu l if swall owed
H331 : Toxic if inhaled .
H319: Causes serious eye irritationH410 : very toxic to
aquatic life with long lasting effects
Specific Concentration Aquatic Acute 1: M- factor = 10

limits, M-Factors Aquatic chronic 1 : M-factor = 10
2.3.2 Classification of biocidal product
2 .3 .2.1 Proposed classification of the representative biocida l product by the RMS
According to the avai lable studies, and to CLP regulation, no classification for the human
health is proposed . The proposed environmental and physico-chemica l classification is
the following.
T a ble 2.3.2-1: proposed classification of biocidal product according to the

available studies and to CLP regulation
Classification accordina to the CLP Reaulation

Hazard Class and I STOT RE, H373
Category Codes Aquatic Acute 1, H400
4
Opinion proposing harmonised classification and labelling at EU level of Copper flakes (coated with aliphat ic
acid) EC num ber: 231-159-6, CAS number: 7440-50-8, CLH-0 -00000014 12-86-30/F- Adopted 04 December
20 14
9
aliphatic acid)
Aquatic chronic l, H4 10
La belling
Pictoarams GHSOS. GHS09
Siqnal Word Warninq
Hazard Statement Codes H373: May cause damage to organs through prolonged or
repeated exposure
H410: very toxic to aquatic life with long lasting effects
2.4 Summary of the risk assessment
2.4.1 Summary of human health risk assessment
2.4.1.1 Hazard identification of active substance
Foreword
Copper is a micronutrient. It is essential for life and necessary for all living cells. I t is
used in many enzyme systems, particularly in energy transfer where the property of
electron transfer is exploited in photosynthesis and catabolism. It is involved in the
reactions and functions of many enzymes (e.g . amine oxidase, ceruloplasm in,
cytochrome- c oxidase ... ) and in addit ion, copper is involved in angiogenesis,
neu rohormoneang iogenesis, neuro-hormone release, oxygen transport and regu lation of
genetic expression . Copper is present in almost all foods, and some products. Most
human diets naturally include between 1 and 2 mg/person/day of copper, with some
contain ing up to 4 mg/person/day.
The copper transport mechanisms in the organism form part of the system of
homeostasis: the body is able to maintain a balance of dietary copper intake and
excretion that allows normal physiolog ica l processes to take place. The relationship
between copper concentration and observed effects show a flattened 'U' -shaped dose-
response curve . The left side of the 'U' curve represents deficiency, where intake of
copper is less than required . Th is can lead to lethality, especially in ch ildren, where
copper is essential for growth. Copper deficiency is associated with growth retardation,
anemia, skin lesions, impa ired immunity, intestinal atrophy, impaired cardiac function,
reproductive disturbance, neurolog ical defects and skeletal lesions. Copper is essential
for normal physiological function such as cellular respiration, free radical defence,
synthesis of melanin, connective t issue, iron metabolism, regulation of gene expression,
and normal function of the heart, bra in and immune system .
10
aliphatic acid)
Figure 1: Dose-response curve for copper (adapted from Ralph and McArdle,
2001).
The central near-horizontal part of the ‘U’ curve represents homeostasis, where intake
and excretion are balanced and copper level is in a normal range. The right-hand part of
the ‘U’ represents toxicity or excess copper disease. Chronic copper toxicity is extremely
rare, and the upper limit of homeostasis has never been strictly defined.
The active substance released from copper flakes (coated with aliphatic acid)is the cupric
ion.
Although a full guideline ADME study has not been performed for copper, the knowledge
of copper in the human body at the level of the organism, organ, cell and gene is
sufficient to meet the requirements of the Regulation. Extensive information is available
relating to the toxicokinetics and toxicodynamics of the copper ion within the human
body. The cupric ion is an inorganic charged species that cannot exist in an un-solvated,
un-associated state and so cannot be prepared in a pure form. Submission of toxicology
data for Cu2+ is therefore not possible or relevant. Under these circumstances,
information relating to copper sulfate pentahydrate is provided instead and where data
for the copper sulfate pentahydrate is not available, information has been supplied with
other forms of copper which have been demonstrated to all produce cupric ion in a
bioequivalence study.
2.4.1.1.1 Metabolism
Absorption
Oral administration:
The proportion absorbed in a clinical study over 90 days varied between 56 % for
subjects receiving 0.8 mg Cu/day, 36 % for individuals receiving 1.7 mg Cu/day and
12% for individuals receiving 7.5 mg Cu/day (A6.2/01).
To determine the systemic NOAEL, as stated in the Technical Meetings (TM) III08, and
consistencely with the EU RAR5, the percentage of the administered copper sulfate
pentahydrate retained to be available for absorption following administration in the diet
for rats is 25 % whereas 36 % will be used as the oral absorption value in humans.
5
Voluntary risk assessment reports (VRAR) submitted to ECHA based on industry initiative to follow the risk
assessment procedures of Existing Substance Regulation (EEC) No 793/93 June 2008
11
aliphatic acid)
Dermal administration:
For the active substance, in order to harmonize BPR dossier and EU RAR, the dermal
delivery of copper compound (in solution) retained in TMIII08 was 5 %.
This value will be used in the risk assessment for general situation of exposure to coated
copper flake.
However, it is recognized that a strong matrix effect of paint on the dermal absorption of
substances exists. Dermal penetration studies on formulations close to VC17M Graphite
were provided in the PT 21 dossier leading to a value (worst case) of 0.14 % for copper.
It should be noted that these studies present some methodological deviations. However,
at this stage it would not be reasonable to require new dermal absorption studies.
Nevertheless, for the purpose of this dossier of substance approval, RMS proposes to use
this value of 0.14% for copper dermal absorption as it is much more realistic than the
default value of 5%. It has been agreed at WG IV-2015 that this values would only apply
for active substance approval. Hence, a study of better reliability should absolutely be
provided at the product authorization level.
In the absence of a new study, the value of 5% will be used.
It is also important to note that the rinse of the skin with water and soap is inefficient.
Consequently, paint stays in the skin and in the stratum corneum. As the stratum
corneum was removed from skin at the end of the study (24 hours) by stripping and
excluded to determination of dermal absorption, an efficient removal of residual paint on
the skin by professional and non-professional should be performed after the use of
paints.
Inhalation administration:
No animal or human studies were available to supply an inhalation absorption level.

Thus, the default absorption value of 100 % is used in risk characterization as worst-case
value of copper salts penetration.
Distribution
Once absorbed by oral route, copper is bound to albumin and transcuprein and then
rapidly transported to the liver where it is incorporated to ceruloplasmin, a transport
protein that circulates in the organism and deliver the copper to other organs. It should
be however noted that a minor fraction of the absorbed dose can directly be distributed
to peripheral organs. In both humans and animals, copper is tightly regulated at a
cellular level, involving metallothionein and metallochaperones. These regulating
molecules prevent from the accumulation of potentially toxic, free copper ions within the
cell. In addition to the liver, the brain is another organ which contains relatively high
concentrations of copper.
Elimination
Biliary excretion, with subsequent elimination in the faeces, represents the main route of
excretion for copper in animals (rats) and humans, with an excretion rate approximately
of 1.7 mg Cu/day in humans.
Available data show that copper is excreted in the bile in a relatively inabsorbable form.
Consequently, little enterohepatic absorption takes place. Biliary excretion of copper and
elimination in the faeces is recognised to be essential to the homeostatic regulation of
copper in animals and humans.
A small amount of copper is also excreted in urine and sweat.
12
aliphatic acid)
2.4.1.1.2 Acute toxicity
Based on the results of the acute oral toxicity study, copper flakes (coated with aliphatic
acid)is classified as “Harmful “ according to the classification criteria as given in Annex VI
of Commission directive 2001/59/EC, with the risk phrase R22 “Harmful if swallowed”
(LD50 = 300-500 mg/kg bw for males and females).
Based on the CLP criteria, a classification Acute Tox.4-H302 is proposed.
Copper flakes (coated with aliphatic acid) is not hazardous or classified by the dermal
route.
The inhalation study highlighted a greater sensitivity in males than in females. According
to the results in males (LC50 (4hr) = 0.733 mg/l), copper powder is classified “Toxic”
with the risk phrase R23 “ Toxic by inhalation” according to the classification criteria as
given in Annex VI of Commission directive 2001/59/EC.
Besides, a classification Acute Tox.3-H331 is proposed based on the CLP criteria.
2.4.1.1.3 Skin and eye irritation
Copper flakes (coated with aliphatic acid)is not hazardous or classified as a skin irritant
but it causes serious eye irritation.
A classification Eye Irrit. 2-H319 was proposed in RAC opinion of December 2014.
2.4.1.1.4 Skin sensitization
Copper flakes (coated with aliphatic acid) is not hazardous or classified as a skin
sensitising.
For systemic effect after repeated exposure, the most toxic form of any copper salt is the
Cu2+ ion. The copper compound which releases more Cu2+ is the most soluble salt:
copper sulphate. In this context, to avoid repeating assay on animals, it was decided at
TM III 08 to extrapolate data from copper sulphate to the other copper compounds when
no other data is available.
For several compounds, toxicity of anion could be suspected. In this case, a specific
assessment could be performed. However, for coated copper flake, there is no anion.
Therefore, use of the data of copper sulphate is a conservative approach.
This read across between copper compounds and copper sulphate for repeated toxicity
and CMR endpoints was adopted by TM for previous PT8 and PT2 copper compunds
dossiers. This approach was also presented in the CLH report for the classification and
labelling of copper compounds.
2.4.1.1.5 Oral repeated toxicity
With regard to oral repeated dose toxicity, the 90-day dietary study was considered to be
the pivotal study for Cu2+ presented as copper sulphate pentahydrate. Based on kidney
damages, consisting in an increase of cytoplasmic protein droplets, a NOAEL of 1000 ppm
in rats (16.3 and 17.3 mgCu/kg bw/day in male and female rats respectively) was
determined. Other findings such as liver inflammation and lesions of the forestomach
were also reported at 2000 ppm and above (corresponding to doses from 34 mgCu/kg
bw/day).The NOAEL of 16.3 mg/kg bw/d was used for the risk characterisation.
13
aliphatic acid)
Mice equally displayed forestomach lesions when exposed through diet to copper
sulphate for 92 days but this occurred at a much higher dose (4000 ppm, corresponding
to 187 and 267 mgCu/kg bw/day in males and females, respectively). No other damage
was observed in mice
Subchronic and chronic studies in the dog can be waived, as the dog is an unsuitable
animal model for studying copper toxicity in relation to man. Indeed, dogs have a
different form of albumin compared to rats and humans, and cannot excrete copper in
the bile as readily as most other species. The dog is not a good animal model for human
risk assessment of copper.
2.4.1.1.6 Dermal repeated toxicity
There were no dermal repeated dose toxicity studies. However, these studies are not
required considering the ability to read-across from the above oral study. Moreover, due
to the lack of toxicity observed in the acute dermal toxicity and the weak rate of dermal
penetration, a toxic effect is not expected.
2.4.1.1.7 Inhalation repeated toxicity
A study performed on cuprous oxide was provided for the antifouling copper compound
dossier.
Cuprous oxide was administered via whole body as 6 hours to male and female Sprague
Dawley rats for 1, 2, 3 or 4 weeks (5 days/week) at 0.2, 0.4, 0.8 and 2 mg/m 3. Effects
observed are essentially local effect (LDH and protein increase in the bronchoalveaolar
lavage fluid, minimal inflammation and the decrease in wet/dry lung weight ratio),
reversible in 13-week recovery period except the decrease the effects on the lung weight.
2.4.1.1.8 Genotoxicity
 In vitro tests
There was no evidence of mutagenic activity in Salmonella typhimurium strains in the
presence or absence of the metabolic activation system when tested with copper
sulphate pentahydrate.
Although limited, these in vitro data were deemed sufficient and no further in vitro
assays were required, considering the results of the in vivo tests.
 In vivo tests
In vivo studies, conducted with copper sulphate pentahydrate, induced neither
micronuclei in the polychromatic erythrocytes from the bone marrow of mice, nor DNA
damage in a rat hepatocyte UDS assay.
Equivocal results of additional in vivo genotoxicity studies from the public domain
(Bhunya and Pati, 1987; Agarwal et al., 1990; Tinwell and Ashby, 1990) are observed,
but these studies do not meet the higher reliability criteria (1 or 2) under the regulation.
Copper is therefore considered as non genotoxic.
2.4.1.1.9 Chronic toxicity and carcinogenicity
No carcinogenic potential of copper sulphate was detected in rats and mice. However, all
available data are of limited value to evaluate the carcinogenic potential of copper
compounds. Study durations are in particular too short (<2 years) and group sizes are
14
aliphatic acid)
small for drawing formal conclusions. However, based on the available data, human data
and due to the lack of genotoxicity there is no need to conduct new carcinogenicity
studies.
2.4.1.1.10 Reproductive toxicity
Developmental toxicity
A developmental study in mice was submitted but suffers from major methodological
deficiencies including no information on maternal toxicity and is neither adequate for
classification and labelling nor for risk assessment. Subsequent to the original
submission, the EU Antifouling Copper Task Force submitted another study, that
conforms to Annex V and OECD methods for a teratogenicity test (Annex V method B.31;
OECD method 414). This study provides the most reliable animal data concerning the
developmental toxicity of copper.
Technical copper hydroxide was given by gavage to groups of mated female rabbit during
days 7 to 28 of pregnancy at three different doses (6, 9 and 18 mg Cu/kg bw/d).
Administration of copper to pregnant rabbits at 18 and 9 mg Cu /kg bw/d was associated
with marked initial bodyweight loss, inappetance, abortion and death.
Pups in litters from surviving dams showed slightly lower mean foetal weight and slightly
increased incidence of retarded ossification of skull and pelvic bones at 18 mg Cu/kg
bw/d.
Therefore, the maternal no observed effect level was 6 mg/kg bw/d and the foetal no
observed effect level was 9 mg/kg bw/d.
Fertility
According to the two-generation oral reproduction study in rats administered with copper
sulphate pentahydrate, the NOAEL for reproductive toxicity for parental males was 1500
ppm (the highest concentration tested corresponding to 23.6 mg/kg bw/d), the NOAEL
for parental females was only 1000 ppm (15.2-35.2 mg/kg bw/d), based on the reduced
spleen weight at 1500 ppm. This reduction also occurred in F1 and F2 generations at the
same dose level in both males and females. However the reduced spleen weights were
not considered a reproductive endpoint as it did not affect growth and fertility.
Therefore as the results of this study do not indicate specific reproductive toxicity at the
highest dose level tested, it is proposed that copper sulphate and Copper flakes (coated
with aliphatic acid)(by read across) should not be classified as reprotoxic compounds.
2.4.1.1.11 Neurotoxicity
From a neurotoxicological point of view, copper has been recently suspected to be

involved in the pathogenesis of the Alzheimer's disease and other prion-mediated
encephalopathies. Although no valid neurotoxicity study was submitted, no evidence of a
neurotoxic potential of copper is suspected from the available studies in animals up to
now. No further study was therefore deemed necessary.
2.4.1.1.12 AEL derivation
The key health effect to consider in the risk characterization is kidney and forestomach
damages observed in the 90-day dietary study, which determined a NOAEL of 1000 ppm
15
aliphatic acid)
(16.3 and 17.3 mgCu/kg bw/day in male and female respectively) in rats. This NOAEL is
considered to be the most appropriate in the risk characterization for short-term and
chronic exposures (carcinogenicity studies considered unnecessary).
To determine the systemic NOAEL, as stated in TMIII08, consistencely with the EU RAR,
the percentage of the administered copper sulphate pentahydrate retained to be
available for absorption following administration in the diet for rats is 25 %. Therefore,
the systemic NOAEL, based on the NOAEL of 16.3 mgCu/Kg bw/d and the oral absorption
of 25% for animals is:
NOAELsystemic  NOAEL * 0.25  4.1 mgCu  kg 1bw / d
To derive the AEL from the NOAEL, the NOAEL is first converted to a systemic NOAEL
then it is divided by the assessment factors taking into account uncertainties and
extrapolations. The assessment factors were discussed during the TM IV08 and TMI09 for
TP 8 copper substances. The same assessment factors wil be used in this copper flakes
(coated with aliphatic acid) dossier.
 Acute-term AEL
The acute-term AEL is the NOAEL (16.3 mg Cu/kg bw/day) times 25%, the absorption
factor, divided by the 50-fold safety factor, corresponding to the MOEref (5 for inter-
species variation and 10 for intra-species variation). An acute-term AEL of 0.082 mg
Cu /kg/d is proposed.
 Medium-term AEL
The medium-term AEL is the NOAEL (16.3 mg Cu/kg bw/day) times 25%, the absorption
species variation and 10 for intra-species variation). A medium-term AEL of 0.082 mg
Cu /kg/d is proposed.
 Long-term AEL
The long-term AEL is the NOAEL (16.3 mg Cu/kg bw/day) times 25%, the absorption
species variation, 10 for intra-species variation and 2 for the duration of exposure from
sub-chronic to chronic). A long-term AEL of 0.041 mg Cu /kg/d is proposed.
Generally AEL long-term is used to characterize the risk for professional. However, it has
been agreed among MS (TM III 2011), the medium-term AEL should be used for risk
characterization of professional applying or removing antifouling product, given the
expected periodic uses of antifouling agents.
The acute-term AEL value is also used to characterize the risk for non professional.
2.4.1.2 Hazard identification of product
VC 17 Graphite was found to be of low oral, dermal and inhalation toxicity in rats. The
median lethal dose in each test exceeded the guideline limit dose levels. It was not
irritant for skin and eyes.
It gave no evidence for inducing delayed contact hypersensitivity in a Buehler test.
However, this test is considered not sufficiently sensitive by RMS (3 applications). In this
context, the toxicity for this endpoint will be determined by calculation according to
Directive 99/45/CE and CLP Regulation.
16
aliphatic acid)
2.4.1.3 Summary of exposure assessment and risk characterization
Copper flakes (coated with aliphatic acid) reference product is a two pack product,
supplied as a one complete product. The two packs comprise of a liquid ‘binder’
(contained in a can) and a powder (contained in a plastic ‘hat’ which is clipped to the lid).
Prior to application the user separates the hat from the can, opens the can (by removing
the lid), splits the plastic bag and tips the contents (i.e. the copper powder) into the can.
The product should be thoroughly mixed before application.
The product is intended to be used by professionals as well as non professionals.

Four steps during the antifouling use could lead to exposure to humans:
 Mixing and loading

 Paint application
 Post-application cleaning
 Paint removal
For professional use, different actors are potentially exposed:

 Potman (on the floor) who mixes and loads the antifoulant paint from supply
container to high pressure pump reservoir ensuring continuous supply to the
spray gun. For this product a mixing of copper powder with paint before mixing
and loading in pump reservoir is also necessary. After application, potman cleans
the spray equipment.
 Professional who applies paint to the surface:
o By spraying (mainly). Sprayer works from a manoeuvrable platform which
is operated either by himself or by an ancillary worker
o By brush and roller (to recover any mistakes)
He can also clean the spray equipment.
 Ancillary worker, keeping paint lines free, manoeuvring mobile spray platforms as
well as other tasks intented to aid the sprayer’s job
 Blast worker who performs a total or partial removal of the expired coating from
the ship hull using abrasive grit or high-pressure water
 Grit filler who assists the blast worker in regulary filling the mixing kettle with grit
and monitoring the grit and water supply to the kettle and air to the tower wagon.
The non professional can apply the product by brushing/roller. He can also remove old
paint, washing the boat with a power washer and the scrubbing loose or blistered parts of
the paint in order to remove the leached layer of paint giving a good surface to apply a
new coat paint.
Secondary exposure can occur in connection to non-professional application of paint:

Toddler touching wet or dry paint with subsequent hand-to-mouth transfer.
Several models (TNsG or Links study) were available to determine the exposure during
the different tasks. However, in order to harmonize the approach, an opinion of HEEG
was endorsed during the TM IV 2012: HEEG opinion on the paper by links at al. 2007 on
occupational exposure during application and removal of antifouling paints. These
recommendations will be followed in the copper flakes (coated with aliphatic acid)
dossier.
17
aliphatic acid)
2.4.1.3.1 Primary exposure
2.4.1.3.1.1 Professional exposure
For professional exposure assessment, the following parameters and models were used:
Model Duration Exposure

min
Spraying
Potman- loading of RISKOFDERM model: filling, mixing and 20 Dermal
powder in paint loading Deo unit 1
Potman – mixing TNsG 2002 Model 6: Loading liquid 180 Dermal and
and loading antifouling into reservoir for airless spray inhalation
application (user guidance)
Potman/sprayer- BEAT model: Delago study 10 Dermal

cleaning of
equipment
Sprayer- spraying TNsG 2002 Model 3: Airless spraying 180 Dermal and
viscous solvent-based liquids at > 100 inhalation
bar pressure, overhead and forwards
Ancillary worker Covered by assessment of sprayer, considering that ancillary
worker wears the same PPEs.
Brushing/roller
Mixing and loading Links study 90 Dermal and
Application inhalation
Cleaning of brush Model proposed by HEEG: “primary Not Dermal
exposure scenario - washing out of a relevant
brush which has been used to apply
paint”
Other
Blast worker Links study 180 Dermal and
inhalation
Grit filler Links study 180 Dermal and
inhalation
Two steps assessments were performed:

 Tier I: no PPE are worn. Gloves can be included at this step when no
exposure without gloves is available in the models
 Tier II: PPE/RPE are worn

Table 2.4.1-1: The exposures compared to AEL medium term
Total
systemic AEL
Exposure
Task PPE exposure mg Risk
% AEL
mg Cu/kg/d
Cu/kg/d
Potman
Mixing and
loading Tier I: No PPE 1.84 E-01 8.2E-02 224% Unacceptable
copper
powder from Tier II: Gloves 9.18 E-03 8.2E-02 11% Acceptable
18
aliphatic acid)
Total
systemic AEL
Exposure
% AEL
mg Cu/kg/d
Cu/kg/d
hat to can
Tier I: No PPE 1.10E-01 8.2E-02 134% Unacceptable
Mixing and
Tier II: Gloves
loading of
and
paint in pump 3.01 E-02 8.2E-02 37% Acceptable
impermeable
reservoir
coverall
Cleaning
spray No PPE 4.78E-03 8.2E-02 6% Acceptable
equipment
No PPE 2.98 E-01 8.2E-02 364% Unacceptable
M&L copper
Combined powder from
exposure: hat to can:
M&L and gloves
cleaning M&L of paint in
4.40E-02
pump reservoir: 8.2E-02 54% Acceptable
gloves and
impermeable
coverall
Cleaning: no
PPE
Application by spraying
Gloves 3.73E-01 8.2E-02 455% Unacceptable
Coated coverall,
Spraying
gloves and 3.87 E-02 8.2E-02 47% Acceptable
mask APF 10
Cleaning spray No PPE
4.78E-03 8.2E-02 6% Acceptable
equipment
Combined Spraying:
exposure: gloves
3.78E-01 8.2E-02 461% Unacceptable
Spraying phase Cleaning: no
and cleaning PPE
Spraying:
coated coverall,
gloves and
4.34 E-02 8.2E-02 53% Acceptable
mask APF 10
Cleaning: no
PPE
Application by brush/roller
Mixing and
loading
Tier I: no PPE 7.24E-02 8.2E-02 88% Acceptable
copper from
hat to can
No PPE 6.25E-02 8.2E-02 76% Acceptable
Brushing Gloves and
1.69E-03 8.2E-02 2% Acceptable
tyvek
19
aliphatic acid)
Total
systemic AEL
Exposure
% AEL
mg Cu/kg/d
Cu/kg/d
Cleaning of
No PPE 5.7E-04 8.2E-02 0.7% Acceptable
brush
Combined No PPE 1.36E-01 8.2E-02 165% Unacceptable
exposure: Tyvek coverall
mixing and and gloves
loading, during brushing
7.47E-02 8.2E-02 91% Acceptable
application by (and mixing and
brush/roller loading of paint
and cleaning into trail)
Sand blasting
No PPE 6.56E-01 8.2E-02 800% Unacceptable
Protective
water-proof
overalls, an
airstream
helmet with
rubber flaps
Paint removal
that covered a 6.8 E-02 8.2E-02 83% Acceptable
large part of
their upper
body, strong
protective
gloves and
mask APF10
Grit filling
No PPE 1.66 8.2E-02 2026 % Unacceptable
Coated coverall,
Grit filling
gloves and 6.89 E-02 8.2E-02 84 % Acceptable
mask APF 40
A risk for potman during mixing and loading phases exists when no PPEs are worn.
However, when impermeable coverall and gloves are worn the risk becomes acceptable.
No PPE is required during cleaning.
A risk for sprayer during application under the conditions specified above (without coated
coverall and mask APF 10) exists. However, when coated coverall, gloves and mask APF
10 are worn the risk becomes acceptable. For sprayer, No PPE is required during
cleaning.
The combined risk is acceptable for brusher when an equivalent Tyvek coverall and
gloves are worn during mixing and loading of paint into trail and brushing.
A risk for sand blaster exists without PPE. However, when protective water-proof
overalls, an airstream helmet with rubber flaps that covered a large part of their upper
body, strong protective gloves and mask APF 10 are worn the risk becomes acceptable.
A risk for grit filler exists when no PPEs are worn. However, when coated coverall, gloves
and mask APF 40 are worn the risk is acceptable.
20
aliphatic acid)
2.4.1.3.1.2 Non-Professional exposure
For non-professional exposure assessment, the following parameters and models were
used:
Model Duration Exposure

min
Brushing/roller
Loading of powder TNsG 2002: Mixing and loading model 5 Not Dermal and
in paint (user guidance) relevant inhalation
Application by brush TNsG 2002: model 4 – non professionals 90 Dermal and
and roller brush and roller painting of antifoulant inhalation
on the underside of small boats (user
guidance)
Cleaning Model proposed by HEEG: « primary Not Dermal
exposure scenario - washing out of a relevant
brush which has been used to apply
paint »
No relevant model is available to assess the exposure of non professional during the
removal of paint. . However, it was considered that this scenario will be covered by the
scenario“application of the paint“.
The use of gloves by non-professional is usually not accepted, several discussions

occurred on the use of PPE by non-professionals at the previous TMs (TM I 2011 and TM
III 2011) and some documents provided (i.e. TMI 2011: Agenda point 3a. "Feasibility for
non-professional users of antifouling to wear gloves"). TMIII 2011 agreed that all PT 21
CARs having non-professional applications should include two exposure/risk
assessments; one assessment where no gloves are worn and a second assessment where
gloves are worn.
In this context, assessment for this product was performed with gloves for non-
professional.
Table 2.4.1-2:The exposures compared to AEL acute term
Total systemic
AEL
exposure Exposure
Task PPE mg Risk
b(dermal) % AEL
Cu/kg/d
mg Cu/kg/d
Mixing and loading
Mixing and No PPE 7.24E-02 8.2E-02 88% Acceptable

loading
copper from
hat to can Household
4.84E-02 8.2E-02 59% Acceptable
gloves
Application
Brushing* No PPE 3.96E-02 8.2E-02 48% Acceptable
21
aliphatic acid)
Household
1.83E-02 8.2E-02 22% Acceptable
gloves
Cleaning
Cleaning of
No PPE 5.7E-04 8.2E-02 0.7% Acceptable
brush
Combined exposure
Combined 1.13E-01 8.2E-02 137% Unacceptable
exposure: No PPE
mixing and
loading
Household 6.73E-02 8.2E-02 82% Acceptable
(powder)
application gloves except
and cleaning during
brush cleaning
phase
Note*: In the study used to determine exposure of non-professional during brushing, the
brushing was performed outdoor.
For non-professionals, an acceptable risk is identified applying (considering mixing and

brushing) copper flakes in the representative product by brush and roller if appropriate
gloves are worn.
An acceptable risk from combined exposure to copper flakes in the representative
product is identified for a non-professional operator applying the representative product
by brush and roller and cleaning the paint brush/roller on the same day provided gloves
are worn during the application phase.
In consequence, according to the guidance document CA-March14-Doc.4.2-Final-

“Antifouling (PT21): Way forward for the management of active substances and the
authorisation of biocidal products”, persons making products containing copper flakes
(coated with aliphatic acid) available on the market for non-professional users shall make
sure that the products are supplied with appropriate gloves.
This measure is however without prejudice to the provisions of paragraph 63 of Annex VI
to BPR, whereby Member States shall normally not authorise antifoulings to the general
public if the wearing of personnel protective equipment (PPE), such as gloves, is the only
risk mitigation measure to reduce exposure to acceptable levels.
An acceptable risk was identified for an adult washing clothes contaminated with copper
flakes following use of the representative product.
2.4.1.3.2 Secondary exposure
For professional uses, secondary exposure could occur to bystanders if individuals

working in the dock yard were to pass by or stop to watch a spraying or blasting
operation. However, it was decided at TM III 2011 that no quantitative risk assessment
should be performed for this group but the product should be labeled with the followed
phrases “unprotected persons be kept out of treatment areas”. If a person is in an area
where he/she could be exposed then that person would need to suitably attire
him/herself with the relevant PPE/RPE.
22
aliphatic acid)
For non professional, secondary exposure could occur in connection to non-professional

application of paint, when toddlers touch wet or dry paint with subsequent hand-to-
mouth transfer. Exposure to the by-stander is covered by the exposure of the non-
professional who applies the paint.
As the use for non professional cannot be authorized, these assessments are presented
only for information.
Table 2.4.1-3: Systemic exposure – toddler touching wet or dried treated

surface
AEL
Exposure Exposure
Scenario mg Risk
mg Cu/kg/d % AEL
Cu/kg/d
Systemic 3.62E-01 8.2E-02 441 % Unacceptable
exposure –
toddler touching
wet treated
surface
Systemic 4.78 E-02 8.2E-02 58 % Acceptable
exposure –
toddler touching
dried treated
surface
An unacceptable risk is identified (from dermal and hand-to-mouth exposure, the % of

AEL is >100) for a toddler touching wet paint on the boat. However, the risk is
acceptable for a toddler touching dry paint. Therefore, it is considered that this potential
risk to children can be mitigated by suitable labelling of products containing copper flakes
intended for non-professional use indicating that unprotected persons should be kept
away from treated surfaces until they are dry. This measure to manage potential risks to
children is proposed in the document of European Commission: “Antifouling (PT21),:
way forward for the management of active substances and the authorisation of biocidal
products”, adopted during the Competant Authorities meeting of March 2014.
2.4.1.3.2.1 Secondary exposure via food contamination
It is stated In the last MOTA6 that “in specific cases for PT 21, where it can be
demonstrated that there residues of the a.s. in fish and shellfish are not to be expected,
even in cases of misuse, the monitoring method is not required. A specific justification
has to be presented, together with the sound proof that there would be no residue also in
cases of misuse”.
As stated in the toxicological foreword, the case of copper is rather particular since this
element is naturally present in the environment and also at stake and essential for many
metabolic functions and reactions for both plants and animals. Copper is also used as
fungicide in plants for phytopharmaceutical purposes and for veterinary purposes 7.
6
Manual of Technical Agreements of the Biocides Technical Meeting (MOTA) V.6 last version n°6 of 2013, p.
1-60 :
http://echa.europa.eu/documents/10162/19680902/mota v6 en.pdf
7
The European Agency for the Evaluation of Medicinal Products (EMEA), Veterinary Medicines Evaluation Unit,
EMEA/MRL/431/98-Final, May 1998, Committee for Veterinary Medicinal Products – Copper Chloride, Copper
Gluconate, Copper Heptanoate, Copper Oxide, Copper Methionate, Copper Sulphate and Dicopper Oxyde –
summary report, p.1-4 :
http://www.ema.europa.eu/docs/en GB/document library/Maximum Residue Limits -
Report/2009/11/WC500013010.pdf
23
aliphatic acid)
Copper is authorized as a feed additive under EU Reg. 479/2006 8 in nutrition of livestock

including fish and shellfish (involved in PT21) with a maximum content in the complete
feedingstuffs of 25 mg/kg for fish and 50 mg/kg for crustaceans. It is also present in
many food supplements, according to Directive 2002/46/EC9.
There is currently no harmonized methodology to assess the level in foodstuff of a

substance involved in PT21. The most relevant methodology currently available to
estimate level in fish and shellfish is based on a rough calculation with highest Predicted
Environmental Concentration (PEC) calculated from the marine environment and the Bio
Concentration Factor (BCF). Based on the particular case of copper (ionic form) and its
properties (high solubility/dilution in sea water, complexation, low bio-accumulation,
natural occurrence and physiological needs), at the state of the art, this approach is not
deemed relevant.
Indeed, because of the homeostasis of metals, BCF values are not indicative of the
potential bioaccumulation. There is therefore limited evidence of accumulation and
secondary poisoning of inorganic forms of metals. In addition, an in-depth literature
search showed the absence of copper biomagnification across the trophic chain in the
aquatic and terrestrial food chains. Differences in sensitivity among species were not
related to the level in the trophic chain but to the capability of internal homeostasis and
detoxification. Field evidence had further provided no indications of secondary poisoning..
Hence no PECoral, predator was assessed for this product. Consequently an assessment
of the risk to food consumers due to contamination of fish/shellfish is not deemed
relevant in this case.
Additionally, copper is already significantly involved for phytopharmaceutical purposes

under EU Reg. 396/2005 with rather significant rates (in the order of kg/ha/year)
covered by MRLs under the EU regulation Reg. (EC) N°149/2008 10 (in the order of 2-
1000 mg/kg). There is currently no EU MRL for fish and shellfish under this regulation or
associated with veterinary purposes and consequently no risk of additive exposures
which would induce MRLs to be revised accordingly.
An acceptable risk is identified for potential exposure via food contamination. This is
based on available knowledge about the natural occurrence of copper, physiological
needs, physico-chemical properties and regulations already in force. Exposure via food
contamination may need to be reassessed when a uniform methodology to assess dietary
exposure induced by an antifouling application is available.
2.4.1.3.2.2 Overall conclusion for the human health
With regard to human health exposures and effects, safe use of copper flakes (coated
with aliphatic acid) antifouling based product is identified if both professional and non-
professional operators wear appropriate personal protective equipment.
8
COMMISSION REGULATION (EC) No 479/2006 of 23 March 2006 as regards the authorization of certain
additives belonging to the group compounds of trace elements, OJ L 86 24/03/2006, p. 4-7 :
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32006R0479&qid=1399886943661&from=EN
9
DIRECTIVE 2002/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 June 2002 on the
approximation of the laws of the Member States relating to food supplements, OJ L 183, 12.7.2002, p. 1-16
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02002L0046-
20111205&qid=1399993783567&from=EN
10
Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of
the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue
levels for products covered by Annex I thereto (Text with EEA relevance), OJ L 58, 01/03/2008, p. 1–398 :
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32008R0149&qid=1399895764828&from=EN
24
aliphatic acid)
2.4.2 Summary of environmental risk assessment
2.4.2.1 Fate and distribution in the environment
As a result of the unique fate of copper in water, soil, sediment and sludge, many of the
data requirements listed in Section A7 of the Technical notes for Guidance are not
applicable for inorganic compounds and metals; in particular e.g. hydrolysis,
photodegradation and biodegradation. It is not applicable to discuss copper in terms of
degradation half-lives or possible routes of degradation. Subsequently, coated copper
flake, which is an inorganic salt cannot be transformed into related degradation products
other than copper ions (Cu2+) and water in solution.
As with all metals, copper becomes complexed to organic and inorganic matter in waters,
soil and sediments and this affects copper speciation, bioavailability and thus toxicity,
which mainly depends of the abundance of the copper ion.
An important parameter determining the distribution of copper in the aquatic and soil
environment is the adsorption onto solid materials and therefore partitioning coefficients.
For an organic compound, solid-liquid/solution partitioning is related to its hydrophobic
properties, as determined using octanol-water partitioning coefficient Kow and organic
carbon partitioning coefficient Koc. Since metals do not have the hydrophobic or lipophilic
characteristics of organic compounds, the concept of Kow and Koc is not applicable. The
distribution of metals is not only controlled by pure adsorption/desorption mechanisms.
The distribution of metals between aqueous phase and soil/sediment/suspended matter
should preferentially be described on the basis of measured soil/water, sediment/water
and suspended matter/water equilibrium distribution coefficient (TECHNICAL GUIDANCE
DOCUMENT on Risk Assessment Part II Appendix VIII, 2003; TECHNICAL GUIDANCE
DOCUMENT Annex 4-VIII Environmental risk assessment for metals and metal
compounds (RIP 3.2-2).
*From the literature overview, the following partitioning coefficients have thus been
derived for Cu metal and Cu compounds:
Partition coefficient in freshwater suspended matter

- Kpsusp = 30,246 l/kg (log Kp (pm/w) = 4.48) (50th percentile)
- (Heijerick et al, 2005)
Partition coefficient in freshwater sediment
- Kpsed = 24,409 l/kg (log Kp(sed/w) = 4.39) (50th percentile)
- (Heijerick et al., 2005)
Partition coefficient in soil
- Kd = 2120 l/kg (log Kp = 3.33) (50th percentile)
(Sauvé et al. 2000)
Partition coefficient in marine suspended matter

- Kpsusp = 131826 l/kg (log Kp (pm/w) = 5.12) (50th percentile)
- (Heijerick and van Sprang 2008)
Partition coefficient in estuarine suspended matter
- Kpsusp = 56234 l/kg (log Kp (pm/w) = 4.45) (50 th percentile)
- (Heijerick and van Sprang 2008)
The 50th percentile value of the distribution function represents a typical suspended
matter/sediment partition coefficient for EU waters and will be used for the derivation of
local and typical regional PECs.
As all metals, copper becomes complexed to organic and inorganic matter in waters, soil
and sediments and this affects copper speciation, bioavailability and toxicity.
25
aliphatic acid)
Because of the homeostasis of metals, BCF values are not indicative of the potential
bioaccumulation. There is therefore limited evidence of accumulation and secondary
poisoning of inorganic forms of metals, and biomagnification in food webs.
2.4.2.2 Effects assessment on environmental organisms (active substance)
2.4.2.2.1 Aquatic compartment (including water, sediment and STP)
2.4.2.2.1.1 PNEC for aquatic organisms
Information on the mode of action of copper exposure indicated that the target tissue for
copper toxicity were the water/organism interface with cell wall and gill-like surfaces
acting as target biotic ligands in all species investigated.
 Freshwater pelagic compartment
For the freshwater pelagic compartment, 139 individual NOEC/EC10 values resulting in
27 different species-specific NOEC values, covering different trophic levels (fish,
invertebrates and algae) were used for the PNEC derivation. The large intra-species
variabilities in the reported single species NOECs were related to the influence of test
media characteristics (e.g., pH, dissolved organic carbon, hardness) on the bioavailability
and thus toxicity of copper. Species-specific NOECs were therefore calculated after
normalizing the NOECs towards a series of realistic environmental conditions in Europe
(typical EU scenario’s, with welldefined pH, hardness and DOC). Such normalization was
done by using chronic copper bioavailability models (Biotic Ligand Models), developed
and validated for three taxonomic groups (fish, invertebrates and algae) and additional
demonstration of the applicability of the models to a range of other species. The species-
specific BLM-normalized NOECs were used for the derivation of log-normal Species
Sensitivity Distributions (SSD) and HC5-50 values (the median fifth percentile of the
SSD), using statistical extrapolation methods.
The HC5-50 values of the typical EU scenarios ranged between 7.8 to 22.1 μg Cu/L.
Additional BLM scenario calculations for a wide range of surface waters across Europe
further demonstrated that the HC5-50 of 7.8 μg Cu/L, is protective for 90% of the EU
surface waters and can thus be considered as a reasonable worst case for Europe in a
generic context.
Copper threshold values were also derived for three high quality mesocosm studies,
representing lentic and lotic systems. The mesocosm studies included the assessment of
direct and indirect effects to large variety of taxonomic group and integrate potential
effects from uptake from water as well as from food.
BLM-calculated HC5-50 values (Assessment Factor (AF) = 1) were used as PNEC for the
risk characterisation.
The AF = 1 has been chosen due to the uncertainty concerning:

- 1) the mechanism of action;
- 2) the overall evaluation of the database;
- 3) the robustness of the HC5-50 values;
- 4) corrections for bioavailability (reducing uncertainty);
- 5) the sensitivity analysis with regards to DOC and read-across assumptions;
- 6) the factor of conservatism “built in into” the data and assessment (such as no
acclimation of the test organisms and no pre equilibration of test media);
- 7) results from multi-species mesocosm studies ;
- 8) comparison with natural backgrounds and optimal concentration ranges for
copper, an essential metal.
26
aliphatic acid)
The choice of the AF of 1 has been challenged during the WG-IV 2015 and it was stated,
with a slight majority of MSs, that the AF of 1 should be kept to derive the PNECwater.
However, it was also concluded that the conditions for using an AF of 1 in general should
be re-discussed in the frame of the revision of Vol. IV Part B of the guidance document.
And therefore, this AF should be re-discussed at the renewal stage of the first copper
substances (in PT8) in case the revision of the guidance or new data available show the
need of a revised AF.
The HC5-50, with an AF = 1, was used to derive a PNECfreshwater of 7.8 µg Cu/l for
Europe in a generic context in absence of site-specific information on
bioavailability parameters (pH, DOC, hardness).
 Marine compartment
For the marine PNEC derivation, 56 high-quality chronic NOEC/EC10 values, resulting in
24 different species-specific NOEC values covering different trophic levels (fish,
invertebrates, algae), were retained for the PNEC derivation. NOEC values were related
to the DOC concentrations of the marine test media. Species-specific NOECs were
therefore calculated after DOC normalizing of the NOECs. These species-specific NOECs
were used for the derivation of species sensitivity distributions (SSD) and HC5-50 values,
using statistical extrapolation methods. Considering that the log-normal distribution had
a poor data fit according to goodness of fit tests, HC5-50 values, obtained by using the
best-fitting parametric distribution, were considered for the PNEC derivation. The organic
carbon normalisation was carried out at a DOC level typical for harbours and marinas (2
mg/l), for surrounding waters (0.5 mg/l) and seaaa (0.2 mg/l) and resulted in an HC5-50
value of 5.2 µg Cu/L for harbours and marinas, 2.3 µg Cu/L for surrounding waters and
1.3 µg Cu/L for sea. Additionally a semi-parametric statistical analysis of the NOECs
distribution was performed and a HC5-50 derived. Because the difference between the
HC5-50 by either approach were similar, the HC5-50 derived by the parametric curve
fitting (using the fit function that fitted best) was used. The evaluations of lower-quality
NOECs and EC50s from single species and multi-species marine studies added weight to
the HC5-50 value derived from the best-fitting distribution.
No reliable mesocosm or semi-field study was available for the marine compartment at
the time of the final version of the effects assessments of copper and its compounds on
the marine organisms of the EU-RAR (2008). This was underlined by the SCHER in its
opinion in 2009. TC NES agreed that, considering the large amount of information
available, the assessment factor used in the derivation of the PNEC (AF=2) could be
reduced in future if the HC5-50 could be validated with reliable, representative and
comprehensive mesocosm data (TC NES opinion 2008). The SCHER also “agreed with the
logic of this approach” (Scher opinion 2009).
Therefore, the applicant has submitted a marine mesocosm which is of high quality. This
study revealed a marine NOEC of 5.7 µg Cu/L which validates the HC5-50 of 5.2 µg Cu/L
derived from the Q1 database.
However, this mesocosm study was not considered sufficient to lower the assessment
factor, in the light of the higher variability of the marine ecosystem during the discussion
at the WG IV-2015. Therefore, an assessment factor of 2 was still applied to the HC5-50
derived from the different marine environments.
The HC5-50 (AF = 2) of 2.6 µg Cu/L for harbours and marinas, 1.15 µg Cu/L for
surrounding waters and 0.65 µg Cu/L for sea areas was used as PNEC to the
risk characterisation.
27
aliphatic acid)
2.4.2.2.1.2 PNEC for STP micro-organisms
For the STP compartment, high-quality NOECs from respiration or nitrification inhibition
studies, relevant to the functioning of a Sewage Treatment Plant (STP), resulted from
biodegradation/removal studies and NOECs for ciliated protozoa were used to derive the
PNEC for STP micro-organisms.
The lowest reliable observed NOEC value was noted for the inhibition of
respiration (AF = 1) of 0.23 mg/l expressed as dissolved copper and carried
forward as PNEC to the risk characterisation.
2.4.2.2.1.3 PNEC for sediment
 Freshwater sediment
The sediment PNEC included using a weight of evidence approach considering different
sources and tiered approaches of information:
- (1) sediment ecotoxicity data ,
- (2) pelagic ecotoxicity data in combination with Kd values derived through
different approaches ;
- (3) soil ecotoxicity data and soil bioavailability models ;
- (4) mesocosm/field ecotoxicity.
High-quality chronic benthic NOECs for six benthic species, representing 62 NOEC values
were retained for the PNEC derivation. NOEC values were related to sediment
characteristics (e.g., Organic Carbon (OC) and Acid Volatile Sulphides (AVS)), influencing
the bioavailability and thus toxicity of copper to benthic organisms. The derivation of the
freshwater HC5-50 sediment for copper was therefore based on the OC-normalized
dataset, containing only low-AVS sediments. Using the log-normal species sensitivity
distribution freshwater HC5-50 sediment of 1741 mg Cu/kg OC was derived through the
statistical extrapolation method.
Using the equilibrium partitioning (EqP) approach, the derived HC5-50 sediment (EP)
values were comparable or higher than the HC5-50 derived from whole sediment tests.
The comparison between the sensitivity of soil and benthic organisms added weight to
the HC5-50 from whole sediment tests. The same did sediment threshold values and
benthic NOECs that were obtained from four mesocosm studies and one field cohort
study.
The AF of 1 has been chosen due to the uncertainty concerning:

- 1) weight of evidence provided;
- 2) the overall quality of the database;
- 3) the robustness of the HC5-50 values;
- 4) corrections for bioavailability (reducing uncertainty);
- 5) the conservative factor built into the system (no acclimation of the test
organisms and only low AVS sediments retained);
- 6) validations from multi-species mesocosm studies and field studies:
- 7) comparison with natural backgrounds and optimal concentration ranges.
As for the PNECwater derivation, the choice of the AF of 1 has been challenged during the
WG-IV 2015 and it was stated, that the AF of 1 should be kept to derive the
PNECsediment. However, this AF should be re-discussed at the renewal stage of the first
copper substances (in PT8) in case the revision of the guidance document or new data
available show the need of a revised AF.
28
aliphatic acid)
In case of natural sediments both the amount of AVS and organic carbon present in the
sediment has dictated the observed effect levels for copper and were used for the risk
characterisation. In absence of AVS data, a default AVS value of 0.77 μmol/kg dry weight
was used. This value corresponded to the 10th percentile of the AVS obtained from a
wide Flemish monitoring database and additional AVS data from other European
countries.
The HC5-50, with an AF = 1, was used to estimate a PNECsediment of 1741 mg

Cu/kg OC, for Europe in a generic context. This corresponding to 87 mg Cu/kg
dry weight for a sediment with 5 % O.C. (TGD default value).
 Marine compartment
As no reliable toxicity data are available for the marine sediment compartment, the
PNECmarine sediment was calculated according to the equilibrium partitioning concept based
on a PNECwater using the 10th percentile of the Kd value for marine sediment according to
the Guidance for environmental risk assessment for metals and metal compounds
(Appendix R.7.13-2).
The PNECmarine sediment of 98.8 mg Cu/kg dw sediment ( corresponding to 21.48

mg Cu/kg ww sediment) is carried forward to the risk characterization.
2.4.2.2.1.4 Terrestrial compartment
A high-quality dataset of 252 individual chronic NOEC/EC10 values from 28 different

species and processes representing different trophic levels (i.e., decomposers, primary
producers, primary consumers) has been retained for the PNEC derivation. The observed
intra-species differences in toxicity data were related to differences in bioavailability, the
latter related to differences in soil properties and to differences in ageing and application
mode and rate.
The soil property best explaining the variability in toxicity for most of the endpoints was
the eCEC (effective Cation Exchange Capacity).
For the normalisation of the ecotoxicity data, the respective Cu background

concentrations were added on all NOEC/EC10 values which were subsequently
normalised to representative EU soils using the relevant regression (bio)availability
models, generating so soil-type specific HC5-50 values.
Species Sensitivity Distributions were constructed using the normalised NOEC/EC10 data.
HC5-50 values from log-normal distributions ranging between 13.2 and 94.4 mg Cu/kg
dry weight were obtained.
A total of eight single species studies were available in which the toxicity of Cu to
microorganisms, invertebrates and plants in field-contaminated aged soils was
investigated for a wide range of European soil types (peaty, sandy, clay).
A total of five multi-species studies were available, three of which studied the effects of
copper in freshly spiked soils and 2 in field contaminated aged soils. Invertebrates, plants
and micro-organisms were studied. Single species and multi-species field studies indicate
that effects did not occur at an exposure level at the HC5-50-value.
Normalized HC5-50 values (AF = 1) were used as PNEC for the risk characterisation.
The uncertainty analysis that provides arguments for the AF = 1 was based on:
- 1) the overall quality of the database and the end-points covered;
- 2) the diversity and representativeness of the taxonomic groups covered by the
database;
- 3) corrections for differences in bioavailability (soil properties);
29
aliphatic acid)
- 4) the statistical uncertainties around the 5th percentile estimate;

- 5) NOEC values below the HC5-50;
- 6) field and mesocosm studies and comparisons of their results with the HC5-50.
To account for the observed difference between lab-spiked soils and field-contaminated
soils, a conservative leaching-ageing factor of 2 was agreed based on test data from the
mechanistic research on ageing and ionic strength (leaching) effects.
For the PT21 biocidal product dossier, unlikely to the VRA, a leaching ageing
“L/A” factor of 2 was not used to derive the PNECsoil but it was taken into
account in the assessment of the PEC soil (PEC divided by 2).
As for the PNECwater derivation, the choice of the AF of 1 has been challenged during the
WG-IV 2015 and it was stated, that the AF of 1 should be kept to derive the PNECsoil.
However, this AF should be re-discussed at the renewal stage of the first copper
substances (in PT8) in case the revision of the guidance document or new data available
show the need of a revised AF.
The HC5-50, with an AF = 1, was used to derive a PNECsoil of 45.6 mg Cu/kg dry
weight for Europe in absence of site-specific information on soil properties.
2.4.2.2.1.5 Non compartment specific effects relevant to the food chain

(secondary poisoning)
An in-depth literature search showed the absence of copper biomagnification across

the trophic chain in the aquatic and terrestrial food chains. Differences in
sensitivity among species were not related to the level in the trophic chain but to the
capability of internal homeostasis and detoxification. Field evidence had further provided
no indications of secondary poisoning.
2.4.2.2.1.6 Summary of PNEC values
Table 2.4.2-1: Summary of the selected PNEC values used for the risk
characterization
ENVIRONMENTAL COMPARTMENT PNEC Unit
PNECSTP 0.23 mg Cu/L
PNECsurface water 7.8 µg Cu/L

PNECmarine water
- Harbour – Marinas 2.6
µg Cu/L
- Surrounding waters 1.15
- Sea 0.65
87 mg Cu/ kgdwt
PNECsediment freshwater
equivalent to 18.9 mg Cu/ kgwwt
98.8 mg Cu/ kgdwt
PNECsediment marinewater
equivalent to 21.48 mg Cu/ kgwwt
30
aliphatic acid)
PNECsoil 45.6 µg Cu/kgdwt
2.4.2.3 Environmental effect assessment (product)
No data were provided for the biocidal product VC17M Graphite.
2.4.2.4 Environmental exposure assessment and risk characterisation
2.4.2.4.1 Environmental exposure
Biocides from antifouling paints enter the marine environment as a result of direct
leaching from the paint while a treated vessel is in service. A second route of
environmental exposure is associated with vessel maintenance and construction. The
OECD ESD presents default scenarios for application, removal and in service phases of
antifouling products (for commercial harbours, marina and shipping lanes when
relevant).
Therefore the two main situations identified in the ESD leading to potential emissions of
biocides from antifouling paint applied on ship hulls to the environment are:
 New Building, Maintenance and Repair (M&R) of ships
During these phases, the antifouling paint is applied or removed. There are potential
emissions of antifouling paint droplets, and thus biocide, to surface water, soil and STP
(Sewage Treatment Plant). For these scenarios, the OECD ESD for PT21 distinguishes
commercial vessels and pleasure crafts but also professional and non-professional users.
 Service-life of ships
During service-life, the antifouling paint leaches into water, preventing organisms to
attach to the ship hulls. For this emission phase, the OECD ESD for PT21 distinguishes
different environments of release: marinas, commercial harbours (and their adjacent
areas) and shipping lanes (open sea).
The OECD ESD scenarios propose releases to the marine compartment only. In fact,
direct emissions to the freshwater environment have not been assessed due to the lack
of a harmonized scenario and should be considered during product assessment, if
appropriate.
The antifouling product VC17m used to support the approval of copper powder is a paint
applied by professional and non-professional users for the following field of uses:
- professional applications on commercial, Navy and Government vessels, super-
yachts and pleasure crafts;
- non-professional applications on pleasure crafts only.
The exposure assessment for the different compartments of interest were conducted
according to the equations of the Emission Scenario Document (ESD) for Antifouling
Products (Product Type 21) in OECD’s countries (OECD, 2004), considering the
amendments from European consultations and papers. Direct releases to the marine
compartments were also covered by MAMPEC 2.5 modelling for their assessment
(service-life phase) and refinement (new-building, maintenance and repair and
cumulative assessment).
31
aliphatic acid)
For every scenario, a ‘typical case’ (TC) and a ‘realistic worst case’ were defined. For the
‘typical case’, more realistic control measures preventing the releases to the environment
are applied. The considered mitigation measures are different for each scenarios and
detailed in the exposure assessment.
The following scenarios were developed to cover all the situations of exposure:
Table 2.4.2-2: Proposed scenarios for the exposure assessment
Boat type User Exposure Environment

New Building –Application of paint
Commercial Professional Direct exposure Aquatic compartment
vessels (harbour)
Pleasure crafts Professional Direct exposure Soil and STP (Sewage
Treatment Plant)
Indirect exposure Aquatic (freshwater and
via the STP marina) and soil
compartments
Maintenance and repair – Removal of paint
vessels (harbour)
Pleasure crafts Professional Direct exposure Aquatic (marina) and soil
compartments, STP
(Sewage Treatment Plant)
compartments
Pleasure crafts Non - Direct exposure Aquatic (marina) and soil
professional compartments, STP
(Sewage Treatment Plant)
compartments
Maintenance and repair – Application of paint
vessels (harbour)
Pleasure crafts Professional Direct exposure Soil and STP (Sewage
Treatment Plant)
compartments
Pleasure crafts Non - Direct exposure Soil and STP (Sewage
professional Treatment Plant)
compartments
Service-life of ships
All types - Direct exposure Marine aquatic
compartment (harbour,
marina, shipping lane)
For each direct release scenario, the exposure assessment considering the ESD equations
was based in Tier 1 on daily releases and on cumulated releases over the year at once.
For the aquatic compartment, a Tier 2 using MAMPEC modelling was proposed for the
cumulative assessment.
32
aliphatic acid)
A cumulat ive assessment using MAMPEC was also conducted considering the potential
simu ltaneous releases from the d ifferent phases of em issions t o harbou r and marina . The
following situations have been considered :
commercial shipping in harbour area : di rect releases during New Build ing and M & R
(daily emission from New Bui lding as a worst case) + service-life;
professional pleasure craft in marina : direct releases during M&R (Removal) +
indirect releases during New Building (Appl ication) + service-l ife;
non professional pleasure craft in ma rina: during M&R (Removal) + indi rect releases
during M&R (Removal) + service- life.
Exposure assessment based on total Cu concentrations
The risk assessment was carried out on the basis of tota l concentrations of copper in t he
environment . The PEC va lues issued from the ESD equations, initially calculated as
"added va lues" were corrected in order to int egrate the backg round concentrations in
copper. Concerning MAMPEC modelling, the concentrat ions were derived in integ rating or
not t he backg round directly in t he model. The worst case value was considered for the
risk assessment (without the integration of the background for surface water and with
the integration of the background for sediment). Total copper concentrations were
calcu lated in taking into account of the regiona l copper background concent rations on ly
(as agreed under the Council Regu lation (EEC) 793/93 on Existing Substances - EU-RAR).
These backg round concentrations are presented in the tabl e below. For the risk
assessment, tota l concentrations considering the regional backgrounds are always
considered.
Table 2.4.2-3: Background concentrations used for the exposure assessment
Natural/ pristine Regional

Compartment background background Unit
concentration concentration
1.1 (coastal waters,
harbou rs, ma rinas)
Marine surface
water - [µg. L-1]
0 .50 (open sea)
Marine 16 .1 [mg .kgdwt-1]

sediment
- 3 .5 [ mg .kgwwt- 1]
Freshwater 0 .88 2.9 [µg .L-1]
Freshwater 21 67 .5 [mg .kgdwt-1]

Sed iment 4. 56 14 .7 [mg .kgwwt-1]
12 24.4 [mg .kgdwt-1]
Soi l
10.6 21. 6 [mg .kgwwt-1]
Ground water 0 .88 2.9 [µg. L-1]
Leaching rate for in-service exposure
A specific leaching rate calcu lated with the CEPE method and based on the intended
application rate (20 . 71 µg/cm 2/day) was used t o evaluate the exposu re from ship hull
service-life . Add it ional information on the leaching rate of copper in antifouling pa ints is
available in the ESD for ant ifou ling products (ESD PT21, 2004 ). A defau lt value of SO
33
aliphatic acid)
µg/cm2/day was determined by the CEPE Antifouling Working Group and can be used in
the MAMPEC model. This value is based on literature data and an expertise available
within the CEPE Antifouling Working Group (MAMPEC v1.4 main report, van Hattum et al.
2002, Report number E-02-04 / Z 3117).
In absence of field studies that can confirm CEPE calculations, RMS also carried out a risk
assessment based on the default leaching rate presented in the ESD. The cumulative
assessment was done with this default value only.
The leaching rate correction factor of 2.9 for vessels at berth was not applied for copper
based paints.
2.4.2.4.2 Risk characterisation
2.4.2.4.2.1 Sewage treatment plant
The PEC values for copper and the corresponding PEC/PNEC ratios for the sewage
treatment plant (STP) resulting from the use of VC17M Graphite product as antifouling
are presented below in
Table 2.4.2-4 for new building and maintenance & repair phases of pleasure crafts by
professionals and non-professionals.
Table 2.4.2-4: PEC/PNEC ratios for the STP after the application of Copper in
VC17m on pleasure crafts by professionals and non-professionals
PEC (mg/L) PEC/PNEC

Exposure Scenario PNECmicro-organisms = 0.23 mg/L
WC TC WC TC
New building, pleasure craft,
1.16E-03 5.06E-03
professional
M&R removal, pleasure craft,
8.90E-04 8.90E-05 3.87E-03 3.87E-04
professional
M&R application, pleasure
5.34E-04 2.23E-04 2.32E-03 9.67E-04
craft, professional
M&R removal, pleasure craft,
1.24E-03 1.60E-04 5.40E-03 6.95E-04
non-professional
M&R application, pleasure
4.44E-05 1.93E-04
craft, non-professional
WC: worst case / TC: typical case / M&R = Maintenance and repair
These results indicate acceptable risks to the STP, with PEC/PNEC ratios < 1, during the
application and removal of paint for pleasure crafts by professional and non-professional
users, whatever the scenario applied (realistic worst case or typical case).
2.4.2.4.2.2 Aquatic compartment (including sediment)
Marine Compartment - Direct releases to the aquatic compartment
The PEC values for copper and the corresponding PEC/PNEC ratios for the marine aquatic
environment (surface water and sediment) resulting from the use of VC17M Graphite
product as antifouling are presented below for new building, maintenance & repair
phases and service-life of commercial vessels and pleasure crafts, leading to direct
releases to harbour and marinas. Table 2.4.2-5 and Table2.4.2-6 present the values
34
aliphatic acid)
for marine surface water in Tier 1 and Tier 2 (refined with MAMPEC when relevant)
respectively.
35
aliphatic acid)
Table 2.4.2-7 and Table 2.4.2-8 contain va lues for marine sediment in Tier 1 and Tier
2 respectively.
Table 2.4.2-5: PEC/ PNEC ratios for marine s urface water afte r direct r e leases to
the environment - TIER 1 - Ave rage dissolve d concentrations cons ide ring the
background (not inte grated in the mode l for service-life )
Expos ure Scenario PEC (µg / L) PEC/ PNEC

PNECmarinas, harbours = 2.6 µg/L
PNECsurrounding waters= 1.15 µg/L
PNECsea = 0.65 µg/L = Sh ipping lane scenario
WC TC WC TC
NEW BUILDING - MAINTENANCE AND REPAIR (MltR) SCENARIOS
Commercial vesse ls - Har bour
New bu ilding
1.34 1.15 0 .52 0.44
Da ily emission
New bu ilding
1.59 1.20 0 .61 0.46
Cu mulative emission
M&R, Removal
1.27 1.12 0.49 0.43
Da ily emission
M&R, Removal
1.87 0 .72
Cumulative emission
M&R, Application Daily
1.34 1.15 0 .52 0.44
em ission
M&R, Application -
10 .82 3. 18 4.16 1.22
Cumulative em ission
Pleasure crafts - Marina - Professionals
M&R, Removal - Daily
1.15 1.11 0.44 0.43
em ission
M&R, Removal - 10 .93 2.08 4.20 0.80
Cumulative emission
Pleasure crafts - Marina - Non-professionals
M&R, Removal - Daily
1.18 1.11 0.45 0.43
em ission
M&R, Removal - 7.93 1.98 3.05 0.76
SERVICE LIFE SCENARIOS (Generic leac hing rate of 50 µg/cm 2 /day)
OECD Shipping Lane 0.50 0 .77

OECD Commercial
1.35 0 .52
Harbour
Surround ings of OECD
1. 11 0 .96
Commercial Harbour
OECD Marina 2.02 0 .78
Surroundings of OECD
1.11 0 .96
Marina
SERVICE LIFE SCENARIOS (Specific lea ching rate of 20.71 µg/cm 2 /day)
OECD Shipping Lane 0 .50 0 .77
OECD Commercial
1.20 0.46
Harbour
36
aliphatic acid)
Exposure Scenario PEC (µg/ L) PEC/ PNEC

1.10 0 .96
Commercial Harbour
OECD Marina 1.48 0 .57
1.10 0 .96
Marina
WC: worst case I TC: typical case I M&R = Maintenance and repai r
Ta ble2.4.2-6: PEC/ PNEC ratios for m a rine surface water after direct rele ases to
the environment - TIER 2 - MAMPEC modelling for New building and
Maintena nce 8t Repair - Ave rage dissolved concentration considering the
background (not inte grated in the model for service life )
Exposure Scenario PEC (µg/ L) PEC/ PNEC

PNECmarinas, harbours = 2 .6 µg/L
PNECsurroundina waters= 1.15 µg/L
WC TC WC TC
NEW BUILDING - MAINTENANCE AND REPAIR (M&.R) SCENARIOS
MAMPEC Modelling
Commercial vessels - Ha rbour
1.36 1.16 0 .52 0.44
( New bu ilding as a worst case)
Commercial vessels -
Surround ing area of Harbour 1.11 1.10 0.96 0.96
( New bu ildina as worst case)
Professionals - Marina
1.10 1.10 0.42 0.42
( M&R, Removal as worst case)
Professionals - Surround ing area
of Marina {M&R, Removal as 1.10 1.10 0.96 0.96
worst case)
Non-professionals - Marina
1.10 1.10 0.42 0.42
( M&R Removal as worst case)
Non-professionals - Surrounding
area of Marina {M&R, Removal as 1.10 1.10 0 .96 0.96
worst case)
WC: worst case I TC: typical case I M&R = Maintenance and repair
As presented in Ta ble 2.4.2-5, considering a one- day emission, the results indicate
acceptable risks to the marine surface water, with PEC/PNEC ratios < 1, during the
application and remova l of paint for commercial vessels and pleasure crafts by
professiona l a non- professional users, whatever the scenario appl ied (real istic worst case
or typical case) . The risks are also deemed acceptable for the service-life of ship hulls
even in considering a generic leaching rate for copper of SO µg/cm 2/day .
The Tier 1 cumu lative assessments considering the releases over the year lead to
unacceptable r isks for the application phase of M&R for commercial vessels and for the
removal phase of M&R for pleasure crafts in worst case conditions. Nevertheless, the Tier
1 approach seems to be unreal istic as it does not consider complex transport and
exchange processes in marine environments. Therefore a Tier 2 approach based on
MAMPEC modelling is proposed to refine the risk assessment for direct releases
{Ta ble 2.4.2-6) and shows acceptable risk for all scenarios.
37
aliphatic acid)
Table 2.4.2-7: PEC/PNEC ratios for marine sediment after direct releases to the
environment (TIER 1) - Concentration on suspended matter considering the
background (integrated in the model for service-life)
Exposure Scenario PEC (mg/kg wwt) PEC/PNEC

PNECmarinesediment = 21.48 mg/kg wwt
WC TC WC TC
Commercial vessels - Harbour
New bu ilding
24.23 7.94 1.13 0 .37
Daily emission
New bu ilding Cumulative
44.96 12.38 2.09 0 .58
em ission
M&R, Removal
17 .71 5.56 0.82 0 .26
Dailv emission
M&R, Removal
69.03 3.21
M&R, Application Daily
24. 23 7.94 1.13 0 .37
em ission
M&R, Appl ication - 832. 69 181. 18 38.77 8.43
Cumulat ive em ission
Pleasure crafts - Marina - Professionals
M&R, Remova l - Daily
8 .08 3.96 0.38 0 .1 8
em ission
M&R, Remova l - 842.12 87.36 39.20 4.07
Pleasure crafts - Marina - Non-professionals
M&R, Remova l - Daily
9 .90 4 .32 0.46 0 .20
em ission
M&R, Remova l - 585 .88 7.61 27.28 0 .35
Cumulat ive em ission
SERVICE LIFE SCENARIOS (Generic leaching rate of 50 pg/cm 2 /day)
OECD Shipping Lane 8.67 0 .40
OECD Commercia l
12.09 0 .56
Harbour
5 .80 0 .27
Commercial Harbour
OECD Marina 31.96 1.49
5 .83 0 .27
Marina
SERVICE LIFE SCENARIOS (Specific leaching rate of 20.71 pg/cm 2 /day)
OECD Shipping Lane 8 .65 0.40
OECD Commercia l
7 .96 0.37
Harbour
5.67 0 .26
Commercial Harbour
OECD Marina 16.48 0.77
5 .70 0 .27
Marina
WC : worst case I TC: typical case I M&R = Maintenance and repair
38
aliphatic acid)
Table 2.4.2-8: PEC/ PNEC ratios for m a rine sediment after direct releases to the
environment - TIER 2 - MAMPEC modelling for New building and Maintenance 8r.
Repair - Ave rage concentration on suspended solids conside ring the
background (inte grat ed in the model)
Exposure Scenario PEC (mg/kg wwt) PEC/ PNEC

PNECmarine sediment = 21.48 mg/kg wwt
WC TC WC TC
NEW BUILDING - MAINTENANCE AND REPAIR (M8r.R) SCENARIOS
MAMPEC Modelling
Commercial vessels - Harbour
12.37 6 .59 0 .58 0.31
(New bu ilding as a worst case)
Commercial vessels -
Surround ing area of Harbour 5.83 5.63 0.27 0.26
(New bu ildina as worst case)
Professionals - Marina
5.65 5.59 0.26 0.26
(M&R, Removal as worst case)
Professionals - Surround ing area
of Marina (M&R, Removal as 5.61 5.61 0.26 0.26
worst case)
Non-professionals - Marina
5.70 5.59 0.27 0.26
(M&R Removal as worst case)
Non-professionals - Surrounding
area of Marina (M&R, Removal as 5.61 5.61 0 .26 0.26
worst case)
WC: worst case I TC: typical case I M&R = Maintenance and repair
As presented in Table 2.4.2-7, in Tier 1, for new bu ilding and M&R, the worst case
scenario leads to acceptable risk for the marine sediment on ly in the case of a one-day
em ission linked to removal from commercial vessels and pleasure crafts. The r isks are
acceptable for the typical case, except for cumu lative em issions during application on
commercial vessels and removal by professionals.
Concerning the service-life of sh ip hulls, the risks are deemed acceptable except for
marinas considering a generic leaching rate for copper of SO µg/cm 2/day. For the specific
leach ing rate of 20 .71 µg/cm 2 /day, the risks are also acceptable inside the commercia l
harbour.
Nevertheless, the Tier 1 approach seems to be unrealistic as it does not consider complex
transport and exchange processes in marine environments. Therefore a
Tier 2 approach based on MAMPEC modelling is proposed to refine the risk assessment
for direct releases (Ta ble 2.4.2-8) and shows acceptable risk for all the scenarios.
Marine Comoa rtment - Indirect relea ses to the aquatic compartment
The PEC values for copper and the corresponding PEC/PNEC ratios for the marine aquatic
environment (surface water and sed iment) resu lting from the use of VC17M Graph ite
product as antifoul ing are presented below for new bu ilding, maintenance & repair
phases of pleasure crafts, leading to indirect releases to marinas v ia the STP.
Ta ble 2.4.2-9 presents the values for marine surface water and Table 2.4.2-10 for
marine sediment. As a worst case for the marine compartment, the PN EC for coastal
waters and surround ings of marina has been considered instead of the PNEC for marina.
39
aliphatic acid)
Table 2.4.2-9: PEC/PNEC ratios for marine surface water after indirect releases
via the STP to the environment - Dissolved concentration considering the
background
Exposure Scenario PEC (1Jg/L) PEC/PNEC

PNECsurrounding waters= 1.15 µg/L
WC TC WC TC
NEW BUILDING - MAINTENANCE AND REPAIR (M8tR) SCENARIOS
Pleasure crafts - Professionals
New bu ilding - Daily emission 1.10 0.96
M&R, Removal - Dai ly em ission 1.10 1.10 0.96 0.96
M&R, Appl ication - Daily em ission 1.10 1.10 0.96 0 .96

Pleasure crafts - Non-professionals
M&R, Removal - Dai ly em ission 1.10 1.10 0.96 0.96
M&R, Appl ication - Daily em ission 1.10 0.96
WC : worst case I TC: t ypical case I M&R = Maintenance and repai r
Table 2.4.2-10: PEC/PNEC ratios for marine sediment after indirect releases via
the STP to the environment - Concentration on suspended matter considering
the background

PNECmarinesediment = 21.48 mg/kg wwt
WC TC WC TC
New bu ilding - Daily emission 3 .6 1 0. 17
M&R, Removal - Dai ly em ission 3.59 3.51 0. 17 0. 16
M&R, Appl icat ion - Daily emission 3.55 3.52 0. 17 0. 16

M&R, Removal - Dai ly emission 3 .62 3 .52 0. 17 0 .16
M&R, Application - Daily emission 3.50 0. 16
WC : worst case I TC: typical case I M&R = Maintenance and repai r
These resu lts indicate accept able r isks to the mar ine surface water and sedi ment, with
PEC/PNEC ratios < 1, du ring the appl ication and removal of paint for pleasu re crafts by
professiona l and non-professional users, whatever the scenario applied (realistic worst
case or typical case), for indirect contamination of the environment via the STP.
Cumulative assessment for direct and indirect releases to the commercial

harbour and marina
40
aliphatic acid)
The following situations have been considered for a cumu lative assessment using
MAM PEC modelling and considering each environment (ha rbou r and marina) and each
activity sector (professional and non - professiona l users) :
Commercia l shipping in harbour area : d irect releases during New Bui lding and M & R
(daily emission from New Bui lding as a worst case) + service-life,
Professional pleasu re craft in marina : direct releases during M&R ( Removal) +
indirect releases during New Building (Appl ication) + service-l ife,
Non professional pleasure craft in marina : during M&R (Removal) + indirect releases
during M&R (Removal) + service- life.
A generic leaching rate for copper of 50 µg/cm 2 /day for the service-life of sh ip hulls was
considered as a worst case for th is cumulative assessment.
Table 2.4.2-11: CUMULATIVE ASSESSMENT - PEC/PNEC ratios for marine

surface water after direct and indirect releases via the STP to the environment -
Average dissolved concentrations considering the background (not integrated in
the model)
Exposure Scenario PEC (µg/L) PEC/PNEC

PNECmarinas, harbours = 2.6 µg/L
PNECsurroundina waters= 1.15 µg/L
WC TC WC TC
MAMPEC Modelling
Commercial vessels - Harbour 1.61 1.40 0.62 0 .54
Commercial vessels - Surrounding

1.12 1. 11 0.97 0 .97
area of Harbour
Professiona ls - Ma rina 2.02 2.02 0.78 0 .78

Professiona ls - Surrou nding area of
1. 11 1.11 0.96 0 .96
Marina
Non- professionals - Marina 2.02 2.02 0.78 0 .78
Non-professionals -Surrounding of
1. 11 1.11 0.96 0 .96
marina
WC : worst case I TC: typical case I M&R = Ma intenance and repair
41
aliphatic acid)
Table 2.4.2-12: CUMULATIVE ASSESSMENT - PEC/PNEC ratios for marine

sediment after direct and indirect releases via the STP to the environment -
Average concentrations on suspended solids considering the background
(integrated in the model)

PNECmarine sediment = 21.48 mg/kg wwt
WC TC WC TC
MAMPEC Modelling
Commercial vessels - Harbour 19 .52 13 .74 0.91 0 .64
Commercial vessels - Surrounding

6.04 5.87 0.28 0 .27
area of Harbour
Professiona ls - Marina 31.96 31.96 1.49 1.49

Professiona ls - Surrounding area of
5. 83 5.83 0.27 0 .27
Marina
Non- professionals - Marina 31.96 3 1.96 1.49 1.49
Non-professionals -Surrounding of
5. 83 5.83 0.27 0 .27
marina
These results ind icat e acceptable risks to the mari ne surface water, with PEC/PNEC ratios
< 1, for a cumulative assessment in harbours and mari nas. For marine sediment the
risks are acceptable except inside marinas. It worth noting that for marinas, the risk is
led by the service-life of ship hulls. I n this case, direct or indirect releases for new
bu ilding or ma intenance & repair consist in negligible emissions compared to service-l if e.
It has to be high lighted that this cumulative risk assessment is based upon the approach
outl ined in the "Transitional Guidance on mixture toxicity assessment for biocida l
products for the envi ronment" (May 20 14).
Freshwater Compartment - Indirect releases to the aquatic compartment
The PEC values for copper and the correspond ing PEC/PNEC ratios for the fresh aquatic
environment (surface water and sediment) resulting from the use of VC l 7m product as
antifouling are presented below for new build ing, maintenance & repa ir phases of
pleasure crafts, leading to ind irect releases to marinas via th e STP .
Table 2.4.2-13 presents t he val ues for freshwater water and Table 2.4.2-14 for fresh
sediment.
42
aliphatic acid)
Table 2.4.2-13: PEC/ PNEC ratios for freshwater after indirect releases via the
STP to the environment - Dissolved concentration considering the background
Exposure Scenario PEC (µg/L) PEC/PNEC

PNECfreshwater= 7.8 µg/L
WC TC WC TC
New bu ilding - Daily emission 2. 98 0.38
M&R, Removal - Dai ly em ission 2 .96 2 .9 1 0.38 0.37

M&R, Removal - Dai ly emission 2. 99 2. 9 1 0.38 0.37
M&R, Appl icat ion - Daily em ission 2. 90 0.37
WC : worst case I TC: t ypical case I M&R = Maintenance and repai r
Table 2.4.2-14: PEC/PNEC ratios for fresh sediment after indirect releases via
the STP to the environment - Concentrations on suspended matter considering
the background

PNECtresh sediment = 18 .90 mg/kg wwt
WC TC WC TC
New bu ilding - Daily emission 15 .23 0.81
M&R, Removal - Dai ly emission 15 .1 0 14 .74 0.80 0.78
M&R, Appl icat ion - Daily emission 14.94 14 .80 0.79 0.78
M&R, Removal - Dai ly emission 15 .26 14 .77 0.81 0 .78
M&R, Applicat ion - Daily emission 14 .72 0.78
WC : worst case I TC: typical case I M&R = Maint enance and repai r
These resu lts indicate acceptable risks to t he freshwater and sediment, with PEC/PNEC
ratios < 1, during t he application and removal of pa int for pleasure crafts by professiona l
and non -professional users, whatever the scenario appl ied ( realistic worst case or typica l
case), for indirect contamination of the environ ment via the STP.
43
aliphatic acid)
2.4.2.4.2.3 Atmospheric compartment
Emission to the air of copper in the VC17m product may occur during the application and
removal phases and through spray drift, HP water wash and abrasion and volatilization
from paint during drying. However, copper powder is an inorganic compound and as such
has negligible volatility. Hence, the amount emitted to air is expected to be very low and
no risk assessment is carried out for the atmosphere compartment.
2.4.2.4.2.4 Terrestrial compartment (including groundwater)
The proposed uses of copper powder as antifouling are anticipated to result in direct and
indirect (via the STP) exposure of the terrestrial environment (including groundwater)
and hence the risk has been assessed for these compartments.
According to the applicant, it should be considered that the majority of the soil emissions
are from old paint flakes and not soluble copper emissions directly to soil. It should be
noted that, for amateur application and removal of paint, it is recommended that these
activities should only be undertaken over a tarpaulin or similar impervious barrier in
order to minimise paint loss to the soil. Once the task is completed (either amateur or
professional), the remaining paint can be swept up and disposed of in accordance with
local and national requirements. This would further ensure that the exposure of
bioavailable copper in soil would be minimal. However, typical and worst-case exposure
values were calculated for the terrestrial compartment from the use of VC17m product
and these are discussed below.
Direct releases to the terrestrial compartment
The PEC values for copper and the corresponding PEC/PNEC ratios for the terrestrial
environment (soil and groundwater) resulting from the use of VC17m product as
antifouling are presented below for new building, maintenance & repair phases of
pleasure crafts, leading to direct releases to soil. Table 2.4.2-15 and
44
aliphatic acid)
Table 2.4.2- 16 present the values for soil and groundwater respectively.
Table 2.4.2-15: PEC/ PNEC ratios for soil afte r direct releases to the
environment - Concentrations cons ide ring the b ackground
Expos ure Scenario PEC (mg/ kg wwt) PEC/ PNEC

PNECsoil = 40.20 mg/kg wwt
WC TC WC TC
Pleasure crafts - Profe ss ionals
New bu ilding - Daily 23.90 0.59
emission
New bu ilding - Cumu lative
159.80 3.98
em ission
M&R, Removal - Daily 22.70 21.71 0.56 0.54
emission
M&R, Remova l - Cumulative
222. 12 41.65 5.53 1.04
em ission
M&R, Appl ication - Daily
22 .26 21.87 0.55 0.54
emission
M&R, Application - 141.91 71.73 3.53 1.78
Cu mulative em ission
Plea sure crafts - Non-Professionals
M&R, Removal - Daily 24 .06 21.92 0.60 0 .55
em ission
M&R, Remova l - Cumu lative
33.90 23 .18 0.84 0.58
emission
M&R, Appl icat ion - Daily
21.69 0.54
em ission
M&R, Application - 22.04 0.55
WC: worst case I TC : typical case I M&R = Maintenance and repa ir
45
aliphatic acid)
Table 2.4.2-16: Risk assessment for groundwater after direct relea ses to the
environment - Concentrations considering the background
Exposure Scenario PEC (µg/ L) Risk characterization

Accept able concentration according to t he drinking water di rective : 2000 µg/L
WC TC WC TC
Pleasure crafts - Profe ssionals
New bu ilding - Daily 4. 13 Accept able
em ission
New building - Cumu lative
76.78 Acceptable
em ission
M&R, Removal - Daily 3.49 2.96 Accept able Acceptable
emission
M&R, Remova l - Cumu lative
110.09 13.62 Acceptable Acceptable
em ission
3.25 3.05 Accept able Acceptable
emission
M&R, Application - 67 .21 29 .70 Acceptable Accept able
Pleasure crafts - Non-Professionals
M&R, Removal - Daily 4.22 3.07 Acceptable Accept able
em ission
M&R, Remova l - Cumulative
9.48 3.75 Accept able Acceptable
emission
2.95 Acceptable
em ission
M&R, Application - 3 . 13 Accept able
Cu mulative emission
WC: worst case I TC : typical case I M&R = Maintenance and repai r
Considering a one- day em ission, the results indicate acceptable risks to the terrestrial
compartment, with PEC/PNEC ratios < 1, du ring the application and remova l of paint for
pleasure crafts by professiona l and non-professional users, whatever t he scenario appl ied
(realistic worst case or typical case) . Nevertheless the risks are deemed unacceptable for
professiona l users over the emission period when copper cu mulate in soil after mult iple
applications. The risks are acceptable for non -professional users for a cumu lative risk
assessment over the emission period.
Concern ing groundwater, all the scenar ios lead to acceptable level of contam inat ion.
Labels and/ or safety data sheet s of products authorised for professiona l uses shall
indicate that applicat ion must be conducted on impermeable hard standing to prevent
direct losses to soil and wat er and that any losses must be collected for disposal.
Indirect releases to the terrestrial compartment
The PEC va lues for copper and the correspond ing PEC/PNEC ratios for t he ter restrial
environment (soil and groundwat er) resulting from the use of VCl 7m product as
antifouling are presented below for new bui lding, maintenance & repai r phases of
pleasure crafts, leading t o ind irect releases to soil via the spreading of STP sludge.
Ta ble 2.4.2-17 presents the values for soil and Table 2.4.2-18 for groundwater.
46
aliphatic acid)
Table 2.4.2-17: PEC/PNEC ratios for soil after indirect releases via the STP to
the environment - Concentrations considering the background

PNECsoil = 40.20 mg/kg wwt
WC TC WC TC
New bu ilding - Daily emission 21. 90 0.54
M&R, Removal - Dai ly em ission 21.83 2 1.62 0.54 0.54

M&R, Removal - Dai ly em ission 21. 92 21. 64 0.55 0.54
M&R, Appl icat ion - Daily em ission 21. 6 1 0.54
WC : worst case I TC: t ypical case I M&R = Maintenance and repair
Table 2.4.2-18: Risk assessment for groundwater after direct releases to the
environment - Concentrations considering the background
Exposure Scenario PEC (µg/L) Risk characterization

Acceptable concentration according to the drinking water di rective : 2000 µg/ L
WC TC WC TC
New bu ilding - Daily emission 3 .06 Accept able
M&R, Removal - Dai ly emission 3 .02 2. 9 1 Acceptable Acceptable
M&R, Appl icat ion - Daily emission 2 .97 2 .93 Acceptable Acceptable
Pleasure crafts - Non-orofessionals

M&R, Removal - Dai ly emission 3 .07 2. 92 Accept able Acceptable
M&R, Applicat ion - Daily emission 2. 9 1 Accept able
These resu lts indicate acceptable risks to soil and groundwater, during t he appl ication
and removal of pa int for pleasure crafts by professional and non -professiona l users,
whatever the scenario applied (real istic worst case or typical case), for indi rect
cont amination of the environment via the STP.
2.4.2.4.2.5 Non-compartmental specific effects relevant to the food chain

(secondary poisoning)
47
aliphatic acid)
An in-depth literature search showed the absence of copper biomagnification across the
trophic chain in the aquatic and terrestrial food chains. Differences in sensitivity among
species were not related to the level in the trophic chain but to the capability of internal
homeostasis and detoxification. Field evidence had further provided no indications of
secondary poisoning.
2.4.2.4.2.6 Overall conclusion for the environment
The marine aquatic compartment can be exposed directly or indirectly (via the STP) to
the product during the phases of application or removal of paint and directly during the
service-life of ship hulls. The proposed scenarios led to acceptable risks for commercial
vessels and pleasure crafts, when the wider marine environments were considered. In
fact, the risks were not deemed acceptable for the sediment inside marinas, but are
acceptable for the whole aquatic compartment in the adjacent areas of the marinas.
It was considered that the freshwater environment (including the sediment) can also be
exposed indirectly via the STP only, during the pleasure crafts application or removal
phases. Whatever the scenarios, the risks were considered acceptable for the STP and
the freshwater environment. Direct emissions to the freshwater environment have not
been assessed due to the lack of a harmonized scenario and should be considered during
product assessment, if appropriate.
The terrestrial compartment (including groundwater) can be exposed directly or indirectly

via the STP during the pleasure craft application or removal of paint by professionals or
non-professionals. The risks for the soil and groundwater were considered acceptable for
non-professional activities (leading to direct or indirect soil emission). On the other hand,
the releases during application and removal of paint by professionals working on pleasure
crafts led to unacceptable risks for soil when a direct exposure of the terrestrial
compartment is foreseen. In this case the risk remained acceptable for groundwater or
when releases were directed to a STP. Labels and/ or safety data sheets of products
authorised for professional uses shall indicate that application must be conducted on
impermeable hard standing to prevent direct losses to soil and water and that any losses
must be collected for disposal.
The regional copper background concentrations were added to the calculated

concentrations of copper issuing from copper flakes (coated with aliphatic acid)antifouling
paint application, for all the environmental compartments. This has been done to cover
all the other possible uses of copper in the calculation of the risk ratios, and in
consequence in the assessment of the risk for environment.
2.5 Overall conclusions
The outcome of the assessment for copper flakes (coated with aliphatic acid)in product-
type 21 is specified in the BPC opinion following discussions at the 13rd meeting of the
Biocidal Products Committee (BPC). The BPC opinion is available from the ECHA web-site.
48
aliphatic acid)
Human primary Human secondary

Aquatic compartment
exoosure exoosure Terrestrial Secondar
Groundwat
SCENARIO Non STP compartme Air y
Professio General Surface er
professi Worker Sediment nt poisoning
nal public water
onal
APPLICATION
Application
Commercia and
I vessel removal of
Acceptable NR Acceptable5 NR4 NR Acceptable1 Acceptable 1 NR NR NR NR
oaint
Acceptable1 Acceptable 2 Direct
releases:
Pleasure Appli cation
- Non
crafts and
Acceptable NR Acceptable5 NR4 Acceptable acceptable Acceptable NR NR
Profession removal of
I ndirect
als paint
releases:
acceotable
Pleasure Acceptable1 Acceptable 2
- Application Acceptabl
crafts
and e only Unaccept
Non-
removal of NR whit h
NR able3
Acceptable Acceptable Acceptable NR NR
Profession
paint PPE6
als
Shipping Acceptable1 Acceptable 1
lane
Service-life NR NR NR NR NR NR NR NR NR
Commercia Acceptable1 Acceptable 1
I Harbour Service-life NR NR NR NR NR NR NR NR NR
Marina Service-life NR NR NR NR NR Acceotable1 Acceotable 2 NR NR NR NR
NR: not relevant
1
with MAMPEC modelling.
2
with MAMPEC modelling, only for surrounding waters for marinas
3
Unacceptable but labels and where provided instructions for use shall indicate that child ren shall be kept away until treated surface are dry.
4
" To protect bystanders in the ship yard the area where painting is performed should be labelled w ith "Unprotected persons should be kept out of t reatment areas".
5
Safe operational procedures and appropriate organizationa l measures shall be established. Where exposu re cannot be reduced to an acceptable level by other
means, products sha ll be used with appropriate personal protective equipment.
6
The risk for non-professionals is acceptable only when gloves are worn.
49
aliphatic acid)
2.6 Requirement for further information related to product
Further data on products VC17M graphite containing copper flakes (coated with aliphatic
acid)shall be required as detailed below:
- The stability at 0°C of the product, the surface tension of the pure product at 25°C,
the kinematic viscosity at 40°C, a long term storage stability study (2 years) with the
effect of light, a study to determine true residue level in container after use or a
management of the packaging in a specialized processing dedicated circuit, and an
analytical method for the determination of the copper flakes (coated with aliphatic
acid)in the product should be provided at the product authorization stage.
Physico-chemical properties on the two separate components and data on the mixing
step should be provided at the authorization of the product:
- Viscosity, surface tension, density, pH, pourability, and compability with
the packaging, of the binder
- Apparent density, particle size distribution and dustability of the powder in
the hat
- With regard to human health assessment, following information should be provided:

A dermal absorption study will be required at product authorisation stage to refine the
risk assessment: Because of deficiencies in the available dermal absorption studies, new
studies would be needed at product authorisation. However, at this point it would not be
reasonable to require new dermal absorption studies before harmonised guidance for PT
21 dermal absorption studies is developed. It was agreed to set a provisional absorption
value for each copper compound based on the products tested, and these values would
only apply for active substance approval).
- With regards to physico-chemical properties, labelling of the product should indicate

‘shake well before use’ and ‘store at maximum 40°C’.
50
aliphatic acid)
APPENDIX 1: LIST OF ENDPOINTS
Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further

Information, and Proposed Classification and Labelling
Active substance (ISO Common Name) Coated copper flake

Function (e.g. fungicide) Prevention of fouling by settling organisms.
Rapporteur Member State France.
Identity (Annex IIA, point II.)

Chemical name (IUPAC) Copper
Chemical name (CA) Copper
CAS No 7440-50-8
EC No 231-159-6
Other substance No. None
Minimum purity of the active substance 953 g/kg as total copper.
as manufactured (g/kg or g/l)
Identity of relevant impurities and Four relevant impurities:
additives (substances of concern) in the Arsenic (max 0.01g/kg)
active substance as manufactured (g/kg) Cadmium (max 0.005g/kg)
Nickel (max 0.05g/kg)
Lead (max 0.02g/kg)
Molecular formula Cu
Molecular mass 63.55
Structural formula Cu
Physical and chemical properties (Annex IIA, point III., unless otherwise indicated)
Melting point (state purity) >600ºC
Purity: 95.8%
Boiling point (state purity) Not necessary as boiling point will occur at
temperatures greater than 360°C based on
the melting point
Temperature of decomposition >600ºC
Appearance (state purity) Extremely fine and reddish metallic powder.
Purity: 95.8%
Relative density (state purity) Tap density: 0.47 g/cm3
Purity: 95.8%
Surface tension Not applicable due to the low water solubility
of copper flakes (coated with aliphatic
acid)(< 1mg/L)
Vapour pressure (in Pa, state 7.5 × 10-9 Pa at 20ºC,
temperature) 1.8 × 10-8 Pa at 25ºC, calculated from
vapour pressure curve
3 -1
Henry’s law constant (Pa m mol ) 1.77 x 10-6 Pa.m3.mol-1 at pH 7
Solubility in water (g/l or mg/l, state pH 4: 192 mg/l at 20°C
temperature)
pH 7: 0.27 mg/L at 20°C and 0.32 mg/L at
30°C
pH 9: 0.13 mg/l at 20°C
51
aliphatic acid)
The solubilisation results of the oxido-

reduction reaction of the copper metal into
ionic copper.
Cu(0) → Cu(I) → Cu (II)
At low pH, these reactions are promoted.
Solubility in organic solvents (in g/l or The provided study is not acceptable, limit of
mg/l, state temperature) (Annex IIIA, 10g/L is not sufficiently low to give useful
point III.1) information.
Moreover based on the composition, the
active substance is not expected to be
soluble in organic solvents.
Stability in organic solvents used in Not required. The active substance as
biocidal products including relevant manufactured does not include any organic
breakdown products (IIIA, point III.2) solvents.
If biocidal products (i.e. antifouling paints)
are formulated with organic solvents, the
compatibility between copper flakes (coated
with aliphatic acid) and solvents and the
stability of the products will be studied in
document III B of the CAR
Partition coefficient (log POW) (state Not relevant for the ecotoxicological risk
temperature) assessement, due to the specific absorption
mechanism of copper.
Hydrolytic stability (DT50) (state pH and pH______:
temperature) (point VII.7.6.2.1)
pH______:
pH______:
Not applicable for metal compounds.
Dissociation constant (not stated in Not relevant, metallic copper cannot
Annex IIA or IIIA; additional data dissociate in water, due to its structure.
requirement from TNsG) Copper flakes (coated with aliphatic acid) is
slightly soluble in water and the solubilisation
results of oxido-reduction reaction of the
copper metal into ionic copper. Any addition
of acid would result in reaction with the
copper
UV/VIS absorption (max.) (if absorption Not applicable to metal
> 290 nm state  at wavelength)
Photostability (DT50) (aqueous, sunlight, Not applicable.
state pH)
(point VII.7.6.2.2)
Quantum yield of direct Not applicable.
phototransformation in water at  > 290
nm (point VII.7.6.2.2)
Flammability Not highly flammable
Explosive properties Not explosive
52
aliphatic acid)
Summary of validated intended uses

Object Memb Product Organisms
and/or er name controlled Formulation Application Applied amount per Remarks:
situation State treatment
or
Count
ry
Type Conc. metho number interval g water g as/m2
(a) (c) (d-f) of as d min max between as/L L/m2 min max (m)
(i) kind (k) applications min min
(f-h) (min) max max
Objects to be EU Antifouling Minimum one Minimum Not Not Depends on

protected coat. Multiple overcoating times: ap applicable required Antifouling product 1
include hulls coats may be plic film should be regarded as a
of commercial, Product 1 – Fouling Antifoulin 17.44 applied to 12 hrs @ 5°C abl thickness representative
naval and see organisms in g paint. % Airless achieve 10 hrs @ 10°C e formulation for the
other confidential marine and w/w spray, required film 6 hrs @ 25°C purpose of supporting an
government file freshwater wet thickness 4 hrs @ 35°C application for approval of
vessels, environments paint brush, dependent on copper powder.
pleasure craft Roller. in-service Reapplication times
and man- lifetime. will depend on
made maintenance
structures and schedule of treated
objects.. vessels.
(a) e.g. biting and suckling insects, fungi, molds;

(b) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(c) GCPF Codes - GIFAP Technical Monograph No 2, 1989 ISBN 3-8263-3152-4);
(d) All abbreviations used must be explained
(e) g/kg or g/l;
(f) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench;
53
aliphatic acid)
(g) Kind, e.g. overall, broadcast, aerial spraying, row, bait, crack and crevice equipment used must be indicated;
(h) Indicate the minimum and maximum number of application possible under practical conditions of use;
(i) Remarks may include: Extent of use/economic importance/restrictions
54
aliphatic acid)
Classification and proposed labelling (Annex IIA, point IX.)
with regard to physical/chemical data Not classified

with regard to toxicological data Acute Tox 4 H302 : Harmful if swallowed
Acute Tox. 3 H331 : Toxic if inhaled
Eye Irrit. 2 H319: Causes serious eye

irritation
with regard to fate and behaviour data R53, May cause long-term adverse effects in
the aquatic environment.
with regard to ecotoxicological data R50, Very toxic to aquatic organisms
Chapter 2: Methods of Analysis
Analytical methods for the active substance

Technical active substance (principle of The method is based on the CIPAC
method) (Annex IIA, point 4.1) electrolytic method (44/TC/M3.1). The
samples are heated with nitric acid. The
copper is electrolytically deposited and
weighed on a tared platinium cathode
(gravimetric method).
Impurities in technical active substance Relevant trace metals can be determined by
(principle of method) (Annex IIA, point Inductively Coupled Plasma – Optical
4.1) Emission Spectroscopy (ICP-OES), the
samples are previously digested in dilute
nitric acid. Complete validation data are
missing and are required for the annex I
inclusion.
Moreover validation data are missing for the
analysis of additive and other impurities.
Analytical methods for residues

Soil (principle of method and LOQ) Residues of copper may be determined in
(Annex IIA, point 4.2) soils using ICP-AES methods (e.g. AOAC
official method 990.8). The estimated
instrumental limit of determination (LOD) is
6 µg Cu/l. Another suitable method is AAS
(e.g. US EPA method 7210), with an LOD of
20 µg Cu/l. For both methods of analysis,
the sample must first be digested.
Air (principle of method and LOQ) Residues of copper may be determined in air
(Annex IIA, point 4.2) using Flame-AAS or ICP-AES methods (e.g.
NIOSH methods 7029 or 7300 respectively).
The estimated instrumental limits of
determination (LOD) are 0.05 and 0.07 µg
Cu/filter (LOQ not determined).
Water (principle of method and LOQ) In water, trace elements may be determined
(Annex IIA, point 4.2) by Inductively Coupled Plasma – Atomic
Emission Spectrometric (ICP-AES) (e.g. US
EPA method 220.7). The LOD for this
method was estimated at 3 µg Cu/l and the
LOQ was determined at 20 µg Cu/l. Other
suitable methods include AAS with direct
aspiration (LOD 20 µg/l, LOQ 200 µg/l) (e.g.
55
aliphatic acid)
US EPA method 220.1) and AAS with

graphite furnace (LOD 1 µg/l, LOQ 5 µg/l)
(e.g. US EPA method 220.2).. For all three
methods of analysis, the sample must first
be digested.
Sea water analysis can be performed by a
voltammetry method such as Differential
Pulse Anodic Stripping Voltammetry at a
Hanging Mercury Drop Electrode (DPASV
HMDE). The detection limit is depending on
the deposition time. For a typical 300
second deposition time, 0.1 µg/l is
achievable.
Body fluids and tissues (principle of ICP-AES may also be used for analysing
method and LOQ) (Annex IIA, point 4.2) elements in body fluids and tissues following
acid digestion of the sample. LOQs are 10
µg/100 g blood, 2 µg/g tissue (e.g. NIOSH
method 8005) and 0.1 µ/sample of urine
(NIOSH method 8310).
Nevertheless no analytical method is

required as the active substance is not
classified T or T+.
Food/feed of plant origin (principle of Not applicable for Antifouling applications
method and LOQ for methods for
monitoring purposes) (Annex IIIA, point
IV.1)
Food/feed of animal origin (principle of ICP-AES may be used for analyzing copper in
method and LOQ for methods for fresh fish. LOQ is 2.5µg/g wet tissue (US EPA
monitoring purposes) (Annex IIIA, point 200.11)
IV.1)
Chapter 3: Impact on Human Health
Absorption, distribution, metabolism and excretion in mammals (Annex IIA, point

6.2)
Rate and extent of oral absorption: It was agreed during the TMIII08 that
an oral absorption of 36% for humans
and 25% for animals have to be used.
Rate and extent of dermal absorption: By default, a dermal absorption of 5%
has to be used for copper compound in
solution.
For product, it has been agreed to set a

provisional absorption value of 0.14%
based on the products tested. This value
would only apply for active substance
approval. Dermal absorption study of
copper in formulated product should be
provided at the product authorization
level.
Rate and extent of inhalative absorption: 100 % (default value)
Distribution: Once absorbed by oral route, copper is
bound to albumin and transcuprein and then
rapidly transported to the liver where it is
56
aliphatic acid)
incorporated to ceruloplasmin, a transport

protein that circulates in the organism and
deliver the copper to other organs. The liver
is the main organ involved in copper
distribution and plays a crucial role in copper
homeostasis by regulating its release. It
should be however noted that a minor
fraction of the absorbed dose can directly be
distributed to peripheral organs. In both
humans and animals, copper is tightly
regulated at a cellular level, involving
metallothionein and metallochaperones.
These regulating molecules prevent from the
accumulation of potentially toxic, free copper
ions within the cell. In addition to the liver,
the brain is another organ which contains
relatively high concentrations of copper.
Potential for accumulation: Mammals have metabolic mechanisms that
maintain homeostasis (a balance between
metabolic requirements and prevention
against toxic accumulation). Because of this
regulation of body copper, indices of copper
status remain stable except under extreme
dietary conditions. This stability was
demonstrated in a study in which human
volunteers received a diet containing total
copper in the range 0.8 to 7.5 mg/d. Under
these conditions, there were no significant
changes in commonly used indices of copper
status, including plasma copper,
ceruloplasmin, erythrocyte superoxide
dismutase and urinary copper.
Rate and extent of excretion: Biliary excretion is quantitatively the most
important route, with a mean copper
excretion estimated to be in the order of 1.7
mg Cu/day (24.6  12.8 µg Cu/kg
bodyweight). A small amount of copper is
also lost in urine and in sweat. Excretion of
endogenous copper is influenced by dietary
copper intake. When the copper intake is
low, turnover is slow and little endogenous
copper is excreted and vice versa. Faecal
copper losses reflect dietary copper intake
with some delay as intake changes and
copper balance is achieved. Urinary losses do
not contribute to the regulation of copper
stores and contribute very little to the overall
balance.
Toxicologically significant metabolite None
Acute toxicity (Annex IIA, point 6.1)

Rat LD50 oral 300-500 mg/kg
Rat LD50 dermal >2000 mg/kg
Rat LC50 inhalation 0.733 mg/l (males)
Skin irritation Negative; not classified as irritating to skin.
Eye irritation Negative; not classified as an eye irritant.
57
aliphatic acid)
Skin sensitization (test method used and Negative; not classified as a skin sensitiser.
result)
Repeated dose toxicity (Annex IIA, point 6.3)

Species/ target / critical effect The test substance used the following study
was copper (II) sulphate.
Rat/ liver/ inflammation

Rat/ kidney/ cytoplasmic droplets
Rat, mouse/ forestomach/ minimal to
moderate hyperplasia of the squamous
mucosa
Lowest relevant oral NOAEL / LOAEL 16.3 mgCu/mg kg/d
Lowest relevant dermal NOAEL / LOAEL Not available
Lowest relevant inhalation NOAEL / 0.2 mgCu/m3
LOAEL
58
aliphatic acid)
Genotoxicity (Annex IIA, point 6.6) The test substance used in each of the
following studies was copper (II) sulphate
pentahydrate.
1. Ames test in Salmonella typhimurium -
negative in both the presence and absence of
S9 mix.
2. Bone marrow micronucleus study in the
mouse – negative at a dose of 447 mg/kg
bw.
3. In vivo/in vitro unscheduled DNA
synthesis study in the livers of orally dosed
male rats – negative, following treatment
with doses of 632.5 or 2000 mg/kg bw.
These studies demonstrate that copper is not
mutagenic in the in vitro and in vivo test
systems used.
Carcinogenicity (Annex IIA, point 6.4)

Species/type of tumour Available studies of the carcinogenicity of
copper compounds in rats and mice,
although not fully reliable, have given no
indication that copper salts are carcinogenic.
lowest dose with tumours Not applicable.
Reproductive toxicity (Annex IIA, point 6.8)

Species/ Reproduction target / critical The test substance used in the following
effect study was copper (II) sulphate pentahydrate.
Rat/Two-generation study/No evidence of
effects on the fertility potential of either male
or female rats.
Lowest relevant reproductive NOAEL / Copper sulphate cannot be regarded as
LOAEL having adverse effects on fertility in the
animals tested.
1500 ppm NOAEL in rat two-generation
study = 23.6-43.8 mgCu/kg bw/d (maximal
dose tested)
Species/Developmental target / critical Mouse/ Developmental toxicity/
effect malformations (study with major
methodological deficiencies)
Lowest relevant developmental NOAEL / 6 mg Cu/kg bw/d
LOAEL (NOAEL maternal toxicity = 6 mg Cu/kg
bw/d)
However rat two-generation study with
copper sulphate pentahydrate does not raise
any particular teratogenic concern.
Neurotoxicity / Delayed neurotoxicity (Annex IIIA, point VI.1)

Species/ target/critical effect Rat/ CNS/ locomotor activity, learning ability,
relearning capacity and memory
Lowest relevant developmental NOAEL / No adverse effects for these endpoints.
LOAEL.
Other toxicological studies (Annex IIIA, VI/XI)

None
59
aliphatic acid)
.........................................................
......................
60
aliphatic acid)
Medical data (Annex IIA, point 6.9)

Direct observation, eg clinical cases, Acute symptoms resulted in metallic taste,
poisoning incidents if available; data salivation, epigastric pain, nausea, vomiting
point 6.12.2. and diarrhoea. Anatomo-pathological
examinations after self-poisoning (ingestion
varying between 1 and 100 g of copper
dissolved in water) revealed ulcerations of
gastro-intestinal mucosa, hepatic damages
(dilatation of central vein, cell necrosis and
bile thrombi) and kidney lesions (congestion
of glomeruli, swelling or necrosis of tubular
cells and sometimes haemoglobin casts).
Chronic symptoms, occurred in a voluntary
intoxication by daily ingestion of 30 mg of
copper for 2 years and 60 mg during the
third year, were malaise, jaundice,
hepatomegaly and splenomegaly. Liver
examination revealed micronodular cirrhosis.
In the particular case of vineyard sprayers
intoxication by the Bordeaux mixture
(unknown doses), lung lesions with focal
distribution were observed: alveoli filled with
desquamated macrophages, granuloma in
the alveoli septa and fibro-hyaline nodules.
Summary (Annex IIA, point 6.10) Value Study Safety factor

ADI (if residues in food or feed) 0.15
Not
mgCu/kg EFSA (2008)
applicable.
bw/day
Acute-term AEL 0.082 mg/kg MOE ref =
90d in rats
bw/d 50
Medium-term AEL 0.082 mg/kg MOE ref =
90d in rats
bw/d 50
Long-term AEL 0.041 mg/kg MOE ref =
90d in rats
bw/d 100
Drinking water limit Not applicable
ARfD (acute reference dose) Not applicable
Acceptable exposure scenarios (including method of calculation)

Professional users Acceptable, if professionals wear the
following PPE/RPE:
Potman: impermeable coverall and gloves
during mixing and loading phases,
Sprayer: coated coverall, gloves and mask

APF 10 during application,
Worker who applies product by roller

and brush: an equivalent Tyvek coverall
and gloves during mixing and loading of
paint into trail and brushing,
Sand blaster: protective protections

equivalent to water-proof overalls, an
61
aliphatic acid)
airstream helmet with rubber flaps that

covered a large part of their upper body,
strong protective gloves and mask APF 10,
Grit filler: coated coverall, gloves and mask

APF 40.
Non-professional users Acceptable only if non-professionals wear:

Gloves during mixing and loading AND
application phases.
In this context, the non professional use
cannot be authorized.
Indirect exposure as a result of use Acceptable under conditions mentioned
below:
Due to application by professionals, no
quantitative risk was performed to assess
exposure of bystander but the product
should be labelled with the phrases
“unprotected persons be kept out of
treatment areas”
Due to application by non professionals,
labels and where provided instructions for
use shall indicate that children shall be kept
away until treated surface are dry
Concerning secondary exposure via food
contamination, pending uniform methodology
to assess dietary exposure induced by an
antifouling treatment, available knowledge
about the natural occurrence of copper,
physiological needs, physico-chemical
properties and regulations already in force
constitute appreciable information to
consider as negligible its influence on the
consumer.
Chapter 4: Fate and Behaviour in the Environment
Route and rate of degradation in water (Annex IIA, point 7.6, IIIA, point XII.2.1,
2.2)
Hydrolysis of active substance and pH______: Not applicable to metals.
relevant metabolites (DT50) (state pH
and temperature)
pH :
pH :
Photolytic / photo-oxidative degradation Not applicable to metals.
of active substance and resulting
relevant metabolites
Readily biodegradable (yes/no) No.
Biodegradation in seawater Not applicable to metals.
Non-extractable residues Not applicable to metals.
Distribution in water / sediment systems The distribution of metals between
(active substance) aqueous phase and
soil/sediment/suspended matter should
preferentially be described on the basis
62
aliphatic acid)
of measured soil/water,
sediment/water and suspended
matter/water equilibrium distribution
coefficient (TECHNICAL GUIDANCE
DOCUMENT on Risk Assessment Part II
Appendix VIII, 2003; TECHNICAL
GUIDANCE DOCUMENT Annex 4-VIII
Environmental risk assessment for
metals and metal compounds (RIP 3.2-
2).
From the literature overview, the following
partitioning coefficients have thus been
Partition coefficient in suspended

matter
Kpsusp = 30,246 l/kg (log Kp (pm/w) = 4.48)
(50th percentile) (Heijerick et al, 2005)
Partition coefficient in sediment

Kpsed = 24,409 l/kg (log Kp(sed/w) = 4.39)
(50th percentile) (Heijerick et al., 2005)
Distribution in water / sediment systems Not applicable to metals.

(metabolites)
Route and rate of degradation in soil (Annex IIIA, point VII.4, XII.1.1, XII.1.4;
Annex VI, para. 85)
Mineralization (aerobic) Not applicable to metals.
Laboratory studies (range or median, DT50lab (20C, aerobic): Not applicable to
with number of measurements, with metals.
regression coefficient)
DT90lab (20C, aerobic): Not applicable to
metals.
DT50lab (10C, aerobic): Not applicable to
metals.
DT50lab (20C, anaerobic): Not applicable to
metals.
degradation in the saturated zone: Not
applicable to metals.
Field studies (state location, range or DT50f: Not applicable to metals.
median with number of measurements)
DT90f: Not applicable to metals.
Anaerobic degradation Not applicable to metals.
Soil photolysis Not applicable to metals.
Non-extractable residues Not applicable to metals.
Relevant metabolites - name and/or Not applicable to metals.
code, % of applied a.i. (range and
maximum)
Soil accumulation and plateau Although unable to degrade, the affect of
concentration ageing on the distribution of copper in soil
results in increased immobilisation by long
term adsorption and complexation reactions
in the soil.
63
aliphatic acid)
Adsorption/desorption (Annex IIA, point XII.7.7; Annex IIIA, point XII.1.2)

Ka , Kd The distribution of metals between aqueous
Kaoc , Kdoc phase and soil/sediment/suspended matter
pH dependence (yes / no) (if yes type of should preferentially be described on the
dependence) basis of measured soil/water,
sediment/water and suspended matter/water
equilibrium distribution coefficient
(TECHNICAL GUIDANCE DOCUMENT on Risk
Assessment Part II Appendix VIII, 2003;
TECHNICAL GUIDANCE DOCUMENT Annex 4-
VIII Environmental risk assessment for
metals and metal compounds (RIP 3.2-2).
From the literature overview, the following

partitioning coefficients have thus been
Partition coefficient in soil

Kd = 2120 l/kg (log Kp = 3.33) (50th
percentile)
(Sauvé et al. 2000)
Fate and behaviour in air (Annex IIIA, point VII.3, VII.5)

Direct photolysis in air Not applicable to metals.
Quantum yield of direct photolysis Not applicable to metals.
Photo-oxidative degradation in air Latitude: ............. Season:
................. DT50 ..............
Not applicable to metals.
Volatilization The potential for volatilisation of copper
under environmentally relevant conditions is
considered not to be significant.
Monitoring data, if available (Annex VI, para. 44)

Soil (indicate location and type of study) No data available relating to the use of
copper in antifouling paints..
Surface water (indicate location and type Two monitoring studies have been conducted
of study) in the UK and Finland and have investigated
the speciation of copper in the marine
environment. The monitoring data of
commercial harbours and estuaries in the UK
(which did not show any elevated copper
concentrations at these sites) also confirm
the modelled output data from MAMPEC.
The measured water results from marinas
compare identically with the modelling data
from MAMPEC with values within the marina
and as with the modelled data, show that the
average concentrations in the marina are
within the normal background levels of
copper in the marine environment. Samples,
taken just outside the marina shows that the
copper levels fall even further indicating that
if increased copper levels are observed, they
are a very localised effect to the actual
marina itself.
64
aliphatic acid)
The results of the Finnish monitoring data

showed that the boating activity and
associated release of Cu2+ from the pleasure
craft and no significant effect on the copper
levels in the water when comparing the
samples taken in the marina and those taken
at the entrance and further downstream of
the marina.
Ground water (indicate location and type No data available relating to the use of
of study) copper in antifouling paints.
Air (indicate location and type of study) No data available relating to the use of
copper in antifouling paints
65
aliphatic acid)
Chapter 5: Effects on Non-target Species
Toxicity data for aquatic species (most sensitive species of each group)
(Annex IIA, Point 8.2, Annex IIIA, Point 10.2)
Acute toxicity to aquatic No acute toxicity data are presented as the toxicity
organisms was evaluated using a SSD based on chronic
toxicity data.
Chronic toxicity to SSD result from 139 individual NOEC/EC10 values:
aquatic organisms in the HC5-50 = 7.8 µg Cu / l as reasonable worst
FRESHWATER COMPARTMENT case
Freshwater algae and higher plants:
Lowest NOEC used in the SSD = 15.7 µg Cu /L
(growth of Pseudokirchneriella subcapitata)
Highest NOEC used in the SSD = 510.2 µg Cu /L
(growth of Chlorella vulgaris)
Freshwater Invertebrates:
Lowest NOEC used in the SSD = 4 µg Cu /L
(mortality and reproduction of Ceriodaphnia dubia)
Highest NOEC used in the SSD = 181 µg Cu /L
(reproduction of Daphnia magna)
Freshwater Fishes:
Lowest NOEC used in the SSD = 2.2 µg Cu /L
(growth of Oncorhynchus mykiss)
Highest NOEC used in the SSD = 188 µg Cu /L
(mortality of Perca fluviatilis)
Chronic toxicity to SSD result from 62 individual NOEC values: HC5-

aquatic organisms in the 50 = 1741 mg Cu/kg OC, corresponding to 87
FRESHWATER SEDIMENT mg Cu/kg dry weight for a sediment with 5 %
COMPARTMENT O.C.(TGD default value)
Sediment organisms:
Lowest NOEC used in the SSD = 18.3 mg Cu /kg
d.w. (growth and reproduction of Tubifex tubifex)
Highest NOEC used in the SSD = 580.9 mg Cu /kg
d.w. (survival of Tubifex tubifex )
Chronic toxicity to The lowest reliable observed NOEC value was

Sewage microorganisms noted for the inhibition of respiration = 0.23 mg/l
Chronic toxicity to SSD result from 56 individual NOEC/EC10 values:
aquatic organisms in the  HC5-50 = 5.2 µg Cu /2for DOC level typical
MARINE WATER for harbours and marinas (2 mg/L)
COMPARTMENT  HC5-50 = 2.3 µg Cu /2for DOC level typical
for surrounding waters (0.5 mg/L)
 HC5-50 = 1.3 µg Cu /2for DOC level typical
for sea (0.2 mg/L)
Marine water algae and higher plants:

Non normalized lowest NOEC = 2.9 µg Cu /L
(growth of Phaeodactylum tricornutum)
Non normalized highest NOEC = 50.1 µg Cu /L
(germination of Macrocystis pyrifera)
66
aliphatic acid)
Marine water Invertebrates:

Non normalized lowest NOEC = 5.9 µg Cu /L
(development of Mytilus galloprovincialis)
Non normalized highest NOEC = 145 µg Cu /L
(growth of Penaeus monodon)
Marine water Fishes:

Non normalized lowest NOEC = 55 µg Cu /L (length
and weight of Atherinops affinis)
Non normalized highest NOEC = 123 µg Cu /L
(hatchability and survival of Atherinops affinis)
Effects on earthworms or other soil non-target organisms
Acute toxicity to soil No acute toxicity data are presented as the toxicity
organisms was evaluated using a SSD based on chronic
(Annex IIIA, point XIII.3.2) toxicity data.
Chronic toxicity to SSD result from 252 individual chronic NOEC/EC10
soil organisms in the values : HC5-50 = 45.6 mg Cu/kg dry weight
TERRESTRIAL COMPARTMENT was used as reasonable worst case value for
Europe in absence of site-specific information
on soil properties.
Terrestrial higher plants:

Lowest NOEC used in the SSD = 18 mg Cu /kg d.w.
(Hordeum vulgare)
Highest NOEC used in the SSD = 698 mg Cu /kg
d.w. (Lycopersicon esculentum)
Terrestrial Invertebrates:
Lowest NOEC used in the SSD = 8.4 mg Cu /kg
d.w. (cocoon production of Eisenia andrei)
d.w. (reproduction of Falsomia candida)
Soil micro-organisms:
Lowest NOEC used in the SSD = 30 mg Cu /kg d.w.
(glucose respiration)
d.w. (maize respiration)
Effects on terrestrial vertebrates

Acute toxicity to mammals Not applicable to active substances used in
(Annex IIIA, point XIII.3.3) antifouling products
Acute toxicity to birds Not applicable to active substances used in
Dietary toxicity to birds Not applicable to active substances used in
Reproductive toxicity to birds Not applicable to active substances used in
67
aliphatic acid)
Effects on honeybees (Annex IIIA, point XIII.3.1)

Acute oral toxicity Not applicable to active substances used in
antifouling products
Acute contact toxicity Not applicable to active substances used in
Effects on other beneficial arthropods (Annex IIIA, point XIII.3.1)

Acute oral toxicity Not applicable to active substances used in
Acute contact toxicity Not applicable to active substances used in
Not applicable to active substances used in
Acute toxicity to ………………………………….. antifouling products
Bioconcentration (Annex IIA, point 7.5)

Bioconcentration factor (BCF) For the naturally occurring substances such
as essential metals as copper,
bioaccumulation is complex, and many
processes are available to modulate both
accumulation and potential toxic impact.
Biota regulates their internal concentrations
of essential metals through homeostatic
control mechanisms (i.e. active regulation,
storage). As a result of these processes, at
low metal concentrations, organisms
accumulate essential metals more actively in
order to meet their metabolic requirements
than when they are being exposed at higher
metal concentrations.
As a consequence of homeostatic processes,
and unlike many organic substances, the
BCF/BAF is not independent of exposure
concentrations for metals and it is inversely
related to exposure concentrations. Thus, the
use of ratios Cbiota/Cwater or
Cbiota/Csediments as an overall approach for
estimating copper bioconcentration factors is
thus not appropriate.
Depration time (DT50) Not applicable for metals.
(DT90)
Level of metabolites (%) in organisms Not applicable for metals.
accounting for > 10 % of residues
Chapter 6: Other End Points
None required
68
aliphatic acid)
APPENDIX 2: LIST(S) OF ABBREVATIONS
List of standard terms and abbreviations (adapted from: (i) Guidelines and criteria for the
preparation of PPP dossiers11; (ii) TNsG on Data Requirements12).
Stand. Explanation Stand. Explanation

Term/ Term/
abbreviation abbreviation
A ampere Bt Bacillus thuringiensis
ACh acetylcholine Bti Bacillus thuringiensis
israelensis
AChE acetylcholinesterase Btk Bacillus thuringiensis kurstaki
ADI acceptable daily intake Btt Bacillus thuringiensis
tenebrionis
ADME administration BUN blood urea nitrogen
distribution metabolism
and excretion
ADP adenosine diphosphate bw body weight
AE acid equivalent c centi- (x 10 –2 )
AF assessment factor °C degrees Celsius (centigrade)
AFID alkali flame-ionisation CA controlled atmosphere
detector or detection
A/G albumin/globulin ratio CAD computer aided design
ai active ingredient CADDY computer aided dossier and
data supply (an electronic
dossier interchange and
archiving format)
ALT alanine aminotransferase cd candela
(SGPT)
Ann. Annex CDA controlled drop(let) application
AEC acceptable concentration cDNA complementary DANN
level
AEL acceptable exposure level CEC cation exchange capacity
AMD automatic multiple cf confer, compare to
development
AMD automatic multiple CFU colony forming units
development
ANOVA analysis of variance ChE cholinesterase
AP alkaline phosphatase CI confidence interval
approx approximate CL confidence limits
ARfD acute reference dose cm centimetre
as active substance CNS central nervous system
AST aspartate COD chemical oxygen demand
aminotransferase (SGOT)
ASV air saturation value CPK creatinine phosphatase
ATP adenosine triphosphate cv coefficient of variation
BAF bioaccumulation factor Cv ceiling value
BCF bioconcentration factor d day(s)
bfa body fluid assay DCA Dichloroacetaldehyde
11
EU (1998a): European Commission: Guidelines and criteria for the preparation of complete dossiers and of
summary dossiers for the inclusion of active substances in Annex I of Directive 91/414/EC (Article 5.3 and
8,2). Document 1663/VI/94 Rev 8, 22 April 1998
12
European Chemicals Bureau, ECB (1996) Technical Guidance Documents in support of the Commission
Directive 93/67/EEC on risk assessment for new notified substances and the Commission Regulation (EC)
1488/94 for existing substances
69
aliphatic acid)
BOD biological oxygen demand DDVP Dimethyl Dichloro Vinyl

Phosphate
bp boiling point DIS draft international standard
(ISO)
BPD Biocidal Products DMSO dimethylsulfoxide
Directive
BSAF biota-sediment DNA deoxyribonucleic acid
accumulation factor
BSP bromosulfophthalein dna designated national authority

Term/ Term/
DO dissolved oxygen FOB functional observation battery
DOC dissolved organic carbon foc organic carbon factor
(compartment dependent)
dpi days post inoculation fp freezing point
DRP detailed review paper FPD flame photometric detector
(OECD)
DT50(lab) period required for 50 FPLC fast protein liquid
percent dissipation (under chromatography
laboratory conditions)
(define method of
estimation)
DT90(field) period required for 90 g gram(s)
percent dissipation (under
field conditions) (define
method of estimation)
dw dry weight GC gas chromatography
 decadic molar extinction GC-EC gas chromatography with
coefficient electron capture detector
EC50 median effective GC-FID gas chromatography with
concentration flame ionisation detector
ECD electron capture detector GC-MS gas chromatography-mass
spectrometry
ED50 median effective dose GC-MSD gas chromatography with
mass-selective detection
EINECS European inventory of GEP good experimental practice
existing commercial
substances
ELINCS European list of notified GFP good field practice
chemical substances
ELISA enzyme linked GGT gamma glutamyl transferase
immunosorbent assay
e-mail electronic mail GI gastro-intestinal
EMDI estimated maximum daily GIT gastro-intestinal tract
intake
EN European norm GL guideline level
EPMA electron probe micro- GLC gas liquid chromatography
analysis
ERL extraneous residue limit GLP good laboratory practice
ESPE46/51 evaluation system for GM geometric mean
pesticides
EUSES European Union system for GMO genetically modified organism
the evaluation of
70
aliphatic acid)
substances
F field GMM genetically modified micro-
organism
F0 parental generation GPC gel-permeation
chromatography
F1 filial generation, first GPMT guinea pig maximisation test
F2 filial generation, second GPS global positioning system
FBS full base set GSH glutathione
FELS fish early-life stage GV granulosevirus
FIA fluorescence immuno-assay h hour(s)
FID flame ionisation detector H Henry’s Law constant
(calculated as a unitless
value)
Fmol fractional equivalent of the ha hectare(s)
metabolite´s molecular
weight compared to the
active substance

Term/ Term/
Hb haemoglobin ISBN international standard book
number
HC5 concentration which will be ISSN international standard
harmless to at least 95 % serial number
of the species present with
a given level of confidence
(usually 95 %)
HCG human chorionic IUCLID International Uniform
gonadotropin Chemical Information
Database
Hct haematocrit iv intravenous
HDT highest dose tested IVF in vitro fertilisation
hL hectolitre k (in kilo
combination)
HEED high energy electron k rate constant for
diffraction biodegradation
HID helium ionisation detector K Kelvin
HPAEC high performance anion Ka acid dissociation constant
exchange chromatography
HPLC high pressure liquid Kb base dissociation constant
chromatography or high
performance liquid
chromatography
HPLC-MS high pressure liquid Kads adsorption constant
chromatography - mass
spectrometry
HPPLC high pressure planar liquid Kdes apparent desorption
chromatography coefficient
HPTLC high performance thin layer kg kilogram
chromatography
HRGC high resolution gas KH Henry´s Law constant (in
chromatography atmosphere per cubic
metre per mole)
HS Shannon-Weaver index Koc organic carbon adsorption
71
aliphatic acid)
coefficient
Ht haematocrit Kom organic matter adsorption
coefficient
HUSS human and use safety Kow octanol-water partition
standard coefficient
I indoor Kp solid-water partition
coefficient
I50 inhibitory dose, 50% kPa kilopascal(s)
IC50 median immobilisation l, L litre
concentration or median
inhibitory concentration 1
ICM integrated crop LAN local area network
management
ID ionisation detector LASER light amplification by
stimulated emission of
radiation
IEDI international estimated LBC loosely bound capacity
daily intake
IGR insect growth regulator LC liquid chromatography
im intramuscular LC-MS liquid chromatography-
mass spectrometry
inh inhalation LC50 lethal concentration,
median
INT 2-p-iodophenyl-3-p- LCA life cycle analysis
nitrophenyl-5-
phenyltetrazoliumchloride
testing method
ip intraperitoneal LC-MS-MS liquid chromatography with
tandem mass spectrometry
IPM integrated pest LD50 lethal dose, median; dosis
management letalis media
IR infrared LDH lactate dehydrogenase
IRAC Insecticide resistance action ln natural logarithm
committee

Term/ Term/
LOAEC lowest observable adverse MLD minimum lethal dose
effect concentration
LOAEL lowest observable adverse mm millimetre
effect level
LOD limit of detection MMAD mass median aerodynamic
diameter
LOEC lowest observable effect mo month(s)
concentration
LOEL lowest observable effect MOE margin of exposure
level
log logarithm to the base 10 mol mole(s)
LOQ limit of quantification mp melting point
(determination)
LPLC low pressure liquid MRE maximum residue expected
chromatography
LSC liquid scintillation counting MRL maximum residue level or
72
aliphatic acid)
or counter limit
LSD least squared denominator mRNA messenger ribonucleic acid
multiple range test
LSS liquid scintillation MS mass spectrometry
spectrometry
LT lethal threshold MSDS material safety data sheet
m metre MTD maximum tolerated dose
M molar MT material test
µm micrometre (micron) MW molecular weight
MAC maximum allowable n.a. not applicable
concentration
MAK maximum allowable n- normal (defining isomeric
concentration configuration)
MC moisture content MT material test
MCH mean corpuscular MW molecular weight
haemoglobin
MCHC mean corpuscular n.a. not applicable
haemoglobin concentration
MCV mean corpuscular volume n number of observations
MDL method detection limit NAEL no adverse effect level
MFO mixed function oxidase nd not detected
µg microgram NEDI national estimated daily
intake
mg milligram NEL no effect level
MHC moisture holding capacity NERL no effect residue level
MIC minimum inhibitory ng nanogram
concentration
min minute(s) nm nanometre
MKC minimum killing NMR nuclear magnetic
concentration resonance
mL millilitre no, n° number
MLT median lethal time NOAEC no observed adverse effect
concentration

Term/ Term/
NOAEL no observed adverse effect PIC prior informed consent
level
NOEC no observed effect pic phage inhibitory capacity
concentration
NOED no observed effect dose PIXE proton induced X-ray
emission
NOEL no observed effect level pKa negative logarithm (to the
base 10) of the acid
dissociation constant
NOIS notice of intent to suspend pKb negative logarithm (to the
base 10) of the base
dissociation constant
NPD nitrogen-phosphorus PND post natal day
detector or detection
NPV nuclear polyhedrosis virus PNEC predicted no effect
concentration
(compartment to be added
as subscript)
73
aliphatic acid)
NR not reported po by mouth

NTE neurotoxic target esterase POP persistent organic
pollutants
OC organic carbon content ppb parts per billion (10 -9 )
OCR optical character PPE personal protective
recognition equipment
ODP ozone-depleting potential ppm parts per million (10 -6 )
ODS ozone-depleting substances PPP plant protection product
OH hydroxide ppq parts per quadrillion (10 -24
)
OJ Official Journal ppt parts per trillion (10 -12 )
OM organic matter content PSP phenolsulfophthalein
OP Organophosphate PrT prothrombin time
Pa pascal PRL practical residue limit
PAD pulsed amperometric PT product type
detection
2-PAM 2-pralidoxime PT(CEN) project team CEN
pc paper chromatography PTT partial thromboplastin time
PC personal computer QA quality assurance
PCV haematocrit (packed QAU quality assurance unit
corpuscular volume)
PEC predicted environmental (Q)SAR quantitative structure-
concentration activity relationship
PECA predicted environmental r correlation coefficient
concentration in air
2
PECS predicted environmental r coefficient of determination
concentration in soil
PECSW predicted environmental RA risk assessment
concentration in surface
water
PECGW predicted environmental RBC red blood cell
concentration in ground
water
PED plasma-emissions-detector REI restricted entry interval
pH pH-value RENI Registry Nomenclature
Information System
PHED pesticide handler’s Rf retardation factor
exposure data

Term/ Term/
RfD reference dose SPE solid phase extraction
RH relative humidity SPF specific pathogen free
RL50 median residual lifetime spp subspecies
RNA ribonucleic acid SSD sulphur specific detector
RP reversed phase SSMS spark source mass
spectrometry
rpm revolutions per minute STER smallest toxicity exposure
ratio (TER)
rRNA ribosomal ribonucleic acid STMR supervised trials median
residue
RRT relative retention time STP sewage treatment plant
RSD relative standard t tonne(s) (metric ton)
deviation
74
aliphatic acid)
s second t½ half-life (define method of

estimation)
S solubility T3 tri-iodothyroxine
SAC strong adsorption T4 thyroxine
capacity
SAP serum alkaline T25 tumorigenic dose that
phosphatase causes tumours in 25 % of
the test animals
SAR structure/activity TADI temporary acceptable daily
relationship intake
SBLC shallow bed liquid TBC tightly bound capacity
chromatography
sc subcutaneous TCD thermal conductivity
detector
sce sister chromatid TG technical guideline,
exchange technical group
SCAS semi-continous activated TGD Technical guidance
sludge document
SCTER smallest chronic toxicity TID thermionic detector, alkali
exposure ratio (TER) flame detector
SD standard deviation TDR time domain reflectrometry
se standard error TER toxicity exposure ratio
SEM standard error of the TERI toxicity exposure ratio for
mean initial exposure
SEP standard evaluation TERST toxicity exposure ratio
procedure following repeated
exposure
SF safety factor TERLT toxicity exposure ratio
following chronic exposure
SFC supercritical fluid tert tertiary (in a chemical
chromatography name)
SFE supercritical fluid TEP typical end-use product
extraction
SIMS secondary ion mass TGGE temperature gradient gel
spectroscopy electrophoresis
S/L short term to long term TIFF tag image file format
ratio
SMEs small and medium sized TLC thin layer chromatography
enterprises
SOP standard operating Tlm median tolerance limit
procedures
sp species (only after a TLV threshold limit value
generic name)
75
aliphatic acid)
Stand. Term/ Explanation

abbreviation
TMDI theoretical maximum daily
intake
TMRC theoretical maximum residue
contribution
TMRL temporary maximum residue
limit
TNsG technical notes for guidance
TOC total organic carbon
Tremcard transport emergency card
tRNA transfer ribonucleic acid
TSH thyroid stimulating hormone
(thyrotropin)
TTC 2,3,5-
triphenylterazoliumchloride
testing method
TWA time weighted average
UDS unscheduled DNA synthesis
UF uncertainty factor (safety
factor)
ULV ultra low volume
UR unit risk
UV ultraviolet
UVC unknown or variable
composition, complex
reaction products
UVCB undefined or variable
composition, complex
reaction products in biological
material
v/v volume ratio (volume per
volume)
vis visible
WBC white blood cell
wk week
wt weight
w/v weight per volume
ww wet weight
w/w weight per weight
XRFA X-ray fluorescence analysis
yr year
< less than
 less than or equal to
> greater than
 greater than or equal to
76
aliphatic acid)
APPENDIX 3: LIST OF STUDIES
Reference list of stud ies submitted and validated by Section number for the active substance :
TNG SECTION AUTHOR(S) YEAR TITLE SOURCE (WHERE DIFFERENT FOR DATA OWNER Essential Essential
COMPANY) COMPANY, REPORT NO. PROTECT studies for studies for
CLAIMED evaluation evaluation
(Yes / No)
YES NO
A 3. 1.1 Franke, J 2006 Copper Powder: Melting point Al (OECD 102). Yes Eckart ~
Siemens A.G., Prozess-Sicherheit. Report No.
20050986.0l · GLP· Unpublished
A 3.1.3 Messerschmidt, S. 2006 Tap Density of Copper Powder; eurofins-GAB Yes Eckart ~
GmbH Report No. 20051384/01-PCTD; GLP;
Unoublished
A 3.2 Franke, J 2006 Copper Powder: Vapour pressure. Siemens A.G., Yes Eckart ~
Prozess-Sicherheit. Report No. 20050986.02; GLP;
Unoublished
A 3.3.1 Messerschmidt, S. 2006 Physical state, colour and odour of Copper Powder; Yes Eckart ~
eurofins-GAB GmbH Report No. 20051384/0 1-
PCAO· GLP· Unpublished
A 3.3.2 Messerschmidt, S. 2006 Physical state, colour and odour of Copper Powder; Yes Eckart ~
eurofins-GAB GmbH Report No. 20051384/01-
A 3.3 .3 Messerschmidt, S. 2006 Physical state, colour and odour of Copper Powder; Yes Eckart ~
A 3.5 Gazotti, L. 2006 Water solubility of Copper Powder. GAB Analisi Yes Eckart ~
S.r .I. Report No. 20051384/01 -PCSB; GLP;
Unoublished
A 3.7 Messerschmidt, S. 2006 Solubility of Copper Powder in organic solvents; Yes Eckart 0
PSBO · GLP· Unoublished
A 3.8 Messerschmidt, S. 2006 Solubility of Copper Powder in organic solvents; Yes Eckart 0
PSBO · GLP· Unoublished
A 4.1 CI PAC - CI PAC method for total copper 44/TC/M/3.2. No Public domain 0
Volumetric thiosulphate method. CIPAC E, Page
44. Not GLP published.
A 4.1 CI PAC - CI PAC method for total copper 44/TC/M/3.1. No Public domain ~
Electrolytic method (Referee method). CIPAC E,
Paae 42. Not GLP oublished .
77
aliphatic acid)
TNG SECTION AUTHOR(S) YEAR TITLE SOURCE (WHERE DIFFERENT FOR DATA OWNER Essential Essent ia l
CLAIMED evaluati on evaluation
( Yes / No)
YE S NO
A 4. 1 Eckart Gmbh 20 12 Determination of Total Copper and Five I mpurities Yes Eckart [81
in Five Batches of Coated Copper Flakes; Eckart
Effect Pigments internal report, October 2012; Not
GLP· Unoublished
A 4. 1 Kiefer, R. 2007 Determination of Total Copper and Three Yes Eckart ~
Impurities in Five Batches of Copper Powder
Technical. eurofins-GAB GmbH Report No.
20051384/01- USB · GLP· Unoublished
A 4.2 AOAC 1993 AOAC Official Method 990.08, . Metals in Solid No Public domain [81
Wastes; Inductively Coupled Plasma Atomic
Emission Method. AOAC Official Methods of
Analysis; Metals and Other Elements, Chapter 9,
page 31. Not GLP, published .
A 4.2 EPA 1983 Methods for Chemical Analysis of Water and No Public domain [81
Wastes. Method 220.2 (Copper. Atomic
Absorption, furnace technique). Washington, DC;
U.S. Environmental Protection Agency. Not GLP,
published .
A 4.2 EPA 1983 Inductively Coupled Plasma - Atomic Emission No Public domain [81
Spectrometric Method for Trace Element Analysis
of Water and Wastes - Method 200.7.
Washington, DC; U.S. Environmental Protection
Agency. Not GLP, published .
A 4.2 EPA 1986 Test Methods for Evaluating Solid Waste, No Public domain [81
Physical/Chemical Methods (SW-846). Method
7210 (Copper. Atomic Absorption, direct
aspiration). Washington, DC; U.S. Environmental
Protection Agency. Not GLP, published. And
appended: EPA, 1986. Test Methods for
Evaluating Solid Waste, Physical/Chemical Methods
(SW-846). Method 30SOB (Acid digestion of
sediments, sludges and soils). Washington, DC;
U.S. Environmental Protection Agency.
(oublished).
A 4.2 EPA 1986 Methods for Chemical Analysis of Water and No Public domain [81
Wastes. Method 220.1 (Copper. Atomic
Absorption, direct aspiration). Washington, DC;
U.S. Environmental Protection Agency. Not GLP,
published .
78
aliphatic acid)
( Yes / No)
YE S NO
A 4.2 NIOSH 1987 Method 8005. NI OSH Manual of Analytical No Public domain [81
Methods, Fourth Edition, 8/15/94. Not GLP,
oublished .
A 4.2 NIOSH 1987 Method 8310. NI OSH Manual of Analytical No Public domain [81
Methods, Fourth Edition, 8/ 15/94. Not GLP,
oublished .
A 4.2 NIOSH N/A Method 7029. NI OSH Manual of Analytical No Public domain [81
Methods, Fourth Edition, 8/15/94. No GLP,
oublished .
A 4.3 Martin TD, Martin 1991 us EPA Method 200.11, Revision 2.1. No Public domain [81
ER, Lobring LB Determination of Metals in Fish Tissue by
and McKee GD. Inductively Coupled Plasma-Atomic Emission
Spectrometry. EPA/600/4- 91-0 10, pp 177-209;
Not GLP· Published
A 6. 1.1 2001 Copper Powder: Acute oral toxicity in the rat Yes Eckart [81
Acute toxic class method.
SPL Project Number: 1451/001. 20 March 2001.
(unoublished).
A 6.1.2 2001 Acute dermal toxicity (limit test) in the rat. Yes Eckart [81
SPL Project
Number: 1451/802. 21 March 2001.
<unoublished).
A 6.1.3 2001 Copper Powder: Acute inhalation toxicity (nose Yes Eckart [81
only) study in the rat.
SPL Project Number: 14!:> 1/UUJ. 3§ March2§§1.
(unoublished).
A 6. 1.4 2001 Copper Powder - Acute dermal irritation in the Yes Eckart [81
rabbit . SPL Project
Number: 145V 004. 21 March 2001.
<unoublished).
A 6. 1.4 2001 Copper Powder: acut e eye irritation in the rabbit. Yes Eckart [81
SPL Project
Number: 145V 005. 21 March 2001.
(unpublished).
A 6. 1.5 2001 Copper Powder: skin sensitisation in the guinea pig Yes Eckart [81
- Magnusson and Kligman Maximisation Method.
SPL Project
Number: 145V 006. 21 March 2001.
(unpublished).
79
aliphatic acid)
( Yes / No)
YE S NO
A 6.12.2 Chuttani HK, 1965 Acute Copper Sulfate Poisoning . Am J Med, 39 : No Public domain [81
Gupta PS, Gulati 849-854; Not GLP; published
S, Gupta DN.
A 6.12.2 O'Donohue JW, 1993 Micronodular cirrhosis and acute liver failure due to No Public domain [81
Reid MA, chronic copper self-intoxication. Eur. J.
Varghese A, Gastroenterol. 5:561-562; Not GLP; published
Portmann B,
Williams R
A 6.12.2 O'Connor, J.M., 2003 Copper supplementation has no effect on markers No Public domain [81
Bonham, M.P., of DNA damage and liver function in healthy adults
Turley, E., (FOODCUE Project) . Ann Nutr Metab, 47: 20 1-
McKeown, A., 206. Not GLP, Published
McKelvey-Martin,
VJ ., Gilmore,
w.s. and Strain,
J.J.
A 6.12.2 Pimentel JC, 1969 Vineyard sprayer's lung - A new occupational No Public domain [81
Marques F disease. Thorax, 24, 678-688; Not GLP; published
A 6.12.2 Pimentel JC, 1977 Liver disease in vineyard sprayers. No Public domain [81
Menezes AP. Gastroenterology 72 : 275-283; Not GLP; published
A 6.12.2 Pimentel JC, 1975 Liver granulomas containing copper in vineyard No Public domain [81
Menezes AP. sprayer's lung - A new Etiology of Hepatic
Granulomatosis. Am. Rev. Respir. Dis. 111:189-
195· Not GLP· oublished
A 6.12.2 Pratt, W.B., 1985 Lack of Effects of Copper Gluconate No Public domain [81
Omdahl, J.L. and Supplementation. The American Journal of Clinical
Sorenson, R.J ., Nutrition, 42: 681 - 682. Not GLP, Published
A 6.12.2 Rock, E., Mazur, 2000 The Effect of Copper Supplementation on Red No Public domain [81
A., O'Connor, Blood Cell Oxidizability and Plasma Antioxidants in
J.M., Bonham, Middle-Aged Healthy Volunteers. Free Radical
M.P., Rayssiguier, Biology and Medicine. 28 (3); 324-329. Not GLP,
Y. & Strain, J.J Published
80
aliphatic acid)
( Yes / No)
YE S NO
A 6.12.2 Tanner MS, 1979 Increased hepatic copper concentration in Indian No Public domain [81
Portmann B, Childhood Cirrhosis. Lancet 1:1203-5; Not GLP;
Mowat AP, published
Williams R, Pandit
AN, Mills CF,
Bremner I.
A 6.12.2 Turley, E., 2000 Copper supplementation in Humans Does Not No Public domain [81
McKeown, A., Affect the Susceptibility of Low Density Lipoprotein
Bonham, M.P., to I n Vitro I nduced Oxidation (Foodcue Project).
O'Connor, J.M, Free Radical Biology & Medicine, 29 : (11); 1129-
Chopra, M., 1134. Not GLP, Published
Harvey, L.J.,
Majsak- Newman,
G., Fairweather-
Tait, S.J., Bugel,
S., Sandstrom, B.
Rock, E., Mazur,
A., Tayssiguier, Y.
& Strain, J.J.
A6.12.4 Plamenac P, 1985 Cytologic changes of the respiratory tract in No Public domain [81
Santic Z, Nikulin vineyard spraying workers. Eur J Respir Dis, 67 :
A, Serdarevic H. 50-55; Not GLP; published
A 6.12.4 Schein berg I H, 1994 Is non-I ndian childhood cirrhosis caused by excess No Public domain [81
Sternlieb I. dietary copper? Lancet, 344: 1002-1004; Not GLP;
nublished
A6.12.4 Tanner MS, 1983 Early introduction of copper-contaminated animal No Public domain [81
Kantarjian AH, milk feeds as a possible cause of Indian Childhood
Bhave SA, Pandit Cirrhosis. Lancet 2 : 992-995; Not GLP; published
AN .
A 6.12.5 International 1990 Poisons Information Monograph (PIM G002) : No Public domain [81
Programme on Copper and copper salts; Not GLP; Published
Chemical Safety
A 6.12.7 International 1990 Poisons Information Monograph (PIM G002) : No Public domain [81
Chemical Safety
81
aliphatic acid)
( Yes / No)
YE S NO
A 6.12 .8 International 1990 Poisons Informat ion Monograph (PIM G002) : No Public domain [81
Chemical Safety
A 6.2 Allen, M.M., 1961 Further studies on various aspects of the use of No Public domain [81
Barber, R.S., high-copper supplements for growing pigs. Brit. J.
Braude, R. and Nutr., 15 : 507 - 522, Not GLP Published
Mitchell K.G.
A 6.2 Amaravadi, R., 1997 Isolation of a cDNA encoding the human homolog No Public domain [81
Glerum, D.M. and of COX17, a yeast gene essential for m itochondri al
Tzagoloff, A. copper recruitment. Hum Genet. 99 : 329-333. Not
GLP Published .
A 6.2 Aoyagi, s. and 1993 Bioavailability of Copper in Analytical-Grade and No Public domain [81
Baker, D.H. Feed Grade Inorganic Copper Sources when Fed to
Provide Copper at Levels Below the Chick's
Requirement. Poultry Science. 72 : 1075- 1083. Not
GLP, Published
A 6.2 Baker, D.H., Odle, 1991 Research Note : Bioavailability of Copper in Cupric No Public domain [81
J., Funk, M.A. and Oxide, Cuprous Oxide, and in a Copper- Lysine
Wieland, T.M. Complex. Poultry Science. 70: 177- 179. Not GLP,
Published
A 6.2 Buescher, R.G., 1961 Copper Availability to Swine from Cu64 Labelled No Public domain [81
Griffin, S.A. and Inorganic Compounds. Journal of Animal Science,
Bell, M.C. 20 : 529-531. Not GLP, Published
A 6.2 Bunch, R.J., 1963 Effects of High Levels of Copper and No Public domain [81
Speer, V.C., Hays, Chlortetracycline on Performance of Pigs. J. Animal
v.w. and McCall, Sci. 22 : 56-60 . Not GLP, Published
J.T.
A 6.2 Bunch, R.J., 1961 Effects of copper Sulfate, Copper oxide and No Public domain [81
Speer, V.C., Hays, Chlortetracycline on Baby Pig Performance. J.
v.w., Hawbaker, Animal Sci. 20 : 723-726. Not GLP, Published
J.H. and Catron,
D.V.
A 6.2 Campbell, C.H., 1981 Circulating Ceruloplasmin is an I mportant Source No Public domain [81
Brown, R. and of Copper for Normal and Malignant Animal Cells.
Linder, M.C. Biochim . Biophys. Acta . 678 : 27-38. Not GLP,
Published.
82
aliphatic acid)
( Yes / No)
YE S NO
A 6.2 Cromwell, G.L., 1989 Effects of Source and Level of Copper on No Public domain [81
Stahly, T.S. and Performance and Liver Copper Stores in Weanling
Monegue, H.J. Pigs. J. Animal Sci. 67 : 2996-3002. Not GLP,
Published
A 6.2 Culotta, v.c., 1997 The Copper Chaperone for Superoxide Dismutase. No Public domain [81
Klomp, J.S., The Journal of Biological chemistry. 272 (38) :
Casareno, R.L.B., 23469 - 23472. Not GLP, Published
Krems, B. And
Git lin, J.D
A 6.2 Darwish, H.M., 1984 Mobilisation of copper (II) from plasma No Public domain [81
Cheney, J.C., components and mechanism of hepatic copper
Schmitt, R.C. and transport. Am. J. Physiol., 246 (9):G72-G79. Not
Ettinaer M.J. GLP Published .
A 6.2 Gunshin, H., 1997 Cloning and Characterisation of a Mammalian No Public domain [81
Mackenzie, B, Proton-Coupled Metal-Ion transporter. Nature.
Berger, u.v., 388 :482-488. Not GLP, Published .
Gunshin, Y.,
Romero, M.F.,
Boron, W. F.,
Nussberger, s.,
Golian, J.L. &
Hediaer M.A.
A 6.2 Kegley, E. B. and 1994 Bioavailability of feed -grade copper sources No Public domain [81
Spears, J.W. (oxide, sulfate, or lysine) in growing cattle. J.
Animal Sci. 72 : 2728-2734. Not GLP, Published
A 6.2 Klomp, L.W.J., 1997 Identification and Functional Expression of HAH1, a No Public domain [81
Lin, S.J., Yuan, Novel Human Gene Involved in Copper
D.S., Klausner, Homeostasis. The Journal of Biological Chemistry
R.D., Culotta, 272(14) : 9221 -9226. Not GLP, Published.
v.c. and Gitlin,
J.D.
A 6.2 Lee S.H., Lancey 1993 Ceruloplasmin and copper transport during the No Public domain [81
R., Montaser A., latter part of gestation in the rat. Proc Soc Exp
Madani N., Linder Biol Med 203 : 428-39. Not GLP, Published .
M.C.
83
aliphatic acid)
( Yes / No)
YE S NO
A 6 .2 Linder M.C., 1987 Structure and function of transcuprein in transport No Public domain [81
Weiss K.C. and of copper by mammalian blood plasma. I n: Hurley
Hai, V.M. LC., Keen C. L , Lonnerdal, B. and Rucker, R.B.
(eds). Trace Elements in Man and Animals (TEMA-
6). New York : Plenum, 141 - 144. Not GLP,
Published.
A 6 .2 McArdle, H.J., 1990 Role of Albumin's Copper Binding Site in Copper No Public domain [81
Gross S.M., Danks Uptake by Mouse Hepatocyt es. Am . J. Physiol. 258
D.M. & Wedd, (Gastrointest. Liver Physiol. 21) : 988-991. Not
A.G. GLP Published .
A 6 .2 McArdle, H.J., 1988 Uptake of Copper by Mouse Hepatocytes. Journal No Public domain [81
Gross, S.M. and of Cellular Physiology, 136 : 373-378 . Not GLP,
Danks D.M. Published.
A 6 .2 Norvell, M.J., 1975 Effects of feeding high levels of various copper No Public domain [81
Gable, D.A. and salts t o broiler chickens. I n Trace Substances in
Thomas, M.C., Environments! Healt h - 9, (Hemphill, D.D., Ed) .
University of Missouri, Columbia, MO. Not GLP,
Published
A 6 .2 Pirot, F., Millet , J., 1996 In vitro Study of Percutaneous Absorption, No Public domain [81
Kalia, Y.N. & Cutaneous Bioavailability and Bioequivalence of
Humbert, P Zinc and Copper from Five Topical Formulations.
Skin Pharmacol. 9 : 259-269. Not GLP, Published .
A 6 .2 Pirot , F., Panisset, 1996 Simultaneous Absorption of Copper and Zinc No Public domain [81
F., Agache, P. & through Human Skin in vit ro. Skin Pharmacol. 9 :
Humbert, P. 43-52. Not GLP, Published .
A 6 .2 Rojas, LX., 1996 Interaction of different organic and inorganic zinc No Public domain [81
McDowell, L R., and copper sources fed to rats. J. Trace Elements
Cousins, R.J., Med . Biol. 10 : 139-144. Not GLP, Published
Martin, F.G.,
Wilkinson, N.S.,
Johnson, A.B. and
Velasquez, J.B.
A 6 .2 Scott, K.C. & 1994 Compartment Model of Copper Met abolism in Adult No Public domain [81
Turnlund, J.R., Men. J. Nutr. Biochem . 5: 342-350. Not GLP,
Published.
84
aliphatic acid)
( Yes / No)
YE S NO
A 6.2 Turnlund, J.R., 1990 Copper status and urinary and salivary copper in No Public domain [81
Keen, C.L. and young men at three levels of dietary copper. Am.
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aliphatic acid)
Reference list of stud ies submitted and validated by Section number for the representative prod uct VCl 7m Graphite:
Section No I Aut hor(s) Year Title Source (where different from com pany) Dat a Protection Own er Essential Essent ial
Reference No Com pany, Report No. GLP (where relevant) / Claimed studies for studies for
( Un) Published ( Yes/ No) e va luation eva luation
Yes No
Section 1 No study reports submitted [8J
Section 2 No study reports submitted [8J
Section 3 Bates M, Wright 2005 VC1 7m: Evaluation of Physical Properties and Storage Yes International [8J
E Stability (New First) Paint
Covance Laboratories Ltd Report
Number 1485/045- D2149 GLP/Unoublished
Section 3 Wolstenholme 2007 HELOS Particel Size Analysis for copper powder and Yes International [8J
B3.11 Molvbdenum disulohide mixture (New First) Paint
Section 4 4 .1/01 Wright E., 2001 Copper Compounds :Validation of the Analytical Yes International [8J
Ristorcelli D Method for the Analysis in Antifouling Paints (New First) Paint
Covance Laboratories Ltd Report
Number 1485/010- D2149 GLP/Unoublished
Section 5 Chapman, J. 2006 Antifouling Efficacy Report; VC1 7m Unpublished Yes International [8J
B5.10.2/01 (New First) Paint
Section 5 B5.10/02 Callow ME 2005 Toxicity of Copper to Algae Yes International [8J
I-. -
University of Birmingham Report (First New) Paint
Number not soecified Unoublished
Section 6 B6.1.1 1991 VC 17M ST Red Acute Oral Toxicity (Limit) Test in Yes International [8J
Rats (New First) Paint
I-. -
Report
Num~er 8083 GLP/Unoublished
Section 6 B6. 1. 2 1991 VC 17M ST Red Acut e Dermal Toxicity (Limit ) Test in Yes International [8J
Rats (New First) Paint
Report
~um~er !~H GLP/Unoublished
1- •
Section 6 B6.1.3 1991 vc 17M Acute Inhalation Toxicity Study in Rats Yes International [8J
1-. -
(New First) Paint
Reoort Number 7707 GLP/Unou~lis~e~
Section 6 B6.2/01 1991 vc 17M ST Red Acute Dermal Irritation Test in Yes International [8J
Rabbits (New First)
GLP/Uno~
Paint
Reoort Number 8089
146
aliphatic acid)
Section No I Aut hor (s) Year Title Source (where different from com pany) Dat a Protection Owner Essential Essent ial
Reference No Com pany, Report No. GLP ( where relevant) / Cla imed studies for studies for
--
( Un) Published ( Yes/ No) eva luation eva luation
Yes No
IX!
1=-
Section 6 B6.2/02 1991 VC 17M ST Red Acute Eye Irritation Test in Rabbits Yes International
(New First) Paint
Report Number 8093 GLP/Unpublis~e~
IX!
Section 6 B6.3
1-. 1991 VC 17M ST Red Buehler Sensitisation study in guinea
pigs
Report Number
Yes
(New First)
International
Paint
8095 GLP, Unoublished

Section 6 B6.4/0 1 Roper c s, 2003 The In Vitro Percutaneous Absorption of Copper in Yes International IX!
Sherratt R Two Paint Preparations Through Human Skin (New First) Paint
Inveresk Research, UK.
Reoort Number 23056 GLP/Unoublished
Section 6 B6.4/02 Roper CS 2005 The In Vitro Percutaneous Absorption of Copper in Yes International IX!
Two Paint Preparations Through Human Skin - Dermal (New First) Paint
Delivery Inveresk
Research, UK.
Report Number 24740 GLP/Unpublished
Section 6 B6.4/03 Roper CS 2005 The In Vitro Percutaneous Absorption of Copper in Yes International IX!
Two Paint Preparations Through Human Skin - An (New First) Paint
Expert Report
Inveresk Research, UK.
Report Number 25631 GLP/Unpublished
Section 6.4/ McGurk C 2014 Dermal Penetration of Copper Compounds from Yes Inernational IX!
Supplimentary Biocidal Antifouling Paints Product Type 21 (PT21) (New First) Paint
International Paint Ltd Report
number not soecified Unoublished
Section 6.4/ Toner F. 2009 The In Vitro Percutaneous Absorption of Radiolabelled Yes International IX!
Supplimentary Zinc Py rithione in an Antifouling Paint Through Human (New First) Paint
Skin, Charles River Study number 785726, Report
number 30556, Charles River.
GLP/Unoublished
Section 6.4/ Roper C, 2006 The In Vitro Percutaneous Absorption of Radiolabelled Yes International IX!
Supplimentary Toner F, Biocide in a Single Solvent-Based Paint Formulation (New First) Paint
Prowse G, Hunter through Human Skin. Charles River Laboratories
J, Madden S. Preclinical Services.
GLP/Published
Section 6.4/ Toner F. 2012 The I n Vitro Assessment of Different Methods for Yes International IX!
Supplimentary Removal of Zinc Pyrithione in Paint from Human Skin, (New First) Paint
Charles River Study number 785380, Report Number
30557, Charles River Laboratories.
GLP/Unoublished.
147
aliphatic acid)
Section No I Author(s) Year Title Source (where different from company) Data Protection Owner Essential Essential
Reference No Company, Report No. GLP (where relevant) / Claimed studies for studies for
(Un)Published (Yes/ No) evaluation evaluation
Yes No
Section 6.4/ Toner F. 2012 The I n Vitro Assessment of Different Methods for Yes International IX!
Supplimentary Removal of Zinc Pyrithione in Paint from Human Skin, (New First) Paint
Charles River Study number 785380, Report Number
30557, Charles River Laboratories.
GLP/ Unoublished.
Section 6.4/ Toner F. 2008 The In Vitro Percutaneous Absorption of Zinc Through Yes International IX!
Supplimentary Human Skin Following Application of Three Paints (New First) Paint
Containing Zinc Oxide to Human Skin, Charles River
Study Number 779529, Report number 28075,
Charles River
GLP/ Unoublished.
Section 6.4/ Toner F, 2005 The In Vitro Percutaneous Absorption of Radiolabelled Yes International IX!
Supplimentary Crow LF, Econea 028 in a Single Paint Formulation Through (New First) Paint
Roper CS. Human Skin, I nveresk Study Number 775566,
Inveresk Report Number 25468, Inveresk Research.
GLP/ Unpublished
Section 7 No study reports submitted
148

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Regulation (EU) No 528/2012

concerning the making available on the

Evaluation of active substance

Copper flakes (coated with

1 STATEMENT OF SUBJECT MATTER AND PURPOSE ......................................... 3

1 STATEMENT OF SUBJECT MATTER AND PURPOSE

1.1 Principle of evaluation and procedure followed

Copper flakes (coated with aliphatic acid)(CAS-no: 7440-50-8) was notified as an

1.2 Purpose of the assessment

Name: EU Antifouling Copper Task Force

2 OVERALL SUMMARY AND CONCLUSIONS

2.1 Presentation of the active substance and biocidal product

2.1.1 Identity, physico-chemical properties and methods of analysis

Table 2.1.1-1: Identification of coated copper flake

IUPAC Name Copper

Molecular weight (g/mol) 63.55

2.1.1.2 Physico-chimical properties

2.1.1.3 Analytical methods for determination and identification

2.1.2 Identity, physico-chemical properties and methods of analysis

Table 2.1.2-1: Identification of VC17M Graphite

Trade name VC17M Graphite

2.1.2.2 Physico-chemical properties

2.1.2.3 Analytical methods for determination and identification

2.2 Intended uses and efficacy

In addition, in order to facilitate the work of Member States in granting or reviewing

2.2.1 Field of use/function

Main group: 4 – Other biocidal products

2.2.2 Object to be protected, target organisms

2.2.4 Mode of action

2.3 Classification and labelling

2.3.1 Current classification of active substance

2 .3.1.1 Current classification

2 .3.1.2 Proposed classification by the RMS

No harmonised classification according to Regu lation (EC) No 1272/ 2008 ( CLP

Ta ble 2.3.1-1: proposed classification according to r egulation 1272/ 2008

Classification accordina to the CLP Re aulation

Signal Word Danger

Specific Concentration Aquatic Acute 1: M- factor = 10

2.3.2 Classification of biocidal product

2 .3 .2.1 Proposed classification of the representative biocida l product by the RMS

T a ble 2.3.2-1: proposed classification of biocidal product according to the

Classification accordina to the CLP Reaulation

H410: very toxic to aquatic life with long lasting effects

2.4 Summary of the risk assessment

2.4.1 Summary of human health risk assessment

2.4.1.1 Hazard identification of active substance

No animal or human studies were available to supply an inhalation absorption level.

2.4.1.1.2 Acute toxicity

Besides, a classification Acute Tox.3-H331 is proposed based on the CLP criteria.

2.4.1.1.3 Skin and eye irritation

2.4.1.1.4 Skin sensitization

2.4.1.1.5 Oral repeated toxicity

2.4.1.1.6 Dermal repeated toxicity

2.4.1.1.7 Inhalation repeated toxicity

2.4.1.1.9 Chronic toxicity and carcinogenicity

2.4.1.1.10 Reproductive toxicity

From a neurotoxicological point of view, copper has been recently suspected to be

2.4.1.1.12 AEL derivation

NOAELsystemic  NOAEL * 0.25  4.1 mgCu  kg 1bw / d

2.4.1.2 Hazard identification of product

2.4.1.3 Summary of exposure assessment and risk characterization

The product is intended to be used by professionals as well as non professionals.

 Mixing and loading