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Registration Of Plant Protection Products In Order

Original Language Title: Augu aizsardzības līdzekļu reģistrācijas kārtība

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The Cabinet of Ministers of the Republic of Latvia, 1999 October 5, Regulation No. 341 (in Riga. No 53, § 11) plant protection products in order of registration issued under the plant protection act, article 5 (2) of these regulations defines 1 of plant protection products in order of registration.
2. Chemical plant protection product, as well as a plant protection product containing micro-organisms or viruses, are registered only if: 2.1. it contains active substances that are included in the European Community list of active substances registered or for which registration has been submitted to the applicant Member State of the European Union's assessment of their eligibility for inclusion on the list, or the active substance has the composition of the plant protection product, which, after 1 January 1995, recorded seven Member States of the European Union;
2.2. registration the applicant has carried out the tests and studies and submit the appropriate documentation that contains information in accordance with the provisions of annexes 1 and 2;
2.3. in the case of plant protection products in the correct use of the consequences of the use conditions foreseen under this provision in annex 1 and 2 this information, found that: 2.3.1. it does not cause direct or indirect (through drinking water, food or feed) harmful effects on human or animal health or on groundwater;
2.3.2. it does not cause unacceptable adverse effects on the environment (water, air, Earth, soil, species of wild fauna and flora, and any interactions between them, as well as any relationship with living organisms): the behavior of the environment, water pollution risk analysis, including drinking water and groundwater, and the effects on unexpected species meets the requirements;
2.3.3. the active substance, its quantity, toxicological, and ecotoxicological important chemical elements and their compounds, which are compounded by the process of synthesis of active substances, including any synthesis process inevitably encountered the substance and any substance included in the composition of the plant protection product (hereinafter referred to as the Formulants), can be determined by standardized methods of well established;
2.3.4. it has a sufficiently high efficiency, certifying that the person referred to in paragraph 5 in Latvia carried out checks on the effectiveness of the two-year trial results (if the active substance is included in the register of plant protection products (hereinafter register) — one year of testing of effectiveness);
2.3.5. it does not have unacceptable adverse effects on plants or plant products;
2.3.6. the physico-chemical properties have been determined by standardised methods and generally comply with the intended use and storage requirements;
2.3.7. the conditions for use of toxicological and ecotoxicological significance of pesticide residues can be determined by standardized methods of well established;
2.4. packaging shall meet the following criteria: 2.4.1. is the manufacturer for use and storage conditions;
2.4.2. packaging material will not form chemical compounds in the plant protection product packed and not subject to it;
2.4.3. packaging design and the material is such that the plant protection product storage, there is content loss;
2.4.4. the package is designed so that after it closes, no loss of contents;
2.4.5. the package is sealed so that opening it for the first time, the seal is damaged;
2.5. the packaging is labelled as containing the relevant information (annex 3) the Latvian language and meet the following criteria: 2.5.1. marking is located horizontally on one or more surfaces of the packaging;
2.5.2. the dimensions of the label shall be determined taking into account the size of the package: If the packaging capacity of up to three litres, the minimum sizes of the label is 52 x 74 mm; if the packaging capacity of from three to 50 litres, the minimum sizes of the label are 74 x 105 mm; if the packaging capacity of 51 litres up to 500 litres, the minimum sizes of the label is 105 x 148 mm, if the package is greater than 500 litres the minimum size of the label is 148 x 210 mm to any volume 2.5.3 and the mass of the plant protection product according to the label of the packaging for classification are defined in the hazard symbols. Each hazard symbol occupy not less than one-tenth of the surface of the label or not less than one square centimeter;
2.5.4. the labelling of the packaging are fully glued;
2.5.5. the basic colour of the marking is such that the hazard symbols clearly stand out;
2.5.6. the mark, there is no indication that the plant protection product does not pose any threat, for example, "not" dangerous "," not "harmful".
3. plant protection products which contain parazītisko and plēsīgo in living organisms, are registered if registration is submitted by the applicant to the established scientific and technical level information (annex 4), labelling of those products meeting the requirements of this Regulation (annex 3), and if the registration applicant has made efficiency testing.
4. compliance with the rules referred to in point 2.3 conditions and this provision in paragraph 3, the requirements shown by official (or as official recognized) trials and analyses made in Latvia the relevant harmful organisms, and environmental (including climatic) conditions.
5. verification of the effectiveness tests be carried out by qualified persons on the basis of good research practices, to satisfy the requirements of said State plant protection service. That person shall appoint by order of the national plant protection services Director.
6. Plant protection product register for ten years, and it can be re-registered.
7. after expiry of the period of validity of the registration of the plant protection product concerned are prohibited to distribute, but such a plant protection product authorised users to use existing stocks two years after the date of expiry of the registration, with the exception of the provisions referred to in paragraph 30.
8. to register the plant protection product, a person (hereinafter applicant for registration) by the national plant protection services: 8.1. registration of the plant protection product applications;
8.2. the registration of the necessary documentation that contains established a scientific and technical level of the relevant information on the plant protection product and the active substance in accordance with the requirements of this Regulation (1., 2., and annex 4), and in Latvia the efficiency test results;
8.3. marking samples with Latvian language text that contain relevant information in accordance with the provisions of annex 3.
9. the national plant protection service is entitled to require in addition to submit a plant protection product or its ingredients and packaging.
10. the national plant protection services: 10.1. check of information submitted, the document, as well as labelling and packaging compliance with this provision of the samples 1, 2, 3, and 4. the requirements set out in the annex and to assess whether the data submitted supports the inspection. If necessary, the national plant protection service requires additional information, data analysis, as well as the involvement of appropriate experts of qualification;
10.2. on the basis of the cost-effectiveness of the plant protection product and the use of risk analysis, prepare the assessment of plant protection products.
11. the assessment of plant protection products shall be subject to the following principles: 11.1. it evaluated the effectiveness and phytotoxicity for each plant protection product intended for use in identifying and evaluating the risks and its effects on humans, animals and the environment; 11.2. evaluate the use of the plant protection product under the proposed the use of effects and assessment, based on the use of the proposed dose, the treatment method, destination, time and process count, as well as taking into account the composition of the plant protection product in the properties and methods of integrated pest management principles;
11.3. evaluate agricultural conditions, the spread of the harmful organism or environmental (including climatic) conditions in the plant protection product intended for use in areas;
11.4. the assessment shall be carried out in two rounds, the first round — based on the information, which reflects the real conditions of use of the plant protection product, the second round — on the basis of possible critical data and considering the worst possible conditions of use, which may lead to adverse consequences;
11.5. use the calculation models that allow you to analyze its assessment relevant parameters, data on the use of plant protection products for use in critical areas, as well as data on the usage of the worst possible conditions of use;
11.6. take into account the relevant criterion only relevant metabolites, degradation or reaction products, which may significantly affect the assessment of plant protection products.
12. the decision on the registration of plant protection products or refusal of registration on the basis of the evaluation and registration of plant protection products on Commission (hereinafter Registration Commission) recommendation, State plant protection service adopted during the year, since the applicant for registration submitted by the national plant protection services in these rules referred to in paragraph 8 of document and information.

13. the Commission comprises seven members: two representatives of the national plant protection service, one representative of the Ministry of welfare, one representative of environmental protection and the Ministry of regional development, as well as three other agricultural and Science representatives. The Chairman of the Commission for registration is the national plant protection services representative.
14. the Commission approved the registration of the establishment of the Minister of agriculture.
15. the Commission shall convene a meeting of the Chairman of the Commission for registration.
16. the Commission is valid, if the hearing shall participate in the registration of not less than five members of the Commission.
17. If necessary, the Chairman of the Commission for the registration of plant protection products in the assessment analysis may require additional information or analysis of the data concerned and invite the appropriate qualification experts.
18. The decision on the registration of plant protection products, the national plant protection service detects the use of the plant protection product (crop, harmful organisms, including methods of use, restrictions, dose, waiting time, season the maximum process count), the registration of plant protection products in the class and package volume or mass distribution in Latvia.
19. the national plant protection service following the adoption of the decision: 19.1 shall inform the applicant of the registration (registration or refusal of registration). If there is a decision on refusal of registration, it must be motivated;
19.2. Approves the text of the label;
19.3. the entry in the register the name of the plant protection product, preparatory form, the name of the active substance, quantity, purity, the registration certificate holder's name and address, details of the plant protection product and the manufacturer of the active substance of this provision the information referred to in paragraph 18, the date of registration and expiration date;
19.4. issuing the registration of plant protection products the applicant's certificate of registration (registration certificate), which attests to the plant protection product into the register;
19.5. the registration certificate shall bear the following information: the name of the plant protection product, in the form of preparatory, the number and date of registration, the person who has registered plant protection product containing the active substance, its purity, this provision of the information referred to in paragraph 18 and the validity of the registration certificate.
20. If the registration certificate holder wishes to distribute the registered plant protection product which has a different form in the preparatory or other active substances content, State plant protection service of the plant protection product register, if these provisions are complied with in point 2.2 requirements and demonstrate compliance with the provisions referred to in point 2.3.
21. the marketing authorisation holder shall inform the national plant protection services on amendments to the registration of the documents submitted in support of this amendment the necessity and compliance with registration in accordance with the provisions of paragraph 2 or 3.
22. the registration certificate holder is obliged to immediately notify the national plant protection service of the registered plant protection products or residues of the potentially dangerous effects on human or animal health and the environment. 23. Upon registration, the expiry of the period of validity of the plant protection product can be one or more times to reregister for ten years, if it is demonstrated compliance with this provision in paragraph 2 or 3.
24. an application for Renewal of the registration certificate holder national plant protection services not later than one year prior to the registration expiration date along with the updated information required for registration in accordance with the provisions of paragraph 2 or 3.
25. If there is reasonable suspicion that the plant protection product does not comply with the provisions in paragraph 4 and in point 2 or 3 requirements of the plant protection product registration compliance can be assessed. In such cases, the national plant protection service require that the holder of the registration certificate, national plant protection services in the time limit set for submission of additional information or individual study.
26. make necessary modifications to the registry can at the national plant protection service of the decision or of the registration certificate holder's request, with reasons, and subject to all the provisions of paragraph 2 or 3.
27. the Entry in the register be cancelled in the following cases: 27.1. a plant protection product are no longer complies with the conditions of these rules;
27.2. the provisions referred to in paragraph 8.2. the information is wrong or deliberately distorted;
16.3. the information requested is not supplied within the time limit laid down;
27.4. the request of the holder of the registration certificate.
28. If the plant protection product necessary to reregister, amend or withdraw the entry in the register, the decision shall be taken according to the procedure of registration in accordance with the provisions of 10, 11, 12, 17, 18 and 19 the requirements set out in paragraph.
29. On the registration of plant protection products shall record in the register the cancellation of the national plant protection services shall immediately inform the holder of the registration certificate, as well as ensure the publication of information in the newspaper "journal".
30. Depending on the registration of plant protection products shall record the reasons for the cancellation of the national plant protection service can determine the time stocks of the plant protection product storage, disposal or removal from the country.
31. by research institutions or persons engaged in agricultural production of State plant protection service can allow to expand the registered use of the plant protection product areas: 31.1. is an objective justification for use of the plant protection extension;
31.2. the planned use of the plant protection product is small.
31.3. a plant protection product intended use is permitted in one of the Member States of the European Union, in which the agricultural conditions and the spread of harmful organisms, plants, and environmental (including climatic) conditions relevant to the use of the plant protection product is comparable to the circumstances in Latvia;
19.5. the use of the plant protection extension agent has provided the necessary information on the intended use for this rule 2.3.1. and 2.3.2. the conditions referred to in point (if such information is not state action by the plant protection service);
31.5. the use of the plant protection extension agent has submitted information on the grounds that a plant protection product is effective and not adversely affecting plants and plant products, when used for the intended use;
19.6. it has been established that this provision 2.3.1. and 2.3.2. referred to conditions are met;
19.7. the use of the plant protection extension agent has additionally presented by the national plant protection services in the approval of the relevant instructions for use of the plant protection product in the area of extension.
32. the national plant protection services in agreement with the owner of the registration certificate authorization to expand the registered use of the plant protection product in the area. If no agreement is reached, the State plant protection service can allow to expand the use of the plant protection product area only if it is the fact that the opposition of the owner of the registration certificates relating to the performance of the plant protection product and its adverse effects on plants or plant products, are not justified.
33. the use of the plant protection product in the area of extension instructions published in the newspaper "journal" provides a State plant protection service.
34. Extending the use of the plant protection product in the area, the mAh is responsible for the plant protection product or the active substance the potentially dangerous effects on human or animal health and the environment. 35. a Person that is using the plant protection product according to the extension of the area of its use, is responsible for the potential harmful effects on plants or plant products and crop losses.
36. the national plant protection service and the Commission must not be used in these rules 1, 2, and 4. the information referred to in the annex to other applicants for registration, unless the applicant and the information the applicant a written agreement.
37. the national plant protection service and the Commission shall ensure the availability of the limited available information, if requested by the applicant for registration.
 
Prime Minister, Minister of Justice v. Birkavs farming Minister a. Halloween annex 1: Cabinet of Ministers of 5 October 1999, regulations No 341 information on plant protection products i. chemical plant protection products 1. Identity: 1.1. applicant (name, address, etc.);
1.2. the plant protection product and the active substance manufacturer (name, address, including location of production);

1.3. plant protection products name or proposed trade name, and manufacturer's code;
1.4. detailed quantitative and qualitative information on the composition of the plant protection product (active substances, impurities and Formulants);
1.5. the plant protection product in a physical state and preparatory form (emulsion concentrate, powder for suspension, solution, etc.);
1.6. category of use (herbicide, insecticide, etc.).
2. Physical, chemical and technical characteristics: 2.1. appearance, colour, odour and physical state;
2.2. the explosive and oxidising properties;
2.3. flash point and other indications of flammability or self-ignition;
2.4. acidity/alkalinity and if necessary pH value;
2.5. viscosity and surface tension;
2.6. relative density and tilpumsvar;
2.7. storage — stability and shelf-life (effects of light, temperature and humidity on technical characteristics of the plant protection product);
2.8. the plant protection technical specification: 2.8.1. samirkšan speed;
2.8.2. foaming characteristics;
2.8.3. suspendējamīb and suspension stability;
2.8.4. dilution stability;
2.8.5. dry sieve test and wet test (powder and pellets for suspension);
2.8.6. particle size, dust and fine particle quantity specification (granules), attrition and erosion (granules);
2.8.7. emulģējamīb, reemulģējamīb and emulsion stability;
2.8.8. flowability, pourability and dustiness;
2.9. physical and chemical compatibility with other products including plant protection products with which permitted use;
2.10. adherence to the seed and banding on them (stains);
2.11. in this paragraph, information required summary and evaluation.
3. the information on use: the estimated 3.1 use, such as in an open field crops, the covered crops, storage of plant products URu.tml.;
3.2. effects on harmful organisms (such as exposure through contact, respiratory or digestive system, fungitoxic, fungistatic effects, as well as system or tangent effects on plants);
3.3. more detailed information on usage, such as the apkarojam and/or harmful organisms protected plants or plant products;
3.4. the dose;
3.5. concentration of active substance in material for use (such as working fluid concentration);
3.6. the method of administration;
3.7 process count and the time of the plant protection product life;
3.8. necessary waiting periods and precautions to avoid phytotoxic effects on pēckultūr;
3.9. the instructions for use.
4. the following information: 4.1. packaging (type, materials, size, etc.) and the plant protection products compatible with the packaging material;
4.2. processing plant equipment and protective clothing cleaning techniques;
4.3. danger periods, necessary waiting periods or other precautions to protect man, animals and the environment; 4.4. precautions the use of the plant protection product, during storage or transport, and in the event of fire;
4.5. instructions for action in case of accidents;
4.6. a plant protection product and of the packaging technology for destruction or neutralization processes: neutralization capabilities controlled incineration and other methods.
5. analytical methods: 5.1. methods for the plant protection product, discovery;
5.2. methods for residues of the active substance (residue): 5.2.1 treated plants, plant products, livestock feed and food or on treated plants, plant products, feed and food;
5.2.2. the soil;
5.2.3. water (including drinking water);
5.2.4. in the air;
5.2.5. animal and human body fluids and tissues.
6. Effectiveness: 6.1 selection trials;
6.2. tests of effectiveness;
6.3. information on the occurrence of resistance or its probable development;
6.4. effects on the yield of treated plants or plant products in terms of quantity and/or quality: 6.4.1. effects on plants or plant products;
6.4.2. effects on plants or plant products recycling processes and product quality;
6.4.3. effects on the yield of treated plants or plant products in storage;
6.5. phytotoxicity of treated plants (different varieties) or plant products;
6.6. observations on undesirable or unintended side-effects: 6.6.1. impact on pēckultūr;
6.6.2. impact on other plants, including adjacent crops and pasēj plants (clover, etc.);
6.6.3. impact on treated plants or parts of plants used for propagation (e.g. seeds, cuttings, shoots);
6.6.4. effects on beneficial and other living organisms;
6.7. the information in this paragraph summary and evaluation.
7. the toxicity study: 7.1 acute toxicity: 7.1.1 oral (oral exposure);
7.1.2. the exposure through the skin;
7.1.3. inhalation;
7.1.4. skin irritancy;
7.1.5. eye irritancy;
7.1.6. skin allergic reaction;
7.1.7. studies on the toxicity of the plant protection product in the working fluid mixed with the application of the plant protection product;
7.2. information on the plant protection product for workers during use: 7.2.1. worker exposure to the plant protection product, its assessment and measurement;
7.2.2. unauthorised exposure of the plant protection product, its assessment and measurement;
7.2.3. agricultural production workers ' exposure to the plant protection product, its assessment and measurement;
7.3. a plant protection product absorption through the skin (if necessary): evaluation and measurement of absorption;
7.4. information on Formulants and impurities toxicity.
8. Residues in or on treated products, food and feed: 8.1. metabolism of residues, locale, identity, quantity, plants, animal tissue or body fluids;
8.2. research on the maximum possible quantity of residue in plants or plant products after treatment, in accordance with the principles of good agricultural practice;
8.3. studies on residues in animal tissues or fluids;
8.4. studies on the residues of animal or plant products by industrial or culinary processing;
8.5. studies on residues of pēckultūr;
5.3. maximum residue limits;
8.7. the interval between the application of the plant protection product and harvesting or waiting or storage, if the treatment provided after the harvest;
8.8. the potential and actual impact assessment limits if they were taken with a diet and in other ways;
8.9. the information in this paragraph summary and evaluation.
9. the movement and behavior of the environment: the movement and behavior of 9.1 soil: 9.1.1. rate of degradation in soil, laboratory studies and field trials;
9.1.2. studies on the movement of soil;
9.1.3. information about the expected concentrations in soil and assessment;
9.2. movements and behaviour in water 9.2.1. information about expected: concentrations in groundwater and assessment;
9.2.2. impact on water treatment processes;
9.2.3. information about the expected concentrations in surface waters and its assessment;
9.3. the movement and behavior of the air.
10. Ecotoxicological studies: 10.1. effects on birds: 10.1.1. acute oral toxicity;
10.1.2. supervised trials to assess risks of plant protection products intended for use in the circumstances;
10.1.3. study to evaluate whether the birds are the plant protection product can be taken with pellets, seed and processed in other ways;
10.1.4. secondary poisoning risk assessment;
10.2. effects on aquatic organisms: 10.2.1. acute toxicity to fish, aquatic invertebrates or effects on algal growth;
10.2.2. microcosm or mesocosm studies;
10.2.3. information on residues in fish;
10.2.4. chronic toxicity to fish;
10.2.5. studies on the effects on fish reproduction and development;
10.2.6. bioaccumulation in fish;
10.2.7. information on Daphnia toxicity;
10.3. effects on terrestrial vertebrates other than birds;
10.4. effects on bees;
10.5. effects on other arthropods other than bees;
10.6. effects on earthworms and other soil macro-organisms: 10.6.1. acute toxicity;
10.6.2. effects of sublethal doses;
10.7. effects on soil micro-organisms;
10.8. studies on the possible effects of the plant protection product on valid and other fauna and flora species and their assessment.
11.9 and 10 of this annex as specified in paragraph summary and evaluation.
12. The information below: 12.1. information on the registration of plant protection products in other countries;
12.2. information on other countries, the maximum residue limit;
12.3. the proposals for classification and labelling and their justification: 12.3.1. hazard symbol;
12.3.2. guidance on hazards;
12.3.3. risk phrases;
12.3.4. security requirements;
12.4. the proposed packing instructions and sample projects.
II. plant protection products containing micro-organisms or viruses 13. Identity: 13.1. applicant (name, address, etc.);
13.2. the plant protection products and active organisms manufacturer (name and address, including the address of the place of manufacture);
13.3. the trade in used or proposed name of the plant protection product and, if necessary, the manufacturer of the plant protection product code;

13.4. detailed quantitative and qualitative information on the composition of the plant protection product (active organisms, without active ingredients, non-organisms etc.);
13.5. the plant protection product in a physical state and preparatory form (emulsion concentrate, powder for suspension, solution, etc.);
8.5. use category (insecticide, fungicide etc.).
14. Physical characteristics: 14.1 appearance, colour and odour;
14.2. storage stability, depending on the storage time, temperature, type of packaging, as well as storage methods and the impact of other factors on the survival of biological activity;
14.3. storage stability and plant protection products the validity of methods of determination;
14.4. a plant protection product technical characteristics: 14.4.1. samirkšan capacity;
14.4.2. foaming;
14.4.3. suspendējamīb and suspension stability;
14.4.4. wet sieve test and dry sieve test;
14.4.5. particle size, dust and fine particle quantity specification (granules), attrition and erosion (granules);
14.4.6. Pellet sieving and inspection instructions for granular mass (at least in cases where a particle size greater than one millimeter);
14.4.7. the active substance content of granules or on treated seed;
14.4.8. emulģējamīb, reemulģējamīb and emulsion stability;
14.4.9. flowability, pourability and dustiness;
14.5. physical and chemical compatibility with other products including plant protection products, which are allowed for use in the working fluid mixtures;
14.6. samirkšan, sticking and moving in treated plants.
15. Information on use: 15.1. intended use: open field crops, the covered crops, food or feed storage facilities;
15.2. details of intended use, e.g. the apkarojam harmful organisms and/or protected plants or plant products;
15.3. the doses to be used;
15.4. If necessary, information on the specific conditions of agriculture, the spread of harmful organisms and/or environmental conditions under which the plant protection product is/it is not possible to use;
15.5. the recommended use concentration of active organism (such as working fluid concentration);
15.6. the method of use;
15.7. use time and process count;
15.8. fitopatogenitāt;
15.9. the instructions for use.
16. further information: 16.1. packaging (type, materials, size, etc.), compatibility of the plant protection product with proposed packaging materials;
16.2. processing plant equipment and protective clothing cleaning techniques;
16.3. necessary waiting periods and information about other precautions to protect humans and animals;
16.4. the methods and precautions the use of the plant protection product, storage and transport;
16.5. the guidelines for action in the event of an accident;
16.6. the methods of the plant protection product and its packaging for disposal.
17. analytical methods: 17.1. methods of plant protection products in the composition;
17.2. methods for the determination of residues in treated plants, plant products or on them (such as bioassays);
17.3. methods of plant protection product microbiological purity;
17.4. the methods of human and mammalian (if necessary also the bee) to identify the pathogen, the plant protection product;
17.5. the used technology standardized by the acquisition of the plant protection product and its quality inspection methods.
18. evaluation of effectiveness: 18.1. pilot selection;
18.2. efficiency test;
18.3. information on the occurrence of resistance or its probable development;
18.4. studies on the effects on the yield of treated plants or plant products in terms of quantity and/or quality: 18.4.1. effects on plants or plant products;
18.4.2. effects on plants or plant products in the recycling process;
18.4.3. effects on the yield of treated plants or plant products;
18.5. phytotoxicity of treated plants or plant products, including the exposure of different varieties;
18.6. observations on undesirable or unintended side-effects: 18.6.1. impact on pēckultūr;
18.6.2. impact on other plants, including adjacent crops exposure;
18.6.3. impact on treated plants or parts of plants used for propagation (e.g. seeds, cuttings, shoots);
18.6.4. effects on beneficial and other living organisms;
11.6. this paragraph contains the summary and evaluation of the information.
19. Toxicity and/or pathogenicity and infection risk study: 19.1. oral (single dose);
19.2. through the skin (single dose);
19.3. inhalation;
19.4. skin and eye irritancy;
19.5. the skin allergic reaction;
12.2. information on the toxicity of active components;
19.7. the information on the exposure of workers to the use of the plant protection product: 19.7.1. worker exposure to the plant protection product, its assessment and measurement;
19.7.2. unauthorised exposure of the plant protection product, its assessment and measurement;
19.7.3. agricultural production workers ' exposure to the plant protection product, its assessment and measurement;
19.7.4. If possible absorption through the skin, exposure assessment and measurement.
20. Residues in or on treated products, food and feed: 20.1. information on viable and non-viable residues, including information about tests on plants, feedingstuffs or foodstuffs in various climatic and agricultural conditions intended use;
20.2. studies on the limits and the nature of products by industrial or culinary processing;
20.3. the residual impact on fresh or processed products, smell, taste or other quality aspects (if necessary);
20.4. studies on residues in products of animal origin;
20.5. studies on residues of pēckultūr;
20.6. the required intervals between the application of the plant protection product and harvesting or waiting or storage, if the processing is for after the harvest;
20.7. maximum residue limits (toxins);
12.9. the information in this paragraph summary and evaluation (based on the corresponding requirements referred to in this paragraph is submitted to the database).
21. the movement and behavior of the environment: 21.1. movements and behavior of soil: 21.1.1. degradation rate, laboratory studies and field trials;
21.1.2. mobility;
21.1.3. information about the expected concentration and assessment;
21.2. the movement and behavior of water;
21.2.1. information about the expected concentrations in groundwater and assessment;
21.2.2. impact on water treatment processes;
21.2.3. information about the expected concentrations in surface waters and assessment;
21.3. the movement and behavior of the air.
22. Ecotoxicological studies: 22.1. effects on aquatic organisms: 22.1.1. effects on fish;
22.1.2. effects on Daphnia magna and in species related apkarojam harmful organisms;
22.1.3. effects on aquatic micro-organisms;
22.2. effects on beneficial and other living organisms: 22.2.1. effects on bees;
22.2.2. effects on other beneficial organisms;
22.2.3. effects on earthworms;
22.2.4. effects on other soil fauna;
22.2.5. effects on other living organisms, which could be at risk;
22.2.6. effects on soil microbial.
23. This annex 21 and 22 contains the summary and evaluation of the information.
24. further information: 24.1. information on the registration of plant protection products in other countries;
24.2. information on other countries, the maximum residue limit;
24.3. the proposals for classification and labelling and their justification: 24.3.1. the hazard symbols;
24.3.2. instructions for danger;
24.3.3. risk;
24.3.4. security requirements;
15.2. the proposed packing instructions and sample projects.
Note the. The studies mentioned in this annex and analysis are supported by appropriately qualified persons.
 
Farming Minister a. Halloween annex 2 Cabinet of 5 October 1999, regulations No 341 information on plant protection products active substances of i. chemical plant protection products active substances 1. chemical plant protection product active substances (hereinafter referred to as the active substance): 1.1. applicant (name, address, etc.);
1.2. manufacturer (name and address, including the address of the place of manufacture);
1.3. proposed or ISO approved name and synonyms;
1.4. chemical name (after both IUPAC and CA nomenclature);
1.5. manufacturer's code (the code);
1.6. CAS, EEC and CIPAC numbers (if available);
1.7. molecular formula, structural formula and molekulsvar;
1.8. the active substance production method (the order of the synthesis process);
1.9. specification of purity of the active substance (excluding inactive isomers);
1.10., isomers and impurities of the Formulants identity, structural formula and quantity specification, g/kg, respectively;
1.11. active substances chemical composition analyses of the sample data and the specification of the quantity up to 98 percent.
2. Physical and chemical properties: 2.1. melting and boiling point;
2.2. relative density;
2.3. vapour pressure (Pa) and evaporation (e.g. Henry constant);
2.4. the appearance, colour, odour and physical state;

2.5. spectrum-UV/visible light rays, infrared, nuclear magnetic resonance, mass spectrum and molecular extinction at relevant wavelengths;
2.6. solubility in water, taking into account the different pH reaction (including pH 4-10);
2.7. solubility in organic solvents;
2.8. partition coefficient n-octanol/water, taking into account the various pH values (including pH 4-10);
2.9. stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product Dissociation constant, taking into account the various pH values (including pH 4-9);
2.10. stability in air, photochemical degradation, identity of breakdown products;
2.11. self-ignition combustion, including;
2.12. flash point;
2.13. explosive properties;
2.14. surface tension;
2.15. oxidation characteristics.
3. further information on the active substances: 3.1 category of use: fungicide, herbicide, insecticide, repellant, or plant growth regulators, indicating respectively: 3.1.1 acaricide;
3.1.2. bactericide;
3.1.3. fungicide;
3.1.4. herbicide;
3.1.5. insecticide;
3.1.6. moluskocīd;
3.1.7. not matocīd;
3.1.8. plant growth regulators;
3.1.9. the repellent;
3.1.10. Rodenticide;
3.1.11. pusķimikālij;
3.1.12. talpicīd;
3.1.13. viricīd;
3.1.14. the remaining (to be presented);
3.2. effects on harmful organisms: contact, respiratory or digestive system, in effect, as well as the fungitoxic or tangent effects on plants;
3.3. intended use, such as in an open field crops, the covered crops, storage of plant products;
3.4. protected plants, apkarojam the harmful organisms, as well as protected or processed products;
3.5. the biochemical and physiological mechanisms of exposure and involvement in the matter of the Exchange processes;
3.6. information on the occurrence or of resistance on its possible occurrence, as well as action on the strategy;
3.7. recommended precautions in use, during storage or transport, and in the event of fire;
3.8. destruction or neutralization procedures;
3.9. safety measures in the event of an accident, providing for procedures for the treatment of contaminated water.
4. analytical methods: 4.1. methods for the concerned produce active substances and impurities of the active substance identification and purity;
4.2. the multimetod (or the alternative method) of the active substance and relevant metabolites the determination of residues: 4.2.1. plants, plant products, foodstuffs (of plant and animal origin) and animal feed;
4.2.2. the soil;
4.2.3. water (including drinking water, ground water and surface water);
4.2.4. the air;
4.2.5. animal and human body fluids and tissues.
5. Toxicity and metabolism studies: the 5.1. absorption, distribution, excretion and metabolism studies in mammals;
5.2. acute toxicity: 5.2.1 oral (oral exposure);
5.2.2. dermal (skin effect);
5.2.3. inhalation (inhalation);
5.2.4. skin irritancy;
5.2.5. eye irritancy;
5.2.6. skin allergic reaction;
5.3. short-term toxicity: 5.3.1. oral toxicity study (study for a period of 28 days);
5.3.2. oral toxicity study (study within 90 days);
5.3.3. other types of research;
5.4. genotoxicity: 5.4.1. studies in vitro;
5.4.2. in vivo studies in somatic cells;
5.4.3. studies in vivo embryo cells;
5.5. long-term toxicity and carcinogenicity;
5.6. reproductive toxicity: 5.6.1. multi-generation studies;
5.6.2. toxicity study embryonic development;
5.7. neurotoxicity study (impact of post-operation);
5.8. the information on the registered medical poisoning;
5.9. the information in this paragraph summary and evaluation.
6. Residues in treated plants, plant products, food and feed or on treated plants, plant products, food and feed: 6.1. metabolism of residues, locale, identity and quantity of plants;
6.2. metabolism of residues, locale, identity and quantity of animal tissues or fluids;
6.3. research on degradation rate of residue in plants and the maximum possible quantity of residue in plants or plant products after treatment, in accordance with the principles of good agricultural practice;
6.4. studies on residues in animal tissues or fluids;
6.5. studies on the residues of animal or plant products by industrial or culinary processing;
6.6. studies on residues of pēckultūr;
6.7. maximum residue limits;
6.8. the required intervals between the application of the plant protection product and harvesting or waiting or storage, if the processing after harvest;
6.9. the potential and actual impact of residues (if taken with diet and other forms);
6.10. the information in this paragraph summary and evaluation.
7. Movement and behaviour in the environment: 7.1. soil movements and behavior: 7.1.1. type and speed of degradation: laboratory studies and field tests: aerobic, anaerobic, biodegradation, fotolītisk degradation, studies on the active substance and relevant metabolites, degradation and reaction products accumulation in soil, research on residues of the active substance in the soil at harvest and sowing time of the pēckultūr;
7.1.2. adsorption and desorption;
7.1.3. mobility: laboratory studies, lizimetrisk studies or soil leaching studies;
7.2. the movement and behaviour in water and air: 7.2.1. type and speed of degradation in aquatic systems, insofar as they do not apply to this annex, point 2.9.;
7.2.2. the type and rate of degradation in air, in so far as they do not apply to this annex 2.10.
7.3. proposal for the residue levels in the soil, water and air;
7.4. monitor surveillance data on the active substance and its degradation of essential metabolites, as well as the reaction product movement and behavior.
8. Ecotoxicological studies: 8.1. effects on birds: 8.1.1. acute oral toxicity;
8.1.2. short-term toxicity — if the active substances taking food;
8.1.3. subchronic and reproductive toxicity;
8.2. effects on aquatic organisms: 8.2.1. acute toxicity to fish;
8.2.2. chronic toxicity to fish;
8.2.3. bioconcentration in fish;
8.2.4. acute toxicity to aquatic invertebrates;
8.2.5. chronic toxicity to aquatic invertebrates;
8.2.6. effects on algae growth;
8.2.7. effects on sediment dwelling organisms;
8.2.8. effects on aquatic plants;
8.3. effects on arthropods: 8.3.1. effects on bees: acute toxicity, studies on the effects on bee brood development;
8.3.2. impact on other arthropods;
8.4. effects on earthworms: 8.4.1. acute toxicity;
8.4.2. sublethal doses;
8.5. effects on soil micro-organisms;
8.6. effects on living organisms (fauna and flora species);
8.7. effects on biological methods for sewage treatment.
9. this annex, point 7 and 8 in summary and evaluation.
10. The proposals for classification and labelling and the grounds: 10.1 the hazard symbols;
10.2. the indication of danger;
10.3. the risk;
10.4. security requirement.
11. This provision in chapter I of annex 1 of the said information on the plant protection product containing the active substance concerned.
II. Microorganisms and viruses, identity: 12.1 12. applicant (name, address, etc.);
12.2. manufacturer (name and address, including the address of the place of manufacture);
12.3. the name or alternative and former names;
12.4. bacteria, protozoa, fungi, taxonomic name and strain, instruction, or it is a mutant or mutants, mutant viruses — the agent, serotype, strain or mutant mutant taxonomic name;
12.5. sample and cultural identification number in the collection;
12.6. identification methods, procedures and criteria (e.g. morphology, biochemistry, serology);
12.7. detailed quantitative and qualitative information on the active organism — microbiological purity, nature, identity, properties, content of impurities and extraneous organisms.
13. Biological properties of the organism being processed: 13.1; pathogenicity or kind of antagonism to host, infective dose, spreading information about ability and experience;
13.2. the body and its history of use; natural occurrence and geographical distribution;
13.3. information on infectivity, pathogenicity and spreading ability: specific hosts and impact to other species which are not harmful organisms involved, also a species that is related to the species concerned;
13.4. infectivity and physical stability to practical conditions for use; temperature and radiation effects of air; stability, using the appropriate environmental conditions;
13.5 the body's relationship with the plant pathogen or to a vertebrate species or invertebrate species involved pathogens;
13.6. information on genetic stability (i.e. mutation rate) of the plant protection product use conditions;
8.5. toxins, their presence, character, identity and stability, as well as the chemical structure (if necessary).
14. the information on use: 14.1. use category: herbicide, fungicide, repellent or growth regulators;

14.2. effects on harmful organisms: contact, respiratory or digestive system, fungitoxic or fungistatic effects system or tangent effects on plants;
14.3. the intended use of the plant protection product, such as the open field crops, the covered crops, food or feed storage facilities;
14.4. studies of specific conditions in the agricultural, plant health or environmental conditions under which the active organism may be (should not) be used;
14.5. harmful organisms and apkarojam protected plants or plant products;
14.6. a standardized technology used to obtain the materials and quality control methods. If the active organism is a strain of mutant, detailed information about it, including information about the differences between mutants and mutant mutant;
9.1. methods for the conservation of virulence;
9.2. methods and precautions the use of the plant protection product, storage and transport;
9.3. the possibility of rendering the active organism.
15. analytical methods: 15.1 methods raw material (mother's cultural) identity and purity determination, including information about the mutation;
15.2. methods for the microbiological purity of the active organism and Toxin detection, including information about the mutation;
15.3. the methods of human or mammalian pathogen identification for the active organisms, including fungi and protozoa in different temperatures (35 ° C and other relevant temperatures);
15.4. methods for the viable and non-viable (e.g. toxins) residues in or on treated products on treated products, food, feed, animal and human tissues and fluids, soil, water and air (as conditions).
16. the toxicological, pathogenicity and infectivity studies: 16.1. bacteria, fungi, protozoa and Mycoplasma: 16.1.1. toxicity and/or pathogenicity and infectivity oral single-, dermal, inhalation intraperitoneal route, dose, if necessary, skin and eye irritancy, skin allergic reactions and extended studies;
16.1.2. short-term toxicity (90 days impacts);
16.1.3. supplementary toxicological and/or pathogenicity and infectivity studies oral chronic toxicity, and carcinogenicity, mutagenicity, teratogenicity, studies generations in mammals (at least two generations), metabolic studies (absorption, distribution and excretion from the body of mammals, including information on metabolic pathways), neurotoxicity, immunotoxicity study, i.e. allergens, pathogenicity and infectivity depressed immunity;
16.2. viruses and viroids: 16.2.1. acute toxicity and/or pathogenicity and infectivity; information specified in 16.1.1 of this annex, and cell culture studies using purified viruses and infekciozo of mammalian, avian and fish cells in primary cell cultures;
16.2.2. short-term toxicity;
16.2.3. additional toxicological pathogenicity and infectivity studies, or referred to in this Appendix 16.1.3.;
16.3. toxic effects on livestock and pets;
16.4. medical data: 16.4.1. crop production workers ' health surveillance;
16.4.2. medical information on industrial and agricultural workers ' health;
16.4.3. observations on exposure of the population of the plant protection product exposure and epidemiological data;
16.4.4. poisoning diagnosis, specific signs of poisoning and clinical tests;
16.4.5. observations on the sensitivity or allergies;
16.4.6. guidelines for action in the event of an accident: first aid, antidotes and drugs (by condition);
16.4.7. expected effects of poisoning forecast;
16.5. Summary of mammalian toxicology and opinions (including NOAEL, NOEL and ADI (as conditions)); General toxicological pathogenicity and infectivity.
17. Residues in plants, on treated products, food and feed: 17.1. viable or non-viable (e.g. toxins) residues in the identification of the treated plants or plant products;
17.2. studies on the reproductive rate of the active organism of plants or foods that contain information about any effects on food quality;
17.3. If residues of toxins remain on edible plant products is required in this annex 4.2 and information referred to in paragraph 6;
17.4. the behaviour of residues summary and evaluation of that sum, collecting the data referred to in this paragraph.
18. the movement and behavior of the environment: 18.1. spread, mobility, multiplication and persistence in air, water and soil;
18.2. information relating to the possible involvement of the feed chain;
18.3. If the toxins are required by this annex, the particulars specified in section 7.
19. Ecotoxicological research: 19.1. effects on birds: acute oral toxicity and/or pathogenicity and infectivity;
19.2. the impact on fish-acute toxicity and/or pathogenicity and infectivity;
19.3. Daphnia magna toxicity;
19.4. effects on algae growth;
19.5. the impact on the species involved significant parasitic and predatory organisms live: acute toxicity and/or pathogenicity and infectivity;
12.2. effects on bees: acute toxicity and/or pathogenicity and infectivity;
19.7. effects on earthworms: acute toxicity and/or pathogenicity and infectivity;
19.8. effects on other living organisms (those at risk): acute toxicity and/or pathogenicity and infectivity;
12.4. the adjacent agricultural crops, wild plants and indirect contamination of water;
19.10. effects on other species of flora and fauna;
19.11. for any toxins, depending on the conditions of this annex is required, 8.1.3, 8.2.2 8.1.2., 8.2.4.8.2.5 8.2.6, 8.2.7.,., and the particulars specified in paragraph 8.3.3.
20.18 and 19 of this annex as specified in paragraph summary and evaluation.
21. The proposals for the classification of the active organism and marking and their justification: 21.1. hazard symbol;
21.2. instructions for danger;
21.3. the risk;
21.4. safety requirements.
22. These provisions in chapter I of annex 1 to that information on the plant protection product containing the respective active organism.
Note the. The studies mentioned in this annex and analysis are supported by appropriately qualified persons.
 
Farming Minister a. Halloween 3. Annex to the Cabinet of Ministers of 5 October 1999, regulations No 341 information to be included in the labelling of plant protection products in protective packaging label I. 1. the name of the plant protection product in trade.
2. Preparatory form (such as a soluble powder, emulsifiable concentrate).
3. Use of the plant protection product category (e.g. insecticide, plant growth regulators).
4. Hazardous characteristics.
5. Registration certificate the name and address of the owner.
6. the manufacturer, distributor or representative's name and address.
7. Registration number.
8. the serial number (lot number).
9. The date of manufacture.
10. The net weight.
11. Storage conditions.
12. warning of danger.
13. Safety requirements.
Note the. For example, the protective crate or cardboard boxes, which provide the essential one or more packages (package), and it must be sufficiently rigid to prevent content compression, or other types of damage. It is used to package one or more package together, and normally ensure special protection of the adjacent packages, for example, protects against damage to the bluff.
II. marking of packaging 14. plant protection products name in trade.
15. the name of the active substance and its concentration in a preparation.
16. the Preparatory form (such as a soluble powder, emulsifiable concentrate).
17. the use of the plant protection product category (e.g. insecticide, plant growth regulators).
18. Hazardous characteristics.
19. Registration certificate the name and address of the owner.
20. dealer of the manufacturer, or the name and address of the representative.
21. the registration number.
22. the registration class.
23. Serial number.
24. The date of manufacture.
25. Net.
26. the storage conditions.
27. The period of validity.
28. warning of danger.
29. the instructions to be followed in giving the first medical assistance.
30. the use of the plant protection product summary.
31. the guidelines of the plant protection product and its packaging.
32. Instructions for use: 32.1. protected crops;
32.2. apkarojam the harmful organisms;
32.3. in use, dosage and process count;
32.4. the interval between processing and human or animal stays on the field;
32.5. the processing methods;
32.6. the conditions of use;
32.7. restrictions on use;
20.4. waiting time until harvest;
32.9. compatibility with other preparations;
32.10. where necessary, the safety interval for each use between and: protected 32.10.1. sowing or planting;
32.10.2. pēckultūr sowing or planting;
32.10.3. human or animal stays on the field;
32.10.4. the harvest;
32.10.5. plant or plant products consumption;
32.11. possible phytotoxicity, different varieties of sensitivity and different reactions, as well as the possible side effects on plants and plant products that must be taken into account in the period between preparation and sowing or planting of:

32.11.1. processed crops;
32.11.2. individual cultures.
33. Legal responsibility.
34. If the packaging space is too small for this posting, 32 and 33 of the annex to the information referred to in paragraph must indicate in a separate instruction. The instructions must contain the information provided for in this annex 1., 2., 3., 4., 26, 28, 29, 30 and 31.. Instructions should be considered as part of the label, and the label must bear the indication "before the use of the plant protection product to read the attached instructions".
Note the. Packing: bags, bottles (glass, polyethylene or plastic bottles, which seals the size must not exceed 63 mm), metal cans and barrels.
 
Farming Minister a. Halloween annex 4 of the Cabinet of Ministers of 5 October 1999, regulations No 341 information on plant protection products containing parazītisko and plēsīgo in living organisms 1. Identity of the plant protection product: 1.1. applicant (name and address);
1.2. manufacturer (name and address);
1.3. trade name or proposed use;
1.4. information on the plant protection product quality, quantity and composition (living organism, not organisms belonging to inactive ingredients);
1.5. category of use;
1.6. proposed packaging and labelling samples.
2. identity of the living organism: the Latin name for the 2.1 and the English text (synonyms);
2.2. a systematic breakdown;
2.3. ontogeny;
2.4. Description;
2.5. natural occurrence and geographical distribution;
2.6. directions for living organisms in mining (natural or artificially created in the isolated population, information about all known differences of natural populations, etc.).
3. Life in the biological properties of the organism: apkarojam 3.1 and the harmful organisms of exposure;
3.2. effects on beneficial insects;
3.3. storage stability, shelf-life and storage conditions of transport (temperature, packaging, influence on biological activity);
3.4. the experience when using the integrated plant protection method.
4. the information on use: 4.1. field of use envisaged (greenhouses, open field crops, orchards, etc.);
4.2. protected crops and apkarojam harmful organisms;
4.3. method of use, the dose, number of times of use and time (the plant vegetation period, pest development phase etc.);
4.4. If needed, all environmental, agricultural conditions and the spread of harmful organisms the circumstances determining or restricting the use of plant protection products.
5. Efficiency: biological efficacy: 5.1 5.1.1. exposure time and the duration of the maintenance of biological activity;
5.1.2. pest mortality percentage unit time;
5.2. If necessary, an assessment of the effectiveness of using the integrated plant protection method.
Note the. The studies mentioned in this annex and analysis are supported by appropriately qualified persons.
Farming Minister a. Halloween