Decree No. 371 / 2006 Coll.
Decree amending Decree No. 329 / 2004 Coll., on preparations and other plant protection products
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21.07.2006
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371
DECLARATION
of 4 July 2006
amending Decree No 329 / 2004 Coll., on preparations and other plant protection products
The Ministry of Agriculture, in cooperation with the Ministry of Health and the Ministry of the Environment, pursuant to § 88 (3) of Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended by Act No. 131 / 2006 Coll.:
Decree No 329 / 2004 Coll., on preparations and other plant protection products, is amended as follows:
1. Paragraph 1, including the title and footnote 1 and 1a, reads as follows:
Subject matter
This decree (1) implements the relevant provisions of the European Communities (1a) and implements the provisions of the law applicable to preparations and other plant protection products.
1) It is issued on the basis and within the limits of the law in which the relevant Directives of the European Communities have already been reflected.
(1a) Council Directive 91 / 414 / EEC of 15 July 1991 concerning the placing of plant protection products on the market. Council Directive 97 / 57 / EC of 22 September 1997 establishing Annex VI to Directive 91 / 414 / EEC concerning the placing of plant protection products on the market. Council Directive 79 / 117 / EC of 21 December 1979 concerning the prohibition of the placing on the market and use of plant protection products containing certain active substances. Commission Directive 2003 / 82 / EC of 11 September 2003 amending Directive 91 / 414 / EEC as regards the standard phrases for specific risks and the standard phrases for specific safety measures for plant protection products. Council Directive 2005 / 25 / EC of 14 March 2005 amending Annex VI to Directive 91 / 414 / EEC as regards protection products containing micro-organisms. '
2. In Article 2, at the end of paragraph 1, the dot is replaced by a comma and the following points (d), (e) and (f) are added:
"(d) administration of the product at doses corresponding to the highest dose or lower dose, the highest dose being the dose specified in the instructions for administration; if the aggregate quantity of the preparation does not exceed the maximum quantity permitted for the purpose of the application as specified in the instructions for use, repeated or divided application,
(e) the application of the product only in mixtures with another registered product or other plant protection product which are not identified as inadmissible in the product instructions;
(f) aero-application of the product only if such an application option is indicated in the application instructions. "
3. Paragraph 4 (2) reads as follows:
"(2) Where a product containing an active substance already included in the list of active substances (7) is concerned, the applicant must provide data on the identification of the active substance, considering the conditions under which the active substance is included in the list of active substances (7), whether it differs significantly from the degree of purity and the nature of the impurities mentioned in the dossier used to include the active substance in the list of active substances (7). The applicant shall provide proof of the composition of the preparation and the methods for determining the ingredients of the preparation. ';
4. In the heading above § 5 to 12, the words "§ 37 (2) 'shall be inserted after the words" § 36 (4)'.
5. In Article 5, paragraphs 3 and 4 are added:
"(3) When deciding to allow the use of the product for another purpose, they are considered comparable to the conditions in the Czech Republic.
(a) the aggregate quantity of the preparation applied during the season per unit of area or weight of seed in the case of the proposed use, which shall not exceed the maximum authorised aggregate quantity of the preparation applied during the season per unit of area or weight of seed which is registered in the Czech Republic for similar uses;
(b) climatic conditions in accordance with internationally recognised rules; This provision does not apply if the product is used outdoors,
(c) the conditions of the environment, agriculture and forestry, provided that, in view of the specificities of the agricultural business, the sensitivity of the plants to which the preparation is intended to be applied and the sensitivity of the harmful organisms and the course of their development in the Czech Republic, it is not necessary to carry out officially recognised tests to determine the efficacy of the product.
(4) Where necessary due to the dosage and method of application, the plant health authority shall carry out a risk assessment of the use of this product for another purpose in the Czech Republic and verify its labelling, taking into account the standard phrases set out in Annexes 5 and 6, independently of the provisions laid down in paragraph 3. ';
6. in Paragraph 11 (1) (d):
"(d) a dossier demonstrating compliance with the requirements of Sections 33 (3) (b) (3) to (5) of the Act, taking into account the proposed use of the product, including a toxicological opinion of the product issued by the Ministry of Health (Section 33 (4) of the Act),"
7. In Article 11 (2), the words "in three copies' are deleted.
8. In Paragraph 12 (1), the words "in three copies' are deleted.
9. in Article 12 (2) (a), the words "and in official translation into English or otherwise" shall be replaced by "and in official translation into Czech or English."
10. In Article 12, at the end of paragraph 2, the dot is replaced by a comma and the following point (k) is added:
"(k) proof that a request for a toxicological assessment has been submitted to the Ministry of Health (Section 33 (5) of the Act)."
11. in Article 12, paragraph 3 is deleted;
Paragraph 4 shall become paragraph 3.
12. in Article 12 (3), the words "on request" shall be inserted after the words "(Article 32 (3) of the Law).
13. in Paragraph 15 (2), the introductory part of the provision reads:
"(2) In addition to the information provided for in Section 42 of the Act, the product packaging shall be indicated in accordance with the conditions laid down in the marketing authorisation '.
14. in Article 15 (2) (b):
"(b) the date of manufacture, '.
15. in Article 15 (1), point (g) is deleted;
Point (h) shall be renumbered as point (g).
16. In Article 15, the following paragraphs 3 and 4 are inserted after paragraph 2, including footnotes 25a, 25b and 25c:
"(3) The retail packaging, which must not contain a dangerous product and is intended for use by natural persons without professional competence, must be designed in such a way that the risk level of the user of such a packaged product when handling it is minimised so that it can be maintained with the personal protective equipment normally available, such as gloves and goggles. The packaging included in the retail packaging shall comply with the technical requirements referred to in paragraph 1 and shall be so constructed that:
(a) special warehouses are not necessary for the storage of retail packages;
(b) adequate tightness of the packaging and connection of the dispersion device to the direct application of the product, provided that it is provided with retail packaging;
(c) the possibility of opening retail packaging by children is difficult;
(d) the water-soluble packaging of the preparation, if it is part of the retail packaging, is protected by a waterproof outer packaging in order to prevent the entry of air moisture into the water-soluble packaging of the preparation;
(e) after emptying, the remainder of the preparation shall not remain unremovable;
(f) its size is derived from the maximum registered dose and its application concentration, if it is a spray product, taking into account:
1. the volume of the sprinkler tank carried by the natural person carrying out the application in such a way that the packaging size corresponds to a dose of water of 1, 5, 10, or 15 litres of application fluid or multiple of it;
2. the concentration of the product in the application liquid, so that at a concentration of less than 0,01% the packaging size corresponds to the volume of the application liquid for single use, and at a concentration of 0,2% or more, not more than 1 kg or 1 litre,
(g) its accessories, not for single use, include a measuring cup for preparing the dose of the product for its administration.
(4) The label of the retail package of the product shall show the particulars in accordance with paragraph 2. The instructions for use shall be adapted to the usual retail procedures for the treatment of plants or plant products consisting of the use of hand or back application devices. The unit dosage shall be expressed as square metres. If a concentration dose is indicated, the corresponding dose shall be given in grams or kilograms, or millilitres or litres of product at the same time, and the procedure for preparation of the dose, application fluid and method of administration shall be described. The label of the retail package shall not indicate:
(a) use of the product not covered by the marketing authorisation;
(b) methods of application requiring a special application device which is not normally available to retail consumers;
(c) abbreviations which make it difficult to understand the instructions for use;
(d) the method of disposal of the residues of the preparation and of the packaging used, which is not feasible to the retail consumer.
Article 86 (1) of the Law.
25b) § 2 (5) of Act No. 356 / 2003 Coll.
Article 86 (2) to (5) of the Law.
Paragraphs 3 to 5 shall become paragraphs 5 to 7. ';
17. in Article 16 (3) (h) (2), the words "the phytosanitary authorities shall supply a sample of the product" shall be replaced by the words "the phytosanitary authorities shall supply a sample of the product upon request."
18. in Article 16 (3), the words "and after all the conditions for the application of the product provided for by this authorisation" shall be added at the end of the text in point (i).
19. In Article 16, at the end of paragraph 3, the dot is replaced by a comma and the following point (j) is added:
"(j) the application of the preparation shall not exceed the area or quantity of seed which:
1. a maximum of 2 hectares of treated area per year, or a quantity of seed or seed seed treated with a sowing or planting preparation on an area of not more than 1 ha per year, if, according to the supporting documents submitted by the applicant, the product has not been assessed whether it meets the requirements laid down in paragraphs 33 (3) (b) (4) and (5) of the Act in accordance with Annex 3 or found not to meet those requirements;
2. a maximum of 5 ha of treated area per year, or the quantity of seed or seed treated with a sowing or planting preparation on an area of not more than 3 ha per year, provided that, according to the supporting documents provided by the applicant, the product has been assessed for compliance with the requirements laid down in Paragraph 33 (3) (b) (4) of the Act in accordance with Annex 3 or found to comply with those requirements;
3. a maximum of 10 ha per year or the quantity of seed or seed treated with a sowing or planting preparation on an area of not more than 10 ha per year, if, according to the supporting documents submitted by the applicant, the product has been assessed for compliance with the requirements laid down in Sections 33 (3) (b) (4) and (5) of the Act in accordance with Annex 3 and meets those requirements. ';
20. in Paragraph 17 (1), footnote 31 reads:
"31) For example, Decree No 219 / 2004 Coll., on the principles of good laboratory practice, as amended by Decree No 279 / 2005 Coll. '.
21. in Article 21 (1) (d), the words "the name and address and, where appropriate, the address of the seller of the parallel product," shall be deleted;
22. in Article 21 (1) (e):
"(e) information on:
1. packaging indicating how the parallel product is offered to users in the country from which it will be imported into the Czech Republic;
2. the first direct customers of the parallel product in the Czech Republic after its import,
3. packaging indicating how the parallel product will be offered to users in the Czech Republic if the applicant intends to import it for further marketing, '.
23. in Article 21 (1), point (f) is deleted;
Points (g) and (h) shall be renumbered as points (f) and (g).
24. in Article 21 (1) (f), the words "official translation into English" are replaced by the words "translation into Czech."
25. In Article 21, at the end of paragraph 1, the dot is replaced by a comma and the following points (h) to (k) are added:
"(h) a sample of the packaging of the product to be imported into the Czech Republic (Section 53 (4) of the Act), if the phytosanitary authorities consider it necessary to establish the actual state of the matter for the decision;
(i) a written statement that the parallel product to be imported from another EU State to the Czech Republic will come exclusively from the market in the State from which it will be imported;
(j) a copy of the safety data sheet for the parallel product placed on the market in the State from which it is to be imported from another European Union State to the Czech Republic and its official translation into the Czech language for the placing on the market of the parallel product in the Czech Republic under a special legislature38),
(k) a statement by the applicant that a parallel product classified as hazardous under a specific legislature39) or a product which may pose a specific health or environmental hazard under a specific legislature40) will be placed on the market in the Czech Republic in accordance with a specific legislature41).
38) § 23 of Act No. 356 / 2003 Coll.
39) Paragraph 2 (5) of Act No 356 / 2003 Coll.
40) § 20 paragraph 7 of Act No 356 / 2003 Coll.
41) Part First Title IV of Act No. 356 / 2003 Coll. '.
26. in Article 21 (2) (c), the words "the name, registered office and, where applicable, the address of the seller of the parallel product in that State," shall be deleted;
27. in Paragraph 21 (2) (d), the word "relevant" is replaced by the word "reference."
28. In Article 21, the following paragraph 6 is added:
"(6) Where the parallel product is labelled with a Czech label, the label shall be affixed to the packaging of the product bearing the label both imported and made clear that it is a transpose of the original label, the batch number of the product marked by its original manufacturer on the packaging being not covered. '
29. in Paragraph 22 (1), in the introductory part, the words "in triplicate" shall be deleted;
30. in Paragraph 22 (2), the words "the application shall include" shall be replaced by the words "the applicant shall transmit on request to the phytosanitary authority."
31. In Annexes 1 and 2, the introductory phrase after the heading "Introduction 'is replaced by the following:" Documentation set of data [processed and supplied together with the application for authorisation of the product in accordance with the instructions of the European Commission published by the Plant Health Administration in the Bulletin (Section 72 (6) of the Act) and by electronic means enabling remote access to the product]:'.
32. In Annex 3, the following is inserted after the introductory phrase:
Principles for the evaluation and registration of chemical plant protection products'.
33. In Annex 3, Section C, the following Part II is inserted after point 2.7.3:
Principles for evaluation and registration of plant protection products containing micro-organisms
A. INTRODUCTION
1. Plant health management shall ensure that, when assessing plant protection products containing micro-organisms ("microbial products") and deciding on their registration, the requirements laid down in accordance with the European Community Regulation (17) are applied at a high level of protection of human and animal health and the environment.
2. In the evaluation of applications and in the granting of a registration (authorisation),
(a) (aa) ensure that the microbial preparation documentation complies with the requirements of Annex 1, Part B18) at the latest at the end of the assessment for decision-making purposes, without prejudice, where appropriate, to the European Community Regulation, 19)
(ab) ensure that the data submitted are acceptable in terms of scope, quality, consistency and reliability, and allow proper evaluation of the dossier;
(ac) where appropriate, assess the reasons for which the applicant has not provided certain data;
(b) taking into account the entries in Annex No 2, Part B20) concerning the active substance of the preparation consisting of micro-organisms (including viruses) which have been submitted for the inclusion of the micro-organism concerned in the list of active substances (21) and the results of the evaluation of these data, without prejudice, where appropriate, to European Communities, 22)
(c) take into account other relevant technical or scientific information which may be reasonably available concerning the effects of the preparation or the potentially adverse effects of the preparation, its constituents or its metabolites / toxins.
3. Where reference is made to the data referred to in Annex No 2, Part B, 20 in the specific assessment guidelines, the data referred to in point 2 (b) shall be treated as such.
4. Where the data and information provided are sufficient to complete the evaluation for one of the proposed uses, the application shall be evaluated and a decision shall be taken for that proposed use.
Taking into account the reasons and clarifications provided at a later date, applications for marketing authorisations in whose data the deficiencies are such that it is not possible to complete the evaluation and make a reliable decision for either of the proposed uses.
5. During the evaluation and decision-making process, the plant health service shall cooperate with the applicant in order to quickly resolve all issues relating to the dossier, to set out in a timely manner any additional studies necessary for the proper evaluation of the dossier or to amend the proposed conditions of use of the product or to amend its nature or composition in order to ensure full compliance with the requirements of this Annex and the European Community Regulation. 23)
Under normal conditions, the plant health administration shall take a decision within 12 months of receipt of the complete technical documentation. The complete technical documentation is a dossier which meets all the requirements of Annex 1, Part B.18)
6. The opinions drawn up during the evaluation and decision-making process shall be based on scientific principles, preferably those which are internationally recognised, and on expert recommendations.
7. The microbial preparation may contain viable and non-viable micro-organisms (including viruses) and co-formulants. It may also contain significant metabolites / toxins produced during growth, residues from the nutrient medium and (microbial) contaminants. The micro-organism, the relevant metabolites / toxins and the preparation with residual nutrient media and microbial contaminants should be evaluated.
8. The plant health management must take into account the methodological guidelines taken into account by the Standing Committee on the Food Chain and Animal Health.
9. With regard to genetically modified organisms, account must be taken of the European Community Regulation. 24) It must be provided and taken into account in the assessment carried out under that Regulation.
10. Definition and explanation of microbiological concepts
Antibiosis: A relationship between two or more species where one species is actively damaged by another (for example by the production of toxins).
Antigen: A substance that, when in contact with the cells concerned, causes a state of sensitivity or immune response after a certain incubation period (days or weeks) and which has been shown to react in vivo or in vitro by antibodies or immune cells of a susceptible entity.
Antimicrobial: Antimicrobial agents or antimicrobials mean naturally occurring, partially synthetic or completely synthetic substances having an antimicrobial effect (destroying or suppressing their growth).
Antimicrobiotics include:
10.1. antibiotics, which are substances produced or derived from micro-organisms, and
10.2. coccidiostats, which are substances, effective against coccidias, single-celled foreign protozoa.
CFU (Colony-forming unit; one or more cells that grow to form a single visible colony): colony forming unit; one or more cells that form one visible colony in growth.
Colonization: The propagation and persistence of the micro-organism in a particular environment, such as the external (skin) or internal (intestines, lungs) surface of the body. In order to be colonised, the micro-organism should persist for at least longer than expected for an organ. The population of the micro-organism may shrink, but at a slower rate than in normal disappearance, it may be constant or growing. Colonisation may be associated with harmless and functional micro-organisms and pathogenic micro-organisms. Possible occurrence of effects is not explicitly stated.
Ecological niche: Unique habitats within the environment, which are occupied by a particular species, are understood in terms of the actual physical space that is inhabited and the function that they perform in the community or in the ecosystem.
Host: Animal (also human) or plant which holds or nourishes another organism (parasite).
Host circle: A circle of different host species that can be colonized by a species or strain of microbes. A micro-organism with a limited host circle colonises or adversely affects one or only a small number of different host species. A wide range of host micro-organism may colonise or adversely affect a large number of different host species.
Infection: The introduction or intrusion of a pathogenic micro-organism into a susceptible host which may or may not cause pathogenic effects or disease. The organism must enter the host's body, usually into cells, and be able to reproduce to create new infectious units. Just entering a pathogen doesn't mean infection.
Infectious: Able to transmit infection.
Infectiveness: The property of a micro-organism that allows the infection of a susceptible host.
Invasion: Invasion of the micro-organism into the host body (e.g. active penetration of the skin, epithelial cells of the intestine, etc.). The primary ability of the invasion is a characteristic of pathogenic micro-organisms.
Reproduction: The ability of micro-organisms to reproduce and increase during infection.
Mycotoxin: Toxin of mushrooms.
Non-viable micro-organism: A micro-organism not capable of replication or transmission of genetic material.
Non-viable residue: Residuum not capable of replication or transmission of genetic material.
Pathogenicity: The ability of the micro-organism to cause disease or damage the host. Many pathogens cause disease by combining toxicity and invasion or toxicity and colony formation. However, some invasive pathogens cause disease due to an abnormal response of the host's immune system.
Symbiosis: A type of interaction between organisms in which one organism lives in close contact with another, which benefits both.
Viable micro-organism: A micro-organism capable of replication and transmission of genetic material.
Viable residue: Residuum capable of replication and transmission of genetic material.
Viroid: Any type of group of infectious agents which consists of a short RNA chain without protein. RNA does not encode proteins and is not transformed; is reproduced by host cell enzymes. Viroids are known as the agents of certain plant diseases.
Virulence: The degree of ability of the micro-organism to cause disease according to the severity of the disease. The amount of inoculum needed to induce a certain degree of pathogenicity. It is measured experimentally using a mean lethal dose (LD50) or a mean infectious dose (ID50).
B. ASSESSMENT
The purpose of the evaluation shall be to identify and assess on a scientific basis and until further experience is gained on a case-by-case basis, the potential adverse effects of the use of the microbial preparation on human and animal health and the environment. The evaluation shall be carried out in order to identify the necessary risk management measures and to recommend appropriate measures.
Due to the ability of micro-organisms to reproduce, there is an obvious difference between chemicals and micro-organisms used as preparations. Hazards caused by micro-organisms may not necessarily be of the same nature as those caused by chemicals, particularly with regard to the ability of micro-organisms to persist and multiply in different environments. In addition, micro-organisms consist of a number of different organisms, each having unique properties. These differences between micro-organisms shall be taken into account in the evaluation.
The micro-organism in the preparation should ideally act as a 'cell factory' that acts directly on the site where the target organism is harmful. Therefore, the crucial step in the evaluation process is to understand the mode of action of the micro-organism.
Microorganisms may produce a number of different metabolites (such as bacterial toxins or mycotoxins), many of which have toxicological significance and one or more of which may be involved in the mode of action of the product. The characterisation and identification of significant metabolites and their toxicity should be assessed. Information on the formation or relevance of metabolites may be derived from:
(a) toxicological studies;
(b) the biological properties of the micro-organism;
(c) the relationship with known plant, animal or human pathogens;
(d) the mode of action;
(e) analytical methods.
On the basis of this information, metabolites may, where appropriate, be considered significant. The potential exposure to these metabolites should therefore be assessed in order to decide their relevance.
1. General principles
1.1. In the light of current scientific and technical knowledge, the information provided in accordance with the requirements of Annex 2, Part B20) and Annex 1, Part B, 18) shall be evaluated and in particular:
(a) identify associated hazards, assess their relevance and assess possible risks to humans, animals or the environment; and
(b) the efficacy, phytotoxicity and pathogenicity of the product shall be assessed for each use for which registration is sought.
1.2 Where standardised test methods are not available, the qualitative level of the test methodology shall be evaluated and the following characteristics of the methods described shall be assessed, where available: relevance, representativeness, sensitivity, specificity, reproducibility, inter-laboratory validation, predictability.
1.3 The interpretation of the evaluation results shall take into account the elements of uncertainty in the information obtained during the evaluation to minimise the risk that adverse effects will not be identified or understated. During the decision-making process, critical decision-points or data items for which the uncertainty element could lead to incorrect classification of risk should be identified.
The first evaluation shall be based on the best available data or estimates reflecting the real conditions of use of the product. It should then be followed by a new assessment which takes into account the potential elements of uncertainty in critical data and the extent of the conditions of use that may occur and which provides a real picture of the least favourable case in order to determine whether it is possible that the first assessment could be significantly different.
1.4 Each microbial preparation for which authorisation has been requested shall be evaluated taking into account the information evaluated on the micro-organism. It must be taken into account that co-formulants may affect the characteristics of the product compared to the micro-organism.
1.5 The evaluation of applications for marketing authorisations shall take into account the specific conditions of use proposed and, in particular, the purpose of use, dose, manner, frequency and timing of applications and the nature and composition of the product. The principles of integrated plant protection shall also be taken into account whenever possible.
1.6 The evaluation of applications submitted shall take into account the agricultural, plant health and environmental (including climatic) conditions in the areas of application.
1.7 If the specific principles in Section 2 foresee the use of calculation models in the evaluation of the product, these models shall:
(a) provide the best possible estimate of all relevant processes taking into account real parameters and assumptions;
(b) be subject to the evaluation referred to in point 1.3;
(c) be reliably validated by measurements carried out in circumstances relevant to the use of the model;
(d) be suitable for conditions of use;
(e) be supported by data on how the model processes those estimates and include an explanation of all input data entered into the model and details of how they were derived.
1.8 The data requirements set out in Annex 2, Part B20) and Annex 1, Part B18) contain guidance on when and how certain information must be provided and what procedures should be used in the preparation and evaluation of the dossier. These guidelines should be followed.
2. Specific Principles
In assessing the data and information submitted as a basis for applications, the following principles shall apply without prejudice to the general principles set out in Section 1:
2.1. Identification
2.1.1. Identification of the micro-organism in the preparation
The identity of the micro-organism must be accurately identified and the data provided must allow its evaluation at strain level. If the micro-organism is a mutant or a genetically modified organism, 25) specific differences should be noted from other strains within the same species. The occurrence of rest stages shall also be recorded.
It must be checked that the strain has been stored in an internationally recognised collection of cultures.
2.1.2. Identification of the product
Detailed quantitative and qualitative data on the composition of the product shall be evaluated, such as data on the micro-organism (see above), relevant metabolites / toxins, residual nutrient medium, co-formulants and the presence of microbial contaminants.
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Regulation Information
| Citation | Decree No. 371 / 2006 Coll., amending Decree No. 329 / 2004 Coll., on preparations and other plant protection products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.07.2006 |
|---|---|
| Effective from | 01.01.2007 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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