Act No. 273 / 2022 Coll.
Act amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended
Valid
Law
Effective from 01.07.2023
Text versions:
01.07.2023
22.09.2022
273
THE LAW
of 6 September 2022
amending Act No. 326 / 2004 Coll., on Plant Health and amending certain related acts, as amended
Parliament has decided on this law of the Czech Republic:
Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Laws, as amended by Act No. 626 / 2004 Coll., Act No. 444 / 2005 Coll., Act No. 131 / 2006 Coll., Act No. 189 / 2008 Coll., Act No. 249 / 2008 Coll., Act No. 245 / 2011 Coll., Act No. 183 / 2012 Coll., Act No. 199 / 2012 Coll., Act No. 503 / 2012 Coll., Act No. 279 / 2013 Coll., Act No. 243 / 2016 Coll., Act No. 183 / 2017 Coll., Act No. 193 / 2017 Coll., Act No. 299 / 2017 Coll., Act No. 369 / 2019 Coll., Act No. 36 / 2021 Coll.
1. in Article 2 (1), the following points (g) and (h) are inserted after point (f):
"(g) the pest threshold is the value of the population density of the harmful organism on the property or in an object where it is economically justified to implement a protective measure in order to limit the negative impact on that site or object of the harmful organism on the reduction of the yield or quality of plants or plant products;
(h) the calamite threshold of the harmful organism is the value of the population density of the harmful organism on the property or in an object which, as a result of the negative effect of that organism, causes a significant reduction in the yield or quality of plants or plant products, risks to the environment of a greater extent or risks to human or animal health, ';
Points (g) to (i) shall be renumbered (i) to (k).
2. in Paragraph 4 (1) (b):
"(b) publish the hurdle thresholds and, without undue delay, provide up-to-date information on the occurrence of harmful organisms, including warnings of their achievement; and"
3. In Article 4, the following paragraph 3 is added:
"(3) Prague publishes the harmful properties of the Institute after an assessment based on current scientific knowledge and taking into account the recommendations of the Plant Health Council of the Ministry of Agriculture. In its assessment, the Institute shall evaluate in particular:
(a) the degree of potential loss of revenue caused by the harmful organism;
(b) the biology of the harmful organism and the biology of the plant which the harmful organism may attack or harm; and
(c) the sensitivity of the plant's development phases to infestation or damage by harmful organisms. ';
4. The following Section 4a is inserted after Section 4:
Calamity threshold and calamity of the harmful organism
(1) The list of harmful organisms which repeatedly reach the calamity threshold and their calamity thresholds are laid down in implementing legislation.
(2) Achieving or crossing the calamity threshold of a harmful organism other than that established in accordance with paragraph 1 The Institute notes on its own assessment that this is justified by current scientific knowledge. In its assessment, the Institute shall evaluate in particular:
(a) the ability and speed of the harmful organism to cause economically significant damage to the crops of cultivated plants or to endanger human, animal health or the environment based on the biological and epidemiological properties of the harmful organism; and
(b) the availability and effectiveness of methods to reduce the population density of the harmful organism.
(3) After the achievement or crossing of the calamite threshold of the harmful organism referred to in paragraph 1 or 2 has been established The Institute shall assess the potential territorial extent of economically significant damage to cultivated plants or the threat to human, animal or environmental health. If there is a threat of economic damage or a threat to human, animal or environmental health, the Institute
(a) the Regulation shall, in accordance with the procedure laid down in Article 76 (2), issue second to fourth sentences by which it shall declare the calamity of the harmful organism and define the territory to which the calamity of the harmful organism applies (hereinafter referred to as "the territory concerned"),
(b) carry out, during the period of validity of the Regulation referred to in point (a) in the territory concerned, a survey of the presence of the harmful organism in such a way that appropriate methods, at appropriate intervals and to a sufficient extent, are monitored and the results of that survey are made public; and
(c) order, taking into account the conditions for the protection of human health and the environment in the territory concerned, exceptional plant health measures in accordance with Article 76 (2) (b), provided that it is possible to stop or restrict the spread of the harmful organism from the territory concerned.
(4) The territory concerned shall be defined by the Institute in particular on the basis of:
(a) the biological and epidemiological properties of the harmful organism, in particular its capacity and speed of spread;
(b) the number of plant species which the harmful organism is capable of attacking or damaging; and
(c) the availability and effectiveness of methods to reduce the population density of the harmful organism. ';
5. In Paragraph 14, the following paragraph 5 is added:
"(5) The information concerning the plant passport to be recorded by the authorised operator in accordance with Article 69 (3) (c) of Regulation (EU) 2016 / 2031 shall be provided for in the implementing legislation.";
6. In Article 15 (1), the word "issue 'is replaced by" issue' and the words "or replacement plant passport 'are deleted.
7. In Section 31a (2), the words "and the date of manufacture of the formulation 'are replaced by the words", the date of manufacture of the formulation and the two-dimensional barcode, if the product is labelled with this code' and the words "Two-dimensional barcode 'are added at the end of the paragraph, for the purposes of this Act, means a standardised data carrier that allows the coding of a unique identifier. A unique identifier for the purposes of this Act means a defined combination of structured data allowing interoperability and traceability in the distribution chain.';
8. In Article 35 (1) (d), the word "or 'is deleted.
9. In Article 35, at the end of paragraph 1, the dot is replaced by a comma and the following points (f) and (g) are added:
"(f) the decision on the authorisation of the product is valid, but the approval of the active substance has expired and there is no procedure for the renewal of the approval of the active substance or the renewal of the authorisation of the product, or
(g) the approval of the active substance of the product has been renewed, but the application for the related renewal of the authorisation of the product or the related dossier has not been submitted within the time limit set by the directly applicable European Union Regulation on the placing of plant protection products on the market (67). "
10. In Paragraph 37, at the end of paragraph 4, the words "which shall be published in accordance with the second to fourth sentences of Paragraph 76 (2) 'shall be added.
11.
Mutual recognition of authorisations
In the case of mutual recognition of authorisations under the directly applicable European Union Regulation, a binding opinion of the Ministry of Health shall not be required. ';
12. in Article 38b (1) to (3):
"(1) Where a product for a given use is authorised under a directly applicable European Union Regulation concerning the placing of plant protection products on the market in a Member State which belongs to the same product authorisation zone as the Czech Republic, the Institute shall authorise such product for that use for its own use by mutual recognition or mutual recognition of the extended authorisation for minor uses.
(2) The authorisations referred to in paragraph 1 shall be subject to the conclusion of an assessment of the effects on the health of the people of the Member State where the product is authorised and a binding opinion of the Ministry of Health shall not be required.
(3) The authorisation of the preparation for its use pursuant to paragraph 1 shall be granted by the Institute by regulation in accordance with the second to fourth sentences of Paragraph 76 (2). "
13. in Article 38b (4), the words "or 2" shall be deleted;
14. in Paragraph 46 (1) (a) (2), the words "or preparations" shall be replaced by "preparations" and the words "or preparations or aids which are not authorised by the Constitution shall be added at the end of the text of the point."
15. in Paragraph 46 (2), "Professional user" is replaced by "Person referred to in paragraph 1" and "received" is replaced by "received."
16. in Paragraph 46b, the following paragraph 10 is added:
"(10) The product for professional users placed on the market shall be visibly marked with a two-dimensional barcode. The technical specification of the unique identifier and barcode and the list thereof shall be laid down in implementing legislation. ';
17. in Paragraph 46c (1), the word "a" shall be deleted at the end of point (o);
18. In Paragraph 46c, at the end of paragraph 1, the dot is replaced by "a 'and the following point (r) is added:
"(r) keep records of products for professional users identified by a two-dimensional barcode, which a registered distributor places on the market, stores, denotes or returns to its supplier, in electronic form, enabling the records to be interconnected with the relevant two-dimensional barcodes and the remote transmission of the required data to a storage site maintained in accordance with Article 60a, and retain those records for at least five years after their establishment.";
19. In Paragraph 49 (1) of the introductory part of the first sentence, the word "or 'is replaced by a comma and at the end of the text of the sentence the words" or by a regulation of the Constitution issued pursuant to Paragraph 38b' are added.
20. in Article 49 (4), the words "the consumption of active substances contained in the preparations' are replaced by the words" the quantity of active substances contained in the consumed and marketed products';
21. In Paragraph 51 (1) (b), the words "on the land which forms part of the chase" and the words "user of the chase" (40) and "including footnote 40 are deleted.
22. in Paragraph 51 (2), the words "at least 48 hours" shall be replaced by the words "no later than 2 days" and the words "whose e-mail address is entered in the register of holdings according to the premises intended for the keeping of registered animals under the Act on Agriculture" shall be inserted after the words "bee breeders."
23. In Article 51 (5), the words "or fish 'are replaced by the words", fish or other non-target organism' and the words ", Czech environmental inspection 'are inserted after the words" the Constitution'.
24. in Paragraph 51 (7), the words "and paragraph 2" shall be added at the end of the text of point (b).
25. In Paragraph 52, the sentence "For the purposes of this Act, the application of a product in the form of granules or capsules by unmanned aircraft from a height not exceeding 5 metres above the land shall not be regarded as an air application at the end of paragraph 1. '
26. in Article 52 (4) (c), the words "classified as" shall be inserted after the words "organisms," the word "organs" shall be replaced by "toxic or very toxic, carcinogenic, mutagenic or toxic for reproduction category 1 or 2," or sensitising airways which have been placed on the market under chemical law "shall be deleted;
27. In Article 54, paragraphs 3 and 4 are added:
"(3) A distributor of an aid which intends to place on the market an aid under Regulation (EU) 2019 / 515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully placed on the market in another Member State and repealing Regulation (EC) No 764 / 2008 (hereinafter referred to as" Regulation (EU) 2019 / 515 ") shall, before its first placing on the market in the Czech Republic, be required to send a notification to the Institute of the placing on the market of such a mutually recognised aid.
(4) Notification pursuant to paragraph 3
(a) take the form of a declaration for mutual recognition under Regulation (EU) 2019 / 515; or
(b) contain at least:
1. the trade name of the mutual recognised assistance;
2. the trade name of the manufacturer or distributor of the mutually recognised aid;
3. a brief description and identification of the means of assistance mutually recognised; and
4. the Member State in which the mutually recognised aid is placed on the market in accordance with the legislation. ';
28. in Paragraph 54d (1), the following shall be inserted after "§ 35 (2), (5) and (6)," § 37. "
29. in Paragraph 60 (4):
"(4) Distributors shall be required to send the data referred to in Section 60a (2) on products for professional users identified by a two-dimensional barcode by means of remote access to the data storage site maintained under Section 60a. The method of sending data to the data repository, the technical conditions, the structure of the data phrase and the frequency of sending data shall be laid down in the implementing legislation. ';
30. In Paragraph 60, paragraphs 5 to 7 are added:
"(5) Professional users are required to keep records of the use of preparation 88) or business aids in a separate book with continuously numbered pages or in electronic form while ensuring their preservation. The records in electronic form shall be kept in machine-readable format. It shall be considered equivalent to keeping records in the fertiliser records kept for the purposes of the Fertiliser Act or, if the use of pheromones or repellents is made against the culling of animals, in the forest records. The content and scope of records of the use of products or aids shall be laid down in the implementing legislation.
(6) Records of the use of products or aids shall be made without delay, no later than the following working day following the application of the product or aid, except for a record of the verification of the effectiveness of the measures to be taken according to the effect of the product or aid used. If the application of the product or the aid is carried out by a professional user on land which he does not own or otherwise use, the user of the property shall also be required to keep records.
(7) The Commission shall be empowered to adopt delegated acts in accordance with Article 108 concerning the detailed rules for the application of this Regulation.
31. After Paragraph 60, the following Section 60a is inserted:
Data storage
(1) Data storage is a public administration information system concerning the marketing of products for professional users established and administered by the Ministry.
(2) In the data storage site, the following data are provided for individual preparations for professional users:
(a) the unique identifier, trade name, batch number and date of manufacture of the product formulation;
(b) the business name or name of the supplier of the product, or the name and surname of the natural person if the supplier of the product is not registered, the address of the supplier's registered office or place of business, and, where appropriate, his identification number, the quantity of the product accepted and the date of receipt of the product;
(c) the business name or the name of the customer of the product or the name or names of the natural person, and the surname of the natural person if the customer of the product is not registered, the address of the registered office or place of business of the product or its identification number, the quantity of the product delivered and the date of delivery of the product; and
(d) the trade firm or the name of the distributor providing the data or the name, or the name or surname of the natural person, if the distributor is not registered, the address of the distributor's registered office or place of business and the registration number assigned by the Institute, or the identification number of the data provider, as appropriate. ";
32. in Paragraph 71 (c), "Ministry" is replaced by "Ministry of Agriculture."
33. In Paragraph 71 (j), the words "in the Bulletin of the Ministry of Agriculture and" shall be deleted.
34. Paragraph 73 (1) is deleted.
Paragraphs 2 to 4 shall be renumbered paragraphs 1 to 3.
35. in Article 73 (1), the words "within the delegation" shall be inserted after the words "within the meaning of Article 73 (1)."
36. Paragraph 73 (3) is deleted.
37. in Paragraph 76 (2) (b), the word 'overpropagation' is replaced by 'condition';
38. Paragraph 76 (6) is deleted.
Paragraphs 7 to 11 shall be renumbered paragraphs 6 to 10.
39. in § 76 (7) and (8), § 76 (9) of the introductory part of the provision and in § 76 (10) of the introductory part of the provision, "7" is replaced by "6."
40. Article 76a, including the title and footnote 53 to 53c, shall be deleted.
41. in Article 79e (1), the word "or" shall be deleted at the end of point (l);
42. In § 79e, at the end of paragraph 1, the dot is replaced by a comma and the following points (n) to (p) are added:
"(n) as holder of an authorisation, does not indicate an extended period of application on the packaging of the product or fulfil any of the obligations relating to the notification provided for in Article 47;
(o) as a distributor of a means of assistance, fails to comply with the notification requirement of Article 54 (3) or (4); or
(p) when organising a course organised by the employer, the employer fails to fulfil the obligation under § 86 (1) or § 86b (3). "
43.In Article 79g (1) (v), the word "or" shall be deleted.
44. In Paragraph 79g, at the end of paragraph 1, the dot is replaced by "or 'and the following point (x) is added:
"(x) as a distributor, it shall not comply with the notification obligation for the transmission of product data to professional users identified by a two-dimensional barcode in accordance with Article 60 (4) or any of the obligations laid down in the implementing act for its implementation.";
45. in Article 79i (1), "§ 73 (2)" is replaced by "§ 73 (1)."
46. in Article 82 (2) (a), "Article 5 (4)" is replaced by "Article 4 (1)."
47. In Paragraph 86 (1), the words "until the end of the calendar year in which the trained person completed the course" shall be replaced by "for 1 year" and the sentence of the eighth shall be replaced by the words "The holder of a certificate of second or third degree shall be entitled to provide knowledge within that course."
48. In Paragraph 86 (2), the word "Institute 'is replaced by the words" educational establishment entrusted with the Ministry' and the words "satisfy the conditions of education for plant health practitioners under § 82 (3) (a) to (c) or § 82 (6), or 'are deleted.
49. in Article 86 (3) (c), the words "and the employer-organised courses to supplement knowledge for the application of the products referred to in Article 86 (1)" shall be deleted;
50. in Paragraph 86 (4):
"(4) The educational establishment shall extend the validity of the second-degree certificate and the Institute shall extend the validity of the third-degree certificate for a further period of 5 years from the date of expiry of the existing certificate on the basis of an application by the certificate holder before the expiry of the period of validity of the certificate, provided that the applicant has complied with the conditions for the renewal of the certificate referred to in paragraph 2 or 3 during the last 12 months of the original certificate. The application for renewal of the second degree certificate shall be submitted to the educational establishment. An application for renewal of a third-degree certificate shall be submitted to the Institute either directly or through an educational establishment for which the applicant has received additional training; In such cases, the training establishment shall immediately forward the application to the Institute, together with evidence of completion of supplementary training. ';
51. in Article 86a (1) (a) and (b), the words "to certify first degree" shall be deleted;
52. in Article 86a (1) (c) and (d), the words "first degree" shall be deleted;
53. In Section 86a (2) of the introductory part of the provision, the comma after the word "courses' is replaced by" a 'and the words "and courses organised by the employer' are deleted.
54. In Section 86a (2) of the final part of the provision, the words "in basic courses and additional training 'shall be inserted after the word" people'.
55. in Paragraph 86b (1):
"(1) The educational establishment shall ensure, in agreement with the Constitution and locally competent public health authorities, 23a) conduct the tests prescribed for obtaining the second degree certificate and declare the dates for their performance at least 6 months before the date of their performance. The Institute shall, in agreement with the local competent public health authorities, ensure 23a) the conduct of the examinations prescribed for obtaining a third-degree certificate and declare the dates for their performance at least 6 months before the date of their performance. ';
(56) In Article 86b (2), the words "Examiners" shall be replaced by the words "Examiners" and the words "must hold a third-degree certificate" shall be replaced by the words "only a person who fulfils the qualification criteria for professional trainers."
57. in § 86b, the following paragraph 4 is added:
"(4) The Institute shall keep a record of certificates of competence for the handling of products."
58. in Article 88 (1) (a), the words "§ 4a (1)" and "§ 13 (3)" shall be inserted after the words "§ 14 (5),"
(59) In Paragraph 88 (3), the words "and 10" shall be inserted after the words "Paragraph 46b (3)" and the words "5 and 7" shall be added at the end of the text of the paragraph.
Transitional provision
The obligations set out in Sections 46b (10), 46c (1) (r) and 60 (4) of Act No. 326 / 2004 Coll., as effective from the date of entry into force of this Act, do not apply to plant protection products for professional users produced before the date of entry into force of this Act.
Final provision
This Act was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 on the procedure for the provision of information in the field of technical and information society services.
Efficacy
This Act shall take effect on 1 July 2023.
Pekarová Adamová v. r.
Zeman v. r.
Fiala v. r.
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Regulation Information
| Citation | Act No. 273 / 2022 Coll., amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.09.2022 |
|---|---|
| Effective from | 01.07.2023 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Agriculture
Parliamentary Paper:
Paper No. 151
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