Decree No. 132 / 2018 Coll.
Decree on plant protection products and aids
Valid
Effective from 13.07.2018
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132
DECLARATION
of 21 June 2018
on products and 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., Act No. 291 / 2009 Coll., Act No. 490 / 2009 Coll., Act No. 245 / 2011 Coll., Act No. 199 / 2012 Coll. and Act No. 299 / 2017 Coll. (hereinafter "the Act '):
Subject matter of the Order
This Decree implements the provisions of the Law applicable to preparations and aids and provides
(a) the requirements for the form and presentation of the label particulars and the model of the product label;
(b) requirements for the packaging and labelling of products for non-professional users;
(c) the areas of testing and the details of the documentation to demonstrate competence for conducting trials and tests;
(d) the maximum range of experiments and trials involving unauthorised preparations and aids for research and development purposes;
(e) criteria for places where products or aids are handled in the course of business in the framework of marketing;
(f) the extent and manner of keeping documentation and records of the placing on the market of preparations or aids and their origin;
(g) the technical specification of the unique identifier and the two-dimensional barcode and the information contained therein;
(h) the way in which data are sent to the data repository, the technical conditions, the structure of the data phrase and the frequency of data transmission;
(i) circumstances in which the product presents a significant risk to non-target organisms in the case of non-professional use;
(j) the extent of documents demonstrating that the aid complies with the requirements for authorisation;
(k) requirements for the labelling of aids;
(l) details of the keeping and transmission of records of the use of preparations or aids; and
(m) means of sampling for preparations or aids.
Requirements for the form and arrangement of the label particulars and the model of the product label
(K § 31a (3) of the Act)
(1) The label contains:
(a) the words "plant protection product" and, in the case of parallel trade, "parallel trade of the plant protection product," as indicated in the label heading,
(b) the particulars given in the operative part of the authorisation decision;
(c) other data pursuant to Regulation (EC) No 1272 / 2008 of the European Parliament and of the Council),
(d) other information pursuant to Commission Regulation (EU) No 547 / 20112), and
(e) other particulars and details on the label by the authorisation holder; such additional particulars and particulars shall not be preceded and shall not conflict with those particulars on the label by data organised in accordance with the model of the label.
(2) The product label model set out in Annex 3 to this Regulation sets out the order of the labelling particulars.
(3) If there is insufficient space on the label, the layout of the data on the package leaflet shall be in accordance with the order set out in the product label model and the requirements of Regulation (EC) No 1272 / 2008 of the European Parliament and of the Council and Commission Regulation (EU) No 547 / 2011.
(4) If the product under Section 46b (10) of the Act is to be identified by a two-dimensional barcode, the label shall contain a unique identifier, batch number and the date of manufacture of the formulation in the form of a machine-readable two-dimensional barcode, while being legible to the naked eye.
(5) In the case of use of protective features to prevent counterfeiting, such protective elements shall not reduce the legibility of the particulars on the product label.
Requirements for packaging and labelling of products for non-professional users
(Paragraph 34 (3) of the Law)
(1) The quantity of the preparation in the package must be:
(a) not more than 1 kg or 1 l; or
(b) to treat an area of not more than 500 m2.
(2) If it is a product that can be administered without further dilution outside rodenticides and moluccocides, the quantity of the product in the package may be greater than that referred to in paragraph 1 (a) and (b).
(3) The accessories of the container include a measuring cup, if not according to the instructions for use on the disposable container, or a product which does not need to be diluted before use.
(4) If, according to the instructions for use, the container is not for single use, the container must be securely and repeatedly closed.
(5) The method of application shall be adapted to the use of hand or rear devices for the application of the products, or, where appropriate, to the application by means of the dosing device or application included in the packaging. The unit dosage shall be expressed as square metres. If the dosage is indicated in concentration, the corresponding dose shall be given in grams or kilograms, or millilitres or litres, respectively.
(6) The label of the package for non-professional use may not indicate
(a) application methods requiring special equipment for the application of products which are not normally available to retail users;
(b) abbreviations which are not generally known and which are not detailed on the label; and
(c) guidelines, the performance of which presupposes the expertise or the use of specialised literature.
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; and
(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, which shall include:
1. description of the workplace and its agricultural activities;
2. organisation of the workplace, including the definition of qualifications 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 and aids;
5. a description of how to ensure the safe collection and disposal of unfit residues of preparations and aids, their packaging, the residues of the application fluid and water after cleaning of equipment for the application of preparations and aids;
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) a metrological order laying down rules for the handling of measuring instruments used, the 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.
Maximum range of experiments and tests with unauthorised products and aids for research and development purposes
(Paragraph 45 (13) of the Law)
(1) The maximum range of trials and trials involving unauthorised products for research and development purposes is:
(a) not more than 1 ha per year or the quantity of seed or seed treated with a sowing or planting preparation on an area of not more than 1 ha per year, provided that, according to the supporting documents provided by the applicant, the effects of the preparation on human health or the environment and non-target organisms have not been assessed in accordance with Regulation (EC) No 1107 / 20093 of the European Parliament and of the Council),
(b) no more than 5 ha per year or the quantity of seed or seed treated with a sowing or planting preparation on an area of not more than 5 ha per year, provided that, according to the supporting documents provided by the applicant, the effects of the preparation on human health have been assessed in accordance with Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council;
(c) a maximum of 10 ha per year or the quantity of seed or seed treated with a sowing or planting preparation on an area not exceeding 10 ha per year, provided that, according to the supporting documents submitted by the applicant, the effects on human health, the environment and non-target organisms have been assessed in accordance with Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council; or
(d) not more than 20 ha per year or the quantity of seed or seed treated with a sowing or planting preparation on an area of not more than 20 ha per year in the case of a micro-organism-based product, a pheromone or a low-risk product, and that preparation has already been authorised in a Member State in accordance with Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council.
(2) The maximum range of trials and trials with unauthorised aid for research and development purposes is a maximum of 10 ha per year or the quantity of seed or seed treated for sowing or planting on a maximum of 10 ha per year if the aid is used.
Criteria for places where products or aids are handled in the course of business in the framework of marketing
(K § 46b (3) of the Act)
(1) The places on which products or aids are handled in the course of business in the course of marketing must comply with the requirements for safe storage in accordance with the information on the label, package leaflet or safety data sheet.
(2) The place where products or aids are handled in the course of commercial activity in the course of marketing must be protected from direct sunlight, rain and frost, allow separate storage of individual types of preparations or aids and must be equipped with an air temperature measuring device which allows for retrospective checking of air temperature records.
(3) For each place where products or aids are handled in the course of business in the course of marketing, separate operational safety rules with specifications of hygiene, safety and fire safety shall be established.
(4) The requirements set out in paragraph 1 shall apply to places where, in the course of business, products or aids are handled in packages intended for non-professional users and where such packages are sold directly to non-professional users.
Scope and manner of storage of documentation and records of the placing on the market and origin of preparations or aids
(K § 46c (2) of the Act)
(1) The distributor shall keep documentation and records of the receipt and return of products and aids, the control of the products and aids received, the storage, cleaning and maintenance of premises, the control of storage conditions, including the protection of products or aids in storage and transport and ordering, the supply and withdrawal of products and aids, and their return to circulation, so as to avoid discrepancies between documentation and records and to ensure that they are unchangeable. The records of the sale or other handling of preparations and aids shall always indicate the name of the preparation or aid, the batch number of the formulation, the date of manufacture of the formulation and the expiry date of the product or aid, in such a way that these particulars are always legible and intact. The records may also be kept in electronic form. Records in paper or electronic form shall be kept on a continuous basis while ensuring their storage.
(2) The records under the law may be replaced by the management and presentation of records under other rules, provided that such records contain information under the law and comply with paragraph 1.
(3) The documentation on the withdrawal of the product or of the device
(a) the definition of the authorisations of staff to carry out and coordinate the withdrawal of the product or aid from the market;
(b) a description of the communication with the competent authorities, the authorisation holder, the manufacturer, distributors and customers of the product or aid product during the download and after the withdrawal of the product or aid;
(c) a description of the actual procedure for withdrawing the product or the aid from the market, including the procedure for identifying and contacting all the customers of the product or the aid;
(d) the way in which records are kept and kept of all activities related to the withdrawal of the product or the aid from the market;
(e) an assessment of the process of withdrawal from the market of the product or aid and of the measures taken where the product or aid cannot be withdrawn from the market;
(f) a description of the provision of separate placing of products or aids withdrawn from the market from other stored products or aids; and
(g) accounting, tax and other records of all activities related to disposal or other means of handling the product or the aid after withdrawal, including evidence of the place, time and method of disposal or movement of the product or the aid after withdrawal.
Technical specifications of the unique identifier and the two-dimensional barcode and the information contained therein
(K § 46b (10) of the Act)
(1) The unique identifier is a series of numerical or alphanumeric characters consisting of the following data elements:
(a) a code enabling the person for whom the code is registered, the trade name or the normal name of the product, the package size and the type of packaging of the product with a unique identifier (hereinafter referred to as the product code);
(b) the batch numbers of the manufacturer of the formulation; and
(c) the dates of manufacture of the formulation manufacturer.
(2) The two-dimensional barcode is a machine-readable data matrix that allows detection and correction of errors equivalent to or greater than the ECC200 data matrix. The requirements set out in this paragraph shall be deemed to be met if the two-dimensional barcode complies with the International Organisation for Standardisation / International Electrotechnical Commission (hereinafter referred to as "the standard ') ISO / IEC 16022: 2006.
(3) The structure of the unique identifier encoded in the data matrix must be consistent with the internationally recognised standardised data syntax and semantics (hereinafter referred to as the coding system), which allows the identification and accurate decoding of each data element from which the unique identifier is composed by the use of a conventional sensing device. The encoding system shall contain data identifiers or applications or any other set of characters identifying the beginning and end of the series of each individual data element of the unique identifier and defining the information contained in those data elements. The requirements set out in this paragraph shall be deemed to be met if the unique identifier coding system complies with ISO / IEC 15418: 2016.
(4) The product code encoded as the data element of the unique identifier in the data matrix shall comply with the coding system and shall have characters specific to the coding system used at the beginning. The product code shall also contain characters or series of characters identifying the product as a plant protection product. The resulting product code shall have less than 50 characters and shall be unique. The requirements laid down in this paragraph shall be deemed to be satisfied if the product code complies with ISO / IEC 15459-3: 2014 and ISO / IEC 15459-4: 2014.
(5) Different coding systems may be used within the same unique identifier provided that this does not prevent the decoding of the unique identifier. In this case, the unique identifier shall contain standardised characters to identify the start and end of the unique identifier as well as the beginning and end of each coding system. The requirements set out in this paragraph shall be deemed to be met if a unique identifier containing multiple coding systems complies with ISO / IEC 15434: 2019.
(6) Information other than a unique identifier may be placed in a two-dimensional barcode carrying a unique identifier provided that this does not prevent its decoding.
(7) The minimum printing quality must guarantee the accuracy of the data matrix throughout the supply chain. The following parameters shall be taken into account when assessing the quality of the printing of the data matrix:
(a) contrast between light parts and dark parts;
(b) the uniformity of reflection of light and dark parts;
(c) axis asymmetry;
(d) network asymmetry,
(e) unused error correction;
(f) damage to fixed patterns; and
(g) the capability of the reference decoding algorithm to decode the data matrix.
(8) The requirements set out in paragraph 7 shall be deemed to be met if the printing quality evaluated in accordance with ISO / IEC 15415: 2011 is at least 1,5.
Method of sending data to the data repository, technical conditions, data phrase structure and frequency of sending data
(Paragraph 60 (4) of the Law)
(1) Distributors who are required to send product data to a two-dimensional barcode designated by professional users to a data storage site shall transmit them via the Ministry's web service in the form of an automated data output containing the data theorem, or by manual entry into the repository. The Ministry shall publish a detailed technical description of the data transmitted through its website.
(2) The structure of the data sentence sent must consist of:
(a) type of operation with the product,
(b) the unique identifier of the product;
(c) the name of the preparation,
(d) the batch number of the formulation manufacturer,
(e) the date of manufacture of the formulation manufacturer,
(f) the quantity of preparation,
(g) the unit packaging content of the preparation,
(h) identification of the supplier of the preparation;
(i) identification of the purchaser of the product; and
(j) identification of the data consignor.
(3) The name of the product may be taken into account at the data storage site only if it is included in the register of plant protection products published by the Ministry in an electronic application on the Ministry's website (hereinafter referred to as the "Register of Plant Protection Products'). The first entry of the data to a specific basic unit of the product is first completed by a catalogue identifying the parameters of the product as determined by the unique identifier. The basic unit shall be registered in this catalogue with the product code, the registration number in the plant protection product register, the description of the packaging, the package size, the unit of measurement and the information on the combined packaging of the same product.
(4) In the data repository, data on movements of specific quantities based on data obtained from individual distributors shall be recorded for each batch of products.
(5) Data are sent to the data storage site within three days of receipt or transmission of the product. In the event of a failure of the data repository or distributor system, data shall be sent to the data repository without delay after the data repository or distributor system has been restored, but no later than 24 hours after the data storage or distributor system has been restored.
Circumstances in which the product presents a significant risk to non-target organisms in the case of non-professional use
(Paragraph 34 (3) of the Law)
In case of non-professional use, the product presents a significant risk to non-target organisms when:
(a) the need to establish a protective distance from surface waters of more than 30 m on plots of less than 3 degrees of lignite;
(b) the need to establish a protective distance from the edge of the treated parcel of more than 30 m; or
(c) with regard to the protection of aquatic organisms and / or non-target arthropods, it is possible to apply the product only with the use of a professional device for the application of products that restrict unwanted drift or other anti-relief measures.
Scope of documents demonstrating that the aid meets the requirements for authorisation
(Paragraph 54a (1) of the Law)
(1) The applicant shall provide supporting documents on the application for authorisation
(a) the information on the aid and related documents set out in Annex 1 to this decree or the data on bioagents and related documents set out in Annex 2 thereto; and
(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, on request of the Institute, transmit a sample of the aid corresponding to its standard production together with evidence of its composition.
Requirements for the marking of aids
(K § 55 of the Act)
(1) The label shall contain:
(a) the words "plant protection aid" in the label heading,
(b) the trade name of the aid;
(c) the type of aid and the type of operation of the aid;
(d) data on all active ingredients;
(e) data on hazardous substances under Regulation (EC) No 1272 / 2008 of the European Parliament and of the Council;
(f) labelling in accordance with Regulation (EC) No 1272 / 2008 of the European Parliament and of the Council;
(g) additional designation pursuant to § 54a (6) of the Act,
(h) details of the authorisation holder and, where appropriate, his legal representative and, if not identical, the name and address of the person responsible for the final packaging and labelling or the final labelling of the plant protection product on the market;
(i) the registration number of the aid;
(j) the batch number of the formulation manufacturer and the date of manufacture of the formulation manufacturer,
(k) information on the period of application and, where appropriate, the expiration date;
(l) an indication of the quantity of the aid in the package,
(m) details of the mode of action of the aid;
(n) conditions of authorised use and dosage,
(o) specifying the use of the aid, in particular the date and method of application, mixing with other preparations and aids;
(p) further restrictions under Paragraph 54a (6) of the Act;
(q) data on the preparation of the application fluid, the application and cleaning of the device for the application of the aid;
(r) personal protective equipment;
(s) information on first aid;
(t) guidance on appropriate storage conditions and safe disposal of the aid and its packaging; and
(u) further particulars and details on the label by the authorisation holder; such additional particulars shall not be preceded on the label by data arranged in accordance with the model of the label and shall not conflict with those particulars.
(2) The model label of the aid referred to in Annex 4 to this Decree sets out the order of the label.
(3) If there is insufficient space on the label, the information referred to in paragraph 1 (m) to (u) may be provided on a separate package leaflet. This leaflet is considered to be part of the label. The layout of the data on the package leaflet shall be in accordance with the order set out in the product label model.
(4) In the case of use of protective elements to prevent counterfeiting, such protective elements shall not reduce the legibility of the particulars on the label of the aid.
Details of the keeping and transmission of records of the use of preparations or aids
(Articles 5 (3) and 60 (5) and (7) of the Law)
(1) Records of the use of products or aids shall include the following:
(a) identification of the entity to the extent:
1. the name and, where applicable, the name, surname, date of birth or identification number of the person, if assigned, and the address of the place of business, if any, of the natural person; or
2. the name or business name, the identification number of the person, if any, and the address of the registered office, if any,
(b) in the case of use on land:
1. if the land is registered in the land use register under the Agricultural Act (4), the abbreviated code of the soil block part, the square of the soil block part and the cadastral territory,
2. if forest land is concerned, the forest economic unit code, the designation of the forest spatial division units (5) and the cadastral territory; the units of the spatial distribution of the forest shall be indicated by separation, workshop, vegetation and the grassland group;
3. if the land is not registered in the land use register under the Agricultural Act (4), it is not a forest parcel as referred to in point 2, a partynumber or partynumbers and a cadastral territory,
4. the area of the parcel in hectares planted or planted with a crop or wood with an accuracy of two decimal places;
5. the date of sowing or planting of the crop, where appropriate, in the format of the day, month, year; not to be indicated in the case of timber and forest land; and
6. the date on which the crop ends in the format of the day, month, year; in the case of crops with one harvest, the date of harvest of the crop, in the case of crops with more than one harvest of the crop; not to be indicated in the case of trees and forestry;
c) if used in the building
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Regulation Information
| Citation | Decree No. 132 / 2018 Coll., on preparations and plant protection products |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 28.06.2018 |
|---|---|
| Effective from | 13.07.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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