Decree of the Ministry of Agriculture No. 91 / 2002 Coll.
Decree of the Ministry of Agriculture on plant protection products
Valid
Order
Effective from 01.10.2002
Text versions:
01.10.2002
20.03.2002
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91
DECLARATION
Ministry of Agriculture
of 26 February 2002
on plant protection products
The Ministry of Agriculture provides, pursuant to Article 45 (3) of Act No. 147 / 1996 Coll., on Phytosanitary Care and Amendments to Certain Related Acts, as amended by Act No. 409 / 2000 Coll. and Act No. 314 / 2001 Coll., hereinafter referred to as "the Act", for the implementation of Sections 18 (1), 19 (1) (g), 19a (5), 19b (2), 21 (1) (h), 25 (7), 26 (1) and 36 (2) (b), and 3 (4) and 37 (2) respectively:
Subject matter
This decree lays down requirements for plant protection products and the documentation submitted at the time of their registration in accordance with the law of the European Communities (1) and the international treaty which the Czech Republic is bound by, and the treatment and registration of plant protection products and their control testing.
Details of the application for registration of the plant protection product and the plant protection aid
(Articles 18 (1) and 19b (2) of the Law)
(1) The application for registration of a plant protection product (hereinafter referred to as "the product") or an assistant plant protection product (hereinafter referred to as "the aid") submitted by the applicant under Article 18 of the Act contains:
(a) details of:
1. the applicant and his legal representatives,
2. the manufacturer of the preparation and its active substance, or the aid;
3. any other party (Paragraph 18 (4) of the Act),
4. the product or aid which is the subject of the application;
(b) the subject matter of the application, including observations on possible use in gardens which are not used for business (hereinafter referred to as "home gardens"), for the treatment of public greenery, sports grounds, room and balcony ornamental plants and on other areas outside agricultural or forest land, where such use is considered;
(c) Annexes which are:
1. the dossier data set (hereinafter referred to as "the dossier") on the active substance, including the active micro-organisms contained in the preparation, in accordance with the documentation requirements set out in Annex 1,
2. documentation of the preparation or aid, as required in Annex 2;
3. a product dossier containing parasites, parasites or predators ("active macroorganisms"), as required in Annex 3,
4. the consent of the person whose rights to data are protected (Sections 20 (3) and (4) of the Act);
5. other documents confirming that the tests and analyses have been carried out by persons entrusted under Paragraph 40 (2) (c) of the Act in accordance with good laboratory practice and good experimental practice, the principles of which are set out in Annex 4;
(d) a safety data sheet, if it is a chemical preparation, in the form and content according to a specific regulatory regulation.3)
(2) Samples of the product or aid provided by the applicant to the State Plant Health Administration (Section 19 (3) of the Act) or authorised person (Section 40 (2) (c) of the Act) designated by the State Plant Health Administration,
(a) shall be marked on the packaging:
1. significantly and indelibly to show that the samples are intended only for test purposes;
2. particulars identifying the product or the aid (date of manufacture and batch number or other means of identification),
3. if it is a chemical preparation, including standard risk phrases (R-phrases) 4) and standard safety instructions (S-phrases), 4)
(b) they must be accompanied by a document indicating their composition.
The application for registration of a biological product containing genetically modified organisms shall be accompanied by documents in accordance with specific legislation. 5)
Technical requirements for preparations
[Paragraph 19 (1) (g) of the Law]
(1) The technical requirements for preparations are set out in Annex 5.
(2) The biological preparation may contain only organisms which are verifiable in terms of species, quantity and durability.
(3) If the design for the use of the preparation indicates that it is to be used in a mixture with another preparation or substance, the results of the tests shall be demonstrated that the substances contained in the mixture are chemically and physically tolerable and do not impair the biological efficacy of the preparation.
Technical requirements for persons entrusted under Section 40 (2) (c) of the Act to be required to meet when testing products
(Paragraph 19a (5) of the Law)
Persons not accredited to test products under a specific legislation, (6) may test products if they demonstrate that:
(a) the handling of dangerous products is ensured in accordance with specific legislation, 7)
(b) they shall have facilities for storing samples of preparations and the conditions created corresponding to the technical requirements referred to in Section 13;
(c) they have created conditions for the safe collection of unfit residues of preparations, their packaging, the residues of the application fluid and water after cleaning the application technique;
(d) they have a procedure for disposing of residues of preparations, packaging after them, residues of application fluid and water after cleaning of application techniques from preparations in accordance with specific legislation, 8)
(e) have the safety instructions for the handling of products and the activity referred to in (d) processed;
(f) are eligible to comply
1. the principles of good experimental practice set out in Annex 4;
2. general technical conditions for the experimental use of the products referred to in Sections 16 to 18.
Warning and labelling with regard to the special risks of the product and instructions for safe handling
[Paragraph 21 (1) (h) of the Law]
(1) Chemical products shall be labelled on the basis of the results of their classification according to the specific legislation9) by assigning:
(a) the hazard warning symbol and its letter, 10)
(b) risk-specific statements (4) (hereinafter referred to as "R- phrases");
(c) standard instructions for safe loading (4) (hereinafter referred to as "S-sentences").
(2) In addition to the R-phrases and the S-phrases, products shall also be labelled with a warning, in accordance with a specific legislation, (11) on the conditions of use of the preparation with regard to the protection of bees, game and other terrestrial vertebrates, fish and other aquatic organisms, soil organisms and useful arthropods. 11)
Paragraph 4 to 6 applies mutatis mutandis to aid (Section 34a of the Law).
Forms of the proposal for extended use of the product or aid (Section 34a of the Act), the scope of such use and the way in which users are informed
(Paragraph 25 (7) of the Law)
Forms of the proposal
(1) The application for authorisation for the use of a registered product or aid for an indication other than that provided for in the marketing authorisation ("extended use of the product") contains:
(a) details of the applicant for the extended use;
(b) particulars of the preparation or aid;
(c) the application destination and other data for the correct application;
(d) documentation demonstrating compliance with the technical requirements referred to in Article 4, taking into account the extended use of the product or aid;
(e) a toxicological assessment pursuant to Article 19 (4) of the Act where it can be assumed that the use of the product or the aid referred to in point (f) may endanger the health of humans with the residues of the product or the aid;
(f) a proposal for a guide to the use of the product or aid, including withdrawal periods and a proposal for restrictions on the use of the product or aid, if necessary to ensure the protection of human and animal health and the protection of the environment;
(g) the justification for the proposal by defining the general interest, the extent of the extended use of the product or the aid and the severity of the foreseeable damage to be avoided.
(2) The application for authorisation of extended use of the preparation or aid shall be submitted to the State Plant Health Administration in three copies, in accordance with the model set out in Annex 6.
Scope of extended use of the product or aid
The scope of the extended use of the product or of the aid shall be defined in such a way as to include the possibilities of its application for indications which are not of normal interest to the applicant or the marketing authorisation holder of the product or device, hereinafter "minor indications', due to their limited nature.
How to inform the users of the product or the aid
(Paragraph 25 (7) of the Law)
(1) The authorisation for the extended use of the product or aid is published in the list of registered products issued by the State Plant Health Administration pursuant to Section 24 (2) of the Act and in the Bulletin of the Ministry of Agriculture of the Czech Republic.
(2) Information on the possibility of extended use of the product or device for minor indications should also be provided on the label or in the package leaflet, provided that the marketing authorisation holder of the product or device has agreed in his opinion (Annex 6, point 9) to this extended use and its presentation on the label or package leaflet.
Technical requirements for packaging and labelling of preparations and aids
[Paragraph 26 (1) and 2 (g) and (h) of the Act]
Products and aids comply with the technical requirements for packaging if:
(a) the packaging, including its seals and markings, is weather-resistant and designed so that the contents of the packaging cannot escape spontaneously during handling and storage;
(b) the construction of packaging allows for full emptying;
(c) the material used for the manufacture of packaging and seals does not react with the contents of the packaging;
(d) the seals are made in such a way that it is clear whether or not the packaging has already been opened;
(e) they also comply with other requirements laid down in a specific legislation, 12) if they are chemical products.
(1) The packaging of preparations and auxiliary products is marked with durable and legible data in accordance with § 26 (2) to (7) of the Act.
(2) The minimum labelling sizes are set out in Annex No 7.
(3) Chemical products are labelled in accordance with special legislation13) and the words "Follow the instructions for use in order to avoid risks to humans and the environment."
(4) The particulars referred to in paragraphs 1 and 3 shall be given in the Czech language. The parallel labelling of packaging also in other languages shall not be excluded if it is in accordance with the information given in the Czech language.
Technical requirements for storage of preparations and aids
(Articles 27 (2) and 34a of the Law)
(1) Storage space used for the storage of preparations and aids within the business14) must:
(a) protect
1. products and aids which could endanger the chemical and physical properties of the stored products and aids and their biological efficacy;
2. the surrounding environment before the effects of stored products and aids, including in accidents, fires or floods;
3. before the introduction of stored products and aids into the subsoil and public sewerage,
(b) allow:
1. the safe handling of products and aids in order to avoid breaches of their packaging, closures and labelling and to endanger human health;
2. the cleaning of objects and areas in the storage area if the products or aids have been contaminated;
3. storage of preparations and aids in accordance with the conditions indicated on the label or package leaflet, for example in closed cabinets or similar facilities;
(c) be equipped with:
1. an available water source and adequate illumination of all spaces,
2. a first aid kit in the event of accidental ingestion or contact of the eyes or skin located outside the premises where the products or aids are stored;
3. means for rendering storage facilities;
4. personal protective equipment in a quantity corresponding to the number of natural persons coming into direct contact with the products or aids placed outside the premises where the products or aids are stored;
5. technical means for the separate storage of preparations or aids, excluding their interactions;
6. equipment for continuous temperature and relative humidity measurement,
7. Technical equipment enabling the storage of biological products in accordance with the conditions of proper storage indicated on the packaging, provided that such products are to be stored in the storage area.
(2) The instructions for the procedure in the event of an accident or fire, the safety data sheet in the Czech language and the records of the products and aids stored shall be placed outside the warehouse in order to be accessible to persons carrying out the destruction of the accident or fire. This measure is part of a major accident prevention safety programme according to a specific legislation, 15) if it involves objects or equipment in which a chemical product corresponding to its characteristics and the quantity of dangerous product selected is stored.
Details of use of vertebrate killing products
(Paragraph 29 (2) of the Law)
Products may be used for the control of harmful vertebrates if:
(a) the population of the harmful species in a particular biotop16) has reached a level of overgrowth where there is a risk of serious damage to grown plants, including forest crops or plant products;
(b) the population of the harmful species is in the growth phase before its peak (programming),
(c) the presence of natural predators is not likely to prevent an excess of the harmful species of vertebrate animals;
(d) protection of animals 17) and especially protected animals under specific legislation is ensured. 18)
Registration of the use of products in business
(Paragraph 29 (3) of the Act)
(1) The use of products in business shall be recorded by recording the data in a separate book with continuously numbered pages, without delay, no later than the following working day after application of the product.
(2) The model for the record of data on the use of products in the business (14) is set out in Annex 8.
General technical conditions for experimental use of products
(Paragraph 33 (2) of the Act)
Experimental use of preparations
(a) in order to obtain the supporting documents for their registration, it is subject to proof that the persons who are to carry out experiments with them are entrusted to this activity under Paragraph 40 (2) (c) of the Act and comply with the technical requirements laid down in Section 5; in the case of animal experiments, they must prove that they fulfil the conditions laid down in specific legislation; 19)
(b) in other cases it shall be subject to proof that:
1. persons who are to carry out experiments with them are persons referred to in point (a) or are accredited to this activity under special legislation (6) or operate a trade in which the activity is a plant protection test activity, 20)
2. persons other than those referred to in point 1 shall be able to ensure that experiments are carried out in order to avoid endangering human and animal health and the environment and to comply with the specific conditions laid down by the State Plant Health Administration;
3. plant products will not be consumed or fed after application of the product.
The experimental use of preparations shall be subject to compliance with the following basic rules:
(a) plant products affected by applied chemical products or derived from plants treated with such products may not be put into circulation as food or feed;
(b) experiments on products may only be carried out in such a way as not to endanger the protection zones of aquatic resources, 21) natural medicinal and mineral water sources, 22) surface water, 23) groundwater (24) and water bodies (25)
(c) the packaging of products not yet registered, tested in the context of experimental use, must bear the following particulars in a durable, legible and Czech language:
1. the distinctive designation "For experimental purposes only,"
2. the designation "Plant protection product,"
3. the trade or provisional name or code name of the preparation,
4. the name or code name and content of each active substance in the preparation,
5. name, address and telephone number of the representative of the consent holder for the experimental use of the product (can be found in the package leaflet),
6. standard risk phrases, 4)
7. proposed guidance on safe handling of S-sentences, 4)
8. Lot number, date of manufacture and expiry date,
9. additional labelling according to the conditions specified in the consent to experimental use of the product;
(d) the application of the product can be carried out only after the consent of the State Plant Health Administration to its experimental use (Section 33 of the Act),
(e) the person conducting the experiments takes appropriate measures to prevent the risk to human, animal and environmental health as a result of the experimental use of the product.
(1) The application for approval of the experimental use of the preparation shall contain the following information:
(a) the purpose;
(b) details of the applicant;
(c) data on the product tested,
(d) data on the active substance in the test product,
(e) the provisional labelling and possible risks arising from its use;
(f) the particulars of the intended use;
(g) experimental use methodology;
(h) data on the intended sites of application, location and extent of experimental use;
(i) the estimated duration of the experimental use;
(j) the method of preventing the consumption or feeding of grown plants or plant products after application of the product.
(2) If the experimental use of the product is to be obtained in order to obtain evidence for its registration, the applicant shall, together with the application referred to in paragraph 1: A sample of each production batch of the product to be used, a safety data sheet and proof of the composition of the sample of the product and its compliance with the batch intended for experimental use, shall be submitted to the State phytosanitary authorities.
Active substances of products whose import is prohibited
(Paragraph 34 (1) of the Law)
Active substances for which import is prohibited, including for use as an ingredient or as part of another product, are listed in Annex 9.
Other mechanical appliances which may be put into circulation and used without being entered in the official register of mechanical appliances
[Paragraph 35 (1) (c) of the Law]
In addition to the mechanising devices referred to in § 35 (1) (a) and (b) of the Act, the types which may be put into circulation and used without being entered in the official register of mechanising devices, which:
(a) are not intended for outdoor use, except in the case of seed pickling aids;
(b) are intended for outdoor use and are equipped with:
1. a horizontal frame with two or one nozzle for spraying or roasting,
2. a frame with two or one nozzle for space spraying or roasting,
(c) are intended for application technologies based on gas, sinks, droplets, baits and other forms of restricted application, unless they pose a threat to the environment;
(d) are products not covered by specific legislation. 26)
Technical and technological requirements for a mechanisation device
(Paragraph 35 (2) of the Law)
A mechanism which is subject to registration in an official register of mechanising devices under Section 35 of the Act complies with technical and technological requirements if it complies with the technical and technological requirements set out in Annex 10.
Forms of application for registration of a mechanisation device in the official register of mechanisation devices
(Paragraph 35 (3) of the Law)
(1) The application for registration of a mechanisation device in the official register of mechanising devices ("the application") contains:
(a) particulars of the applicant, the manufacturer of the mechanisation device or, where appropriate, his distributor;
(b) details of the mechanical means applied for
1. the type designation and the extent of its use;
2. a description of the type,
3. instructions for use containing the information set out in Annex No 11,
4. further information needed due to the particularities of the mechanisation device,
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Regulation Information
| Citation | Decree of the Ministry of Agriculture No. 91 / 2002 Coll., on Plant Protection Products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.03.2002 |
|---|---|
| Effective from | 01.10.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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