What is Act No. 299 / 2017 Coll.?

Act No. 299 / 2017 Coll., amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended, and other Related Acts — Act amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the amendment of certain related laws, as amended, and other related laws.

When it became Act No. 299 / 2017 Coll. effectiveness?

Act No. 299 / 2017 Coll. became effective 01.12.2017.

Is Act No. 299 / 2017 Coll. still valid?

Yes, Act No. 299 / 2017 Coll. is still valid and effective.

How many times was it Act No. 299 / 2017 Coll. amended?

Act No. 299 / 2017 Coll. has 3 time versions of the text.

Act No. 299 / 2017 Coll. - Act amending Act No. 326 / 2004 Coll., o...

299

THE LAW

of 16 August 2017

amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the amendment of certain related laws, as amended, and other related laws

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment to the Plant Health Act

Čl. I

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.

1. in Paragraph 1 (1) (c) and (e), the word "others" shall be replaced by "ancillary."

2. in § 1 (1) (c) and § 3 (1) (b), the word "further" is replaced by the word "ancillary."

3. in Paragraph 2 (1) (z):

"(z) equipment for the application of preparations of equipment specifically designed for the application of preparations, including accessories necessary for the efficient operation of such equipment, such as nozzles, pressure gauges, filters, sieves and tank cleaning equipment.";

4. In Article 2 (2) (u), the word "distribute 'is replaced by" place on the market'.

5. Paragraph 5 (1) to (3) reads as follows:

"(1) The professional user shall take into account all available plant protection methods and shall subsequently introduce appropriate measures that can be justified from an economic and environmental point of view and which reduce or minimise risks to human health or the environment.

(2) In deciding on the use of integrated plant protection, a professional user is always obliged to ensure optimal growth of healthy plants and the health and quality of plant products at the least possible disruption of agricultural ecosystems and to consider the application of integrated plant protection measures provided for in the implementing legislation.

(3) The professional user shall record data on the self-monitoring of the presence of harmful organisms, on the products used by him and on the evaluation of the success of the plant protection measures implemented by him in accordance with the implementing legislation. ';

6. In Article 5 (4), at the end of point (d), "a 'is replaced by" a'; at the end of paragraph, the dot is replaced by "a 'and the following point (f) is added:

"(f) carry out testing of authorised products and aids in order to determine their optimum use in accordance with the principles of integrated plant protection under the conditions of the Czech Republic and compare the effectiveness of authorised products and aids and publish the results of such testing."

7.

„§ 6

Exploration of the presence of harmful organisms before planting of propagating or reproductive material

A natural or legal person intending to cultivate breeding, reproduction or reproduction material under specific legislation6), 7) may, before establishing the relevant crop, request the Institute to carry out a survey of the presence of harmful organisms the presence of which is an obstacle to the recognition of the relevant material. The survey shall be carried out at the place designated for the production of the material and, where appropriate, in the immediate vicinity thereof. The types of plants covered by the possibility of carrying out the survey and other details shall be laid down in implementing legislation. ';

8.

„§ 9

Reporting obligation

Any person who discovers or has reasonable grounds for suspecting the presence of a harmful organism pursuant to Article 7 (1) or (3) or a harmful organism pursuant to Article 10 (1) (b), against which the introduction and spread of which the Institute has ordered emergency plant health measures pursuant to the second sentence of Article 76 (2), shall be required to notify the Institute without undue delay of such findings or of any reasonable suspicion and, where the Institute so requests, to provide information concerning the presence of that harmful organism known to him. On receipt of this information, the Institute shall proceed in accordance with Article 11 (1). ';

9. In Article 21, the following paragraph 10 is added:

"(10) Where a procedure for the allocation of a customs-approved designation gives rise to a reasonable suspicion that a consignment which is imported from a third country into the Czech Republic contains the plants set out in the Annex to Commission Implementing Regulation (EU) 2016 / 1141 adopting a list of invasive non-indigenous species having a significant impact on the Union under Regulation (EU) No 1143 / 2014 of the European Parliament and of the Council, such consignment shall be subject to control by the Constitution. The authority responsible for the customs clearance of the consignment shall inform the Institute in writing without delay of the suspected occurrence. Where the consignment has been found to contain the plants set out in the Annex to Commission Implementing Regulation (EU) 2016 / 1141 and the conditions laid down in Regulation (EU) No 1143 / 2014 of the European Parliament and of the Council for the introduction into the European Union of the consignment are not fulfilled, the Institute shall, without delay, in accordance with Article 75, order the refusal of the consignment to enter the territory of the European Union or the destruction of the consignment or part thereof. ';

10. in Article 25 (3) and in Article 26 (7), the word "institution" shall be replaced by "Authority."

11. In Title IV, the word "OTHERS 'is replaced by" ASSISTANT'.

12. in Article 31 (3), the word "met" shall be inserted after the word "composition."

13. in Article 31, paragraphs 4 to 6 read:

"(4) Products which are placed on the market under provisions other than this Act shall not be labelled on the packaging or in the package leaflet with information on their activity against the presence of harmful organisms on plants or plant products or on the effect on the effects of such harmful organisms. The packaging or package leaflet of these products shall not contain any graphic or other information indicating such action or influence.

(5) The trade name, packaging and label of the product must not indicate characteristics or effects which have not been substantiated by documentation submitted by the applicant and assessed in the context of the authorisation process.

(6) The trade name of the product must not be the same as that of another product. The use of the distinguishing supplement is sufficient to distinguish the trade name; This shall be without prejudice to authorisations for the protection of markings under other legislation. ';

14. In Article 31, the following paragraph 7 is added:

"(7) The product or chemical constitutes a serious hazard unless authorised for placing on the market and use. ';

15. The following Sections 31a and 31b are inserted after Section 31:

„§ 31a

Label of the product

(1) The product placed on the market must be labelled in the Czech language.

(2) In the case of parallel trade, the original labels by which the preparation has been labelled for manufacture and marketing shall not be removed. The original batch number and the date of manufacture of the formulation shall not be overglued and shall remain visible on the packaging.

(3) The authorisation holder shall send the Institute no later than 10 working days before the first placing on the market of the product on the basis of the authorisation issued and any modification of the authorisation to the text of the product label, including the relevant risk limits.

(4) The Institute publishes on its website the text of the product labels sent.

(5) The implementing legislation lays down the requirements for the form and layout of the product label and the model of the product label.

§ 31b

Removal of preparations

(1) Only the holder of the authorisation may change products, except for the holder of the parallel trade permit.

(2) The re-packaging shall be notified to the Institute no later than 3 working days before the change, indicating the place of repackaging and the name and address of the body which repackaging the products.

(3) The following conditions shall be met when changing the product:

(a) 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;

(b) the product authorised for placing 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 Institute in relation to the preparation and which is listed in the decision authorising the preparation;

(c) the various batches of the changed product must not be mixed during repackaging;

(d) the product packaging must bear the original batch number and the date of manufacture of the formulation of the repackaged product,

(e) the documentation on repackaging contains:

1. date of repackaging,

2. the name of the preparation before and after re-packaging,

3. the quantity delivered, the original batch number and the date of manufacture of the preparation for re-packaging, indicated on its original packaging by the manufacturer of the formulation.

(4) The repackaging documentation shall be kept in accordance with the directly applicable European Union Regulation concerning the placing of plant protection products on the market. "

16. Paragraph 33 (1) is deleted.

Paragraphs 2 to 6 shall be renumbered paragraphs 1 to 5.

17. In the third sentence of Article 33 (1), the words "toxicological opinion of the product (" toxicological opinion ') in the form of a binding opinion' are replaced by "binding opinion '; in the fourth sentence, the words" toxicological opinion' are replaced by the words "binding opinion '; the words" pursuant to Article 2 (1) (x)' are deleted; and at the end of the paragraph, the sentence "Ministry of Health in the binding opinion shall be added and the reasons shall be given for the protection of the health of people placing on the market or use of the product should be limited to professional users, in cases where the applicant indicates that the product will also be intended for non-professional users'.

18. In Paragraph 33 (3), "3 'is replaced by" 2';

19. in Article 34 (2) and (3):

"(2) The Institute shall authorise the sale and use of the product for non-professional use if:

(a) the binding opinion of the Ministry of Health does not require restrictions on marketing for professional users only;

(b) it is not a product presenting a significant risk to non-target organisms in non-professional use; and

(c) the product complies with the requirements for the packaging and labelling of products for non-professional users laid down in the implementing legislation.

(3) The implementing legislation lays down requirements for the packaging and labelling of products for non-professional users and the circumstances in which the product poses a significant risk to non-target organisms in the case of non-professional use. ';

20. in Paragraph 35 (1), the word "or" shall be deleted at the end of point (a), the dot shall be replaced by a comma and the following points (c) and (d) shall be added:

"(c) it is necessary to amend the decision taken in the framework of a comparative assessment following the directly applicable European Union Regulation on the placing of plant protection products on the market (67) before the entry into force of this Decision; or

(d) establish that the holder of the authorisation has repeatedly failed to comply with the conditions imposed by the final decision on an emergency plant health measure referred to in Article 76 (1) (f) and (g) within the time limit laid down in this Decision. ";

21. In Article 35, at the end of paragraph 2, the dot is replaced by "a 'and the following point (f) is added:

"(f) a change in the name of the co-formulant or a change in the producer of the co-formulant in so far as the substance or mixture is chemically identical and is the basis for the authorisation decision."

22. In Article 35 (6), the words "and the distributor" are inserted after the words "the holder of the authorisation," the words "on marketing" are inserted, the words "in writing" are inserted after the word "in way" and, at the end of the text of the paragraph, the words "immediately after the entry into force of this Decision."

23. At the end of Paragraph 36, the sentence "Evaluation of equivalence is carried out by the Institute. 'is added.

24. in Paragraph 37 (2):

"(2) The criteria for minority use are met if:

(a) the growing area of the crop is less than 10 000 ha in the Czech Republic in the year in which the application for authorisation has been submitted;

(b) the area treated has been less than 10 000 ha per year in the three years preceding the application for extension;

(c) the presence of the harmful organism is irregular and treatment required less than once every 3 years;

(d) the product is applicable in organic farming; or

(e) the daily dietary intake of a crop for an adult is less than 1,5 g. ';

25. in Paragraph 37, the following paragraphs 3 and 4 are added:

"(3) In the case of an extension of authorisations to minor uses in accordance with the directly applicable European Union Regulation concerning the placing of plant protection products on the market, the public interest in particular shall be:

(a) preventing resistance to harmful organisms;

(b) the diversity or sustainability of agricultural production; or

(c) protection of public green and conservation of landscape.

(4) The Institute authorises the extension of the authorisation to minority uses by the Regulation. "

26. in Paragraph 37a (2):

"(2) An assessment of the effects on human health is carried out by the Ministry of Health at the request of the Institute."

27. § 38, including the title:

„§ 38

Mutual recognition of authorisations

(1) In the case of mutual recognition of authorisations under the directly applicable European Union Regulation, the Institute shall request a binding opinion from the Ministry of Health on the conditions of use of the product relevant to the territory of the Czech Republic for the protection of human health. In its application, the Institute shall inform the Ministry of Health of the conditions of use of the product under which the product was authorised by the Reference Member State.

(2) The Ministry of Health shall issue a binding opinion within 75 days of receipt of the request from the Institute on the basis of an evaluation by the State Health Institute. In its opinion, the Ministry of Health may lay down conditions of use different from those under which the product was authorised by the Reference Member State under the conditions laid down in Article 36 (3) of Regulation (EC) No 1109 / 2009.

(3) The applicant will pay the State Health Institute a price to be determined under the specific legislature23b) for the preparation of the evaluations. Paragraph 33 (3) shall apply mutatis mutandis. ';

28. in Article 38b (1), the words "necessary plant protection against harmful organisms" shall be replaced by the words "necessary plant treatment products."

29. in Article 38b (1), the words "with a different mode of action" shall be added at the end of the text of point (a).

30. in Article 38b (1) (b), the words "harmful organism" shall be inserted after the word "resistance."

31. in Article 38b (1) (d), the words "the product shall be used in organic" shall be replaced by the words "ecological," in the final part of the provisions of paragraph 1, the words "for reasons of public interest" shall be deleted and the words "where at least one minority use criterion is met" shall be inserted after the words "the publication of the Constitution Regulation."

32. in Paragraph 38b, the following paragraph 2 is inserted after paragraph 1:

"(2) Where the same extent of use of the preparation which the Institute intends to authorise under paragraph 1 is already authorised under a directly applicable European Union Regulation in a Member State of the same zone where the Czech Republic is included, the procedure laid down in paragraph 38 shall apply mutatis mutandis. ';

Paragraphs 2 and 3 shall become paragraphs 3 and 4.

33. in Article 38b (3), the words "for reasons of public interest" shall be deleted;

Article 34 (38c) shall be deleted, including the title.

35.

„§ 39

(1) The Institute shall inform the public of the identified dangerous effects of the preparation on human, animal health and the environment, including residues of the active substance.

(2) The Institute publishes the names of the preparations, their identification marks and the names or names of the persons who placed the products on the market in the event of findings of variations in composition, labelling or packaging which led to the issue of a prohibition on the placing on the market of the product or its lot, after the decision has become final. "

36. Paragraph 40, including the title, reads:

„§ 40

Testing programmes for preparations and aids

(1) The Institute sets out and publishes pre-published testing programmes for authorised products and aids in order to verify their optimum use in accordance with the principles of integrated protection in the regions of the Czech Republic and to compare the effectiveness of authorised products under different conditions.

(2) The holder of a decision to authorise a product or an aid device shall provide the Institute, at its request, with the product or aid in the amount necessary for the implementation of the testing programme, free of charge if the product is part of the programme as a tested or reference product.

(3) The results obtained under the examination programme are published on its website.

(4) The results obtained under the testing programme may be used as a basis for the procedure for the renewal of the product authorisation or minor use authorisation. ';

37. Paragraph 43, including the title and footnote 92, reads:

„§ 43

Monitoring of preparations and aids

(1) For control purposes, the product or the aid in the sales packaging shall normally be taken. Individual sampling methods shall be laid down in implementing legislation.

(2) Where an obligation on the controller to return the product or the aid is established under the control regulation92), compensation shall be granted to the person to whom the sample has been taken, equal to the difference between the price of the remaining product or the aid and the price of the product or aid in the undamaged sales packaging for which that person normally sells the case at the time of removal on the market; If this price cannot be determined, the compensation shall be equal to the price at which the case was issued and, where appropriate, to the cost effectively incurred. This sample may continue to be placed on the market if it is accompanied by a certificate from the Institute on the possibility of selling such a package of product or aid.

(3) The holder of the authorisation is required to deliver at his own expense at the request of the Institute

(a) the analytical standard of the active substance contained, where appropriate, of the active ingredients accompanied by an analytical certificate;

(b) analytical standards of toxicological or ecotoxicological impurities;

(c) a sample in intact sales packaging corresponding to a lot of the product or aid placed on the market in the Czech Republic in the quantities strictly necessary for carrying out the control analyses and within the time limit and place specified by the Institute;

(d) information on a particular batch of product or aid and its manufacturer.

92) Act No. 255 / 2012 Coll., on Control (Control Regulations). '.

38. Paragraph 45 (3) is deleted.

Paragraphs 4 to 13 shall become paragraphs 3 to 12.

39. in Paragraph 45 (7), "6" is replaced by "5."

40. In Paragraph 45, the following paragraph 12 is inserted after paragraph 11:

"(12) The decision referred to in paragraph 1 shall not be taken where such trials and trials are carried out by a research institution or university in the framework of scientific or educational activities. ';

Paragraph 12 shall become paragraph 13.

41. In Paragraph 45, at the end of paragraph 13, the words "and the requirements for the maximum range of experiments and tests with unauthorised preparations and aids' shall be added.

42. Paragraph 46, including the title:

„§ 46

Storage of products or aids by professional users

(1) Professional users who store products or aids are required to:

(a) ensure:

1. storage of products or aids by species, separately from other products and preparations or aids intended for disposal as waste 34) and out of the reach of substances likely to affect the properties of the products or aids stored;

2. the separate storage of products or aids which have expired, or products or aids which return to their supplier;

3. Continuous keeping of evidence of receipt and disposal of products or aids, including products with expired shelf life,

4. compliance with technical requirements for the storage of preparations or aids and other conditions laid down by special legislation35),

5. storage only of such preparations or aids which are packaged and labelled in accordance with specific legislation, if they are intended for storage of preparations or aids intended for use; and

(b) inform the Institute, upon request, of the places of storage of preparations or aids.

(2) Professional users may only store products intended for professional users if they have been received from a registered distributor or if they are authorised to place those products on the market in the Czech Republic. "

43. Paragraph 46a, including the title, reads:

„§ 46a

Registration of product distributors for professional users

(1) The Institute maintains a register of distributors of products for professional users (hereinafter referred to as the "Register of Distributors"), which is a public administration information system and is publicly accessible in a way that allows remote access.

(2) The following data on registered distributors are kept in the register of distributors:

(a) the trading firm or the name of the legal person, or the name or, where applicable, the names and surnames of the natural person, unless it is registered in the commercial register;

(b) the address of the registered office or place of business, the address of the establishment, if different from the address of the registered office, and the address of other places where the preparations are handled;

(c) the identification number of the person and establishment;

(d) the date of registration; and

(e) the registration number assigned by the Institute.

(3) The Institute shall decide on the registration of a natural person or legal person in the register of distributors upon request.

(4) The application for registration in the Register of Product Distributors shall contain:

(a) for persons having their registered office in a third country or in the Swiss Confederation, their registered office in the Czech Republic; in the case of a registered office in the Swiss Confederation, the registered office of the organisational unit in the Czech Republic must be indicated only if the activity of the distributor of products for professional use is carried out for more than 90 days; and

(b) the address of the place of the premises and other places where the products are handled, namely warehouses, places where packaging and labelling take place, and places of sale and handling.

(5) The applicant shall add to the application for registration:

(a) a declaration by the applicant that he / she has become acquainted and will comply with good distribution practice procedures to be provided by persons qualified for the handling of products; and

(b) the document referred to in paragraph 4 (a).

(6) If there is a change in the data kept in the distributor register, the registered distributor shall notify the change to the Institute within 15 days of the date of the change.

(7) The Institute shall decide to amend, suspend or revoke the registration in the register of distributors on the basis of a request from a registered distributor.

(8) The Institute will decide to suspend or revoke the registration in the Register of Distributors,

(a) where the distributor infringes any of the obligations referred to in Article 46c (1) (a), (b), (c), (d), (e), (g), (i), (j), (k), (l), (m) or (n); or

(b) if the distributor repeatedly fails to comply with the measures imposed by the decision on an emergency plant health measure under Article 76 (1) (f) and (g) within the time limit set by that decision.

(9) The suspension of the registration in the register of distributors referred to in paragraph 8 shall be applied by the Institute in cases where deficiencies of a nature which is removable are identified. The revocation of the registration in the register of distributors referred to in paragraph 8 shall be applied by the Institute in cases where deficiencies of a non-removable nature are identified. The Institute shall, in the decision suspending the registration in the register of distributors, lay down the rights and obligations of the distributor for the duration of the suspension. After removing the reasons which led to the suspension of the registration in the register of distributors, the Institute shall decide to terminate the suspension. If the reasons for the suspension of the registration in the Register of Distributors have not been removed, within a specified period, or within 3 years of the date on which the decision to suspend the registration is taken, if the deadline for their removal has not been established, the Institute shall decide to revoke the registration in the Register of Distributors. The appeal against the suspension decision in the register of distributors shall not have suspensory effect.

(10) The registration of a distributor in a register of distributors will cease to be the death of a distributor, if the person is a natural person, or the person is the death of a distributor, if the person is a legal person, if it has died without a legal successor. "

44. The following Sections 46b to 46d are inserted after Section 46a, including the headings and footnotes No 93 to 96:

Citation	Act No. 299 / 2017 Coll., amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended, and other Related Acts
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	19.09.2017
Effective from	01.12.2017
Effective until	-
Status	Valid

Act No. 299 / 2017 Coll.

Act amending Act No. 326 / 2004 Coll., on Phytosanitary Care and on the amendment of certain related laws, as amended, and other related laws

Contents