Decree No. 32 / 2012 Coll.
Decree on preparations and other plant protection products
Valid
Effective from 01.02.2012
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32
DECLARATION
of 19 January 2012
on products 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. 245 / 2011 Coll., (hereinafter "the Act '):
This decree builds on the directly applicable European Union regulation on the placing of plant protection products on the market (1) and implements the provisions of the law applicable to products and other plant protection products.
Conditions for repackaging plant protection products
(K § 31 (6) of the Act)
(1) The repackaging of the product intended for placing on the market must not affect the composition or physical and chemical properties of the repackaged product.
(2) A product authorised to be placed on the market may only be packed in a package the characteristics of which and the risks of its use have been assessed by the plant health authority in relation to that product and which is listed in the decision authorising that preparation.
(3) The different batches of the changed product must not be mixed during repackaging.
(4) The packaging of the preparation after repackaging must bear the same batch number and the date of manufacture as the original packaging of the repackaging.
(5) The documentation on repackaging contains:
(a) date of repackaging,
(b) the name of the preparation before and after re-packaging,
(c) the quantity delivered, the batch number and the date of manufacture of the preparation for repackaging, as shown on the original package.
(6) The documentation referred to in paragraph 5 shall be kept in accordance with the Regulation of the European Union governing the placing on the market of preparations (2).
Criteria defining minor uses of the preparation
(Paragraph 37 (2) of the Act)
The use of the product is considered to be minor if:
(a) the cultivation area of a crop in the Czech Republic less than 10 000 ha in the year in which the application for extension of the authorisation was submitted;
(b) the area treated has been less than 10 000 ha per year in the last three years prior to the application for extension;
(c) the presence of the harmful organism irregular and the treatment required less than once every three years; or
(d) the product applicable in organic farming (3).
Areas of testing and details of documentation to demonstrate competence for conducting experiments and tests
(Paragraph 45 (13) of the Law)
(1) The test areas are:
(a) field crops and vegetables;
(b) permanent crops including forest crops;
(c) greenhouses and other indoor areas;
(d) seed pickling,
(e) laboratory tests and analyses.
(2) The documentation to demonstrate the competence to carry out experiments and tests in accordance with the requirements of good experimental practice includes:
(a) documentation on the organisational and technical conditions, containing:
1. description of the workplace and its agricultural activities;
2. organisation of the workplace, including the definition of competence in the management of the workplace and in the conduct of its professional activities;
3. the internal system of staff training in the field of quality assurance of work, working practices and work safety,
4. a description of the construction, premises and experimental plots including the storage of samples of preparations;
5. a description of how to ensure the safe collection and disposal of unfit residues of preparations, their packaging, the residues of the application fluid and water after cleaning of the application technique;
6. a description of how treated plants or plant products are handled,
7. an overview of machines, apparatus and other apparatus for conducting tests,
8. Rules on the retention of documentation; and
9. the rules of the internal quality control system;
(b) standard operating procedures for all test activities;
(c) metrological rules laying down rules for the handling, maintenance and calibration of measuring instruments used;
(d) the maintenance and calibration records of the equipment and equipment used; and
(e) records of education, courses and training for carrying out an activity.
Criteria for places where products or other means of distribution are handled in business
(Paragraph 46a (1) of the Law)
(1) Places where products or other means of distribution are handled shall correspond to the type and quantity of products distributed to enable the safe handling of the products.
(2) The place where products or other means of distribution are handled in business must be protected from rain, freezing, allow separate storage of individual types of preparations or other means and must be equipped with an air temperature measuring device.
(3) For each location referred to in paragraph 1, separate operational safety rules shall be established with the specifications of sanitary, operational safety and fire regulations.
(4) In places where products or other means in retail packages are handled in business and these retail packages are sold directly to non-professional users, the requirements set out in paragraph 1 shall apply.
Principles of good distribution practice
[K § 46a (6) (a) of the Act]
(1) For the distribution of products or other means of distribution
(a) establish and systematically apply the requirements referred to in paragraphs 2 and 3 throughout it;
(b) ensure that staff members are trained in the activities they carry out and their competence is defined in writing; and
(c) ensure that premises and technical equipment intended for the distribution of products or other means are consistent with the type and extent of the products or other means distributed and that such premises and technical equipment are maintained and controlled in such a way as to ensure that the products or other means are properly handled.
(2) Products or other means shall be stored by the distributor in such a way that:
(a) the storage conditions corresponding to the hazards of the preparations or other means and other requirements for the storage of preparations laid down directly by the applicable European UnionRegulation (1), (4), (law and other legislation5) are respected;
(b) a system for the replacement of stocks has been established;
(c) the products or other devices which have expired have been placed separately and have not been further distributed;
(d) products or other devices with broken packaging or preparations or other means which are suspected to be contaminated or falsified, or products or other means for which claims have been made have been placed separately and have not been further distributed;
(e) preparations or other devices intended for export to third countries have been stored separately from preparations or other devices intended for marketing;
(f) the preparations or other means referred to in points (c) to (e) have been stored in an area which is marked significantly;
(g) they have not been contaminated, damaged, stolen, degraded and confused; and
(h) there were no discrepancies between the documentation referred to in Article 7 and the activities carried out in the context of the reception, storage and supply of preparations or other means.
(3) The transport of products or other means shall be ensured by the distributor in such a way that:
(a) are not subject to adverse effects;
(b) they have not been contaminated, damaged, stolen, degraded and confused.
(4) Where a product or other device has been returned to the distributor on suspicion of an unauthorised product or other device not included in the official register, the distributor shall keep records of this fact and keep the documents referred to in Article 7 mutatis mutandis.
(5) The distributor has repeatedly carried out internal controls to verify the implementation and compliance with good distribution practice and takes the necessary corrective measures. Within the framework of internal controls, the distributor shall carry out a check at least once a year to compare the state of the products received and distributed or other means with the current stock status of the products or other means. Any discrepancies identified in this comparison shall be recorded.
Scope and manner of storage of documentation and records of the distribution of products or other products and their origin
[K § 46a (6) (b) of the Act]
(1) The distributor shall draw up and maintain up-to-date written procedures for activities which may affect the quality of preparations, other means or distribution activities, such as reception, control of supplies, storage, cleaning and maintenance of premises, checks on storage conditions, including protection of products or other means of storage and transport, withdrawal of products from circulation, ordering, returning and supplying, shall keep the records referred to in paragraph 4 and retain the documents referred to in paragraph 6.
(2) The documentation on the withdrawal of the product or other device from circulation under Section 46a of the Act is provided for in written procedures. This documentation shall include:
(a) the definition of staff competences in the implementation and coordination of downloads;
(b) a description of the communication with the competent authorities, the authorisation holder, the manufacturer and the suppliers and customers of the product or other device during and after the withdrawal;
(c) a description of the download process itself, including the procedure for the immediate identification and contact of all customers of the product or other device;
(d) the manner in which records are kept and kept of all withdrawal activities or other means;
(e) an assessment of the withdrawal process or other means and of the measures taken where withdrawal is not possible; and
(f) a description of the separate location of the withdrawn products or other means from other stored products or other means.
(3) Records of receipt and supply of preparations or other means include:
(a) the name of the preparation or other device;
(b) the date of receipt or delivery;
(c) the name and, where applicable, the name, surname, place of business of the natural person who is the supplier or the customer, and his identification number, if assigned, with the customer or supplier who is a legal person, his business name or, where applicable, his name, registered office and identification number, if assigned,
(d) the address for delivery,
(e) details of quantities purchased or sold and identification of the products or other means supplied, enabling monitoring of the route of distribution of each product or other device, including information on their shelf life; and
(f) the batch number and the date of manufacture;
when keeping such records, the distributor shall ensure that the items referred to in points (a) to (f) are not interchangeable.
(4) Evidence of the purchase of the product or other device includes:
(a) the order,
(b) delivery and consignment note,
(c) the declaration on dangerous goods and the safety data sheet;
(d) the invoice.
(5) Evidence of subsequent distribution of the product or other device includes:
(a) the order,
(b) delivery and consignment note,
(c) the declaration on dangerous goods and the safety data sheet;
(d) the invoice;
(e) the book of invoices received and sent.
(6) The distributor keeps the documentation in accordance with the Regulation of the European Union regulating the placing on the market of products (2).
Requirements for the entry of another plant protection product in the official register and technical details of the application for such registration
(Paragraph 54 (3) and (4) of the Law)
(1) The applicant shall provide evidence of the application for the entry of another device in the official register:
(a) the information on the aid and related documents set out in Annexes 1 and 3 to this Regulation or the data on bioagents and related documents set out in Annexes 2 and 3 thereto;
(b) a statement on possible use in gardens which are not used for business purposes, for the treatment of public green, school land and children's playground, room and balcony ornamental plants, recreational areas, sports grounds and other areas outside agricultural or forest land.
(2) The applicant shall submit, on request by the phytosanitary authority, a sample of an additional device corresponding to its standard production, together with evidence of its composition.
Labelling of other resources
(K § 55 of the Act)
In addition to the requirements laid down in the directly applicable European Union5) and other legislation6), the packaging of another device shall include:
(a) the business name or name of the holder of the decision on registration in the official register and registered office, in the case of legal persons, in the case of natural persons, the name and, where applicable, the name, surname, address and place of business, if different from the place of residence;
(b) the composition of the additional device in accordance with the conditions laid down in the decision on its entry in the official register;
(c) the number of the decision to register;
(d) the other particulars provided for in the decision on registration in the official register.
Method of keeping records of products used by professional users
(K § 60 (5) of the Act)
(1) Professional users shall keep records, in accordance with the Regulation of the European Union regulating the placing on the market of preparations or other means of business, in a separate book with continuously numbered pages, where appropriate in electronic form, while ensuring their preservation. Records shall be made without delay, no later than the following working day following the application of the product or other plant protection product.
(2) Records in electronic form must be kept in such a way as to enable subsequent electronic processing of data.
(3) Records of products or other plant protection products used include:
(a) identification of the application site
1. the land is determined by the cadastral territory, municipalities, district and parcustoms numbers, or by the soil block number of the agricultural land register according to user relations, in the case of forest land, by the spatial distribution unit of the forest,
2. the warehouse of plant products is designated by the municipality, the name of the warehouse,
3. the greenhouse is designated by the municipality, the designation of the greenhouse,
4. the sea station is designated by the municipality, the name of the sea station,
5. in other cases keeping records of the products or other plant protection products used, the identification of the treated object shall be treated mutatis mutandis in accordance with points 1 to 4;
(b) identification of the treated object
1. type of crop,
2. the species or, where appropriate, the genus of fruit, ornamental or ornamental plants grown in a greenhouse,
3. the type of plant product, seeds and seed,
4. other data such as the spatial distribution unit of the forest, the railway body, the stubble after the oilseed, the winter wheat,
(c) the extent or quantity of the treated object, and the record shall not be made if the treated area of an empty greenhouse or warehouse cannot be indicated or if it is an application other than flat;
(d) date of application (day, month, year in format),
(e) the full name of the plant protection product or other plant protection product;
(f) batch per unit,
(g) the identification of the target harmful organism in accordance with the labelling given on the packaging of the preparation or any other device against which application has been made; or
(h) other purpose of use, in particular pickling, desiccation, defoliation, regulation of biological processes, treatment of plant wounds, treatment of the appearance of plants, disinfection of soil, disinsectisation of soil.
(4) Paragraph 3 shall apply mutatis mutandis for the joint record of the use of plant protection products and fertilisers.
Repeal
It shall be repealed:
1. Decree No. 329 / 2004 Coll., on Products and Other Plant Protection Products.
2. Decree No. 371 / 2006 Coll., amending Decree No. 329 / 2004 Coll., on Products and Other Plant Protection Products.
3. Decree No. 146 / 2009 Coll., amending Decree No. 329 / 2004 Coll., on preparations and other plant protection products, as amended by Decree No. 371 / 2006 Coll.
Efficacy
This Decree shall take effect on 1 February 2012.
Minister:
Ing. Bendl v. r.
Příloha č. 1
Annex No 1 to Decree No 32 / 2012 Coll.
Information on the assistance and related documents, which shall include an application for entry of the aid in the official register.
A Information on the aid (hereinafter referred to as "the aid ')
1 Identification of the device
1.1. Data on the applicant
1.2. Manufacturer data:
(a) the company and its registered office, if it is a legal person; or
(b) the name, names and surnames, address of the place of permanent residence or place of business, if not the same as the place of permanent residence, if the natural person
1.3. Trade name of the device or proposed trade name
1.4 Function and purpose of use
Mechanism of action
1.6 Active component
1.7. Qualitative and quantitative composition of the device
1.8 A safety data sheet of the device processed in accordance with the provisions directly applicable to the European Union1)
1.9 Safety data sheets for device components, processed according to the directly applicable European Union Regulation (2)
1.10 Proposal for a device designation, label text or label, if any, of the package leaflet,
1.11 Classification by means of 3) in terms of its properties chemical and physical, toxicological, ecotoxicological (including existing studies)
2 Use data
2.1 Expected area of use
2.2. Details of the proposed use
2.3 Application levy
Method of administration
2.5 Number of applications and use dates,
2.6. Risk to plant or plant products
2.7 Procedures for cleaning application equipment, if used
2.8 Form of combination with another plant protection product, if anticipated
3 Further information about the device
3.1 Packaging - e.g. size, type of packaging
3.2 Proposals for protective and other time limits or other measures to protect persons, livestock and the environment
4 Analytical methods
4.1 Analytical methods for determining the composition of the device
4.2 Methods to determine the standard of the device and its purity
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Regulation Information
| Citation | Decree No. 32 / 2012 Coll., on Products and Other Plant Protection Products |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.01.2012 |
|---|---|
| Effective from | 01.02.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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