Decree of the Ministry of Agriculture No. 42 / 2001 Coll.
Decree of the Ministry of Agriculture amending Decree of the Ministry of Agriculture No. 84 / 1997 Coll., regulating the registration and treatment of plant protection products and the technical and technological requirements for plant protection devices and their control testing, as amended by Decree No. 120 / 1997 Coll.
Valid
Order
Effective from 06.02.2001
Text versions:
06.02.2001
42
DECLARATION
Ministry of Agriculture
of 12 January 2001
amending Decree No. 84 / 1997 of the Ministry of Agriculture Coll., regulating the registration and treatment of plant protection products and the technical and technological requirements for plant protection devices and their control testing, as amended by Decree No. 120 / 1999 Coll.
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.:
Decree No. 84 / 1997 Coll., governing the registration and treatment of plant protection products and the technical and technological requirements for plant protection products and their control testing, as amended by Decree No. 120 / 1999 Coll., is amended as follows:
1. the following Section 2a to 2d is inserted after Section 2, including the headings and footnotes No 1b to 1d:
Assessment aspects of the active substance
(Paragraph 19 (2) of the Act)
(1) An active substance shall be considered fit for circulation if:
(a) the prohibition laid down in Paragraph 10 or the international treaty to which the Czech Republic is bound does not prevent this;
(b) given the current level of scientific and technical knowledge, the product containing it may be expected to satisfy the following conditions:
1. if properly used, it does not harm human and animal health and the environment;
2. Residues after application of the product with proper use will not have harmful effects on human and animal health and the environment, these residues being measurable by generally used methods.
(2) The active substance should be assessed
(a) permissible human daily intake (ADI);
(b) acceptable worker exposure level (AOEL);
(c) estimation of disintegration and movement in the environment and effects on non-target organisms, if possible,
(d) the minimum purity of the active substance;
(e) the nature, characteristics and maximum content of the impurities;
(f) restrictions resulting from the evaluation of data on the properties of the active substance, taking into account the specificities of agriculture and forestry, plant health and the environment including climate in the Czech Republic;
(g) the characteristics and method of use of the product,
(h) whether its entry into circulation is not restricted by special legislation, 1c)
(i) whether it has been evaluated at international level and with what result;
(j) classification of the substance under specific legislation. 1d)
(3) The active substance shall be assessed on the basis of the data provided for in Annex 1, Parts A to C.
Forms of the proposal for extended use of the authorised product, scope of use and how users of the product are informed
(Paragraph 25 (7) of the Law)
Forms of the proposal
(1) The application for authorisation to use a registered product for a purpose other than that provided for in the marketing authorisation ("extended use") contains:
(a) identification of the applicant for the extended use;
(b) identification of the product;
(c) the application destination and other data for the correct application;
(d) a documentation set of the necessary data demonstrating compliance with the technical requirements referred to in Article 2, taking into account the extended use of the product;
(e) an opinion on the protection of human health pursuant to Article 19 (5) (c) of the Act,
(f) draft instructions for use of the product, including withdrawal periods and proposed restrictions on use of the product, if necessary to ensure the protection of human and animal health and the protection of the environment;
(g) the justification for the proposal extends to the general interest, by defining the scope of the extended use of the product and the severity of the foreseeable damage to be avoided.
(2) The application for authorisation of extended use of the product shall be submitted to the State Plant Health Administration (hereinafter referred to as the "Plant Health Administration") in three copies, in accordance with the model set out in Annex No 15; the proposal may also be made by the Plant Health Administration on its own initiative.
(3) Before deciding on a proposal, the plant health authority shall seek the opinion of the marketing authorisation holder.
Scope of extended use of the product
(1) Extended use of the product means its application for minor indications which mean uses which are not of interest to the marketing authorisation holder due to their low need.
(2) In cases other than those referred to in paragraph 1, the provision concerning the authorisation of the use of the product shall apply by way of derogation from the conditions laid down in the marketing authorisation decision referred to in Article 25 (1) of the Act.
Method of informing product users
(1) Authorisation for extended use of products is published in the Official Journal of the European Union.
(a) in the list of registered products issued by the plant health authority pursuant to Article 24 (2) of the Act,
(b) other ways in which information on the extended use of the product becomes generally available.
(2) The information on the extended use of the product should also be provided on the label on its packaging or in the package leaflet (Section 4 (2)), but separately from the information on the scope of the marketing authorisation and the instructions for use provided for by the Marketing Authorisation Decision (Section 21 (1) of the Act).
1b) Communication from the Ministry of Foreign Affairs No 7 / 1995 Coll., on the negotiation of a Europe Agreement establishing an association between the Czech Republic, of the one part, and the European Communities and their Member States, of the other part.
1c) § 15 paragraphs 1 and 3 of Act No. 157 / 1998 Coll., on Chemicals and Chemicals and on the amendment of certain other laws, as amended by Act No. 352 / 1999 Coll. Decree No 301 / 1998 Coll., establishing a list of chemicals and chemical products whose production, placing on the market and use are restricted.
1d) Act No. 157 / 1998 Coll., as amended. '
2. Annex 5 shall read as follows:
"Annex No 5 to Decree No. 84 / 1997 Coll.
Labelling with regard to the special risks of products and instructions for the safe handling of products
Products shall be labelled in accordance with the model set out in this Annex in accordance with the decision on their registration [Paragraph 21 (1) (e), (g) and (h) of the Act].
1. General standard phrases indicating a specific hazard shall be selected from the R-phrases (including the relevant code number) specified in the separate legislation.1)
1) Point 1 of Annex 5 to Government Regulation No. 25 / 1999 Coll., laying down a procedure for the assessment of the hazards of chemicals and chemical products, the way in which they are classified and the labelling and the list of hazardous chemicals still classified.
2. The general standard phrases identifying the product safe-handling instructions shall be selected from the S-phrases (including the relevant code number) specified in the separate legislation.2)
2) Point 2 of Annex 5 to Government Decree No. 25 / 1999 Coll.
3. Guidelines for the protection of drinking water sources (specified by the registrant).
4. Product designation for bee protection
Acc 1: The product is poisonous to bees
Acc 2: The product is harmful to bees, with compliance with the prescribed dose or spray fluid concentration
Acc 3: The product is relatively harmless to bees, with compliance with prescribed dosage or spray fluid concentration
The use of the product is governed by Decree No. 40 / 1997 Coll., laying down details of the protection of bees, game and fish when using plant protection products.
5. Labelling of the product in terms of animal protection
Z 1: The product is particularly dangerous to animals
Z 2: The product is dangerous for animals
Z 3: The product is relatively harmless to animals
From 4: The use of the product is governed by Decree No. 40 / 1997 Coll.
6. The product designation with regard to the protection of aquatic organisms shall be chosen from these models and words corresponding to the classification of the product
Vo 1: The product is very toxic to fish *) / toxic *) / harmful *)
Vo 2: The product is very toxic to algae *) / toxic *) / harmful *)
Vo 3: The product is very toxic to fish for food *) / toxic *) / harmful *)
Vo 4: The product, its residues and packaging after use must not be allowed to enter surface water.
7. Product designation with regard to the protection of birds outside animals
Pt 1: The preparation is toxic to birds
Pt 2: Product-infested seed is toxic to birds
Pt 3: The preparation is toxic to birds and must therefore not be used for spraying lettuce, brassica vegetables and other plant species at a time when the spray fluid is accumulating on them and the birds can drink it
Pt 4: The product is toxic to birds and must therefore not be used or kept in places where birds could be accepted as food
Pt 5: The product is harmful to birds if the prescribed dose or concentration is not exceeded
Pt 6: The product is relatively harmless to birds if the prescribed dose or concentration is not exceeded.
8. Labelling of the preparation for the protection of useful arthropods outside bees
Teaching 1: The product is toxic to the population... * *)
Teaching 2: The product is moderate to the population... * *)
Teaching 3: The product is weakly harmful to the population... * *)
Teaching 4: The product is relatively harmless to the population... * *).
9. Labelling in terms of soil protection
After 1: The product is toxic for earthworms
After 2: The product is harmful for earthworms if the prescribed dose is not exceeded
After 3: The product is relatively harmless for earthworms if the prescribed dose is not exceeded
After 4: The preparation is toxic for soil micro-organisms
After 5: The product is harmful to soil micro-organisms if the prescribed dose is not exceeded
After 6: The product is relatively harmless for soil micro-organisms, with compliance with the prescribed dose
After 7: The product can be reused on the same property after the expiry of... * * *).
*) The appropriate words are chosen according to the product classification result.
* *) Specify the type of useful arthropod or higher systematic unit of these arthropods.
* * *) Indicate the length of time in days or weeks or months. "
3. The following Annex 15 is inserted after Annex 14:
"Annex No 15 to Decree No 84 / 1997 Coll.
MODEL
DRAFT
to authorise the extended use of the plant protection product
Specified:
Ministry of Agriculture
Agricultural production department
Tešnov 17, Prague
through:
State Plant Health Administration
Department of Plant Protection Products
Agricultural 1a, Brno
1. Proposer
1.1. Name and surname of the natural person authorised to do business or business company (name) of the legal person:
Address
telephone
telefax
e-mail
1.2 Contact person:
Name and surname
Address
telephone
telefax
e-mail
2.
2.1. Trade name of the preparation:
2.2. Registration number:
Marketing Authorisation Holder:
3. Application destination
3.1 Indications (application area)
(a) Type of plant or plant product or other treatment subject:
(b) Harmful organism:
(c) Other purpose of use:
3.2 Other data for the correct application:
4. Documentation set of technical compliance data
| Položka | Požadavek | Doklad |
|---|---|---|
| 4.1 | Prokazatelný účinek z hlediska účelu, pro nějž je přípravek určen | |
| 4.2 | Přípravek nezpůsobuje | |
| 4.2.1 | nepříznivé snížení či ohrožení výnosu ošetřených rostlin | |
| 4.2.2 | zhoršení kvality sklizeného nebo ošetřeného rostlinného produktu | |
| 4.2.3 | genetické změny ošetřených rostlin | |
| 4.3 | Účinky na složky životního prostředí podle požadavků uvedených v příloze č. 3 k vyhlásče č. 84/1997 Sb., pokud nejsou známé z dokladů doložených v registračním řízení o přípravku |
5. Toxicological Assessment
5.1 Submitted: yes - no; document No:
6. A risk assessment with regard to the protection of bees, fish, game and other non-target organisms where exposure to the product is possible.
7. Instructions for use
- indicated as document No:
7.1 Specifying the indication (in relation to a plant, plant product or other treatment subject, a harmful organism or other purpose of use)
7.2 Application
- frequency of application
- maximum number of applications
- intervals between applications
- withdrawal period
- additional periods between administration and, for example,
(a) entry into the crop
(b) processing of a plant product;
(c) feeding the plant product
- application dates
- dosage of the product and, if necessary, water
- application technique
- restrictions on application
7.3. Sensitivity of varieties
7.4 Other preparation for application mixture
- trade name
- application dose
- conditions of use of the mixture
7.5 Other information for use of the product.
8. Justification of the proposal
- indicated as document No:
8.1. Width of general interest:
8.2 Definition of the scope of the extended use of the product:
8.3 The severity of the anticipated damage to be avoided.
9. Opinion of the Marketing Authorisation Holder
10. Proposal to supplement the text of the label
Date:
Name and surname and signature of the person authorised to act as applicant: '.
This decree shall take effect on the day of its publication.
Minister:
Ing. Fencl v. r.
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Regulation Information
| Citation | Decree of the Ministry of Agriculture No. 42 / 2001 Coll., amending Decree of the Ministry of Agriculture No. 84 / 1997 Coll., regulating the registration and treatment of plant protection products and the technical and technological requirements for plant protection devices and their control testing, as amended by Decree No. 120 / 1997 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.02.2001 |
|---|---|
| Effective from | 06.02.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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