Decree No. 329 / 2004 Coll.
Decree on preparations and other plant protection products
Valid
Order
Effective from 31.05.2004
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329
DECLARATION
of 30 April 2004
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, hereinafter referred to as "the Act":
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.
PLANT PROTECTION PREPARATIONS
Conditions of use
(Paragraph 31 (4) and (5) of the Act)
(1) Conditions of use of the plant protection product (hereinafter referred to as "the product") mean:
(a) its use according to the instructions by which it is labelled (correct use of the product);
(b) preventing contamination of water and damage to other environmental compartments, including animal health (2) as a result of the use of the product;
(c) compliance with the principles of integrated plant protection where objectively possible;
(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) the aero-application of the product only if such an application option is indicated in the application instructions.
(2) The active substance in the form of a preparation must be classified, packaged and labelled in accordance with the requirements of specific legislation.3)
Forms of application for marketing authorisation
(Paragraph 32 (3) and (7) of the Act)
Documentation files
(1) The required documentation set of product data and the related requirements are set out in Annex 1.
(2) The required documentation set of data on the active substance and the related requirements are set out in Annex 2.
Technical requirements for processing the application and its components
(1) An application for registration of a product (Section 32 (1) of the Act), which is processed in a manner consistent with the principles of evaluation of the underlying data and the criteria for the assessment of the product for the purpose of its registration (hereinafter referred to as "the principles of evaluation of the product"), shall include:
(a) details of:
1. to the applicant and to the person who is entitled to act on his behalf, including in particular the name and registered office of the legal person, or the name and surname, address and place of business, if any, if different from his place of residence,
2. the manufacturer of the preparation and its active substance, including the particulars referred to in point 1, mutatis mutandis,
3. any other party to the proceedings, including the information referred to in paragraph 1, mutatis mutandis,
4. the product which is the subject of an application, which is referred to by reference to the dossier for the product (Section 3 (1)),
(b) a proposal for the packaging and labelling of the preparation provided for in Article 42 of the Act, including comments on possible use in gardens which are not used for business purposes (hereinafter referred to as "home gardens"), on the treatment of public greenery, sports grounds, room and balcony ornamental plants and other places other than agricultural or forest land where such use is considered;
(c) Annexes
1. the required documentation set of product data listed in Annex 1,5)
2. the required documentation set of data on the active substance contained in the preparation listed in Annex No 2,6), if not an active substance already included in the list of active substances [Section 2 (2) (m) of the Act], 7)
3. consent of the person whose rights to data are protected (§ 40 of the Act), 8)
4. a safety data sheet in accordance with a specific legislation, (9) if it is a preparation for which the safety data sheet must be drawn up,
5. evidence that a request for a toxicological assessment has been submitted to the Ministry of Health (Section 33 (5) of the Act),
(d) additional documents if, because of the nature of the product, they are necessary as a basis for the marketing authorisation.
(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.
(3) Sample of the preparation provided by the applicant under the requirement of the State Plant Health Administration (hereinafter referred to as the "Plant Health Administration") for registration purposes
(a) shall be marked on the packaging:
1. significantly and indelibly to show that the sample is intended for test purposes only;
2. data identifying the product to which the sample corresponds (manufacturer, date of manufacture and batch number or other means of identification),
3. If this corresponds to the nature of the product, also with the risk phrases (R-phrases) and the safety instructions (S-phrases) according to the specific legislation, 3)
(b) be accompanied by a document indicating its composition.
(4) The application for authorisation of a product containing genetically modified organisms is accompanied by supporting documents in accordance with specific legislation. 10)
Assessment of application for marketing authorisation
[Articles 33 (1) and (6), 34 (1) and (2), 36 (1) (a), 36 (4), 37 (2), 40 (1) (c), 40 (2) (c) of the Law]
Principles for evaluating background data and criteria for assessing the properties of the product for the purpose of its marketing authorisation
(1) The characteristics of the product shall be assessed in the registration procedure in accordance with the principles of the evaluation of the product and the criteria set out in Annex 3.
(2) Analytical methods for the determination of the nature and quantities of active substances, toxicologically or ecotoxicologically relevant impurities and additives (Section 33 (3) (c) of the Act) are determined in accordance with Annex 1, if it is a preparation, and Annex 2, if it is an active substance.
(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 preparation 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.
(1) The application for a toxicological assessment of the product ("toxicological assessment") contains, in accordance with Annex 15.
(a) identification of the applicant, the manufacturer of the product and its active substance and the preparation;
(b) information on the use of the product and other information on the use of the product.
(2) The documentation for the preparation of the toxicological assessment must contain the information in accordance with Annex 15) and Annex 2; 6) where necessary due to the nature of the preparation, additional supporting documents may be required.
(1) Toxicological assessment includes results
(a) an assessment of the risks to human health from the correct use of the product, directly exposed to the toxicologically relevant components contained in the product or indirectly through residues after application of the product ("the risk assessment"), carried out in accordance with the principles of the assessment of the product set out in Annex 3,4);
(b) verification of the accuracy of the assignment of risk phrases (R-phrases) and safe loading instructions (S-phrases), taking into account the classification under specific legislation3), including the associated hazard pictograms and their letter expression;
(c) verification of the accuracy of the labelling by other standard phrases
1. special risks for humans as defined in Annex 5,11)
2. safety instructions for the protection of humans as set out in Annex No 6,11)
(d) verification of the suitability of personal protective equipment.
(2) The risk assessment referred to in paragraph 1 (a) shall be carried out broken down by items corresponding to points 2.4, 2.4.1, 2.4.1.1 to 2.4.1.6, followed by 2.4.2, 2.4.2.1 to 2.4.2.7 of Part C of Annex 3.
(3) The toxicological assessment of the preparation with the old active substance shall be carried out with a view to ensuring compliance with specific legislation, (3) by European Commission legal acts (hereinafter referred to as "the Commission") and to assigning the sentences referred to in Annexes 511) and 6.11).
(1) The data contained in the application and in the data file shall be assessed and checked for compliance with the requirements for:
(a) completeness and method of finding the data in respect of Annex 15) and Annex 2,6)
(b) the underlying adequacy for the marketing authorisation in accordance with Annex 3.4)
(2) A product containing an old active substance not included in the list of active substances or a product subject to a change of registration procedure shall be assessed whether it meets the requirements of § 33 (3) (b) (1) to (5) of the Act.
Data requirements for the active substance and preparation for the marketing authorisation for a transitional period
For marketing authorisation for a transitional period in accordance with European Community rules 12) must
(a) the data on the active substance comply with the completeness requirements and be confirmed by the Commission;
(b) the data on the product containing the active substance referred to in (a) meet the requirements for the marketing authorisation referred to in Annex 34 and be confirmed by the Commission.
Specific procedure for the authorisation of products with old active substances
(1) Specific procedure for the authorisation of a product with an old active substance means the procedure for its registration where the inclusion of an active substance in the list of active substances in that product is (7) The Commission has not yet decided or, if there is a procedure for amending or withdrawing the marketing authorisation for an old active substance (the old product), for the reasons set out in Paragraph 35 (4) of the Act.
(2) The background data for the authorisation of the old product shall be supplied by the registrant or the marketing authorisation holder of the old product to the phytosanitary authorities.
(3) The background data referred to in paragraph 1 shall be:
(a) information on:
1. the effectiveness and adverse effects of the old preparation on plants or plant products, on human or animal health (13) and on the environment,
2. the registration (authorisation) of the old product in the Member States of the European Union, including data on its packaging and labelling,
3. the risks to bees,
4. the essential toxicological and ecotoxicological properties of the preparation and its active substance and, where appropriate, the active substances contained therein; the sources from which the data were drawn shall be indicated,
5. the manufacturer of the product and its active substance (s),
6. on the physical and chemical properties of the preparation and its active substance (s),
(b) proposals
1. the designation of the old preparation in accordance with § 15 (1) and (2) and with special legislation, 3)
2. labels,
3. packaging in accordance with § 15 (1) and with special legislation, 3)
(c) the product composition specification,
(d) additional supporting documents as determined by the plant health service, if they are necessary for the decision due to the nature of the old preparation.
(4) The old product is not registered if:
(a) it does not comply with the conditions of registration under § 33 (3) (b) and (c) of the Act;
(b) contains an active substance which must not be placed on the market for plant protection uses and whose use in plant protection is prohibited; or
(c) there are risks to human health, expressed in a toxicological opinion under § 33 (4) to (6) of the Act, which cannot be confronted with instructions for safe handling of the product.
(5) If the active substance in the old product is included in the list of active substances, 7) the phytosanitary authority shall examine whether the authorisation of the old product corresponds to:
(a) the conditions and specific characteristics of the inclusion of the active substance in the list of active substances, 7)
(b) the principles of evaluation and the criteria set out in Annex No 3,4)
(c) registration requirements under § 33 (3) (b) to (f) of the Act, packaging and labelling under § 42 of the Act and special legislation.3), 10)
According to the outcome of this review, the plant health authorities shall decide on any modification or withdrawal of the authorisation of the old product, taking into account the Commission Regulation on the active substance contained in the old product under review.
Technical details of the proposal for extended use of the product
(Paragraph 37 (1) of the Law)
(1) The application for authorisation of extended use of the preparation shall include: 14)
(a) details of the applicant for the extended use of the product, including, in particular, the business name and registered office of the legal person, or its name and registered office, if not the legal person registered in the business register, or the name or names, if any, and surname, address and place of business, if different from the place of residence, if different from the natural person;
(b) particulars of the preparation, which shall be referred to the authorised product, the extension of which is requested,
(c) use data and other data for correct application,
(d) documentation demonstrating compliance with the requirements laid down in § 33 (3) (b) (3) to (5) of the Act with regard to the proposed use of the product, including a toxicological assessment of the product issued by the Ministry of Health (§ 33 (4) of the Act);
(e) draft instructions for use of the product, including protective or other safety periods and proposed restrictions on use of the product, if necessary to ensure the protection of human and animal health (13) and environmental protection;
(f) the justification for the proposal by defining the public interest, the scope of the extended use of the product and the seriousness of the foreseeable damage to be avoided.
(2) The application for authorisation of extended use of the product shall be submitted to the phytosanitary authority in accordance with the model set out in Annex 4.
Forms of application for mutual recognition
(Paragraph 38 (5) of the Law)
(1) An application for mutual recognition of a marketing authorisation (hereinafter referred to as "recognition of a marketing authorisation") in accordance with the provisions of the European Community (15) and pursuant to Article 38 of the Act shall be submitted by the applicant to the phytosanitary service in the Czech or English language if the phytosanitary service agrees.
(2) Part of this application is the annexes
(a) a copy of the marketing authorisation applied for by the applicant, in the original language and in the official translation into the Czech or English language, as referred to in paragraph 1;
(b) copies of the label in the language referred to in (a);
(c) proof of officially provided packaging and labelling of the product which is the subject of a procedure for the recognition of marketing authorisations in accordance with specific legislation, 16), 3), 11) if these conditions of packaging and labelling are not included in the marketing authorisation referred to in point (a);
(d) evidence of product classification and assignment of specific risk phrases (R-phrases), safety instructions (S-phrases), hazard pictograms and their expression, in accordance with specific legislation, 3)
(e) safety data sheet, in accordance with specific legislation, 3), 17)
(f) proof that the maximum residue limit for the active substance (s) contained in the preparation has been established in the Member State in which the use is registered or by the Commission in accordance with European Community rules;
(g) evidence of the identification of the preparation at least to the extent of the particulars in points 1 and 1.1 to 1.6 of Annex 118) Part A and points 1 and 1.1 to 1.6 of Annex 118) Part B;
(h) a statement that the marketing authorisation has been carried out in accordance with the principles for the evaluation of the product as set out in Annex No 3.19) if this is not the case, the derogation procedures need not be indicated and justified;
(i) a statement that the technical documentation and the formulation of the product are the same as those on which a marketing authorisation has been granted in the Member State concerned;
j) other documents, if necessary for the assessment of comparability from the aspects mentioned in Section 38 of the Act, in particular an overview of the risks and their assessment in relation to the recognition of the marketing authorisation in the Czech Republic, taking into account the proposed doses and the time of application of the product,
(k) evidence that a request for a toxicological assessment has been submitted to the Ministry of Health (Section 33 (5) of the Act).
(3) The applicant for recognition of a marketing authorisation shall provide a sample of the product, the active substance or, where appropriate, the active substances contained therein and other ingredients, if identified and their values are defined in the marketing authorisation and in the Commission Regulation on the inclusion of the active substance in the list of active substances. 7)
Evaluation of active substance
(Paragraph 41 (4) of the Law)
Data, documents and data processing process for the evaluation of the active substance and requirements for its inclusion in the list of active substances
(1) The active substance shall be included in the list of active substances (7) on the basis of an evaluation of the dossier for the active substance and the procedures set out in Annex No 22), taking into account current scientific and technical knowledge, if products containing this active substance can be expected to meet the following requirements:
(a) their use in accordance with good plant protection practice has neither harmful effects on human health, animals, 13) nor unacceptable effects on the environment, 20)
(b) their residues after application in accordance with good plant protection practice do not have harmful effects on human and animal health, groundwater and the environment, and these residues, if relevant toxicologically or from the point of view of the environment, may be measured by normal methods.
(2) In particular, the inclusion of the active substance in the list of active substances (7) is considered.
(a) acceptable daily intake (ADI) for humans, where relevant;
(b) an acceptable level of worker exposure, if necessary;
(c) the estimation of degradation and distribution in the environment and effects on non-target species.
(3) For the first inclusion of an active substance in the list of active substances, 7) if it is an active substance which is not yet on the market and is not an old active substance, the requirements are deemed to have been met if this has been demonstrated for at least one product containing that active substance.
(4) If there are reasons for this, the inclusion of the active substance in the list of active substances (7) may be subject to an assessment of the level of compliance with the requirements of:
(a) the minimum degree of purity of the active substance;
(b) the nature and maximum content of certain impurities;
(c) restrictions resulting from the evaluation of information, 19) considering the conditions of agriculture, plant health and the environment (including climate);
(d) the type of modified substances;
(e) the method of use.
(5) The evaluation of an active substance, whether it meets the requirements for inclusion in the list of active substances, (7) or for the renewal of that inclusion, shall be carried out in accordance with the provisions of the European Communities. 1)
(6) The plant health management, on receipt of an application for inclusion of an active substance in the list of active substances, (7) shall ensure without delay that the dossier data set, if it meets the requirements of Annex 2.3) is sent by the applicant to the other Member States of the European Union and to the Commission, together with the dossier set out in Annex 15) for at least one product containing that active substance.
(7) The compliance of the documentation sets with the requirements set out in Annex 22) and Annex 15) shall be assessed in accordance with the procedure laid down in European Community rules. 21)
(8) If the evaluation of the documentation files of the data referred to in paragraph 1 reveals that further information is required, it shall be carried out in accordance with the European Community Regulation. 22) This shall also be the case if, after the active substance has been included in the list of active substances (7), facts are found to call into question compliance with the requirements referred to in paragraphs 1 and 2 or if a renewal of the inclusion is considered pursuant to paragraph 5.23)
(9) The procedure for submitting and evaluating an application for the inclusion of an active substance in the list of active substances (7) and for establishing or amending the conditions for such inclusion is governed by the European Communities Regulation. 24)
(10) The inclusion of the active substance in the list of active substances (7) and any changes to the conditions for such inclusion are notified by the plant health administration in a generally available form, such as publication in the Bulletin of the State Plant Health Administration or in the Bulletin of the Ministry of Agriculture.
Requirements for the toxicological evaluation of active substances, including the individual items under evaluation
Toxicological evaluation of active substances
(a) is part of the process of evaluating active substances (Section 41 of the Act) for their inclusion in the list of active substances, 7) which in the Czech Republic is coordinated by the plant health administration, and is carried out in accordance with European Community regulations, 25)
(b) includes:
1. an assessment of the submitted documentation set of data on the active substance in conjunction with the dossier set of product characteristics in terms of completeness and other requirements set out in Annexes 15 and 2,6)
2. the processing of a summary assessment, including the conditions for the inclusion of an active substance in the list of active substances (7), or an indication of the reasons why such inclusion cannot be recommended; the reasons justifying the non-inclusion of the active substance in that list must be informed without undue delay and the applicant for the evaluation and registration of the active substance containing the product must be given the opportunity to comment without undue delay,
(c) shall be processed broken down by the items indicated in:
1. In Annex No 26, Part A, point 5 "Toxicological and metabolism studies" and point 6 "Residua in or on treated products, food and feed" and in Part B, point 5 "Effects on human health" and point 6 "Residua in or on treated products, food and feed,"
2. in Annex 15, Part A, point 7 "Toxicological studies" and point 8 "Residua in or on treated products, food and feed" and Part B, point 7 "Effects on human health" and point 8 "Residua in or on treated products, food and feed,"
taking into account the provisions contained in the "Introduction 'of Part A and in the" Introduction' of Part B of Annex 2.6)
Technical requirements for packaging and labelling of preparations
[Articles 42 (1) (g) and 42 (7) of the Law]
(1) Products comply with the technical requirements for packaging if:
(a) there is no leakage of the product from the packaging under the conditions laid down, thereby endangering human or animal health (13) or the environment;
(b) the material used for the manufacture of packaging and sealing shall not be infringed by the contents or interfere with the contents of the packaging;
(c) the product packaging, in the normal way of handling it, is resistant to damage and does not spontaneously release the cap,
(d) the packaging closures intended for re-use are designed so that the seal can be closed again after opening so that the contents do not escape;
(e) the seals are made in such a way that it is clear whether or not the packaging has already been opened;
(f) the packaging of preparations differs from those normally used for packing food, drinking water, pharmaceuticals and do not take the shape of toys;
(g) the packaging complies with the additional requirements laid down in the specific legislation.3)
(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
(a) the trade firm or the name of the manufacturer of the preparation and his registered office, if it is a legal person, residence and place of business, if it is different from his place of residence, if it is a natural person or, where appropriate, his business name;
(b) the date of manufacture;
(c) marketing restrictions and other restrictions with regard to the protection of groundwater and surface water;
(d) the words "Follow the instructions for use in order to avoid risks to humans and the environment," if any, 3); and
(e) information on:
1. proper storage conditions;
2. first aid in human exposure by the product,
3. Procedures
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Regulation Information
| Citation | Decree No. 329 / 2004 Coll., on preparations and other plant protection products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.05.2004 |
|---|---|
| Effective from | 31.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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