MT
Biocides Regulations, 2010
Table of Provisions (104)
Statutory Text (104 Articles)
L.N. 525 of 2010
PESTICIDES CONTROL ACT
(CAP. 430)
Biocides Regulations, 2010
IN exercise of the powers conferred by articles 4 and 5 of
the Pesticides Control Act, the Minister of Resources and Rural
Affairs, has made the following regulations
The title of these regulations is the Biocides Regulations, Citation.
2010, and they shall come into force as follows
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When assessing the application for
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'/06/@.&2"T.&/#4&5/*"#@&4+8#&
)-.&/0)"1.&2%32)/#0.&2-/55&#+)&
Annex VI, Member States shall
Y-.&/0)"1.&2%32)/#0.&2-/55&3.&
2%3U.0)&)+&/&0+$'/(/)"1.&("26&
/''5*"#@&/55&/''(+'("/).&/#4&
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)-.&2.0+#4&2%3'/(/@(/'-&+,&
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accordance with Article 5 and
IW&'(+4%0)2&2-/55&0+#)/"#&/#&
assess, when relevant for the
/1.(2"1.&/@.#)&/#4A&8-.(.&
authorisation of a product in
=W&'("$/(*&/#4&2.0+#4/(*&
+35"@/)"+#2&)+&%2.&)/$'.(&
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31 July 2022
=:&S/#%/(*&
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31 July 2014
:&\.3(%/(*&
1 August
IJ:I
N:J&@R6@
960 g/kg
D+4"%$&IK+?+K=K<=K+?+K:K&
'-.#*53%)*5>0-(+$.#KQK&
1,3,5-thiadiazine-2-thione
Tetrahydro-3,5-dimethyl-
BF&G+H&IJQKNINKQ&
F9D&G+H&:INKJ;K;
EC No: 208-576-7
+5/).&
&
&
^/(,/("#&
Dazomet
2+4"%$
that have not been representatively
protective equipment, unless it can
for product authorisation that risks
exposure scenarios and those risks
shall be minimized by considering
be demonstrated in the application
application on human skin, hair or
two and twelve years old, and that
restricted use on children between
acceptable level by others means.
where applicable, instructions for
2. labels on products intended for
Products authorised for industrial
to compartments and populations
professional use outdoors for the
particular product, those uses or
assessment. In particular, where
Member States shall ensure that
Member States shall ensure that
to industrial and/or professional
authorisations are subject to the
authorisations are subject to the
mitigation measures, including,
and/or professional use shall be
1. primary exposure of humans
used with appropriate personal
poles by insertion of granules.
clothing shall indicate that the
remedial treatment of wooden
addressed in the EU level risk
relevant, Member States shall
and applying appropriate risk
application of the product on
the amount and frequency of
product is intended only for
users can be reduced to an
assess any other use than
following conditions
following condition
human skin;
31 July 2022
31 July 2014
1 August
970 g/kg
N,N-diethyl-m- toluamide
CAS No: 533-74-4
CAS No: 134-62-3
EC No: 205-149-7
meta-toluamide
N,N-diethyl-
3. products must contain deterrents
meet the requirements of Article 5
authorisation that the product will
children less than two years old,
unless it can be demonstrated in
and Annex VI without such
it is not intended for use on
the application for product
for ingestion.
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PART C
List of Basic Substances with Requirements agreed at Community Level
(1) These regulations concern
(a) the authorisation and the placing on the market for
use of biocidal products;
(b)
the mutual recognition of authorisations;
(c) the establishment of a positive list of active
substances which may be used in biocidal products.
(2) These regulations apply to biocidal products as
defined in regulation 3(1)(a) but shall exclude products that are
defined or within the scope of the following instruments for the
purposes of these regulations
(a) the Medicinal Products (Labelling and Packaging) L.N. 393 of 2005.
Regulations, 2005;
(b)
the Herbal Medicinal Products Regulations, 2005;
(c)
the Veterinary Medicinal Products Regulations,
2004;
(d) Regulation (EC) No 726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down
Community procedures for the authorization and supervision
of medicinal products for human and veterinary use and
establishing a European Medicines Agency;
(e) the Active Implantable Medical Devices
Regulations, 2008;
(f) the Medical Devices Regulations, 2008;
(g) the Additives in Food Regulations, 1994;
(h) the Flavourings for Use in Foodstuffs and Source
Materials for their Production Regulations, 1998;
(i) the Permitted Food Additives Regulations, 2005;
(j) Regulation (EC) No 1935/2004 of the European
Parliament and of the Council of 27 October 2004 on
materials and articles intended to come into contact with food
and repealing Directives 80/590/EEC and 89/109/EEC,
(k) the Food Hygiene and Health Conditions for the
Production and Placing on the Market of Certain Products
of Animal Origin intended for Human Consumption
(Amendments and Repeals) Rules, 2006;
(l) the Conditions governing the preparation, placing
on the market and use of medicated feedingstuffs Rules,
2005;
(m) Regulation (EC) No 1831/2003 of the European
Parliament and of the Council of 22 September 2003 on
additives for use in animal nutrition;
(n)
the Products Used in Animal Nutrition Rules,
2005;
(o)
the Circulation and Use of Feed Materials Rules,
2005;
(p) the Cosmetic Regulations, 2004;
(q) Council Directive 95/5/EC of 27 February 1995
amending Directive 92/120/EEC on the conditions for
granting temporary and limited derogations from specific
Community health rules on the production and marketing of
certain products of animal origin,
(r) the Plant Protection Products Regulations, 2009
with the exception of substances listed in Schedule VII
thereto;
(s) the In Vitro Diagnostic Medical Devices, 2002;
(3) These regulations transpose the provisions of
Directive 98/8/EC of the European Parliament and of the Council
of 16 February 1998 concerning the placing of biocidal products
on the market.
(4) These regulations shall apply, without prejudice to
relevant Community provisions or measures taken in accordance
with them, in particular, to
(a) Regulation (EC) No 1907/2006 of the European
Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency, amending Directive 1999/45/
EC and repealing Council Regulation (EEC) No 793/93 and
Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/
EEC, 93/67/EEC, 93/105/EC and 2000/21/EC;
(b) Schedule VII to the Plant Protection Products
Regulations, 2009;
(c) Regulation (EC) No 304/2003 of the European
Parliament and of the Council of 28 January 2003 concerning
the export and import of dangerous chemicals;
(d) the Protection of the Health and Safety of
Workers from the Risks related to Chemical Agents at Work
Regulations, 2003, and the General Provisions for Health and L.N. 227 of 2003.
Safety at work Places Regulations, 2003;
(e) article 32 of the Commercial Code concerning Cap. 13.
misleading and comparative advertising.
(5) Regulation 21 of these regulations shall not apply
to the carriage of biocidal products by rail, road, inland waterway,
sea or air.
PART A
COMMON CORE DATA SET FOR ACTIVE SUBSTANCES
CHEMICAL SUBSTANCES
1. Dossiers on active substances are required to address at least all the points listed
under `Dossier requirements'. Responses are required to be supported by data.
The dossier requirements must be in line with technical development.
2. Information which is not necessary owing to the nature of the biocidal product or
of its proposed uses need not be supplied. The same applies where it is not
scientifically necessary or technically possible to supply the information. In such
cases a justification, acceptable to the competent authority must be submitted.
Such a justification may be the existence of a frame-formulation to which the
applicant has the right of access.
Dossier requirements
Applicant
Identity of the active substance
Physical and chemical properties of the active substance
Methods of detection and identification
Effectiveness against target organisms and intended uses
Toxicological profile for man and animals including metabolism
Ecotoxicological profile including environmental fate and behaviour
Measures necessary to protect man, animals and the environment
Classification and labelling
Summary and evaluation of Sections II to IX
The following data will be required to support submission on the above points.
I. APPLICANT
Name and address, etc.
Active substance manufacturer (name, address, location of plant)
II. IDENTITY
Common name proposed or accepted by ISO and synonyms
Chemical name (IUPAC nomenclature)
Manufacturer's development code number(s)
CAS and EC numbers (if available)
Molecular and structural formula (including full details of any isomeric
composition), molecular mass
Method of manufacture (syntheses pathway in brief terms) of active substance
Specification of purity of the active substance in g/kg or g/l, as appropriate
Identity of impurities and additives (e.g. stabilisers), together with the
structural formula and the possible range expressed as g/kg or g/l, as
appropriate
The origin of the natural active substance or the precursor(s) of the
active substance, e.g. an extract of a flower
Exposure data in conformity with Annex VI of Regulation (EC) No.
1907/2006.
III. PHYSICAL AND CHEMICAL PROPERTIES
Melting point, boiling point, relative density 1
Vapour pressure (in Pa) 1 above
These data must be submitted for the purified active substance of stated specification
Appearance (physical state, colour) 2
Absorption spectra (UV/VIS, IR, NMR), and a mass spectrum, molar
extinction at relevant wavelengths, where relevant 1
Solubility in water including effect of pH (5 to 9) and temperature on
solubility, where relevant 1
Partition coefficient n-octanol/water including effect of pH (5 to 9) and
temperature 1
Thermal stability, identity of relevant breakdown products
Flammability including auto-flammability and identity of combustion products
Flash-point
Surface tension
Explosive properties
Oxidising properties
Reactivity towards container material
IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
Analytical methods for the determination of pure active substance and,
where appropriate, for relevant degradation products, isomers and
impurities of the active substance and additives (e.g. stabilisers)
Analytical methods including recovery rates and the limits of determination for
the active substance, and for residues thereof, and where relevant in/on the
following
(a) Soil
(b) Air
(c) Water: the applicant should confirm that the substance itself and any of its
degradation products which fall within the definition of pesticides given for
“pesticides” and “pesticides – total” under Part B of Annex I Parameters and
Parametric Values Of Legal Notice 17 of 2009 Water Intended for Human
These data must be submitted for the active substance of stated specification
B
Consumption Regulations can be estimated with adequate reliability at the MAC
specified in those Regulations for individual pesticides !
(d) Animal and human body fluids and tissues
V. EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USES
Function, e.g. fungicide, rodenticide, insecticide, bactericide
Organism(s) to be controlled and products, organisms or objects to be protected
Effects on target organisms, and likely concentration at which the active
substance will be used
Mode of action (including time delay)
Field of use envisaged
User: industrial, professional, general public (non-professional)
Information on the occurrence or possible occurrence of the
development of resistance and appropriate management strategies
Likely tonnage to be placed on the market per year
VI. TOXICOLOGICAL AND METABOLIC STUDIES
Acute toxicity
For studies 6.1.1 to 6.1.3, substances other than gases shall be administered via
at least two routes, one of which should be the oral route. The choice of the
second route will depend on the nature of the substance and the likely route of
human exposure. Gases and volatile liquids should be administered by the
inhalation route.
Oral
Dermal
Inhalation
Skin and eye irritation 3
Skin sensitisation
Metabolism studies in mammals. Basic toxicokinetics, including a
dermal absorption study
For the following studies, 6.3 (where necessary), 6.4, 6.5, 6.7 and
6.8, the required route of administration is the oral route unless it
can be justified that an alternative route is more appropriate
Short-term repeated dose toxicity (28 days)
This study is not required when a sub-chronic toxicity study is available in a
rodent
Subchronic toxicity 90-day study, two species, one rodent and one non-rodent
Chronic toxicity( 4 )
One rodent and one other mammalian species
Mutagenicity studies
In-vitro gene mutation study in bacteria
In-vitro cytogenicity study in mammalian cells
In-vitro gene mutation assay in mammalian cells
If positive in 6.6.1, 6.6.2 or 6.6.3, then an in-vivo mutagenicity study
will be required (bone marrow assay for chromosomal damage or a
micronucleus test)
If negative in 6.6.4 but positive in-vitro tests then undertake a second in-vivo
study to examine whether mutagenicity or evidence of DNA damage can be
demonstrated in tissue other than bone marrow
If positive in 6.6.4 then a test to assess possible germ cell effects may be
required
Eye irritation test shall not be necessary where the active substance has been shown to have potential
corrosive properties.
B
Carcinogenicity study 4
One rodent and one other mammalian species. These studies may be combined
with those in 6.5
Reproductive toxicity 5
Teratogenicity test — rabbit and one rodent species
Fertility study — at least two generations, one species, male and female
Medical data in anonymous form
Medical surveillance data on manufacturing plant personnel if available
Direct observation, e.g. clinical cases, poisoning incidents if available
Health records, both from industry and any other available sources
Epidemiological studies on the general population, if available
Diagnosis of poisoning including specific signs of poisoning and clinical
tests,
if available
Sensitisation/allergenicity observations, if available
Specific treatment in case of an accident or poisoning: first
aid
measures, antidotes and medical treatment, if known
Prognosis following poisoning
Summary of mammalian toxicology and conclusions, including no
observed adverse effect level (NOAEL), no observed effect level
(NOEL), overall evaluation with regard to all toxicological data and any other
information concerning the active substances. Where possible any
suggested worker protection measures should be included in summary form
VII. ECOTOXICOLOGICAL STUDIES
Acute toxicity to fish
The long-term toxicity and carcinogenicity of an active substance may not be required where a full
justification demonstrates that these tests are not necessary
If, in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully
B
7.2.
Acute toxicity to Daphnia magna
7.3.
Growth inhibition test on algae
7.4.
Inhibition to microbiological activity
7.5.
Bioconcentration
Fate and behaviour in the environment
7.6.
Degradation
7.6.1.
Biotic
7.6.1.1. Ready biodegradability
7.6.1.2. Inherent biodegradability, where appropriate
7.6.2.
Abiotic
7.6.2.1. Hydrolysis as a function of pH and identification of breakdown products
7.6.2.2. Phototransformation in water including identity of the products of
transformation 1
7.7.
Adsorption/desorption screening test
Where the results of this test indicate the need to do so, the test described in
Schedule III – Part A Section XII.1 paragraph 1.2 shall be required, and/or the
test described in Schedule III – Part A Section XII.2 paragraph 2.2
7.8.
Summary of ecotoxicological effects and fate and behaviour in the environment
VIII. MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE
ENVIRONMENT
8.1.
Recommended methods and precautions concerning handling, use, storage,
transport or fire
8.2.
In case of fire, nature of reaction products, combustion gases, etc.
8.3.
Emergency measures in case of an accident
8.4.
Possibility of destruction or decontamination following release in or on
the following: (a) air (b) water, including drinking water (c) soil
B
Procedures for waste management of the active substance for industry or
professional users
8.5.1. Possibility of reuse or recycling
8.5.2. Possibility of neutralisation of effects
8.5.3. Conditions for controlled discharge including leachate qualities on disposal
8.5.4. Conditions for controlled incineration
Observations on undesirable or unintended side-effects, e.g. on beneficial and
other non-target organisms
IX. CLASSIFICATION AND LABELLING
Proposals including justification for the proposals for the classification and
labelling of the active substance according to L.N 306 of 2008.
Hazard symbol(s)
Indications of danger
Risk phrases
Safety phrases
X. SUMMARY AND EVALUATION OF SECTIONS II TO IX
PART B
COMMON CORE DATA SET FOR BIOCIDAL PRODUCTS
CHEMICAL PRODUCTS
1. Dossiers on biocidal products are required to address at least all the points listed
under `Dossier requirements'. Responses are required to be supported by data. The
dossier requirements must be in line with technical development.
2. Information which is not necessary owing to the nature of the biocidal product or
of its proposed uses need not be supplied. The same applies where it is not
scientifically necessary or technically possible to supply the information. In such
cases a justification, acceptable to the competent authority must be submitted.
Such a justification may be the existence of a frame-formulation to which the
applicant has the right of access.
3. Information may be derived from existing data where a justification acceptable to
the competent authority is provided. In particular, the provisions of Legal Notice
10 of 2007 should be used wherever possible to minimise animal testing.
Dossier requirements
Applicant
Identity of the biocidal product
Physical and chemical properties of the biocidal product
Methods for identification and analysis of the biocidal product
Intended uses of the biocidal product and efficacy for these uses
Toxicology data for the biocidal product (additional to that for the active
substance)
Ecotoxicology data for the biocidal product (additional to that for the active
substance)
Measures necessary to protect man, animals and the environment
B
Classification, packaging and labelling
Summary and evaluation of Sections II to IX
The following data will be required to support submission on the above points.
I. APPLICANT
Name and address, etc.
Formulator of the biocidal product and the active substance(s) (names, addresses,
including location of plant(s))
II. IDENTITY
Trade name or proposed trade name, and manufacturer's
development
code
number of the preparation, if appropriate
Detailed quantitative and qualitative information on the composition of
the
biocidal product, e.g. active substance(s), impurities, adjutants, inert components
Physical state and nature of the biocidal product, e.g. emulsifiable concentrate,
wettable powder, solution
III. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
Appearance (physical state, colour)
Explosive properties
Oxidising properties
Flash-point and other indications of flammability or spontaneous ignition
Acidity/alkalinity and if necessary pH value (1% in water)
Relative density
Storage stability — stability and shelf-life. Effects of light, temperature and
humidity on technical characteristics of the biocidal product; reactivity towards
container material
Technical characteristics of the biocidal product, e.g. wettability, persistent
foaming, flowability, pourability and dustability
Physical and chemical compatibility with other products including other biocidal
products with which its use is to be authorised
IV. METHODS OF IDENTIFICATION AND ANALYSIS
Analytical method for determining the concentration of the active
substance(s) in the biocidal product
In so far as not covered by Schedule II – Part A, paragraph 4.2, analytical
methods including recovery rates and the limits of determination for
toxicologically and ecotoxicologically relevant components of the biocidal
product and/or residues thereof, where relevant in or on the following
(a) Soil
(b) Air
(c) Water (including drinking water)
(d) Animal and human body fluids and tissues
(e) Treated food or feedingstuffs
V. INTENDED USES AND EFFICACY
Product type and field of use envisaged
Method of application including description of system used
Application rate and if appropriate, the final concentration of the biocidal product
and active substance in the system in which the preparation is to be used, e.g.
cooling water, surface water, water used for heating purposes
Number and timing of applications, and where relevant, any particular
information relating to geographical variations, climatic variations, or necessary
waiting periods to protect man and animals
Function, e.g. fungicide, rodenticide, insecticide, bactericide
B
Pest organism(s) to be controlled and products, organisms or objects to be
protected
Effects on target organisms
Mode of action (including time delay) in so far as not covered by Schedule II –
Part A, paragraph 5.4
User: industrial, professional, general public (non-professional)
Efficacy data
The proposed label claims for the product and efficacy data to support these
claims, including any available standard protocols used, laboratory tests, or field
trials, where appropriate
Any other known limitations on efficacy including resistance
VI. TOXICOLOGICAL STUDIES
Acute toxicity
For studies 6.1.1 to 6.1.3, biocidal products other than gases shall be administered
via at least two routes, one of which should be the oral route. The choice of the
second route will depend on the nature of the product and the likely route of
human exposure. Gases and volatile liquids should be administered by the
inhalation route
6.1.1. Oral
6.1.2. Dermal
6.1.3. Inhalation
6.1.4. For biocidal products that are intended to be authorised for use with other
biocidal products, the mixture of products, where possible, shall be tested for
acute dermal toxicity and skin and eye irritation, as appropriate
Skin and eye irritation( 1 )
Skin sensitisation
Information on dermal absorption
Available toxicological data relating to
toxicologically
relevant
non-
active substances (i.e. substances of concern)
Information related to the exposure of the biocidal product to man and the
operator
Where necessary, the test(s) described in Schedule II – Part A, shall be required
for the toxicologically relevant non-active substances of the preparation
VII. ECOTOXICOLOGICAL STUDIES
Foreseeable routes of entry into the environment on the basis of the use
envisaged
Information on the ecotoxicology of the active substance in the
product, where this cannot be extrapolated from the information on
the active substance itself
Available ecotoxicological information relating to exotoxicological relevant
non-active substances (i.e. substances of concern), such as information from
safety data sheets
VIII. MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMALS AND THE
ENVIRONMENT
Recommended methods and precautions concerning handling, use, storage,
transport or fire
Specific treatment in case of an accident, e.g. first-aid measures, antidotes,
medical treatment if available; emergency measures to protect the environment;
in so far as not covered by Schedule II – Part A, paragraph 8.3
Procedures, if any, for cleaning application equipment
Identity of relevant combustion products in cases of fire
Procedures for waste management of the biocidal product and its packaging for
industry, professional users and the general public (non-professional users), e.g.
possibility of reuse or recycling, neutralisation, conditions for controlled
discharge, and incineration
Possibility of destruction or decontamination following
release in or on the following
(a) Air
B
(b) Water, including drinking water
(c) Soil
Observations on undesirable or unintended side-effects, e.g. on
beneficial and other non-target organisms
Specify any repellents or poison control measures included in the preparation that
are present to prevent action against non-target organisms
IX. CLASSIFICATION, PACKAGING AND LABELLING
— Proposals for packaging and labelling
— Proposals for safety-data sheets, where appropriate
— Justification for the classification and labelling according to the
principles of regulation 21 of these Regulations
— Hazard symbol(s)
— Indications of danger
— Risk phrases
— Safety phrases
— Packaging (type, materials, size, etc.), compatibility of the preparation
with proposed packaging materials to be included
X. SUMMARY AND EVALUATION OF SECTIONS II TO IX
( 1 ) Eye-irritation test shall not be necessary where the biocidal product has been shown to
have potential corrosive properties.
For the purposes of these regulations the following
definitions shall apply
“active substance” means a substance or micro-
organism including a virus or a fungus having general or
specific action on or against harmful organisms;
“authorisation” means an administrative act by which
the Director authorises, following an application submitted by
an applicant, the placing on the market of a biocidal product
in its territory or in a part thereof;
“basic substance” means a substance which is listed in
Schedule I – Part C, whose major use is non-pesticidal but
which has some minor use as a biocide either directly or in
a product consisting of the substance and a simple diluent
which itself is not a substance of concern and which is not
directly marketed for this biocidal use; the substances, which
could potentially enter Schedule I – Part C in accordance with
the procedure laid down in regulations 11 and 12, are inter
alia the following
(i)
carbon dioxide,
(ii)
nitrogen,
(iii)
ethanol,
(iv)
2-propanol,
(v)
acetic acid,
(vi)
kieselguhr;
“biocidal products” means active substances and
preparations containing one or more active substances, put
up in the form in which they are supplied to the user, intended
to destroy, deter, render harmless, prevent the action of, or
otherwise exert a controlling effect on any harmful organism
by chemical or biological means; an exhaustive list of 23
product types with an indicative set of descriptions within
each type is given in Schedule V hereto;
“director” means the head of the Regulatory Affairs
Directorate established under the Malta Standards Authority
Act or such other head of any Directorate as the Minister may
by Order designate in his stead and includes, to the extent of
the authority given, any officer authorised by him, in writing,
to act in that behalf for any of the purposes of the Pesticides
Control Act;
“frame-formulation” means specifications for a group
of biocidal products having the same use and user type. This
group of products must contain the same active substances of
the same specifications, and their compositions must present
only variations from a previously authorised biocidal product
which do not affect the level of risk associated with them and
their efficacy. In this context, a variation is the allowance of
a reduction in the percentage of the active substance and/or
an alteration in percentage composition of one or more non-
active substances and/or the replacement of one or more
pigments, dyes, perfumes by others presenting the same or a
lower risk, and which do not decrease its efficacy;
“harmful organism” means any organism which has an
unwanted presence or a detrimental effect for humans, their
activities or the products they use or produce, or for animals
or for the environment;
“letter of access” means a document, signed by the
owner or owners of relevant data protected under the
provisions of these regulations, which states that these data
may be used by the Director for the purpose of granting an
authorisation or a registration of a biocidal product under
these regulations;
“low-risk biocidal product” means a biocidal product
which contains as active substance only one or more of those
listed in Schedule I – Part B and which does not contain any
substance of concern; under the conditions of use, the biocidal
product shall pose only a low risk to humans, animals and the
environment;
“placing on the market” any supply, whether in return
for payment or free of charge, or subsequent storage other
than storage followed by consignment from the customs
territory of the Community or disposal. Importation of a
biocidal product into the customs territory of the Community
shall be deemed to constitute placing on the market for the
purposes of these regulations;
“preparation” means a mixture or solution composed of
two or more substances;
“product and process orientated research and
development” means any scientific development related
to product development or the further development of a
substance, on its own, in preparations or in articles in the
course of which pilot plant or production trials are used to
develop the production process and/or to test the fields of
application of the substance.
“registration” means an administrative act by which
the Director, following an application submitted by an
applicant, after verification that the dossier meets the relevant
requirements of these regulations, allows the placing on the
market of a low-risk biocidal product in its territory or in a
part thereof;
“residues” means one or more of the substances present
in a biocidal product which remains as a result of its use
including the metabolites of such substances and products
resulting from their degradation or reaction;
“scientific research and development” means any
scientific experimentation, analysis or chemical research
carried out under controlled conditions in a volume less than
1 tonne per year;
“substance” means a chemical element and its
compounds in the natural state or obtained by any
manufacturing process, including any additive necessary
to preserve its stability and any impurity deriving from the
process used, but excluding any solvent which may be
separated without affecting the stability of the substance or
changing its composition;
“substance of concern” means any substance, other than
the active substance, which has an inherent capacity to cause
an adverse effect on humans, animals or the environment and
is present or is produced in a biocidal product in sufficient
concentration to create such an effect; such a substance, unless
there are other grounds for concern, would be normally a
substance classified as dangerous according to the Dangerous
Substances (Notifications) Regulations, 2008 and present in
the biocidal product at a concentration leading the product to
be regarded as dangerous within the meaning of regulation
6 and 7 of the Dangerous Substances and Preparations
Regulations, 2007.
PART A
ADDITIONAL DATA SET FOR ACTIVE SUBSTANCES
CHEMICAL SUBSTANCES
1. Dossiers on active substances are required to address at least all the points listed
under `Dossier requirements'. Responses are required to be supported by data. The
dossier requirements must be in line with technical development.
2. Information which is not necessary owing to the nature of the biocidal product or
of its proposed uses need not be supplied. The same applies where it is not
scientifically necessary or technically possible to supply the information. In such
cases a justification, acceptable to the competent authority must be submitted.
Such a justification may be the existence of a frame-formulation to which the
applicant has the right of access.
III. PHYSICAL AND CHEMICAL PROPERTIES
Solubility in organic solvents, including effect of temperature on solubility 1
1.
2. Stability in organic solvents used in biocidal products and identity of relevant
breakdown products 2
IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
1. Analytical methods including recovery rates and the limits of determination for
the active substance, and for residues thereof, in/on food or feedstuffs and other
products where relevant
VI. TOXICOLOGICAL AND METABOLIC STUDIES
1. Neurotoxicity study
These data must be submitted for the purified active substance of stated specification.
These data must be submitted for the active substance of stated specification.
B
If the active substance is an organophosphorus compound or if there are any other
indications that the active substance may have neurotoxic properties
neurotoxicity studies will be required. The test species is the adult hen unless
another test species is justified to be more appropriate. If appropriate, delayed
neurotoxicity tests will be required. If anticholine esterase activity is detected a
test for response to reactivating agents should be considered
2. Toxic effects on livestock and pets
3. Studies related to the exposure of the active substance to humans
4. Food and feedingstuffs
If the active substance is to be used in preparations for use where food
for human consumption is prepared, consumed or stored, or where
feedingstuff for livestock is prepared, consumed or stored the tests
referred to in Section XI, part 1 shall be required
5. If any other tests related to the exposure of the active substance to
humans, in its proposed biocidal products, are considered necessary,
then the test(s) referred to in Section XI, part 2 shall be required
6. If the active substance is to be used in products for action against plants
then tests to assess toxic effects of metabolites from treated plants, if
any, where different from those identified in animals shall be required
7. Mechanistic study — any studies necessary to clarify effects reported in toxicity
studies
VII. ECOTOXICOLOGICAL STUDIES
1. Acute toxicity test on one other, non-aquatic, non-target organism
2. If the results of the ecotoxicological studies and the intended use(s) of the
active substance indicate a danger for the environment then the tests
described in Sections XII and XIII shall be required
3. If the result of the test in paragraph 7.6.1.2 of Schedule II – Part A is
negative and if the likely route of disposal of the active substance is by
sewage treatment then the test described in Section XIII, part 4.1 shall
be required
4. Any other biodegradability tests that are relevant from the results in
paragraphs 7.6.1.1 and 7.6.1.2 of Schedule II – Part A
5. Phototransformation in air (estimation method), including identification of
breakdown products 1
6. If the results from paragraphs 7.6.1.2 in Schedule II – Part A or from paragraph 4,
above, indicate the need to do so, or the active substance has an overall low or
absent abiotic degradation, then the tests described in Section XII, part 1.1, part 2.1
and, where appropriate, part 3 shall be required
VIII. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE
ENVIRONMENT
1. Identification of any substances falling within the scope of List I or List II of the
Schedule of Legal Notice 203 of 2002 Regulations for the Protection of
Groundwater against Pollution caused by Certain Dangerous Substances on the
protection of groundwater against pollution caused by certain dangerous
substances
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies
Identification of degradation and reaction products and of metabolites
of the active substance in treated or contaminated foods or feedstuffs
Behaviour of the residue of the active substance, its degradation
products and, where relevant, its metabolites on the treated or
contaminated food or feedstuffs including the kinetics of disappearance
Overall material balance for the active substance. Sufficient residue
data from supervised trials to demonstrate that residues likely to arise
from the proposed use would not be of concern for human or animal
health
Estimation of potential or actual exposure of the active substance to
humans through diet and other means
If residues of the active substance remain on feedingstuffs for a
significant
period of time then feeding and metabolism studies in livestock shall be
required to permit evaluation of residues in food of animal origin
Effects of industrial processing and/or domestic preparation on the nature and
magnitude of residues of the active substance
Proposed acceptable residues and the justification of their acceptability
B
Any other available information that is relevant
Summary and evaluation of data submitted under 1.1 to 1.8
2. Other test(s) related to the exposure to humans
Suitable test(s) and a reasoned case will be required
XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT
1. Fate and behaviour in soil
Rate and route of degradation including identification of the processes
involved and identification of any metabolites and degradation
products in at least three soil types under appropriate conditions
Absorption and desorption in at least three soil types and, where
relevant, absorption and desorption of metabolites and
degradation
products
Mobility in at least three soil types and where relevant mobility of
metabolites and degradation products
Extent and nature of bound residues
2. Fate and behaviour in water
Rate and route of degradation in aquatic systems (as far as is not
covered by Schedule II – Part A, paragraph 7.6) including
identification of metabolites and degradation products
Absorption and desorption in water (soil sediment systems) and, where
relevant, absorption and desorption of metabolites and degradation
products
3. Fate and behaviour in air
If the active substance is to be used in preparations for fumigants, if it
is to be applied by a spray method, if it is volatile, or if any other
information indicates that this is relevant, then the rate and route of
degradation in air shall be determined as far as is not covered by
Section VII, part 5
4. Summary and evaluation of parts 1, 2 and 3
XIII. FURTHER ECOTOXICOLOGICAL STUDIES
1. Effects on birds
Acute oral toxicity — this need not be done if an avian species was
selected for study in Section VII, part 1
Short-term toxicity — eight-day dietary study in at least one species (other than
chickens)
Effects on reproduction
2. Effects on aquatic organisms
Prolonged toxicity to an appropriate species of fish
Effects on reproduction and growth rate on an appropriate species of fish
Bioaccumulation in an appropriate species of fish
Daphnia magna reproduction and growth rate
3. Effects on other non-target organisms
Acute toxicity to honeybees and other beneficial arthropods, e.g.
predators. A different test organism shall be chosen from that used in
Section VII, part 1
Toxicity to earthworms and to other soil non-target macro-organisms
Effects on soil non-target micro-organisms
Effects on any other specific, non-target organisms (flora and fauna) believed to
be at risk
4. Other effects
Activated sludge respiration inhibition test
5. Summary and evaluation of parts 1, 2, 3 and 4
B
PART B
ADDITIONAL DATA SET FOR BIOCIDAL PRODUCTS
CHEMICAL PRODUCTS
1. Dossiers on biocidal products are required to address at least all the
points listed under `Dossier requirements'. Responses are required to be
supported by data. The dossier requirements must be in line with
technical development.
2. Information which is not necessary owing to the nature of the biocidal
product or of its proposed uses need not be supplied. The same applies
where it is not scientifically necessary or technically possible to supply
the information. In such cases a justification, acceptable to the
competent authority must be submitted. Such a justification may be the
existence of a frame-formulation to which the applicant has the right of
access.
3. Information may be derived from existing data where a justification
acceptable to the competent authority is provided. In particular, the
provisions of Legal Notice 10 of 2007 should be used wherever
possible to minimise animal testing.
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies
If residues of the biocidal product remain on feedingstuffs for a
significant period of time, then feeding and metabolism studies in
livestock shall be required to permit evaluation of residues in food of
animal origin
Effects of industrial processing and/or domestic preparation on the
nature and magnitude of residues of the biocidal product
1. Other test(s) related to the exposure to humans
Suitable test(s) and a reasoned case will be required for the biocidal
product
XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT
1. Where relevant all the information required in Schedule III – Part A, Section XII
2. Testing for distribution and dissipation in the following
(a) Soil
(b) Water
(c) Air
Test requirements 1 and 2 above are applicable only to ecotoxicologically
relevant components of the biocidal product
XIII. FURTHER ECOTOXICOLOGICAL STUDIES
1. Effects on birds
Acute oral toxicity, if not already done in accordance with Schedule II – Part B,
Section VII
2. Effects on aquatic organisms
In case of application on, in, or near to surface waters
2.1.1. Particular studies with fish and other aquatic organisms
2.1.2. Residue data in fish concerning the active substance and including
toxicologically relevant metabolites
The studies referred to in Schedule III – Part A, Section XIII, parts 2.1,
2.2, 2.3 and 2.4 may be required for relevant components of the
biocidal product
If the biocidal product is to be sprayed near to surface waters then an
overspray study may be required to assess risks to aquatic organisms
under field conditions
3. Effects on other non-target organisms
Toxicity to terrestrial vertebrates other than birds
Acute toxicity to honeybees
Effects on beneficial arthropods other than bees
Effects on earthworms and other soil non-target macro-organisms, believed to be
at risk
Effects on soil non-target micro-organisms
Effects on any other specific, non-target organisms (flora and fauna) believed to
be at risk
If the biocidal product is in the form of bait or granules
3.7.1. Supervised trials to assess risks to non-target organisms under field conditions
3.7.2. Studies on acceptance by ingestion of the biocidal product by any non-
target organisms thought to be at risk
4. Summary and evaluation of parts 1, 2, and 3
(1) A biocidal product shall not be placed on the market
and used in Malta unless it has been authorised in accordance with
these regulations.
(2) By way of derogation from sub-regulation (1)
(a) subject to registration, the placing on the market
and use of a low-risk biocidal product shall be allowed,
provided that a dossier in accordance with regulation 9(3) has
been submitted and verified by the Director; unless otherwise
specified, all provisions relating to authorisation under these
regulations shall also apply to registration; and
(b) placing on the market and use of commodity
substances for biocidal purposes shall be allowed once they
have been entered in Schedule I – Part C.
(3) (a) Every application for authorisation shall be
decided on without undue delay; and
(b) for applications for biocidal products that require
registration, the Director shall take a decision within a period
of 60 days.
(4) The Director shall, on his own account or where
requested, establish a frame-formulation and communicate it to the
applicant when issuing an authorisation for a particular biocidal
product
Provided that without prejudice to regulations 9 and 13
and providing that the applicant has a right of access to the frame-
formulation in the form of a letter of access, when a subsequent
application for authorisation for a new biocidal product is based
on this frame-formulation, the Director shall take a decision with
regard to this application within a period of 60 days.
(5) Biocidal products are to be classified, packaged
and labelled in accordance with the provisions of these regulations.
(6) Without prejudice to regulation 8(1), authorisations
shall be granted for a maximum period of 10 years from the date
of first or renewed inclusion of the active substance in Schedule
I – Part A or Part B for the product type, without exceeding the
deadline specified for the active substance in Schedule I – Part A or
Part B; they may be renewed after verification that the conditions
imposed in regulation 6(1) and (2) are still satisfied. Renewal may,
where necessary, be granted only for the period necessary to allow
the Director to make such verification, where an application for
renewal has been made.
(7) Biocidal products are to be properly used. Proper
use shall include compliance with conditions established pursuant
to regulation 6 and specified under the labelling provisions of these
regulations. Proper use shall also involve the rational application
of a combination of physical, biological, chemical or other
measures as appropriate, whereby the use of biocidal products is
limited to the minimum necessary. Where biocidal products are
used at work, use shall also be in accordance with the requirements
of regulations for the protection of workers.
PART A
DATA SET FOR ACTIVE SUBSTANCES
MICRO-ORGANISMS INCLUDING VIRUSES AND FUNGI
1. For the purposes of these regulations, the term micro-organisms shall
be understood as including also viruses and fungi. Dossiers on active
micro- organisms shall address at least all the points listed under
‘Dossier requirements’ below. For all micro-organisms subject to an
application for inclusion into Schedule !" #" $%&'" (" )&" $%&'" *, all
available relevant knowledge and information in literature must be
provided.
The information related to the identification and
characterization of a micro-organism including mode of action is
particularly important and must be entered in sections I to IV and
provides the bases for an assessment of potential impacts on human
health and of environmental effects.
2. Where information is not necessary owing to the nature of the micro-
organism regulation 9(5) shall apply.
3. A dossier within the meaning of regulation 12(1) shall be prepared on
strain level of the micro-organism unless information is submitted that
shows that the species is known to be sufficiently homogenous
regarding all characteristics, or the applicant provides other arguments
in accordance with regulation 9(5).
4. Where the micro-organism has been genetically modified within the
meaning of regulation 2(1) of Legal Notice 170 of 2002 concerning
the Deliberate Release into the Environment of Genetically Modified
Organisms Regulations, a copy of the evaluation of the data
concerning the assessment of the risks to the environment as
established in regulation 4(2) of that Legal Notice, shall also be
submitted.
5. If the biocidal product action is known to be partly or entirely due to
the effect of a toxin/metabolite, or if significant residues of
toxins/metabolites are to be expected not related to the effect of the
active micro-organism, a dossier for the toxin/metabolite shall be
submitted in accordance with the requirements of Schedules II – Part
A and, where specified, the relevant parts of Schedule III – Part A.
B
Dossier requirements
SECTIONS
I. Identity of the micro-organism
II. Biological properties of the micro-organism
III. Further information on the micro-organism
IV. Analytical methods
V. Effects on human health
VI. Residues in or on treated materials, food and feed
VII. Fate and behaviour in the environment
VIII. Effects on non-target organisms
IX. Classification and labeling
X. Summary and evaluation of sections I to IX including conclusions of the risk
assessment and recommendations
The following data will be required to support submissions on the above points.
I. IDENTITY OF THE MICRO-ORGANISM
1.1. Applicant
1.2. Manufacturer
1.3. Name and species description, strain characterization
1.3.1. Common name of the micro-organism (including alternative and superseded
names)
1.3.2. Taxonomic name and strain indicating whether it is a stock variant, a mutant strain
or a genetically modified organism (GMO); for viruses, taxonomic designation of the
agent, serotype, strain or mutant
1.3.3. Collection and culture reference number where the culture is deposited
B
1.3.4. Methods, procedures and criteria used to establish the presence and identity of the
micro-organism (e.g. morphology, biochemistry, serology, etc.)
1.4. Specification of the material used for manufacturing of formulated products
1.4.1. Content of the micro-organism
1.4.2. Identity and content of impurities, additives, contaminating microorganisms
1.4.3. Analytical profile of batches
II. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
2.1. History of the micro-organism and its uses. Natural occurrence and geographical
distribution
2.1.1. Historical background
2.1.2. Origin and natural occurrence
2.2. Information on target organism(s)
2.2.1. Description of the target organism(s)
2.2.2. Mode of action
2.3. Host specificity range and effects on species other than the target organism
2.4. Development stages/life cycle of the micro-organism
2.5. Infectiveness, dispersal and colonisation ability
2.6. Relationships to known plant or animal or human pathogens
2.7. Genetic stability and factors affecting it
2.8. Information on the production of metabolites (especially toxins)
2.9. Antibiotics and other anti-microbial agents
2.10. Robustness to environmental factors
2.11. Effects on materials, substances and products
III. FURTHER INFORMATION ON THE MICRO-ORGANISM
B
3.1. Function
3.2. Field of use envisaged
3.3. Product type(s) and category of users for which the micro-organism should be listed
in Schedule I
3.4. Method of production and quality control
3.5. Information on the occurrence or possible occurrence of the development of
resistance of the target organism(s)
3.6. Methods to prevent loss of virulence of seed stock of the microorganism
3.7. Recommended methods and precautions concerning handling, storage, transport or
fire
3.8. Procedures for destruction or decontamination
3.9. Measures in case of an accident
3.10. Procedures for waste management
3.11. Monitoring plan to be used for the active micro-organism including handling,
storage, transport and use
IV. ANALYTICAL METHODS
4.1. Methods for the analysis of the micro-organism as manufactured
4.2. Methods to determine and quantify residues (viable or non-viable)
V. EFFECTS ON HUMAN HEALTH
TIER I
5.1. Basic information
5.1.1. Medical data
5.1.2. Medical surveillance on manufacturing plant personnel
5.1.3. Sensitisation/allergenicity observations
5.1.4. Direct observation, e.g. clinical cases
B
5.2. Basic studies
5.2.1. Sensitisation
5.2.2. Acute toxicity, pathogenicity, and infectiveness
5.2.2.1. Acute oral toxicity, pathogenicity and infectiveness
5.2.2.2. Acute inhalation toxicity, pathogenicity and infectiveness
5.2.2.3. Intraperitoneal/subcutaneous single dose
5.2.3. In vitro genotoxicity testing
5.2.4. Cell culture study
5.2.5. Information on short-term toxicity and pathogenicity
5.2.5.1. Health effects after repeated inhalatory exposure
5.2.6. Proposed treatment: first aid measures, medical treatment
5.2.7. Any pathogenicity and infectiveness to humans and other mammals under
conditions of immunosuppression
END OF TIER I
TIER II
5.3. Specific toxicity, pathogenicity and infectiveness studies
5.4. Genotoxicity — In vivo studies in somatic cells
5.5. Genotoxicity — In vivo studies in germ cells
END OF TIER II
5.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall
evaluation
VI. RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED
6.1. Persistence and likelihood of multiplication in or on treated materials, feedingstuffs
or foodstuffs
B
6.2. Further information required
6.2.1. Non-viable residues
6.2.2. Viable residues
6.3. Summary and evaluation of residues in or on treated materials, food and feed
VII. FATE AND BEHAVIOUR IN THE ENVIRONMENT
7.1. Persistence and multiplication
7.1.1. Soil
7.1.2. Water
7.1.3. Air
7.2. Mobility
7.3. Summary and evaluation of fate and behaviour in the environment
VIII. EFFECTS ON NON-TARGET ORGANISMS
8.1. Effects on birds
8.2. Effects on aquatic organisms
8.2.1. Effects on fish
8.2.2. Effects on freshwater invertebrates
8.2.3. Effects on algae growth
8.2.4. Effects on plants other than algae
8.3. Effects on bees
8.4. Effects on arthropods other than bees
8.5. Effects on earthworms
8.6. Effects on soil micro-organisms
B
8.7. Further studies
8.7.1. Terrestrial plants
8.7.2. Mammals
8.7.3. Other relevant species and processes
8.8. Summary and evaluation of effects on non-target organisms
IX. CLASSIFICATION AND LABELLING
The dossier shall be accompanied by a reasoned proposals for allocating an active
substance which is a micro-organism to one of the risk groups specified in regulation 2 of
Legal Notice 228 of 2003 on the protection of workers from risks related to exposure to
biological agents at work together with indications on the need for products to carry the
biohazard sign specified in Schedule II to that Legal Notice.
X. SUMMARY AND EVALUATION OF SECTIONS I TO IX INCLUDING
CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS
B
PART B
DATA SET FOR BIOCIDAL PRODUCTS
MICRO-ORGANISMS INCLUDING VIRUSES AND FUNGI
1. For the purposes of these Regulations, the term micro-organisms shall
be understood as including also viruses and fungi. This Schedule
provides stat requirements for the authorization of a biocidal product
based on preparations of micro-organisms. For all biocidal products
based on preparations containing micro-organisms that are subject to
application, all available relevant knowledge and information in should
be provided. The information related to the identification and
characterization of all components in a biocidal product is particularly
important and must be entered in sections I to IV and provides the basis
for an assessment of possible impacts on human health and
environmental.
2. Where information is not necessary owing to the nature of the micro-
organism regulation 9(5) shall apply.
3. Information may be derived from existing data where a justification
acceptable to the competent authority is provided. In particular, the
provisions of Legal Notice 306 of 2008 and Legal Notice 10 of 2007
!"#!$%#&#'( )*$( +,#'$%"-.( /-0.),#!$.( ,#1( 2%$3,%,)&"#.(
4$'-5,)&"#. shall be used wherever possible to minimize animal
testing.
4. Where testing is done, a detailed description (specification) of the
material used and its impurities, according to the provisions of Section
II, must be provided. Where necessary, data as established in
Schedules II – Part B, II – Part B shall be required for all the
toxicologically/eco-toxicologically relevant chemical components of
the biocidal product, in particular if the components are substances of
concern as defined in regulation 3(1)(e).
5. In cases where a new preparation is to be dealt with, extrapolation from
Schedules IV – Part A, could be acceptable, provided that all the
possible effects of the components, especially on pathogenicity and
infectiveness, are evaluated.
Dossier requirements
SECTIONS
I. Identity of the biocidal product
II. Physical, chemical and technical properties of the biocidal product
III. Data on application
IV. Further information on the biocidal product
V. Analytical methods
VI. Efficacy data
VII. Effects on human health
VIII. Residues in or on treated materials, food and feed
IX. Fate and behaviour in the environment
X. Effects on non-target organisms
XI. Classification, packaging and labelling of the biocidal product
XII. Summary and evaluation of sections I to XI including conclusions of the risk
assessment and recommendations
The following data will be required to support submissions on the above points.
I. IDENTITY OF THE BIOCIDAL PRODUCTS
1.1.Applicant
1.2. Manufacturer of the biocidal product and the micro-organism(s)
1.3. Trade name or proposed trade name, and manufacturer's development code number
of the biocidal product
1.4. Detailed quantitative and qualitative information on the composition of the biocidal
product
1.5. Physical state and nature of the biocidal product
1.6. Function
II. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL
PRODUCT
2.1. Appearance (colour and odour)
2.2. Storage stability and shelf-life
2.2.1. Effects of light, temperature and humidity on technical characteristics of the
biocidal product
2.2.2. Other factors affecting stability
2.3. Explosivity and oxidising properties
2.4. Flash point and other indications of flammability or spontaneous ignition
2.5. Acidity, alkalinity and pH value
2.6. Viscosity and surface tension
2.7. Technical characteristics of the biocidal product
2.7.1. Wettability
2.7.2. Persistent foaming
2.7.3. Suspensibility and suspension stability
2.7.4. Dry sieve test and wet sieve test
2.7.5. Particle size distribution (dustable and wettable powders, granules), content of
dust/fines (granules), attrition and friability (granules)
2.7.6. Emulsifiability, re-emulsifiability, emulsion stability
2.7.7. Flowability, pourability (rinsability) and dustability
2.8. Physical, chemical and biological compatibility with other products including
biocidal products with which its use is to be authorised or registered
2.8.1. Physical compatibility
2.8.2. Chemical compatibility
2.8.3. Biological compatibility
2.9. Summary and evaluation of physical, chemical and technical properties of the
biocidal product
III. DATA ON APPLICATION
3.1. Field of use envisaged
3.2. Mode of action
3.3. Details of intended use
3.4. Application rate
3.5. Content of micro-organism in material used (e.g. in the application device or bait)
3.6. Method of application
3.7. Number and timing of applications and duration of protection
3.8. Necessary waiting periods or other precautions to avoid adverse effects to human and
animal health and the environment
3.9. Proposed instructions for use
3.10. Category of users
3.11. Information on the possible occurrence of the development of resistance
3.12. Effects on the materials or products treated with the biocidal product
IV. FURTHER INFORMATION ON THE BIOCIDAL PRODUCT
4.1. Packaging and compatibility of the biocidal product with proposed packaging
materials
4.2. Procedures for cleaning application equipment
4.3. Re-entry periods, necessary waiting periods or other precautions to protect man,
livestock and the environment
4.4. Recommended methods and precautions concerning: handling, storage, transport or
fire
B
4.5. Measures in the case of an accident
4.6. Procedures for destruction or decontamination of the biocidal product and its
packaging
4.6.1. Controlled incineration
4.6.2. Others
4.7. Monitoring plan to be used for the active micro-organism and other micro-
organism(s) contained in the biocidal product including handling, storage, transport and
use
V. ANALYTICAL METHODS
5.1. Methods for the analysis of the biocidal product
5.2. Methods to determine and quantify residues
VI. EFFICACY DATA
VII. EFFECTS ON HUMAN HEALTH
7.1. Basic acute toxicity studies
7.1.1. Acute oral toxicity
7.1.2. Acute inhalation toxicity
7.1.3. Acute percutaneous toxicity
7.2. Additional acute toxicity studies
7.2.1. Skin irritation
7.2.2. Eye irritation
7.2.3. Skin sensitisation
7.3. Data on exposure
7.4. Available toxicological data relating to non-active substances
7.5. Supplementary studies for combinations of biocidal products
7.6. Summary and evaluation of effects on human health
VIII. RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED
IX. FATE AND BEHAVIOUR IN THE ENVIRONMENT
X. EFFECTS ON NON-TARGET ORGANISMS
10.1. Effects on birds
10.2. Effects on aquatic organisms
10.3. Effects on bees
10.4. Effects on arthropods other than bees
10.5. Effects on earthworms
10.6. Effects on soil micro-organisms
10.7. Additional studies on additional species or higher tier studies such as studies on
selected non-target organisms
10.7.1. Terrestrial plants
10.7.2. Mammals
10.7.3. Other relevant species and processes
10.8. Summary and evaluation of effects on non-target organisms
XI. CLASSIFICATION, PACKAGING AND LABELLING OF THE BIOCIDAL
PRODUCT
As established in regulation 21, proposals including justification for the classification
and labelling of the biocidal product in accordance with the provisions set in Legal
Notice 306 of 2008 and Legal Notice 10 of 2007 must be submitted. The
classification comprises of the description of the category/categories of danger and
qualifying risk phrases for all dangerous properties. On the basis of the classification,
a proposal for labelling including the hazard symbol(s) and indications of danger, risk
phrases and safety phrases should be given. The classification and labelling shall be
in regard to the chemical substances contained in the biocidal product. If necessary,
specimens of proposed packaging shall be submitted to the competent authority of a
Member State.
The dossier shall be accompanied by a reasoned proposal for allocation to one of the
risk groups specified in regulation 2 of Legal Notice 228 of 2003 together with
B
indications on the need for products to carry the biohazard sign specified in Schedule
II to that Legal Notice.
XII. SUMMARY AND EVALUATION OF SECTIONS I TO XI INCLUDING
CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS
B
(1) (a) Without prejudice to regulation 13 hereof,
a biocidal product that has already been authorised or registered
in one Member State shall be authorised or registered in Malta
within 120 days, or 60 days respectively, of an application being
received by the Director, provided that the active substance of the
biocidal product is included in Schedule I – Part A or Part B and it
conforms to the requirements thereof. For the mutual recognition
of authorisations, the application shall include a summary of the
dossier as required in regulation 9(2)(a) and Schedule II - Part B,
Section X and a certified copy of the first authorisation granted. For
mutual recognition of registration of low-risk biocidal products, the
application shall include the data requirements of regulation 9(3),
except for the efficacy data for which a summary shall suffice.
(b) The authorisation may be subject to provisions
resulting from the implementation of other measures in
accordance with Community law, relating to the conditions for
distribution and use of biocidal products intended to protect
the health of the distributors, users and workers concerned.
(2)
If, in accordance with regulation 6, it is established
that
(a) the target species is not present in harmful
quantities,
(b) unacceptable tolerance or resistance of the target
organism to the biocidal product is demonstrated, or
(c)
the relevant circumstances of use, such as climate
or breeding period of the target species, differ significantly
from those in the Member State where the biocidal product
was first authorised, and an unchanged authorisation may
therefore present unacceptable risks to humans or the
environment, certain conditions referred to in regulation 21(3)
(e), (f), (h), (j) and (l) may be requested to be adjusted to the
different circumstances, so that conditions for issue of an
authorisation laid down in regulation 6 are satisfied.
(3) (a) Where a low-risk biocidal product has been
registered by another Member State does not comply with the
definition provided for in the definition “low-risk biocidal product”
in regulation 3, the Director may provisionally refuse registration
thereof and shall immediately communicate his concerns to the
competent authority responsible for the verification of the dossier.
(b) If, within a maximum period of 90 days, an
agreement is not reached between the authorities concerned,
the matter will be forwarded to the Commission for a decision
in accordance with the procedure laid down in regulation
5(4).
(4) Notwithstanding regulations 5(2) and 5(3), where
it is believed that a biocidal product authorised by another Member
State cannot meet the conditions set out pursuant to regulation
6(1) and consequently proposes to refuse the authorisation or the
registration or to restrict the authorisation under certain conditions,
the Director shall notify the Commission, other Member States and
the applicant and shall provide them with an explanatory document
containing the name of the product and its specification and setting
out the grounds on which it proposes to refuse or to restrict the
authorisation.
(5) (a) If the procedure laid down in regulation 5(4)
leads to the confirmation of a refusal of a second or subsequent
registration, the Member State that had previously registered the
low-risk biocidal product shall, where deemed appropriate by
the Standing Committee, take this refusal into consideration and
review its registration according to regulation 7.
(b) If this procedure confirms the initial
registration, the Member State having introduced the
procedure shall register the low-risk biocidal product
concerned.
(6) By way of derogation from sub-regulation 5(1),
Director may refuse, subject to the Treaty, mutual recognition of
authorisations granted for product types 15, 17 and 23 of Schedule
V provided that such a limitation can be justified and does not
jeopardise the purpose of these regulations.
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED
TO IN REGULATION 3(1)(a) OF THESE REGULATIONS
These product-types exclude products where they are covered by the regulations
mentioned in regulation 2(2) of these regulations for the purposes of these regulations
and their subsequent modifications.
MAIN GROUP 1: Disinfectants and general biocidal products
These product types exclude cleaning products that are not intended to have a biocidal
effect, including washing liquids, powders and similar products.
Product-type 1: Human hygiene biocidal products
Products in this group are biocidal products used for human hygiene purposes.
Product-type 2: Private area and public health area disinfectants and other biocidal
products
Products used for the disinfection of air, surfaces, materials, equipment and furniture
which are not used for direct food or feed contact in private, public and industrial areas,
including hospitals, as well as products used as algaecides.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters;
air-conditioning systems; walls and floors in health and other institutions; chemical
toilets, waste water, hospital waste, soil or other substrates (in playgrounds).
Product-type 3: Veterinary hygiene biocidal products
Products in this group are biocidal products used for veterinary hygiene purposes
including products used in areas in which animals are housed, kept or transported.
Product-type 4: Food and feed area disinfectants
B
Products used for the disinfection of equipment, containers, consumption utensils,
surfaces or pipework associated with the production, transport, storage or consumption
of food, feed or drink (including drinking water) for humans and animals.
Product-type 5: Drinking water disinfectants
Products used for the disinfection of drinking water (for both humans and animals).
MAIN GROUP 2: Preservatives
Product-type 6: In-can preservatives
Products used for the preservation of manufactured products, other than foodstuffs or
feedingstuffs, in containers by the control of microbial deterioration to ensure their
shelf life.
Product-type 7: Film preservatives
Products used for the preservation of films or coatings by the control of microbial
deterioration in order to protect the initial properties of the surface of materials or
objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
Product-type 8: Wood preservatives
Products used for the preservation of wood, from and including the saw-mill stage, or
wood products by the control of wood-destroying or wood-disfiguring organisms.
This product type includes both preventive and curative products.
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
Products used for the preservation of fibrous or polymerised materials, such as leather,
rubber or paper or textile products and rubber by the control of microbiological
deterioration.
Product-type 10: Masonry preservatives
Products used for preservation and remedial treatment of masonry or other construction
materials other than wood by the control of microbiological and algal attack.
Product-type 11: Preservatives for liquid-cooling and processing systems
Products used for the preservation of water or other liquids used in cooling and
processing systems by the control of harmful organisms such as microbes, algae and
mussels.
Products used for the preservation of drinking water are not included in this product
type.
Product-type 12: Slimicides
Products used for the prevention or control of slime growth on materials, equipment
and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand
strata in oil extraction.
Product-type 13: Metalworking-fluid preservatives
Products used for the preservation of metalworking fluids by the control of microbial
deterioration.
MAIN GROUP 3: Pest control
Product-type 14: Rodenticides
Products used for the control of mice, rats or other rodents.
Product-type 15: Avicides
Products used for the control of birds.
Product-type 16: Molluscicides
Products used for the control of molluscs.
Product-type 17: Piscicides
Products used for the control of fish; these products exclude products for the treatment
of fish diseases.
Product-type 18: Insecticides, acaricides and products to control other arthropods
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans).
Product-type 19: Repellents and attractants
Products used to control harmful organisms (invertebrates such as fleas, vertebrates
such as birds), by repelling or attracting, including those that are used for human or
veterinary hygiene either directly or indirectly.
MAIN GROUP 4: Other biocidal products
Product-type 20: Preservatives for food or feedstocks
Products used for the preservation of food or feedstocks by the control of harmful
organisms.
Product-type 21: Antifouling products
Products used to control the growth and settlement of fouling organisms
(microbes and higher forms of plant or animal species) on vessels, aquaculture
equipment or other structures used in water.
Product-type 22: Embalming and taxidermist fluids
Products used for the disinfection and preservation of human or animal corpses, or parts
thereof.
Product-type 23: Control of other vertebrates
Products used for the control of vermin.
B
(1) A biocidal product is authorised only if -
(a) the active substance(s) included therein are listed in
Schedule I – Part A or Part B and any requirements laid down
in the Schedules hereto are fulfilled;
(b) it is established, in the light of current scientific
and technical knowledge, and is shown from appraisal of the
dossier provided for in regulation 9, according to the common
principles for the evaluation of dossiers as laid down in
Schedule VI, that, when used as authorised and having regard
(1) all normal conditions under which the biocidal
product may be used,
(2)
how the material treated with it may be used,
(3) the consequences from use and disposal, the
biocidal product
(i)
is sufficiently effective,
(ii) has no unacceptable effects on the target
organisms, such as unacceptable resistance or cross-
resistance or unnecessary suffering and pain for
vertebrates,
(iii) has no unacceptable effects itself or as a
result of its residues, on human or animal health, directly
or indirectly, such as through drinking water, food or
feed, indoor air or consequences in the place of work, or
on surface water and groundwater,
(iv) has no unacceptable effect itself, or as
a result of its residues, on the environment having
particular regard to the following considerations
(1) its fate and distribution in the environment;
particularly contamination of surface waters, including estuarian
and seawater, groundwater and drinking water,
(2)
its impact on non-target organisms;
(c) the nature and quantity of its active substances and,
where appropriate, any toxicologically or ecotoxicologically
significant impurities and co-formulants, and its residues of
toxicological or environmental significance, which result from
authorised uses, can be determined according to the relevant
requirements in Schedule II – Part A or Part B, III – Part A or
Part B, IV – Part A or Part B;
(d) its physical and chemical properties have been
determined and deemed acceptable for purposes of the
appropriate use, storage and transport of the product.
(2) A biocidal product classified according to
regulation 21(1) as toxic, very toxic or as a category 1 or 2
carcinogen, or as a category 1 or 2 mutagen or classified as
toxic for reproduction category 1 or 2, shall not be authorised
for marketing to, or use by the general public.
(3) Authorisation may be conditional on, and must
stipulate the conditions relating to marketing and use
necessary to ensure compliance with the provisions of sub-
regulation 6(1).
(4) Where other legal provisions impose requirements
relevant to the conditions for the issue of an authorisation
and for use of the biocidal product, and particularly where
these are intended to protect the health of distributors, users,
workers and consumers or animal health or the environment,
the Director shall take these into account when issuing an
authorisation and where necessary shall issue the authorisation
subject to those requirements.
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR
BIOCIDAL PRODUCTS
CONTENTS
Definitions
Introduction
Evaluation
— General principles
— Effects on humans
— Effects on animals
— Effects on the environment
— Unacceptable effects
— Efficacy
— Summary
Decision-making
— General principles
— Effects on humans
— Effects on animals
— Effects on the environment
— Unacceptable effects
— Efficacy
B
— Summary
Overall integration of conclusions
DEFINITIONS
(a) Hazard identification
This is the identification of the adverse effects which a biocidal product
has an inherent capacity to cause.
(b) Dose (concentration) — response (effect) assessment
This is the estimate of the relationship between the dose, or level of
exposure, of an active substance or substance of concern in a biocidal
product and the incidence and severity of an effect.
(c) Exposure assessment
This is the determination of the emissions, pathways and rates of
movement of an active substance or a substance of concern in a
biocidal product and its transformation or degradation in order to
estimate the concentration/doses to which human populations, animals
or environmental compartments are or may be exposed.
(d) Risk characterisation
This is the estimation of the incidence and severity of the adverse
effects likely to occur in a human population, animals or environmental
compartments due to actual or predicted exposure to any active
substance or substance of concern in a biocidal product. This may
include `risk estimation' i.e. the quantification of that likelihood.
(e) Environment
Water, including sediment, air, land, wild species of fauna and flora,
and any interrelationship between them, as well as any relationship
with living organisms.
INTRODUCTION
1. This Schedule lays down principles to ensure that evaluations made
and decisions taken by a Member State concerning the authorisation
of a biocidal product providing it is a chemical preparation results in
a harmonised high level of protection for humans, animals and
the
environment in accordance with regulation 6(1)(b) of these regulations.
2. In order to ensure a high and harmonised level of protection of human
and animal health and of the environment, any risks arising from the
use of a biocidal product shall be identified. To achieve this, a risk
assessment shall be carried out to determine the acceptability or
otherwise of any risks identified during the proposed normal use of the
biocidal product. This is done by carrying out an assessment of the
risks associated with the relevant individual components
of
the
biocidal product.
3. A risk assessment on the active substance or substances present in the
biocidal product is always required. This will already have been carried
out for the purpose of Schedule I. This risk assessment shall entail
hazard identification, and, as appropriate, dose (concentration) —
response (effect) assessment, exposure assessment and risk
characterisation. Where a quantitative risk assessment cannot be made
a qualitative assessment shall be produced.
4. Additional risk assessments shall be carried out, in the same manner as
described above, on any other substance of concern present in the
biocidal product where relevant for the use of the biocidal product.
5. In order to carry out a risk assessment data are required. These data are
detailed in Schedules II, III and IV and, recognising that there are a
wide variety of product types, are flexible according to the product
type and associated risks. The data required shall be the minimum
necessary to carry out an appropriate risk assessment. Member
States should take due consideration of the requirements of regulations
13 and 14 of these regulations in order to avoid duplication of data
submissions. The minimum set of data required for an active substance
in any biocidal product type, however, shall be that detailed in
Annex VI to Regulation 1907/2006; these data will already have
been submitted and assessed as part of the risk assessment required for
entry of the active substance into Schedule I to these regulations. Data
may also be required on a substance of concern present in a biocidal
product.
6. The results of the risk assessments carried out on an active substance
and on a substance of concern present in the biocidal product shall be
integrated to produce an overall assessment for the biocidal
product itself.
7. When making evaluations and taking decisions concerning the
authorisation of a biocidal product the Member State shall
(a) take into consideration other relevant technical or scientific
information which is reasonably available to them with regard to the
properties of the biocidal product, its components, metabolites, or
residues;
(b) evaluate, where relevant, justifications submitted by the applicant for
not supplying certain data.
8. The Member State shall comply with the requirements of mutual
recognition as stated in regulation 5(1), (2) and (6) of these
regulations.
9. It is known that many biocidal products present only minor differences
in composition and this should be taken into account when evaluating
dossiers. The concept of `frame-formulations' is relevant here.
10. It is known that certain biocidal products are considered as posing only a
low
risk, these biocidal products, while complying with the
requirements of this Schedule, are subject to a simplified procedure as
detailed in regulation 4 of these regulations.
11. The application of these common principles shall lead to the Member
State deciding whether or not a biocidal product can be authorised, such
authorisation may include restrictions on use or other conditions. In
certain cases the Member State may conclude that more data are
required before an authorisation decision can be made.
12. During the process of evaluation and decision-making, Member States
and applicants shall cooperate in order to resolve any questions on the
data requirements quickly or to identify at an early stage any
additional studies required, or to amend any proposed conditions for
the use of the biocidal product or to modify its nature or its composition
in order to ensure full compliance with the requirements of this
Schedule or of these regulations. The administrative burden,
especially for small and medium-sized enterprises (SMEs), shall be kept
to the minimum necessary without prejudicing the level of protection
afforded to humans, animals and the environment.
13. The judgments made by the Member State during the evaluation and
decision-making process must be based on scientific principles,
preferably recognised at international level, and be made with the benefit
of expert advice.
EVALUATION
General principles
14. The data submitted in support of an application for authorisation of a
biocidal product shall be examined for completeness and overall
scientific value by the receiving Member State. After acceptance of
these data the Member State shall utilise them by carrying out a risk
assessment based on the proposed use of the biocidal product.
15. A risk assessment on the active substance present in the biocidal
product shall always be carried out. If there are, in addition, any
substances of concern present in the biocidal product then a risk
assessment shall be carried out for each of these. The risk assessment
shall cover the proposed normal use of the biocidal product together
with a realistic worst-case scenario including any relevant production
and disposal issue either of the biocidal product itself or
any
material treated with it.
16. For each active substance and each substance of concern present in the
biocidal product, the risk assessment shall entail a hazard identification
and
the establishment of appropriate no-observed-adverse-effect
levels (NOAEL), where possible. It shall also include, as appropriate,
a dose (concentration) — response (effect) assessment, together with
an exposure assessment and a risk characterisation.
17. The results arrived at from a comparison of the exposure to the no-
effect level concentrations for each of the active substances and any
substances of concern shall be integrated to produce an overall risk
assessment for the biocidal product. Where quantitative results are not
available the results of the qualitative assessments shall be integrated
in a similar manner.
18. The risk assessment shall determine
(a) the risk to humans and animals,
(b) the risk to the environment,
(c) the measures necessary to protect humans, animals and the general
environment during both the proposed normal use of the biocidal
product and in a realistic worst-case situation.
19. In certain cases it may be concluded that further data are required before
a risk assessment can be finalised. Any such additional data requested
shall be the minimum necessary to complete such a risk assessment.
Effects on humans
20. The risk assessment shall take account of the following potential
effects arising from the use of the biocidal product and the populations
liable to exposure.
21. The effects previously mentioned result from the properties of the active
substance and any substance of concern present. They are
— acute and chronic toxicity,
— irritation,
— corrosivity,
— sensitisation,
— repeated dose toxicity,
— mutagenicity,
— carcinogenicity,
— reproduction toxicity,
— neurotoxicity,
— any other special properties of the active substance or substance of
concern,
— other effects due to physico-chemical properties.
22. The populations previously mentioned are
— professional users,
— non-professional users,
— humans exposed indirectly via the environment.
23. The hazard identification shall address the properties and potential
adverse effects of the active substance and any substances of
concern present in the biocidal product. If this results in the
biocidal product being classified according to the requirements of
regulation 21 of these Regulations then dose (concentration) —
response (effect) assessment, exposure assessment and
risk
characterisation shall be required.
24. In those cases where the test appropriate to hazard identification in
relation to a particular potential effect of an active substance or a
substance of concern present in a biocidal product has been
conducted but the results have not lead to classification of the
biocidal product then risk characterisation in relation to that effect shall
not be necessary unless there are other reasonable grounds for
concern, e.g. adverse environmental effects or unacceptable residues.
25. The Member State shall apply paragraphs 26 to 29 when carrying out a
dose (concentration) — response (effect) assessment on an active
substance or a substance of concern present in a biocidal product.
26. For repeated dose toxicity and reproductive toxicity the dose response
relationship shall be assessed for each active substance or substance of
concern and, where possible, the no-observed-adverse-effect level
(NOAEL) identified. If it is not possible to identify a NOAEL, the
lowest- observed-adverse-effect level (LOAEL) shall be identified.
27. For acute toxicity, corrosivity and irritation, it is not usually possible to
derive a NOAEL or LOAEL on the basis of tests conducted in
accordance
with the requirements of these Regulations. For acute
toxicity, the LD50 (median lethal dose) or LC50 (median lethal
concentration) value or, where the fixed dose procedure has been used,
the discriminating dose shall be derived. For the other effects it shall be
sufficient to determine whether the active substance or substance of
concern has an inherent capacity to cause such effects during use of the
product.
28. For mutagenicity and carcinogenicity it shall be sufficient to determine
whether the active substance or substance of concern has an inherent
capacity to cause such effects during use of the biocidal product.
However, if it can be demonstrated that an active substance or a
substance of concern identified as a carcinogen is non-genotoxic, it
will be appropriate to identify a N(L)OAEL as described in paragraph
26.
29. With respect to skin sensitisation and respiratory sensitisation, in so far
as there is no consensus on the possibility of identifying a
dose/concentration below which adverse effects are unlikely to occur
in a subject already sensitised to a given substance, it shall be
sufficient to evaluate whether the active substance or substance of
concern has an inherent capacity to cause such effects during use of
the biocidal product.
30. Where toxicity data derived from observations of human exposure, e.g.
information gained from manufacture, from poison centres or
epidemiology surveys, are available special consideration shall be given
to those data when carrying out the risk assessment.
31. An exposure assessment shall be carried out for each of the human
populations (professional users, non-professional users and humans
exposed indirectly via the environment) for which exposure to a
biocidal product occurs or can reasonably be foreseen. The objective
of the assessment shall be to make a quantitative or qualitative estimate
of the dose/concentration of each active substance or substance of
concern to which a population is, or may be exposed during use of the
biocidal product.
32. The exposure assessment shall be based on the information in the
technical dossier provided in conformity with regulation 9 of these
regulations and on any other available and relevant information.
Particular account shall be taken, as appropriate, of
— adequately measured exposure data,
— the form in which the product is marketed,
— the type of biocidal product,
— the application method and application rate,
— the physico-chemical properties of the product,
— the likely routes of exposure and potential for absorption,
— the frequency and duration of exposure,
— the type and size of specific exposed populations where such
information is available.
33. Where adequately measured, representative exposure data are available,
special consideration shall be given to them when conducting the
exposure assessment. Where calculation methods are used for the
estimation of exposure levels, adequate models shall be applied.
These models shall
— make a best possible estimation of all relevant processes taking into
account realistic parameters and assumptions,
— be subjected to an analysis taking into account possible elements of
uncertainty,
— be reliably validated with measurements carried out under
circumstances relevant for the use of the model,
— be relevant to the conditions in the area of use.
Relevant monitoring data from substances with analogous use and
exposure patterns or analogous properties shall also be considered.
34. Where, for any of the effects set out in paragraph 21 a NOAEL or
LOAEL had been identified, the risk characterisation shall entail
comparison of the NOAEL or LOAEL with the evaluation of the
dose/concentration to which the population will be exposed. Where
a NOAEL or LOAEL cannot be established a qualitative comparison
shall be made.
Effects on animals
35. Using the same relevant principles as described in the section dealing
with effects on humans, the Member State shall consider the risks posed
to animals from the biocidal product.
Effects on the environment
36. The risk assessment shall take account of any adverse effects arising in
any of the three environmental compartments — air, soil and water
(including sediment) — and of the biota following the use of the
biocidal product.
37. The hazard identification shall address the properties and potential
adverse effects of the active substance and any substances of
concern present in the biocidal product. If this results in the
biocidal product being classified according to the requirements of these
regulations then dose (concentration) — response (effect) assessment,
exposure assessment and risk characterisation shall be required.
38. In those cases where the test appropriate to hazard identification in
relation to a particular potential effect of an active substance or a
substance of concern present in a
biocidal
product
has
been
B
conducted but the results have not led to classification of the
biocidal product then risk characterisation in relation to that effect shall
not be necessary unless there are other reasonable grounds for concern.
Such grounds may derive from the properties and effects of any active
substance or substance of concern in the biocidal product, in particular
— any indications of bioaccumulation potential,
— the persistence characteristics,
— the shape of the toxicity/time curve in ecotoxicity testing,
— indications of other adverse effects on the basis of toxicity studies
(e.g. classification as a mutagen),
— data on structurally analogous substances,
— endocrine effects.
39. A dose (concentration) — response (effect) assessment shall be carried
out
in order to predict the concentration below which adverse
effects in the environmental compartment of concern are not expected
to occur. This shall be carried out for the active substance and for any
substance of concern present in the biocidal product. This
concentration is known as the predicted no-effect concentration
(PNEC). However, in some cases, it may not be possible to establish a
PNEC and a qualitative estimation of the dose (concentration) —
response (effect) then has to be made.
40. The PNEC shall be determined from the data on effects on organisms
and
ecotoxicity studies submitted in accordance with requirements
of regulation 9 of these regulations. It shall be calculated by applying
an assessment factor to the values resulting from tests on organisms,
e.g.LD50
(median
lethal
dose),
LC50
(median
lethal
concentration), EC50 (median
effective
concentration),
IC50
(concentration causing 50% inhibition of a given parameter, e.g.
growth), NOEL(C) (no-observed-effect level (concentration)), or
LOEL(C) (lowest-observed-effect level (concentration)).
During the period for which an authorisation has been
granted, it may be reviewed at any time, such as following
information received according to regulation 15 if there are
indications that any of the conditions referred to in regulation 6
are no longer satisfied. In such instances, the authorisation holder,
or the applicant to whom a modification of the authorisation has
been granted in accordance with regulation 8, may be required to
submit further information necessary for the review. If need be,
the authorisation may be prolonged only for the period necessary
to complete the review, but shall be prolonged for the period
necessary to provide for further information.
(1) An authorisation shall be cancelled if
(a) the active substance is no longer included in
Schedule I – Part A or Part B as required by regulation 6(1)
(a);
(b) the conditions within the meaning of regulation
6(1) for obtaining the authorisation are no longer satisfied;
(c) it is discovered that false or misleading particulars
were supplied concerning the facts on the basis of which the
authorisation was granted.
(2) An authorisation may also be cancelled if the
authorisation holder so requests and states the reasons for the
cancellation.
(3) When the Director intends to cancel an
authorisation, he shall inform and hear the authorization holder.
When cancelling the authorisation, a period of grace may be
granted for the disposal or for the storage, marketing and use
of existing stocks, of a length in accordance with the reason for
the cancellation without prejudice to any period provided for by
decision taken pursuant Regulation (EC) No 1907/2006 or in
connection with sub-regulation 8(1)(a).
(4) The conditions of use of an authorisation and, in
particular, the manner of use or the amounts used shall be modified
by the Director if necessary, on the basis of developments in
scientific and technical knowledge and to protect health and the
environment.
(5) An authorisation may also be modified if the
authorisation holder requests it and states the reasons for the
modification.
(6) Where a proposed modification concerns an
extension of uses, the Director shall extend the authorisation
subject to the particular conditions placed on the active substance
listed in Schedule I – Part A or Part B.
(7) Where a proposed modification of an authorisation
involves changes to the particular conditions placed on the active
substance listed in Schedule I – Part A or Part B, such changes can
be made only after evaluation of the active substance, with regard
to the proposed changes, in accordance with the procedures laid
down in regulation 12.
(8) Modifications shall be granted only if it is
established that the conditions within the meaning of regulation 6
remain satisfied.
(1) Application for an authorisation shall be made by,
or on behalf of, the person who will be responsible for the first
placing on the market of the biocidal product in Malta and shall
be to the competent authority of Malta. Every applicant shall be
required to have a permanent office within the Community.
(2) An applicant for authorisation of a biocidal product
shall submit to the Director
(a) a dossier or a letter of access for the biocidal
product satisfying, in the light of current scientific and
technical knowledge, the requirements set out in Schedule II
– Part B and, where specified, the relevant parts of Schedule
III – Part B, and
(b) for each active substance in the biocidal product, a
dossier or a letter of access satisfying, in the light of current
scientific and technical knowledge, the requirements set out
in Schedule II – Part A and, where specified, the relevant parts
of Schedule III – Part A.
(3) By way of derogating from sub-regulation 9(2)
(a), a dossier comprising the following data for a low-risk biocidal
product is required
(i) applicant
(1)
name and address,
(2) manufacturers of the biocidal product and
the active substances, (names and addresses including
location of manufacturer of the active substance),
(3) where appropriate, a letter of access to any
relevant data needed;
(ii) identity of the biocidal product
(1)
trade name,
(2)
full composition of the biocidal product,
(3) physical and chemical properties as referred
to in regulation 6(1)(d);
(iii)
intended uses
(1)
product type (Schedule V) and field of use,
(2)
category of users,
(3)
method of use;
(iv)
efficacy data;
(v) analytical methods;
(vi) classification, packaging and labelling, including a
draft label, according to regulation 21 of these regulations;
(vii) safety data sheet prepared in accordance
with regulation 17 of the Dangerous Substances and
Preparations Regulations, 2007 or Article 31 of Regulation
(EC)1907/2006.
(4) Dossiers shall include a detailed and full
description of the studies conducted and of the methods used or
a bibliographical reference to those methods. The information in
the dossiers supplied in accordance with regulation 9(2) shall be
sufficient for an evaluation to be made of the effects and properties
referred to in regulation 6(1)(b), (c) and (d). It shall be submitted
to the Director in the form of technical dossiers, containing the
information and results of the studies referred to in Schedules
II – Part A and Part B and, where specified, the relevant parts of
Schedules III – Part A and Part B.
(5) Information which is not necessary owing to the
nature of the biocidal product or of its proposed uses need not be
supplied. The same applies where it is not scientifically necessary
or technically possible to supply the information. In each such case,
a justification, acceptable to the Director must be submitted. Such
a justification may be existence of a frame-formulation which the
applicant has the right to access.
(6) If the evaluation of the dossier shows that further
information, including data and results from further testing, is
necessary to evaluate the risks of the biocidal product, the Director
shall ask the applicant to submit such information. The time period
for the evaluation of the dossier shall start only after the dossier is
complete.
(7) The name of an active substance must be given
as registered in the list contained in Schedule I to the Dangerous
Substances Regulations, 2008 or, if the name is not included L.N. 306 of 2008.
therein, as given in the European Inventory of Existing Chemical
Substances (Einecs), or, if the name is not included therein,
the active substance must be given its International Standards
Organisation (ISO) common name. If the latter is not available,
the substance must be designated by its chemical designation
according to International Union of Pure and Applied Chemistry
(IUPAC) rules.
(8) As a general principle, tests must be conducted
according to the methods described in Commission Regulation
(EC) 465/2008 and Commission Regulation (EC) 466/2008.
In the event of a method being inappropriate or not described,
other methods used should, whenever possible, be internationally
recognised and must be justified. Where appropriate, tests must
be conducted in accordance with the provisions laid down in
the Animal Experimentation Regulations, 2003 and in the Good
Laboratory Practice Regulations, 2004.
(9) Where test data exist that have been generated
before the adoption of these regulations by methods other than
those laid down in Commission Regulation (EC) 465/2008 and
Commission Regulation (EC) 466/2008, the adequacy of such
data for the purposes of these regulations and the need to conduct
new tests according to Schedule V must be decided on a case-by-
case basis, taking into account, among other factors, the need to
minimise testing on vertebrate animals.
(10) The Director shall ensure that a file is compiled
on each application. Each file shall contain at least a copy of
the application, a record of the administrative decisions taken by
the Member State concerning the application and concerning the
dossiers submitted in accordance with sub-regulation 9(2), together
with a summary of the latter. On request, the Director shall make
available to the other competent authorities and to the Commission
the files provided for in this sub-regulation; he shall supply to
them, on request, all information necessary for full comprehension
of applications and shall, where requested, ensure that applicants
provide a copy of the technical documentation laid down in sub-
regulation 9(2).
(11) Samples of the preparation and of its ingredients
may be required to be provided.
(12) Applications for authorisation may be submitted
either in English or in Maltese.
(1) Where a substance is an active substance for use in
biocidal products, it may not be placed on the market for such use
unless
(a) where the active substance was not on the market
before the 8th of March 2000, a dossier has been forwarded to
a Member State, which satisfies the requirements of regulation
12(1) and is accompanied by the declaration that the active
substance is intended for inclusion in a biocidal product. This
shall not apply to substances for use pursuant to regulation
18;
(b) it is classified, packaged and labelled in accordance
with the provisions of the Dangerous Substances Regulations,
2008.
(1) In view of current scientific and technical
knowledge, an active substance shall be included in Schedule I for
an initial period not exceeding 10 years if it may be expected that -
(a) biocidal products containing the active substance,
(b) low-risk biocidal products complying with the
definition “low-risk bicidal product” in regulation 3,
(c) commodity substances complying with the
definition “basic substance” in regulation 3, will fulfil the
conditions laid down in regulation 6(1)(b), (c) and (d), taking
into account, where relevant, cumulation effects from the use
of biocidal products containing the same active substances
Provided that an active substance cannot be included
in Schedule I – Part B if it is classified according to the
Dangerous Substances Regulations, 2008 as
(i) carcinogenic,
(ii) mutagenic,
(iii) toxic for reproduction,
(iv)
sensitising, or
(v)
is bioaccumulative and does not readily
degrade
Provided further that, where appropriate, the entry of
an active substance in Schedule I – Part A shall refer to the
concentration ranges between which the substance can be
used.
(2) Inclusion of an active substance in Schedule I
shall, where appropriate, be subject to the following
(a) requirements on
(i) the minimum degree of purity of the active
substance,
(ii) the nature and maximum content of certain
impurities,
(iii) product type in which it may be used,
(iv) manner and area of use,
(v) designation of categories of users, such as
industrial, professional or non-professional,
(vi) other particular conditions from the
evaluation of the information which has been made
available in the context of these regulations;
(b) the establishment of the following
(i) acceptable operator exposure level (AOEL), if
necessary,
(ii) where relevant, an acceptable daily intake for
man (ADI) and a maximum residue limit (MRL),
(iii) fate and behaviour in the environment and
impact on non-target organisms.
(3) The inclusion in Schedule I of an active substance
shall be restricted to those product types in Schedule V for which
relevant data have been submitted in accordance with regulation 9.
(4) The inclusion of an active substance in Schedule
I may be renewed on one or more occasions for periods not
exceeding 10 years. The initial inclusion, as well as any renewed
inclusion, may be reviewed at any time if there are indications
that any of the requirements referred to in regulation 11(1) are not
longer satisfied. Renewal may, where necessary, be granted only
for the minimum period necessary to complete a review, where an
application has been made for such renewal, and shall be granted
for the period necessary to provide further information requested in
accordance with regulation 12(2).
(5) (a) An entry of an active substance in Schedule
I – Part A and, where relevant, Part B or part C may be refused or
removed,
(i) if the evaluation of the active substance in
accordance with regulation 12(2) shows that, under normal
conditions under which it may be used in authorised biocidal
products, risks to health or the environment still give rise to
concern, and
(ii) if there is another active substance on Schedule
I – Part A for the same product type which, in the light of
scientific or technical knowledge, presents significantly less
risk to health or to the environment
Provided that when such a refusal or removal is
considered, an assessment of an alternative active substance or
substances shall take place to demonstrate that it can be used
with similar effect on the target organism without significant
economic and practical disadvantages for the user and without
an increased risk for health or for the environment.
(b) The refusal or removal of a Schedule I – Part A
and, where relevant, Part B or Part C entry shall be carried
out under the following conditions
(i) the chemical diversity of the active substances
should be adequate to minimise occurrence of resistance
in the target organism;
(ii) it should be applied only to active substances
which, when used under normal conditions in authorised
biocidal products, present a significantly different level
of risk;
(iii) it should be applied only to active substances
used in products of the same product type;
(iv) it should be applied only after allowing the
possibility, where necessary, of acquiring experience
from use in practice, if it is not already available;
(v) the complete data dossiers of the evaluation
serving or having served for entry in Schedule I shall be
put at the disposal of the committee referred to in Article
28(1) of Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market.
(c) A decision to remove a Schedule I – Part A entry
shall not have immediate effect but shall be delayed for a
period of up to a maximum of four years from the date of that
decision.
(1) Inclusion, or subsequent changes to the inclusion, Inclusion of an active
of an active substance in Schedule I shall be considered when
(a) an applicant has forwarded to the Director
(i) a dossier for the active substance satisfying
the requirements of Schedule IV – Part A or the
requirements of Schedule II – Part A and, where
specified, the relevant parts of Schedule III – Part A;
(ii) a dossier for at least one biocidal product
containing the active substance satisfying the
requirements of regulation 9, with the exception of sub-
regulation 12(3) thereof;
(b) the receiving Director has verified the dossiers and
is of the opinion that they satisfy the requirements of Schedule
IV – Part A and Schedule IV – Part B or the requirements of
Schedule II – Part A and Schedules II – Part B and, where
relevant, Schedules III – Part A and III – Part B, accepts them
and agrees to the applicant forwarding a summary of the
dossiers to the Commission and the other Member States.
(2) The receiving Director shall, within 12 months of
accepting the dossiers, carry out an evaluation thereof. A copy of
the evaluation shall be sent by the Director to the Commission,
the other Member States and to the applicant, together with a
recommendation for the inclusion, or otherwise, of the active
substance in Schedule I
Provided that if, when the dossiers are evaluated, it
appears that further information is necessary for full evaluation to
be made, the receiving Director shall ask that the applicant submit
such information. The 12-month period shall be suspended from the
date of issue of the Director’s request until the date the information
is received. The Director shall inform the other Member States and
the Commission of its action when it informs the applicant.
(1) The Director shall not make use of the information
referred to in regulation 9 for the benefit of a second or subsequent
applicant
(a) unless the second of subsequent applicant has the
written agreement in the form of a letter of access of the first
applicant that use may be made of such information, or
(b) in the case of an active substance not on the market
on the 8th of March 2000, for a period of 15 years from the
date of first inclusion in Schedule I – Part A or Part B, or
(c) in the case of an active substance already on the
market on the 8th of March 2000
(i) until 14 May 2014 for any information
submitted for the purposes of these Regulations, except
where such information is already protected under
existing national rules relating to biocidal products.
In such cases, the information shall continue to be
protected nationally until the expiry of any remaining
period of data protection provided for under national
rules, but not beyond 14 May 2014 or, if applicable, not
beyond the date to which the transitional period referred
to in regulation 17(1) is extended in accordance with
regulation 17(2);
(ii) for a period of 10 years from the date of entry
of an active substance onto Schedule I – Part A or Part
B for information submitted for the first time in support
of the first inclusion in Schedule I – Part A or Part B of
either the active substance or an additional product type
for that active substance,
(d) in the case of any further information submitted for
the first time for any of the following
(i) variation of the requirements of the entry on
Schedule I – Part A or Part B;
(ii) maintenance of the entry of Schedule I – Part
A or Part B
for a period of five years from the date of decision
following receipt of further information unless the five-
year period expires before the period provided for in
sub-regulation 13(1)(b) and (c), in which case the period
of five years shall be extended so as to expire on the
same date as those periods.
(2) The Director shall not make use of the information
referred to in regulation 9, for the benefit of a second or subsequent
applicant
(a) unless the second or subsequent applicant has the
written agreement in the form of a letter of access of the first
applicant that use may be made of such information; or
(b) in the case of a biocidal product containing an
active substance not on the market on the 8th of March 2000
for a period of 10 years from the date of first authorisation in
any Member State, or
(c) in the case of a biocidal product containing an
active substance already on the market on the 8th of March
2000;
(i) until 14 May 2014 for any information
submitted for the purposes of these regulations, except
in the case where data are already protected according
to existing national rules relating to biocidal products, in
which case such data shall be protected nationally until
the expiry of any remaining period of data protection
provided for under those national rules, but not beyond
14 May 2014 or, if applicable, not beyond the date to
which the transitional period referred to in regulation
17(1) is extended in accordance with regulation 17(2);
(ii) for a period of 10 years form the date of entry
of an active substance onto Schedule I – Part A or Part
B, for information which is submitted for the first time in
support of the inclusion in Schedule I – Part A or Part B
either of the active substance or of an additional product
type for that active substance;
(d) in the case of any data submitted for the first time
for either of the following
(i) variation of the conditions of authorization of
a biocidal product;
(ii) submission of data necessary to maintain
entry of an active substance onto Schedule I – Part
A or Part B for a period of five years from the date of
first receipt of further information, unless the five-year
period expires before the period in sub-regulations 13(2)
(b) and (c), in which case the period of five years shall
be extended so as to expire on the same date as those
periods.
(3) For decisions to be taken in accordance with
regulation 11(5), the information referred to in sub-regulations
13(1) and (2) can be used by the Commission, the Scientific
Committees as referred to in Article 27 of Directive 98/8/EC of
the European Parliament and of the Council of 16 February 1998
concerning the placing of biocidal products on the market and the
Member States.
(1) In the case of a biocidal product which has already
been authorised in accordance with regulations 4 and 6, and
without prejudice to the obligations imposed pursuant to regulation
13, the Director may agree that a second or subsequent applicant
for authorization may refer to data provided by the first applicant in
so far as the second or subsequent applicant can provide evidence
that the biocidal product is similar and its active substances are the
same as the one formerly authorised, including degree of purity
and nature of impurities.
(2)
Notwithstanding regulation 9(2)
(a) an applicant for authorisation of biocidal products
shall, before carrying out experiments involving vertebrate
animals, enquire of the Director
(i) whether the biocidal product for which an
application is to be made is similar to a biocidal product
for which authorisation has been granted, and
(ii) as to the name and address of the holder or
holders of the authorisation or authorisations.
Provided that the enquiry shall be supported by
evidence that the prospective applicant intends to apply
for authorisation on his own behalf and that the other
information specified in regulation 9(2) is available;
(b) the Director, if satisfied that the applicant intends
to apply, shall provide the name and address of the holder
or holders of former relevant authorisations and shall at the
time inform the holders of the authorisations of the name and
address of the applicant.
Provided that -
(i) the holder or holders of former authorisations
and the applicant shall take all reasonable steps to reach
agreement on the sharing of information, so as to avoid,
if possible, the duplication of testing on vertebrate
animals;
(ii) the Director shall encourage data-holders to
cooperate in the provision of the requested data, with a
view to limiting the duplication of testing on vertebrate
animals; and
(iii) if it is still not possible for the applicant
and holders of former authorizations of the same
product to reach an agreement on the sharing of data,
national measures may be introduced, obliging the
applicant and holders of former authorisations located
within their territory to share the data with a view to
avoiding duplicative testing on vertebrate animals and
determine both the procedure for utilizing information,
and the reasonable balance of the interests of the parties
concerned.
(1) The holder of an authorization for a biocidal
product shall immediately notify the Director of information of
which he or she is aware or of which he or she may reasonably
be expected to be aware concerning an active substance or a
biocidal product containing it and which may affect continuing
authorisation. In particular, the following shall be notified
(a) new knowledge or information on the effects of
the active substance or biocidal product for humans or the
environment,
(b) changes in the source or composition of the active
substance,
(c) changes in composition of a biocidal product,
(d) development of resistance,
(e) changes of an administrative nature or other
aspects, such as the nature of the packaging.
(2) The Director shall immediately notify other
Member States and the Commission of any such information they
receive concerning potentially harmful effects for humans or the
environment of the new composition of a biocidal product, its
active substances, impurities, co-formulants or residues.
(1) By way of derogating from regulations 4 and 6,
the placing on the market of biocidal products not complying with
the provisions of these regulations may be authorised temporarily
for a period not exceeding 120 days for a limited and controlled
use if such a measure appears necessary because of an unforseen
danger which cannot be contained by other means. In this case,
the Director concerned shall immediately inform the other Member
States and the Commission of its action and justification for it.
(2) By way of derogation from regulation 6(1)(a) and
until an active substance is listed in Schedule I – Part A or Part
B, the placing on the market of a biocidal product containing an
active substance not listed in Schedule I – Part A or Part B and not
yet available on the market on the 8th of March 2000 for purposes
other than those defined in regulation 3(2)(c) and (d) may be
authorised provisionally for a period not exceeding three years.
Such an authorisation may be issued only if, after dossiers have
been evaluated in accordance with regulation 12, it is believed that
(a) the active substance satisfies the requirements of
regulation 11, and,
(b) the biocidal product may be expected to satisfy the
conditions of regulations 6(1)(b), (c) and (d),
and no other Member State, on the basis of the summary
it receives, makes legitimate objection, in accordance with
regulation 19(2), to the completeness of the dossiers. Where
an objection is made, a decision on the completeness of
dossiers shall be taken in accordance with the procedure
laid down in Article 28(2) of Directive 98/8/EC of the
European Parliament and of the Council of 16 February 1998
concerning the placing of biocidal products on the market
without undue delay
Provided that -
(a) if, following the procedures laid down in Articles
27 and 28(2) of Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market, it is decided
that the active substance does not satisfy the requirements
specified in regulation 11, the Director shall ensure that the
provisional authorisation is cancelled;
(b) in cases where evaluation of dossiers for the
purposes of inclusion of an active substance in Schedule I –
Part A or Part B is not completed when the period of three
years expires, the Director may further provisionally authorise
the product for a period not exceeding one year, providing
there are good reasons to believe the active substance will
satisfy the requirements of regulation 11.
(1) By way of further derogating from regulations
4(1), 6(1), 9(2) and 9(4), and without prejudice to sub-regulations
17(3), the Director may, until 14 May 2014, continue to apply
its current system or practice of placing biocidal products on the
market. If a decision to include an active substance in Schedule I
or I – Part A sets a later date for compliance with regulation 17(3)
than 14 May 2014, this derogation shall continue to apply for
products including that active substance until the date set in that
decision. The Director may, authorise the placing on the market in
its territory of a biocidal products containing active substances not
listed in Schedule I – Part A or Part B for that product type. Such
active substances must be on the market on the 8th of March 2000
as active substances of a biocidal product for purposes other than
those defined in regulation 3(2)(c) and (d).
(2) Following such a decision to include or not to
include an active substance in Schedule I, the Director shall ensure
that authorisations or, where relevant, registrations for biocidal
products containing the active substances and complying with the
provisions of these Regulations are granted, modified or cancelled
as appropriate.
(1) By way of derogation from regulation 4, any
experiment or test for the purposes of research or development
involving the placing on the market of an unauthorised biocidal
product or an active substance intended exclusively for use in a
biocidal product shall not take place unless
(a) in the case of scientific research and development,
the persons concerned draw up and maintain written records
detailing the identity of the biocidal product or active
substance, labelling data, quantities supplied and the names
and addresses of those persons receiving the biocidal product
or active substance and compile a dossier containing all
available data on possible effects on human or animal health
or impact on the environment. This information shall, if
requested, be made available to the Director;
(b) in the case of process-oriented research and
development, the information required in regulation 18(1)(a)
is notified to the Director before placing on the market occurs
and where the experiment or test is to be conducted.
(2) Unauthorised biocidal products or an active
substance for exclusive use in a biocidal product may not be placed
on the market for the purpose of any experiment or test which
may involve, or result in, release into the environment unless the
Director has assessed the available data and issued an authorisation
for this purpose which limits the quantities to be used and the areas
to be treated and may impose further conditions.
(3) Where any experiment or test takes place in a
Member State other than in Malta, the applicant shall obtain
experiments or tests authorisation from the competent authority of
the Member State in the territory of which the experiments or tests
are to be conducted
Provided that if the proposed experiments or tests
referred to in regulation 18(1) and (2) are liable to have harmful
effects on human or animal health or to have an unacceptable
adverse influence on the environment, the Director may either
prohibit them or only allow them subject to such conditions as it
considers necessary to prevent those consequences.
(4) Regulation 18(2) shall not apply if the Director
has granted the person concerned the right to undertake certain
experiments and tests and has determined the conditions under
which the experiments and tests have to be undertaken.
(5) Common conditions for the application of
regulation 18, in particular the maximum quantities of active
substances or biocidal products that may be released during
experiments and the minimum data to be submitted in order to
permit an assessment in accordance with regulation 18(2), shall
be adopted. Those measures, designed to amend non-essential
elements of these Regulations by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 28(4) of Directive 98/8/EC of the European
Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market.
(1) Within a period of one month from the end of each Information exchange.
quarter, the Director shall inform other Member States and the
Commission of any biocidal products which have been authorised
or registered within their territory or for which an authorization
or registration has been refused, modified, renewed or cancelled,
indicating at least
(a) the name or business name of the applicant for, or
the holder of, the authorization or registration;
(b) the trade name of the biocidal product;
(c) the name and amount of each active substance
which it contains, as well as the name and amount of each
dangerous substance in the meaning of regulation 3(2) of
the Dangerous Substances Regulations, 2008 and their
classification;
(d) the product-type and the use or uses for which it is
authorised;
(e) the type of formulation;
(f) any proposed limits on residues which have been
established;
(g) conditions of the authorisation and where relevant,
the reasons for the modification or cancellation of an
authorisation;
(h) an indication of whether the product is of a special
type, such as within a frame-formulation, low risk biocidal
product.
(2) Where a Director receives a summary of the
dossiers in accordance with regulations 12(1)(b) and 16(2) and has
legitimate reason to believe the dossiers are incomplete, it shall
immediately communicate its concerns to the competent authority
responsible for the evaluation of the dossiers and shall without
undue delay inform the Commission and other Member States of
its concerns.
(3) The Director shall draw up an annual list of
the biocidal products authorised or registered in its territory and
shall communicate that list to the other Member States and the
Commission.
(4) In accordance with the procedure laid down in
Article 28(2) of Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing of
biocidal products on the market, a standardised information system
shall be set up to facilitate the application of regulations 19(1) and
(2).
(1) Without prejudice to the Freedom of Access to Confidentiality.
Information on the Environment Regulations, 2005, an applicant L.N. 116 of 2005.
may indicate to the Director the information which he considers
to be commercially sensitive and disclosure of which might harm
him industrially or commercially and which he therefore wishes
to be kept confidential from all persons other than the competent
authorities and the Commission. Full justification will be required
in each case. Without prejudice to the information referred to in
regulation 20(3) and the provisions of the Dangerous Substances
Regulations, 2008 and the Dangerous Substances and Preparations L.N. 306 of 2008.
Regulations, 2007 the Director shall take the necessary steps to L.N. 10 of 2007.
ensure the confidentiality of the full composition of product
formulations if requested by the applicant.
(2) The Director shall decide, on the basis of
documentary evidence produced by the applicant, which
information shall be confidential within the terms of regulation 20
(1)
Provided that information accepted as being confidential
by the Director shall be treated as being confidential by the other
competent authorities, Member States and the Commission.
(3) After the authorisation has been granted,
confidentiality shall not in any case apply to
(a) the name and address of the applicant;
(b) the name and address of the biocidal product
manufacturer;
(c) the name and address of the active substance
manufacturer;
(d) the names and content of the active substance
or substances in the biocidal product and the name of the
biocidal product;
(e) the names of other substances which are regarded
as dangerous within the meaning of the Dangerous Substances
Preparations, 2008 and contribute to the classification of the
product;
(f) physical and chemical data concerning the active
substance and biocidal product;
(g) any ways of rendering the active substance or
biocidal product harmless;
(h) a summary of the results of the tests required
pursuant to regulation 9 to establish the substance’s or
product’s efficacy and effects on humans, animals and the
environment and, where applicable, its ability to promote
resistance;
(i) recommended methods and precautions to reduce
dangers from handling, storage, transport and use as well as
from fire or other hazards;
(j) safety data sheets;
(k)
methods of analysis referred to in regulation 6(1)
(l) methods of disposal of the product and of its
packaging;
(m) procedures to be followed and measures to be
taken in the case of spillage or leakage;
(n) first aid and medical advice to be given in the case
of injury to persons
Provided that the Director shall be informed if the
applicant or manufacturer or importer of the biocidal
product or active substance should later disclose previously
confidential information.
(4) The detailed provisions and format for making
information publicly available and for implementing regulation
20 shall be decided in accordance with the procedures set out in
Article 28(2) of Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing of
biocidal products on the market.
(1) Biocidal products shall be classified in accordance
with the provisions relating to classification in the Dangerous
Substances and Preparations Regulations, 2007.
(2) Biocidal products shall be packaged in accordance
with regulation 12 of the Dangerous Substances and Preparations
Regulations, 2007. In addition
(a) products which may be mistaken for food, drink or
feedingstuff shall be packaged to minimize the likelihood of
such a mistake being made;
(b) products available to the general public which
may be mistaken for food, drink or feedingstuff shall contain
components to discourage their consumption.
(3) Biocidal products shall be labelled in accordance
with the provisions relating to labelling in the Dangerous
Substances and Preparations Regulations, 2007. Labels shall not L.N. 10 of 2007.
be misleading or give an exaggerated impression of the product
and, in any case, not mention the indications ‘low-risk biocidal
product’, ‘non-toxic’, ‘harmless’ or similar indications. In addition,
the label must show clearly and indelibly the following
(a) the identity of every active substance and its
concentration in metric units;
(b) the authorisation number allocated to the biocidal
product by the Director;
(c) the type of preparation, such as liquid concentrates,
granules, powders, solids;
(d) the uses for which the biocidal product is
authorised, such as wood preservation, disinfection, surface
biocide, anti-fouling;
(e) directions for use and the dose rate, expressed in
metric units, for each use provided for under the terms of the
authorisation;
(f) particulars of likely direct or indirect adverse side
effects and any directions for first aid;
(g) if accompanied by a leaflet, the sentence ‘Read
attached instructions before use’;
(h) directions for safe disposal of the biocidal product
and its packaging, including, where relevant, any prohibition
on reuse of packaging;
(i) the formulation batch number or designation and
the expiry date relevant to normal conditions of storage;
(j) the period of time needed for the biocidal effect,
the interval to be observed between applications of the
biocidal product or between application and the next use of
the product treated, or the next access by man or animals to
the area where the biocidal product has been used, including
particulars concerning decontamination means and measures
and duration of necessary ventilation of treated areas;
particulars for adequate cleaning of equipment; particulars
concerning precautionary measures during use, storage and
transport (e.g. personal protective clothing and equipment,
measures for protection against fire, covering of furniture,
removal of food and feedingstuff and directions to prevent
animals from being exposed);
and where applicable
(k) the categories of users to which the biocidal
product is restricted;
(l) information on any specific danger to the
environment particularly concerning protection of non-target
organisms and avoidance of contamination of water;
(m) for microbiological biocidal products, labelling
requirements according to the Protection of Workers from
Risks related to Exposure to Biological Agents at Work
Regulations, 2003
Provided that the definition terms:-
(a) items of sub-regulation 3(a), (b), (d) and where
applicable (g) and (k) shall always be required to be carried
on the label of the product;
(b) the Director shall permit the definition terms of
items of sub-regulation 3(c), (e), (f), (h), (i), (j) and (l) to be
carried elsewhere on the packaging or on an accompanying
leaflet integral to the packaging. These items of information
shall be regarded as label information for the purposes of
these regulations.
(4) Where a biocidal product identified as insecticide,
acaricide, rodenticide, avicide or molluscicide is authorised
pursuant to this regulation and is also subject to classification,
packaging and labeling according to the Dangerous Substances
and Preparations Regulations, 2007 by virtue of other Community L.N. 10 of 2007.
provisions, changes shall be permitted to the packaging and
labelling of that product which may be required as a consequence
of those provisions in so far as they do not conflict with the
conditions of an authorisation issued under these regulations.
(5) Provision of samples, models or drafts of the
packaging, labelling and leaflets may be required and shall be
submitted upon request from the Director.
(6) Labelling of the biocidal products on the market
shall be in English and Maltese. Giving justifiable reasons and
depending on the product type, the Director may give permission
in writing for the labelling to be in only one language, either in
English or Maltese.
(7) The label shall be resistant to exposure to normal
conditions of storage, handling and use and shall ensure that its
contents shall remain clear and legible throughout the expected
product shelf-life.
(1) The Director shall take the necessary measures to Safety-data sheets.
ensure that a system of specific information is established to enable
professional and industrial users and, as appropriate, other users of
biocidal products to take the necessary measures for the protection
of the environment and health as well as helath and safety at the
workplace. This shall be done in the form of a safety-data sheet
provided by those responsible for the placing on the market of the
product.
Provided that the safety-data-sheets shall be prepared
(a) for biocidal products classified as dangerous
and in accordance with regulation 17 of the the Dangerous
Substances and Preparations Regulations, 2007, and
(b) for active substancess used exclusively in biocidal
products in accordance with the requirements of Article 31 of
Regulation (EC)1907/2006.
(1) Every advertisement for a biocidal product shall be
accompanied by the sentences ‘Use biocides safely. Always read
the label and product information before use’.
(2) The sentences shall be clearly distinguishable
in relation to the whole advertisement. The word ‘Biocides’
in the prescribed sentences may be replaced with an accurate
description of the product-type being advertised, for example wood
preservatives, disinfectants, surface biocides, and anti-fouling
products.
(3) Advertisements for biocidal products shall not
refer to the product in a manner which is misleading in respect of
the risks from the product to man or the environment. Under no
circumstances may the advertising of a biocidal product mention
‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar
indications.
(1) (a) The Malta Standards Authority shall be
responsible for receiving information on biocidal products which
have been placed on the market, including information on the
chemical composition of such products, and for making such
information available in cases where suspected poisoning arises
from biocidal products. Such information may only be used to
meet any medical demand by formulating preventive and curative
measures, in particular in emergencies. The Director shall ensure
that the information is not used for other purposes.
(b) The Director shall take the necessary steps to
ensure that the appointed bodies provide all the requisite
guarantees for maintaining the confidentiality of the
information received. The Director shall ensure that the
appointed bodies have at their disposal all the information
required to carry out the tasks for which they are responsible
form the manufacturers or persons responsible for marketing.
(c) For biocidal products already on the market on
the 8th of March 2000, the Director shall take measures to
comply with regulation 24 within three years of the 8th of
March 2000.
(1) (a) The Director shall take the necessary
arrangements for biocidal products which have been placed on the
market to be monitored to establish whether they comply with the
requirements of these regulations.
(b) Every three years after the 8th of March 2000, the
Director shall forward to the Commission by 30 November of
the third year a report on their action in these matters together
with information on any poisonings involving biocidal products.
(1) The Director shall establish systems obliging those
having placed or seeking to place biocidal products on the market
and those supporting entries for active substances on Schedule I
to pay charges, corresponding as far as possible to their costs in
carrying out all the different procedures associated with the
provisions of these regulations.
(1) The Malta Standards Authority shall be the
competent authority within the meaning of these regulations.
(1) Measures necessary to adapt Schedules II – Civil and criminal
Part A, II – Part B, III – Part A, III – Part B, IV – Part A or IV liability.
– Part B or the descriptions of product types in Schedule V to
technical progress or to specify data requirements for each of
these product types shall be adopted. Those measures, designed
to amend non-essential elements of these Regulations, inter alia,
by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 28(4) of
Directive 98/8/EC of the European Parliament and of the Council
of 16 February 1998 concerning the placing of biocidal products
on the market.
(1) The granting of authorisation and all other Adaptation to
measures in conformity with these Regulations shall be without technical progress.
prejudice to general civil and criminal liability in the Member
States of the manufacturer and, where applicable, of the person
responsible for placing the biocidal product on the market or using
it. The sanctions applicable for infringement of the provision
of these regulations shall be those provided for in Part 9 of the Cap. 430.
Pesticides Control Act.
(1) Where the Director has valid reasons to consider
that a biocidal product which was authorised, registered or is bound
to authorise or register pursuant to regulations 4 or 5, constitutes an
unacceptable risk to human or animal health or the environment,
it may provisionally restrict or prohibit the use or sale of that
product on its territory. The director shall immediately inform
the Commission and the other Member States of such action and
give reasons for its decision. A decision shall then be taken on the
matter within 90 days in accordance with the procedure laid down
in Article 28(3) of Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing of
biocidal products on the market.
(1)
No person shall deal in any
(a) active substance unless this is authorized in
accordance with these regulations;
(b) biocidal product unless this is authorized for
placing on the market in Malta in accordance with these
regulations.
(2) No person shall deal in any active substance or
biocidal product unless he is in possession of an authorisation to
deal in active substances or biocidal products granted to him in
accordance with regulation 32 of these regulations.
(1) Any application for the granting of an authorisation
to deal in biocidal products or active substances shall be made in
writing to the Director and shall contain such information, and
accompanied by such documents, samples and other material as the
director may require.
(2) Any application shall contain as a minimum the
following requirements
(a) the nature of any activity related to the dealing of
active substances and biocidal products the applicant wishes
to undertake;
(b) the place where such activity is to take place, and
suitable information, documentation and evidence as may
be required in order to show that such place is suitable and
sufficient for that purpose;
(c) evidence to show that the place where such activity
is to take place has the necessary equipment and control
facilities as may be required by the director;
(d) evidence to show that the health and safety of staff
shall be protected and ensured at all times;
(e) the name and postal address and any other contact
details of the applicant;
(f) the name of the person who will be effectively
responsible for carrying out the activity, in the case of an
application for the manufacture of a biocidal product, the
name of the biocidal product and any formulation which is to
be, or intended to be manufactured, assembled or in any way
modified including details of the type and concentration of
any active substance to be found within the formulation.
(3) The Director shall determine the application within
a reasonable period of time, not exceeding 45 working days from
the date of receipt of an application
Provided that this time limit can be suspended until all
relevant information is submitted.
(4) Where an application has been made to the Director
for the granting of an authorisation to deal in accordance with this
regulation, the Director may, before determining the application,
request the applicant to submit such further information relating
to the application as he may consider requisite and where any such
request has been made, the provision of regulation 32(5) of this
regulation shall be suspended until the additional information, has
been submitted.
(5) Any authorisation issued in accordance with this
regulation shall be made in writing and be subject to any such
condition the Director may deem necessary so that the business of
dealing shall be carried out in accordance with the provisions made
by or under the Act.
(1) Any authorisation issued by the Director in
accordance with regulation 32 of these regulations shall be valid
for such a period not exceeding three years as may be specified in
the authorisation
Provided that the Director may extend the validity of
any such authorisation upon the submission of an application for
its renewal of the authorisation submitted to him in accordance
with regulation 36 of these regulations and if he is satisfied that the
conditions established by regulation 32 of these regulations are still
being complied with.
(1) Without prejudice to regulation 35 of these
regulations, and if the Director suspects that any of the conditions
established by regulation 31 of these regulations is no longer
satisfied, the Director
(a) shall require the applicant for authorisation or
the holder of the authorisation to submit further information
necessary to establish compliance with the provisions of
regulation 32 of these regulations or such other information
as may be reasonably required;
(b) may carry out any inspection, review or test that he
deems necessary;
(c) may suspend the authorisation in accordance with
regulation 35 of these regulations.
(1) Any authorisation issued in accordance with
regulation 31 of these regulations may be suspended or revoked by
the Director if it is established that
(a) any information or particular supporting the
application for an authorisation was incorrect, false or
misleading; or
(b) any requirement as detailed in regulation 31 of
these regulations is no longer satisfied; or
(c) the applicant for authorisation requests that the
Director revokes the authorisation to deal in biocidal products
or active substances; or
(d) if the activity is being carried out in contravention
to any provision made by or under the Act.
(2) Where the Director suspends or revokes an
authorisation, he shall notify the holder of the authorisation in
writing of such suspension or revocation also providing reasons on
which such a decision was based.
On the expiry of an authorisation, the Director shall
renew the authorisation if
(a) he has received an application for renewal in such
form and in such manner and within such time as the Director
may, from time to time require;
(b) he is satisfied that the conditions detailed in
regulation 32 of these regulations are still being complied
with
Provided that the Director may request the applicant
for any additional information he may deem necessary prior to the
renewal or otherwise of the authorisation
Provided further that any renewal of any authorisation
may be subject to any such as the director may deem appropriate.
(1) Without prejudice to the provisions of regulation
34 of these regulations, the Director may, upon the written request
of the holder of the authorisation, modify an authorisation to
carry out a dealing activity if the Director is satisfied that such
modification is justified and appropriate, and where relevant,
reflects current scientific opinion.
(2) Without prejudice to regulation 35 of these
regulations, the Director may modify the original authorisation
if he considers that any condition on which the authorisation was
based in accordance with regulation 31 of these regulations has
been substantially altered.
(3) Any request for a modification to the authorisation
in accordance with sub-regulation (1) of this regulation shall be
made by the holder of the authorisation in such form and in such
manner and within such a time as the Director may, from time to
time require.
.
(1) Without prejudice to any other provision made
by or under the Act, it shall be the duty of any person holding an
authorization granted to him in accordance with regulation 32 of
these regulations to
(a) keep such records in such manner as the Director
may from time to time establish
Provided that the Director may establish different
records to be kept for different types of dealing activities;
(b) inform the Director, as soon as practicable and in
writing, of any change in any information provided to the
Director for the granting of the authorisation;
(c) allow the Director or his authorised representative
access to the land or premises where dealing is carried out at
any reasonable time;
(d) make available to the Director or his authorized
representative such records that he may require; and
(e)
comply with the provisions made by or under the
Act.
(2) To the extent that may be applicable a person
holding an authorisation under regulation 31 of these regulations
shall exercise general supervision over his employees and shall,
before requiring or permitting any of such employees to handle or
to apply any biocidal product
(a) provide such employees with proper training in the
safe handling and application of biocides;
(b) ensure that any safety precaution set out in the
label, or otherwise prescribed, is understood and complied
with; and
(c) ensure that such workers wear suitable protective
clothing provided by him.
(3) Where a person holding an authorisation of
biocidal products has even the slightest suspicion that any biocidal
product has caused any poisoning, he shall immediately notify the
appropriate health authority.
(1) Any person authorised to deal in biocidal products
shall notify the Director of any consignment of any authorised
biocidal product or active substance the person shall bring into
Malta.
(2) The information supplied in relation to a biocidal
product or active substance shall as a minimum include the
following information
(a) the name of the product and the batch number;
(b) the authorisation number;
(c) the country of origin;
(d) the quantity of the consignment; and
(e) the date and place of bringing into Malta.
(3) The Import Licence shall be submitted to the
Director for approval at least one week before importation of
biocidal products together with other documents that deem
necessary.
The Biocides Regulations, 2004 are hereby revoked.
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An assessment factor is an expression of the degree of uncertainty in
extrapolation from test data on a limited number of species to the real
environment. Therefore, in general, the more extensive the data and
the longer the duration of the tests, the smaller is the degree of
uncertainty and the size of the assessment factor.
The specifications for the assessment factors shall be elaborated in the
notes for technical guidance which, to this end, shall be based
particularly on the indications given in Subsidiary Legislation
427.15 – Legal Notice 40 of 2002 Dangerous Substances (Risk
Assessment) Regulations.
For each environmental compartment an exposure assessment shall be
carried out in order to predict the concentration likely to be found of
each active substance or substance of concern present in the biocidal
product. This concentration is known as the predicted
environmental concentration (PEC). However in some cases it may not
be possible to establish a PEC and a qualitative estimate of exposure
then has to be made.
A PEC, or where necessary a qualitative estimate of exposure, need
only be determined for the environmental compartments to which
emissions, discharges, disposal or distributions including any
relevant contribution from material treated with biocidal products are
known or are reasonably foreseeable.
The PEC, or qualitative estimation of exposure, shall be determined
taking account of, in particular, and if appropriate
— adequately measured exposure data,
— the form in which the product is marketed,
— the type of biocidal product,
— the application method and application rate,
— the physico-chemical properties,
— breakdown/transformation products,
— likely pathways to environmental compartments and potential for
adsorption/desorption and degradation,
— the frequency and duration of exposure.
Where adequately measured, representative exposure data are
available, special consideration shall be given to them when
conducting the exposure assessment. Where calculation methods are
used for the estimation of exposure levels, adequate models shall be
applied. The characteristics of these models shall be as listed in
paragraph 33. Where appropriate, on a case-by-case basis, relevant
B
monitoring data from substances with analogous use and exposure
patterns or analogous properties should also be considered.
For any given environmental compartment, the risk characterisation
shall, as far as possible, entail comparison of the PEC with the PNEC
so that a PEC/PNEC ratio may be derived.
If it has not been possible to derive a PEC/PNEC ratio, the risk
characterisation shall entail a qualitative evaluation of the likelihood
that an effect is occurring under the current conditions of exposure or
will occur under the expected conditions of exposure.
Unacceptable effects
Data shall be submitted to and evaluated by the Member State to assess
whether the biocidal product does not cause unnecessary suffering in
its effect on target vertebrates. This shall include an evaluation of the
mechanism by which the effect is obtained and the observed
effects on the behaviour and health of the target vertebrates; where the
intended effect is to kill the target vertebrate the time necessary to
obtain the death of the target vertebrate and the conditions under
which death occurs shall be evaluated.
The Member State shall, where relevant, evaluate the possibility of the
development of resistance to an active substance in the biocidal product
by the target organism.
If there are indications that any other unacceptable effects may occur the
Member State shall evaluate the possibility of such effects occurring.
An example of such an unacceptable effect would be an adverse reaction
to fastenings and fittings used in wood following the application of a
wood preservative.
Efficacy
Data shall be submitted and evaluated to ascertain if the efficacy claims
of the biocidal product can be substantiated. Data submitted by the
applicant or held by the Member State must be able to demonstrate the
efficacy of the biocidal product against the target organism when used
normally in accordance with the conditions of authorisation.
Testing should be carried out according to Community guidelines if
these are available and applicable. Where appropriate, other methods can
be used as shown in the list below. If relevant acceptable field data exist,
these can be used.
— ISO, CEN or other international standard method
— national standard method
— industry standard method (accepted by Member State)
— individual producer standard method (accepted by Member State)
— data from the actual development of the biocidal product (accepted
by Member State).
Summary
In each of the areas where risk assessments have been carried out, i.e.
effects on man, animals, and the environment, the Member State shall
combine the results for the active substance together with the results for
any substance of concern to produce an overall assessment for the
biocidal product itself. This should take account of any likely
synergistic effects of the active substance(s) and substances of
concern in the biocidal product.
For biocidal products containing more than one active substance any
adverse effects shall also be combined to produce an overall
effect for the biocidal product itself.
DECISION MAKING
General principles
Subject to paragraph 96, the Member State shall come to a decision
regarding the authorisation for use of a biocidal product as a result of
the integration of the risks arising from each active substance together
with the risks from each substance of concern present in the biocidal
product. The risk assessments shall cover normal use of the biocidal
product together with a realistic worst-case scenario including any
relevant disposal issue either of the biocidal product itself or any
material treated with it.
In making a decision concerning authorisation, the Member State shall
arrive at one of the following conclusions for each product type and for
B
each area of use of the biocidal product for which application has been
made
1. the biocidal product cannot be authorised;
2. the biocidal product can be authorised subject to specific
conditions/restrictions;
3. more data is required before a decision on authorisation can be made.
If the conclusion arrived at by the Member State is that additional
information or data are required before an authorisation decision can be
made, then the need for any such information or data shall be justified.
This additional information or data shall be the minimum necessary to
carry out a further appropriate risk assessment.
The Member State shall comply with the principles of mutual
recognition as detailed in regulation 4 of these Regulations.
The Member State shall apply the rules concerning the concept of
`frame formulations' when making an authorisation decision on a
biocidal product.
The Member State shall apply the rules concerning the concept of `low
risk' products when making an authorisation decision on such a
biocidal product.
The Member State shall only grant authorisation to those biocidal
products which, when used according to their conditions of
authorisation, do not present an unacceptable risk to humans, animals
or the environment, are efficacious and which contain active
substances permitted at Community level to be used in such biocidal
products.
The Member State shall impose, where appropriate, conditions or
restrictions when giving authorisations. The nature and severity of these
shall be selected on the basis of, and be appropriate to, the nature and
extent of the expected advantages and the risks likely to
arise from
the use of the biocidal product.
In the decision-making process the Member State shall take into
consideration the following
— the results of the risk assessment, in particular the relationship
between exposure and effect,
— the nature and severity of the effect,
— the risk management which can be applied,
— the field of use of the biocidal product,
— the efficacy of the biocidal product,
— the physical properties of the biocidal product,
— the benefits of using the biocidal product.
The Member State shall, when taking a decision concerning the
authorisation of a biocidal product, take into account the uncertainty
arising from the variability in the data used in the evaluation and
decision-making process.
The Member State shall prescribe that biocidal products shall be used
properly. Proper use shall include application at an efficacious dose
and minimisation of use of biocidal products where possible.
The Member State shall take the necessary measures to ensure that the
applicant proposes a label, and, where relevant, the safety-data
sheet, for the biocidal product which
— fulfils the requirements of regulation 19 and 20 of these Regulations,
— contains the information on the protection of users required by
Community legislation on worker protection,
— specifies in particular the conditions or restrictions under which the
biocidal product may or may not be used.
Before issuing an authorisation the Member State shall confirm that
these requirements must be satisfied.
The Member State shall take the necessary measures to ensure that the
applicant proposes packaging and, where appropriate, the procedures for
destruction or decontamination of the biocidal product and its packaging
or any other relevant material associated with the biocidal product,
which conforms to the relevant regulatory provisions.
Effects on humans
B
The Member State shall not authorise a biocidal product if the risk
assessment confirms that, in foreseeable application including a
realistic worst possible scenario, the product presents an
unacceptable
risk to humans.
The Member State shall consider possible effects on all human
populations, namely professional users, non-professional users and
humans exposed directly or indirectly through the environment
when
making a decision on the authorisation of a biocidal product.
The Member State shall examine the relationship between the exposure
and the effect, and use this in the decision-making process. A number
of factors need to be considered when examining this relationship and
one of the most important is the nature of the adverse effect of the
substance. These effects include acute toxicity, irritancy, corrosivity,
sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity,
neurotoxicity, reproduction toxicity together with physico-chemical
properties, and any other adverse properties of the
active
substance or substance of concern.
The Member State shall, where possible, compare the results obtained
with those obtained from previous risk assessments for an identical
or similar adverse effect and decide on an appropriate margin of
safety (MOS) when making an authorisation decision.
An appropriate MOS is typically 100 but an MOS higher or lower than
this may be appropriate depending on, among other things, the nature
of the critical toxicological effect.
The Member State shall, if appropriate, impose, as a condition of
authorisation, the wearing of personal protective equipment such as
respirators, breathing-masks, overalls, gloves and goggles in order to
reduce exposure for professional operators. Such equipment must be
readily available to them.
If for non-professional users the wearing of personal protective
equipment would be the only possible method for reducing exposure,
the product shall not normally be authorised.
If the relationship between the exposure and the effect cannot be
reduced to an acceptable level then no authorisation can be given by
the Member State for the biocidal product.
No biocidal product classified according to regulation 21(1) of these
regulations as toxic, very toxic or as a category 1 or 2 carcinogen, or as a
category 1 or 2 mutagen, or classified as toxic for reproduction category
1 or 2, shall be authorised for use by the general public.
Effects on animals
The Member State shall not authorise a biocidal product if the risk
assessment confirms that, in normal use, the biocidal product presents
an unacceptable risk to non-target animals.
Using the same relevant criteria as described in the section dealing with
effects on humans, the MemberState shall consider the risks posed to
animals from the biocidal product when making an authorisation
decision.
Effects on the environment
The Member State shall not authorise a biocidal product if the risk
assessment confirms that the active substance, or any substance of
concern, or any degradation, or reaction product presents an
unacceptable risk in any of the environmental compartments, water
(including sediment), soil and air. This shall include the assessment of
risks to non-target organisms in these compartments.
In considering whether there is an unacceptable risk Member States
shall, when coming to a final decision in accordance with paragraph
96, take into account the criteria in paragraphs 81 to 91.
The basic tool used in the decision making is the PEC/PNEC ratio or, if
this is not available, a qualitative estimation. Due consideration shall be
given to the accuracy of this ratio due to variability in the data used both
in measurements of concentration and of estimation.
In the determination of the PEC the most appropriate model should be
used taking into account the environmental fate and behaviour of the
biocidal product.
For any given environmental compartment if the PEC/PNEC ratio is
equal to or less than 1 the risk characterisation shall be that no
further information and/or testing are necessary.
If the PEC/PNEC ratio is greater than 1 the Member State shall judge,
on the basis of the size of that ratio and on other relevant factors, if
further information and/or testing are required to clarify the concern or
if risk reduction measures are necessary or if the product cannot be
B
given an authorisation at all. Relevant factors to be considered are those
previously mentioned in paragraph 38.
Water
The Member State shall not authorise a biocidal product, if under the
proposed conditions of use, the foreseeable concentration of the active
substance or of any other substance of concern or of relevant
metabolites or breakdown or reaction products in water (or its
sediments) has an unacceptable impact on non-target species in the
aquatic, marine or estuarine environment unless it is scientifically
demonstrated that under relevant field conditions there is no
unacceptable effect.
The Member State shall not authorise a biocidal product if, under the
proposed conditions of use, the foreseeable concentration of the active
substance or of any other substance of concern or of relevant metabolites
or breakdown or reaction products in groundwater exceeds the lower of
the following concentrations
(a) the maximum permissible concentration laid down by Legal Notice
17 of 2009, or
(b) the maximum concentration as laid down following the procedure for
including the active substance in Schedule I to these regulations, on the
basis of appropriate data, in particular toxicological data unless it is
scientifically demonstrated that under relevant field conditions the lower
concentration is not exceeded.
The Member State shall not authorise a biocidal product if the
foreseeable concentration of the active substance or a substance of
concern or of relevant metabolites, breakdown or reaction products to
be expected in surface water or its sediments after use of the biocidal
product under the proposed conditions of use
— exceeds, where the surface water in or from the area of envisaged
use is intended for the abstraction of drinking water, the values fixed
by
! Subsidiary Legislation 435.36 - Legal Notice 339 of 2001, as
amended by Legal Notice 426 of 2007, Quality Required of
Surface Water intended for the Abstraction of Drinking Water
Regulations,
! Legal Notice 17 of 2009 or
— has an impact deemed unacceptable on non-target species unless it is
scientifically demonstrated that under relevant field conditions this
concentration is not exceeded.
The proposed instructions for use of the biocidal product, including
procedures for cleaning application equipment, must be such that the
likelihood of accidental contamination of water or its sediments is
minimised.
Where unacceptable contamination of soil is likely to occur, the Member
State shall not authorise a biocidal product if the active substance or
substance of concern contained in it, after use of the biocidal product
— during tests in the field, persists in soil for more than one year, or
— during laboratory tests, forms non-extractable residues in amounts
exceeding 70% of the initial dose after 100 days with a mineralisation
rate of less than 5% in 100 days,
— has unacceptable consequences or effects on non-target organisms,
unless it is scientifically demonstrated that under field conditions there
is no unacceptable accumulation in soil.
The Member State shall not authorise a biocidal product where there is a
foreseeable possibility of unacceptable effects on the air compartment
unless it is scientifically demonstrated that under relevant field
conditions there is no unacceptable effect.
Effects on non-target organisms
The Member State shall not authorise a biocidal product where there is a
reasonably foreseeable possibility of non-target organisms being
exposed to the biocidal product if for any active substance or substance
of concern
— the PEC/PNEC is above 1 unless it is clearly established in the risk
assessment that under field conditions no unacceptable effects occur
B
after use of the biocidal product according to the proposed conditions of
use, or
— the bioconcentration factor (BCF) related to fat tissues in non-target
vertebrates is above 1 unless it is clearly established in the risk
assessment that under field conditions no unacceptable effects occur,
either directly or indirectly, after use of the product according to the
proposed conditions of use.
The Member State shall not authorise a biocidal product where there is a
reasonably foreseeable possibility of aquatic organisms including marine
and estuarine organisms being exposed to the biocidal product if for
any active substance or substance of concern in it
— the PEC/PNEC is above 1 unless it is clearly established in the risk
assessment that under field conditions the viability of aquatic organisms
including marine and estuarine organisms is not threatened by the
biocidal product according to the proposed conditions of use, or
— the bioconcentration factor (BCF) is greater than 1 000 for substances
which are readily biodegradable or greater than 100 for those which are
not readily biodegradable unless it is clearly established in the risk
assessment that under field conditions no unacceptable impact, either
directly or indirectly, occurs on the viability of exposed organisms
including marine and estuarine organisms after use of the biocidal
product according to the proposed conditions of use.
By way of derogation from this paragraph, Member States may,
however, authorise an anti-fouling product used on commercial, public
service and naval seagoing vessels for a period of up to 10 years from
the date on which Directive 98/8/EC !"#$%&#'()!*&+,#-+)./+0&,$#+,1#
$%!(,3/.#!"#45#6&7)(+)8#499:#3!,3&),/,;#$%&#*.+3/,;#!"#7/!3/1+.#
*)!1(3$<# !,# $%&# 0+)=&$ enter into force if similar fouling control
cannot be achieved by other practicable means. When implementing
this provision, Member States shall, if appropriate, take into account
relevant International Maritime Organisation (IMO) resolutions and
recommendations.
The Member State shall not authorise a biocidal product where there is
a reasonably foreseeable possibility of micro-organisms in sewage
treatment plants being exposed to the biocidal product if for any active
substance, substance of concern, relevant metabolite, breakdown or
reaction product the PEC/PNEC ratio is above 1 unless it is clearly
established in the risk assessment that under field conditions no
unacceptable impact, either directly or indirectly, occurs on the viability
of such micro-organisms.
Unacceptable effects
If the development of resistance to the active substance in the biocidal
product is likely the Member State shall take steps to minimise the
consequences of this resistance. This may involve modification of the
conditions of authorisation or even refusal of any authorisation.
An authorisation for a biocidal product intended to control vertebrates
shall not be given unless
— death is synchronous with the extinction of consciousness, or,
— death occurs immediately, or,
— vital functions are reduced gradually without signs of obvious
suffering.
For repellent products, the intended effect shall be obtained without
unnecessary suffering and pain for the target vertebrate.
Efficacy
Member States shall not authorise a biocidal product which does not
possess acceptable efficacy when used in accordance with the
conditions specified on the proposed label or with other conditions of
authorisation.
The level, consistency and duration of protection, control or other
intended effects must, as a minimum, be similar to those resulting from
suitable reference products, where such products exist, or to other means
of control. Where no reference products exist, the biocidal product must
give a defined level of protection or control in the areas of proposed use.
Conclusions as to the performance of the biocidal product must be valid
for all areas of proposed use and for all areas in the Member State except
where the proposed label prescribes that the biocidal product is intended
for use in specific circumstances. Member States shall evaluate dose
response data generated in trials (which must include an untreated
control) involving dose rates lower than the recommended rate, in order
to assess if the recommended dose is the minimum necessary to achieve
the desired effect.
Summary
In each of the areas where risk assessments have been carried out, i.e.
effects on humans, animals, and the environment, the Member State
shall combine the conclusions arrived at for the active substance and the
substances of concern to produce an overall conclusion for the biocidal
product itself. A summary should also be made of the efficacy
assessment and of the unacceptable effects.
The result shall be
— a summary of the effects of the biocidal product on humans,
— a summary of the effects of the biocidal product on animals,
— a summary of the effects of the biocidal product on the environment,
— a summary of the efficacy assessment,
— a summary of the unacceptable effects.
OVERALL INTEGRATION OF CONCLUSIONS
The Member State shall combine the individual conclusions arrived at
with regard to effects of the biocidal product on the three sectors
namely, humans, animals and the environment to arrive at an overall
conclusion for the global effect of the biocidal product.
The Member State shall then take due consideration of any relevant
unacceptable effects, the efficacy of the biocidal product and the
benefits of using the biocidal product before taking an authorisation
decision on the biocidal product.
The Member State shall ultimately decide whether or not the biocidal
product can be authorised and whether this authorisation shall be subject
to any restrictions or conditions in conformity with this Schedule and
these regulations.
€13.79