A-form: Information on the active substance - micro-organism, including viruses or fungi
A-form: Information on the active substance –
micro-organism, including viruses or fungi
All the points in the form should be filled with information. In cases where the data requirement is not covered by a
study/report, a detailed justification should be given.
For micro-organisms there is a guidance document to the data requirements, TNsG on data requirements for microorganisms including viruses and fungi (in the following TNsG mo). In the first part of the guidance document the data
requirements for the active micro-organism are met and in the second part are the data requirements for the microbiological biocidal product.
If you have any questions, please contact the Swedish Chemicals Agency at: kemi@kemi.se
December 2011
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A-form: Information on the active substance - micro-organism, including viruses or fungi
Point
Data requirement
Information/value
Reference to the application
Reference to
guidance
A1. Information about the identity of the micro-organism
A1.1
Name and species description,
strain characterisation
TNsG mo 1.3
A1.1.1
Common name of the microorganism (including alternative
and superseded names)
TNsG mo
1.3.1
Common name, or alternative or
superseded names and possible code
names that have been used during the
development must be specified
A1.1.2
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
TNsG mo
1.3.2 and
OECD
Guidance
Taxonomy1
Each micro-organism in the application
must be identified named at species
level. Scientific name and the taxonomic
affiliation, i.e. family, species, strain,
serotype, pathotype or other
denomination of relevance must be
specified.
A1.1.3
Collection and culture reference
number where the culture is
deposited
TNsG mo
1.3.2
The micro-organism must be deposited in
an internationally acknowledged culture
collection and given a reference number.
Information on this must be provided.
1
Guidance Document on the Use of Taxonomy in Risk Assessment of micro-organisms: Bacteria, OECD iLibrary,
http://www.oecd-ilibrary.org/science-and-technology/safety-assessment-of-transgenic-organisms/section2_9789264096158-9-en
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A-form: Information on the active substance - micro-organism, including viruses or fungi
Point
Data requirement
A1.1.4
Methods, procedures and
criteria used to establish the
presence and identity of the
micro-organism (e.g.
morphology, biochemistry,
serology, etc.)
Information/value
Reference to the application
Reference to
guidance
TNsG mo
1.3.4 and
OECD
Guidance
Detection2
The micro-organism must be identified
and characterised at strain level with
bets available technology. Test
procedures and criteria for identification
(e.g. morphology, biochemistry, serology
and identification with molecular
techniques) must be specified.
A1.2
Manufacturer
State name or company
A1.3
Production plant(s)
State address(es) of all production
plant(s)
A2. Specification of the material used for manufacturing of formulated products
A2.1
Content of the micro-organism
TNsG mo
1.4.1
Minimum and maximum number of the
technical micro-organism used for
preparation of the final product must be
specified. The number shall be given in
suitable units, for example number of
active units per volume or weight unit or
in another way relevant for the microorganism.
2
Guidance Document on Methods for Detection of Micro-organisms introduced into the Environment: Bacteria,
OECD iLibrary; http://www.oecd-ilibrary.org/content/chapter/9789264096158-10-en
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Point
Data requirement
A2.2
Identity and content of
impurities, additives,
contaminating micro-organisms
Information/value
Reference to the application
Reference to
guidance
TNsG mo
1.4.2
The product shall if possible be free from
contaminants (also with regard to
contaminating micro-organisms). The
Competent Authority shall based on a
risk assessment determine the number
and type of acceptable contaminants. If
possible and appropriate all
contaminating micro-organisms shall be
identified and the maximum content
shall be specified in a suitable unit.
Relevant metabolites (i.e. those that can
be expected to affect human health and
the environment) and which are known
to be produced by the micro-organism
shall be identified and characterised in
the different states or growth stages of
the micro-organism.
A2.3
Analytical profile of batches
TNsG mo
1.4.3
When relevant this information shall be
specified in suitable units.
A3. Biological properties of the micro-organism
A3.1
History of the micro-organism
and its uses. Natural occurrence
and geographical distribution
TNsG mo 2.1
A3.1.1
Historical background
TNsG mo
2.1.1
A3.1.2
Origin and natural occurrence
TNsG mo
2.1.2
The geographical dissemination of the
micro-organism and role in the
ecosystem (e.g. host plant, host animal
or soil from which the micro-organism
was isolated) must be specified and also
the isolation methodology. The natural
occurrence of the micro-organism in the
environment of interest shall be
described if possible on strain level.
A3.2
Information on target
organism(s)
A3.2.1
Description of the target
organism(s)
December 2011
TNsG mo 2.2
TNsG mo
2.2.1
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A-form: Information on the active substance - micro-organism, including viruses or fungi
A3.2.2
Mode of action
TNsG mo
2.2.2
The main mode of action shall be
described; among other it must be clear
if the micro-organism produces any toxin
with a remaining effect on the target
organism. If that is the case the mode of
action of the toxin has to be described.
A3.3
Host specificity range and effects
on species other than the target
organism
TNsG mo 2.3
All accessible information shall be
specified on the effects on other
organisms than the target organisms
within the area to which the microorganism will be disseminated. There
must also be information if there are
non-target organisms that either are
closely related to the target organism or
especially exposed. All experiences must
be specified on toxic effects of the active
micro-organism or its metabolites on
humans or animals, whether the microorganism can colonise or invade humans
or animals (also immunosuppressed
people) and whether it is a pathogen. All
experiences must be specified showing
that the active micro-organism or its
toxins/metabolites can irritate the skin,
eyes or the inhalation routes in humans
or animals or that it is allergenic at skin
contact or inhalation.
A3.4
Development stages/life cycle of
the micro-organism
TNsG mo 2.4
Information must be specified on the lifecycle of the micro-organism, described
symbiosis, parasitism, competition,
predators, host organisms etc. Also virus
vectors must be specified. The generation
time for the micro-organism must be
specified and the reproductive form.
Information must be specified on the
occurrence of resting stages and their
survival time, virulence and infectivity.
Information must be specified on the
capability of the micro-organism to in
different developmental stages after the
dissemination produce
metabolites/toxins that affect human
health and/or the environment.
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A-form: Information on the active substance - micro-organism, including viruses or fungi
A3.5
Infectiveness, dispersal and
colonisation ability
TNsG mo 2.5
The persistence of the micro-organism
must be specified and a description of its
life-cycle under environmental conditions
typical for the use. Furthermore special
sensitivity of the micro-organism for
certain factors (e.g. UV-light, soil and
water) in the environment must be
specified. The environmental
requirements (temperature, pH,
humidity, nutrition requirements, etc.)
for survival, reproduction, colonisation,
damage (including human tissues) and
effectiveness of the micro-organism must
be stated. The presence of specific
virulence factors should be indicated. The
temperature range at which the microorganism grows must be determined,
including minimum, maximum and
optimum temperatures. This information
is of particular value as a trigger for
studies of effects on human health.
A3.6
Relationships to known plant or
animal or human pathogens
TNsG mo 2.6
The possible existence of one or more
species of the genus of the active and/or,
where relevant, contaminating microorganisms known to be pathogenic to
humans, animals, plants or other nontarget species and the type of disease
caused by them shall be indicated. It shall
be stated whether it is possible, and if so,
by which means to clearly distinguish the
active micro-organism from the
pathogenic species.
A3.7
Genetic stability and factors
affecting it
TNsG mo 2.7
Where appropriate, information on
genetic stability (e.g. mutation rate of
traits related to the mode of action or
uptake of exogenous genetic material)
under the environmental conditions of
proposed use must be provided.
Information must also be provided on the
micro-organism's capacity to transfer
genetic material to other organisms as
well as its capacity to being pathogenic
for plants, animals or man. If the microorganism carries relevant additional
genetic elements, the stability of the
encoded traits should be indicated.
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A-form: Information on the active substance - micro-organism, including viruses or fungi
A3.8
Information on the production
of metabolites (especially toxins)
TNsG mo 2.8
It must be specified under which
circumstances the micro-organism
produces metabolite(s) or especially
toxin(s). All available data must be
provided about the mechanism
regulating the production of the
metabolite(s) and also about the
produced metabolites involvement in the
mode of action of the micro-organism
A3.9
Antibiotics and other antimicrobial agents
TNsG mo 2.7
Many micro-organisms produce some
antimicrobial substances. Interference
with the use of these substances in
human or veterinary medicine must be
avoided at any stage of the development
of a microbial biocidal product.
Information on the micro-organism's
resistance or sensitivity to antibiotics or
other antimicrobial agents must be
provided.
A3.10
Robustness to environmental
factors
TNsG mo
2.10
A3.11
Effects on materials, substances
and products
TNsG mo
2.11
A4. Further information on the micro-organism
A4.1
Function
TNsG mo 3.1
The biological function must be described
in one of the following ways:
- Control of bacteria
- Control of fungi
- Insect control
- Mite control
- Molluscicide
- Nematode control
- Other (must be specified)
A4.2
Field of use envisaged
TNsG mo 3.2
The field(s) of use, existing or proposed
for the biocidal product containing the
micro-organism must be specified in one
of the following ways:
- For use outdoors like in water
- Use indoors
- Recreational areas
- Storage products
- Other (must be specified)
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A-form: Information on the active substance - micro-organism, including viruses or fungi
A4.3
Method of production and
quality control
TNsG mo 3.4
Full information on how the microorganism is produced in bulk must be
provided. Both production
method/process and product must be
subject to a continuous quality control by
the applicant. In particular, the
occurrence of spontaneous changing of
major characteristics of the
microorganism and of the
absence/presence of significant
contaminants should be monitored. The
quality assurance criteria for the
production should be submitted. The
techniques used to ensure a uniform
product and the assay methods for its
standardisation, maintenance and purity
of the micro-organism must be described
and specified
A4.4
Information on the occurrence
or possible occurrence of the
development of resistance of the
target organism(s)
TNsG mo 3.5
Available information on the possible
occurrence of the development of
resistance or cross-resistance of the
target organism(s) must be provided.
Where possible, appropriate
management strategies should be
described.
A4.5
Methods to prevent loss of
virulence of seed stock of the
micro-organism
TNsG mo 3.6
Methods to prevent loss of virulence of
starting cultures are to be provided. In
addition, any method, if available, that
could prevent the micro-organism from
losing its effects on the target species
must be described.
A4.6
Recommended methods and
precautions concerning
handling, storage, transport or
fire
TNsG mo 3.7
A safety data sheet similar to that
required for chemical active substances
in Article 27 of Directive 67/548/EEC
must be provided for the biocidal product
containing micro-organisms, when
applicable.
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A-form: Information on the active substance - micro-organism, including viruses or fungi
A4.7
Procedures for destruction or
decontamination
TNsG mo 3.8
In many cases the preferred or sole
means of safe disposal of microorganisms, contaminated materials, or
contaminated packaging, is through
controlled incineration in a licensed
incinerator. Methods to dispose safely of
the micro-organism or, where necessary,
to kill it prior to disposal, and methods to
dispose of contaminated packaging and
contaminated materials, must be fully
described. Data must be provided for
such methods to establish their
effectiveness and safety.
A4.8
Measures in case of an accident
TNsG mo 3.9
Information on procedures and methods
used for rendering the micro-organism
harmless in the environment (e.g. water
or soil) must be provided.
A4.9
Procedures for waste
management
TNsG mo
3.10
A4.10
Monitoring plan to be used for
the active micro-organism
including handling, storage,
transport and use
TNsG mo
3.11
A5. Analytical methods
The rules in this section include only analytical methods required for control and monitoring after approval. Monitoring after approval can be
considered in all respects related to the risk assessment.
A5.1
Methods for the analysis of the
micro-organism as
manufactured
TNsG mo 4.1
- Methods to identify the microorganism.
- Methods to determine the amount of
relevant contaminants in the final
product.
A5.2
Methods to determine and
quantify residues (viable or nonviable)
TNsG mo 4.2
Methods to determine and quantify
residues (viable or non-viable) of the
micro-organism and significant or
relevant metabolites (in particular
exotoxins/endotoxins), on and/or in a
biocidal product, in crops, in foodstuffs
and feeding stuffs, in animal and human
body tissues and fluids, in soil, in water
(including drinking water, ground water
and surface water) and in air where
relevant should be submitted.
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A-form: Information on the active substance - micro-organism, including viruses or fungi
Point
Data requirement
Information/value
Reference to the application
Reference to
guidance
A6. Effects on human health
Tier I
A6.1
Basic information
A6.1.1
Medical data
TNsG mo 5.1
TNsG mo
5.1.1
Information on symptoms of toxicity,
infection or pathogenicity. Where
relevant suitable treatment methods and
the efficacy of these should be provided.
A6.1.2
Medical surveillance on
manufacturing plant personnel
TNsG mo
5.1.2
Available reports of occupational health
surveillance programmes, supported with
information on the design of the
programme and on exposure to the
micro-organism must be submitted.
Special attention should be devoted to
those whose susceptibility may be
affected, e.g. pre-existing disease,
medication, compromised immunity,
pregnancy, or breast feeding.
A6.1.3
Sensitisation/allergenicity
observations
TNsG mo
5.1.3
Available information on the
sensitisation and allergenic response of
workers, including workers in
manufacturing plants, agricultural and
research workers and others exposed to
the micro-organism must be provided.
A6.1.4
Direct observation, e.g. clinical
cases
TNsG mo
5.1.4
Available reports from the open
literature on the micro-organism or
closely related members of the
taxonomic group (relating to clinical
cases). The information shall also include
the occurrence of pathogenicity and
transmission of infection for humans and
other mammals at immunosuppression.
The information must be as detailed as
possible with regard to exposure,
symptom, first aid/medical treatment
and clinical observations
December 2011
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A-form: Information on the active substance - micro-organism, including viruses or fungi
Point
Data requirement
A6.2
Basic studies
Information/value
Reference to the application
Reference to
guidance
TNsG mo 5.2
Studies shall be performed with the
active micro-organism in the form (e.g.
whole or lysed cells) which is the most
relevant for the purpose with the
respective study. ”Read across” from a
representative product can be used if this
is supported by a discussion on dose and
the influence of the non-active
substances on the toxicity of the product.
If a metabolite/toxin is produced and can
be expected to give a relevant exposure
to humans studies on the substance shall
be performed in accordance with
Directive 98/8/EC Annex IIA.
A6.2.1
Sensitisation
TNsG mo
5.2.1
Result from performed studies, if
applicable, or a discussion on why studies
are not necessary. Available test
methods for skin sensitisation are not
suitable for micro-organisms, and
validated methods for inhalation
sensitisation are missing. Until validated
methods exist all micro-organisms are
considered as sensitising.
A6.2.2
Acute toxicity, pathogenicity,
and infectiveness
TNsG mo
5.2.2
A6.2.2.1
Acute oral toxicity, pathogenicity
and infectiveness
TNsG mo
5.2.2.1
Studies performed with test animals or a
discussion on why this is not necessary.
A6.2.2.2.
Acute inhalation toxicity,
pathogenicity and infectiveness
TNsG mo
5.2.2.2
Studies performed with test animals or a
discussion on why this is not necessary.
Inhalatory exposure can be exchanged
for intratracheal exposure.
A6.2.2.3
Intraperitoneal/subcutaneous
single dose
TNsG mo
5.2.2.3
Studies performed with test animals or a
discussion on why this is not necessary.
A6.2.3
In vitro genotoxicity testing
TNsG mo
5.2.3
Performed studies with a discussion on
the suitability of the method and on the
form of the micro-organism that has
been used in the study, or a discussion on
why this is not necessary.
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Point
Data requirement
A6.2.4
Cell culture study
Information/value
Reference to the application
Reference to
guidance
TNsG mo
5.2.4
Only relevant for micro-organisms that
reproduce intra-cellulary. Information on
capability of reproduction in mammalian
cells or a discussion on why this is not
necessary.
A6.2.5
Information on short-term
toxicity and pathogenicity
TNsG mo
5.2.5
A6.2.5.1
Health effects after repeated
oral exposure
TNsG mo
5.2.5.1
Studies performed with test animals or a
discussion on why this is not necessary. In
the performed study the capability of
infection should be addressed. The study
should include exposure for at least 28
days.
A6.2.5.2
Health effects after repeated
inhalatory exposure
Studies performed with test animals or a
discussion on why this is not necessary. In
the performed study the capability of
infection should be addressed. The study
should include exposure for at least 28
days.
A6.2.6
Proposed treatment: first aid
measures, medical treatment
TNsG mo
5.2.6
Detailed description of the first aid at
infection and eye contamination and of
the medical treatment at consumption
and eye and skin contamination.
A6.2.7
Any pathogenicity and
infectiveness to humans and
other mammals under
conditions of
immunosuppression
TNsG mo
5.2.7
Tier II
A6.3
Specific toxicity, pathogenicity
and infectiveness studies
TNsG mo 5.3
Only relevant in case earlier studies have
shown detrimental effects. Also
performed studies, not listed in point
6.1 - 6.2, must be filled in.
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Point
Data requirement
A6.4
Genotoxicity - in vivo studies in
somatic cells
Information/value
Reference to the application
Reference to
guidance
TNsG mo 5.4
Only relevant in case positive results have
been shown in vitro. Performed studies
with a discussion on the suitability of the
method and on the form of the microorganism that has been used in the
study, or a discussion on why this is not
necessary.
A6.5
Genotoxicity - in vivo studies in
germ cells
TNsG mo 5.5
Only relevant in case positive results have
been shown in vivo. Performed studies
with a discussion on the suitability of the
method and on the form of the microorganism that has been used in the
study, or a discussion on why this is not
necessary.
Tier III
A6.6
Summary of mammalian toxicity,
pathogenicity and infectiveness
and overall evaluation
TNsG mo 5.6
Summary of data from point 6.1 - 6.5
including a detailed qualitative overall
assessment of expected health effects on
humans and animals with the proposed
use.
A7. Residues in or on treated materials, food and feed
A7.1
Persistence and likelihood of
multiplication in or on treated
materials, feeding stuffs or
foodstuffs
TNsG mo 6.1
A7.2
Further information required
TNsG mo 6.2
A7.2.1
Non-viable residues
TNsG mo
6.2.1
A7.2.2.
Viable residues
TNsG mo
6.2.2
A7.3
Summary and evaluation of
residues in or on treated
materials, food and feed
December 2011
TNsG mo 6.3
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Point
Data requirement
Information/value
Reference to the application
Reference to
guidance
A8. Fate and behaviour in the environment
A8.1
Persistence and multiplication
TNsG mo 7.1
Information on the persistence of the
micro-organism and of its relevant
metabolite(s)/toxin(s) and potential for
proliferation must be specified for all
relevant compartments of the
environment unless it can be confirmed
that exposure of specific compartments
of the environment is unrealistic. The
climatic conditions at the time for
application must be especially taken into
account with regard to season and/or
climate related competition capability
and/or population dynamics.
A8.1.1
Soil
TNsG mo
7.1.1
Studies on survival capability/population
dynamics in different soils at use of the
product in relevant environmental
conditions or a discussion on why studies
are not necessary.
A8.1.2
Water and sediment
TNsG mo
7.1.2
Studies on capability of
survival/population dynamics in natural
sediment/water systems under both light
and dark conditions, or a discussion on
why studies are not necessary.
A8.1.3
Air
TNsG mo
7.1.3
Studies on capability of survival in air or a
discussion on why studies are not
necessary.
A8.2
Mobility
TNsG mo 7.2
Information on the micro-organism and
its metabolite(s)/toxin(s) (relevant only if
these are expected to have negative
effects on humans or other organisms)
possible dissemination routes for all
relevant compartments of the
environment; unless it can be confirmed
that exposure of specific compartments is
not likely. The phase in life-cycle,
occurrence of vectors and capability to
colonise habitats nearby shall be taken
into account.
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Point
Data requirement
A8.3
Summary and evaluation of fate
and behaviour in the
environment
Information/value
Reference to the application
Reference to
guidance
TNsG mo 7.3
Summary of data from point 8.1 - 8.2
including a qualitative overall
assessment of expected persistence,
proliferation and fate in the environment
with proposed use.
A9. Effects on non-target organisms
A9.1
Effects on birds
TNsG mo 8.1
Studies on toxicity, infectivity,
pathogenicity on birds or a discussion on
why this is not necessary.
A9.2
Effects on aquatic organisms
A9.2.1
Effects on fish
TNsG mo 8.2
TNsG mo
8.2.1
Studies on toxicity, infectivity,
pathogenicity on fish or a discussion on
why this is not necessary
A9.2.2
Effects on freshwater
invertebrates
TNsG mo
8.2.2
Studies on toxicity, infectivity,
pathogenicity on freshwater
invertebrates or a discussion on why this
is not necessary
A9.2.3
Effects on algae growth
TNsG mo
8.2.3
Studies on effects on algae growth and
capability to recovery or a discussion on
why this is not necessary.
A9.2.4
Effects on plants other than
algae
TNsG mo
8.2.4
Studies or a discussion on why this is not
necessary.
A9.3
Effects on bees
TNsG mo 8.3
Studies on toxicity, infectivity,
pathogenicity on bees or a discussion on
why this is not necessary.
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Point
Data requirement
A9.4
Effects on arthropods other than
bees
Information/value
Reference to the application
Reference to
guidance
TNsG mo 8.4
Studies on toxicity, infectivity,
pathogenicity on arthropods other than
bees or a discussion on why this is not
necessary. The choice of test organism
shall be related to the potential area of
use for the product. Arthropods used for
biological control shall especially be
taken into account.
A9.5
Effects on earthworms
TNsG mo 8.5
Studies on toxicity, infectivity,
pathogenicity on earthworms or a
discussion on why this is not necessary.
A9.6
Effects on soil micro-organisms
TNsG mo 8.6
Impact on relevant non-target microorganisms and on their predators (e.g.
protozoa for bacterial inoculants) should
be reported
A9.7
Further studies
TNsG mo 8.7
The additional studies might include
further acute studies on additional
species or processes (such as sewage
systems) or higher tier studies such as
chronic, sub-lethal or reproductive
studies on selected non-target
organisms. Only relevant in case earlier
studies have shown detrimental effects
or if negative effects in a special nontarget organism are suspected with
special attention to host specificity
and/or the proposed use
A9.7.1
Terrestrial plants
TNsG mo
8.7.1
Only relevant in case earlier studies have
shown detrimental effects or if negative
effects in a special non-target organism
are suspected with special attention to
host specificity and/or the proposed use.
A9.7.2
Mammals
TNsG mo
8.7.2
Only relevant in case earlier studies have
shown detrimental effects or if negative
effects in a special non-target organism
are suspected with special attention to
host specificity and/or the proposed use.
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Data requirement
A9.7.3
Other relevant species and
processes
Information/value
Reference to the application
Reference to
guidance
TNsG mo
8.7.3
Only relevant in case earlier studies have
shown detrimental effects or if negative
effects in a special non-target organism
are suspected with special attention to
host specificity and/or the proposed use.
A9.8
Summary and evaluation of
effects on non-target organisms
TNsG mo 8.8
Summary of data from point 9.1 - 9.7
including a qualitative overall
assessment of expected effects on nontarget organisms with the proposed use.
A10. Classification and labelling
A10.1
Classification and labelling
TNsG mo 9
In addition to a proposal for allocation of
the micro-organism to one of the risk
groups outlined in Article 2 of Directive
2000/54/EC the applicant should
provide justifications together with
indications on the need for products to
carry the biohazard sign specified in
Annex II to Directive.
A11. Summary and evaluation of sections 1-10 including conclusions of the risk
assessment and recommendations
A11.1
Summary
TNsG mo 10
A12. Reference list
A12.1
Reference list
Specify title, author, laboratory and other
information that can facilitate the
identification of attached material.
December 2011
17 (17)