Key Benefits:
Minister of Ecology and Sustainable Development, Minister of Agriculture, Food, Fisheries and Rural Affairs, Minister Responsible for Industry and Secretary State to small and medium-sized enterprises, trade, craft, professional and consumer professions,
In view of Commission Directive 2001 /36/EC of 16 May 2001 amending Council Directive 91 /414/EEC concerning The placing of plant protection products on the market;
In view of the Labour Code, and in particular Articles R. 231-53 and R. 231-53-1, and Articles R. 231-60 to R. 231-65-3;
In view of Decree No. 93-774 of 27 March 1993 fixing the list of techniques Genetic modification and classification criteria for genetically modified organisms;
In view of Decree No. 94-359 of 5 May 1994 on the control of plant protection products;
In the light of the amended decree of 20 April 1994 on the Declaration, classification, packaging and labelling of substances;
Having regard to the order of 6 September 1994 implementing Decree No 94-359 of 5 May 1994 on the control of plant protection products,
Stop:
Schedule I of the September 6, 1994 Order is amended as follows:
1. A 2.4 point is added in the introduction and written as follows:
" 2.4. By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses carried out in order to collect data on properties and/or safety in respect of aspects other than the Human health may be carried out by officially recognised or officially recognised services or bodies performing at least the conditions set out in points 2.2 and 2.3 of the introduction to Annex II. "
2. Part B reads as follows:
Introduction
i) Active substances are Defined in Article 2 (4). They include chemicals and micro-organisms, including viruses. This Part sets out the information required for active substances consisting of micro-organisms, including viruses. For the purposes of Annex I, Part B, the term "microorganism shall be used in the following sense:
" Microbiological identity, whether cellular or not, capable of replicating or transferring genetic material. The definition applies, but not exclusively, to bacteria, fungi, protozoa, viruses and viroids.
(ii) Any request for microorganisms must be accompanied by all information and documentation Available in the current state of knowledge. The most important and useful information is provided by the identification and identification of the microorganism. Information of this type is defined in sections 1, 2 and 3 (identity, biological properties, additional information). They form the basis for assessing the effects of the micro-organism on human health and the environment. Recent data from toxicological and/or pathological experiments on laboratory animals are normally required, unless the applicant is able to demonstrate, on the basis of the information previously provided, that The use of the micro-organism under the proposed conditions has no adverse effect on human or animal health or groundwater, and has no unacceptable impact on the environment.
iii) Pending adoption of Specific procedures at the international level, the required information will be obtained by applying the test procedures adopted by the competent authority [such as those of the USEPA, for example (cf. Footnote 1)]. Where appropriate, the procedures described in Annex I, Part A should be adapted so that they may be suitable for micro-organisms. Tests shall be carried out on viable micro-organisms and, where appropriate, non-viable, and include a blank check.
(iv) For the tests carried out, a detailed description (technical specifications) of the equipment should be provided. Used and the impurities it contains, in accordance with the provisions of Section 1, point 1.4. The equipment used shall correspond to the technical specifications defined for the manufacture of the preparations to be authorised. If studies are carried out with micro-organisms obtained in the laboratory or in a pilot plant, they must be repeated with industrially obtained micro-organisms, unless it can be shown that the material used is Essentially the same for testing and evaluation purposes.
(v) In the case of genetically modified micro-organisms, a copy of the assessment of the risk assessment data for the environment should be provided, as As provided for in Article 30 of Decree No. 94-359 of 5 May 1994.
(vi) Where appropriate, the data shall be analysed using appropriate statistical methods. Statistical analyses should be reported in a comprehensive manner (for example, all point estimates should be delimited by a confidence interval, and exact probability values should be provided instead of Use the word "significant/not significant".
(vii) In the case of studies providing for prolonged administration over a period of time, the administration should preferably be carried out by means of a single lot of micro-organisms, if Stability of the system allows. If the studies are not carried out using a single batch of micro-organisms, the similarity of the different batches used should be certified. If a study involves the use of different doses, the relationship between the dose and the adverse effect should be noted.
viii) If it is assumed that the plant protection action is due to the residual effect of a toxin or metabolite, or If the presence of significant residues of toxins or metabolites not related to the effect of the active substance is to be expected, these toxins or metabolites shall be the subject of a dossier established in accordance with the requirements of Annex I, Part A.
1. Identity of the Microorganism
The identification and characterization of the microorganism provides the most important information and is a key element of decision-making.
1.1. Applicant
The name and address of the applicant (permanent address in the Community) must be indicated, along with the name, quality, telephone and fax numbers of the contact person. Where, in addition, the applicant has an office, agent or representative in the Member State to which the application for entry is made in Annex I to Council Directive 91 /414/EEC concerning the placing on the market of products Plant protection and, if it is different, in the rapporteur Member State appointed by the Commission, the name and address of the office, agent or local representative, as well as the name, position, telephone number and Fax of the contact person.
1.2. Producer
The name and address of the producer (s) of the microorganism must be provided, along with the name and address of each unit that produces the microorganism. Indicate a point of contact (preferably central, with name, telephone number and fax number), to which the update data will be sent and where questions concerning production technology, processes and The quality of the product (including, where applicable, individual lots). If the location or number of producers is to be changed after the registration of the active substance in the Annex to the decree of 14 April 1998 amending the list of active substances whose incorporation is authorised in the The information required must be notified to the Commission and the Member States again.
1.3. Name and Description of Species, Characterization of Strain
i) Microorganism must be deposited with a collection bank of internationally recognized cultures. Indicate the corresponding deposit number, as well as the coordinates of the institution.
(ii) Each of the microorganisms covered by the application must be identified and designated by its species name. The scientific name and taxonomic group, i.e., family, genus, species, strain, serotype, pathovar and any other relevant denomination of each microorganism, should be indicated. Specify whether the microorganism:
-is native or non-native, at the species level, of the proposed field of application;
-is a wild-type strain;
-is a spontaneous or induced mutant;
-has been modified using described techniques The annexes to Decree No. 93-774 of March 27, 1993.
In the latter two cases, all known differences between the modified micro-organism and the original wild strain should be indicated.
iii) Most advanced technology Available should be used to identify and characterize the microorganism at the strain level. Specify test procedures and criteria used for identification (e.g., morphology, biochemistry, serology, molecular identification).
(iv) Indicate the common name and, if applicable, any additional name, Replacement or code used in the development phase.
v) Indicate any relationships with known pathogens.
1.4. Technical specifications for hardware used
for manufacturing formulated products
1.4.1. Micro-organism content.
The minimum and maximum micro-organism content of the equipment used in the manufacture of formulated products shall be indicated, in appropriate terms, such as the number of active units per unit of volume or Weight, or any other suitable means for the microorganism concerned. Where the information provided relates to a pilot production system, the information required must be provided to the Commission and the Member States again when industrial production methods and procedures have taken place. Stabilized and if changes in production modify specifications in terms of purity.
1.4.2. Identity and content of impurities and additives contaminating micro-organisms.
To the extent possible, it is desirable for plant protection products to be free of contaminants (including micro-organisms). The level and nature of acceptable contaminants must be established by the competent authority on the basis of a risk assessment. Where possible, the identity and maximum content, expressed in the appropriate unit, of all micro-organisms, should be indicated. Wherever possible, identity data shall be provided in accordance with the requirements of Annex I, Part B, Section 1, point 1.3. Any sensitive metabolite (i.e., likely to pose a risk to human health or the environment) produced by the micro-organism should be identified and characterized in different states or stages of growth [introduction, item (viii), of Annex I B]. Provide, where appropriate, detailed information on all components such as condensates, media, etc.
For chemical impurities sensitive to human health or the environment, indicate their identity And their maximum content, expressed in the appropriate unit. For additives, indicate their identity and content, expressed in grams per kilogram. Data on the identity of chemical substances such as additives should be provided as prescribed in Annex I, Part A, Section 1, point 1.10
Batch Profile.
To provide, where applicable, the data referred to in Part A, Part A, Section 1, point 1.11, in the appropriate units.
2. Biological properties of the
2.1 micro-organism. History of the Microorganism and its Uses
Natural Presence and Geographic Distribution
The familiarity of the microorganism, that is, the availability of appropriate knowledge, should be presented. For.
2.1.1. History.
To present the history of the microorganism and its uses (experiments and research projects or commercial uses).
2.1.2. Origin and natural presence.
Indicate the geographical region and the situation in the ecosystem (for example, the host plant, the host animal, or the soil in which the organism has been isolated), specifying the mode of isolation used. The natural presence of the microorganism in the relevant environment should be indicated, if possible, at the level of the strain.
In the case of a mutant or genetically modified micro-organism (as defined in Decree No. 93-774 referred to above), provide a Detailed description of the mode of production and isolation, as well as the means to clearly distinguish it from the initial wild-type strain.
2.2. Target organization/target organization information
2.2.1. Description of target organism/target organism.
If applicable, specify the harmful organisms against which protection is provided.
2.2.2. Action mode.
Specify the main action mode. In conjunction with the mode of action, also indicate whether the microorganism produces a toxin with a residual effect on the target organism. If so, describe the mode of action of this toxin. Where appropriate, provide information on the site of infection, the mode of entry into the target organism and its sensitive phases. The results of any experimental studies should be reported. It is necessary to specify the possible routes of inoculation of the microorganism or its metabolites, especially toxins (contact, ingestion, inhalation). Also indicate whether the microorganism or its metabolites are transported in plants and, if so, how this displacement occurs. In the case of a pathogenic effect on the target organism, specify the infective dose (dose necessary to infect a target species with the desired effect) and the transmissibility of the microorganism (diffusion faculty in the target population, but also From a target species to another (target) species after application under the proposed conditions of use.
2.3. Host specificity range and
effects on species other than the target pest
Provide any available information regarding the effects on organisms other than the target organism in the Where the microorganism can spread, also indicating the presence of any organism other than the target organism that would be very close to the target species, or particularly exposed. Any knowledge concerning the toxicity of the active substance or its metabolites to humans or animals, its potential ability to colonize or infest humans or animals (including immunocompromised individuals) and its potential Pathogenic effects should be mentioned. It is also important to point out any known elements that indicate whether the active substance or its derivatives are irritating to the skin, eyes or respiratory organs of humans or animals, and whether they can lead to Allergic reactions to skin contact or inhalation.
2.4. Development phase/life cycle of the micro-organism
All available information on the life cycle of the microorganism, the described cases of symbiosis, parasitism and competition, predators, should be presented. Etc., as well as host organisms. For viruses, also report vectors. Indicate the generation time and type of reproduction of the microorganism, as well as data on the possible resting phases of the microorganism, its duration of life, its virulence and its potential for infection. Also specify whether the microorganism, during the different phases of development following its release, has the ability to produce metabolites, including toxins, that may present a risk to human health or to human health. Environment.
2.5. Infectivity, Propagation Capability, Colonization Capacity
Indicate the persistence of the microorganism and provide information about its life cycle under the environmental conditions characteristic of Intended use. Report any particular sensitivity of the micro-organism to certain environmental components (ultraviolet light, soil, water). Indicate the environmental conditions (temperature, pH, humidity, nutrients, etc.) Necessary for the survival and reproduction of the microorganism, as well as its ability to colonize and destroy (including human tissue) and its effectiveness. The presence of specific virulence factors should be mentioned.
It is appropriate to determine the temperature range in which the growth of the microorganism is possible, specifying the minimum, maximum, and optimal temperatures. These data are particularly useful in conducting human health effects studies (Section 5). Also indicate the potential influence of factors such as temperature, ultraviolet radiation, pH, and the presence of certain substances on the stability of the toxins involved. Provide any information regarding possible routes of propagation of the micro-organism (via airborne dust, host organisms playing the role of vectors, etc.), in environmental conditions Expected usage characteristics.
2.6. Related to known plant pathogens,
of animals or humans
Indicate the existence of one or more species of the same genus as the active micro-organisms and/or, where applicable, Contaminants that have a known pathogenic effect on humans, animals, crops or non-target species. Specify the types of pathologies caused. Specify whether there is an unambiguous distinction between the active microorganism of pathogenic species (and in this case, by what means).
2.7. Genetic stability of the microorganism
and factors likely to affect it
Provide, as appropriate, information on the genetic stability of the microorganism (rate of mutation of the traits relative to the mode of action, by Example, or absorption of exogenous genetic material), in the environmental conditions of the proposed use.
Also provide information on the ability of the microorganism to transfer genetic material to other organisms And its pathogenic potential for plants, animals and humans. If the microorganism carries additional sensitive genetic elements, specify the stability of the encoded features.
2.8. Information on the production of metabolites
(and especially toxins)
When it is known that other strains of the same microbial species as the subject strain of the application are capable of producing Metabolites (especially toxins) whose effects on human health and/or the environment, in application or after the application, are notoriously unacceptable, it is necessary to describe the nature and structure of the substance in question. Cause, its mode of action (by specifying the internal and external factors necessary for the action of the microorganism), as well as its effects on human beings, animals or other non-target species. In addition, the conditions for the production of metabolites (including toxins) by the micro-organism should be described, including all available information on the mechanism for regulating the production of metabolites as well as The influence of metabolites produced on the mode of action of the microorganism.
2.9. Antibiotics and other antimicrobial agents
Many microorganisms produce certain antibiotics. At all stages of the development of a microbial plant protection product, it is imperative to avoid interference with the use of antibiotics in human or veterinary medicine. It is therefore appropriate to provide information on the resistance or susceptibility of the micro-organism to antibiotics and other antimicrobial agents, in particular as regards the stability of genetic codes determining the Antibiotic resistance, unless it can be demonstrated that the organism has no adverse effect on human or animal health, or does not have the ability to transfer its resistance to antibiotics and other antimicrobial agents.
3. Additional
Information for the
Introduction
i) The information provided must indicate for which purposes the preparations containing the microorganism are used or are intended to be used.
ii) The information provided should specify the standard methods and precautions to be observed in the handling, storage and transportation of the microorganism.
iii) Studies, Data and the information presented must demonstrate that the proposed measures are appropriate in emergency situations.
iv) The information and data referred to are required for all micro-organisms, unless otherwise indicated.
3.1. Function
Specify the biological function to be one of the following:
-bactericide;
-fungicide;
-insecticide;
-acaricide;
-molluscicide;
-nematicide;
-herbicide;
-other (specify).
3.2. Intended Area of Use
Specify, in the following list, the current and proposed use domain (s) of preparations containing the micro-organism:
-field use (agriculture, horticulture, Forest, viticulture, etc.) ;
-protected crops (under greenhouse conditions, for example);
-ornamental crops;
-uncultivated land weeding;
-gardening;
-indoor plants;
-stored products;
-others (specify).
3.3. Protected or treated crops or products
Specify the current and intended use in terms of protected crops, groups of crops, plants or plant products.
3.4. Production Mode and Quality Control
Provide a comprehensive description of the large-scale mode of production of the microorganism. The applicant must ensure continuous quality control of the process or method of production as well as the product obtained. In particular, it is important to monitor any spontaneous modification of the main characteristics of the micro-organism and the presence or absence of significant contaminants.
Submit details of the quality assurance criteria
Describe and specify the techniques used to ensure the uniformity of the product and the titration methods used to ensure the standardization, preservation and purity of the microorganism (e.g. HACCP).
3.5. Information on the appearance or possible emergence of the development of resistance of the target organism/target organisms
Provide any available information on the possible emergence of resistance or resistance Cross the target organism/target organizations.
Describe the appropriate response strategies, if any.
3.6. Methods used to prevent the
loss of virulence from the seed stock of the micro-organism
Describe the methods to prevent the loss of virulence of the initial cultures. In addition, describe any method that may be available to prevent the microorganism from losing its effectiveness on target species.
3.7. Recommended procedures and precautions for
handling, storage, transport, or fire
For each microorganism, provide a safety data sheet similar to that required for the Substances under sections R. 231-53 and R. 231-53-1 of the Labour Code.
3.8. Destruction or decontamination procedures
In many cases, the best or only way to safely dispose of micro-organisms, contaminated materials or contaminated packaging is to Controlled incineration in an approved incinerator. Provide a comprehensive description of the methods used to safely dispose of the micro-organism, or, where appropriate, to kill it before disposal, as well as the disposal methods for packaging and contaminated materials. Provide data to determine the effectiveness and safety of these methods.
3.9. Accident Measures
Describe procedures to make the micro-organism harmless to the environment (e.g. water or soil) in the event of an accident.
4.
Analysis Methods Introduction
The provisions in this section apply exclusively to the analysis methods required for post-authorization monitoring and follow-up.
For all elements Risk assessment, post-authorisation monitoring may be considered, in particular when a request concerns (strains) micro-organisms that are not indigenous to the proposed area of application. For the analytical methods used in the production of the data required by this Order or for other purposes, the applicant shall be required to provide a justification of the method used. If necessary, specific orders will be drawn up for these methods on the basis of the same standards as those required for the post-authorisation monitoring and follow-up methods. A description of the analytical methods containing all relevant data relating to the equipment and equipment used and the conditions of application should be provided. The application of any internationally recognized method must be reported.
These methods should, as far as possible, follow the simplest approach, be inexpensive, and use common equipment. For the methods of analysis of micro-organisms and their residues, the data relating to the specificity, linearity, accuracy and repeatability, as defined in Annex I, Part A, points 4.1 and 4.2.
The following definitions apply for the purposes of this section.
Impurities: all components (including micro-organisms and/or chemical substances) other than the designated micro-organism from the Process of manufacturing or degradation occurring during storage.
Impurities: Impurities, as defined above, that pose a risk to human or animal health and/or the environment.
Metabolism: Products resulting, in particular, of biosynthetic reactions and degradation in the micro-organism or other organisms used for the production of the relevant microorganism.
Sensitive metabolism: metabolites Risk to human or animal health and/or the environment
Residues: viable micro-organisms and substances manufactured in significant quantities by micro-organisms, which persist after the disappearance of micro-organisms and present A risk to human or animal health and/or the environment.
The following samples must be provided upon request:
i) Samples of the microorganism as produced;
ii) Standards for the analysis of metabolites Sensitive (especially toxins) and all other components included in the definition of residues;
iii) If available, samples of reference materials for sensitive impurities.
4.1. Methods of analysis of the microorganism as it is produced
Methods of identification of the microorganism.
Methods of obtaining information on the possible variability of the active seed/micro-organism.
Methods used to differentiate the mutants of the initial wild-type microorganism.
Methods used to determine the purity of the seed stock from which the batches are produced and methods used to control the Purity.
Methods used to determine the micro-organism content of manufactured equipment used in the production of formulated products and methods to demonstrate that the micro-organisms contaminants are contained within limits Acceptable.
Methods for identifying sensitive impurities in manufactured equipment.
Methods used to verify the absence or quantify the presence (with appropriate limits of determination) of any pathogen for the Human beings and mammals.
Methods for determining the storage stability and shelf life of the organism, if applicable.
4.2. Methods of determining and quantifying residues
(viable or non-viable)
Active micro-organism (s).
Sensitive metabolites (especially toxins), present on and/or in cultures, in Foodstuffs and feedingstuffs, in the tissues and fluids of human beings and animals, in soil, in water (i.e., drinking water, groundwater and surface water) and in the air, as the case may
. Include analytical methods for determining the content or activity of protein products, such as analysis of exponential cultures and supernatants in a bioassay of animal cell culture.
5. Health Effects of Individuals
Introduction
i) The information available on the properties of the micro-organism and the organisms concerned (sections 1 to 3), including health and medical reports, can be Be sufficient to determine whether or not the microorganism is likely to have an effect (infectious, pathogenic or toxic) on human health.
(ii) The information provided, together with those concerning one or more preparations containing the Micro-organisms must be sufficient to enable a risk assessment for persons arising, directly or indirectly, from the handling and use of plant protection products containing the micro-organism, thus The risk to people related to residues or contaminants in food and water. In addition, the information provided should enable:
-to adopt a decision on the possible inclusion of the active substance in Annex I to Council Directive 91 /414/EEC on the placing on the market of products Plant protection;
-specify the appropriate conditions or restrictions to accompany any inclusion in Annex I to Council Directive 91 /414/EEC on the placing of plant protection products on the market;
- To decide on warnings related to risks and safety standards (when introduced) concerning the protection of people, animals and the environment to be included on packaging (containers);
-to define emergency care Appropriate and appropriate diagnostic and therapeutic measures to be applied to persons in the event of infection or other adverse effect.
(iii) All effects identified during the course of research must be reported. It is also appropriate to initiate research that may be necessary to identify the mechanism that is likely to cause the observed effects and to assess the severity of these effects.
iv) For all studies, the actual dose used, Expressed in colonies per kilogram of body weight, as well as in other appropriate units, should be mentioned.
v) The assessment of the microorganism must be carried out in phases.
The first phase concerns the Basic information and basic studies, which must be carried out for all micro-organisms. It is up to the experts to decide on the appropriate test programme. Recent data from toxicological and/or pathological experiments on laboratory animals are normally required, unless the applicant is able to demonstrate, on the basis of the information previously provided, that The use of the microorganism under the proposed conditions has no adverse effect on human or animal health. Pending the adoption of specific procedures at the international level, the required information is obtained by applying the available test procedures (USEPA OPPTS, for example).
A second phase of studies should be conducted if the First phase tests expose adverse health effects. The type of studies to be carried out depends on the nature of the effects. Prior to commencing these studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried out.
5.1. Basic information
Basic information should be provided on the possible harmful effects of the microorganism, including its ability to form colonies, cause damage and produce toxins, and Other sensitive metabolites.
5.1.1. Medical data:
If available, and without prejudice to the provisions of Articles R. 231-62 to R. 231-65-3 of the Labour Code concerning the protection of workers against the risks associated with exposure to biological agents at Work, data and practical information regarding the recognition of symptoms of infection or pathogenicity and the effectiveness of first aid and therapeutic measures should be presented.
Where applicable, effectiveness Potential antidotes should be studied and reported and methods to kill or inactivate the microorganism should be indicated (Section 3, point 3.8).
Data and information on the effects of human exposure, Provided they are available at the required level of quality, have a special value because they can confirm the validity of the extrapolations and conclusions about the target organs, virulence and reversibility Adverse effects. Such data may be collected as a result of exposures resulting from accidents or occupational
. Medical surveillance of facility staff.
Available reports from occupational health surveillance programs, supported by detailed information on program design and exposure to the micro-organism, must be provided. Be submitted. Such reports shall include, to the extent possible, information on the mechanism of action of the micro-organism. As well, they should include any data available concerning persons exposed in production plants or after application of the microorganism (for example, in the context of efficacy tests)
Special attention to persons whose sensitivity may be affected, for example, by a pre-existing disease, a drug, a weakened immune system, pregnancy or lactation
Possible awareness/allergenicity observations.
There is a need to provide all available information on awareness and allergic reactions among professionals, namely plant workers, Agricultural workers, researchers and any other person exposed to the microorganism, including, where appropriate, a detailed description of any incidence of hypersensitivity and chronic sensitization. The information provided should include details of the frequency, level and duration of exposure, observed symptoms, and other relevant clinical observations. It is also necessary to specify whether the professionals concerned have been subjected to allergic tests or have been questioned about allergic
. Direct observation (e.g. clinical cases).
Reports from public bibliographic sources relating to clinical cases involving the microorganism or closely related members of the same group should be provided. Taxonomic, if derived from authorized journals or official reports, as well as any reports of possible follow-up studies. These reports, which are particularly useful, should include comprehensive descriptions of the nature, degree and duration of exposure, as well as the indication of observed clinical symptoms, first aid, and applied therapeutic actions. Measured data and observations made. A summary or brief information is of little interest.
In the case of animal studies, reports on clinical cases can be particularly useful in confirming the validity of the extrapolations From the animal to humans and identify any unexpected adverse effects specific to humans.
5.2. Basic studies
In order to properly interpret the results obtained, it is of the utmost importance that the proposed test methods be appropriate for sensitivity, mode of administration, Etc., and also be biologically and toxicologically appropriate. The mode of administration of the microorganism used for testing is a function of the main types of exposure of individuals.
To assess the medium-and long-term effects of acute, subacute or semi-chronic exposure to the Microorganism, it is compulsory to apply the procedure in most OECD guidelines, which consists in complementing studies carried out by a period of recovery after which a pathological analysis is carried out Macro-and complete microscopic, with exploratory research of the microorganism in tissues and organs. It is thus possible to facilitate the interpretation of certain facts and to establish infectivity or pathogenicity, which in turn allows decisions on other issues, such as the need for long-term studies (of Carcinogenesis, etc., as discussed in point 5.3) or whether or not to carry out residue studies (see section 6.2
. Awareness (cf. Note 2).
Test Object:
The purpose of the test is to provide sufficient information to assess the ability of the microorganism to induce inhalation and dermal sensitization reactions. A maximized test is required.
Situations in which tests are required (cf. Note 3):
Any awareness information should be reported.
5.2.2. Acute toxicity, pathogenicity and infectivity.
The studies, data and information to be provided and evaluated must be sufficient to detect the effects of a single exposure to the microorganism, and in particular to establish or Indicate:
-the toxicity, pathogenicity and infectivity of the microorganism;
-the evolution over time and the characteristics of the effects, with a comprehensive description of the behavioural changes and possible changes Macropathological findings in post-mortem inspection;
-if possible, the toxic mode of action;
-the relative risks associated with the various routes of exposure;
-blood tests carried out in all studies, in order to Assess the removal of the microorganism.
Acute toxic effects/pathogens may be accompanied by infectivity and/or other long-term effects that cannot be observed immediately. In view of the health assessment, it is therefore necessary to study the capacity of infection by ingestion, inhalation and intraperitoneal/subcutaneous injection in laboratory mammals.
Toxicity studies, pathogenicity studies, and Acute infectivity must include an assessment of the removal of the microorganism and/or active toxin in the organs considered appropriate for the microbial examination (e.g., liver, kidneys, spleen, lungs, brain, blood, and The administrative site).
The observations to be made should reflect an expert scientific judgement and may include a count of the microorganism in all tissues likely to be affected (for example, lesions) and in Vital organs: kidneys, brain, liver, lungs, spleen, bladder, blood, lymph nodes, gastrointestinal tract, thymus, and lesions at the site of inoculation in dead or moribund animals, during testing and at the time of testing Animal sacrifice.
The information generated by acute toxicity, pathogenicity and infectivity tests is particularly useful in assessing the risks that may arise in the event of an accident, as well as the risks to The consumer in case of exposure to possible residues.
5.2.2.1. Oral toxicity, pathogenicity and acute infectivity.
Circumstances in which tests are required:
Acute oral toxicity and the pathogenicity and acute infectivity of the microorganism must be Reported.
5.2.2.2. Acute toxicity by inhalation; acute pathogenicity and infectivity.
Situations in which tests are required:
Acute inhalation toxicity (cf. Note 4) as well as the pathogenicity and acute infectivity of the microorganism Must be reported.
5.2.2.3. Single intraperitoneal/subcutaneous dose.
The intraperitoneal/subcutaneous test is considered a highly sensitive mode of highlighting, in particular, infectivity.
Situation where tests are required:
Intraperitoneal injection is routinely required for all microorganisms. However, in the event that the maximum temperature of growth and multiplication is below 37 ° C, it is left to the experts to decide whether it is preferable to substitute a subcutaneous injection for injection Intraperitoneal.
5.2.3. Genotoxicity tests.
Situation in which tests are required:
If the microorganism produces exotoxins as defined in point 2.8, these toxins and any other sensitive metabolite present in the culture medium must also be Tested for genotoxicity, if possible, on a purified form of the chemical.
When the basic studies do not reveal the formation of toxic metabolites, the microorganism itself should be examined. Based on expert advice on the importance and validity of the baseline data. In the case of viruses, there is a need to examine the risk of insertional mutagenesis in mammalian cells and the risk of carcinogenesis.
Test object:
These studies have an interest in:
-the prediction of power Genotoxic;
-early identification of genotoxic carcinogens;
-an explanation of the mechanism of action of some carcinogens.
It is important to adopt a flexible attitude, the other tests to be performed as a function of Interpretation of the results at each step.
Test procedures (cf. Note 5):
The genotoxicity of cellular microorganisms should be studied, to the extent possible, after the cell partition. The method of sample preparation should be described. The genotoxicity of viruses should be investigated on infectious isolates.
5.2.3.1. In vitro tests.
Situations in which tests are required:
The results of in vitro mutagenesis tests (bacterial assay for gene mutation, clastogenicity testing in mammalian cells) should be provided. And gene mutation test in mammalian cells).
5.2.4. Study of cell cultures.
This information is required for replicable intracellular micro-organisms such as viruses, viroids, certain bacteria and certain protozoa, except in cases where it is clear from the Information provided in Sections 1 and 3 that the micro-organisms concerned do not replicate in hot-blooded organisms. The study to be carried out must involve cultures of human cells or tissues from different organs, selected for example on the basis of organs potentially affected by infection. If cultures of human cells or tissues from specific organs are not available, it is possible to use cultures of cells and tissues from other mammals. For viruses, the ability to interact with the human genome is a key element.
5.2.5. Information on short-term toxicity and pathogenicity.
Purpose of the test:
Short-term toxicity studies should be designed to provide information on the amount of micro-organism that can be tolerated without causing Toxic effects under the conditions of the study. These studies provide useful data on the risks faced by people who handle and use preparations containing the microorganism. In particular, short-term studies provide an important insight into the potential cumulative effects of the micro-organism and the risks to workers who are exposed to it in an intensive way. In addition, they provide useful information for the design of chronic toxicity studies.
Studies, data and information to be provided and evaluated must be sufficient to detect effects resulting from a Repeated exposure to the microorganism and, in addition, to establish or indicate in particular:
-the relationship between the dose and the adverse effects;
-the toxicity of the microorganism, including the NOAEL, if any, (level with no negative effect Visible) corresponding to the toxins;
-the target organs, if any;
-the evolution over time and the characteristics of the effects, with a comprehensive description of the behavioural changes and any findings Pathology to post-mortem inspection;
-specific toxic effects and induced pathological changes;
-where applicable, persistence and reversibility of some toxic effects observed following an interruption Administration;
-if possible, the toxic mode of action; and
-the relative risks associated with the various routes of exposure.
An estimate of the removal of the microorganism in the main organs must be carried out at the Short-term toxicity study. It must also include research on the endpoints of pathogenicity and infectivity.
Circumstances in which tests are required:
Short-term toxicity of the microorganism (at least 28 days) Must be described. The choice of the type of test should be justified and the duration of the study should be based on the data on acute toxicity and the elimination of the microorganism. The best route of administration should be selected from the expert opinion.
5.2.5.1 Health effects after repeated inhalation exposure.
Information on health effects following repeated inhalation exposure is Considered necessary, particularly for risk assessment in the workplace. Repeated exposure may affect the ability to remove the host (human), including by strengthening the resistance of the microorganism. In addition, for a good risk assessment, toxicity after repeated exposure to contaminants, culture medium, adjuvants and micro-organism should be investigated, not to mention the adjuvants contained in the product. Plant protection may affect the toxicity and infectivity of a microorganism.
Situations in which the test is required:
Information on the infectivity, pathogenicity and short-term toxicity of the Micro-organisms (respiratory tract) are required, unless information already provided is sufficient to assess the health effects of individuals. This may be the case if it is shown that the test substance has no respirable fraction and/or repeated exposure is not considered.
5.2.6. First aid and medical treatment.
The first aid to be applied in the event of infection or eye contamination should be provided.
The treatment regimen to be implemented in the event of ingestion or Contamination of the eyes or skin should be fully described. Where appropriate, any available information on the efficacy of alternative therapeutic regimes, based on practical experience or, failing that, on theoretical considerations,
be provided. Information on antibiotic resistance should also be provided
5.3. Specific toxicity studies,
of pathogenicity and infectivity
In some cases, additional studies may be required to clarify adverse effects on individuals.
Studies of Toxicity, pathogenicity and chronic infectivity, and carcinogenicity and reproductive toxicity should be performed when the results of previous studies indicate that the microorganism can have long-term effects Health term. In cases where a toxin is produced, kinetic studies should also be carried out.
The studies required can be designed on an individual basis, taking into account the specific parameters to be examined and the objectives to be achieved. Reach. Prior to commencing such studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried out.
5.4. In vivo somatic cell studies
situations in which tests are required:
If the results of in vitro studies are all negative, additional tests should be performed on the basis of others Useful information available. This may be an in vivo or in vitro study using a metabolic system different from that used previously.
If in vitro cytogenetic testing is positive, somatic cells should be tested in vivo (analysis of metaphase of rodent bone marrow cells or micronucleus test in rodents).
If either of the in vitro gene mutation tests is positive, then either an in vivo test should be performed to analyze the Unscheduled synthesis of DNA, one " Spot test " Mouse.
5.5. Genotoxicity. -In Vivo Germ Cell Studies
Test Object and Terms:
See point 5.4.
Situations where the test is required:
If any of the results of in vitro tests performed on Somatic cells are positive, carrying out an in vivo test to determine the effects on germ cells can be justified. The need to carry out these tests must be examined on a case-by-case basis, taking into account the other available information, in particular on the modalities of use and the foreseeable situations of exposure. Appropriate tests (such as the dominant lethality test) will be required to examine the interaction with DNA, to determine the possibility of developing heritable effects and, if possible, to carry out a quantitative estimate. Given the complexity of this type of study, it is recognized that the use of quantitative studies requires a solid justification
5.6. Summary:
toxicity, pathogenicity and infectivity for mammals and global assessment
A synthesis of all data and information provided under points 5.1 to 5.5 must be presented. Include a detailed and critical assessment of the data on the basis of relevant criteria and guidelines for evaluation and decision-making, particularly in view of the potential or actual risks to human beings And the extent, quality and reliability of the database.
It is important to explain whether the exposure of animals or humans has implications for vaccination or serological control.
6. Residues in or on processed products,
food and feed
Introduction
i) The information provided, combined with the information presented for one or more preparations containing the Micro-organisms must be sufficient to carry out an assessment of the risks to humans and/or animals of exposure to the micro-organism such as residues and metabolites (toxins) which it leaves in or on plants or products Plant protection.
(ii) In addition, the information provided must be sufficient for:
-Decision on whether the micro-organism should be included in Annex I to Council Directive 91 /414/EEC on The market for plant protection products;
-specify the appropriate conditions or restrictions to accompany any inclusion in Annex 1 of Council Directive 91 /414/EEC on the placing on the market of products Plant protection;
-where appropriate, fix maximum residue levels, pre-harvest time limits to protect consumers and waiting periods to protect crops and crops Processed products.
(iii) For the assessment of residues risks, experimental data concerning exposure levels to residues are not always required as long as it can be demonstrated that the micro-organism and its Metabolites are not harmful to human persons at the concentrations expected for the authorized use. The corresponding demonstration elements may be based on public bibliographic sources, practical experience and the information referred to in Sections 1, 2, 3 and 5.
6.1. Persistence and probability of multiplication in or on crops, animal feed or food
A duly justified estimate of the persistence/competitiveness of the micro-organism and its metabolites should be provided Sensitive secondary (especially toxins) in or on crops in the usual environmental conditions at the time of intended use, taking into account, in particular, the information presented in Section 2
In addition, the application file must specify to what extent and on what basis it is believed that the microorganism possesses (or not) the ability to multiply in or on plants or plant products or during processing operations of the Raw products.
6.2. Additional Information Required
Consumers can be exposed to micro-organisms for a considerable amount of time as a result of the consumption of processed foods. Therefore, the potential effects on consumers should be determined on the basis of chronicity or semi-chronicity studies to define, for risk management purposes, a toxicological threshold (e.g., DJA
. Non-viable residues.
A non-viable microorganism is a microorganism that is unable to reproduce or transfer genetic material.
If section 2, points 2.4 and 2.5, reveals the persistent nature of sensitive amounts of the Micro-organism or metabolites produced by the latter, especially toxins, it is necessary to provide a comprehensive statement of the experimental data on the residues referred to in Annex I, Part A, Section 6, as soon as the micro-organism and/or its Toxins are likely to be found on or in foods or foods treated at concentrations above observed levels under natural conditions or in a different phenotypic state.
Findings Relating to Difference Between natural concentrations and high concentrations due to treatment by the microorganism must be based on experimental data, not extrapolations or calculations made from models.
Prior to commencing such studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried
. Viable residues.
If the information provided in accordance with point 6.1 suggests that there is a persistence of a significant amount of micro-organism on or in the products, foodstuffs or feedingstuffs treated, it should be studied Possible effects on human beings and/or animals, unless it is demonstrated under Section 5 that the micro-organism and its metabolites and/or products resulting from their degradation do not present a risk to humans in The condition and concentrations corresponding to the permitted use.
The conclusions regarding the difference between natural and high concentrations due to treatment by the micro-organism must be based on Data obtained by the experimental track, and not on extrapolations or calculations made from models.
The persistence of viable residuals should be given special attention if the information provided under the sections 2.3, 2.5 or 5 is a mammalian infectivity or pathogenicity and/or if any other information suggests a risk to consumers and/or professionals. In this case, the competent authorities may require studies similar to those set out in Part A.
Before undertaking such studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried out.
6.3. Summary and evaluation of the behaviour of the residues,
based on the data provided in accordance with points 6.1 and 6.2
7. Becoming and Behavior in the Environment
Introduction
i) Information about the origin, properties and survival of the microorganism and its residual metabolites, as well as the proposed use of the Microorganism forms the basis for the assessment of its fate and behaviour in the environment.
Experimental data are normally required, unless it can be demonstrated that this assessment is feasible from the Information already available. The corresponding demonstration elements may be based on public bibliographic sources, practical experience and the information referred to in Sections 1 to 6. Particular attention will be paid to the function of the micro-organism in environmental processes (as defined in Section 2, point 2.1.2).
(ii) The information provided, together with other relevant information, and in particular Which concern one or more preparations containing the microorganism, must be sufficient to assess the fate and behaviour of the microorganism, its residual traces and its toxins when they present a risk to the Human health and/or the environment.
(iii) In particular, the information provided must be sufficient to:
-decide whether or not the micro-organism can be included in Annex I to Council Directive 91 /414/EEC on the Placing plant protection products on the market;
-specify the appropriate conditions or restrictions to accompany any inclusion in Annex I to Council Directive 91 /414/EEC on the placing on the market of products Plant protection;
-definition of hazard symbols (once introduced), warnings and standard references to the nature of risks and precautionary statements for the protection of the environment to be included on the Packaging (containers);
-predict the dispersion, fate and behaviour in the environment of the micro-organism and its metabolites as well as the corresponding durations;
-identify the measures necessary to limit to the minimum Contamination of the environment and impacts on non-target species.
(iv) Any sensitive metabolite (i.e., which poses a risk to human health and/or the environment) produced by the test organism under all conditions Appropriate environmental assessment should be carried out. In cases where sensitive metabolites are present in or produced by the micro-organism, the data set out in Annex I, Part A, point 7 may be required as soon as all the following conditions are met:
-the Sensitive metabolite is stable outside the micro-organism (see paragraph 2.8);
-the toxic effect of the metabolite is independent of the presence of the microorganism;
-the sensitive metabolite is expected to be found in the environment Levels considerably higher than under natural conditions.
v) Information available on links with wild relatives in nature should be taken into account.
vi) Before engaging It is for the applicant to obtain the agreement of the competent authorities on the appropriateness of carrying out such studies and, if so, on the type of studies to be undertaken. The information in the other sections must also be considered.
7.1. Persistence and multiplication
Relevant information should be provided, where appropriate, on the persistence and multiplication of the micro-organism in all environmental media, giving attention to Particular:
-to competitiveness under normal environmental conditions at the time of the proposed use and after the proposed use;
-to population dynamics under climates marked by extremes of seasonal nature or Regional (particularly hot summers, particularly cold winters, heavy precipitation) and agricultural practices implemented after the application of the product.
Estimated levels of presence of the product should be indicated. Microorganism over a period of time after use of the product under the proposed conditions.
7.1.1. Soils.
Information on population viability/dynamics should be presented for several types of cultivated or uncultivated soil characteristic of the different regions of the Community where the use of the product is foreseen or Already effective. It is appropriate for this purpose to observe the provisions laid down in Part A, point 7.1, introduction, with regard to the choice and method of soil sampling. If the test organism is intended to be used in combination with other constituents such as rock wool, these should be included in the battery of tests.
7.1.2. Water.
Information should be provided on the viability/population dynamics of the micro-organism in sedimentary/hydraulic systems, both in the dark and in the light.
7.1.3. Air.
In the event of specific concerns related to the exposure of operators, workers or any other person present, information on concentrations in the air may be required.
7.2. Mobility
The potential spread of the organism and products resulting from its degradation in all environmental media must be evaluated, unless it can be demonstrated that any exposure of the Different media considered to be micro-organisms is unlikely.
In this perspective, attention will be paid specifically to intended use (in fields or under greenhouse, soil or crop application), to the life cycle of the Microorganism and its various stages, the presence of vectors, the persistence and the ability of the microorganism to colonize adjacent habitats.
The spread, persistence and probable dispersal distances call a Particular attention if toxicity, infectivity or pathogenicity have been reported or if other information suggests the possibility of risk to humans, animals or the environment. In this case, the competent authorities may require studies similar to those set out in Part A. Prior to commencing such studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried out.
8. Effects on non-target organisms
Introduction
i) Information on the identity and biological properties as well as the additional information referred to in Sections 1 to 3 and 7 are critical to assess Effects on non-target species. In addition, useful information on, on the one hand, the fate and behaviour of the micro-organism in the environment and, on the other hand, the levels of residues in plants are, respectively, in Sections 7 and 6. Associated with information about the nature of the preparation and how it is used, they are used to define the nature of the potential exposure and to delineate its extent. The information provided under Section 5 provides essential information on the effects on mammals and the mechanisms involved. Experimental data are normally required, unless it can be demonstrated that the assessment of effects on non-target organisms is feasible based on the information already available.
ii) Selection of non-target organisms Inclusion in the study of environmental effects should be based on the nature of the organism (including host specificity, mode of action, and ecological functioning of the organism). These elements should make it possible to select for testing the appropriate bodies, i.e., bodies closely related to the target organism.
(iii) The information provided, together with those relating to one or more Preparations containing the microorganism, must be sufficient to allow an assessment of the effects on non-target species (flora and fauna) whose exposure to the microorganism can be dangerous, when they are important for Environment. These effects may be due to a single, prolonged or repeated exposure and may be reversible or irreversible.
iv) In particular, the information provided on the microorganism, together with other relevant information and Information relating to one or more preparations containing the micro-organism, must be sufficient for:
-decide whether or not the micro-organism can be included in Annex I to Council Directive 91 /414/EEC on The market for plant protection products;
-specify the appropriate conditions or restrictions to accompany any inclusion in Annex I to Council Directive 91 /414/EEC on the placing on the market of products Plant protection;
-allow for short-term and long-term risk assessment for non-target species (populations, communities and processes, as the case may be);
-classify the microorganism according to the biological risks Present;
-specify precautions to be taken to protect non-target species; and
-define hazard symbols (once introduced), warnings and standard references to the nature of risks and advice Caution for the protection of the environment to be included on packaging (containers).
v) All potentially adverse effects noted during routine environmental effects investigations should be mentioned. It is also appropriate, at the request of the competent authorities, to carry out and record the additional studies which would prove necessary in order to identify the mechanisms that may be involved and to assess the significance of the effects observed. It is essential to report all available biological information and information to the assessment of the ecological profile of the micro-organism.
vi) For all studies, the average dose used, expressed in colonizing units Per kilogram of body weight and in other appropriate units should be mentioned.
vii) Separate studies on sensitive metabolites (including toxins) may be required when these products can present a risk Not negligible for non-target organisms and the results of the micro-organism studies do not permit an assessment of their effects. Before undertaking the work, it is for the applicant to obtain the agreement of the competent authorities on the desirability of carrying out such studies and, if so, on the type of studies to be undertaken. The information referred to in Sections 5, 6 and 7 shall be taken into account.
(viii) To facilitate the evaluation of the results obtained and their scope, as far as possible, it should be used for the different tests Strain (or certified origin) of each species concerned.
ix) Testing is mandatory unless it can be demonstrated that the non-target organism will not be exposed to the microorganism. If it is shown that the organism has no toxic, pathogenic or infectious effects on vertebrates or plants, investigations are limited to the reactions of the appropriate non-target organisms.
8.1. Bird Effects
Test Object:
Information must be provided on the toxicity, infectivity, and pathogenicity of birds.
8.2. Effects on Aquatic Organisms
Test Object:
Information should be provided on toxicity, infectivity and pathogenicity for aquatic organisms.
8.2.1. Effects on fish.
Purpose of the test:
Information should be provided on toxicity, infectivity, and pathogenicity for fish.
8.2.2. Effects on freshwater invertebrates.
Purpose of the test:
Information should be provided on toxicity, infectivity and pathogenicity for freshwater invertebrates.
8.2.3. Effects on algal growth.
Test object:
Information must be provided for effects on algal growth, growth rate, and recovery capacity.
8.2.4. Effects on plants other than algae.
Test Object:
Information must be provided for effects on plants other than algae.
8.3. Effects on Bees
Test Object:
Information must be provided on toxicity, infectivity, and pathogenicity for bees.
8.4. Effects on arthropods other than bees
Purpose of the test:
Information must be provided on toxicity, infectivity, and pathogenicity for arthropods other than bees. The species to be included in the test must be selected on the basis of the potential uses of the plant protection products concerned (e.g. leaf application or on the soil). Particular attention should be paid to biological control organisms and those that play an important role in an integrated pest management system.
8.5. Effects on earthworms
Test object:
Information must be provided on toxicity, infectivity, and pathogenicity to earthworms.
8.6. Effects on non-target
micro-organisms present in soils
Effects on non-target microorganisms and their predators (for example, protozoa, in the case of bacterial inoculants) must be Reported. An expert opinion is required to decide whether further studies should be undertaken.
This decision must take into account the information available under this section, but also other sections, and Data relating to the specificity of the microorganism and the exposure situations. Efficacy testing observations can also provide useful information.
Special attention should be given to agencies used in integrated crop management.
8.7. Additional Studies
Additional studies may include other pointed studies of additional species or systems (such as a sewer system) or studies at a higher level, by For example, the chronic or sublethal effects on certain non-target organisms or the effects on their reproduction.
Before beginning these studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried out.
9. Summary and Environmental Impact Assessment
A synthesis and evaluation of all environmental impact data should be developed. The document should include a critical and detailed assessment of these data in the context of important guidelines and criteria for evaluation and decision-making, with particular attention to potential risks, or The environment and non-target species, as well as the importance, quality and reliability of the database. These include:
-dissemination and fate in the environment, with reference to corresponding durations;
-identification of non-target species and populations likely to be affected, and the extent of Potential exposure;
-identification of precautions necessary to avoid or minimize environmental contamination and protect non-target species. "
Schedule II of the Order of September 6, 1994, is amended as follows:
1. A 2.6 point is added in the introduction and written as follows:
" 2.6. By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses carried out in order to collect data on properties and/or safety with regard to aspects other than health May be carried out by official or officially recognised experimental services or bodies performing at least the conditions set out in points 2.2 and 2.3 of the introduction to Annex II. "
2. Part B reads as follows:
Introduction
i) The This Part sets out the data required for the authorisation of plant protection products based on preparations of micro-organisms, including viruses.
The definition of the term " microorganism as it appears in the introduction of Annex I, Part B, also applies to Annex II, Part B.
(ii) Where appropriate, the data are analysed using appropriate statistical methods. Statistical analyses should be reported in detail (for example, all point estimates should be delimited by a confidence interval and the exact probability values should be provided instead of Use the statement " significant/non-significant.
(iii) Pending the adoption of specific procedures at the international level, the required information will be obtained by applying the test procedures adopted by the authority Competent [such as those of the USEPA, for example (cf. (6)]; where appropriate, the procedures described in Annex I, Part A, should be adapted so that they may be suitable for micro-organisms. Tests shall be carried out on viable micro-organisms and, where appropriate, non-viable and contain a blank check.
iv) If a study involves the use of different doses, the relationship between the dose and the adverse effect must be Note:
(v) For the tests carried out, a detailed description (technical specifications) of the equipment used and the impurities contained therein should be provided in accordance with the provisions of Section l, point 1.4.
vi) Where a New preparation must be considered, the extrapolation from Annex I, Part B, is acceptable, provided that all the possible effects of adjuvants and other components, including the pathogenic and infectious power, are also Evaluated.
1. Identity of the plant protection product
The information provided, together with the data required for micro-organisms, must be sufficient to enable precise identification and definition of the Preparations. The information and data mentioned, unless otherwise specified, is required for all plant protection products. The objective is to determine whether any factor may alter the properties of the micro-organism as a plant protection product, as opposed to the micro-organism as such, which is the subject of Annex 1, Part B, of the present Stopped.
1.1. Applicant
The name and address of the applicant (permanent address in the Community) must be indicated, along with the name, quality, telephone and fax numbers of the contact person.
If, in addition, the The applicant has an office, agent or representative in France, the name and address of the office, agent or local representative must be provided as well as the name, quality, telephone and fax numbers of the person in question. Contact.
1.2. Manufacturer of the preparation and/or micro-organism (s)
The name and address of the manufacturer of the preparation and of each microorganism contained in it must be provided, as is the name and address of each Installation in which the preparation and the microorganism are produced.
A point of contact (preferably a central point of contact with name, telephone and fax numbers) must be indicated for each manufacturer.
When the Micro-organism originates from a manufacturer for which the data set out in Annex I, Part B, have not been communicated, the detailed information required in Annex I, Part B, Section 1.3, with regard to the name and description of the species As well as those required in Schedule I, Part B, section 1.4, with respect to impurities must be provided.
1.3. Proposed trade name or trade name and, if applicable, development code number assigned to the manufacturer for the preparation
All trade names, old and current, proposed trade names and development code numbers of the The preparation referred to in the file and the names and current numbers must be provided. Full details of any possible differences should be provided. (The proposed trade name should not be confused with the trade name of plant protection products already authorized.)
1.4. Detailed quantitative and qualitative information
on the composition of the preparation
i) Each of the microorganisms covered by the application must be identified and designated by its species name. The microorganism must be deposited with a collection bank of internationally recognized cultures and be assigned a deposit number. The scientific name must be indicated along with the group assignment (bacteria, viruses, etc.) And any other name for the microorganism (for example, strain, serotype). In addition, the stage of development of the micro-organism in the marketed product (for example, spores or mycelium) must be specified.
ii) With regard to preparations, the following information must be communicated:
-the content In micro-organism (s) of the plant protection product and the micro-organism content of the equipment used in the manufacture of plant protection products. The maximum content, minimum content and nominal content of viable material and non-viable material must be specified;
-the content of the adjuvants;
-the content of other components (such as by-products, condensates, environment Culture, etc.) And micro-organisms contaminants, derived from the production process.
The content shall be expressed in accordance with the terms set out in section 34 (c) of this Order for chemical substances and as appropriate for micro-organisms (number of active units per unit of volume or weight or any other suitable means for the microorganism concerned).
(iii) Adjuvants are, if possible, identified either by the chemical name specified in Annex I to the decree of 20 April 1994 Amendments relating to the declaration, classification, packaging and labelling of substances, or, if they are not included, in accordance with the nomenclature of UICPA and the Governing Council. The structure or formula developed should be specified. For each component of the adjuvants, indicate, if available, the UNECE number (Einecs or Elincs) and the CAS number. If the information provided does not permit the full identification of an adjuvant, appropriate specifications should be provided. If it exists, the trade name of the adjuvants should also be indicated.
(iv) The adjuvants function must be specified:
-adhesive;
-antifoam agent;
-antifreeze;
-binding;
-buffer;
-carrier agent;
- Deodorant;
-dispersant agent;
-colorant;
-emetic;
-emulsifier;
-fertilizers;
-fragrant agent;
-perfume;
-conservative;
-propellant;
-repellent;
-phytoprotec;
- Solvent;
-stabilizer;
-synergist;
-thickening;
-wetting agent;
-various (to be specified).
iv) Identification of contaminants and other components of the production process.
Micro-organisms must be identified in accordance with the provisions of Annex I, Part B, Section 1, point 1.3.
Chemical substances (inert components, sub-products, etc.) Shall be identified in accordance with the provisions of Annex I, Part A, Section 1, point 1.10.
Where the information provided does not permit the identification of a component, such as condensate or the culture medium, Detailed information must be given on the composition of each of these components.
1.5. Nature and physical state of preparation
The type and code of preparation must be specified in accordance with the Catalogue of Pesticide Formulation Types and the International Code System (Technical Monographs GIFAP No. 2, 1989).
Where a given preparation is not specifically defined in this publication, a complete description of the nature and physical condition of the preparation and a description proposal should be provided. Appropriate preparation type and corresponding definition proposal.
1.6. Function
The biological function should be retained among the following:
-bactericide;
-fungicide;
-insecticide;
-acaricide;
-molluscicide;
-nematocidal;
-herbicide;
-other (specify).
2. Physical, chemical, and technical
of the plant protection product
It is necessary to indicate the extent to which the plant protection products for which the authorisation is sought are in conformity with the Corresponding FAO specifications, established by the Expert Group on Pesticide Specifications of the FAO Expert Group on Specifications, Certification Criteria and Pesticide Application Standards. Any differences in the FAO specifications should be described in detail and justified.
2.1. Appearance (colour and odour)
A description of the colour and odour, if any, and the physical state of the preparation must be provided.
2.2. Storage stability and retention time
2.2.1. Impact of light, temperature and humidity on the technical characteristics of the plant protection product.
i) The physical and biological stability of the preparation at the recommended storage temperature and the Growth of contaminant micro-organisms must be identified and described. The conditions for carrying out the test must be justified.
(ii) In addition, for liquid preparations, it is necessary to determine and describe the impact of low temperatures on stability in accordance with CIMAP methods (cf. Note 7) MT 39, MT 48, MT 51 or MT 54, as applicable.
(iii) The shelf life of the recommended storage temperature should be specified.
If it is less than two years, this duration should be indicated in months, in Giving the appropriate temperature specifications. Monograph No. 17 of the GIFAP (cf. Note 8) contains useful information.
2.2.2. Other factors affecting stability
The impact of exposure to air, packaging, etc. on product stability needs to be assessed.
2.3. Explosive and oxidizing properties
The explosive and oxidizing properties will be determined as provided for in Annex II, Part A, section 2, point 2.2, unless the utility of such a study on the technical level or Can be demonstrated.
2.4. Inflammation point and other indications
on flammability or spontaneous ignition
The explosive and oxidizing properties shall be determined as provided for in Annex II, Part A, section 2, point 2.3, unless The inutility of such a technical or scientific study cannot be demonstrated.
2.5. Acidity, alkalinity and, if necessary, pH value
Acidity, alkalinity and pH will be determined as provided for in Annex II, Part A, Section 2, point 2.4, unless the inutility of such a study on the plan Can be demonstrated.
2.6. Viscosity and surface tension
Viscosity and surface tension will be determined as provided for in Annex II, Part A, section 2, point 2.5, unless the technical usefulness of such a study Or scientist cannot be demonstrated.
2.7. Technical characteristics of the plant protection product
The technical characteristics of the preparation must be determined for a decision on its acceptability. If tests are required, they must be performed at temperatures that allow the survival of the microorganism.
2.7.1.
wettability of solid preparations used in dilution (for example, wettable powders and hydrodispersible granules) shall be determined and described in accordance with the method CIMAP MT 53.3.
2.7.2. Persistent foam formation.
The persistence of foam in preparations to be diluted in water must be determined and described in accordance with the method CIMAP MT 47.
2.7.3. Faculty of suspension and stability of suspension.
It is necessary to determine and describe the ability to suspend hydrodispersible products (wettable powders, hydrodispersible granules, concentrated suspensions, by Example) in accordance with the method CIMAP MT 15, MT 161, or MT 168, as the case may be.
For hydrodispersible products (e.g., concentrated and water-dispersible suspensions), the spontaneity of dispersion must be determined and Described in accordance with the methods CIMAP MT 160 or MT 174, as applicable.
2.7.4. Test of wet sieve, test of dry sieve
In order to ensure particle size distribution in powdery powders that make their use easy, a dry sieve test should be performed and described in accordance with Method CIMAP MT 59.1.
For hydrodispersible products, a wet sieve test shall be carried out and described in accordance with the method CIMAP MT 59.3 or MT 167, as applicable.
2.7.5. Particle size distribution (powders for powder and wettability, granules), dust/fine particles (granules), wear and friability (granules).
i) If powders are, particle size distribution must be Determined and described in accordance with OECD Method 110.
The nominal grain size for a direct application shall be determined and described in accordance with the CIMAP MT 58.3 method and the granulate method Hydrodispersible in accordance with the method CIMAP MT 170.
ii) The dust content of the granulated preparations shall be determined and described in accordance with the method CIMAP MT 171. If the operator exposure is to be evaluated, the size of the dust particles should be determined and described in accordance with OECD method 110.
iii) The characteristics of the friability and wear of the granules will be determined And described as soon as methods have been adopted at international level. If data is already available, it must be specified, along with the method used.
2.7.6. Emulsibility, emulsibility and stability of emulsion.
i) Emulsibility, emulsion stability and emulsibility of emulsion preparations should be determined and described in accordance with CIMAP MT 36 or MT methods 173, as applicable.
ii) The stability of dilute emulsions and preparations in the form of emulsions shall be determined and described in accordance with the method CIMAP MT 20 or MT 173.
2.7.7. Flow, discharge (rinse) and dust processing faculty.
i) The flow capacity of granulated preparations shall be determined and described in accordance with CIMAP MT 172.
ii) Faculty Discharge (including rinse residue) of suspensions (e.g., concentrated suspensions or suspoemulsions) shall be determined and described in accordance with the method CIMAP MT 148.
iii) The Faculty of Dust Transformation must be Determined and described in accordance with the method CIMAP MT 34 or any other appropriate method.
2.8. Physical, chemical and biological compatibility with other products, including plant protection products, with which to allow the use of the preparation
2.8.1. Physical compatibility.
The physical compatibility of recommended vat mixtures must be determined and described.
2.8.2. Chemical compatibility.
Chemical compatibility of recommended tank mixtures must be determined and described, except when the examination of the specific properties of the preparations establishes with a sufficient degree of certainty that no reaction Cannot take place. In this case, it is sufficient to provide this information to justify the inutility of an effective chemical compatibility determination.
2.8.3. Biological compatibility.
The biological compatibility of the tank mixtures must be determined and described. Effects (e.g., antagonism or fungicidal effects) on the activity of the micro-organism after mixing with other micro-organisms or chemicals should be described. The possible interaction of the plant protection product with other chemicals to be applied to crops under the planned conditions of use of the preparation should be investigated on the basis of the data on efficacy. In order to avoid any loss of efficacy, it is necessary to specify, where appropriate, the intervals between the application of the biological pesticide and the application of chemical pesticides.
2.9. Seed Adherency and Distribution
When preparations are for seed treatment, both the distribution and the adhesion must be studied and described; in the case of distribution, proceed In accordance with CIMAP MT 175.
2.10. Summary and evaluation of data provided
under points 2.1 to 2.9
3.
3.1 application data. Proposed Agricultural Use
Specify the current and proposed agricultural use (s) of the preparations containing the micro-organism, among the uses of the agricultural use catalogue.
3.2. Mode of action
Possible routes of absorption of the product (contact, ingestion or inhalation, for example) or pest control (fungitoxic action, fungistatic action, nutritional competition, etc.)
the translocation is apoplastic, symplastic or both.
3.3, it is necessary to indicate whether the product is being translocated into the plants. Terms and conditions of intended use
The terms and conditions of the intended use, such as the types of organisms to be combed and/or plants or plant products to be protected, must be specified.
It is appropriate Also to indicate the intervals to be observed between the application of the plant protection product containing micro-organisms and that of chemical pesticides, or to provide a list of active substances present in products Chemical plant protection not to be used with the plant protection product containing microorganisms on the same culture.
3.4. Application Dose
For each application method and use, the application dose per treated unit (ha, m², m³) must be specified in grams, kilograms or litres for preparation and in units Appropriate for the microorganism.
Application doses are normally expressed in grams or kilograms/ha or in kilograms/cubic metres and, where applicable, in grams or kilograms/tonne; for greenhouses and gardens Household, the doses are indicated in grams or kilograms/100 square metres or in grams or kilograms/cubic metres.
3.5. Microorganism content of the equipment used (for example in the diluted spray product, bait or seed treated)
The micro-organism content is specified in the number of active/millilitre units, in grams or in any other Appropriate unit, as applicable.
3.6. Application Method
The application method should be described in full, indicating, where applicable, the type of equipment to be used, and the type and volume of diluent to be used per unit of surface or unit. Volume.
3.7. Number and timing of
applications and duration of protection
The maximum number of applications with their calendar should be specified. Where appropriate, the stages of development of the crop or plants to be protected, as well as those of harmful organisms, must also be specified. If possible and if necessary, the interval between two applications should be specified in a number of days.
Also indicate the amount of protection for each application and the maximum number of applications.
3.8. Wait periods required or other precautions to be taken
to avoid any phytopathogenic effects on subsequent crops
If applicable, indicate, on the basis of the data provided for in Section 6, point 6.6, the minimum necessary waiting period between the last application and the seeding or planting of the following crops to prevent any phytopathogenic effects on the latter.
Indicate any limitations on the choice of Next cultures.
3.9. Proposed Usage Guidelines
The proposed use instructions for preparing, for printing on labels and notices, must be specified.
4. Additional information
on the
4.1 plant protection product. Packaging and compatibility of the
preparation with the proposed packaging materials
i) The packaging to be used must be described and specified in an exhaustive manner, specifying the materials used, the method of manufacture (e.g., extrusion, welding, etc.), size and capacity, size of opening, type of closure and sealing. It shall be designed in accordance with the criteria and guidelines specified in the FAO Guidelines for the Packaging and Storage of Pesticides.
(ii) The suitability of the packaging, including the closing devices, on the plan The strength, impermeability and resistance to normal transport and handling conditions shall be determined and described in accordance with ADR methods 3552, 3553, 3560, 3554, 3555, 3556, 3558 or the appropriate ADR methods for Large bulk receptacles and, if safety closures for children and devices for detecting the hazards to the touch are necessary for the preparation concerned, in accordance with Annex IX to the decree of 20 April 1994 Amendments relating to the declaration, classification, packaging and labelling of substances (concerns provisions on safety closures for children and detection of hazards to touch).
iii) Resistance of the material Package to its contents must be specified as indicated in the GIFAP Product Monograph No. 17.
4.2. Procedures for Cleaning Equipment Used
for Applications
The procedures to be implemented for cleaning application equipment and protective clothing should be described in detail. The efficiency of the cleaning procedure must be determined, using biological tests, for example, and reported.
4.3. Time limits for return, necessary wait times or other precautions to be taken to protect people, livestock and the environment
The information provided must be derived and corroborated by the data provided for the Micro-organisms and those referred to in sections 7 and 8.
i) Where appropriate, it is necessary to specify the pre-harvest waiting times, the return periods and the withdrawal periods necessary to minimise the presence of residues in or On crops, plants and plant products or in treated areas or spaces, in order to protect persons and livestock. For example:
-the pre-harvest wait time (in days) for each crop;
-the return time (in days) of the cattle in the pasture areas;
-the return time (in hours or in days) of the man in the Cultures, buildings or spaces processed;
-the withdrawal period (in days) of feed;
-the waiting period (in days) between the application and handling of the treated products.
ii) If necessary, taking into account the Test results, information should be provided on the particular agronomic, phytosanitary or environmental conditions in which the preparation may or may not be used.
4.4. Recommended methods and precautions for
handling, storage, transport, or fire
Recommended methods and precautions for handling procedures (detailed) in Storage, both at the level of the warehouse and of the user, of plant protection products for transport and in the event of fire must be indicated. Where appropriate, information on combustion products should be provided. Specify the likely risks as well as the methods and procedures to be implemented to minimize hazards. It is also necessary to indicate the procedures to be observed in order to prevent or minimise the formation of waste or any phenomenon of remanence. Where appropriate, an evaluation shall be conducted in accordance with IS0 TR 9122.
The nature and characteristics of the protective clothing and proposed equipment shall be specified. The information provided must be used to assess their suitability and effectiveness under realistic conditions of use (for example, in fields or under greenhouses).
4.5. Accident Measures
The terms and conditions of the measures to be implemented in the event of an accident during transport, storage or use must be specified and include:
-spill containment;
-decontamination of land, vehicles and buildings;
-disposal of damaged packaging, adsorbents and other materials;
-protection of intervention personnel and assistants;
-first measures Backup.
4.6.
destruction or decontamination procedures for the plant protection product and its packaging
The destruction and decontamination procedures shall be developed for small quantities (level of The user) and large quantities (warehouse level). The procedures must comply with the provisions in force concerning the disposal of waste and, in particular, toxic waste. The proposed means of disposal should not have an unacceptable impact on the environment and should be the most practical and cost effective means of disposal.
4.6.1. Controlled incineration.
In many cases, the best or only way to safely dispose of plant protection products, including the adjuvants they contain, contaminated materials or contaminated packaging, is Subject to controlled incineration in an approved incinerator. The applicant must provide the necessary instructions to ensure the security of the operation.
4.6.2. Other methods.
To describe in a comprehensive manner other methods of disposal of plant protection products, packaging and contaminated materials, where they are proposed. Provide information on these methods to determine their effectiveness and safety.
5.
Analysis Methods Introduction
The provisions in this section apply only to the analysis methods required for post-authorization monitoring and follow-up.
To the extent that It is desirable that plant protection products should be free of contaminants. The level of acceptable contaminants must be established by the competent authority on the basis of a risk assessment.
The applicant must ensure continuous quality control of both the production process and the product obtained. The quality criteria applicable to the product should be submitted.
With regard to the analytical methods used for the production of the data required by this Order or for other purposes, the applicant is required to provide a Rationale for the method used. If necessary, specific orders will be developed for these methods on the basis of the same standards as those required for the post-authorisation monitoring and follow-up
. Analysis containing all relevant data relating to the equipment and equipment used and the conditions of application. The applicability of current CIMAP methods should be reported. These methods should, as far as possible, follow the simplest approach, be inexpensive, and use common equipment.
The following definitions apply for the purposes of this section.
Impurities: All Component (including micro-organisms contaminants and/or chemicals) other than the designated micro-organism, arising from the manufacturing process or the degradation that occurred during storage.
Sensitive Impurities: Impurities, as defined above, that pose a risk to human or animal health and/or the environment.
Metabolism: products that result from degradation reactions and biosynthetic reactions in the Micro-organism or in any other organism used for the production of the relevant microorganism.
Sensitive metabolism: metabolites that pose a risk to human or animal health and/or the environment.
Residues: Viable micro-organisms and substances manufactured in significant quantities by micro-organisms, which persist after the disappearance of micro-organisms and pose a risk to human or animal health and/or the environment
Samples should be provided upon request:
i) Samples of the preparation;
ii) Samples of the microorganism as produced;
iii) Pants for pure micro-organism analysis;
iv) Standards for analysis Sensitive metabolites and all other components included in the residue definition;
v) If available, samples of reference materials for sensitive impurities.
5.1. Methods of Analysis of Preparation
Methods for identifying and determining the micro-organism content of the preparation should be provided and described in a comprehensive manner. In the case of a preparation containing several micro-organisms, the methods for identifying and determining the contents of each microorganism should be indicated.
Methods for ensuring regular monitoring of the final product (preparation) to ensure that it does not contain other organisms other than those indicated and to ensure consistency.
Methods of identification of micro-organisms contaminants in the preparation.
Methods should be specified Used to determine the storage stability and shelf life of the preparation.
5.2. Methods of Determination and Quantification of Residues
Analytical methods should be presented for the determination of residues, in accordance with Annex I, Part B, Section 4, Section 4.2, unless it is established that Information already submitted under Annex I, Part B, Section 4, point 4.2, is sufficient.
6. Efficacy Data
The effectiveness data to be provided is defined in Part A of this Annex, Section 6.
7. Effects on human health
In order for toxicity, including the pathogenicity and infectivity of preparations, to be properly assessed, sufficient information should be available for acute toxicity Of the micro-organism, as well as the irritation and sensitization phenomena which it can be responsible for. To the extent possible, additional information on the toxic mode of action, the toxicological profile and any other known toxicological aspects of the microorganism must be presented. Special attention should be given to adjuvants.
Toxicological studies should indicate any signs of infection or pathogenicity. They must also explore the means of disposal.
Given the influence that impurities and other components may have on the toxicological behaviour, it is essential to provide a description for any proposed study Detailed (technical specifications) of the equipment used. Tests shall be carried out with the plant protection product to be authorised. In particular, it must be clear that the micro-organism used in the preparation and the conditions under which it is grown are identical to the microorganism and the culture conditions for which the information and data are submitted Part B.
The study of the plant protection product will be carried out on the basis of sequential tests.
7.1. Basic acute toxicity studies
The studies, data and information to be provided and evaluated must be sufficient to assess the effects of a single exposure to the plant protection product and, in Specific, to determine or indicate:
-the toxicity of the plant protection product;
-the toxicity of the plant protection product to the microorganism;
-the evolution over time and the characteristics of the effects, With a comprehensive description of the behavioural changes and possible macropathological findings in the post-mortem inspection;
-if possible, the toxic mode of action, as well as;
-the relative risks associated with the various pathways
If the emphasis is to be placed on the estimation of the toxicity levels considered, the information obtained must also allow the classification of the plant protection product in accordance with the amended 20 February 1990 order Defining the classification criteria and labelling and packaging conditions for dangerous preparations. Information obtained from acute toxicity tests is particularly useful in assessing potential hazards in the event of an accident.
7.1.1. Acute Oral Toxicity.
Situations where tests are required:
An acute oral toxicity test must always be performed.
Test Guideline:
Tests must be performed according to the method B 1 or B 1a of Annex V to Directive 67 /548/EEC on the classification, packaging and labelling of dangerous substances, as amended in particular by Directive 92 /69/EEC.
7.1.2. Acute inhalation toxicity.
Purpose of the test:
The objective of the test is to determine the inhalation toxicity of the plant protection product in rats.
Situations in which tests are required:
The test must be Carried out when the plant protection product:
-is used with nebulisation equipment, is an aerosol;
-is a powder containing a significant proportion of particles of a diameter < 50 micrometres (> 1 % on the base Weight);
-is applied by air in the case where an inhalation exposure is possible;
-is applied in a manner that induces a significant proportion of particles or droplets of a diameter < 50 Micrometers (> 1 % on the basis of weight);
-contains a volatile component of more than 10 %.
Test Guideline:
Tests are to be carried out in accordance with Method B 2 of Annex V of the Directive 67 /548/EEC on the classification, packaging and labelling of dangerous substances, as amended in particular by Directives 92 /69/EEC and 93 /21/EEC.
7.1.3. Acute percutaneous toxicity.
Circumstances in which tests are required.
An acute percutaneous toxicity test must always be performed.
Test Guideline:
Tests must be performed in accordance with the Method B 3 of Annex V to Directive 67 /548/EEC on the classification, packaging and labelling of dangerous substances, as amended in particular by Directive 92 /69/EEC.
7.2. Additional Studies on Acute Toxicity
7.2.1. Skin Irritation.
Test Object:
The objective of the test is to assess the skin irritant of the plant protection product, including the potential reversibility of the observed effects.
Situations in which tests Are required:
Irritant power of the plant protection product must always be determined, except when adjuvants are not supposed to irritate the skin or when it is shown that the organism does not irritate the skin, or when Any serious risk to the skin may be reasonably excluded, as specified in the test execution guidelines.
Test Guideline:
Tests shall be carried out in accordance with Method B 4 of Annex V of the Directive 67 /548/EEC on the classification, packaging and labelling of dangerous substances, as amended notably by Directive 92 /69/EEC.
7.2.2. Eye irritation.
Purpose of the test:
The objective of the test is to assess the irritant power for the plant protection product, including the potential reversibility of the observed effects.
Situations in which tests Are required:
Irritant power for the eye of the plant protection product should be determined when adjuvants are suspected of causing eye irritation, except in cases where the microorganism is irritating to the eye or Is likely, as indicated in the guidelines for testing, that the eye has serious damage.
Test Guideline:
Eye irritation shall be evaluated in accordance with Method B 5 of Annex V of the Directive 67 /548/EEC on the classification, packaging and labelling of dangerous substances, as amended notably by Directive 92 /69/EEC.
7.2.3. Skin Sensitization
Test Object:
The objective of the test is to provide sufficient information to assess the ability of the plant protection product to cause skin sensitization reactions.
Situations in Which tests are required:
Tests are to be performed when adjuvants are suspected of having dermal sensitization properties, except in cases where it is established that the microorganism (s) or adjuvants are Skin sensitization properties.
Test Guideline:
Tests shall be carried out in accordance with method B 6 of Annex V to Directive 67 /548/EEC on the classification, packaging and labelling of Dangerous substances, as amended in particular by Directive 96 /54/EC.
7.3. Exposure data
Risks to people in contact with plant protection products (operators, third parties, workers) depend on the physical, chemical and toxicological properties of the product Plant protection concerned and the type of product (undiluted/diluted), type of formulation and pathway, degree and duration of exposure. Sufficient information and data shall be collected and reported in order to assess the extent of exposure to the plant protection product likely to occur under the proposed conditions of use. Where there is reason to be concerned about possible dermal absorption on the basis of the information provided on the micro-organism in Annex I, Part B, Section 5, or on the basis of the information concerning the preparation, set out in Annex II, B, this section, additional data on dermal absorption may be required. The results of exposure control during the production or use of the product must be communicated. The information and data referred to above shall serve as a basis for the selection of appropriate protective measures, including the personal protective equipment to be used by operators and workers and to specify on Label.
7.4. Available toxicological data for non-active substances in relation to
A copy of the notification and safety data sheet referred to in R. 231-53 and the safety data sheet should be submitted for each adjuvant. R. 231-53-1 of the Labour Code. All other available information must also be provided.
7.5. Additional studies relating to
associations of plant protection products
Purpose of the test:
It may sometimes be necessary to carry out the studies referred to in points 7.1 to 7.2.3 in the case of association of Several plant protection products, where the label of the product includes indications of use of the plant protection product with other plant protection products and/or mixtures in the reservoir of the apparatus Spray. Decisions concerning the need for further studies must be taken on a case-by-case basis, taking into account the results of acute toxicity studies on different plant protection products, the possibility of exposure to products Involved and available information or practical experience regarding the products or similar products.
7.6. Summary and Assessment of Health Effects
A synthesis of all data and information provided in accordance with points 7.1 to 7.5 must be presented; it must include a detailed and critical assessment Data on the basis of relevant criteria and guidelines for assessment and decision-making, particularly in view of the potential or actual risks to human beings and animals and the extent, Quality and reliability of the database.
8. Residues in or on the products processed,
foodstuffs and feedingstuffs
The same provisions as those referred to in Part B, Part B, Part B, Part B, are applicable; the information required in Under this section shall be provided, unless it is possible to extrapolate the behaviour of the plant protection product to the persistence of residues from the data available for the microorganism. Particular attention should be paid to the influence of substances included in the preparation on the behaviour of the micro-organism and its metabolites, with regard to the persistence of residues.
9. Becoming and Behaviour in the Environment
The same provisions as those referred to in Part B, Part B, Part B, are applicable; the information required under this section shall be provided, unless otherwise specified. It is not possible to extrapolate the fate and behaviour of the plant protection product to the environment based on the data available in Annex I, Part B, Section 7.
10. Effects on non-target organisms
Introduction
i) The information provided, together with the information concerning the microorganism (s), must be sufficient to assess the effects of the product Plant protection, under the proposed conditions of use, on non-target species (flora and fauna). A single, prolonged or repeated exposure may cause reversible or irreversible effects.
ii) The choice of appropriate non-target organisms for the experimental assessment of environmental effects must be based on the Information concerning the micro-organism as required in Annex I, Part B, and information concerning adjuvants and other components, as required in Sections 1 to 9 of this Annex. These elements should make it possible to select for testing the appropriate bodies, e.g., organisms closely related to the target organism.
(iii) In particular, the information on the plant protection product and The other relevant data as well as the information relating to the micro-organism must be sufficient to:
-define the hazard symbols, the warnings and the standard statements relating to the nature of the risks and the advice of Caution for the protection of the environment to be included on packaging (containers);
-allow for short-term and long-term risk assessment for non-target species (populations, communities and processes) Case);
-decide whether special precautions should be taken to protect non-target species.
(iv) All potentially adverse effects identified during routine effects investigations should be reported Environment. It is also appropriate to carry out and report additional studies that would be necessary to identify the mechanisms involved and to assess the significance of the observed effects.
v) In general, much of the data concerning The impact on non-target species required for the authorisation of plant protection products will have been presented and evaluated for the inclusion of the micro-organism (s) in Annex I to Council Directive 91 /414/EEC on the implementation of On the market for plant protection products.
(vi) If it is necessary to have exposure factors in order to decide whether a study is to be carried out, the data obtained in accordance with the provisions of the Annex should be used. II, Part B, Section 9. All relevant data concerning the plant protection product and the micro-organism must be taken into account in the assessment of the exposure. Where appropriate, the parameters provided for in this Chapter should be used. If the available data indicate that the plant protection product has a stronger effect than the micro-organism, the data on the effects of the plant protection product on the non-target organisms for the calculation of the Significant effects/exposure reports.
vii) To facilitate the evaluation of the results obtained and their scope, as far as possible, the same strain of each of the species concerned should be used for different tests.
10.1. Effects on birds
Where the information available on the microorganism does not predict the effects of the plant protection product, the information referred to in Annex I, Part B, should be provided. Section 8, point 8.1, unless it can be demonstrated that any exposure of birds is unlikely.
10.2. Effects on aquatic organisms
Where the information available on the microorganism does not predict the effects of the plant protection product, the information referred to in the Annex should be provided I, Part B, Section 8, Section 8.2, unless it can be demonstrated that any exposure of aquatic organisms is unlikely.
10.3. Effects on bees
Where the information available on the microorganism does not predict the effects of the plant protection product, the information referred to in Annex I, Part B, should be provided. Section 8, point 8.3, unless it can be demonstrated that any exposure of bees is unlikely.
10.4. Effects on arthropods other than bees
Where the information available on the microorganism does not predict the effects of the plant protection product, the information should be provided Annex I, Part B, Section 8, point 8.4, unless it is possible to demonstrate that any exposure of arthropods other than bees is unlikely.
10.5. Effects on earthworms
Where the information available on the microorganism does not predict the effects of the plant protection product, the information referred to in Annex I shall be provided. B, section 8, point 8.5, unless it can be demonstrated that any exposure to earthworms is unlikely.
10.6. Effects on soil micro-organisms
Where the information available on the micro-organism does not predict the effects of the plant protection product, the information referred to in the Annex should be provided I, Part B, Section 8, section 8.6, unless it can be demonstrated that any exposure of non-subject soil microorganisms is unlikely.
10.7. Further studies
An expert opinion is required to decide whether further studies should be undertaken. This decision must take into account the information available under this section but also other sections, including data on the specificity of the microorganism and the exposure situations. Observations made in efficacy tests may also provide useful information in this regard. Special attention should be paid to bodies that are useful in the integrated management of crops, whether they are naturally present or that they have been deliberately introduced. In particular, it is necessary to take into account the compatibility of the product with integrated crop management. Additional studies may include advanced studies of other species or studies at a higher level, for example, in some non-target organisms. Prior to commencing such studies, the applicant must obtain the consent of the competent authorities for the type of studies to be carried out.
11. Summary and Environmental Impact Assessment
A synthesis and evaluation of all environmental impact data should be conducted in accordance with established guidelines. By the competent authorities of the Member States concerning the format of such summaries and evaluations. The document should include a critical and detailed assessment of these data in the context of important guidelines and criteria for evaluation and decision-making, with particular attention to potential risks, or The environment and non-target species, as well as the importance, quality and reliability of the database. In particular, the following topics should be addressed:
-prediction of the spread and fate in the environment, as well as the corresponding durations;
-identification of non-target species and populations likely to be And the estimated magnitude of their potential exposure;
-identification of precautions necessary to avoid or minimize environmental contamination and protect non-target species. "
The Director General of Food, the Director General of Competition, Consumer and Consumer Affairs Fraud, the Director General of Industry, Information and Post Technologies and the Director of Pollution Prevention and the Director of Pollution Prevention shall each have responsibility for the execution of this Order, Which will be published in the Official Journal of the French Republic
Done at Paris, December 17, 2002.
Minister of Agriculture, Food,
Fisheries and Rural Affairs,
For the Minister and delegation:
The General Manager of Power,
C. Geslain-Lanéelle
Minister of Ecology
and Sustainable Development,
For the Minister and delegation:
The Director of Prevention
of the Pollution and risk,
P. Vesseron
Associate Minister for Industry,
For the Minister and Delegation:
The Director General of Industry,
Information Technologies
Entries,
J. Seyvet
Secretary of State
to small and medium-sized enterprises,
to business, crafts,
to liberal professions
and consumption,
For the Secretary of State and by Delegation:
The Director General of Competition,
for
consumption and fraud enforcement,
J.
Gallot
