What is Act No. 245 / 2011 Coll.?

Act No. 245 / 2011 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. 245 / 2011 Coll. effectiveness?

Act No. 245 / 2011 Coll. became effective 01.09.2011.

Is Act No. 245 / 2011 Coll. still valid?

Yes, Act No. 245 / 2011 Coll. is still valid and effective.

How many times was it Act No. 245 / 2011 Coll. amended?

Act No. 245 / 2011 Coll. has 4 time versions of the text.

Act No. 245 / 2011 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

Valid Law Effective from 01.09.2011

Text versions: 01.01.2012 01.09.2011 30.08.2011

ČÁST PRVNÍ Čl. I „§ 31 „§ 32 „§ 33 „§ 34 „§ 35 „§ 36 „§ 36a „§ 37 „§ 37a „§ 38 „§ 38a § 38b § 38c „§ 45 „§ 47 „§ 53 „§ 60 „§ 69 „§ 69a „Díl 1 „Díl 2 „HLAVA VII Díl 1 § 79a § 79b § 79c § 79d Díl 2 § 79e § 79f § 79g § 79h Díl 3 § 79i „§ 87 Čl. II ČÁST TŘETÍ Čl. IV „§ 5g ČÁST ČTVRTÁ Čl. V ČÁST PÁTÁ Čl. VI

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245

THE LAW

of 20 July 2011

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 Acts, 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. 227 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 490 / 2009 Coll. and Act No. 102 / 2010 Coll., is amended as follows:

1. In Paragraph 1 (1), the introductory part of the provision reads: "This law incorporates the relevant European Unionprovisions (1), following the directly applicable European UnionRegulation (67) and regulates the rights and obligations of natural and legal persons relating to '.

Footnote 67 reads:

"(67) Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC."

2. In footnote 1, the sentence "Council Directive 91 / 414 / EEC of 15 July 1991 concerning the placing of plant protection products on the market. ', the sentence" Council Directive 97 / 57 / EC of 22 September 1997 establishing Annex VI to Directive 91 / 414 / EEC concerning the placing of plant protection products on the market' and the sentence "Council Directive 79 / 117 / EEC of 21 December 1978 concerning the prohibition of the placing on the market and use of plant protection products containing certain active substances. 'is replaced by the sentence" Council Directive 2009 / 143 / EC of 26 November 2009 amending Directive 2000 / 29 / EC as regards authorisations for the performance of laboratory testing tasks.';

3. Article 2 (1) (a) (11), Article 2 (1) (n) of the introductory part of the provisions and paragraphs 1 and 3, § 7 (2) and § 7 (3) of the introductory part of the provision, § 7 (5) (c), (e) and (f), § 26 (1) (b), § 11 (2) and (3), § 23 (1) (b), § 23 (1) (b), § 25 (2), § 21 (7) and (9), § 22 (5) (b) and the final paragraph, § 22 (6), § 23 (1), § 23 (1) (b), § 23 (2), § 25 (1) (b), § 25 (2), § 22), § 22 (5)

4. In Paragraph 1 (1) (c), the word "registration," is replaced by "conditions."

5. in Article 2 (2) (b), the word 'single' shall be replaced by 'separate';

6. in Article 2 (2) (g) and (h):

"(g) by the distributor, the person who places the product on the market,

(h) a professional user who uses pesticides in the context of his professional activities, both in the field of agriculture and in other sectors, ';

7. in Article 2 (2), points (i) to (p), including footnote 4, are deleted;

Points (q) to (y) shall be renumbered as points (i) to (q).

8. In Paragraph 2 (2), point (j) is deleted.

Points (k) to (q) shall be renumbered as points (j) to (p).

9. in Paragraph 2 (2) (k), the words "responsible for the exercise of responsibility in the field of plant health under European Union68" shall be inserted after the word "Authority."

Footnote 68:

"(68) Article 1 (1) of Council Directive 2000 / 29 / EC of 8 May 2000 on protective measures against the introduction into and spread within the Community of organisms harmful to plants or plant products."

10. in Article 2 (2) (l), the words "responsible for the exercise of responsibility in the field of plant health under European Union68" shall be inserted after the word "Authority."

11. in Article 2, the following paragraph 3 is added:

"(3) The basic terms referred to in paragraphs 1 and 2 shall be without prejudice to the terms in the directly applicable European Union69).

69) For example, Article 3 of Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC. '

12. in Article 3 (1) (b), the words "where appropriate, biocidal products placed on the market under special legislation (4e) and authorised by the plant health administration (§ 37 (3))" shall be deleted;

13. in Article 6a (2), the words "natural or" shall be deleted and after the words "to entrust" shall be inserted the words "natural or legal person."

14. In Article 6a, paragraph 6 is added, including footnote 70:

"(6) The authorisation of national reference laboratories referred to in paragraph 2 shall be deemed to be an authorisation to carry out laboratory testing tasks under the European Union Regulation (70). The result of the laboratory analysis of the sample carried out by the national reference laboratory shall be equivalent to the result of the analysis of the sample carried out by the laboratory responsible for the performance of the plant health sector in accordance with the European Union70) in another Member State of the European Union.

70) Council Directive 2009 / 143 / EC of 26 November 2009 amending Directive 2000 / 29 / EC as regards the authorisation to carry out laboratory testing tasks. ';

15. in the first sentence of Article 7 (7), the words "and k" shall be replaced by the words "or" and after the words "organisms" shall be added the words "referred to in Paragraph 10 (1) or harmful organisms against which the introduction and spread of which are subject to measures pursuant to paragraph 4 or Article 11 (2) and (3)";

16. In the second sentence of Article 11 (3), the word "threatened 'is replaced by" threatened'.

17. in Article 12 (1) of the final part of the provision, the words "(the register)" shall be deleted;

18. in Paragraph 12 (4):

"(4) The plant health service shall register the applicant within 3 months of the date of receipt of the application referred to in paragraph 3 if it finds that the applicant is competent to fulfil the obligations set out in paragraph 13 and, taking into account the required scope of registration, also the special conditions referred to in paragraph 15 (1) or the obligations resulting from the exceptional plant health measures ordered under paragraph 76 (2). The plant health service shall issue to the applicant a document indicating the designation of the person registered in the official register referred to in paragraph 1, his registration number, the activity for which that person is entered in the official register and the date of the registration. ';

footnote 11 is deleted.

19. in Article 12 (5), the words', initiate proceedings and 'shall be deleted.

20. Paragraph 12 (6) is deleted.

Paragraphs 7 to 9 shall be renumbered paragraphs 6 to 8.

21. in Article 12 (7), the words "and the content and manner of keeping the official register referred to in paragraph 5" shall be deleted.

22. In Section 12, the following paragraph 9 is added:

"(9) The obligation to register is also met by registration in another Member State of the European Union71). This is without prejudice to the obligation of registered persons under Paragraph 21 (6).

(71) Article 6 of Council Directive 2000 / 29 / EC of 8 May 2000 on protective measures against the introduction into and the spread within the Community of organisms harmful to plants or plant products. "

23. in Paragraph 13 (1) (d) (2):

"2. any changes to the information contained in the official register referred to in Article 12 (1) without undue delay, but not later than 1 month after the date on which the relevant changes took place;"

24. in Paragraph 14 (1) (a), the words "or, if they do not comply with the specific requirements laid down in the same implementing act," shall be inserted after the words "pursuant to Paragraph 18 (1)."

25. in Paragraph 14 (1) (b), the word "subsequently" shall be inserted after the words "in and";

26. In Article 14 (4), the words "and k 'are replaced by the words" or' and at the end of the text of the paragraph the words' referred to in Article 10 (1) or harmful organisms against which measures are provided for in Article 7 (4) or Article 11 (2) and (3) 'are added.

27. In Paragraph 14, the following paragraph 5 is added:

"(5) Plant health management shall not control plants, plant products and other objects not referred to in paragraph 1, even if accompanied by a plant passport. ';

28. In Article 15 (5), the words "and k 'shall be replaced by the words" or' and at the end of the text of the paragraph the words' referred to in Article 10 (1) and (2) or harmful organisms against which measures are provided for under Article 7 (4) or Article 11 (2) and (3) 'shall be added.

29. In the third sentence of Article 15 (6), "Article 16 (2) 'is replaced by" Article 16 (1) (b)'.

30. In Article 16 (3), the words "and 3 'shall be inserted after the words" Paragraph 15 (2)' and the words "and this part may be marketed 'shall be added at the end of the text of the paragraph.

31. in Article 21 (1) (d), the words "or outputs from the authorised conversion of documents" shall be inserted after the words "copies."

32. In the first sentence of Article 21 (2), the words "(wood packaging material) 'shall be inserted after the words" packaging material'.

33. In Paragraph 21, the sentence "A copy of the inspection report shall also be transmitted to the customs office of entry or destination at the end of paragraph 2. ';

34. In Article 21, the words "or Article 12 (9) 'shall be added at the end of the text of paragraph 6.

35. in Articles 21 (8), 22 (5) (c), 27 (3) and 80 (2) (c), the words "the European Communities" shall be replaced by "the European Union."

36. in Article 25 (2) and (5), "3" is replaced by "4."

37. In Paragraph 25, the following paragraph 3 is inserted after paragraph 2:

"(3) A check of the marking showing that the wood packaging material used for the transport of goods of all kinds imported from third countries into the Czech Republic has been properly treated against the presence of harmful organisms shall be carried out at the points of entry provided for in paragraph 1 or at the destination of the imported goods. The inspection shall be carried out by the customs authority; where the customs authority is unable to carry out the inspection, it shall inform the phytosanitary authority which shall carry out the inspection. ';

Paragraphs 3 to 7 shall be renumbered paragraphs 4 to 8.

38. in Paragraph 25 (4):

"(4) The plant health service may, in whole or in part, carry out an identity check and a health check at the place of destination, on the basis of the opinion of the point of entry office, that the identity check and health check may not be carried out at the place referred to in paragraph 2 to the extent provided for in paragraph 22 (1) in order to meet the objective of the check referred to in paragraph 22 (2), without prejudice to paragraphs 5 and 6. ';

39. In Paragraph 25, the following paragraph 8 is inserted after paragraph 7:

"(8) The operator of the point of entry shall place containers on his cargo at his premises intended for the disposal of plants, plant products and other objects imported from third countries in the context of personal contact and not complying with the requirements laid down in Article 21 (1). The operator of the point of entry shall be responsible for the safe disposal of the contents of the containers under the supervision of the plant health administration. ';

Paragraph 8 shall become paragraph 9.

40. in Article 25 (9) (b) and (c) and in Article 25a (4), first sentence, "5" is replaced by "6."

41. in the first sentence of Article 25a (1), the words' in agreement with 'shall be replaced by' on the basis of a written mandate ';

42.In § 25a (2) of the introductory part of the provision and in § 25a (2) (b) the number "7" is replaced by "9" and "5" by "6."

43.In Article 25b (1), "3" is replaced by "4" and "5" is replaced by "6."

44. in Article 25b (2), second sentence, "3" is replaced by "4."

45. in Article 25b (3), "5" is replaced by "6," the words "or by electronic transmission of data" are deleted and the comma after the words "point of entry" is replaced by "a."

46. In Paragraph 28 (1), the sentences of the second and third paragraphs are replaced by the following: "Plant health management shall not be subject to the plant health certificate if, on the basis of an investigation carried out, it is found that plants, plant products and other objects do not comply with the requirements of the importing or accompanying State for protection against the introduction of harmful organisms, or have not been established by the importing or accompanying State. The application for certification shall be submitted to the phytosanitary service of the exporter or the person authorised by him, at least two working days before the date of loading of the consignment. The applicant shall submit to the phytosanitary service the requirements of the importing or, where appropriate, accompanying State for protection against the introduction of harmful organisms, unless they have been published by the plant health service, and shall propose a place in which the plant health service may carry out the necessary investigations. ';

47. in Paragraph 28 (3):

"(3) If, according to the requirements of the importing or accompanying third countries, wood is to be treated for protection against introduction of harmful organisms, including its designation in the territory of the Czech Republic, it must be treated by means of a technical plant eligible under § 68 to 69a. The exporter shall be responsible for the treatment and labelling of exported wood and wood packaging material. The method and places of treatment of wood and wood packaging material shall be laid down in the implementing legislation. ';

48. In Paragraph 28 (4), the words "the output from the authorised conversion of documents' shall be inserted after the words" the original '.

49. in Paragraph 28 (8) (a), "7" is replaced by "8."

(50) footnote 22 reads as follows:

"(22) Commission Regulation (EC) No 690 / 2008 of 4 July 2008 recognising protected zones in the Community where plant health is exposed to a particular risk, as amended."

51. in Article 29 (5), the words "or, where appropriate, by electronic means" shall be deleted;

52. Paragraph 31, including the title, reads:

„§ 31

Basic provisions

(1) The plant health service is authorised to set grace periods for the preparation in accordance with the relevant European Union rules, if any.

(2) The holder of the authorisation must notify the phytosanitary authorities without undue delay of changes in the facts contained in the authorisation.

(3) The holder of the authorisation shall ensure that the active substance or active substances in the product and the product itself retain the composition, technical specification and other requirements of the preparation corresponding to the particulars provided in the supporting documents on the basis of which the authorisation was granted, throughout the period of validity of the authorisation.

(4) The holder of the authorisation shall be obliged to send the text of the instructions for use of the product or other means, including the relevant risk limits, to the phytosanitary authorities before the product is first placed on the market on the basis of the authorisation issued and any modification of the authorisation.

(5) The plant health service publishes the text of the instructions for use of the product or other device in a way that allows remote access.

(6) The re-packaging of the product authorised to be placed on the market and used in the Czech Republic shall be notified to the phytosanitary service no later than 24 hours before the re-packaging, indicating the place of repackaging and the name and address of the body which repackaging the products. The conditions laid down in the implementing legislation shall be fulfilled when changing the product. '

53. Paragraph 32, including the title, reads:

„§ 32

Application for authorisation

Applications for authorisation granted under a directly applicable European Union regulation concerning the placing of plant protection products on the market or the modification of an authorisation already granted shall be decided by the plant health authority. ';

54. Paragraph 33, including the title and footnote 72, reads as follows:

„§ 33

Authorisation procedure

(1) If, according to the instructions for use of the product, it is to be possible to mix it with another product or device, the applicant must demonstrate the consent of the holder of the product authorisation or the consent of the person at whose request the additional device has been entered in the official register for such use.

(2) The assessment of the product, including its use in terms of health protection, is carried out by the Ministry of Health on the basis of an evaluation by the State Health Institute (23a). The applicant shall pay to the State Health Institute a price to be fixed under the special legislation 23b) for the preparation of the evaluation. On the basis of the evaluation of the State Health Institute, the Ministry of Health shall issue a toxicological assessment of the product ("the toxicological assessment ') in the form of a binding opinion.

(3) In fulfilling the obligations arising for the Czech Republic under the directly applicable European Union67 law, the plant health administration is entitled to require the Ministry of Health to issue a binding opinion.

(4) The evaluation of the product referred to in paragraph 3 shall be carried out by the State Health Institute without payment.

(5) The authorisation procedure shall be suspended even if the plant health administration does not have the information necessary to carry out the evaluation of the product in accordance with the requirements of the directly applicable European Union Regulation (72), without prejudice to the provisions on the establishment of time limits resulting from the directly applicable European Union regulation on the placing of plant protection products on the market (67).

(6) The fact that an application for authorisation of a product has been submitted to the phytosanitary authority may be published before the end of the procedure only with the consent of the applicant for authorisation.

72) Article 29 of Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC. ';

footnote 24 is deleted.

55.

„§ 34

Authorisation decision

The plant health service may also provide for:

(a) requirements and restrictions in relation to the prevention of the emergence of resistance to the harmful organism;

(b) the requirements for the labelling of the product, including mandatory particulars in the product label,

(c) the data requirements for the group packaging containing the product in the sales package and the transport packaging containing the product in the group packaging or in the sales packaging;

(d) risk reduction measures;

(e) the requirements for the preparation set out in the technical specification;

(f) the requirements and time limits for the supply of further information concerning the preparation or its constituents;

(g) the requirement to monitor the adverse effects of the use of the product, including the determination of the extent of the monitoring;

(h) the obligation to obtain the original packaging or label of the information product in accordance with a new decision, if issued. ';

56. Paragraph 35, including the title and footnote 73, reads as follows:

„§ 35

Amendment and revocation of authorisation

(1) The plant health administration shall amend or withdraw authorisations, except for the reasons set out in European Union Regulation (67) concerning the placing of plant protection products on the market if:

(a) the existing authorisation should be brought into compliance with the relevant European Union Regulation (67) concerning the placing of plant protection products on the market, by legislation issued on the basis thereof; or

(b) a difference has been found in the composition of the product placed under control and the composition of the product resulting from the documentation set of product characteristics on the basis of which the authorisation was granted and this difference in the composition was demonstrated by the authorisation holder in two successive product controls.

(2) The plant health service will note in the file changes reported by the authorisation holder:

(a) a person entitled to act as a legal person;

(b) the change in the address of the registered office or place of residence of the holder of the authorisation;

(d) the change of the manufacturer or manufacturing plant of the preparation;

(e) a change in the manufacturer or manufacturing plant of the active substance, provided that such change has been assessed and approved within the European Union.

(3) In the procedure for the amendment of the authorisation, the plant health administration shall proceed mutatis mutandis in accordance with Sections 33 and 34. If the authorisation has been revoked on the grounds referred to in paragraph 1 (b), a new application for authorisation for that preparation may be submitted not earlier than 2 years after the decision to revoke the product.

(4) The appeal against a decision of the plant health authority referred to in paragraph 1 (a) and (b) shall not have suspensory effect.

(5) The person holding the authorisation is required to withdraw the product from the market without delay after the decision to revoke the authorisation has become final, unless a period of grace is provided for in the decision to revoke the authorisation by the plant health authority.

(6) The holder of the authorisation shall inform in a verifiable and appropriate manner the legal or natural persons taking the product from him, the reasons for the revocation or modification of the authorisation and the time limits laid down in the relevant decision.

73) Article 46 of Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC. '

57. Paragraph 36, including the title and footnote 74, reads as follows:

„§ 36

Assessment of the equivalence of the active substance

In the case of an assessment of the impact on human health, the 74).

74) Article 38 of Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC. '

58. After Paragraph 36, the following Section 36a is inserted:

„§ 36a

Active substances, safeners, synergists and co-formulants

(1) The plant health management shall carry out the tasks associated with the approval of the active substance, safener, synergist and co-formulants in accordance with the directly applicable European Union regulation on the placing on the market of plant protection products).

(2) The Ministry of Health shall, in accordance with § 33 (2) to (5) of the Act, provide an assessment of the protection of human health by means of a binding opinion. "

59. Paragraph 37, including the title and footnote 75, reads as follows:

„§ 37

Extension of authorisations to minor uses

(1) The plant health administration shall proceed mutatis mutandis in the procedure for extending the authorisation to minority uses75) under § 32 to 35.

(2) Criteria defining minor uses of the preparation shall be laid down in implementing legislation.

75) Article 51 of Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC. '

60. The following Section 37a is inserted after Section 37:

„§ 37a

Exceptional plant protection conditions

(1) In the event of exceptional plant protection conditions, plant health authorities are authorised to authorise the preparation without design. In this case, instead of the decision to authorise a product, the plant health authority shall issue a regulation in accordance with the second to fourth sentences of Paragraph 76 (2), which shall also lay down the conditions for the placing on the market and use of the product.

(2) The assessment of human health effects shall be carried out at the request of the plant health administration in the cases referred to in Section 38b (1) by the Ministry of Health.

(3) The Ministry of Health shall issue a binding opinion, mutatis mutandis, in cases of exceptional plant protection conditions pursuant to Article 33 (2) to (5); no remuneration is required for the preparation of the report in such cases. ';

61. Paragraph 38, including the title, reads:

„§ 38

Mutual recognition of authorisations

The amendment and withdrawal of mutual recognition of authorisations shall be treated mutatis mutandis in accordance with Article 35. ';

62. The following Sections 38a, 38b and 38c are inserted after Section 38, including footnotes 76 and 77:

„§ 38a

Transfer of authorisation

(1) The holder of a product authorisation may transfer the authorisation to another natural or legal person. For the transfer of authorisation, an application with appropriate documentation shall be submitted by the applicant to the phytosanitary authorities. The request for the transfer of an authorisation shall specify the date on which the transfer of the authorisation is to take place. The application for the transfer of authorisation shall be accompanied by the consent of the authorisation holder to the transfer, including the consent of the proposed date of the transfer of the authorisation, and by proof of the agreement of the owner of the documentation with access to the dossier and to the active substance or of the transfer of rights or consent of access to the dossier and the active substance to the new holder.

(2) The transfer authorisation shall also specify the date on which the transfer takes place and any time limit for the sale and consumption of the product's stocks as provided for in the previous authorisation, if any, if the sale and consumption of the product's stocks has been requested. The new authorisation holder shall enter fully into the rights and obligations of the previous authorisation holder. The period of time specified by the previous authorisation holder shall not affect their transfer.

§ 38b

Other measures

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Regulation Information

Citation	Act No. 245 / 2011 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	30.08.2011
Effective from	01.09.2011
Effective until	-
Status	Valid

Legal Areas: Finance Economic (State) Commercial law Fees Labour law Advertising, Marketing, Promotion Governance of the national economic sectors Administrative authorities Administrative law State (official) control Health Agriculture Business Eligibility for the pursuit of certain professions (activities)

The regulation text is for informational purposes only.