245/2011 Sb.
LAW
of 20 December. July 2011,
amending the Act No. 326/2004 Coll., on phytosanitary care and amendments
some related laws, as amended, and other
related laws
Change: 350/2011 Sb.
PART THE FIRST
Amendment of the Act on plant health care
Article. (I)
Act No. 326/2004 Coll., on phytosanitary care and amendments
related laws, as amended by Act No. 626/2004 Coll., Act No.
444/2005 Coll., Act No. 137/2006 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., shall be amended
as follows:
1. In article 1 (1). 1 introductory provisions read as follows:
"This law incorporates the relevant provisions of the European Union ^ 1), at the same time
builds on the directly applicable European Union regulation ^ 67) and regulates the rights of
and obligations of natural and legal persons relating to ".
Footnote # 67:
"67) European Parliament and Council Regulation (EC) No 1107/2009 of 21 October 2003.
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 phrase "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
"Council Directive 79/117/EEC of 21. December 1978 prohibiting the placing on the market and
the use of plant protection products containing certain active
substances. "shall be replaced by ' Council directive 2009/142/EC of 26 July 2000. November
2009 amending Directive 2000/29/EC, with regard to the mandate for the performance of
the tasks of laboratory testing. "
3. In article 2 (2). 1 (b). and paragraph 11, section) 2 (2). 1 (b). n) the introductory part of
the provisions of points 1 and 3, § 2, paragraph 1. 1 (b). r) points 1 and 2 and
the final part of the provision of section 2 (2). 2 (a). and), e), s) and w) to s) §
3 (2). 2, § 7 (2). 1 (b). and, § 7 (1)). 2, § 7 (2). 3 of the introductory part
the provisions of § 7 para. 5 (b). a), section 10(4). 3 of the introductory part of the provisions,
§ 11 (1) 2 and 3, article 15, paragraph 2. 1 (b). and), § 21, art. 1 (b). (d)), section 21
paragraph. 7 and 9, § 22 para. 2, § 22 para. 5 (b). (b)) and the final part
the provisions of § 22 para. 6, § 23 para. 1 (b). (b)), § 23 para. 2 (a). (b)),
Section 25a paragraph 1. 1, § 25b para. 3, § 26 para. 1 (b). (c)), e) and (f)), section 26
paragraph. 11 (a). (b)), section 27 para. 1 introductory provisions of section a (c). a) and
(b)), section 27 para. 3, § 29 para. 1 and 6, § 54 para. 9, § 63 para. 9, § 71
paragraph. 1 (b). g) to (i)), § 71 para. 3 (b). and), § 72 para. 2, § 72 para.
5 (b). (j)), § 72 para. 6, 12 and 14, section 74 para. 1 (b). k), section 75 para. 7,
§ 76 para. 6 (a). section 76a), para. 1 and 2, § 80 para. 1, § 80 para. 2
(a). (f)), § 80 para. 4 (b). (b)) and § 80 para. 6, the words ' of the European
the Community ' shall be replaced by the words "European Union".
4. In section 1 (1). 1 (b). (c)), the word "registration" shall be replaced by
"terms and conditions".
5. In article 2 (2). 2 (a). (b)), the word "only" is replaced by
"standalone".
6. In article 2 (2). 2 letter g) and (h)):
"(g)), the distributor of the person who places the product on the market,
h) professional user-a person who uses pesticides in the framework of the
their professional activities, both in the field of agriculture and in other
the sectors ".
7. In article 2 (2). 2 points, i) to p) including footnote # 4
shall be deleted.
Letters q) to y) are known as letters i) to q).
8. In article 2 (2). 2 the letter j) repealed.
Letters to) to q) shall become letters (j)) to (p)).
9. in section 2 (2). 2 (a). k) after the word "authority" the words "responsible
for the performance of the plant health care as prescribed by the
The European Union ^ 68).
Footnote # 68:
"68) article 1, paragraph 1. 1 Council Directive 2000/29/EC of 8 June 2004. May 2000 on
protective measures against the introduction into the community of organisms harmful to plants
or plant products and against their spread to the community on
territory of the community. ".
10. In section 2 (2). 2 (a). l) after the word "authority" the words "responsible
for the performance of the plant health care as prescribed by the
The European Union ^ 68) ".
11. In paragraph 2, the following paragraph 3, including footnote No. 69
added:
"(3) basic concepts referred to in paragraphs 1 and 2 are without prejudice to the terms
in the directly applicable regulations of the European Union ^ 69).
for example, article 69). 3 European Parliament and Council Regulation (EC) No.
1107/2009 of 21 October 2003. October concerning the placing of plant protection products on the
the market and repealing Council Directives 79/117/EEC and 91/414/EEC. '.
12. in section 3, paragraph 3. 1 (b). (b) the words ", where appropriate,) biocidal products
placed on the market under a special legal regulation ^ 4e) and permitted
plant protection management (§ 37 (3)) "shall be deleted.
13. in section 6a of paragraph 1. 2 the words "natural or" shall be deleted and the words "and
instructs "are the words" natural or legal persons ".
14. in section 6a, the following paragraph 6, including footnotes.
70:
"(6) the credentials of the national reference laboratories referred to in paragraph 2 shall
considered the performance of the tasks of laboratory testing in accordance with
Regulation of the European Union ^ 70). The result of the laboratory sample analysis
carried out by the national reference laboratory is equivalent to the result of the
analysis of a sample carried out by the laboratories of the Office responsible for the performance of
scope in the field of plant health care according to the regulation of the European
Union ^ 70) in another Member State of the European Union.
70) Council directive 2009/142/EC of 26 July 2000. November 2009 amending
Directive 2000/29/EC as regards the authorisation to carry out the tasks of the laboratory
testing. ".
15. in section 7 (2). 7 the first sentence, the words "and to" shall be replaced by "or", and
After the word "organisms", the words "referred to in section 10, paragraph 1. 1 or
harmful organisms whose introduction or the spread are
measures referred to in paragraph 4 or in accordance with § 11 para. 2 and 3 ".
16. in paragraph 11 (1) 3 the second sentence, the word "danger" is replaced by
"If there is".
17. § 12 para. 1 the final part of the provision, the words "(hereinafter referred to as
"the register") ' shall be deleted.
18. in section 12 paragraph 4 is added:
"(4) the phytosanitary administration registers the applicant within 3 months from the date of
receipt of the request referred to in paragraph 3, if it is satisfied that the applicant is
competent to discharge the obligations laid down in paragraph 1 and having regard to the
the scope of registration also special conditions under section 15(2). 1 or
obligations arising from the emergency phytosanitary measures
ordered according to § 76 para. 2. the registration of phytosanitary administration
shall issue the applicant a document in which the marked persons registered in the
the official register referred to in paragraph 1, its registration number, activity, for
which is this person into the official registry is registered, and the date
registration. ".
Footnote No 11 is deleted.
19. in § 12 para. 5, the words "initiate the procedure and" are deleted.
20. In article 12, paragraph 6 shall be deleted.
Paragraphs 7 to 9 shall be renumbered 6 to 8.
21. in § 12 para. 7, the words "and the content and conduct of the official registry
referred to in paragraph 5 "are deleted.
22. in section 12, the following paragraph 9, including footnotes.
71:
"(9) registration obligation is fulfilled and registration in another Member
State of the European Union ^ 71). This does not affect the obligation of registered
persons referred to in section 21 para. 6.
71) article 6 of Council Directive 2000/29/EC of 8 June 2004. May 2000 on
protective measures against the introduction into the community of organisms harmful to plants
or plant products and against their spread to the community on
territory of the community. ".
23. in § 13 para. 1 (b). d) point 2 is added:
"2. any changes to the data that are on the official register referred to in section
12 paragraph 1. 1, and without undue delay, but not later than one month from the
the date when the relevant changes occurred, ".
24. in § 14 para. 1 (b). a), the words ' pursuant to § 18 para. 1.0 "
the words "or if you do not meet the specific requirements laid down by the
an implementing regulation, ".
25. in § 14 para. 1 (b). (b)), after the words "into them and" shall be replaced
"subsequently".
26. in § 14 para. 4, the words "and to" shall be replaced by the word "or" at the end of
the text of the paragraph the words "referred to in section 10, paragraph 1. 1 or
harmful organisms whose introduction or the spread are
made pursuant to § 7 para. 4 or under section 11 (1) 2 and 3 ".
27. in article 14, the following paragraph 5 is added:
"(5) the phytosanitary Administration does not check the plants, plant products
and other items that are not listed in paragraph 1, even if they are
plant Passport attached. ".
28. in article 15, paragraph 2. 5, the words "and to" shall be replaced by the word "or" at the end of
the text of the paragraph the words "referred to in section 10, paragraph 1. 1 and 2 or
harmful organisms whose introduction or the spread are
made pursuant to § 7 para. 4 or under section 11 (1) 2 and 3 ".
29. in article 15, paragraph 2. 6 the third sentence, the words "§ 16 para. 2 "shall be replaced by
"§ 16 para. 1 (b). (b)) ".
30. In article 16(1). 3, after the words "§ 15 para. 2 "the words" and 3 "and on the
the end of text in a paragraph, the following words "and this section may be placed on the
the market ".
31. in section 21 para. 1 (b). (d)), after the words "copies" the words "or
outputs from the authorized conversion of documents ".
32. In section 21 para. 2 the first sentence, after the words "packing material"
the words "(hereinafter referred to as" wood packaging material ")".
33. In paragraph 21, at the end of paragraph 2 the following sentence "a copy of the
Protocol on the control of phytosanitary Administration also passes to the Customs Office
the point of entry or destination. ".
34. In paragraph 21 of the text at the end of paragraph 6, the words "or § 12 para.
9. "
35. In section 21 para. 8, § 22 para. 5 (b). (c)), section 27 para. 3 and § 80 para. 2
(a). (c)), the words ' European Communities ' shall be replaced by
"The European Union".
36. In § 25 para. 2 and 5, the number "3" by "4".
37. In article 25, paragraph 2, the following paragraph 3 is added:
"(3) a sign which shows that the wood packaging material,
which is used in the carriage of goods of any kind imported from third
countries into the United States, was properly treated against the occurrence of harmful
organisms, is carried out in points of entry referred to in paragraph 1
or in the places of destination of the imported goods. Control is carried out by the customs authority;
If the customs authority is unable to control this, he shall inform the plant protection
the Administration, which control executes. ".
Paragraphs 3 to 7 shall become paragraphs 4 to 8.
38. In article 25, paragraph 4 reads:
"(4) the phytosanitary Administration can control the identity and control
the health status of wholly or partially accomplished in the place of destination, on the
the basis of the observations of the Office of point of entry, the identity check and the
check the State of health cannot be in the position referred to in paragraph 2
performed in the scope of § 22 para. 1, so that was filled with target
checks pursuant to section 22 paragraph 1. 2, without prejudice to the provisions of paragraphs 5 and
6. ".
39. In paragraph 25, after paragraph 7, the following paragraph 8 is added:
"(8) the operator places the point of entry at their own expense in their
the premises of the containers for swapping the plants, plant products
and other items imported from third countries in the context of personal contact and
not satisfying the requirements provided for in § 21 para. 1. the operator
point of entry is responsible for the safe disposal of the contents of the containers under the
the supervision of the phytosanitary administration. ".
The present paragraph 8 shall become paragraph 9.
40. In § 25 para. 9 (a). (b)), and (c)) and in section 25a paragraph 1. 4, the first sentence is the number
"5" is replaced by "6".
41. In section 25a paragraph 1. 1 the first sentence, the words "in agreement with the" shall be replaced by
"stomer".
42. In section 25a paragraph 1. 2 of the introductory part of the provisions in section 25a paragraph 1 and. 2 (a). (b))
the number "7" is replaced by "9" and the number "5", "6".
43. In paragraph § 25b. 1, the number "3" by "4" and the number "5"
replaced by the number "6".
44. In paragraph § 25b. 2 the second sentence of the number "3" by "4".
45. In paragraph § 25b. 3, the number "5" shall be replaced by the number "6", the words "or
electronic transmission of data "shall be deleted and the comma after the words" the input
"shall be replaced by the word" and ".
46. In § 28 para. 1, the second and third sentences are replaced by the phrases
"Phytosanitary Administration will not issue a phytosanitary certificate, if
on the basis of investigation found that plants, plant
products and other items do not meet the requirements of the importing or
provážejícího State to guard against affecting harmful organisms,
or these requirements the importing or provážející State has provided. The request for
the issue serves the phytosanitary administration of the exporter or person
his delegate, at least 2 working days before the day of loading of the consignment.
The applicant shall provide the phytosanitary requirements of the importing, management
where appropriate, the provážejícího of the State for protection against harmful affecting
organisms, unless they have been published by the Administration, and propose to plant
Instead, in which the plant will allow the Administration to make the necessary
investigation. ".
47. In section 28 paragraph 3 reads:
"(3) If it is to be based on the requirements of the importing, or provážející
third country, treated wood to protect against the introduction of harmful
organisms, including its designation on the territory of the Czech Republic, must be
treated with technical equipment is eligible under sections 68 to 69. For
implementation of handling and labelling of exported timber and wooden packing
the material corresponds to the exporter. The method and place of treatment of wood and wood
packaging material, lays down implementing legislation. ".
48. In § 28 para. 4, after the word "original" is inserted after ", the output from the
authorized conversion of documents ".
49. In § 28 para. 8 (a). and the number ")" is replaced by "8".
50. the footnote No 22:
"22) Commission Regulation (EC) no 690/2008 of 4 February. July 2008 laying
recognising protected zones in the community in which it is the State of health
exposed to particular plant threats, as amended. ".
51. In section 29 para. 5, the words "or by electronic means"
shall be deleted.
52. section 31, including the title reads as follows:
the "section 31
Basic provisions
(1) the phytosanitary administration is authorized to establish a standstill
the time limit under the applicable legislation of the European Union, if it had been established.
(2) the holder of an authorisation shall without undue delay notify the
the phytosanitary administration changes in the facts referred to in the authorization.
(3) the permit holder is obliged to ensure that the active substance or
the active substance in the product and the product itself to maintain the composition,
the technical specifications and other requirements for the preparation of the corresponding
the data indicated in the submitted supporting documents, on the basis of
authorisation has been granted, and during the whole period of validity of the permit.
(4) the holder of an authorisation shall submit the phytosanitary administration before
the first product on the market on the basis of issued permits and when
any change to enable the text of the instructions for use of the product, or the next
resource including the appropriate risk reduction.
(5) the phytosanitary administration exposes the way allowing remote
to access the text of the instructions for use of the product, or other resource.
(6) the Repackaging of the product permitted to be placed on the market and use of the
the Czech Republic shall be notified to the phytosanitary administration
no later than 24 hours before through repackaging, with an indication of the place of repackaging and name
and the body which repackages products. When the repackaging of the product
must comply with the conditions laid down by the implementing regulation. ".
53. section 32, including the title reads as follows:
"§ 32
Application for authorisation
Of the applications for the issue of authorizations granted by directly applicable
Regulation of the European Union concerning the placing of plant protection products on the market,
or about changing the authorisation, shall be decided by the plant health
Administration. ".
54. section 33 including title and footnotes # 72:
"§ 33
The authorisation procedure for
(1) if it is to be in accordance with the instructions for use of the product mixed with the
another product or device, the applicant must prove consent
the holder of the authorisation or consent of the person on whose application was
another means of written into the official registry, for such use.
(2) an assessment of the product, including its use in terms of the protection of health
ensures that the Ministry of health on the basis of the assessment drawn up by the
The State Health Institute ^ 23a). Making reviews will pay
the applicant to the National Institute of health, a price that is determined by the
special legal regulation ^ 23b). Based on the assessment of the State
the Ministry of health shall issue the Health Institute's toxicological
the opinion of a product (hereinafter referred to as "the toxicological assessment") in the form of a binding
the opinion.
(3) the phytosanitary administration is in fulfilling the obligations arising
for the Czech Republic from the directly applicable European Union legislation ^ 67)
or this Act shall be entitled to require the Department of health
issue binding opinions.
(4) the Reviews of the product referred to in paragraph 3 makes the State Health Institute
without payment.
(5) an authorization procedure is interrupted even if the user has the
phytosanitary administration of the Ministry of health or the competent
authority of the Member State of the European Union or the competent authority of the European
Union information necessary to carry out the assessment of the product according to the requirements
directly applicable European Union legislation ^ 72) while this adjustment
are without prejudice to the provisions for the period of interruption resulting from direct
of the applicable legislation of the European Union relating to the placing of
plant protection products on the market ^ 67).
(6) the fact that an application for authorisation has been submitted
the phytosanitary administration, can be made public before the proceedings only with the
consent of the applicant for authorisation.
72) Article. 29 of the European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC. '.
Footnote 24 is repealed.
55. section 34 including the title reads as follows:
"§ 34
The decision to allow
Phytosanitary Administration decision on the authorisation may also provide
and) requirements and restrictions in relation to the prevention of the emergence of resistance
the harmful organism,
(b) requirements for marking of packaging) of the product, including the compulsory data
placed within the text of the label of the product,
(c)) the data requirements, which must be indicated by a group package containing
product in the sales packaging and transport packaging containing the product in
group packages or in sales packages,
d) measures to reduce the risks
(e) requirements for preparation set out) in the technical specifications,
f) requirements and the time limit for the delivery of other information relating to the product
or its components,
(g) the requirement for monitoring undesirable) consequences of the use of the product including
determination of the extent of this monitoring,
(h) the obligation to supply) the original packaging or the label of the product information in the
accordance with the new decision, it was granted. ".
56. section 35, including title and footnotes # 73:
"§ 35
Amendment and revocation of authorisations
(1) the phytosanitary Administration amend or revoke the permit, in addition to the reasons
laid down in the EU regulation ^ 67) concerning the placing of protection
plants on the market if
and authorisation) should be brought into line with the relevant regulation
The European Union ^ 67) concerning the placing of plant protection products on the market,
the legislation issued on the basis of, or
(b)) under the control of a difference in the composition of the
secured when you check the preparation and composition of the product resulting from the
dossier to the product which has been granted
authorization, and this difference in the composition of the holder of the permit was in two
subsequent inspections of the product shown.
(2) the phytosanitary Administration notes the changes reported to the file holder
authorisation of
and the person authorized to act on behalf of) a legal person,
(b)) change of address of the registered office or the address of the place of residence of the holder
the authorization,
(c) a change in the name or names) of the holder of the authorisation,
(d)), the manufacturer or the manufacturing plant changed the product,
(e) change in manufacturer or manufacturing) plant active substances, if this change was
evaluated and approved within the European Union.
(3) the procedure for amendment of the authorisation it shall proceed in accordance with § phytosanitary administration
33 and 34. If the authorization was revoked because of a referred to in paragraph
1 (b). (b)), a new application for a permit to that of lodge
at least 2 years from the effective date of the decision on revocation of authorisations
of the product.
(4) an appeal against a decision of the phytosanitary Administration referred to in paragraph 1
(a). a) and b) does not have suspensory effect.
(5) the person who was the holder of the authorization, shall be obliged to acquire legal
the decision on the revocation of the authorisation shall forthwith withdraw the product from the
market, if not in the decision to cancel the authorisation of plant protection management
fixed standstill period ^ 73).
(6) the holder of an authorisation shall be proved, and in an appropriate manner
inform the legal or natural person, the product
be taken, of the reasons for cancellation or amendment of the authorisation and of the time limits
laid down in the decision.
Article 73). 46 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC. '.
57. section 36 including title and footnote No 74 reads as follows:
"§ 36
Assessment of the equivalence of the active substance
In the case of evaluation of the impact on the health of people in the procedure for examining an
equivalence ^ 74) according to § 33 shall proceed mutatis mutandis.
Article 74). 38 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC. '.
58. under section 36 shall be inserted a new section 36a, which including the title reads as follows:
"§ 36a
Active substances, safeners, synergists and co-Formulants
(1) the phytosanitary administration shall carry out the tasks associated with the approval of the active
substance, safener, Synergist or co-formulant by directly
of the applicable legislation of the European Union relating to the placing of
plant protection products on the market ^ 67).
(2) an assessment of the health of the people in the form of a binding
the opinion provides the Ministry of health in accordance with § 33 para. 2 to 5
the Act similarly. ".
59. § 37 including heading and footnote # 75:
"§ 37
Extension to enable the minority to use
(1) the phytosanitary administration progresses in the proceedings to extend the authorisation of the
minority use ^ 75) under section 32 to 35 apply mutatis mutandis.
(2) the criteria defining minority use of laying down detailed
legal prescription.
Article 75). 51 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC. '.
60. under section 37 shall be added to § 37a, which reads as follows:
"§ 37a
The extraordinary conditions for plant protection
(1) the phytosanitary administration is in the case of emergency States in the protection of
plants may even without proposal does allow. In this case, issue a
phytosanitary administration instead of a decision on the authorisation of
Regulation of plant health management in a manner pursuant to § 76 para. 2 the second sentence of
until the fourth, in which lays down the conditions for the placing on the market and use of
of the product.
(2) an assessment of the effects on human health, done at the request of the plant health
authorities in the cases referred to in section 38b para. 1 the Ministry of
the health sector.
(3) the Ministry of health shall issue, without delay, a binding opinion in
cases of exceptional conditions in plant protection in accordance with § 33 para. 2 to 5
by analogy; for expert reimbursement in such cases
not required. ".
61. section 38, including the title reads as follows:
"§ 38
Mutual recognition of authorisations
When you change and cancellation of the mutual recognition of authorisation shall be applied, mutatis mutandis,
According to § 35. ".
62. in paragraph 38, the following new section 38a, 38b and 38 c, including notes
footnote No. 76 and 77 shall be added:
"§ 38a
Transfer of permit
(1) the holder of a permit to the product may transfer authorization
a natural or legal person. The transfer authorization must be submitted to the
the applicant, a plant health management application with appropriate documentation. In
the request for conversion shall be proposed to the date on which it is to be
the transfer of authorisation takes place. The annex to the request for conversion shall be
the consent of the holder of the authorization of the transfer, including the agreement to the proposed date of
transfer of authorization and proof of the consent of the owner of the documentation with the approach
documentation of the product and the active substance or evidence of the transfer of rights
or consent to access documentation on the product and active substance in
the new holder.
(2) a transfer shall be entered in the permit also the date on which the transfer
take place, and any time limit for doprodeji and stocks of
According to the previous authorization, if there was a clearance sale and stocks
the product requested. The new holder of the authorisation shall enter fully the rights and
the obligations of the previous holder. The time limits provided for by the previous
the holder of the permit is not converting them.
section 38b
Other measures
(1) in the event that it is necessary to protect plants from harmful organism
and
and) for a given use is allowed 5 or less in the form of active substances
separate products
(b) the products are not allowed in) due to the occurrence of resistance in a sufficiently
effective,
(c)) allowed preparations cannot be used with regard to the specific requirements of the
the protection of human health or the environment, or
(d)) the use of integrated plant protection requires or is
the product can be used in organic farming,
enables the phytosanitary Administration on grounds of public interest, extension
to enable the minority to use the release of plant health management regulation.
Plant health management regulation issued phytosanitary administration
According to § 76 para. 2 the second sentence to the fourth.
(2) for the purpose of the authorisation of a plant protection product to be placed on the market and
the use of the grounds of public interest referred to in paragraph 1 shall issue
phytosanitary administration after completion of the peer review form
mutual recognition or mutual recognition of the extended authorization for the
the use of plant health management regulation, a minority in the manner pursuant to § 76
paragraph. 2 the second sentence to the fourth, in which lays down the conditions for the marketing of
on the market and use of the product.
(3) in accordance with paragraph 1 or 2 shall not affect the emergency
situations by directly applicable European Union legislation governing
the placing of plant protection products on the market ^ 76).
section 38 c
Adjuvants
In the authorisation procedure for the placing on the market and use of adjuvant ^ 77), proceed
under section 32 to 35 apply mutatis mutandis.
76) chapter IX European Parliament and Council Regulation (EC) No.
1107/2009.
Article 77). 2 (2). 3 (b). d) European Parliament and Council Regulation (EC)
No 1107/2009 of 21 October 2003. October 2009 concerning the placing of protection
plants on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. '.
63. In section 39 paragraph 1 reads:
"(1) the phytosanitary administration no later than within 1 month from the end of each
calendar quarter, whether or not in writing, inform the other Member States
The European Union and the Commission of issued permits and repealing authorization. ".
64. In article 39, paragraph 2 shall be deleted.
Paragraphs 3 and 4 shall become paragraphs 2 and 3.
65. In § 39 para. 2 the words "pursuant to § 34 to 38, § 53 or 54.
Phytosanitary administration each year also refer the list referred to in the first sentence,
the other Member States of the European Union and the Commission "shall be deleted.
66. In § 39 para. 3 the words "to the extent referred to in paragraph 2 (a).
a) to (h)) "shall be deleted.
67. section 40 to 42, including the footnotes # 28, 28a, 28b and 28 c,
shall be deleted.
68. In section 43 paragraph 1 reads:
' (1) medicinal products and other means of Control shall mean control
compliance with the conditions, requirements and obligations established directly
the applicable law of the European Union ^ 67), this law, its
the implementing legislation, and permits the phytosanitary administration
natural and legal persons, and concerning the products as products
their placing on the market in the Czech Republic, storage, storage under
distribution and use. ".
69. In § 43 para. 2, the words "decisions or" shall be deleted.
70. in § 43 para. 3 the words "hand, or ' shall be deleted.
71. In § 43 para. 7 (b). a) and b), the words "decisions or the holder of the
authorization under section 53 or 54 "shall be replaced by the word" permit ".
72. In § 43 para. 8, the words "of the marketing authorisation or permit
under section 53 or 54 "shall be replaced by the word" permit ".
73. In § 43 para. 9, the words "of the marketing authorisation or the holder of the
authorization under section 53 or 54 "shall be replaced by the word" permit ".
74. In section 43 paragraph 10 is added:
"(10) if the phytosanitary administration, that the sample taken in accordance with
paragraph 7 complies with the law and implementing regulations, it shall transmit to the holder
to enable the rest of the controlled product and at the same time issue a certificate
the composition of the product for its further placing on the market and use. For
the quantity of the product, which was used for laboratory analysis,
provide phytosanitary administration relative to pay the holder of the authorisation
According to the price paid in accordance with paragraph 9 and which does not exceed the price of the
the usual, if the permit holder requests the replacement within 2 months from the
the date on which he was notified of the result of a laboratory examination. A waste of
expiry of this period, the entitlement to the refund shall be lost. Compensation for plant health
the Administration will provide no later than 30 days from the date on which the holder of the authorization for it
asked. Compensation shall not be granted if the price is less than the sample taken
$ 300. ".
75. In § 43 para. 11, the words "of the marketing authorisation or the holder of the
authorization under section 53 or 54 "shall be replaced by the word" permit ".
76. section 44, including the footnotes # 30, 31 and 33 shall be deleted.
77. paragraph 45, including the title reads as follows:
"§ 45
The decision on eligibility to conduct experiments and tests with the products or
other resources
(1) the decision on eligibility to conduct experiments and testing issues
phytosanitary Administration on request of a natural or legal
a person who is qualified to carry out experiments and tests in accordance with the
requirements of good pokusnické practice. If the administrative authority finds that the applicant
is not eligible under the first sentence, it shall reject the application.
(2) the decision lays down in particular the phytosanitary administration
and testing area)
(b) the period of validity of the decision).
(3) the phytosanitary administration issues a decision in compliance with the requirements referred to in
paragraph 1 within a period of 60 days, in particularly complex cases within 90 days.
(4) the decision shall be issued for a period of 5 years and may be renewed.
(5) the request for extension of the validity of the decision is served at least 90 days
before the date of expiry of the decision.
(6) the phytosanitary administration shall not extend the validity of the decision and the application
be refused if
and the holder of the decision violates the requirements) of good practice or pokusnické
the facts set out in the decision, or
(b) the applicant has not demonstrated at the time) deciding on the extension of the
the decision of the fulfillment of any of the requirements of good pokusnické practice.
(7) the phytosanitary administration is entitled to in relation to the persons referred to in
paragraph 1
and) to carry out controls in terms of the requirements of good practice, pokusnické
(b) establish and approve the methodology) testing of the products,
(c)) to require such information and documentation on the fulfilment of the requirements of good
pokusnické practice
d) require information about the preparation and testing of the products, as well as
submission to test the products and places where experiments
are in progress.
(8) the phytosanitary Administration decision suspends the validity of the decision in
case of infringement of the requirements referred to in paragraph 6. The decision on the
the suspension of the decision is the first act in the proceedings and appeals
against a decision does not have suspensory effect.
(9) if the side of the holder to remedy the identified
deficiencies on the basis was suspended,
phytosanitary administration cancels the decision on suspension of the
decision. Information about the suspension of a decision and its cancellation
exposes the phytosanitary administration manner allowing remote
access.
(10) when deciding on the suspension of a decision shall take into account
phytosanitary administration of the seriousness of violations of the requirements of good
pokusnické practice, to the duration of this condition, the effects of this condition
caused by, as well as to the fact that there is a remedy for this condition.
(11) the holder is obliged to no later than 3 days prior to the first application
of the product, by planting seed sowing seed or treated with
notify the phytosanitary administration
and the name or code of the product),
(b)) name or code of the active substances,
c) crop,
d) purpose of use,
(e)) the maximum dose.
(12) an application for the issue or renewal decision decision on
competence to carry out experiments and tests will be made in writing and includes
and) identification data
1. the applicant and the person authorized to act for the applicant (name, where applicable,
name, last name, title, and address of the place of residence, telephone or
electronic connection),
2. where the tests are carried out,
(b) a proposal for the definition of the field) of the testing referred to in paragraph 2,
(c) a declaration by the applicant) who intends to carry out an official test that
1. agrees with the audit to assess eligibility for the implementation
tests of the products and shall provide for that purpose in accordance with the requirements of the
the phytosanitary administration of the necessary cooperation,
2. immediately notify the plant is committed to managing the changes
conditions on the basis of a decision.
(13) the implementing legislation provides for requirements documentation
establish eligibility to conduct experiments and trials and area
testing. ".
78. In paragraph 46 of the introductory part of the provisions, the word "entrepreneurs" is replaced by
the words "professional users" and after the word "preparations" shall be inserted after
the words "or other means".
79. In the title of § 46, § 46 (a). and) and (b)) and in the title of section 46a,
"products", the words "or other means".
80. in paragraph 46 (a). and (2)) the word "registration" shall be replaced by
"enable".
81. In paragraph 46 (a). and section 5), the words "§ 42" shall be replaced by the words "directly
the applicable law of the European Union ^ 67) ".
82. In article 46a, paragraph 1 shall be deleted.
Paragraphs 2 to 5 shall be renumbered 1 to 4.
83. In paragraph 46a of paragraph 1. 3 at the end of the text of subparagraph (a)), with the words "
exception of those or other resources that have been subjected to
laboratory analysis pursuant to § 43 para. 7 and they are exposed to
phytosanitary certificate of the composition of the management pursuant to § 43
paragraph. 10. "
84. section 47 reads as follows:
"§ 47
Preparations which have passed the expiry date, may be placed on the market for
1 year, if it is established on the basis of the analysis of the corresponding sample
that their chemical and physical properties match the properties of the
under which the permit was granted. Laboratory analyses of the product
for this purpose, shall ensure that the owner of the product in accredited laboratories and
extended the period of application shall be obliged to indicate on the packaging
product. ".
85. In § 49 paragraph 1. 1 the words "decision on the registration" and the words
"the use of (§ 37 para. 1) "is replaced by" authorization "and the words" (section 44) "and
"(§ 45)" shall be deleted.
86. In § 49 paragraph 1. 1 at the end of the text of subparagraph (a)) the following words "or
set number of applications ".
87. In article 49, paragraph 3 shall be deleted.
Paragraph 4 becomes paragraph 3.
88. In paragraph 49, the following paragraphs 4 and 5 are added:
"(4) the phytosanitary administration exposes the way allowing remote
access data on consumption of active substances that are in products
contained, summarized in annex III of regulation of the European Parliament
and Council Regulation (EC) No 1185/2009 concerning statistics on pesticides.
(5) disclosure or provision of information about consumptions for the active substances and
preparations in relation to the territorial unit shall not be considered a violation of
business secrets. ".
89. In § 50 para. 1 the words "decision on the registration" shall be replaced by
the word "permit".
90. in paragraph 51, paragraphs 1 to 3, including footnote # 78:
"(1) a natural or legal person who, in the business uses
products in the outdoor environment shall not apply the preparations which are
According to the authorisation marked as
and) dangerous or particularly dangerous to bees, if prior to application
in accordance with paragraph 2; This provision shall also apply to
application of other drugs and substances whose use is for bees
dangerous,
(b)) preparations for rodent control (rodenticides) on the property which is
part of the hunting ground, if these have not been notified to the authorised application
the user class ^ 40), the Czech environmental inspection ^ 78) and
the phytosanitary administration, not later than 3 days before the start of the application
of the product; the use of seed namořeného with dangerous or especially
dangerous for the terrestrial vertebrates shall be notified 3 days before sowing
a lawful user of a hunting license ^ 40), the Czech environmental inspection
Environment ^ 78) and plant health management.
(2) prior to application of the products referred to in paragraph 1 shall be
and the locally applicable) municipal authorities information to location
habitats of hives in range of at least 5 km from the border of the land on which it has
the application is made, and at least 48 hours prior to making the application
notify the affected farmers of bees and the locally competent municipal authorities
application of the product,
(b)) to discuss measures to protect the game with authorized user
^ 40) hunting license.
(3) the Keeper of the bees is obliged to notify in accordance with the implementation of the legal
prescription locally competent municipal office of information for the location of permanent and
Transitional habitats of hives.
78) Act No. 283/1991 Coll., on the Czech environmental inspection and its
the scope of the forest protection, as amended. ".
91. In paragraph 51, paragraphs 4 and 5 shall be deleted.
Paragraphs 6 to 10 shall be renumbered as paragraphs 4 to 8.
92. In § 51 para. 5 is the number "6" is replaced by "4".
93. In § 51 paragraph 6 is added:
"(6) a local authority shall, on request, the information referred to in paragraph 2
(a). and paragraph 3) is campaigning to crops and livestock farmers bees. ".
94. In § 51 para. 7, after the words "other products", the words ",
auxiliary means "and the words", which performed on insects, "shall be deleted.
95. In § 51 para. 8 (a). (c)), the number "8" is replaced by "2 and 3".
96. section 52, including the title.
97. section 53 including the title reads as follows:
"section 53
Parallel trade
(1) If, in a permit for the reference product to the amendment of the authorisation of the
terms and conditions of its placing on the market or use, the plant health
the Administration will carry out the procedure for changing a parallel trade permit.
(2) the holder of the authorisation of the reference product is not
a participant in the authorisation procedure for parallel trade.
(3) in proceedings for the authorization of the parallel trade is advancing plant health
management referred to in paragraph 3 to 35 accordingly. ".
98. In § 54 para. 3, "writes another means of" shall be replaced by
"Decides to write another resource", after the words "the registry"
the words "within six months" and the words "58" is replaced by "referred to in
section 58 ".
99. In paragraph 54, paragraph 5 shall be deleted.
100. In paragraph 54, the following new paragraph 4, paragraphs 5 to 7, which
shall be added:
"(5) in the event that the instructions for use of an additional resource to be listed
the ability to blend with another medicine or other means, it can
phytosanitary Administration require the applicant to furnish proof of the holder's consent
product authorisation with regard to the product, or, in the case of other
resource, the consent of the person on whose application was another means of written
in the official registry, with which the product should be mixed, such
the use of the.
(6) If an additional resource that contains genetically modified
organisms can be written into the official registry in compliance with the requirements
provided for in this law and the law governing the handling of genetically
modified organisms and genetic products ^ 32).
(7) another means of phytosanitary administration shall not be registered in the official
If the registry contains macro-organisms presenting a risk
for the health of humans, animals or the environment. ".
Paragraphs 6 to 15 shall be renumbered as paragraphs 8 to 17.
101. In § 54 para. 15 the number "12" is replaced by "14".
102. In § 54 para. 17, the words "§ 33 para. 2 "shall be replaced by ' paragraph 31 to
35. "
103. In paragraph 54, the following paragraph 6 is added:
(18) the provisions on the transfer of authorisation under section 38a, the provision
information on adverse reactions to medicinal products and the exchange of information pursuant to §
39, and the use of products under section 49 applies to other resources
accordingly. ".
104. In § 58 para. 3, the word "register" is replaced by "authorization".
105. In paragraph 59 (a). (b)), the words "not foreign" are replaced by the words "are
the original ".
106. section 60, including the title reads as follows:
"section 60
Record keeping and information about the marketing of products or other resources
on the market
(1) the business people, who place on the market products or other resources
or entrepreneurs who products or other resources in the territory of the United
the Republic are held for the purpose of export to third countries, are
required to
and plant health) to notify the Administration always within 3 days of the relocation on the territory
The United States their newly stored products or other
funds that moved from another Member State of the European Union
or imported from third countries, including the names and lot numbers, and
(b) the phytosanitary Administration) on demand to provide information on packaging and
deliver samples of packaging products or other means.
(2) entrepreneurs, who within the territory of the United Kingdom other resources
manufactures, are required to provide on request the phytosanitary administration
the phytosanitary administration of the quantities sold to other resources
including names and lot numbers.
(3) the Entrepreneurs who sell products or other resources, are
required in the proof of their sale to indicate whether or not the batch number and date
the end of the period of application of the product, or other resource. This
the provisions shall not apply to seller at retail stores.
(4) the information referred to in paragraphs 1 to 3 shall not affect the right
applicable provisions of the regulations of the European Union ^ 67) governing
information or record keeping bodies governed by private law. ".
107. In § 63 para. 2, the last sentence shall be deleted.
108. In paragraph 68, paragraph 2 reads as follows:
"(2) a legal or natural person who intends to use the technical
the device for a purpose referred to in paragraph 1 (hereinafter referred to as "operator
technical equipment "), is required to apply plant protection management about
recognition of the competence of this device and the entry in the register
operators. ".
109. In paragraph 68, the following paragraphs 3 and 4 are added:
"(3) if it satisfies the technical equipment of the applicant's technical and technological
requirements laid down by the implementing regulation, shall issue a plant health
management decision on the recognition of the competence of this device and its
inclusion in the register of operators of technical equipment, including
the allocation of marks for the marking of timber and wooden packing material
treated in a technical plant approved for this operator
technical equipment.
(4) the operator of technical equipment registered under
paragraph 2
and) may to control harmful organisms use only operated
recognised technical equipment,
(b)) is obliged to operate the technical equipment for the purpose of exterminating
harmful organisms adhere to the implementing regulation provided for
technical and technological requirements and follow the technological
procedure, approved plant protection management, whose formalities
sets out detailed legislation, and
(c) the phytosanitary Administration) reports without undue delay of any
changes to the recognised technical equipment, which can lead to non-compliance with
technical and technological requirements referred to in point (b)), and
closure of the recognised technical equipment. ".
110. section 69:
"§ 69
(1) legal or natural person, who intends to produce from
wood packaging material treated wood or treated wood packaging
material label (hereinafter referred to as "the manufacturer of treated wood packaging
material "), is required to apply plant protection management for inclusion in the
Register of producers.
(2) the phytosanitary administration shall issue a decision on the applicant's signed for the
Register of producers of treated wood packaging material, including
the allocation of marks for labelling wooden packing material, if
technology meets the labelling requirements for wood packaging
material.
(3) the treated wood packaging material Manufacturer registered in the
the register referred to in paragraph 2
and to produce), may wood packaging material, which intends to mark the
mark allocated pursuant to paragraph 2, use only wood treated in
accordance with the technical and technological requirements, referred to in section 68
paragraph. 4 (b). (b)),
(b)) is obliged to comply with the labelling requirements of technology
wood packaging material and follow the technological
procedure agreed by the phytosanitary administration, and
(c) the phytosanitary Administration) reports without undue delay of any
changes in the marking of wood packaging material, that may
lead to non-compliance with the technological requirements referred to in point (b)), and
their marking of wood packaging material.
(4) the technological requirements for the marking of wood packaging
material and requisites of the technological procedure lays down detailed
legislation. ".
111. in paragraph 69, the following new section 69a is inserted:
"§ 69a
(1) legal or natural person who is not registered in the register of
operators of technical equipment under section 68 and the register of manufacturers
treated wood packaging material pursuant to § 69, may refer to
or procure a proof of completion of the treatment of wood or wood packaging
material.
(2) the operator of technical equipment and the manufacturer of treated wood
the packaging material, which is the holder of the plant health
Administration pursuant to § 68 para. 3 and § 69 para. 2 only use the tag
allocated him to plant management, and only
and wood or marking) wood packaging material treated in the
a technical plant approved in accordance with § 68 para. 3 and in compliance with the
technical and technological procedure provided for in § 68 para. 4 (b). (b))
and or in § 69 para. 3 (b). (b)), and
(b)) the manner prescribed by an implementing regulation.
(3) the phytosanitary Administration keeps a register of operators of the technical
device pursuant to section 68 and a register of manufacturers of treated wood packaging
material under section 69.
(4) the phytosanitary administration cancels the decision on recognition
technical equipment, the entry in the register of operators of the technical
device pursuant to section 68 or the register of producers of treated wood
material in accordance with § 69 and on the allocation of marks for marking wood
packaging material treated in a technical plant approved
the operator and labelling wooden packing material or its
by the manufacturer, if it finds that the holder of the decision is not likely to
labelling of treated wood packaging material according to the international
standard that does not meet the technical and technological requirements
referred to in § 68 para. 4 (b). (b)) or the technological requirements set out
in § 69 para. 3 (b). (b)).
(5) Implementing law provides
and the brand and model) the details referred to in § 68 para. 3 and § 69 para. 2 and
the method of marking referred to in paragraph 2,
(b)) the technical and technological requirements for technical equipment under section 68
paragraph. 3 and § 68 para. 4 (b). (b)) and particulars of the routing
(c) the technological requirements for marking) wood packaging material
and routing requirements pursuant to § 69 para. 3 (b). b).“.
112. In part one, title VI is inserted at the beginning of part 1, including
the title, which reads as follows:
"Part 1
Plant health care institutions ".
113. in the § 70 para. 1, the word "and" is replaced by a comma and at the end of the text
paragraph the words "and the Administration".
114. In § 71 para. 1 (b). (g)), after the words "United States"
the words "in international organizations and".
115. In paragraph 71, the dot at the end of paragraph 1 is replaced by a comma and the following
the letter j) is added:
"j) exposes the way allowing remote access list, use the
considered to be minority. ".
116. In § 72 para. 4 (b). (c)), the words "under section 32 to 45, § 50, 51, 53,
54, 57 and 58 ' shall be deleted.
117. In § 72 para. 4 (d)):
"(d)), the operation of machinery, technical equipment to
Pest organisms and labelling wooden packing
material ".
118. In § 72 para. 5 (b). and) the words "including the invasive alien harmful
organisms ' shall be deleted.
119. In § 72 para. 5 (c)):
"(c)) on the applications of natural and legal persons about their
Ministry credentials to perform professional plant health
activities pursuant to § 71 para. 1 (b). (b)), and (c)) and performs specialized audit
authorised persons according to the instructions of the Ministry ".
120. In § 72 para. 5 letter m) is added:
"m) monitors and validates the impact of products on the treated crop, plant
products and the effects on harmful organisms ".
121. In § 72 para. 6, the word "issues" is replaced by "exposes the
manner allowing remote access, "and after the words" additional resources "
the words "in accordance with the directly applicable European law
Union governing the placing of plant protection products on the market ^ 67). ".
122. In section 74 para. 1 (b). f), the words "[§ 3 (1). 1 (b). (b)), section 31, 43,
46, 47, 49] ' shall be deleted.
123. In section 74 para. 1 letter h) is added:
"h) the conditions referred to in the decision on registration of the mechanized resource
into the official registry (section 63), provisions concerning the use and control
testing machinery [§ 3, paragraph 1 (b)), section 66 and 67] and
the conditions for the operation of technical installations for pest
organisms and labelling wooden packing material, ".
124. In section 74 para. 9, the word "of" is deleted.
125. In part one, title VI, section 74 following designation of part 2, which
including the title reads as follows:
"Part 2
The measures ".
126. In section 75 para. 3 (b). and) and in section 75 para. 6, after the word "animals"
inserted the word "plant".
127. In § 76 para. 1 letter f) is added:
"f) restriction or suspension or prohibition of the manufacture of manufacturers in the Czech
Republic, restriction or suspension or prohibition of the placing on the market and
the use of, or the next resource or determining the Special
conditions for the production, placing on the market or use of or repackaging ".
128. In paragraph 76, the dot at the end of paragraph 1 is replaced by a comma and the following
the letter i), which read as follows:
"i) prohibition of the operation of technical equipment for pest
organisms or the ban on wood packaging material marking. ".
129. In § 76 para. 2 of the introductory part of the provisions, the word "State" be deleted.
130. In § 76 para. 2 at the end of paragraph (e) is replaced by a comma and dot)
the following paragraph 4 is added:
"4. the technical equipment to control harmful organisms and labelling
wood packaging material do not comply with the conditions laid down in § 68
and 69. ".
131. In § 76 para. 3, the first sentence shall be deleted.
132. In paragraph 76, paragraph 8 is added:
"(8) to the person concerned an exceptional plant health measures referred to in
paragraph 1 (b). b), c), (d)) shall be granted compensation at the written request
costs and losses incurred as a result of the implementation of these measures.
Compensation shall be granted from the State budget on the basis of
the decision of the phytosanitary administration and under the
and one-time destruction) the plants, plant products and other objects
infected or suspected of harmful organisms or their
one-time treatments laid down procedures and resources,
(b) the rehabilitation of the land) one time, cleaning and disinfection of the warehouses, operational
spaces, machinery, transport vehicles, equipment, tools or other
articles. ".
133. In paragraph 76, paragraph 10 is added:
"(10) a person to be granted a refund under paragraph 8, must
refund request within 1 year since the inception of costs and losses for which it is to be
refund is granted, otherwise the claim shall cease to exist. Refunds shall be granted in the amount of
reasonably incurred costs and losses and the amount due is the person
to be granted a refund, shall demonstrate. ".
134. In § 76 para. 11, the words "material damage and how to determine and
the proof of its amount "shall be replaced by" costs and losses ".
135. section 78, including title and footnote No 55 is deleted.
136. In § 79 paragraph 2. 1 (b). (d)), the words "paragraph. 2 ' shall be deleted.
137. In § 79 paragraph 2. 1 (b). f), the words "and the investigation for the export of plants,
plant products and other objects referred to in § 28 para. 1 and 7 ' shall be deleted.
138. In § 79 paragraph 2. 1 the letter g) is added:
"(g)), the authorisations".
139. In § 79 paragraph 2. 1 (b). I), the words "import concurrent products"
replaced by the words "parallel trade".
140. In § 79 paragraph 2. 1 (b). (j)), the word "other" is replaced by
"assistive technology".
141. In § 79 paragraph 2. 1 (b). l), after the words "in accordance with" the words "§ 68 and
eligibility for the marking of wood packaging material in accordance with ".
142. In § 79 paragraph 2. 1 for the letter m) the following point (n)), which read as follows:
"n) delegation of the scope of the national reference laboratories and
reference laboratories for laboratory activities, pursuant to section 6a of paragraph 1. 2, ".
143. In paragraph 79, the dot at the end of paragraph 4 is replaced by a comma and the following
the letter d), which read as follows:
"(d)) of the person, if the application for mutual recognition of a public
interest. ".
144. In the first for title VI the following new title VII, including
Title:
"TITLE VII
ADMINISTRATIVE OFFENCES
Part 1
Misdemeanors
Section 79a
(1) a natural person has committed the offence by
and more) uses a resource that is not written into the official registry, in
contrary to § 54 para. 1, or
(b)) the next resource in violation of § 54 para. 14.
(2) for the offence referred to in paragraph 1 can be used to impose a fine of up to $ 2,000.
§ 2
(1) a natural person has committed the offence by
and) as the person who cultivates, produces, processes or placed on the market
plants, plant products or other objects, or as the owner of
of the land or of the object or person that is taken from a different legal
reason, breach of an obligation under section 3 (1). 1 (b). and)
(b)) as a person who cultivates, produces, processes or placed on the market
plants, plant products or other objects, or as the owner of
of the land or of the object or person that is taken from a different legal
reason, breach of an obligation under section 3 (1). 1 (b). (b)),
c) fails to comply with the obligation under section 9,
(d) notify the phytosanitary Administration) the repackaging of the product permitted to be
placing on the market or its use pursuant to § 31 para. 6,
e) as an importer pursuant to § 24 para. 2 or any other person designated by the importer
1. notifies the expected date of importation in accordance with § 24 para. 2 (a).
and)
2. in violation of § 24 para. 2 (a). (b)) does not notify data relating to
the relevant consignment or lot or details about the documents, or
3. does not update the data according to § 24 para. 2 (a). (c)),
(f)) as a carrier consignment or lot which is subject to import
plant health inspection according to § 21 para. 1 to 4, will not allow the implementation of
control to the extent and in the manner pursuant to § 24 para. 3,
g) neuskladní according to § 26 para. 1 (b). (b)) at the place of consignment or lot and
under the terms of the phytosanitary administration of the pending will be
final results of the officially established laboratory or other tests,
h) moves through a protected zone, with the ultimate goal of outside plant
plant products or other objects without a plant passport in
contrary to § 30 para. 1,
I) as the person who is the owner of the land or the object in the territory in which
is ordered by an emergency phytosanitary measure, or as a person who
such property taken from another legal reason, fails to provide the information
pursuant to section 76 para. 5,
j) takes or repositions the quarantine material according to § 8 paragraph. 1 without
permission according to § 8 para. 2 or 3, or
k) does not apply when the import or export of plants, plant products or
other subjects of the phytosanitary certificate or plant health
certificate for re-export in accordance with § 23 para. 1 or § 28 para. 1.
(2) for the offence referred to in paragraph 1 may be to impose a fine up to CZK 30,000.
§ 79c
(1) a natural person has committed the offence by
and) uses a product which is not allowed in the Czech Republic by directly
of the applicable legislation of the European Union relating to the placing of
the market,
b) contrary to section 35 para. 5 places on the market or uses the product after
cancellation of an authorisation with the exception of those for which a standstill has been enabled
the time limit,
(c)), the product is used in accordance with the conditions
1. implementation of experiments or tests with the products by directly applicable
Regulation of the European Union relating to the placing on the market,
2. use products according to § 49 paragraph 1. 1, 2, 3, or 4, or
3. imports of the product in accordance with European Union legislation directly applicable
relating to the placing on the market,
(d)) as a nurse crop, apply the products in violation of § 51 para. 1
and (2),
e) moves and preparations used in the framework of the parallel trade in conflict with
directly applicable EU regulation governing the placing of the product
on the market, or
f) distributes the product in violation of § 46 para. 3.
(2) for the offence referred to in paragraph 1 can be used to impose a fine of up to $ 40,000.
section 79 d
(1) a natural person has committed the offence by
and lead, extend,) bring or move contrary to section 7 (2). 1, 2, 3
or (5) or contrary to section 8 (2). 2 harmful organism, plant,
plant product or other object
(b)), extending the lead, takes or moves in violation with the authorization pursuant to §
8 (2). 2 harmful organism, plant, plant product or other
subject matter,
(c) fails to comply with the measures set out to plant) Administration pursuant to section 26
paragraph. 1 (b). and), (b)) or e) for a consignment, which does not respond after
the import requirements laid down by law to plant-health checks, or
fails to comply with the phytosanitary measures extraordinary pursuant to § 76 para. 1, or
d) it illegally, without a decision on the allocation of the mark for labelling
treated wood packaging material pursuant to § 69 para. 2.
(2) for the offence referred to in paragraph 1 can be used to impose a fine of up to $ 50,000.
Part 2
Administrative offences of legal entities and natural persons-entrepreneurs
§ .79e
(1) a legal person commits an administrative offense, by
and) contrary to section 54 para. 1 places on the market or uses other means,
that is not written into the official registry, although this is subject to enrollment,
b) contrary to section 47 launches yet another vehicle after the expiry of the
usability,
(c)) use the next resource conflict with
1. the experimental use of other funds pursuant to § 54 para. 14,
2. the labelling of other funds pursuant to § 55,
3. the compulsory inspection testing machinery, pursuant to § 66,
4. the notification and the book of obligations under section 60, or
5. the terms of distribution under section 46a para. 3,
(d)) as a manufacturer of treated wood packaging material produced wood
the packaging material in accordance with the conditions under § 69 para. 3, or
e) it wrongly tag for labelling of treated wood
the packaging material in accordance with § 69 para. 2.
(2) for the administrative offence referred to in paragraph 1 shall be fined in the amount of 200 000
CZK.
section 79e
(1) a legal person commits an administrative offense, by
and) as the person who cultivates, produces, processes or placed on the market
plants, plant products or other objects, or as the owner of
of the land or of the object or person that is taken from a different legal
reason, breach of an obligation under section 3 (1). 1 (b). and)
(b)) as a person who cultivates, produces, processes or placed on the market
plants, plant products or other objects, or as the owner of
of the land or of the object or person that is taken from a different legal
because, contrary to section 3 (2). 1 (b). (b) shall apply to the treatment plant),
plant products or other objects concerned against harmful organisms
medicine, mechanization additional resource or resource that is not
allowed for use under this Act or by directly applicable
Regulation of the European Union relating to the placing on the market, or when
treatments will damage the surrounding vegetation, human or animal health or the
environment,
(c)) as the operator violates any of the duties during storage
plant products in accordance with § 4 para. 1 or fails to comply with a discovery method
or the regulation of the presence of harmful organisms in stored plant
products fixed by legislation issued on the basis of §
4 (4). 2,
d) fails to comply with the obligation under section 9,
(e) fails to comply with the obligation of registration) according to § 12 para. 1,
(f)) does not connect the plant passport for plants, plant products
or other objects under section 20 (2). 1,
g) replaces a plant passport or a passport for a protected
zone or a replacement plant passport in violation of § 19 para. 1,
h) as a person according to § 12 para. 1 violates any of the requirements of section
in article 13(3). 1 or fails to comply with the measures imposed by the phytosanitary administration
According to § 13 para. 2,
I) where plants, plant products or other objects in front of the
placing on the market means the systematic plant-health checks in accordance with § 15 para. 1
(a). (b)),
j) fails to comply with the measures referred to in section 11 (1) 2 or 3 or measures under section 15
paragraph. 6,
shall issue a plant passport) contrary to section 17 para. 2 as a person
an unauthorized,
l) purchases or otherwise acquires the plants, plant products and
other items in violation of § 20 para. 2,
m) as the person who is in the business activities of ^ 12) deals with the
the cultivation of plants, or as the ultimate user, who purchases or
Another way gets the plants, plant products and other objects,
1. contrary to section 20 (2). 2 (a). and does not retain the related plant passports)
or about them does not register
2. the development of the phytosanitary administration of the purchase or other acquisition
the relevant plants, plant products and other objects
originating from third countries, pursuant to section 20 (2). 2 (a). (b)),
3. employees of the plant health management will not allow entry to land and
objects under section 20 (2). 2 (a). (c)),
4. does not allow employees to access the plant administration grown,
stored or processed plants, plant products or
other objects under section 20 (2). 2 (a). (c)), or
5. employees of the plant health management free subscription
plants, plant products or other objects, and the collection of their
sampling and checking of the relevant documents referred to in section 20 (2). 2 (a). (c)),
n) will not allow the shipment as a carrier or a batch import
phytosanitary inspection according to § 24 para. 3,
o) neuskladní in the consignment or lot and under the conditions laid down
phytosanitary administration until the final results are known
officially provided for laboratory or other tests according to section 26 para. 1
(a). (b)),
p) as the carrier does not guarantee shipment shipments exported under section 28
paragraph. 9,
q) travels through a protected zone, plants, plant products or
other objects with the ultimate aim of outside without a plant passport in
contrary to § 30 para. 1,
r) does not provide information pursuant to § 76 para. 5,
s) takes or repositions the quarantine material according to § 8 paragraph. 1 without
permission according to § 8 para. 2 or 3, or
t) does not apply when the import or export of plants, plant products or
other subjects of the phytosanitary certificate or plant health
certificate for re-export in accordance with § 23 para. 1 or § 28 para. 1.
(2) for the administrative offence referred to in paragraph 1 shall be fined up to 500 000 CZK.
§ 79 grams
(1) a legal person commits an administrative offense, by
and) uses a product which is not allowed in the Czech Republic by directly
of the applicable legislation of the European Union relating to the placing of
the market,
(b)) to market the product after the expiry of its application in conflict
with section 47,
(c)) in violation of § 36 odst. 5 places on the market or uses the product after
cancellation of an authorisation with the exception of those for which a standstill has been enabled
the time limit,
(d)) as the holder of the permit or the distributor of the product, or
another resource's not hitting or does not mark the product or other resource
According to the applicable European Union legislation directly governing the marketing of
products on the market,
(e)) does not perform experiments or tests with the products by directly applicable
Regulation of the European Union relating to the marketing of products on the market,
f) storing products in violation of § 46,
g) uses the products in violation of § 49 paragraph 1. 1, 2, 3 or 4,
h) as a person who, in commercial activities treated with medicines,
to secure the exercise of those activities by a competent natural person
or graduate vocational course pursuant to § 86 para. 1,
I) as a nurse crop, apply the products in violation of § 51 para.
1,
j) placing on the market or uses of the active substance in contravention of a directly applicable
the EU regulation governing the placing on the market,
to the contrary, the product moves) with the directly applicable European law
Union governing the placing on the market,
l) as the holder of the authorization allowed the product moves in violation of § 53
paragraph. 1 or m) to notify that the phytosanitary administration of the repackaging of the product
no later than 24 hours before through repackaging in violation of § 31 para. 6.
(2) for the administrative offence referred to in paragraph 1 shall be fined up to 1 0000 0000 CZK.
§ 19.
(1) a legal person commits an administrative offense, by
and lead, extend,) bring or move contrary to section 7 (2). 1, 2, 3
or (5) or contrary to section 8 (2). 2 harmful organism, plant,
plant product or other object
(b) fails to comply with the measures set out to plant) Administration pursuant to section 26
paragraph. 1 (b). a), d) or (f)),
(c) fails to comply with the phytosanitary measures) emergency pursuant to § 76 para. 1,
(d)) as the operator of point of entry does not place on their premises
the container specified for the postponing of the plants, plant products and other
articles referred to in § 25 para. 8, or
e) contrary to section 25 para. 8 as the operator of point of entry
destroyed the contents of the container without the supervision of plant health management.
(2) for the administrative offence referred to in paragraph 1 shall be fined up to $ 1 500 0000.
Part 3
section 79i
Provisions common to administrative offences
(1) a legal person for an administrative offence is not liable if he proves that
made every effort, that it was possible to require that the infringement of the
a legal obligation is prevented.
(2) in determining the amount of the fine on a legal person shall take account of the seriousness of the
the administrative offense, in particular, the way a criminal offence and its consequences, and
the circumstances under which it was committed.
(3) the liability of a legal person for an administrative offense shall cease, if the
administrative authority about him has not initiated proceedings within 1 year from the date on which it
learned, but not later than within 3 years from the date on which it was committed.
(4) administrative offences under this law in the first instance hearing
phytosanitary administration or municipal office municipality with extended competence
According to § 73 para. 3.
(5) The liability for the acts, which took place in the business
person or in direct connection with him, subject to the provisions of the law on
liability and sanctions legal persons.
(6) a fine to be imposed on the phytosanitary Administration selects a phytosanitary
Administration.
(7) the supervisory authority may waive the imposition of a fine in the event of a
to remedy the infringement in accordance with the measures imposed pursuant to §
75, or immediately after, when it was found a breach of duty, and
found the infringement to prevent damage to health
natural persons, animals or the environment. ".
Heading of title VII to IX are referred to as title VIII to X.
145. In § 81 para. 1 at the end of the text of subparagraph (b)) the following words
"the technical equipment to control harmful organisms".
146. In § 81 para. 1 at the end of the text of subparagraph (c)), the words "and with her
related sampling ".
147. In § 82 para. 1 (b). and) the words "paragraph 2 (hereinafter referred to as
"rostlinolékaři") shall be replaced by ' paragraphs 2 or 3, or ".
148. In § 82 para. 1 (b)):
"(b)) have a different professional qualifications if they perform only professional
plant health activities referred to in § 81 para. 1 (b). (b)), or (c)). ".
149. In section 82 para. 2 of the introductory part of the provisions, the word "Rostlinolékaři"
shall be replaced by "a person with a higher level of vocational education (hereinafter referred to as
"rostlinolékaři") ".
150. In section 82 para. 2 (a). and) and in section 82 para. 3 (b). and after the words)
"curricula" is inserted after the word "plant" and the words
"focusing on the plant or the plant protection product ' shall be deleted.
151. In § 82 para. 2 (a). (b)), after the words "lifelong learning"
inserted the word "plant" and the words "aimed at the plant
or plant protection products ' shall be deleted.
152. In § 82 para. 3 (b). (b)), the words "of plants, gardening,
chmelarstvi, forestry or viticulture "are deleted.
153. In § 82 para. 3 the letter b) the following point (c)), which read as follows:
"(c)) are graduates of accredited bachelor, master or
doctoral programs in the field of agriculture with a focus on
farming, gardening, hop-growing and vineyard or area
forestry, or have secondary education with a GCSE or above
vocational training culminating in a final examination in the field of education
plant protection, horticulture, forestry or viticulture and practice
at least 2 years in the field of plant health, plant protection, or ".
154. In section 82, paragraph 6 shall be deleted.
155. section 83, including the title.
156. In § 85 para. 1 at the end of the text of subparagraph (a)) the following words "or section
paragraph 82. 5. "
157. § 87 including the title reads as follows:
"§ 87
The content and keeping of registries and the official plant health management registers
(1) in the official register pursuant to § 12 para. 1 leads the phytosanitary administration
These data
and) date of birth, the name or names and surnames of the registered
the person, in the case of a natural person, or the business name, the name,
where appropriate, the name, in the case of a natural person, or business name,
where applicable, the trading name of the registered person, in the case of a legal person,
and the identification number, if assigned,
(b)) the address designated to deliver and the address of the registered person
in the case of a legal person,
(c)) the registration number assigned to the person registered plant protection
the Administration,
(d)) whether and what risk plants registered person intends to
imported or placed on the market and whether she has been granted permission to issue
plant passports pursuant to § 17 of the Act,
e) information about the termination, interruption, renewal or change of activity, for
you are registered persons registered.
(2) in the official register of machinery according to section 63
phytosanitary administration leads
and) date of birth, the name or names and surnames of the registered
the person, in the case of a natural person, or the business name, the name,
where appropriate, the name, in the case of a natural person, or business name,
where applicable, the trade name of the applicant, in the case of a legal person, and
the identification number, if assigned,
(b) where appropriate, the manufacturer) information about a resource within the scope of the mechanized importers
business name or name and surname, residence or place
residence,
(c)), the type and the type designation of the mechanized device, including
enumeration of possible production variant,
(d) the data on the area of use) of the mechanized device,
(e) the effective date of registration) of the mechanized device,
(f) the registration number).
(3) in the register of operators pursuant to § 68 para. 2 leads in the plant health
These data management
and) date of birth, the name or names and surnames of the registered
the person, in the case of a natural person, or the business name, the name,
where appropriate, the name, in the case of a natural person, or business name,
where applicable, the trade name of the operator, in the case of a legal person, and
Furthermore, the identification number, if assigned,
(b) the place of business or address) of the seat,
(c)) the address designated to deliver, contact phone or e-mail
the address,
(d) identification of the assigned marks for) the labelling of wood,
e) registration number person in the register,
f) date of the registration shall,
(g)) end date of activity.
(4) in the register of producers in accordance with § 69 para. 3 leads the phytosanitary administration
These data
and) date of birth, name, or first and last names, in the case of physical
the person, or the business name, the name or names, in the case of
entrepreneurial natural person, or the name or business name
the manufacturer, in the case of a legal person, and the identification number, if
allocated,
(b) the place of business or address) of the seat,
(c)) the address designated to deliver, contact phone or e-mail
the address,
(d) identification of the assigned marks for) the labelling of wood,
e) registration number person in the register,
f) date of the registration shall,
(g)) end date of activity.
(5) the official registers and the registers are public information systems
the Administration, which by the phytosanitary administration, that is
exposes the way allowing remote access. ".
158. In § 88 para. 1 (b). (b)), after the words "§ 2 (2). 1 (b). (e)) "
the words "§ 4 paragraph 2. 1 (b). (c)), ", the words" § 12 para. 2 and 8 "
replaced by the words "§ 12 para. 2 and 7 ", the words" § 25 para. 7 "shall be replaced by
the words "§ 25 para. 9 ", the words" § 28 para. 1, 2, and 4 "shall be replaced by the words" §
28 para. 1, 2, 5 and 8 "and after the words" § 30 paragraph 2. 1 "with the words" § 69
paragraph. 4. "
159. In § 88 para. 1 (b). (c)), the words "§ 68 para. 2.0 "shall be replaced by
"§ 69 para. 5. "
160. In § 88 para. 1 (b). (d)), the words "§ 51 para. 6 and 10 "shall be replaced by
the words "§ 51 para. 3, 4, and 8 ".
161. In paragraph 88, paragraph 3 reads:
"(3) the Ministry shall issue, in cooperation with the Ministry of health and
The Ministry of the environment Decree on preparations and other
resources for the implementation of § 31 para. 6, § 37 para. 2, § 45 para. 13, §
paragraph 46A. 1 and 4, § 49 para. 2, § 54 para. 3 and 4 and § 55. ".
162. In § 88 para. 4, the words "§ 82 para. 6, § 83 para. 2 ' shall be deleted.
Article. (II)
Transitional provisions
1. the Mandate for the performance of the activities of reference laboratories issued according to law
No. 326/2004 Coll., in the version in force until the date of entry into force of this
law, shall expire on the expiry of 30 June. June 2012.
2. A certificate of competence to carry out experiments and tests issued pursuant to
Act No. 326/2004 Coll., in the version in force until the date of entry into force of this
law, shall expire on the expiry of 5 years from the date of entry into force of
of this Act.
3. the administrative proceedings that has not been completed before the date of the acquisition of
the effectiveness of this law shall be completed in accordance with the existing laws,
regulations.
PART TWO
cancelled
Article. (III)
cancelled
PART THREE
Amendment of the Act on regulation of advertising
Article. (IV)
Act No. 40/1995 Coll., on regulation of advertising and amending and supplementing Act No.
468/1991 Coll., on radio and television broadcasting, in
as amended, as amended by Act No. 258/2000 Coll., Act No.
231/2001 Coll., Act No. 257/2001 Coll., Act No. 138/2002 Coll., Act No.
320/2002 Coll., Act No. 132/2003 Coll., Act No. 326/2004 Coll., Act No.
480/2004 Coll., Act No. 384/2005 Coll., Act No 444/2005 Coll., Act No.
25/2006 Coll., Act No. 109/2007 Coll., Act No. 160/2007 Coll., Act No.
36/2008 Coll., Act No. 297/2008 Coll., Act No. 281/2009 Coll., Act No.
129/2010 Coll. and Act No. 28/2010 Coll., shall be amended as follows:
1. In article 1 (1). 1, § 3 para. 4 (b). (e)), section 5 d of paragraph 1. 1 and section 7 c of paragraph 1. 1
the second sentence, the words ' European Community ' shall be replaced by the words "of the European
the Union ".
2. § 5 g including the title and the note after footnote # 26a:
"§ 5 g
Plant protection products
Advertising on plant protection products is governed by a directly applicable
the EU regulation ^ 26a).
26A) European Parliament and Council Regulation (EC) No 1107/2009 of 21 October 2003.
October 2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC. '.
PART FOUR
Amendment of the Act on administrative fees
Article. In
In the annex to the Act No 634/2004 Coll., on administrative fees, item 81
up to 86 including the footnotes no 49b-49n are added:
"Item 81
Receipt of the request
and) mutual recognition of authorisations ^ 49) or the authorization of the
^ 49b) the plant protection product if it contains:
-the only active substance or active substances included by directly
the applicable prescription
Of the European communities ^ 49n) EUR 5 000
-the active substance or active substances not included under direct
the applicable prescription
Of the European communities ^ 49n) EUR 6 000
(b)) more resource on plant protection products into the official
^ registry 49 c) $ 1,000
A mandate
Administrative Office will reduce the fee by 90%, if it is a preparation based on live
organisms, food raw materials, commodity substances, plant
extracts of pheromones or repellents or authorisation of the
plant protection products in the public interest.
Item 82
Receipt of the request for renewal of the decision on the
and) permit the plant protection product ^ 49d) $ 500
(b) write the next resource on) a plant protection product into the official
^ registry 49 c) $ 200
Item 83
Receipt of the request
and) extend the authorisation of the plant protection product for
minority use ^ 49e)-$ 300
(b)) change in the authorisation of plant protection products in
the next resource, unless
the acts referred to under (a)) ^ 49f) or transfer authorization ^ 49l)
CZK 100
Item 84
Acceptance of the application for revocation of the authorisation of the protection
^ 49f) plant-$ 100
Item 85
Receipt of the request
and) permission to use the unauthorized product protection
plants for research purposes
or d ^ 49 g) $ 1,000
(b)) to enable the extraordinary placing on the market and use of unauthorised
plant protection product ^ 49h) EUR 1 500
Item 86
Receipt of the request
and a parallel trade permit) ^ 49i)
-for business use $ 1 000
-for own account-$ 300
(b)) issue of a certificate of competence to carry out tests for
the authorization ^ 49j) $ 100
(c)) perform the examination of professional competence for the management of
plant protection products ^ 49k) $ 200
49B) § 32 Act No. 326/2004 Coll.
49 c) § 54 of Act No 326/2004 Coll.
49d) Article. 43 regulation of the European Parliament and of the Council (EC) of 21 September 2005. October
2009 No 1107/2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC.
49e) Article. 51 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC.
49f) section 35 of Act No. 326/2004 Coll.
49 g) Article. 54 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC.
49h) Article. 53 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC.
49i) section 53 of Act No 326/2004 Coll.
49j) section 45 of Act No. 326/2004 Coll.
49k) § 86 of Act No 326/2004 Coll.
49l) § 38a of Act No 326/2004 Coll.
49) Article. 40 of the European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC.
49n) European Parliament and Council Regulation (EC) No 1107/2009 of 21 October 2003.
October 2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC. '.
PART FIVE
The EFFECTIVENESS of the
Article. (VI)
This Act shall take effect on the first day of the calendar month
following the date of its publication.
Němcová in r.
Klaus r.
Nečas in r.