Amendment Of The Act On The Use Of Genetically Modified Organisms

Original Language Title: změna zákona o nakládání s geneticky modifikovanými organismy

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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.

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