371/2016 Sb.
LAW
of 19 December 2003. October 2016,
amending Act No. 78/2004 Coll., on the management of genetically
modified organisms and genetic products, as amended
regulations, and Act No. 252/1997 Coll., on agriculture, as amended
the laws of the
Parliament has passed the following Act of the United States:
PART THE FIRST
Amendment of the Act on the use of genetically modified organisms and
genetic products
Article. (I)
Act No. 78/2004 Coll., on the use of genetically modified organisms
and genetic products, as amended by Act No. 346/2005 Coll., Act No.
124/2008 Coll., Act No. 227/2009 Coll., Act No. 281/2009 Coll., Act No.
18/2012 Coll., Act No. 279/2013 Coll. and Act No. 243/2016 Coll., is amended
as follows:
1. in article 1 paragraph 1 including the footnotes 1 and 21:
"(1) this Act incorporates the relevant provisions of the European Union ^ 1)
at the same time follows the directly applicable European Union regulations ^ 21) and
regulates the rights and obligations of the parties and the scope of the administrative authorities in the
use of genetically modified organisms and genetic products.
1) European Parliament and Council Directive 2001/18/EC of 12 July 2005. March
2001 on the deliberate release of genetically modified organisms into the
environment and repealing Council Directive 90/220/EEC.
European Parliament and Council directive 2009/41/EC of 6 May 1999. May 2009
on the contained use of genetically modified micro-organisms.
Directive of the European Parliament and of the Council (EU) 2015/412 of 11 June 2002. March
2015, amending Directive 2001/18/EC as regards the possibility for Member
States limit or prohibit the cultivation of genetically modified organisms
(GMOs) within its territory.
21) European Parliament and Council Regulation (EC) No 1829/2003 of 22 July 2003.
September 2003 on genetically modified food and feed.
European Parliament and Council Regulation (EC) no 1830/2003 of 22 July 2003. September
2003 concerning the traceability and labelling of genetically modified organisms
and the traceability of food and feed products produced from genetically
modified organisms and amending Directive 2001/18/EC.
European Parliament and Council Regulation (EC) no 1946/2003 of 15 July.
July 2003 on transboundary movements of genetically modified
organisms. ".
2. in article 1, paragraph 4, including the footnotes 2 and 22 reads:
"(4) If a genetically modified organism or gene product
medicinal product subject to registration according to the directly applicable
the European Union's regulation governing procedures for the authorisation and
veterinary medicinal products and supervision of ^ 2) or with the
the plant protection product for which marketing authorisation is issued directly by the
of the applicable legislation of the European Union relating to the placing of
plant protection products on the market), 22 ^ ^ it section 11 and the provisions of the
part four of this Act.
2) European Parliament and Council Regulation (EC) No 726/2004 of 31 March 2004.
March 2004 laying down Community procedures for the authorisation
medicinal products for human and veterinary supervision and which
a European Medicines Agency.
22) 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. '.
3. In paragraph 2 (a). (f)), section 3 (2). 1 (b). a) to (c)), the title of § 5, § 5 para. 7
and 10, § 6 (1). 2, § 7 (2). 3 (b). a) and (c)), § 8 para. 1, 4 and 5, § 9
paragraph. 2 (a). (d)), section 11 (1) 3 and 4, the heading to § 12, § 12 para. 1 introductory
part of the provisions, section 12 paragraph 1. 1 (b). b), c) and § 12 para. 2, section 13 (a).
a) and (d)), § 17 para. 2, § 28 para. 1 (b). (g)) and in section 37 paragraph 2. 2, the words
"circulation" shall be replaced by "on the market".
4. In article 3, paragraph 3. 1 (b). and a) and b), the number "2" is replaced by "1".
5. in paragraph 4 of the text at the end of paragraph 2, the words "up to 16 c".
6. In section 4, paragraph 4, including footnote # 23:
"(4) permission to marketing arises on the date of acquisition of legal power
the decision to write a genetically modified organism, or
gene product in the list for the placing on the market or by issuing
written consent to the placing on the market by the competent authority of another
the Member State of the European Union (hereinafter referred to as "Member State") or permit
According to the applicable European Union legislation directly governing the genetically
genetically modified food and feed, ^ 23). For detailed terms and conditions of this
the permissions of the § 23 to 24 c.
23) European Parliament and Council Regulation (EC) No 1829/2003. ".
7. in section 5, paragraphs 1 and 2 shall be added:
"(1) an application for the granting of permits for contained use, enabling for
putting into the environment, or for entry in the list for the placing on the
the market served by the applicant pursuant to this Act to the Ministry of
and, through a data box)
(b) in electronic form) signed by a recognized electronic signature,
or
(c)) in paper form, if it is at the same time gives the technical data medium
or shall be sent in electronic form via a public data network.
(2) the applicant may, in a request to refer to the data, information or results,
which are the contents of previously filed applications. The data, information, or
the results contained in the requests filed by other applicants refer only
If these data, information or results are not subject to
protection under section 9 or, if the applicant, on whose application is
references, written consent. ".
8. in § 5 para. 4, the words "every single copy of the application in paper
the form and also by electronic means "shall be replaced by the word" request "and the words" and
at the same time in a manner pursuant to section 10 (b). (b) shall publish a summary of the content of the application) and
information about the initiation of the proceeding, information on the initiation of the proceedings shall be published also
According to section 10 (b). and) and (c)) "shall be deleted.
9. in § 5 para. 4, the first sentence shall be inserted after the phrase "information about the begin
the procedure for granting an authorisation for putting into the environment, or
the procedure for entry on the list for the placing on the market, the Ministry shall publish
manner in accordance with § 10. A summary of the content of the application for the authorisation for the entry into
of the environment or of the request for entry on the list for the placing on the market
the Ministry will publish in the manner referred to in section 10 (b). b).".
10. in § 5 para. 7, the words "in the case of an application for the grant of authorisation for
putting into the environment, or for entry in the list for entry into
circulation ' shall be deleted.
11. in section 5, paragraph 12 reads as follows:
(12) in the same position as the Ministry concerned according to paragraphs 4,
5, 9 and 11, section 16 c para. 4 and § 18 para. 7 regional office in whose administrative
District is to immediately experience the contained use or the putting into
the environment. ".
12. In paragraph 7 (2). 3 (b). (b)), § 9 para. 1, section 20 (2). 2 (a). (b)) and section 22
paragraph. 4 and 6, the words "2 or 3" shall be replaced by the words "paragraph 3 or section 16a. 5. "
13. in section 7 (2). 3 the letter b) the following point (c)), which read as follows:
"(c)) a person authorized under this Act for contained use first
category of risk in cases under section 16a, paragraph 2. 4. "
Subparagraph (c)) and (d)) shall become points (d) and (e)).)
14. in section 7 (2). 3, letter e) repealed.
15. in article 7, paragraph 5 shall be deleted.
Paragraphs 6 and 7 are renumbered as paragraphs 5 and 6.
16. in § 8 para. 4, the words "of the European Communities (hereinafter referred to as" Member
States ") ' shall be deleted.
17. in § 8 para. 5, the words "given the approval or authorisation" shall be replaced by
"received written consent".
18. in § 8 para. 6 (a). (c)), the word "granted" is replaced by
"written", the words "or permits" shall be deleted and the words "of the authorisation
or "shall be replaced by the word" written ".
19. in § 9 para. 2 (a). (b)) and § 18 para. 6 (a). and), the word "headquarters"
replaced by the words "legal address" and the words "place of business" shall be replaced by
the words "legal address".
20. in § 9 para. 2 (a). (b)), section 18 para. 6 (a). and), section 22 para. 5 (b).
and) and § 25 para. 7 (b). (c)), and (d)), after the words "identification number"
is inserted after the word "persons".
21. in § 9 para. 2 (a). (b)), section 18 para. 6 (a). and), section 22 para. 5 (b).
and) and § 25 para. 7 (b). (c)), and (d)), the words ", where appropriate, the name, the last name"
shall be deleted.
22. in paragraph 10 (b)):
"(b)) on their website,".
23. in article 11 paragraphs 1 and 2 shall be added:
"(1) a person providing genetically modified organism exclusively for
the purpose of the contained use or putting into the environment,
required to ensure that on the label or accompanying document of genetically
the GMO was clearly marked with the words "genetically
modified organism "and that the labelling of genetically modified
the organism meets any additional requirements for marking
resulting from the authorisation for the contained use or the authorisation for the placing
into the environment.
(2) a person who in the course of its business shows a genetically
modified organism or gene product on the market shall be obliged to
ensure that on the label or accompanying document of genetically
the modified organism or gene product was the words
"This product contains genetically modified organisms". Mark
a genetically modified organism or a gene product must also
contain
and the trade name of the genetic product),
(b)) the name of a genetically modified organism,
(c) the name and address of the registered office) of the person established in the territory of one of the Member
States, which is responsible for placing on the market,
(d)), an indication of where it is possible to obtain additional publicly available information about the
the genetic product. ".
24. In article 11, paragraph 2, the following paragraph 3 is added:
"(3) the designation of a genetically modified organism or genetic
product placed on the market must also comply with any additional requirements
on its designation arising from the registration list for the placing on the market
or written consent issued for the placing on the market by the competent authority
another Member State or a permit issued under the directly applicable
Regulation of the European Union relating to genetically modified food and
feed ^ 23). ".
Paragraphs 3 and 4 shall become paragraphs 4 and 5.
25. In section 11 (1) 4 and § 28 para. 1 (b). (h)), the words "of the European
the Community ' shall be replaced by the words "European Union".
26. in section 11 (1) 4, the words "paragraph. 2 "shall be replaced by" paragraph. 1 "and the words
"paragraphs 1 and 2" shall be replaced by the words "paragraphs 2 and 3".
27. in paragraph 13 (b). e), the words "or the authorisation for putting into circulation
the competent authority of another Member State "shall be replaced by the words" to be placed on
the market by the competent authority of another Member State or for which it was
an authorization issued in accordance with regulation directly applicable in the European Union
regulating genetically modified food and feed, ^ 23). "
28. in section 13 is at the end of paragraph (e)) dot replaced with a comma and the following
subparagraph (f)), which read as follows:
"(f) if the person entitled) for contained use will not introduce new
notification in cases under section 16b, para. 2. ".
29. in article 15, paragraph 2. 3, the words "in accordance with § 16" shall be replaced by "pursuant to section 16 to
16 c ".
30. section 4 reads as follows:
"section 16 of the
(1) Permission for contained use may give rise to legal
a person or a natural person authorised to do business.
(2) Permission for contained use, which was based on the outcome of the
the risk assessment under section 7 included in the first or second category
the risk arises. Permissions for contained use which has been
on the basis of the outcome of the risk assessment pursuant to § 7 enrolled in the third or
the fourth risk category, the date of authorisation for the acquisition of legal power
contained use.
(3) the notification or application for a permit for contained use must be
the Ministry submitted before the first time the contained use in a closed
space pursuant to § 15 para. 2. the notification or application for a permit for
the contained use can be administered together for more enclosed spaces,
If they are located in one building.
(4) notice of the contained use of first or second categories of risk and
application for the grant of authorisations for the contained use of third or fourth
categories of risk shall, in addition to the General requirements under the administrative code
always include the
and identification, contact) and other information about the professional advisers and
contact person at the workplace,
(b)) information about genetically modified organisms,
(c)) the purpose of the contained use, the
d) address and description of the site where the contained use
take place,
(e) assessment of the space and equipment) of the workplace, which will be closed
loading take place, in terms of the fulfillment of the requirements for the enclosure, and
the safeguard measures laid down for the category of risk and
(f) the observations of the expert advisor).
(5) an application for the grant of authorizations for the contained use of third or fourth
risk category must also include
and) description of contained use and
b) information about the duration of the contained use.
(6) the implementing legislation lays down the specimen notification or application
detailed table of contents
and the contained use) notification of the first category of risks,
(b)) a notice of the contained use of other risk categories,
(c) the grant of an authorization request) for contained use third or fourth
risk category. ".
31. in article 16, the following new section 16a to 16 c shall be inserted:
"§ 16a
(1) the notice on the contained use of first or second categories of risk
serves the notifier to the Ministry
and, through a data box)
(b) in electronic form) signed by a recognized electronic signature,
or
(c)) in paper form, if it is at the same time gives the technical data medium
or shall be sent in electronic form via a public data network.
(2) the notifier may refer to data in the notification, information or
the results that are the content of the previously submitted notifications. The data,
information or the results contained in the notifications submitted in other
the notifier, you can point only if the following particulars, information or
the results are not subject to protection under section 9, or if the
the notifier at the notice refers, written consent.
(3) the first category contained use of risk can be initiated immediately
after submission of the notification. The other risk categories of contained use may be
initiated after the 45 days of the date of notification, unless within that period
the Ministry will not issue any of the decisions referred to in article 16b, para. 1.
the consent of the Ministry can be contained use other risk categories
start even before the expiry of that period; on the issue of the consent of the Ministry of the
the second and third section of the administrative code shall not apply.
(4) if the confined space has subsequently notified under
paragraph 1 to dispose of genetically modified organisms, in this
the notifications have not been given, and as a result of the risk assessment contained
the management of these organisms under section 7 is its inclusion in the first
risk category, the notifier shall submit only the competent Ministry
risk assessment with reference to the prior notification made in accordance with paragraph
1. closed treatment of these organisms can be initiated immediately after the
presentation of the risk assessment. Risk evaluation for contained use
the first category of risks must in addition to the reference to the prior notification
contain information about the newly used genetically modified
organisms and the observations of the expert advisor. Model of risk evaluation for
the case of the first category contained use of risk provides for
the implementing legislation.
(5) if the confined space has subsequently notified under
paragraph 1 to dispose of genetically modified organisms, in this
the notifications have not been given, and as a result of the risk assessment contained
the management of these organisms under section 7 is its inclusion in the second
risk category, it is obliged to submit to the Ministry of the new notifier
the notification.
(6) the Ministry shall send the acknowledgement to the notifier receipt of the notification referred to in
paragraph 1 or 5 or of the adoption of the risk assessment referred to in paragraph 4 to the
5 working days from the date of submission of the notification. The Ministry is authorised to
requested from the notifier, within 30 days of the date of notification,
or from the presentation of the risk assessment referred to in paragraph 4, for more information
or refine the information referred to in the notice or in the assessment of the risk.
section 16b
(1) the Ministry may, on the basis of a submitted notification, risk assessment,
further information or clarification of the information under § 16a para. 6 or new
information according to § 8 save the notifier to modify the conditions of
contained uses referred to in the notice, ranked the contained use
the other risk categories, or contained use suspend or
ended, if it is necessary for the protection of health or the
environment. The appeal against the decision by which the notifier has been saved
make an adjustment to the conditions of the contained use referred to in the notice,
to include the contained use in a different category of risk, or closed
suspend or terminate, does not have suspensory effect.
(2) the person authorized for contained use must file a new notification,
If
and) modify the enclosed space or the contained use in a way that would
could have significant consequences for the risks associated with that use, or
(b)) gets new information which could have significant implications for
the risks associated with this treatment.
(3) establishing permissions for contained use under section 16(1). 3 or §
16A para. 4 the Ministry of the notifier on request confirmation.
section 16 c
(1) the contained use of a third or fourth risk category can be
operate only to the extent and under the conditions laid down in the authorisation for the
contained use.
(2) in proceedings for the grant of authorisation for contained use, proceed
According to § 5.
(3) the authorisation for contained use contains
and the name or) the name or business name, home address, the address of the registered office
and the identification number of the person, if allocated, the claimant, if the
a natural person authorized to conduct business, or the name or business name,
the address of the registered office and identification number of the person, if any,
authorized, if the person is a legal,
(b) the genetically modified organism) specification,
c) specification of the genetic modification,
(d)) conditions of the contained use, taking into account the requirements for protection
health and the environment,
(e)), for which a risk category has been granted,
(f)) the purpose of the contained use
(g)) any additional marking requirements under section 11 (1) 1,
(h) the period of validity of the permit).
(4) the validity of permits for contained use must be limited in time.
The Ministry may, on request of the authorized, no later than
60 days before the date of expiry of the permit, and after consultation with the
the ministries concerned to extend the period of validity of the permit. Authorized
the person can continue in contained use within the scope and in accordance with the
the conditions laid down in the permit until the release of the decision on the application for
its extension.
(5) Permits for contained use is non-transferable to any other person. ".
32. In article 17, after paragraph 1 the following new paragraphs 2 and 3 shall be added:
"(2) an application for the grant of authorisation for placing into the environment must
In addition to the General requirements of the application according to the code of administrative procedure always contain
and the name of the project)
(b)), contact and other identifying details of the professional advisers and
contact person at the workplace,
c) information about the GMO,
d) information about the place where you will be putting into the environment,
(e) the purpose and time) into the environment,
(f) a description of the waste), genetically modified organisms,
g) information about the monitoring,
(h) information on the measures being taken) after the entry into the
environment and waste management,
I) information about the marketing of genetically modified organisms into the environment
the environment in other States, and
j) observations of the expert advisor.
(3) Implementing law provides in the form of a detailed model application
the content of the application for the grant of authorisation for placing into the environment for
the case of the genetically modified organism that is
and) higher plant,
(b)) other organisms than a higher plant,
(c)) into the environment for the purposes of a clinical trial
medicinal products. ".
The current paragraph 2 shall become paragraph 4.
33. In section 18 para. 2, the words "at the same time with the application or at the latest within 10
days of its submission "is replaced by" on demand ".
34. In section 18 para. 6 for the letter c) the following point (d)), which read as follows:
"(d) the outcome of the risk assessment carried out) pursuant to section 7,".
Subparagraph (d))) to (i) shall become point (e)) to (j)).
35. In section 18 para. 6 (a). h) after the word "run," the words "in the
If field trials ".
36. In section 18 para. 7, the last sentence is replaced by the phrase "release information
the decision on authorisation for placing into the environment or on the
extension of its validity, the Ministry shall inform the Commission thereof. ".
37. In paragraph 19 (b). (b)), after the words "for each site", the words "
, including the regulations of the workplace, whose requirements are
set out in annex 4 to this Act, "and the words" 10 years after the end
This treatment "is replaced by" 5 years from their treatment in
the case of contained use and 10 years after their treatment in the event of
putting into the environment, and to provide it on request to the administrative
the authorities referred to in section 27 ".
38. In paragraph 19 (c)):
"(c) to send to the Ministry always) 15. February calendar year overview
genetically modified organisms, information on the quantities, about how
management and representation to the review of the risk assessment for the past
the calendar year ".
39. In section 20 (2). 2 (a). (b)), after the words "reporting"
the words "the second category on the contained use of risk".
40. In section 20 (2). 2 (a). (c)), and (d)) and § 21 para. 1 and 2, after the word
"loading" the words "of the second and higher risk category".
41. In section 20 (2). 2 (a). (c)), and (d)), after the word "or" shall be inserted after
"person entitled to".
42. In article 20 (2). 3, the words "the applicant and ' shall be deleted and the word" shall "
shall be replaced by "shall".
43. In § 20 paragraph 4 is added:
"(4) an emergency plan is processed in accordance with the model laid down in the implementing
legislation. ".
44. In paragraph 22 of the paragraph. 3 the words "§ 16 para. 9 "shall be replaced by ' paragraph 16 c para.
3 ' and the words ', which shall be treated as confidential "shall be replaced by
"designated as business secrets".
45. In paragraph 22 of the paragraph. 5 (b). a), the words "place of business" is replaced by
"registered address" and the word "headquarters" shall be replaced by the words "registered address".
46. In paragraph 22 of the paragraph. 5 (b)):
"(b)) the genetically modified organism for which authorization was
the user has been granted, or a group of organisms referred to in the notice or in the
the risk assessment under section 16a of the present paragraph. 4. "
47. In section 22 para. 7, the words "2 or 3" shall be replaced by "3 or section 16a
paragraph. 5, or on the basis of the risk assessment pursuant to section 16a paragraph submitted.
4. "
48. Part four, including title and footnotes 24 and 25:
"PART FOUR
PLACING ON THE MARKET
TITLE I OF THE
GENERAL PROVISIONS
Article 23 of the
(1) the genetically modified organism or a gene product can be
placed on the market only if it has been entered in the list for the placing on the market
or if it was put on the market written consent issued by the competent
authority of another Member State or if it has been authorised pursuant to
directly applicable European Union legislation governing genetically
genetically modified food and feed, ^ 23). To deal with genetically modified
organism or genetic product approved for placing on the market can be
only in the scope of that registration, consent or authorization, and under the conditions
laid down herein.
(2) any person who cultivates genetically modified organisms authorised for the
placing on the market referred to in paragraph 1, shall be obliged to provide to the Ministry of
written information about the location of their cultivation, and at the latest within 60 days
from the start of their cultivation, in the case that it has already done so pursuant to
the law on Agriculture ^ 20). The Ministry publishes the place of production
genetically modified organisms on their website.
(3) a person entered in the list for the placing on the market is required to ensure
the implementation of the monitoring and reporting of its results in accordance with the
the requirements set out in these minutes. The Ministry is authorised to
the basis of these reports, after the first monitoring period requirements
specify the monitoring. The results of the monitoring, the Ministry shall make available
the public on their website.
(4) reports on the results of the monitoring referred to in paragraph 3 passes
the Department of the Commission and the competent authorities of the Member States.
TITLE II
PROCEDURE FOR REGISTRATION IN THE LIST FOR THE PLACING ON THE MARKET
section 24
(1) the procedure for registration in the list for the placing on the market shall follow the procedure referred to in
§ 5, unless otherwise stipulated. The application for registration may be made only
a legal person or a natural person authorised to do business.
(2) the request for entry on the list for the placing on the market must, in addition to the General
the request pursuant to the administrative code requirements always contain
and the name of the genetic product)
(b)), contact and other identifying details of the professional advisers and
contact person at the workplace,
c) information about the GMO contained in genetic
the product,
(d) information about gene product),
(e) the purpose and procedure of placing) genetically modified organism, or
the genetic product on the market,
(f) information about the preceding marketing) into the environment, where appropriate, the
the previous placing on the market,
g) cover design of the genetic product and its labelling which complies with the
the requirements of § 11 (1) 2,
h) monitoring plan,
I) details of the provision of samples and
j) observations of the expert advisor.
(3) Implementing law provides in the form of a detailed model application
content of the request for entry on the list for the placing on the market for a case
and genetically modified organism), which is a higher plant, or
the genetic product containing genetically modified higher
the plant,
b) genetically modified organisms other than higher plants or
the genetic product other than containing the genetically modified
a higher plant.
(4) If, based on the results of the previous entry into the
environment or on the basis of relevant scientific knowledge, the applicant
considers that the placing on the market and use of genetically modified organism
or genetic product does not present any risk to the health and
the environment, can some of the requirements for an application for entry in the List
for the placing on the market only to a limited extent. This procedure is
the applicant must specify in the application to justify.
(5) the applicant shall provide the Ministry or entity with which
the Ministry has concluded a cooperation agreement in the exercise of its competence
According to § 28 para. 1 (b). (f)), at the same time with the application or at the latest within 10
days of the filing of a sample of a genetically modified organism, or
the genetic product for control purposes.
§ 24a
(1) without delay after receipt of the request, the Department shall provide a summary of the
content of the application according to § 5 para. 4 the Commission and competent authorities of the Member
States. A copy of the complete application, the Ministry shall provide the Commission at the latest
at the same time with the evaluation report referred to in paragraph 2.
(2) taking into account the opinions of the ministries concerned shall draw up
Ministry within 90 days from the date of receipt of the application and the assessment report
send it to the applicant within that time and the concerned government departments. In the period of 90
days not including the duration for which the Ministry is waiting for information from the
the applicant pursuant to § 5 para. 3 or 5. Department of evaluation report
be published on its website. The assessment report shall be
stated that the
and) the genetically modified organism or gene product may be
placed on the market and under which conditions, or
(b)) the genetically modified organism or gene product may not be
placed on the market.
(3) in the case referred to in paragraph 2 (a). the Ministry will send the evaluation)
report within 90 days of receipt of the request, whether or not the Commission. In the case referred to in
paragraph 2 (a). (b) the Ministry shall forward the evaluation report) to the Commission
no later than 105 days after receipt of the request. For counting periods are
It shall apply the provisions of paragraph 2, second sentence.
(4) if the Commission or the competent authority of the Member State within the period of 60
days from the date on which the assessment report was circulated by the Commission, the other
information or submit comments or reasoned objections to the placing
of the genetically modified organism or gene product
on the market, the Ministry shall provide such information and comments or
the reservations of the Commission or by the competent authority of the Member State shall consult the 45
days from the expiry of that period.
(5) the Ministry is authorised to request based on request, comments
or the reservations submitted by the applicant under paragraph 4 for more information.
In this case, the period of time when you are waiting for a response from the applicant,
not included in the 45 day period referred to in paragraph 4.
(6) if in the case referred to in paragraph 2 (a). the Commission does not submit a)
the Ministry of the period of 60 days referred to in paragraph 4 no reasoned
comments or reservations, or if it was reached within 45
days referred to in paragraph 4, the Department chooses to perform the write to the
The list for the placing on the market. The Ministry about this decision within 30 days
Since its release, inform the Commission and the competent authorities of the Member States.
(7) If it has not been reached within a period of 45 days in accordance with paragraph 4,
the Ministry, in accordance with the outcome of the procedure laid down for such cases
European Union law within 30 days of the notification of its results, decide on the
perform the write to the list for the placing on the market or to reject an application
and shall inform the Commission of any such decision and the competent authorities of the Member
States. Within 45 days does not include the period during which you are waiting for
the answer from the applicant in accordance with paragraph 5.
section 24b
(1) if the Ministry decides to perform the write to the list, for
placing on the market, makes this registration within 15 days from the date of the legal
the decision. In the decision to perform the write to the Marketing List
on the market shall be defined by the Ministry of the contents of this notation.
(2) in the case referred to in § 24a para. 2 (a). (b) the Ministry shall decide to 15)
days from the submission of the assessment report referred to in section 24a of para. 3 to reject
request.
(3) write to the Marketing List contains
and the name or) the name or business name, home address, the address of the registered office
and the identification number of the person, if any, was the person who made the
the application for registration, a natural person authorized to conduct business, or
the name or business name, address and identification number of the person
If it was allocated, the person who filed the application for registration if the person
legal,
(b)) the specification of the genetically modified organism or genetic
the product,
c) specification of the genetic modification,
(d) the results of the risk assessment)
(e) the conditions and purpose of placing) genetically modified organism, or
the genetic product, including any specific condition
the use, handling and packaging, and Furthermore, the conditions for the protection of certain
ecosystems, environments or geographical areas,
(f)) for any additional marking requirements under section 11 (1) 3,
(g)) the way the laboratory checks the presence of the genetic modification, including
the description of the modified section or ribonucleic acid deoxyribonucleic
enabling unique identification of genetically modified
the organism, even under international rules,
h) conditions for the provision of control samples to the competent administrative authority,
I) requirements for the monitoring and reporting of the results,
j) possibly modify the territorial scope of the cultivation of this
genetically modified organism excludes the territory of a Member State or
its part under section AA.
(4) in the decision to perform the write to the list for the placing on the market
the Ministry shall determine its validity period, which cannot be longer than 10
years of age.
(5) in the case of a genetically modified organism, in which it is assumed
trading only with his seed, ends the validity of the decision to
registration under paragraph 4 no later than the expiry of 10 years from the date of final
the decision on the registration of the first plant variety containing genetically
modified organism under the law on circulation of seeds and plants of ^ 24). In
the case of forest reproductive material ends the validity of
the implementation of a registration pursuant to paragraph 4, the expiry of 10 years from the date of implementation
write a recognised source of forest reproductive material to the
Register of approved basic material maintained by the law
on trade in forest reproductive material ^ 25).
(6) the list for the Marketing Department on their published
website.
(7) the details of the assessment report referred to in section 24a of para. 2 lays down the detailed
legal prescription.
TITLE III
EXTENSION OF THE VALIDITY OF THE DECISION TO WRITE TO THE LIST, FOR
PLACING ON THE MARKET
§ 24 c
(1) the validity of the decision to write to the Marketing List
the market may be at the request of the person entered in the list for the placing on the market
extended, even repeatedly. Application for renewal of
the decision to write to the list for the placing on the market must be
submitted at the latest 9 months before the expiry of its validity. In the management of
the application for extension of the validity of the decision to write to the
The list for the placing on the market are proceeding according to § 5, 24-24b, mutatis mutandis,
If it is not stipulated otherwise.
(2) an application for extension of the validity of the decision to write to the
Marketing list contains
and report on the results of the monitoring),
(b)) of any new information on the risks arising from genetically
the modified organism or gene product to human health
or the environment, and
(c) where appropriate, the design changes) or complementing the conditions of the waste referred to in
write to the Marketing List.
(3) the Ministry shall draw up an evaluation report without delay within which the
be noted that the
and) the genetically modified organism or gene product may be
also placed on the market and under which conditions, or
(b)) the genetically modified organism or gene product cannot
to be placed on the market.
(4) the assessment report, the Ministry shall send the Commission, together with copies of applications for
extension of the validity of the decision to write to the list, for
placing on the market. Any comments or reservations must be with the Commission or
the competent authority of the Member State discussed in 75 days from the date of
circulation of the assessment report by the Commission.
(5) the decision on the extension of the decision on the implementation of the registration
to the list for the placing on the market, the Ministry shall determine the time of
the validity of the decision on the implementation of the registration to be extended. The validity of the decision
to perform the write to the list for the placing on the market can be extended
not more than 10 years. The Ministry may in the decision on the extension of the
the validity of the decision to write to the list for the placing on the market
its validity limit or expand and modify the terms and conditions of registration to a list
for the placing on the market referred to in section 24b of paragraph 1. 3.
TITLE IV
RESTRICTION OR PROHIBITION OF THE CULTIVATION OF A GENETICALLY MODIFIED ORGANISM
section AA
(1) where the competent authority of the Member State in the course of the procedure for the registration of
to the list for the placing on the market or in the course of proceedings concerning the extension
the validity of the decision to write to the list for the placing on the market of
adjustment of the territorial scope of the entry in the list for the placing on the market, which
the territory of that Member State or its part excludes from the cultivation
a genetically modified organism, and edited by virtue of this
the applicant shall request its application for entry on the list for the placing on the market
30 days from the date of its submission by the Commission, the Ministry shall decide on the
perform the write to the list for the placing on the market on the basis of the following
customized application and in the minutes to a list for the placing on the market adjusts its
the territorial scope of the cultivation of the genetically
the GMO is the territory of that Member State or its
a certain part of the excluded.
(2) the Ministry of the minutes to the list for the placing on the market adjusts its
territorial scope so that the territory of a Member State or a
a certain part of the excreted from the cultivation of the genetically modified
the body, also in the case where, during the procedure for entry in the
The list for the placing on the market or in the course of proceedings concerning the extension
the validity of the decision to write to the list for the placing on the market
the competent authority of that Member State for such adjustment and the applicant
the original application for entry on the list for the placing on the market within 30 days from the date of
the submission of this request, the Commission has not committed.
(3) where the competent authority of the Member State to amend the territorial
the scope of the territory of that Member State or a
part excludes from the cultivation of a genetically modified organism, until after the date of
circulation of the assessment report by the Commission, the time limit for the issue of
the decision to write to the list for the placing on the market for 15 days;
the time limit for the issuance of the decision to write to the List for marketing
on the market shall be extended only once regardless of the number of Member States,
the competent authority shall apply to the application after the date of circulation of the assessment
report by the Commission.
(4) the Ministry will cancel editing the territorial scope of registration for
the placing on the market of the territory of a Member State or a
part excludes from the cultivation of the genetically modified
the body, if so requested by the competent authority of the Member State about the re
the integration of the territory of that Member State or to territorial
the scope of the entry in the list for the placing on the market.
(5) the Ministry shall immediately inform about cancellation of territorial adjustment
the scope of the entry in the list for the placing on the market, which is the territory of the
Member State or a certain part of the cultivation of the excluded
genetically modified organisms, the Commission, the other Member States and the
the person registered to the list for the placing on the market.
section 24e
(1) the Ministry in agreement with the Ministry of agriculture may, not later than
within 45 days from the date of receipt of the assessment report submitted to the Commission a request
on the adjustment of the territorial scope of the provision of a written consent to the placing
of the GMO on the market by the competent authority of the Member
the State, which is the territory of the Czech Republic or the particular part thereof, excludes from the
the cultivation of the genetically modified organism.
(2) the Ministry of agriculture, in agreement with the Ministry may, not later than
within 45 days from the date of receipt of the opinion of EFSA
food to the application for a permit granted by the placing
the GMO on the market by directly applicable legislation
The European Union governing genetically modified food and
feed ^ 23) submit to the Commission a request to modify the territorial scope of
This authorization, which is the territory of the Czech Republic or the particular part thereof,
excludes from the cultivation of the genetically modified organism.
(3) if the request was not submitted in accordance with paragraph 1, or if confirmed
the notifier the territorial scope of their original notification within 30 days from the date of
the submission of the request of the Ministry by the Commission and the competent authority of the Member
the State has been issued with a written consent to the placing of the genetically
the GMO on the market, can the Government of growing
a genetically modified organism or a group of genetically
GMOs as defined on the basis of specific crops or
character (hereinafter referred to as "the Group of genetically modified organisms") on the territory of the
The United States, or specific parts of the limit or prohibit.
(4) if the request was not submitted in accordance with paragraph 2, or if confirmed
the applicant the territorial scope of its original application within 30 days from the date of
the submission of the request by the Commission, and the Ministry of agriculture to the placing
of the GMO on the market, was released
authorisation in accordance with the applicable European Union legislation directly governing the
genetically modified food and feed, ^ 23), can the Government growing
of a genetically modified organism or a group of genetically
GMOs on the territory of the Czech Republic or its specific
part of the limit or prohibit.
(5) the Ministry in agreement with the Ministry of agriculture to the competent
authority of the Member State which issued the written consent for placing genetically
the GMO on the market, to submit a request to cancel editing
its territorial scope, that is territory of the United States or its
a certain part of the excreted from the cultivation of the genetically modified
of the organism.
(6) the Ministry of agriculture may, in agreement with the Ministry of the Commission
submit a request to cancel editing the territorial scope of an authorisation
published by the placing of a GMO on the market under
directly applicable European Union legislation governing genetically
genetically modified food and feed, ^ 23), which is the territory of the Czech Republic
or particular part excludes from the cultivation of the genetically
modified organism.
section 24f
(1) the Government may restrict or prohibit the cultivation of the genetically modified
the organism or group of genetically modified organisms, to whose
placing on the market has been issued with the written consent of the competent authority of the Member
State or to the placing on the market was granted a permit by directly
applicable European Union legislation governing genetically modified
Food and feed ^ 23), in the event that their cultivation
and) be in violation of the national environmental policy,
(b)) to be contrary to the objectives and tasks of spatial planning,
(c)) to be in violation of the State's agricultural policy,
(d)) to be in violation of the principles of the protection of agricultural land,
e) cause unacceptable social or economic impacts,
(f)), despite the measures taken in accordance with the law on Agriculture ^ 20) cause
the presence of GMOs in other products, or
(g)) is contrary to public policy, if it is at the same time to comply with one of the
the conditions referred to in points a) to (f)).
(2) the restriction or prohibition of the cultivation of a genetically modified organism
or group of genetically modified organisms as determined by the Government measures
of a general nature.
(3) the measures of a general nature shall establish a genetically modified organism
or group of genetically modified organisms whose cultivation
restricts or prohibits, the territory to which the restriction or prohibition applies,
and in the case of restrictions on the cultivation of the scope of this restriction.
(4) if the reasons for the defection of the restriction or prohibition of the cultivation of
the modified organism or group of genetically modified
organisms, the Government measures of a general nature.
section 24 g
(1) on the measures of a general nature under this Act, section 172 of the administrative
the order does not apply.
(2) a draft of the measures of a general nature, the Ministry shall send to the Commission; If this is
about the genetically modified organism or a group of genetically
modified organisms for which the marketing authorisation was granted
According to the applicable European Union legislation directly governing the genetically
genetically modified food and feed, ^ 23), will send a draft of the measures of a general nature
The Commission of the Ministry of agriculture. Measures of a general nature may be made
soon as possible after the expiry of 75 days from the date of sending its proposal to the Commission.
(3) the Ministry or the Ministry of agriculture shall make available on its official
information about the Board, that the proposal for measures of a general nature was posted
To the Commission. Ministry or the Ministry of agriculture shall publish on its
the official Board along with this information also to draft measures to the General
nature, including its justification.
(4) for a period of 75 days from the date of publication of the information referred to in paragraph 3 shall not
be on the territory of the Czech Republic or a part thereof, as defined in the draft measures
of a general nature initiated the cultivation of a genetically modified organism
or group of genetically modified organisms as defined in this
the proposal.
(5) the measures of a general nature shall be notified to the public by a decree of the Ministry;
in the case of a genetically modified organism or a group of genetically
modified organisms for which the marketing authorisation was granted
According to the applicable European Union legislation directly governing the genetically
genetically modified food and feed, ^ 23), to announce the measures of a general nature
a public decree of the Ministry of agriculture.
(6) Ministry or the Ministry of agriculture shall immediately inform the
The Commission and the other Member States about the measures of a general nature according to the
This Act has been issued. The Ministry shall promptly forward the release
measures of a general nature person entered in the list for the placing on the market or
the person to whom the competent authority of another Member State issued
written consent to the placing of a GMO on the market.
The Ministry of agriculture shall promptly forward the release of General measures
the nature of the holder of the permit issued under the directly applicable legislation
The European Union governing genetically modified food and feed, ^ 23).
24) Act No. 218/2003 Coll., on marketing of seeds and plants grown
plants and amending some laws (law on the circulation of seeds and plants), in
as amended.
25) Act No. 149/2003 Coll., on the marketing of reproductive material
forest tree species, tree species and artificial hybrids, intended to
regeneration and afforestation, and amending certain related laws
(law on trade in forest reproductive material of tree species), as amended by
amended. ".
49. In § 25 para. 2 the words "into circulation, or for which consent has been granted
or the authorisation for putting into circulation by the competent authority of a Member State "
replaced by the words "on the market or for which you have received written consent for
placing on the market by the competent authority of another Member State or for which a
authorised pursuant to the applicable legislation of the European Union directly
regulating genetically modified food and feed, ^ 23). This
the provisions shall not apply to imports and exports of genetically modified
organisms referred to in paragraphs 3 and 4. ".
50. in § 25 para. 3 the words "(§ 16)" shall be replaced by "pursuant to section 16 to
16 c ".
51. In § 25 para. 6, after the words "food inspection, in the case of"
the words "feed, seeds and".
52. In § 25 para. 7 (b). (c)), and (d)), the words "place of business" is replaced by
the words "legal address".
53. In § 25 para. 8 (a). and) the words "§ 16 para. 6 "shall be replaced by the words" §
paragraph 16B. 3. "
54. In § 25 para. 8 at the end of the text of the letter b), the words ",
unless the first category contained use of risk ".
55. In section 27 is at the end of the letter k) dot replaced with a comma and the following
the letter l) is added:
"l) regional authorities.".
56. In paragraph 28, the dot at the end of paragraph 1 is replaced by a comma and the following
the letter i), which read as follows:
"i) shall inform without delay the cases of unauthorized handling of
genetically modified organisms or genetic products the Commission
the competent authorities of the Member States and in a manner pursuant to section 10 (b). (b)), and (c))
public. ".
57. In paragraph 30, subparagraph (a) at the end of the text), the words "and forestry
the economy ".
58. In paragraph 30, at the end of subparagraph (b)) the dot replaces the comma and the following
subparagraph (c)), and (d)), which read as follows:
"(c)) is a central administrative authority in the area of genetically modified
Food and feed according to the directly applicable European Union legislation
regulating genetically modified food or feed ^ 23),
(d)) governs the conditions of cultivation of genetically modified plant varieties
under the law on Agriculture ^ 20). ".
59. In § 31 para. 1 letter b) including footnote # 26:
"(b)) requires legal and natural persons, measures to remedy; If there is a
the immediate injury to health or to the environment, without delay,
arrange for the necessary remedial measures and saves the person who
When loading or other treatment of genetically modified organism
or genetic product infringed an obligation imposed by law
or the decisions issued on its basis or directly applicable
European Union regulations ^ 26) to pay the costs associated with implementation of the
measures,
26) European Parliament and Council Regulation (EC) No 1829/2003.
European Parliament and Council Regulation (EC) no 1830/2003. ".
60. In § 31 para. 1, the following point (c)), and (d)), including notes
footnote # 27:
"(c)) may prohibit further treatment or other treatment of genetically
a genetically modified organism, or the product, if it is found in the
control of loading or other treatment of genetically modified
organisms or genetic products in violation of the obligations imposed in this
the law or the decisions issued on the basis of, or directly
the applicable provisions of the European Union ^ 27) and to delete the offending
the State is not sufficient to remedy the imposition of measures,
(d)) shall immediately inform the Ministry about the cases of unauthorized
use of genetically modified organisms or genetic
products and about the fact that the decision on the introduction of measures to
remedy or treatment or other treatment of genetically modified
organism or genetic product was prohibited.
27) European Parliament and Council Regulation (EC) no 1830/2003.
European Parliament and Council Regulation (EC) no 1946/2006. ".
61. In paragraph 33, the following paragraph 5 is added:
"(5) the scope of the regional authority established under this Act are
performance by. ".
62. Part seven including title and footnotes # 28 to 30:
"PART SEVEN
REMEDIAL MEASURES AND ADMINISTRATIVE OFFENCES
TITLE I OF THE
MEASURES TO REMEDY THE
§ 34
(1) if the inspection when checking for the treatment or other treatment
genetically modified organisms or genetic products in violation of
the duty imposed by this Act or the decisions issued on his
basis or directly applicable European Union regulations ^ 27), saves
the person that violates these obligations appropriate measures to remedy the situation.
(2) the inspection authority may, in particular,
and) suspend the loading or other treatment of genetically modified
organism or genetic product until such time as the conditions of this
treatment or other treatment will be provided in accordance with this
the law or the decisions issued on the basis of, or directly
the applicable provisions of the European Union ^ 27),
(b) order the removal of the consequences of such) treatment or other treatment
with the genetically modified organism or a genetic product,
(c) order the destruction) of the genetically modified organism, or
the genetic product, if there is injury to health or the
environment, or
(d) order the adoption of other measures) necessary to protect the health or
of the environment.
(3) the inspection of the decision imposing the remedy shall provide to the
its implementation.
(4) an appeal against a decision imposing a remedy does not have
suspensory effect.
(5) the owner of immovable property may, in connection with the implementation of inspection
measures to remedy an obligation to tolerate the extent and after
the necessary time limits of normal use. Compensation for any damage
the resulting shall be borne by the owner of the State against a person, as a result of the
illegal activity were measures to remedy saved, entitlement to the refund
damage.
TITLE II
ADMINISTRATIVE OFFENCES
§ 35
Misdemeanors
(1) a natural person has committed the offence by
and) contrary to section 3 (2). 4 does not follow when dealing with genetically
modified organism or genetic conditions marked product
on the packaging or in the accompanying document or treated him for a purpose other than
there referred to,
(b)) in violation of § 23 para. 1 placing on the market of a genetically modified
organism or a gene product that has not been written into the list for the
placing on the market, for the placing on the market has not received written consent
the competent authority of another Member State or with its authorisation by directly
applicable European Union legislation governing genetically modified
Food and feed ^ 23) or when handling does not follow the scope and
terms and conditions of this registration, the written consent or authorization,
(c) does not provide the Ministry) within the time limit the written information on the site
the cultivation of GMOs authorised for placing on the
market in accordance with § 23 para. 2,
d) grown genetically modified organism in breach of the prohibition or
restrictions laid down measures general nature issued pursuant to section 24e
paragraph. 3 or 4,
(e)) will launch the cultivation of a genetically modified organism in violation of §
24 g of paragraph 1. 4, or
f) imported or exported in genetically modified organisms or genetic
products in violation of § 25 para. 2.
(2) a fine may be imposed for the offense to
and 500 000 CZK), if it is a misdemeanor pursuant to paragraph 1. a), b), (d))
or (f)),
(b)) $50,000, in the case of an offense referred to in paragraph 1 (b). (c)), or (e)).
section 35a
Administrative offences of legal entities and natural persons-entrepreneurs
(1) a legal entity or individual entrepreneur is committed by the administrative
tort by
and) contrary to section 3 (2). 4 does not follow when dealing with genetically
modified organism or genetic conditions marked product
on the packaging or in the accompanying document or treated him for a purpose other than
there referred to,
(b)) shall be treated with the genetically modified organism in an enclosed space
without the appropriate permission according to § 16 para. 2,
c) lists the genetically modified organism into the environment without
an authorisation pursuant to § 17 para. 1,
(d)) in violation of § 23 para. 1 placing on the market of a genetically modified
organism or a gene product that has not been written into the list for the
placing on the market, for the placing on the market has not received written consent
the competent authority of another Member State or with its authorisation by directly
applicable European Union legislation governing genetically modified
Food and feed ^ 23) or when handling does not follow the scope and
terms and conditions of this registration, the written consent or authorization,
(e)) does not provide the Ministry within the time limit the written information on the site
the cultivation of GMOs authorised for placing on the
market in accordance with § 23 para. 2,
f) grown genetically modified organism in breach of the prohibition or
restrictions laid down measures general nature issued pursuant to section 24e
paragraph. 3 or 4,
g) will launch the cultivation of a genetically modified organism in violation of §
24 g of paragraph 1. 4, or
h) imported or exported in genetically modified organisms or genetic
products in violation of § 25 para. 2.
(2) a legal entity or individual entrepreneur as a person entitled to
contained use or putting into the environment, or a person
registered in the list for the placing on the market and/or the person about the emergence of
such permission, or for entry in the list for marketing calls
committing an administrative offense, by
and) does not adopt measures necessary to protect health and the environment
pursuant to section 8 (2). 1 (b). and)
b) contrary to section 8 (2). 1 (b). (b) fails to provide to the Ministry in writing)
new information on the GMO risk
or genetic product for health or the environment, or
the Ministry has not notified the measures taken, or
c) contrary to section 8 (2). 2 within the specified period will not perform or fail to submit
the Ministry of the new risk assessment.
(3) a legal entity or individual entrepreneur as a person who
provides the genetically modified organism exclusively for the purposes of
contained use or putting into the environment, committed by
the administrative offense by that, contrary to section 11 para. 1 does not ensure that the
a label or in a document accompanying the GMO
was clearly marked with the words "genetically modified organism" or
genetically modified organism in order to meet additional requirements for its
marking set out in the permit for the contained use or the authorisation for
entry into the environment.
(4) a legal entity or individual entrepreneur as a person who places the
a genetically modified organism or a gene product on the market within the
his business, committing an administrative offense, by
and) does was a genetically modified organism or genetic
the product is marked according to the applicable legislation of the European Union directly
relating to the traceability and labelling of genetically modified
organisms ^ 28) or under section 11 (1) 2 and 3, or
b) fails to comply with any of the requirements on traceability of genetic products
According to the applicable European Union legislation directly governing the
traceability and labelling of genetically modified organisms ^ 29).
(5) a legal entity or individual entrepreneur as a person entitled to
contained use committed an administrative offence, by
and) contrary to section 15(1). 2 disposes of genetically modified
organisms in a space that does not meet the requirements for containment and protective
the measures laid down for the appropriate risk category or higher,
b) contrary to section 15(1). 3 does not check the enclosure or protective
or does not keep records of the checks carried out,
(c) fails to file a new notification) under section 16b, para. 2, or
(d) fails to comply with the scope or conditions) the treatment provided for in the authorization for the
contained use under section 16 c para. 1.
(6) a legal entity or individual entrepreneur as a person entitled to
entry into the environment the administrative offense committed by
and does not comply with the conditions or range) the treatment provided for in the authorization for the
entry into the environment pursuant to § 17 para. 1,
(b)) does not ensure that no material derived from the genetically modified
the organism, which gives to the environment, was not placed on the market
According to § 17 para. 4, or
(c) does not ensure the implementation of the monitoring or) reporting on its
the results, in accordance with the requirements laid down in the authorisation for the entry into
of the environment, pursuant to section 6 para. 9.
(7) the legal entity or individual entrepreneur as a person entitled to
contained use or for entry into the environment commits
the administrative offense by
and to secure a professional performance) checks over the handling of genetically
modified organisms professional adviser pursuant to section 7 (b). and)
b) contrary to section 7 (b). (b)) does not or does not retain documentation about
use of genetically modified organisms,
c) contrary to section 7 (b). (c)) has not sent in due time to the Ministry of
Overview of genetically modified organisms, information on the quantities,
How to dispose of them or the representations to the review of the risk assessment
for the previous calendar year,
(d)) has not sent to the Ministry by the deadline, a final report on the progress of
and the consequences of the use of genetically modified organisms in accordance with § 19
(a). (d)),
e) provide false information in the documentation on the management of genetically
modified organisms or in the final report of the progress and implications
use of genetically modified organisms,
(f)) does not ensure that the operational rules of the workplace in which is treated with
genetically modified organisms, contained all the elements
listed in annex 4 to this Act pursuant to section 19 (a). (f)),
g) contrary to section 7 (b). g) does not provide employee training or is
proven to be familiar with the operational regulations of the workplace,
h) fails to provide the prescribed administrative authorities in control by
section 19 (a). (h)), or
I will not provide the Ministry) within the prescribed period the information on the type and
the amount of genetically modified organisms and expected
the point of entry or exit according to § 25 para. 5.
(8) a legal entity or individual entrepreneur as a person entitled to
contained use of second and higher risk categories or to putting into
the environment of the administrative offense committed by
and) do not submit to the Ministry of emergency plan for contained use second
and the higher risk category under section 20 (2). 2 (a). (c)),
(b)) do not submit Ministry of emergency plan within a specified period when changing
facts which may have a significant effect on the measures laid down for the
accident, pursuant to section 20 (2). 2 (a). (d)),
c) contrary to section 20 (2). 3 does not process or does not submit the relevant
municipalities, the fire rescue Corps of competent State or regional
the Office of the emergency plan,
(d)) does not make in case of disaster measures to eliminate or mitigate the
its harmful consequences pursuant to § 21 para. 2,
(e) fails to notify the accident caused by the Ministry) immediately by telephone and
in writing or by electronic mail pursuant to § 21 para. 3, or
(f) shall immediately notify the resulting accident) other administrative authorities referred to in
§ 21 para. 4.
(9) the legal entity or individual entrepreneur as a person registered to the
The list for the placing on the market of committing an administrative offense that does not ensure
implementation of monitoring or reporting of the results according to paragraph 23 of the
paragraph. 3.
(10) a legal entity or individual entrepreneur, who is the importer or
exporter of genetically modified organism or gene product,
committing an administrative offense, by
and) contrary to section 25 para. 6 realize immediately the competent Customs Office, or
other administrative authorities of the arrival of goods to the point of entry;
(b) the Customs Office) do not submit accompanying documents in accordance with § 25
paragraph. 7, or
(c) the Customs Office) do not submit an authenticated copy of the authorisation for closed
loading or putting into the environment, or a copy of the emergency
plan pursuant to § 25 para. 8.
(11) the legal entity or individual entrepreneur, which is exporter
a genetically modified organism or a gene product, the
committing an administrative offense that fails to meet any of the requirements of the exporter
stored directly applicable EU regulation governing the
cross-border movement of genetically modified organisms ^ 30).
(12) an administrative offense shall be fined in the
and 5 000 000 Czk), in the case of an administrative offence referred to in paragraph 1 (b). b), c)
or (f)),
(b) 1 500 000 Czk), in the case of an administrative offence under paragraph 5 (b). and) or
(d)),
(c) $1 000 000), in the case of an administrative offence referred to in paragraph 2, 3, paragraph
4 (b). and) or (b)), paragraph 5 (b). (b)), or (c)), paragraph 6, paragraph 7
(a). (h)), paragraph 8 (a). d) to (f)) or paragraph (9),
d) 500 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). a), (d)),
g) or (h)), paragraph 7 (b). a) to (e)), or i), paragraph 8 (a). a) to
(c)), paragraphs 10 or 11,
(e)) $50,000, in the case of an administrative offence referred to in paragraph 1 (b). (e)), or
paragraph 7 (b). f) or (g)).
(13) if at the time of 1 year from the date of the decision of the
the imposition of fines again committing a similar administrative offense, for
that was a fine is imposed, the upper limit of the amount referred to in paragraphs 1
up to 5, increasing to double.
section 36
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
the administrative authority has commenced proceedings about him within 2 years from the date on which it
learned, but not later than 5 years from the date on which it was committed;
liability of legal persons for the administrative offence under section 35a of the paragraph. 1 (b).
e) or section 35 para. 7 (b). f) or (g)) shall cease no later than 3 years from the
the day when it was committed.
(4) The liability for the acts, which took place in the business
person or in direct connection with it shall be subject to the provisions of this
the law on liability of legal persons and sanctions.
(5) administrative offences under this Act dealt with the inspection.
(6) the Fines collected. Income from fines is the income of the State Fund
the environment of the Czech Republic. Penalty is due within 30 days from the
the effective date of the decision, in which it was stored.
28) Article. 4 (4). 6 European Parliament and Council Regulation (EC) No.
1830/2003.
29) Article. 4 (4). 1 to 4 of the European Parliament and Council Regulation (EC) No.
1830/2003.
30) European Parliament and Council Regulation (EC) no 1946/2003. ".
63. section 38 reads as follows:
"§ 38
The Ministry shall determine the implementing regulation
and a summary of the content of the application) the details referred to in § 5 para. 4,
(b)) the details and procedures of risk assessment pursuant to § 7 para. 6,
(c) the threshold limit of occurrence of admixture), pursuant to section 11 (1) 4,
d) enclosed space requirements and protective measures in the case of
contained use under § 15 para. 2,
e) patterns the notice of contained use of the first or second category
risk and the application for the grant of authorizations for the contained use of a third or
the fourth risk category according to § 16 para. 6,
f) pattern of risk assessment for contained use, the first risk category
under section 16a, paragraph 2. 4,
g) model application for the grant of authorisation for entry into the environment
According to § 17 para. 3,
(h)) the manner and extent of documentation according to § 19 (f). (b)),
I) model of emergency plan under section 20 (2). 4 and the scope of the Ministry of
published information about the plan, pursuant to section 20 (2). 5,
j) model application for entry on the list for the placing on the market pursuant to § 24 para.
3,
to) the details of the assessment report referred to in section 24b of paragraph 1. 7. ".
64. In Appendix 1, point 1, introductory part, the words "provisions may
arise, "the words" inter alia ".
65. Appendix 4:
"Appendix No. 4 to Act No. 78/2004 Coll.
The elements of the operating regulations of the workplace in which is treated with genetically
modified organisms
The rules of operation of the workplace, which is treated with genetically modified
organisms, must contain at least the following information:
and the name or) the name or business name, address of the registered office and identification
number, if assigned, the person is a natural person
authorized to do business,
(b)) the name or business name, address and identification number,
If it was allocated, the person is a legal person, as well as
name and address of the place of residence of the statutory authority of an authorized person,
(c) the name and address of residence) of the owner of the building, if it is a closed
loading, or land, in the case of entry into the environment, if the
a natural person, or the name or the business name, address of the registered office and
the identification number of the person, if any, and the name and address of the
residence of the statutory authority, if the owner is a legal entity,
If the owner is not the same as the authorised person,
(d)) name, home address, telephone number and e-mail address
Professional Advisor,
e) name, home address, telephone number and e-mail address
the person responsible for the operation of the site,
(f) risk management) the category of genetically modified organisms,
that may be carried out at the workplace, in the case of closed
loading,
g) enumeration and the approximate amount of genetically modified organisms,
which will be treated in the workplace,
h) list of workers trained to work at the workplace,
I) obligations of workers at work, in particular the observance of working
procedures, procedure sanitation of space and equipment after the termination of the work
activities, the process of decontamination, personal protective tools
equipment and clothing,
j) list and description of binding used on the workflows
workplace,
to) prohibited activities in the workplace,
l) principles of hygiene and safety at work, in accordance with the provisions of other
^ 6) legislation,
m) list of personal protective equipment and other AIDS
that the employer shall, in accordance with other legislation ^ 19), with the
indicating the activities which must be used,
n) organizational and technological security of workplaces,
about) the obligations of workers when maintenance of equipment,
p) character, purpose and description of the technical elements that ensure the conclusion of the
area, if this is a contained use,
q) measures to prevent the entry of unauthorised persons,
r) system, and the frequency of checks of the space, equipment and protective measures,
with) the measures for disaster and fire, including the emergency plan referred to in
section 20,
t) method of waste management and contaminated materials and articles
in particular, the procedures for the disposal of genetically modified organisms and the way
control of their effectiveness,
for the record-keeping) the principles of operation of the equipment, carried out sanitization and
inspections of safety elements,
in the case of the placing in) genetically modified organisms into the environment
environment
1. the means of transport on land, including security measures,
2. location and method of storage of genetically modified organisms before
putting into the environment, and after its completion, including the
packaging and labelling
w) an indication of the possible time limits the validity of the regulations. ".
Article II
Transitional provision
Notice of contained use under section 16(1). 2 and 3 of Act No. 78/2004
Coll., in the version in force before the date of entry into force of this Act,
the Inbox to the Ministry before the date of entry into force of this Act,
governed by Act No. 78/2004 Coll., in the version in force prior to the date of acquisition
the effectiveness of this Act.
PART TWO
Agriculture (Amendment) Act
Article. (III)
Act No. 252/1997 Coll., on agriculture, as amended by Act No 62/2000 Coll.
Act No. 308/2000 Coll., Act No. 128/2003 Coll., Act No. 85/2004 Coll.
Act No 317/2004 Coll., Act No. 94/2005 Coll., Act No. 441/2005 Coll.
Act No 444/2005 Coll., Act No. 230/2006 Coll., Act No. 262/2006 Coll.
Constitutional Court, declared under no 409/2006 Coll., Act No.
35/2008 Coll., Act No. 95/2009 Coll., Act No. 109/2009 Coll., Act No.
291/2009 Coll., Act No. 73/2011 Coll., Act No. 167/2009 Coll., Act No.
64/2014 Coll. and Act No. 179/2014 Coll., is amended as follows:
1. In section 2i is at the end of paragraph 2, a dot is replaced by a comma and the following
subparagraph (f)), which read as follows:
"(f) to respect the minimum distance of) the cultivation of
a variety of State borders of the Czech Republic established
by Decree. "
2. In section 2i is at the end of paragraph 4, dot replaced with a comma and the following
the letter g) is added:
"(g)) the minimum distance of the place of the cultivation of a genetically modified variety
from the border of the Czech Republic in accordance with paragraph 2 (a). f).".
PART THREE
The EFFECTIVENESS of the
Article IV
This Act shall take effect on 1 January 2000. January 2017.
Hamáček in r.
Zeman in r.
Sobotka in r.
