372/2016 Sb.



DECREE



of 25 June 2002. October 2016,



amending Decree No 207/2004 Coll., on detailed conditions

use of genetically modified organisms and genetic products

as amended



Ministry of the environment shall determine pursuant to section 38 of Act No. 78/2004

Coll. on the use of genetically modified organisms and genetic

products, as amended by Act No. 346/2005 Coll. and Act No 371/2016 Coll.:



Article. (I)



Decree No 207/2004 Coll., on detailed conditions of disposal of genetically

modified organisms and genetic products, as amended by Decree No.

86/2006 Coll. and Decree No. 29/2010 Coll., shall be amended as follows:



1. § 1, including title and footnote No 1 is added:



"§ 1



The subject of the edit



This Decree incorporates the relevant provisions of the European Union ^ 1) and

modifies more conditions use of genetically modified organisms

and genetic products by laying down



and requests for patterns) to grant an authorisation for the contained use of a third or

the fourth risk category, the application for the grant of authorisation for entry into

of the environment and of the request for entry on the list for the placing on the market,



(b) a summary of the content of the application) the details of the grant of the authorization for placing the

environment and for entry in the list for the placing on the market,



(c)) the details and procedures for risk assessment,



(d) the threshold limit of occurrence of admixture),



e) enclosed space requirements and protective measures in the case of

the contained use, the



(f) notice of patterns) the contained use of the first or second category

risks,



g) model of the risk evaluation for contained use, the first risk category

under section 16a, paragraph 2. 4 of the Act,



(h)) the manner and extent of documentation,



I) model of emergency plan and the scope of the Ministry of information published

about emergency response plan,



j) the details of the assessment report.



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 ".



2. In paragraph 2, point (e)) the following new subparagraph (f)), which read as follows:



"f) therapeutic vector nebuněčný Department, in particular the plasmid or

transpozón, containing hereditary material and able to inject this hereditary

material into the cells of the body being treated, which is applied in order to

gene therapy ".



Subparagraph (f)) to (j)) are known as the letters g) to).



3. the title of section 3 is "Patterns, notification of applications and other documents".



4. in section 3, paragraph 1 reads:



"(1)



and) notification of contained use is listed in part A of annex 1 to the

This Decree



1. in part 1, in the case of the first category of risks of contained use,



2. in part 3, in the case of the second category of risks of contained use,



3. in part 4, in the case of other categories of contained use of risk

submitted pursuant to section 16a para. 5 of the Act,



(b)) the contained use of risk assessment first risk category

under section 16a of the present paragraph. 4 of the Act is set out in part A of the annex.

1 to this Ordinance in part 2,



(c) the grant of an authorization request) for contained use third or fourth

risk category is listed in part B of annex 1 to this notice,



(d) risk assessment procedures) contained use is shown in part C

Appendix No. 1 to this notice,



(e) the grant of an authorization request) for entry into the environment

listed in annex 2 to this Decree



1. in part A, part 1, in the case of a genetically modified organism

is the organism other than higher plants,



2. in part A, part 2, in the case of a genetically modified organism

is a higher plant,



3. in part B, in the case of a genetically modified organism, that is to

the environment is placed for the purposes of a clinical trial of medicinal

products,



f) applications for entry on the list for the placing on the market is given in annex No.

3 to this notice



1. in part and, in the case of a genetically modified organism, other than a higher

a plant or a genetic product other than containing genetically

modified higher plant



2. in part B, in the case of a genetically modified organism, that is

a higher plant, or a genetic product containing genetically

modified higher plant. ".



5. In section 3, paragraph 3. 2, after the word "notice" the words ", reviews

the risk of ", the words" referred to in paragraph 1 shall be filed in any language, "

replaced by the words "serving" and the words "electronic mail" shall be replaced by

the words "in electronic form".



6. In section 3, paragraph 3 shall be deleted.



Paragraph 4 becomes paragraph 3.



7. in section 3, paragraph 3. 3, the words "it is necessary to mention" shall be replaced by "shall be

in it ".



8. section 4, including the title reads as follows:



"§ 4



A summary of the content of the application requirements, which is the online version



(§ 5, paragraph 4, of the Act)



Requirements summary of application for the grant of authorisation for entry into

of the environment and of the request for entry on the list for the placing on the market

are indicated in annexes 2 and 3 to this Ordinance. ".



9. In the title of § 5, the text "paragraph. 7 ' is replaced by the text "paragraph. 6. "



10. in § 5 para. 8, the word "community" shall be replaced by ' the European

the Union ".



11. in § 5 para. 10 the initial part of the provisions of § 6 and § 10(b). and) and (e))

the words "put into circulation" shall be replaced by "on the market".



12. in section 5, paragraph 10, insert a new paragraph 11, which read:



"(11) the assessment of the risks in the case of the placing of genetically modified

organisms into the environment, for the purposes of a clinical trial

of medicinal products also contains



and) description of the ways you can genetically modified organism, or

parts of it spread from the test subject (human or animal) into the

of the environment,



(b) inclusion and reject) the criteria for the selection of subjects

the clinical trial and the effect of these criteria to the risks to the

environment,



(c) identify and evaluate) the potential harmful effects in case

interacts genetically modified organism with a man who

It is not the body of a clinical trial carried out in accordance with paragraph

7. ".



The present paragraph 11 shall become paragraph 12.



13. In the title of § 6 of the text "paragraph. 3 "shall be replaced with" paragraph 1. 4. "



14. In paragraph 6 of the text "paragraph. 3 "shall be replaced with" paragraph 1. 4 "and the words" or 2 "

shall be deleted.



15. In § 8 para. 1 (b). and the word ")" be deleted, the words "in circulation"

are replaced by the words "on the market or for an extension of its period of validity", the word

"or" shall be deleted and the words "2 or 3 of the Act" shall be replaced by "3

or section 16a para. 5 of the Act, or risk assessment submitted pursuant to §

16A para. 4 of the law ".



16. in § 8 para. 1 (b). (b) "), the text of § 16 para. 10 "is replaced by the text" section

16 c para. 4. ", the text" section 17 "is replaced by" section 18 ", the text" § 16 para.

5 "is replaced by" section 16b, para. 1 "and the words" in accordance with § 35 "

the words "or 35".



17. in § 8 para. 6, the words ", where appropriate, the name, the last name" shall be deleted.



18. in § 8 para. 8 (a). (h)), the words ", where appropriate, the names and surnames"

shall be deleted.



19. in § 8 para. 8 (a). j), the words ", where appropriate, the name and surname"

shall be deleted.



20. section 9, including the title reads as follows:



"section 9



The pattern of emergency plan and the scope of the Ministry disclosed information

about the plan



(To § 20 paragraph 4 and 5 of the Act)



(1) the model emergency plan is reproduced in annex 5 to this notice



and in part A) in the case of an emergency plan for contained use, the



b) in part B, in the case of an emergency plan for entry into the

environment.



(2) information on the plan, the Ministry will publish in the range of the data,

that are in Appendix 5 to this Ordinance. ".



Footnote # 5 and 6 are deleted.



21. In the heading of section 10, the text "§ 24 para. 17 "is replaced by the text" section 24b

paragraph. 7. "



22. in the introductory part of the provisions of section 10, the text "§ 24 para. 5 "is replaced by

the text "§ 24a para. 2. "



23. in paragraph 10 (a). e), the words ' European Community ' shall be replaced by

"The European Union".



24. Annexes 1 to 4, including the footnote # 7 to 18 shall be added:



' Annex 1 to the Decree No 209/2004 Coll.



Model notice of contained use of risk categories, the first pattern

risk evaluation for contained use, the first risk category

submitted pursuant to section 16a para. 4 of the Act, notice of the closed pattern

the second category of risk management, the model notice of the contained use of

the second category of risk under section 16a of the present paragraph. 5 of the Act, the pattern

applications for the granting of permits for contained use third or fourth

risk category and pattern procedure the risk assessment of the contained uses



Documents marked with



(+)

It is necessary to attach as a separate attachment.



All relevant documents must be labeled with the name, or the name of the

(trade name) of the applicant.



PART AND



MODEL NOTICE OF CONTAINED USE OF RISK CATEGORIES, THE FIRST PATTERN

RISK EVALUATION FOR CONTAINED USE, THE FIRST RISK CATEGORY

SUBMITTED PURSUANT to section 16a para. 4 of the ACT, notice of the CLOSED PATTERN

THE SECOND CATEGORY OF RISK MANAGEMENT AND THE MODEL NOTICE OF THE CONTAINED USE OF

The SECOND CATEGORY of RISK under section 16a of the PRESENT PARAGRAPH. 5 of law



Part 1



MODEL NOTICE OF CONTAINED USE FIRST RISK CATEGORY




[To section 16 para. 6 (a)) of the Act]



Date of submission



1. the person giving the notice (hereinafter referred to as "the notifier")



1.1. The name or business name of the Notifier is a natural

a person authorized to do business



1.2. The name or business name and legal form, if the notifier

legal person



1.3. nationality (for natural persons)



1.4. the registered address and home address (for natural persons)



1.5. IDENTIFICATION NUMBER (if assigned)



1.6. the names of the persons who are members of the statutory body of the notifier,

If Notifier is a legal person, with an indication of the way in which

the notifier shall represent the



2. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



2.1. Name, academic title



2.2. the Occupation or employer, and job title



2.3. Education



2.4. Training courses



2.5. Current practice



2.6. Address of residence



2.7. the phone



2.8. E-mail



3. the contact person at the workplace, if different from the professional advisor



3.1. Name, academic title



3.2. the phone



3.3. Email



4. the Purpose of the contained use-the nature of the activities, which will be provided by the notifier

carried out (research, training, detection, production, etc.)



5. the site where the contained use will be



5.1. workplace Address



5.2. the nature of the workplace:



5.2.1. microbiology/molecular-genetic laboratory



5.2.2. demonstration



5.2.3. production facilities



5.2.4. greenhouse/culture room



5.2.5. breeding animals



5.2.6. other (that uniquely identifies the description of the workplace, such as

handling spaces, means of transport)



(+) Plan of the rooms, the floors and the area



(+) Proof of accreditation by other legislation in the

the case of breeding facilities for animals ^ 8)



6. Used genetically modified organisms

I-------------------------I-----------I-------------------------I------------I

And the recipient/parent and donor and gene/insert/Insert and Vector and

(I) the organism; possibly even exempted gen; where appropriate, and

Even a group of beneficiaries and their group I I

I/parental organisms I I I I

I-------------------------I-----------I-------------------------I------------I

I I I I I

I-------------------------I-----------I-------------------------I------------I

I I I I I

I-------------------------I-----------I-------------------------I------------I



For each item (recipient/parental organism, the donor,

the gene/insert/exempted gene vector) can be placed in the case

certain classification to the first category of the risk of the contained use

the entire group, for which the individual members of the risk assessment

identical. For recipients and donors may be placed as a group in particular tribes

microbial species (eg. "the strains of Saccharomyces cerevisiae")

insertion of genes/s, or their mutated and deletovaných

variants, their group (e.g.. "the genes of Bacillus subtilis and their

the mutated and deletion variants "," human genes "," mouse "," chromosomal genes

Corynebacterium glutamicum fragments ").



7. the quantity of genetically modified organisms



7.1. The approximate amount of genetically modified organisms, which has

be used per year (the numbers of the volumes of the cultures, flora or fauna)



(+) The project from other legislation in the case of breeding

equipment for animals ^ 8)



8. Risk assessment



8.1. A summary of the risk assessment pursuant to section 7 of the Act and section 5 of this order for

use of genetically modified organisms referred to in point 5,

processed by filling in the tables referred to in part C of this annex.



8.2. The result of the risk assessment-risk classification in category



9. the assessment of the premises and facilities of the workplace according to the enclosed

space and the protective measures laid down for the category of risk

Annex No 4 to this Ordinance



(+) Comparative table of requirements for the workplace



10. data on waste management for the workplace



(waste water, hazardous waste and others)



11. the workplace code of conduct



(+) Workplace code of conduct according to annex No 4 to the Act



12. the observations of the expert advisor



Part 2



MODEL OF RISK EVALUATION FOR CONTAINED USE, THE FIRST RISK CATEGORY

SUBMITTED PURSUANT to section 16a para. 4 of the law



(Section 16a, paragraph 4, of the Act)



Date of submission



1. A link to the notice filed pursuant to section 16 para. 3 of the law



1.1. reference number



1.2. Date of submission



1.3. Risk category



2. Newly used genetically modified organisms

I-------------------------I-----------I-------------------------I------------I

And the recipient/parent and donor and The gen/I Vector and

(I) the organism; possibly even insert/exempted gen; I I

And a group of recipients and, where applicable, their group I I

I/parental organisms I I I I

I-------------------------I-----------I-------------------------I------------I

I I I I I

I-------------------------I-----------I-------------------------I------------I

I I I I I

I-------------------------I-----------I-------------------------I------------I



3. Risk assessment



3.1. Summary of the risk assessment of the contained uses with the newly used

genetically modified organisms pursuant to section 7 of the Act and section 5 of this

the Decree, processed by filling in the tables referred to in part C of this annex



3.2. the outcome of the risk assessment-risk classification in category



4. the observations of the expert advisor



Part 3



MODEL NOTICE OF CONTAINED USE OF OTHER RISK CATEGORIES



[To section 16 para. 6 (b)) law]



Date of submission



1. the person giving the notice (hereinafter the "notifier")



1.1. The name or business name of the Notifier is a natural

a person authorized to do business



1.2. The name or business name and legal form, if the notifier

legal person



1.3. nationality (for natural persons)



1.4. the registered address and home address (for natural persons)



1.5. IDENTIFICATION NUMBER (if assigned)



1.6. the names of the persons who are members of the statutory body of the notifier,

If Notifier is a legal person, with an indication of the way in which

the notifier shall represent the



2. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



2.1. Name, academic title



2.2. the Occupation or employer, and job title



2.3. Education



2.4. Training courses



2.5. Current practice



2.6. Address of residence



2.7. the phone



2.8. E-mail



3. the contact person at the workplace, if different from the professional advisor



3.1. Name, academic title



3.2. the phone



3.3. Email



4. the Purpose of the contained use-the nature of the activities, which will be provided by the notifier

carried out (research, training, detection, production, etc.)



5. the site where the contained use will be



5.1. workplace Address



5.2. the nature of the workplace:



5.2.1. microbiology/molecular-genetic laboratory



5.2.2. demonstration



5.2.3. production facilities



5.2.4. greenhouse/culture room



5.2.5. breeding animals



5.2.6. other (that uniquely identifies the description of the workplace, such as

handling spaces, means of transport)



(+) Plan of the rooms, the floors and the area showing locations relevant to the

limit the consequences of any possible accident (the main driver of energy supply and

assistive media, the place of storage of genetically modified organisms,

security features of the closure area, location of resources for averting

the crash or its consequences)



(+) Proof of accreditation by other legislation in the

the case of breeding facilities for animals ^ 8)



6. Used genetically modified organisms



6.1. Overview of the use of genetically modified organisms

I-------------------------I----------------I----------------I----------------I

And the recipient/parent and donor and Gene/insert and Vector and

And organism I I I I

I-------------------------I----------------I----------------I----------------I

I I I I I

I-------------------------I----------------I----------------I----------------I

I I I I I

I-------------------------I----------------I----------------I----------------I



6.2. data for any genetically modified organism



6.2.1. data about, unlike the organism, including its origin



6.2.2. The recipient information and the parent organism, including their origin



6.2.3. the vector data, including its origin



6.2.4. the data on insertu



6.2.5. the Method of injecting insertu



6.2.6. The specification of the resulting genetically modified organism



6.2.7. the function brought by or exempted by genes



6.2.8. the method of detection and control of the presence of genetic modification,

including methods of identification of a genetically modified organism




6.2.9. The approximate amount of genetically modified organisms, which has

be used (the volumes of the cultures, the numbers of plants or animals)



6.2.10. the data about whether genetically modified organism has already been

approved in another State and for what purposes



7. Risk assessment



(+) The risk assessment under section 7 of the Act and section 5 of this order, processed

by filling in the tables referred to in part C of this annex for each

genetically modified organism separately



7.1. the outcome of the risk assessment-risk classification in category



8. assessment of the premises and facilities of the workplace according to the enclosed

space and the protective measures laid down for the category of risk

Annex No 4 to this Ordinance



(+) Comparative table of requirements for the workplace



9. Description of the handling of genetically modified organism



5.7. in the case of imports or exports of genetically modified organism

intended for contained use



9.1.1. the State of origin, or destination



9.1.2. Importer or exporter



9.1.3. The maximum amount of a genetically modified organism, which has

be imported or exported



9.1.4. Shipping method



9.1.5. the method of packaging and labelling



9.2. Description of the handling of genetically modified organisms in accordance with the

risk evaluation



9.3. Measures to protect public and animal health, the environment and

biological diversity



9.4. the frequency and method of carrying out the checks occurrence of genetically

GMOs both inside and outside the closed area



9.5. Disposal of genetically modified organisms and control

its effectiveness



9.6. A description of the waste management (waste water, waste gas emissions,

other hazardous waste)



10. the workplace code of conduct



(+) Workplace code of conduct according to annex No 4 to the Act



11. the emergency response plan



(+) Emergency plan in accordance with annex 5 to this notice



12. additional information



12.1. The location where documentation on the use of genetically modified

organisms held under section 19 (a). (b)) of the Act



12.2. staff training Plan before you start dealing with genetically

modified organisms and their subsequent training



13. the observations of the expert advisor



Part 4



MODEL NOTICE OF CONTAINED USE OF SECOND CATEGORY OF RISK PRESENT

Under section 16a, PARAGRAPH 2. 5 of law



(Section 16a, paragraph 5, of the Act)



Date of submission



1. the reference to the prior notice of the contained use of second category

the risk of



1.1. reference number



1.2. Date of submission



2. Newly used genetically modified organisms



2.1. Overview of the newly used genetically modified organisms

I-------------------------I----------------I----------------I----------------I

And the recipient/parent and donor and Gene/insert and Vector and

And organism I I I I

I-------------------------I----------------I----------------I----------------I

I I I I I

I-------------------------I----------------I----------------I----------------I

I I I I I

I-------------------------I----------------I----------------I----------------I



2.2. data for each newly used genetically modified organism



2.2.1. information about, unlike the organism, including its origin



2.2.2. The recipient information and the parent organism, including their origin



2.2.3. the vector data, including its origin



2.2.4. data on insertu



2.2.5. in the case of Method insertu



2.2.6. The specification of the resulting genetically modified organism



2.2.7. the function brought by or exempted by genes



2.2.8. method of detection and control of the presence of genetic modification,

including methods of identification of a genetically modified organism



2.2.9. The approximate amount of genetically modified organisms, which has

be used (the volumes of the cultures, the numbers of plants or animals)



2.2.10. the data about whether genetically modified organism has already been

approved in another State and for what purposes



3. Risk assessment



(+) The risk assessment under section 7 of the Act and section 5 of this order, processed

by filling in the tables referred to in part C of this annex for each newly

used genetically modified organism separately



3.1. the outcome of the risk assessment-risk classification in category



4. Description of the handling of genetically modified organism



4.1. in the case of imports or exports of genetically modified organism

intended for contained use



4.1.1. the State of origin, or destination



4.1.2. the importer or exporter



4.1.3. The maximum amount of a genetically modified organism, which has

be imported or exported



4.1.4. The transport method



4.1.5. the method of packaging and labelling (article 11, paragraph 1, of the Act)



4.2. Description of the handling of genetically modified organisms in accordance with the

risk evaluation



4.3. Measures to protect public and animal health, the environment and

biological diversity



4.4. the frequency and method of carrying out the checks occurrence of genetically

GMOs both inside and outside the closed area



4.5. the method of disposal of genetically modified organisms and control

its effectiveness



4.6. Description of the waste management (waste water, waste gas emissions,

other hazardous waste)



5. workplace code of conduct



(+) Workplace code of conduct according to annex No 4 to the Act



6. the emergency response plan



(+) Emergency plan in accordance with annex 5 to this notice



7. additional information



7.1. Location where documentation on the use of genetically modified

organisms held under section 19 (a). (b)) of the Act



7.2. staff training Plan before you start dealing with genetically

modified organisms and their subsequent training



8. observations of the expert advisor



PART (B)



MODEL APPLICATION FOR THE GRANT OF AUTHORIZATIONS FOR THE CONTAINED USE OF A THIRD OR

THE FOURTH RISK CATEGORY



[To section 16, paragraph 3 (b), (c)) of the Act]



Date of submission



1. the applicant shall



1.1. The name or business name of the Notifier is a natural

a person authorized to do business



1.2. The name or business name and legal form, if the notifier

legal person



1.3. nationality (for natural persons)



1.4. the registered address and home address (for natural persons)



1.5. IDENTIFICATION NUMBER (if assigned)



1.6. the names of the persons who are members of the statutory body of the notifier,

If Notifier is a legal person, with an indication of the way in which

the notifier shall represent the



2. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



2.1. Name, academic title



2.2. the Occupation or employer, and job title



2.3. Education



2.4. Training courses



2.5. Current practice



2.6. Address of residence



2.7. the phone



2.8. E-mail



3. the contact person at the workplace, if different from the professional advisor



3.1. Name, academic title



3.2. the phone



3.3. Email



4. the site where the contained use will be



4.1. Address



4.2. the nature of the workplace:



4.2.1. microbiology/molecular-genetic laboratory



4.2.2. demonstration



4.2.3. production facilities



4.2.4. greenhouse/culture room



4.2.5. breeding animals



4.2.6. other (that uniquely identifies the description of the workplace, such as

handling spaces, means of transport)



4.3. Description of the location of the space for contained use and technical description

their device



(+) Plan of the rooms, the floors and the area showing locations relevant to the

limit the consequences of any possible accident (the main driver of energy supply and

assistive media, the place of storage of genetically modified organisms,

security features of the closure area, location of resources for averting

the crash or its consequences)



(+) Proof of accreditation, and the project attempts by other legal

prescription ^ 8) in the case of breeding facilities for animals



5. The purpose and duration of the contained use



5.1. The purpose of the contained use-the nature of the work, the applicant will

carried out (research, training, detection, production, etc.)



5.2. The expected outcome of the contained use



5.3. The total duration of the contained use, and the date of its expected

begin if contained use divided into intermediate stages also time

their duration and the date of their expected start



6. data on (A) Unlike the organism, (B) to the recipient, or, where this is

applicable (C) parent organism (specify for A, B, C)



6.1. The body is:



6.1.1. the minimum



6.1.2. RNA virus



6.1.3. DNA virus



6.1.4. bacteria



6.1.5. sponge (fibrous mikromyceta, yeast)



6.1.6. higher plant



6.1.7. animal



6.1.8. another organism (Advanced)



6.2. The Czech and Latin genus and species name of the organism with the exact

by specifying the cultivar (variety, race, breed, lineage, the forms of hybrid, strain,

patovaru)



6.3. origin (collection, collection number, vendor)



6.4. Please state whether the organism pathogenic or harmful in any other way

(alive or inanimate, including extra-cellular products).



If Yes, please indicate whether for people, animals, plants or

otherwise. Always uniquely identify the harm.




Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



6.4.1. pathogenicity: infectivity, infectivity, virulence



6.4.2. allergenic effects



6.4.3. toxic effects



6.4.4. carrier of the pathogen



6.4.5. possible vectors, host range including non-target organism



6.4.6. the possibility of activation of latent viruses (proviruses)



6.4.7. the ability to penetrate into other organisms or to colonize other

organisms



6.4.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



6.4.9. other (unique characteristics)



6.5. The natural occurrence of the organism,



6.6. Data about whether the natural exchange of hereditary material

between the donor and recipient organism



7. Information on the genetic modification



7.1. The type of genetic modification:



7.1.1. in the case of the hereditary material of extraneous



7.1.2. the exclusion of part of the hereditary material



7.1.3. the combination of exemption and, in the case of hereditary material



7.1.4. cell fusion



7.1.5. another (uniquely identify)



7.2. The intended result of the genetic modification



7.3. Information about the vector, if one was when the genetic modification

used



(+) A genetic map of the vector



7.3.1. data about whether the vector is present in whole or in part

the final GMO



7.3.2. A vector type:



7.3.2.1. plasmid



7.3.2.2. Bacteriophage



7.3.2.3. virus



7.3.2.4. cosmid



7.3.2.5. phasmids



7.3.2.6. transposon



7.3.2.7. another object (clearly identify)



7.3.3. the vector Identity



7.3.4. Host range vector



7.3.5. the presence of the vector sequence that passes the selection

(a selectable) or identifiable Phenotype:



7.3.5.1. resistance to antibiotics (indicate the exact name of the active substance)



7.3.5.3. resistance to heavy metals



7.3.5.3. resistance to pesticides (Please indicate the exact name of the active substance)



7.3.5.4. fault other (clearly identify)



7.3.5.5. another (uniquely identify)



7.3.6. the method of injecting the vector into the recipient organism:



7.3.6.1. transformation



7.3.6.2. elektroporace



7.3.6.3. makroinjekce



7.3.6.4. mikroinjekce



7.3.6.5. biolistický transmission



7.3.6.6. infections (agrobakteriální, virus)



7.3.6.7. other (clearly identify)



7.3.7. partial fragments of the vector, and their presence in the final

genetically modified organism



7.4. If no genetic modification used vector method of injecting

insertu into the recipient organism:



7.4.1. the transformation of



7.4.2. mikroinjekce



7.4.3. microencapsulation



7.4.4. makroinjekce



7.4.5. biolistický transmission



7.4.6. other (clearly identify)



8. the insertu (data 8. 1. up to 8. 3. can be summarised in the table and

attach a genetic map insertu)



8.1. The composition of the insertu



8.2. each part of insertu Source



8.3. The intended function of each constituent parts insertu in the resulting genetically

modified organism



8.4. The location of insertu on the final GMO:



8.4.1. on free plasmid



8.4.2. the insert integrated into the chromosome



8.4.3. other (Please specify)



8.5. the Details about whether the insert statement contains a section, whose products or

features are not known



5.3. information on whether the sequence contained in the insertu any

role of pathogenic or harmful characteristics

the donor organism or vector



9. information on the final GMO



9.1. Specification of the resulting genetically modified organism



9.2. the genetic characteristics and phenotypic characteristics of the beneficiary or

parental organism that have changed as a result of genetic

modification of the



9.2.1. information on whether the genetically modified organism distinguishes

from the recipient or parental organism for its ability to survive



9.2.2. information on whether the genetically modified organism distinguishes

from the recipient or parental organism manner or speed

reproduction



9.2.3. information on whether the genetically modified organism distinguishes

from the recipient or parental organism for its ability to spread in

environment



9.3. Genetic stability of the GMO



9.4. Indicate whether the GMO pathogenic or

otherwise harmful (alive or inanimate, including extra-cellular

products).



If Yes, please indicate whether for people, animals, plants or

otherwise. Harmfulness always unambiguously identify



9.5. Description of identification and detection methods of genetically modified

organisms



9.5.1. Enabling unique identification of the modified section

hereditary material



9.5.2. the procedures for detecting the presence of genetically modified

organisms, including their clear identification methods



10. Risk assessment



(+) The risk assessment under section 7 of the Act and section 5 of this order, processed

by filling in the tables referred to in part C of this annex for each of the genetically

modified organism separately



10.1. the outcome of the risk assessment-risk classification in category



11. the assessment of the premises and facilities of the workplace and its location by

enclosed space requirements and protective measures as provided for

the final category of risks Appendix No. 4 to this Ordinance



(+) Comparative table of the requirements for the category of risk and

the actual equipment of the workplace



12. Description of the contained use



12.1. in the case of imports or exports of genetically modified organism

intended for contained use



12.1.1. the State of origin, or destination



12.1.2. the importer or exporter



12.1.3. Maximum amount of genetically modified organism, which has

be imported or exported



12.1.4. Shipping method



12.1.5. the method of packaging and labelling (article 11, paragraph 1, of the Act)



12.2. A description of the handling of genetically modified organisms in accordance with the

risk evaluation



12.3. the measures to protect the health of humans, animals, the environment and

biological diversity



12.4. protection of workers ' health at work in accordance with other legal

^ regulations 9)



12.5. Details of carrying out the checks occurrence of genetically

modified organisms



12.5.1 metric method and the frequency of application controls within the confined space



12.7.2. method and frequency of carrying out checks outside the confined space



12.6. the disposal of genetically modified organisms and control

its effectiveness



12.7. A description of the waste management (waste water, waste gas

pollutants, hazardous and other wastes)



13. the workplace code of conduct



(+) Workplace code of conduct according to annex No 4 to the Act



14. the emergency response plan in accordance with annex 5 to this notice



15. additional information



15.1. The location where documentation on the use of genetically modified

organisms held under section 19 (a). (b)) of the Act



15.2. staff training Plan before you start dealing with genetically

modified organisms and their subsequent training



16. observations of the expert advisor



PART (C)



MODEL OF RISK EVALUATION PROCEDURE OF THE CONTAINED USE



(Section 7 (6) of the Act)



Table 1. The risk characterisation of the waste with the investigational GMO-options

I----------------I-----------------------------I-----------------------------I

The source of the risk and the nature of the risk and potential harmful effects and

I----------------I-----------------------------I-----------------------------I

And the recipient as well as Pathogenic micro-organism and Infection and

I----------------I-----------------------------I-----------------------------I

Even the presence of viral genes and the emergence of the term of Office of the virus, and

I I I the cancer transformation and

I----------------I-----------------------------I-----------------------------I

(I) the parent and Pathogenic micro-organism and Infection and

And organism I I I

I----------------I-----------------------------I-----------------------------I

Even donor and Pathogenic micro-organism and Infection, increased virulence and

Even a link function and even

I cloned the gene with the I I

(I) toxicity, pathogenicity or I I

I I I I the virulence

I----------------I-----------------------------I-----------------------------I

I Pasted I Cloned the gene for toxin and Toxin Exposure and

And gene/insert I I I

I----------------I-----------------------------I-----------------------------I

I Cloned the gene for even an allergic reaction and

And even a potential allergen and even

I----------------I-----------------------------I-----------------------------I

I Cloned the gene whose function and pathogenic effect, increased and

I even linked to pathogenicity or virulence and I

I I I I the virulence

I----------------I-----------------------------I-----------------------------I

I Exempt gen and Deletions of the gene and the creation of harmful product and

I----------------I-----------------------------I-----------------------------I

As well as Vector and genes for resistance and horizontal gene transfer and

Even antibiotics even for resistance even

I----------------I-----------------------------I-----------------------------I

As well as other genes contained in even horizontal gene transfer and

I I I I vector


I----------------I-----------------------------I-----------------------------I

Even Intermediate and Pseudovirová particles (when both the human and the Transduction

Even loading and use of retrovirových and the genome, cancer and

I even vectors) and the transformation of cells and

I----------------I-----------------------------I-----------------------------I

I I Shotgun cloning of the genome as well as the possibility of toxigenic and

And even unknown organisms and virulent strains and even

I----------------I-----------------------------I-----------------------------I

And the resulting emergence of a new pathogenic and even pathogenic effect, increased and

Both genetically and virulent or virulence, toxigenita, and

I also modified the body of toxin-producing, and resistance

And even the emergence of resistant strain of the organism as well as antibiotics or other (I)

And even with antibiotics and medicines, as well as

I----------------I-----------------------------I-----------------------------I

The place and the extent and the biotechnology process and horizontal gene transfer to the I

Even loading and even other organisms and

I----------------I-----------------------------I-----------------------------I



Table 2. The next steps of the risk assessment-options

I--------------I--------------------------------------------------------------I---------I-----------I

Even the effects and potential harmful effects and the estimation and Classification and

Even the management of I-----------------------I-------------------I------------------Irizika and I

And Identification of GMOS and also an assessment of the probability of a, I, category I

And of the products and the effects of even that threat I I I

I I I I I I I it occurs

I--------------I-----------------------I-------------------I------------------I---------I-----------I

Direct and potential allergen and Allergenic response and low and low 1 and

I I-----------------------I-------------------I------------------I---------I-----------I

And even infectious agents and Infection in Central Istřední I 2 I

I I-----------------------I-------------------I I I I

And even Toxin and harmful to I I I I

I I I man and animals I I I I

I I-----------------------I-------------------I------------------I---------I I

I I I Potential Transduction of very low Inebylo I I

I I pseudovirovou I and Ipopsáno I and malignant

(I) particle, integration and transformation I I I I

Even gene into the genome and somatic cells I I I I

Even I (retrovirové vectors) I I I I I

I--------------I-----------------------I-------------------I------------------I---------I-----------I

As well as indirect and potential allergen and Allergenic reactions and medium and low I 2 I

I I-----------------------I-------------------I I I I

And even Toxin and harmful to I I I I

I I I man and animals I I I I

I I-----------------------I-------------------I I I I

And even resistance to the restrictions options I I I I

Even antibiotics and treatments I I I I

I--------------I-----------------------I-------------------I------------------I---------I-----------I

And immediate and potential allergen and Allergenic response and low and low 1 and

I I-----------------------I-------------------I------------------I---------I-----------I

And even harmful to the Toxin and Central Istřední I 2 I

I I I man and animals I I I I

I--------------I-----------------------I-------------------I------------------I---------I-----------I

Delayed and also reduce the potential for resistance and low and low 1 and

I or I antibiotics and treatments I I I I

And the cumulative I---------------------I-------------------I I I I

And even Affecting both natural and Diarrheal I I I I

(I) microflora of the human disease I I I I

Even the organism I I I I I

I I-----------------------I-------------------I------------------I---------I-----------I

Even the extension in the environment and affecting the very low and very I 1 I

I I I I I also low diversity and

I I-----------------------I-------------------I------------------I---------I-----------I

I I I Potential Transduction of very low and it was not even 2 I

I I pseudovirovou I Ipopsáno is a part I I

Transfection and transformation I I I I I

I I DNA, adenovirovou and somatic cells I I I I

And even recombination with the I I I I I

Latent adenovirus I I I I I I I

I--------------I-----------------------I-------------------I------------------I---------I-----------I

And Installation in the Installation in the water and even influence the quality and unlikely to even very I 1 I

And the environment and the soil and water affecting even low I I

I I I I I I I diversity

I--------------I-----------------------I-------------------I------------------I---------I-----------I

And the impact on and Affect both natural and Diarrheal and not described very well 1 and

And the dynamics of the microflora of the human disease and even the low I I

Even stocks and even the organism I I I I I

(I) genetic I---------------------I-------------------I I I I

The diversity and introduction and even affecting the I I I I

I I extrusion both natural and diversity I I I I

I I I I I I population and

I I-----------------------I-------------------I I I I

And even affecting the ecosystems and affecting the I I I I

I I I I I I I diversity

I--------------I-----------------------I-------------------I------------------I---------I-----------I

(I) phenotypic and even the loss and reconstruction of some middle and low and I 1 I

(I) genetic diversity and a plasmid which is I I I I I

And instability I-----------------------I-------------------I I I I

I I I the emergence of wild Complementation deletions I I I I

I I I I I I I trunk

I--------------I-----------------------I-------------------I------------------I---------I-----------I

And interaction with and transfer of plasmid and Affecting even low and very I 1 I

And even cloned organisms and diversity as well as the low and I

And even to direct/genes I I I I I

I I-----------------------I-------------------I I I I

And even Toxin and harmful to I I I I

I I I man and animals I I I I

I I-----------------------I-------------------I I I I

I I I I I I I

I--------------I-----------------------I-------------------I------------------I---------I-----------I

And the natural and the transfer of plasmids and Affecting even low and low 1 and

(I) transfer and cloned and diversity I I I I

And even to direct/genes I I I I I

I I-----------------------I-------------------I I I I

I I I I I I I

I--------------I-----------------------I-------------------I------------------I---------I-----------I



Annex 2 to the Decree No 209/2004 Coll.



Patterns of applications for the grant of authorisation for entry into the environment



Documents marked with



(+)

It is necessary to attach as a separate attachment



All relevant documents must be identified by name or title

(trade name) of the applicant.



The data that make up the summary of the contents of the request for publication, are

underlined.



PART AND



PATTERNS OF APPLICATIONS FOR THE GRANT OF AUTHORISATION FOR PLACING INTO THE ENVIRONMENT FOR

PURPOSES OTHER THAN CLINICAL EVALUATION OF MEDICINAL PRODUCTS



Part 1



MODEL APPLICATION FOR A GENETICALLY MODIFIED ORGANISM, OTHER THAN A HIGHER

PLANT



[To section 17, paragraph 3 (b)) law]



Date of submission



1. Project name



2. the applicant



2.1. name or company name or business, when the applicant is a natural

a person authorized to do business



2.2. The name or business name and legal form, when the applicant is

legal person



2.3. nationality (for natural persons)



2.4. Registered address and home address (for natural persons)



2.5. IDENTIFICATION NUMBER (if assigned)



2.6. the names of the persons who are members of the statutory body of the applicant, if

the applicant legal person, with an indication of the way in which the applicant shall represent the



3. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7)



3.1. Name, academic title




3.2. Occupation or employer, and job title



3.3. Education



3.4. Training courses



3.5. the current practice



3.6. Address of residence



3.7. the phone



3.8. E-mail



4. the contact person at the workplace, if different from the professional advisor



4.1. Name, academic title



4.2. the phone



4.3. E-mail



5. The purpose of entry into the environment



6. the period of entry into the environment



6.1. The total duration of the placing of the GMO into

the environment and the date of its expected start



6.2. Binding timetable (breakdown of the intermediate stages, the date

their anticipated start and their duration)



7. the applicant plans to placing the same genetically modified organism

into the environment in a Member State of the European Union or

outside its territory?



If Yes, please indicate:



7.1. the State in which the applicant is planning to marketing to the environment,



7.2. estimated time of commencement and duration of entry into the

environment.



8. the applicant has submitted an application for marketing the same GM

the organism into the environment in another Member State of the European Union?



If Yes, please indicate:



8.1. the State in which the application was lodged,



8.2. the date of filing and the application number or other designation,



8.3. date and designation of permit, if issued, bvlo



8.4. the period for which the authorisation applies.



9. the applicant has submitted an application for marketing the same GM

the organism into the environment or on the market outside the European Union?



If Yes, please indicate:



9.1. the State in which the application was lodged,



9.2. the date of filing and the application number or other designation,



9.3. the date and indicate the permit, if issued,



9.4. the period for which the authorisation applies.



10. the assessment of the risk of a genetically modified organism into the

of the environment



(+) The risk assessment under section 7 of the Act and section 5 of this order, including

documentation of the results of a previous entry into the environment,

especially in terms of the different scope of activity and different beneficiary

ecosystems



10.1. A summary of the risk assessment



11. characteristics of the genetically modified organism



11.1. A genetically modified organism is:



11.1.1. viroid



11.1.2. RNA virus



11.1.3. DNA virus



11.1.4. bacteria



11.1.5. sponge (fibrous mikromyceta, yeast)



11.1.6. other micro-organism



11.1.7. mammal



11.1.8. insects



11.1.9. fish



11.1.10. another animal (indicate class)



11.1.11. another body (Please specify)



11.2. The Czech and Latin genus and species name of the genetically modified

the organism with accurate race (breed, forms, strain, cell lines,

patovaru)



11.3. Genetic stability



11.3.1. Measures to ensure genetic stability and factors that

affecting it



11.3.2. Authentication methods, genetic stability



11.3.3. Description of inheritable properties to exclude or restrict the

extension of the genetic material



12. the data about the recipient, or (where applicable) for parent

the organism



12.1. The body is:



12.1.1. viroid



12.1.2. RNA virus



12.1.3. DNA virus



12.1.4. bacteria



12.1.5. sponge (fibrous mikromyceta, yeast)



12.1.6. animal (indicate class)



12.1.7 update another body (Please specify)



12.2. The Czech and Latin genus and species name of the organism with the exact

by specifying the race (breed, forms, strain, cell lines, patovaru)



12.3. the origin (collection, collection number, vendor)



12.4. Plasmids (in the case of micro-organisms)



12.5. the Phages (in the case of micro-organisms)



12.6. Phenotypic and genetic marker characters



12.7. Degree of relatedness between donor and recipient organism



12.8. The presence and living conditions



12.8.1. Geographic distribution



12.8.1.1. original or established in the Czech Republic



12.8.1.2. original or established in countries of the European Union



12.8.1.3. If the organism is original in the Czech Republic or in countries

The European Union, indicate the ecosystem in which it is located:



Atlantic 12.8.1.3.1.



12.8.1.3.2. the Mediterranean,



12.8.1.3.3. boreal



12.8.1.3.4. forest fires



Continental 12.8.1.3.5.



12.8.1.3.6. another (uniquely identify)



12.8.2. The body is commonly used in the Czech Republic?



12.8.3. The body is commonly grown (bred) in the Czech Republic?



12.8.4. Habitat (natural birds) of the organism:



12.8.4.1. aquatic environment



12.8.4.2. land, wild



12.8.4.3. the land in connection with the root system of plants



12.8.4.4. in conjunction with the above-ground parts of plants



12.8.4.5. in conjunction with the animals



12.8.4.6. other (clearly identify)



If the organism is an animal, please provide natural habitat or usual

ecosystem.



12.9. The methods of identification and detection of the organism



12.9.1. Detection methods, including data on their sensitivity, reliability,

and specificity



12.9.2. Identification methods, including data on their sensitivity,

reliability and specificity



12.10. The body is included under other legislation

relating to the protection of the health of workers at work ^ 10)?



If Yes, please indicate the applicable group.



12.11. Indicate whether the organism pathogenic or harmful in any other way

(alive or inanimate, including extra-cellular products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



12.11.1. pathogenicity: infectivity, infectivity, virulence



12.11.2. allergenic effects



12.11.3. toxic effects



12.11.4. carrier of the pathogen



12.11.5. possible vectors, host range including non-target organism



12.11.6. possibility of activation of latent viruses (proviruses)



12.11.7. the ability to penetrate into other organisms or to colonize other

organisms



12.11.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



12.11.9. other



12.12. Reproduction



12.12.1. Generation time in natural environment



12.12.2. Generation time in the ecosystem, in which genetically

modified organism is placed



12.12.3. method of reproduction (sexual, asexual)



12.12.4. Specific factors affecting reproduction (if

There are)



12.13. Survivability



12.13.1. Ability to create durable surviving forms:



12.13.1.1. seeds



12.13.1.2. endospores



12.13.1.3. cysts



12.13.1.4. pieces



12.13.1.5. asexual spores (fungi)



12.13.1.6. sexual spores (fungi)



12.13.1.7. eggs



12.13.1.8. the helmet



the larvae of the 12.13.1.9.



12.13.1.10. other (clearly identify)



12.14. The dissemination in the environment



12.14.1. the method and scope of the dissemination of



12.14.2. Specific factors affecting dissemination, if any



12.15. Natural predators, prey, parasites and competitors, symbionts and

hosts



12.16. Other potential interactions with other organisms



12.16.1. other specific factors allowing survival



12.16.2. Survivability in the different seasons of the year



12.17. mezibuněčný Possible transfer of genetic material between donor

(parental organism) and other organisms



12.17.1. Transmission method (with the plasmid, bakteriofágem, otherwise)



12.17.2. Organisms with which is a natural exchange of genetic

material



12.18. verification of the genetic stability of the organisms and factors that

affecting it



12.19. involvement in environmental processes:



12.19.1. primary production



12.19.2. conversion of nutrients (consumer, predator)



12.19.3. decomposition of organic matter



12.19.4. other (clearly identify)



12.20. The custom vector organism



12.20.1. Sequence vector



12.20.2. frequency of mobilisation of the vector



12.20.3. Specificity of the vector



12.20.4. the presence of vector resistance genes



12.10. Previous genetic modifications of the recipient or parental

body authorised in the Czech Republic (including date and number

decision)



13. information on the genetic modification



13.1. The type of genetic modification:



13.1.1. the introduction of extraneous hereditary material



13.1.2. the exclusion of part of the hereditary material



13.1.3. the combination of exemption and, in the case of hereditary material



13.1.4. cell fusion



13.1.5. another (uniquely identify)



13.2. The intended result of the genetic modification



13.3. When genetic modification used vector?



If the vector has not been used, point 13. 4.



13.3.1. The vector wholly or partially present in the resulting genetically

modified organism?



If the vector is not even partially present, proceed to step 13. 5.



13.3.2. Vector type:



13.3.2.1. plasmid



13.3.2.2. Bacteriophage



13.3.2.3. virus



13.3.2.4. cosmid



13.3.2.5. phasmids



transposon 13.3.2.6.



13.3.2.7. another object (clearly identify)



(+) vector map



13.3.3. identity of the vector (origin)



13.3.4. Host range vector



13.3.5. the presence of the vector sequence that passes the selection

(a selectable) or identifiable Phenotype:



13.3.5.1. resistance to antibiotics (indicate the exact name of the active substance)



13.3.5.2. resistance to heavy metals



13.3.5.3. resistance to pesticides (indicate the exact name of the active substance)



13.3.5.4. another (uniquely identify)




13.3.6. partial fragments of the vector, and their presence in the final

genetically modified organism



13.3.7. Method of injecting the vector into the recipient organism:



13.3.7.1. the transformation of



13.3.7.2. elektroporace



13.3.7.3. makroinjekce



13.3.7.4. mikroinjekce



13.3.7.5 infections



13.3.7.6. other (Please specify)



13.3.8. Details on how far the vector is limited to the sequence

nucleic acids, needed to ensure the intended function, and whether it contains

a sequence whose product or function are not known



13.4. If there has not been genetic modification used vector method

injecting insertu into the recipient organism:



13.4.1. transformation



13.4.2. mikroinjekce



13.4.3. microencapsulation



13.4.4. makroinjekce



13.4.5. (uniquely identify)



13.5. The methods and criteria used for the selection of



14. data on insertu



14.1. details of any part of the insertu, where appropriate, on each set aside part of the

the hereditary material, with particular reference to any known harmful

sequences



14.1.1. The size of the



14.1.2. Sequence



14.1.3. the origin of



14.1.4. Functional characteristics



14.2. The location of the insertu in the body of the recipient:



14.2.1. on free plasmid



14.2.2. the insert integrated into the chromosome



14.2.3. other (clearly identify)



14.3. Contains the insert part, whose products or features are not known?



If Yes, please specify.



14.4. Data about how far it is limited to insert a sequence of nucleic

acids, needed to ensure the intended function



14.5. information on whether the sequence contained in the insertu involved in

in any way on the pathogenic or harmful characteristics

the donor organism or vector



14.6. the structure and the size of each segment of nucleic acid originating in

the vector or the donor organism, which remained in the final genetically

modified organism, including the methods and data needed to identify

and detection of the inserted sequence



9.1. In the event of the exclusion of part of the hereditary material (deletion) size and

function of nucleic acid Department exempted



9.2. The number of copies of the inserted hereditary material



9.3. the hereditary stability of the inserted material and the stability of its location



15. Unlike the organism (organism, from which the insert is

derived)



15.1. The donor organism is:



15.1.1. viroid



15.1.2. RNA virus



15.1.3. DNA virus



15.1.4. bacteria



15.1.5. sponge (fibrous mikromyceta, yeast)



15.1.6. other micro-organism



15.1.7. animal (indicate class)



15.1.8. another organism (specify which)



15.2. The Czech and Latin genus and species name of the donor organism with

accurate cultivar (variety, race, breed, lineage, forms,

the hybrid, strain, patovaru)



15.3. Please indicate whether ie dárcovskv organism pathogenic or otherwise

malicious (alive or inanimate, including extra-cellular products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



15.3.1. pathogenicity: infectivity, infectivity, virulence



15.3.2. allergenic effects



15.3.3. toxic effects



15.3.4. carrier of the pathogen



15.3.5. possible vectors, host range including non-target organism



15.3.6. possibility of activation of latent viruses (proviruses)



15.3.7. ability to penetrate into other organisms or to colonize other

organisms



15.3.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



15.3.9 other



15.4. The donor organism classified under other legislation

relating to the protection of the health of workers at work ^ 10)?



If Yes, please indicate the applicable group.



15.5. Exchange recipient and the donor organism genetic material

in a natural way?



16. information on the final GMO



16.1. Description of heritable genetic and phenotypic characters that have been

changed as a result of the genetic modification



16.1.1. Differs genetically modified organism from the recipient in the

survival skills?



If so, clearly identify.



16.1.2. Different, genetically modified organism from the recipient in the

method or rate of reproduction?



If so, clearly identify.



16.1.3. Differs genetically modified organism from the recipient in the

ability to spread?



If so, clearly identify.



16.1.4. a genetically modified organism is different from the beneficiary in

pathogenicity?



If so, clearly identify.



16.2. Genetic stability of the GMO



10.1. the characteristics of the GMO, that affect the

his survival, reproduction and dissemination in the environment



10.2. known or predicted environmental conditions which may

have an effect on survival, multiplication and dissemination (wind, water, soil,

temperature, pH, etc.)



10.3. Sensitivity to specific substances (resources)



10.3. Indicate whether the GMO pathogenic or

otherwise harmful (alive or inanimate, including extra-cellular

products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Familiar with pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



16.6.1. pathogenicity: infectivity, infectivity, virulence



16.6.2. allergenic effects



16.6.3. toxic effects



16.6.4. carrier of the pathogen



16.6.5. possible vectors, host range including non-target organism



16.6.6. possibility of activation of latent viruses (proviruses)



16.6.7. ability to penetrate into other organisms or to colonize other

organisms



16.6.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



16.6.9. other (unique characteristics)



10.4. Description of identification and detection methods of genetically modified

the organism



16.7.1. Methods used for the detection of genetically modified organisms,

including a verified methodology for detecting



16.7.2. The methods used to identify genetically modified

organism in the environment, including the proven methodology of identification, and data on

reliability and sensitivity methods



16.7.3. Enabling unique identification of the modified section

hereditary material



10.4. the embedded Expression of hereditary material



16.8.1. Speed and level of expression of inserted original material,

the life cycle of dependency, where the expression of



16.8.2. Description of the methods of measurement with an indication of their sensitivity



16.8.3. stability of expression



10.5. The expressed protein



16.9.1. Activity of the expressed protein



16.9.2. Description of the methods for the identification and detection of the protein being expressed with

an indication of their sensitivity, specificity and reliability



16.10. The relevant data on the previous cases, the placing of the same

a genetically modified organism into the environment, if any,

in particular, in relation to the potential effects of those activities on human health and the

animals, environment and biodiversity



17. Information on the site, on which it will be put into the environment

take place



17.1. the putting into place of Different environment from the ecosystem, in

the recipient or parental organism usually occur, or

they are grown or cultured?



If Yes, please specify.



17.2. The site and the land on which the entry into the

the environment take place



(+) A copy of the cadastral maps showing the land on which the marketing of

into the environment take place, and a clear plan of the area of cultivation

genetically modified organism with an indication of the use of the surrounding land,

including the type of crops



17.3. The owner of the land, if it is not identical with the applicant, and Contracting

the relationship between the owner and the applicant



17.4. The specification of the land



17.4.1. Region



17.4.2. The municipality



17.4.3. The name of the cadastral territory and parcel number



17.4.4. The identification number of the soil block and possibly part of the soil

the block, if the land subject to registration of agricultural land use in accordance with

another law ^ 11)



17.5. The total area of the areas for which the entry into the

the environment has to be effected (m2)



17.5.1. Current area,



17.5.2. Area of the experimental land (including the insulation zone, and so on).



10.9. the distance of the experimental land from specific territory (in metres

or kilometres)



17.6.1. Specially Protected areas ^ 12)



17.6.2. Dwelling, mansion



17.6.3. Protection of water resources



17.6.4. water flows, water tank



17.6.5. the territory cultivated in organic farming ^ 13)



17.6.6. Other



17.7. The use of the surrounding land, including the crops grown on the adjacent

land (indicate in the plan)



11.1. Flora and fauna, including crops, livestock and

migratory species, which could come into contact with genetically

modified organism



11.1. How to land security:



17.9.1. against unauthorized persons



17.9.2. against the beasts



17.9.3. against splachu



17.10. The size and method of using the isolation zone around the areas

cultivation of genetically modified organisms



17.11. Other methods of elimination or minimization of the spread of the

modified organisms off the experimental plot




17.12. brief description of the usual weather conditions



17.13. the description of the ecosystem at the point of entry into the environment and the

active interference:



17.13.1. soil type



17.13.2. water including irrigation mode



17.13.3. climatic conditions



17.14. Description of ecosystems which could be affected by the



5. any planned changes in the use of the land around the site

putting into the environment, which could be relevant to the action of the

the genetically modified organisms to the environment



18. Description of the handling of genetically modified organism



(+) The methodology of experiments



(+) Emergency plan in accordance with annex 5 to this notice



(+) Workplace code of conduct according to annex No 4 to the Act



18.1. The handling of genetically modified organism before it is placed

into the environment (contained use, transport)



11.3. the procedure that will be inducted into the genetically modified organism

of the environment



18.3. The approximate amount of genetically modified organisms, which has

be used



11.4. The density of the genetically modified organisms (the approximate number of the

M2 or m3)



11.5. the preparation and presentation of the plot before placing the genetically

modified organism into the environment



11.6. the method of transport of a GMO



11.6. How to protect the health of workers in the course of management of genetically

GMO in accordance with other legislation ^ 9)



11.7. the method of cultivation of the genetically modified organism



11.7. the description of the next dealing with genetically modified organisms,

including its disposal



18.10. The term and how to evaluate the marketing of genetically modified

the organism into the environment



19. the information on possible interactions between genetically modified organisms

and the environment and their impact on the environment



19.1. The Czech and Latin genus and species name of the target organism, if

There is, with accurate cultivar (variety, race, breed, lineage,

forms of hybrid, strain, patovaru)



19.2. Anticipated mechanism and result of interaction between the genetically

modified organism reported to the environment and the target

the organism



19.3. Anticipated mechanism and result of interaction with other

organisms in the environment, which may be significant



12.1. It is likely that selection occurs after the

environment, such as. increased competitiveness or invazivnosti

genetically modified organism?



12.1. the possibility of sharp increases in the population of genetically modified

the organism in the environment, and the conditions under which this

the increase could occur



12.2. The path of biological dispersal of genetically modified organism

known or potential modes of interaction with expansion agent



12.2. Types of ecosystems, in which genetically modified organism

It can extend from the point of entry into the environment and in which

may settle



12.3. The name (the Czech and Latin genus and species name with accurate

cultivar-varieties, race, breed, lineage, the forms of hybrid, strain,

patovaru) non-target organism, which, taking into account the nature of the

a receiving environment, may be damaged, marketing of the genetically

modified organism into the environment



12.4. Anticipated mechanism identified adverse interaction between

the GMO with non-target organisms including

of competitors, prey, hosts, symbionts, predators, parasites and

pathogens



19.10. hereditary material transfer capability in vivo



19.10.1. the possibility of the transmission of hereditary material from genetically modified

organism to another organism after the introduction of the genetically modified

the organism into the environment and the consequences of such transfer



19.10.2. the possibility of the transmission of hereditary material from naturally

prevalent organism to the genetically modified organism Mon

the placing of a GMO into the environment and

the consequences of such transfer



19.11. Results of studies the behavior and characteristics of the genetically modified

the organism and its ecological impact carried out in simulated

natural environment



19.12. known or predicted involvement in biogeochemical processes



19.13. Other possible effects on the environment and biodiversity

Diversity (uniquely identify)



20. information on the monitoring of



20.1. the methods of detecting the presence of a genetically modified organism



20.2. Specificity of methods of identification of a genetically modified organism

and the differentiation of a GMO from the donor organism,

the recipient or parental organism; the sensitivity and the reliability of the

These methods



12.6. the methods of monitoring the effects on the ecosystem



12.7. Techniques (methods) detection of embedded transmission of hereditary material

on other organisms



12.7. the area on which the monitoring is carried out (m2)



12.8. The duration of the monitoring



12.9. the frequency of monitoring



21. Information on the measures after the entry into the environment and

about waste management



21.1. Description of the measure after the end of the experiment



13.2. the method of disposal of genetically modified organisms and control

its effectiveness



13.2. the plan of checks and surveillance



13.3. types of waste generated and the foreseeable quantity



13.4. the potential risks arising from waste management



13.4. A description of the disposal of waste and the methods of control of its effectiveness



22. in the case of imports or exports of genetically modified organism

intended solely for entry into the environment (article 25, paragraph 4,

of the Act)



13.7. the State of origin, or destination



13.8. the importer or exporter



13.9. the maximum quantity of genetically modified organisms, which is to be

imported or exported



13.9. Transport method



22.5. the method of packaging and labelling



23. The location where documentation on the use of genetically modified

organisms held under section 19 (a). (b)) of the Act



24. staff training Plan before you start dealing with genetically

modified organisms and their subsequent training



25. the observations of the expert advisor



Part 2



MODEL APPLICATION FOR A GENETICALLY MODIFIED ORGANISM, WHICH IS HIGHER

PLANT



[To section 17, paragraph 3 (a)) of the Act]



Date of submission



1. Project name



2. the applicant



2.1. name or company name or business, if the applicant is a natural person

authorized to do business



2.2. The name or business name and legal form, when the applicant is

legal person



2.3. nationality (for natural persons)



2.4. Registered address and home address (for natural persons)



2.5. IDENTIFICATION NUMBER (if assigned)



2.6. the names of the persons who are members of the statutory body of the applicant, if

the applicant legal person, with an indication of the way in which the applicant shall represent the



3. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



3.1. Name, academic title



3.2. Occupation or employer, and job title



3.3. Education



3.4. Training courses



3.5. the current practice



3.6. Address of residence



3.7. the phone



3.8. E-mail



4. the contact person at the workplace, if different from the professional advisor



4.1. Name, academic title



4.2. the phone



4.3. E-mail



5. characteristics of the handling of genetically modified organism



5.1. The purpose of putting into the environment, such as in particular agronomic

the purpose of the test, the hybridization, changing the ability of survival or propagation or

the discovery of the effects on the target or non-target organisms



6. the period of entry into the environment



6.1. The total duration of the placing of the GMO into

the environment and the date of its expected start



6.2. Binding timetable (breakdown of the intermediate stages, the date

their anticipated start and their duration)



7. the applicant plans to placing the same genetically modified organism

into the environment in a Member State of the European Union or

outside its territory?



If Yes, please indicate:



7.1. the State in which the applicant is planning to marketing to the environment



7.2. estimated time of commencement and duration of entry into the

environment



8. the applicant has submitted an application for marketing the same GM

the organism into the environment in another Member State of the European Union?



If Yes, please indicate:



8.1. the State in which the application was made



8.2. the date of filing and the application number or other designation



8.3. date and designation of permit, if issued



8.4. the period covered by the authorization



9. the applicant has submitted an application for marketing the same GM

the organism into the environment or on the market outside the European Union?



If Yes, please indicate:



9.1. the State in which the application was made



9.2. the date of filing and the application number or other designation



9.3. the date and indicate the permit, if issued



9.4. the period covered by the authorization



10. the assessment of the risk of a genetically modified organism into the

of the environment



(+) The risk assessment under section 7 of the Act and section 5 of this order, including


documentation of the results of a previous entry into the environment,

especially in terms of the different scope of activity and different beneficiary

ecosystems



10.1. A summary of the risk assessment



11. the data about the recipient, or, where applicable, the parent

the organism



11.1. The Czech and Latin genus and species name of the organism, with the exact

by specifying the cultivar (variety, line, hybrid)



11.2. the origin (collection, collection number, vendor)



11.3. Reproduction



11.3.1. method of reproduction



11.3.2. The specific factors affecting reproduction (if

There are)



11.3.3. Generation time



11.3.4. Sexual compatibility with other cultivated or wild species

and the expansion of these compatible species in the Czech Republic



11.4. Survivability



11.4.1. The ability to create structures that allow survival or

dormancy, and the length of the possible survival or dormancy



11.4.2. other specific factors allowing survival, if there are



11.5. The spread of plants in the environment



11.5.1. the method and scope of dissemination (decrease quantity of pollen and seeds in

According to the distance from the source, the force and direction of the wind, the flow of water and

other factors)



11.5.2. Specific factors affecting dissemination, if any



11.6. The geographical distribution of plants



7.3. If the plant is not cultivated in the Czech Republic, a description of the Habitus do

including information on natural konzumentech, pathogens, parasites,

competitors and symbionts



7.3. Other possible relevant interaction with other organisms in plants

the ecosystem in which the plant is usually grown



7.4. Effects on the health of humans, animals and the environment:



11.9.1. toxicity



11.9.2. alergenita



11.9.3. other (clearly identify)



12. information on the genetic modification and the genetically modified higher

plant



12.1. The Czech and Latin genus and species name of genetically modified

higher plants, with accurate cultivar (variety, line, hybrid)



12.2. Description and characteristics of inheritable properties that are inserted

or changed, including signaling and selection genes and the previous

modifications, and a description of their phenotypic manifestations



12.3. The type of genetic modification



12.3.1. The introduction of extraneous hereditary material



12.3.2. The exclusion of part of the hereditary material



12.3.3. The combination of exemption and, in the case of hereditary material



12.3.4. Cell fusion



12.3.5. Other (clearly identify)



12.4. the Properties and origin of the vector (used if the vector when you

genetic modification used)



(+) Map vector



12.5. details of any part of a stretch of DNA that has been introduced into the organism

the recipient (if the genetic modification involves the injecting of hereditary

material)



12.5.1 metric. Origins (the Czech and Latin genus and species name of donor

the organism accurate cultivar-varieties, race, breed, lineage,

forms of hybrid, strain, patovaru)



12.7.2. Functional characteristics



12.5.3. The size of the



12.5.4 Imperial position-if it has been integrated



12.5.5. Sequence



12.6. As regards the exclusion of part of the hereditary material (deletion),

the size and function of the exempted section



12.7. A description of the methods used for the genetic modification



12.8. The location of the inserted material in the plant cell, hereditary (inserted

into chromosomes, chloroplasts, or in a non-integrated form)



12.9. The number of copies of the inserted hereditary material



12.10. the hereditary stability of the inserted material and its stability

the location of the



12.11. Methods for the determination of these data



12.12. the information about the embedded expression of hereditary material



12.12.1. Location where in the plant to the expression of inserted genes (e.g..

roots, stem, leaves, pollen)



12.12.2. changes of expression depending on the life cycle of plants



12.12.3. stability of expression



12.12.4. Methods used for the characterisation of the expression



12.13. the information allowing the unique identification of a genetically

genetically modified higher plants



12.13.1. Description of DNA modified section



12.13.2. Methods for detection and identification of genetically modified higher

plants and their proven methodology



12.14. Behavior of the inserted genes:



12.14.1. the hybridization with the same kind of



12.14.2. when hybridization with distant species



12.15. Clear information about what genetically modified higher

plant differs from the recipient or parental organism:



12.15.1. route and rate of reproduction



12.15.2. the dissemination in the environment



12.15.3. survivability



12.15.4. effects on the health of humans, animals and the environment



12.15.5. other (Please specify)



12.16. Phenotypic stability of the GMHP



12.17. Any change to the ability of genetically modified higher plants

to transfer genetic material to other organisms as a result of genetic

modification



12.18. Information on any possible harmful effects of genetically

the GMHP on human health caused by the genetic

modification of the



12.19. data on the safety of genetically modified higher plants for

animal health, in particular with regard to any harmful effects caused by

through genetic modification, if it has to be genetically modified higher

plants used as animal feed



12.20. Mechanism of interaction between the genetically modified higher

the plant and the target organism, if the target organism exists



12.10. potential changes in the interactions of the GMHP

with non-target organisms resulting from the genetic modification



12.22. Possible interactions of the GMHP with inanimate

the components of the environment



13. The site and the land on which the entry into the

the environment take place



(+) Emergency plan in accordance with annex 5 to this notice



(+) Workplace code of conduct according to annex No 4 to the Act



(+) A copy of the cadastral maps showing land and clear plan in

appropriate scale showing the experimental areas and crops grown on

the surrounding grounds



13.1. The location of the land



13.1.1. Region



13.1.2. The municipality



13.1.3. The name of the cadastral territory and parcel number



13.1.4. Identification number of the soil block and possibly part of the soil

the block, if the land subject to registration of agricultural land use in accordance with

another law ^ 11)



13.2. The owner of the land, if it is not identical with the applicant, and Contracting

the relationship between the owner and the applicant



13.3. The size and land use



13.3.1. The total area of the land



13.3.2. The size and location of the areas for which they are to be genetically

genetically modified higher plants grown (m2)



13.3.3. Size (m2) and the method of using isolation zone around the areas

the cultivation of genetically modified higher plants (indicate in the plan)



13.4. the use of surrounding land



13.5. The distance of the land from the specific territory (metres or

kilometres)



13.5.1. Specially Protected areas ^ 12)



13.5.2. Protection of water resources



13.5.3. water flows, water tank



13.5.4. the territory cultivated in organic farming ^ 13)



13.5.5. Other



13.6. Security land



13.6.1. the land Security against unauthorized persons



13.6.2. the plot against the Security game



13.6.3. plot against the Security splachu



13.7. A description of the location of the land ecosystem



13.7.1. Soil type



13.7.2. water including irrigation mode



13.7.3. Climatic conditions



13.7.4. Flora including agricultural crops



13.7.5. Fauna including economic and migratory animals



8.6. the presence of sexually compatible wild or cultivated

plants on the land and in the surrounding area



13.9. The relevant data relating to the previous cases, the putting into

the environment the same genetically modified higher plants, if

There are, in particular in relation to the potential effects on human and animal health,

environment and biodiversity



14. Description of the handling of genetically modified higher plants



14.1. the use of genetically modified higher plants before

they are putting into the environment (contained use, transport)



14.2. the Preparation and presentation of the land prior to planting the genetically

modified higher plants



14.3. the means of transport of genetically modified higher plants



14.4. the approximate amount of genetically modified higher plants,

to be placed into the environment



14.5. The approximate number of genetically modified higher plants per m2



14.6. the method of cultivation of genetically modified higher plants on the

land



9.1. the method of harvest of genetically modified higher plants



9.2. Description of the further use of genetically modified higher

plants, including samples



9.3. The term and how to evaluate the marketing of genetically modified

higher plants into the environment



14.10. How to protect the health of workers in the course of management of genetically

the GMHP in accordance with other legal

^ regulations 9)



15. Measures to protect the health of people, animals, the environment and

biodiversity and waste management



15.1. the distance areas growing genetically modified higher

plants from the wild or grown sexually compatible species

plants



15.2. Measures to reduce or prevent drift of pollen or seeds,

If they are used



15.3. Description of methods for modifying the site after the end of the experiment



15.4. Monitoring




15.4.1. methods for detecting the presence of genetically modified higher

plants and monitoring its effects on the ecosystem



15.4.2. Specificity of methods of identification of genetically modified higher

plants and differentiate the genetically modified plants from the donor

the body, the recipient, where appropriate, the parental organisms, sensitivity and

the reliability of these methods



15.4.3. Techniques (methods) detection of embedded transmission of hereditary material

on other organisms



15.4.4. the area on which the monitoring is conducted



15.4.5. The duration of the monitoring



15.4.6. frequency of monitoring



15.5. Management of waste, including disposal of genetically modified,

higher plants



15.6. Summary of protective measures



16. summary information on the planned field experiments carried out in

to obtain new information on the impact of the marketing of genetically modified

higher plants into the environment on the health of humans, animals and the

environment



17. the observations of the expert advisor



PART (B)



MODEL APPLICATION FOR THE GRANT OF AUTHORISATION FOR PLACING INTO THE ENVIRONMENT FOR

THE PURPOSES OF A CLINICAL TRIAL OF MEDICINAL PRODUCTS



[To section 17, paragraph 3 (b), (c)) of the Act]



Date of submission



1. Project name



2. the applicant



2.1. name or company name or business, when the applicant is a natural

a person authorized to do business



2.2. The name or business name and legal form, when the applicant is

legal person



2.3. nationality (for natural persons)



2.4. Registered address and home address (for natural persons)



2.5. IDENTIFICATION NUMBER (if assigned)



2.6. the names of the persons who are members of the statutory body of the applicant, if

the applicant legal person, with an indication of the way in which the applicant shall represent the



3. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



3.1. Name, academic title



3.2. Occupation or employer, and job title



3.3. Education



3.4. Training courses



3.5. the current practice



3.6. Address of residence



3.7. the phone



3.8. E-mail



4. the contact person at the workplace, if different from the professional advisor



4.1. Name, academic title



4.2. the phone



4.3. E-mail



5. Information about the medicinal product and treatment procedure



5.1. The medicinal product contains



5.1.1. a genetically modified organism



5.1.2. therapeutic vector



5.2. A medical procedure is:



5.2.1. gene therapy (in vivo or ex-vivo)



5.2.2. somatobuněčná therapy



5.2.3. other (Please specify)



6. characteristics of the genetically modified organism, or

therapeutic vector in medicine



6.1. the genetically modified organism in the medicinal product is:



6.1.1. the virus



6.1.2. bacteria



6.1.3. cell line



6.1.4. other (Please specify)



6.2. Therapeutic vector in the medicinal product is:



6.2.1. pseudovirová particles



6.2.2. plasmid,



6.2.3. transpozón



6.2.4. a fragment of DNA/RNA



6.2.5. interfering RNA



6.2.6. other (Please specify)



Part 7. up to 19. shall be given only if the medicinal product contains

genetically modified organism



7. characteristics of the handling of genetically modified organism



7.1. The purpose of entry into the environment



8. the period of entry into the environment



8.1. The total duration of the placing of the GMO into

the environment and the date of its expected start



8.2. A binding timetable (breakdown of the intermediate stages, the date

their anticipated start and their duration)



9. the applicant plans to placing the same genetically modified organism

into the environment in a Member State of the European Union or

outside its territory?



If Yes, please indicate:



9.1. the State in which the applicant is planning to marketing to the environment



9.2. estimated time of commencement and duration of entry into the

environment



10. the applicant has submitted an application for marketing the same GM

the organism into the environment in another Member State of the European Union?



If Yes, please indicate:



10.1. the State in which the application was made



10.2. the date of filing and the application number or other designation



10.3. date and indicate the permit, if issued



10.4. the period covered by the authorization



11. the applicant has submitted an application for marketing the same GM

the organism into the environment or on the market outside the European Union?



If Yes, please indicate:



11.1. the State in which the application was made



11.2. the date of filing and the application number or other designation



11.3. date and designation of permit, if issued



11.4. the period covered by the authorization



12. the evaluation of the risk of a genetically modified organism into the

of the environment



(+) The risk assessment under section 7 of the Act and section 5 of this order



7.5. A summary of the risk assessment



13. the data about the recipient, or, where applicable, the parent

the organism



13.1. The body is



13.1.1. virus



13.1.2. bacteria



13.1.3. cell line



13.1.4. other (Please specify)



13.2. The Czech and Latin genus and species name of the organism with the exact

by specifying the race (breed, forms, strain, cell lines, patovaru)



13.3. the origin (collection, collection number, vendor)



13.4. Phenotypic and genetic marker characters



13.5. Degree of relatedness between donor and recipient organism



13.6. Occurrence and living conditions



13.6.1. Geographic distribution, the natural occurrence of the organism,



13.6.2. The body is commonly used in the Czech Republic/in the European

Union?



8.5. methods of identification and detection of the organism



13.7.1. Detection methods, including data on their sensitivity, reliability,

and specificity



13.7.2. Identification methods, including data on their sensitivity,

reliability and specificity



13.8. The body is included under other legislation governing

protection of the health of workers at work ^ 10)?



If Yes, please indicate the applicable group.



13.9. Indicate whether the organism pathogenic or harmful in any other way

(alive or inanimate, including extra-cellular products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



13.9.1. pathogenicity: infectivity, infectivity, virulence



13.9.2. allergenic effects



13.9.3. toxic effects



13.9.4. carrier of the pathogen



13.9.5. possible vectors, host range including non-target organism



13.9.6. possibility of activation of latent viruses (proviruses)



13.9.7. ability to penetrate into other organisms or to colonize other

organisms



13.9.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



13.9.9. other.



13.10. Reproduction



13.10.1. Generation time in natural environment



13.10.2. method of reproduction (sexual, asexual)



13.10.3. Specific factors affecting reproduction (if

There are)



13.10.4. Survivability



13.10.5. Ability to create durable surviving forms:



13.10.5.1. endospores



13.10.5.2. cysts



13.10.5.3. other (clearly identify)



13.11. The dissemination in the environment



13.11.1. method and the extent of the spread of



13.11.2. Specific factors affecting dissemination, if any



13.12. Natural parasites and competitors, symbionts and hosts,



13.13. Other potential interactions with other organisms



13.13.1. other specific factors allowing survival



13.14. the potential mezibuněčný transfer of genetic material between donor

(parental organism) and other organisms



13.14.1. Transmission method (with the plasmid, bakteriofágem, otherwise)



13.14.2. Organisms with which is a natural exchange of genetic

material



13.15. verification of the genetic stability of the organisms and factors that

affecting it



13.16. Custom vector organism



13.16.1. Sequence vector



13.16.2. frequency of mobilisation of the vector



13.16.3. Specificity of the vector



13.16.4. Presence of genes causing the resistance of the vector



13.17. Previous genetic modifications of the recipient or parental

body authorised in the Czech Republic (including date and number

decision)



14. the information on the genetic modification of an organism



14.1. The type of genetic modification:



14.1.1. the introduction of extraneous hereditary material



14.1.2. the exclusion of part of the hereditary material



14.1.3. the combination of exemption and, in the case of hereditary material



14.1.4. cell fusion



14.1.5. another (uniquely identify)



14.2. The intended result of the genetic modification



14.3. When genetic modification used vector?



(+) vector map



If the vector has not been used, point 14. 4.



14.3.1. The vector wholly or partially present in the resulting genetically

modified organism?



If the vector is not even partially present, proceed to step 14. 5.



14.3.2. A vector type:



14.3.2.1. plasmid



14.3.2.2. Bacteriophage



14.3.2.3. virus



14.3.2.4. cosmid



14.3.2.5. phasmids



transposon 14.3.2.6.



14.3.2.7. another vector (uniquely identify)



14.3.3. The identity of the vector (origin, full scientific name, trivial name)




14.3.4. Host range vector (natural hosts, reservoirs)



14.3.5. the presence of the vector sequence that passes the selection

(a selectable) or identifiable Phenotype:



14.3.5.1. resistance to antibiotics (indicate the exact name of the active substance)



14.3.5.2. other (clearly identify)



14.3.6. partial fragments of the vector, and their presence in the final

genetically modified organism



14.3.7. The method of injecting the vector into the recipient organism:



14.3.7.1. the transformation of



14.3.7.2. elektroporace



14.3.7.3. makroinjekce



14.3.7.4. mikroinjekce



14.3.7.5 infections



14.3.7.6. other (Please specify)



14.3.8. Details on how far the vector is limited to the sequence

nucleic acids, needed to ensure the intended function, and whether it contains

a sequence whose product or function are not known



14.4. If no genetic modification used vector method

injecting insertu into the recipient organism:



14.4.1. the transformation of



14.4.2. mikroinjekce



14.4.3. microencapsulation



14.4.4. makroinjekce



14.4.5. other (clearly identify)



14.5. the methods and criteria used for the selection of



15. data on insertu



15.1. Information about each section of insertu, where appropriate, on each set aside part of the

the hereditary material, with particular reference to any known harmful

sequences



15.1.1. The size of the



15.1.2. Sequence



15.1.3. origin



15.1.4. Functional characteristics



15.2. The location of the insertu in the body of the recipient:



15.2.1. the free plasmid



15.2.2. insert integrated into the chromosome



15.2.3. other (clearly identify)



15.3. Contains the insert part, whose products or features are not known?



If Yes, please specify.



15.4. Information about how far the insert is limited to a sequence of nucleic

acids, needed to ensure the intended function



15.5. Data on whether the sequence contained in the insertu involved in

in any way on the pathogenic or harmful characteristics

the donor organism or vector



15.6. The structure and the size of each segment of nucleic acid originating in

the vector or the donor organism, which remained in the final genetically

modified organism, including the methods and data needed to identify

and detection of the inserted sequence



9.8. In the case of exclusion of part of the hereditary material (deletion) size and

function of nucleic acid Department exempted



9.8. The number of copies of the inserted hereditary material



9.9. the hereditary stability of the inserted material and the stability of its location



16. information on the organism (unlike the organism from which the insert is

derived)



16.1. The donor organism is:



16.1.1. viroid



16.1.2. RNA virus



16.1.3. DNA virus



16.1.4. bacteria



16.1.5. sponge (fibrous mikromyceta, yeast)



16.1.6. other micro-organism



16.1.7. animal (indicate class)



16.1.8. another body (Please specify which).



16.2. The Czech and Latin genus and species name of the donor organism with

accurate cultivar (variety, race, breed, lineage, forms,

the hybrid, strain, patovaru)



16.3. Indicate whether the donor organism pathogenic or otherwise

malicious (alive or inanimate, including extra-cellular products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Familiar with pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



16.3.1. pathogenicity: infectivity, infectivity, virulence



16.3.2. allergenic effects



16.3.3. toxic effects



16.3.4. carrier of the pathogen



16.3.5. possible vectors, host range including non-target organism



16.3.6. possibility of activation of latent viruses (proviruses)



16.3.7. ability to penetrate into other organisms or to colonize other

organisms



16.3.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



16.3.9. other



10.2. The donor organism classified under other legislation

relating to the protection of the health of workers at work ^ 8)?



If Yes, please indicate the applicable group.



10.3. Exchange recipient and the donor organism genetic material

in a natural way?



17. information on the final GMO



17.1. Description of heritable genetic and phenotypic characters that have been

changed as a result of the genetic modification



17.1.1. Differs genetically modified organism from the recipient in the

survival skills?



If so, clearly identify.



17.1.2. Differs genetically modified organism from the recipient in the

method or rate of reproduction?



If so, clearly identify.



17.1.3. Differs genetically modified organism from the recipient in the

ability to spread?



If so, clearly identify.



17.1.4. Differs genetically modified organism from the recipient in the

pathogenicity?



If so, clearly identify.



17.2. Genetic stability of the GMO



17.2.1. Measures to ensure genetic stability and factors that

affecting it



17.2.2. genetic stability of the authentication methods



10.7. properties of genetically modified organisms, which have an impact on the

his survival, reproduction and dissemination in the environment



17.4. Known or predicted environmental conditions which may

have an effect on survival, multiplication and dissemination (wind, water, soil,

temperature, pH, etc.)



17.5. Sensitivity to specific substances (resources)



17.6. Indicate whether the GMO pathogenic or

otherwise harmful (alive or inanimate, including extra-cellular

products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



17.6.1. pathogenicity: infectivity, infectivity, virulence



17.6.2. allergenic effects



17.6.3. toxic effects



17.6.4. carrier of the pathogen



17.6.5. possible vectors, host range including non-target organism



17.6.6. possibility of activation of latent viruses (proviruses)



17.6.7. ability to penetrate into other organisms or to colonize other

organisms



17.6.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



17.6.9. other (unique characteristics)



17.7. Description of identification and detection methods of genetically modified

the organism



17.7.1. Methods used for the detection of genetically modified organisms,

including a verified methodology for detecting



17.7.2. Methods used to identify genetically modified

organism in the environment, including the proven methodology of identification, and data on

reliability and sensitivity methods



17.7.3. Enabling unique identification of the modified section

hereditary material



11.1. the embedded Expression of hereditary material



17.8.1. Speed and level of expression of inserted original material,

the life cycle of dependency, where the expression of



17.8.2. stability of expression



17.8.3. Description of the methods of measurement with an indication of their sensitivity



11.1. The expressed protein



17.9.1. The activity of the expressed protein



17.9.2. Description of the methods for the identification and detection of the protein being expressed with

an indication of their sensitivity, specificity and reliability



17.10. Relevant data on previous cases, the placing of the same

a genetically modified organism into the environment, if the

There are, in particular in relation to the potential effects of those activities on health

people and animals, the environment and biodiversity



18. the information on the site, on which it will be put into the environment

take place



11.2. Workplaces in which will be putting into the environment take place



18.2. workplace Address



(+) The methodology of experiments



(+) Emergency plan in accordance with annex 5 to this notice



(+) Workplace code of conduct according to annex No 4 to the Act



(+) Plan of the site on which it will be put into the environment

take place



19. Description of the treatment with a medicine that contains genetically

modified organism



19.1. The handling of genetically modified organism prior to its placing

into the environment (contained use, transport)



19.2. How genetically modified organism is placed into the

of the environment



19.2.1. The method of preparation of the medicinal product



19.2.2. the method of storage of the medicinal product



19.2.3. the system of transport of medicinal product



19.2.4. Method of application of the medicinal product



19.2.5. the plan for the observation of clinical trial subjects



19.2.6. Measures relating to the clinical trial subjects



19.2.7. the system of collection, processing and storage of samples



19.2.8. Method of collecting and disposing of contaminated materials



19.3. The approximate amount of genetically modified organisms, which has

be used, the number of subjects and benefits



12.1. Measures to protect the health of the persons who are engaged in healing

product or are in contact with the operators of a clinical trial



12.1. Measures against the spread of the GMO into

of the environment



12.2. A description of the further handling of the medicinal product and waste management, including the

their disposal



19.6.1. Description of the measures after the end of the clinical trial




19.6.2. Disposal of genetically modified organisms and control

its effectiveness



19.6.3. Plan of checks and surveillance



19.6.4. types of generated waste and its estimated quantity



19.6.5. the potential risks arising from waste management



19.6.6. Description of the disposal of waste and the methods of control of its effectiveness



12.2. a description of the after-care of the tested subjects



12.3. term and how to evaluate the marketing of genetically modified

organisms into the environment



20. Information on possible interactions between genetically modified organism

and the environment and its impact on the environment



20.1. Anticipated mechanism and result of interaction with other

organisms in the environment, which may be significant



20.2. The probability that the selection occurs after the

environment



12.6. the possibility of sharp increases in the population of genetically modified

the organism in the environment, and the conditions under which this

the increase could occur



12.7. The path of biological dispersal of genetically modified organism

known or potential modes of interaction with expansion agent



12.7. The types of ecosystems, in which genetically modified organism

It can extend from the point of entry into the environment and in which

may settle



12.8. Anticipated mechanism identified adverse interaction between

genetically modified organisms and non-target organisms including

of competitors, prey, hosts, symbionts, predators, parasites and

pathogens



12.9. The ability of the transmission of hereditary material in vivo



12.9. the possibility of the transmission of hereditary material from genetically modified

organism to another organism after the introduction of the genetically modified

the organism into the environment and the consequences of such transfer



20.9. The option to transfer of hereditary material from naturally occurring

the organism of the GMO after placing

modified organism into the environment and the consequences of such

transfer



20.10. the results of the studies the behavior and characteristics of the genetically modified

organisms and their ecological impact carried out in simulated

natural environment



20.11. Other possible effects on the environment and biodiversity

Diversity (uniquely identify)



21. Monitoring



13.1. the methods of detecting the presence of a genetically modified organism



13.2. Specificity of methods of identification of a genetically modified organism

and the differentiation of a GMO from the donor organism,

the recipient or parental organism; the sensitivity and the reliability of the

These methods



13.2. Techniques (methods) detection of embedded transmission of hereditary material

on other organisms



13.3. The methods of detection of the effects of genetically modified organisms on

non-target organisms



13.4. the places on which the monitoring is conducted



13.4. The duration of the monitoring



13.5. the frequency of monitoring



22. in the case of imports or exports of genetically modified organism

intended solely for entry into the environment (transmission of the third

the person is not regarded as placing on the market)



13.7. the State of origin, or destination



13.8. the importer or exporter



13.9. the maximum quantity of genetically modified organisms, which is to be

imported or exported



13.9. Transport method



22.5. the method of packaging and labelling



23. The location where documentation on the use of genetically modified

organisms held under section 19 (a). (b)) of the Act



24. staff training Plan before you start dealing with genetically

modified organisms and therapeutic vectors and their subsequent

training



25. the observations of the expert advisor



Annex No. 3 to Decree No 209/2004 Coll.



Application for entry on the list for the placing on the market



Documents marked with



(+)

It is necessary to attach as a separate attachment



All relevant documents must be identified by name or title

(trade name) of the applicant



The data that make up the summary of the contents of the request for publication, are

underlined



PART AND



MODEL APPLICATION FOR A GENETICALLY MODIFIED ORGANISM, OTHER THAN A HIGHER

A PLANT OR A GENETIC PRODUCT OTHER THAN CONTAINING GENETICALLY

MODIFIED HIGHER PLANT



[To section 24, paragraph 3 (b)) law]



Date of submission



1. name of the genetic product (commercial name and other names)



2. the applicant



2.1. name or company name or business, when the applicant is a natural

a person authorized to do business



2.2. The name or business name and legal form, if the notifier

legal person



2.3. nationality (for natural persons)



2.4. Registered address and home address (for natural persons)



2.5. IDENTIFICATION NUMBER (if assigned)



2.6. the names of the persons who are members of the statutory body of the applicant, if

the applicant legal person, with an indication of the way in which the applicant shall represent the



2.7. the applicant is:



2.7.1. the domestic manufacturer



2.7.2. the importer



2.7.3. other (Please specify)



2.8. in the case of importation:



2.8.1. the name or business name of the manufacturer, if the physical

the person, or the name or trade name, if the person is a legal



2.8.2. registered address and home address (for natural persons) manufacturer



3. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



3.1. Name, academic title



3.2. Occupation or employer, and job title



3.3. Education



3.4. Training courses



3.5. the current practice



3.6. Address of residence



3.7. the phone



3.8. E-mail



4. the contact person at the workplace, if different from the professional advisor



4.1. Name, academic title



4.2. the phone



4.3. E-mail



5. characteristics of the genetically modified organism contained in

gene product



5.1. The name and the properties of each genetically modified organism

contained in the genetic product



6. purpose of and the procedure for the marketing of a genetically modified organism, or

the genetic product on the market



6.1. The purpose of the marketing of a genetically modified organism or genetic

product on the market



6.2. the date envisaged for the commencement of marketing of the genetically modified

organism or gene product on the market and its schedule (schedule

each of the intermediate stages, the date envisaged for the commencement and duration of

their duration)



6.3. The estimated amount of genetically modified organism, or

the genetic product, which will be used at each stage, including

specify whether it will be a production of the territory of the Czech Republic,

where appropriate, the European Union and imports



7. the evaluation of the risk of a genetically modified organism, or

the genetic product on the market



(+) The risk assessment under section 7 of the Act



If the product contains multiple, genetically modified organisms,

they are handled paragraphs 8 through 13 for each genetically modified organism

separately.



8. A general description of the genetically modified organism or genetic

the product and the genetically modified organism, which is the content of the

gene product



8.1. Types of GMOs or genetic product

(intended use of the GMO as or in

gene product)



8.2. The composition of the genetic product



8.3. The specificity (diversity) of the genetic product (in comparison with the same

type of product free of genetically modified organisms)



8.4. The target group of consumers (e.g. industry, agriculture, small

consumers)



8.5. The conditions of treatment, in particular the differences between the treatment of genetically

a genetically modified organism or product and waste management

similar non-GMOs or products containing

unmodified organisms



5.3. where appropriate, a clear definition of the geographical area in the European Union,

to which the marketing of a genetically modified organism, or

the genetic product on the market shall be limited



8.7. The type of environment in which is the use of genetically modified

the organism (gene product) inappropriate



8.8. The estimated annual demand:



8.8.1. in the Czech Republic



8.8.2. in the European Union



8.8.3. on export markets



5.5. the unique identification code of the genetically modified organism

or genetically modified organisms contained in genetic

product



8.10. A request was made for marketing the same GM

organism or a genetically modified organism, which is part of the

the genetic product, into the environment by the same applicant?



If Yes, please indicate the number or other indication of the application (date and designation

permit, if issued) and State in which it was submitted.



If no, please indicate the risk assessment of genetically modified organism

According to the requirements of the request for the grant of authorisation for placing into the

environment (part A, part 1, paragraph 10 of annex 2 to the Ordinance).



8.11. the applicant Served at the same time a request for marketing the same genetically

the modified organism or gene product on the market in a

another Member State of the European Union?



If Yes, please indicate the number or other indication of the application and the State in which the

It was submitted.



8.12. The product with the same genetically modified organism

(the same combination of genetically modified organisms) placed on the market in


The European Union, the other by the applicant?



If Yes, please provide the applicant, the date and identification of the authorisation, the Member State in which

It was released, and the period for which it was granted.



8.13. The request was made (notification) for marketing the same genetically

the modified organism or gene product on the market in another Member State

outside the European Union? If Yes, please indicate the State in which the application was

(notification) is filed, the application number or other designation (date and designation

permit, if issued), the applicant, purpose and period the placing on the market.



8.14. The summary of the data obtained from past or ongoing cases

the placing of the same GMOs or the same

a combination of genetically modified organisms into the environment,

different conditions representing the different environments in which you might be

genetically modified organism used



8.15. the proposed guidelines and recommendations regarding the use, transportation,

storage and further treatment of the genetically modified organism

(genetic), including any limitations that are

proposed as a condition of the authorisation requested



8.16. the proposed packing method of genetically modified organism, or

gene product



8.17. Proposed labelling beyond what is provided directly

the applicable provisions of the European Union ^ 14)



8.18. the measures to be taken in the event of an accident or

unauthorized use of genetically modified organisms, or

genetic products



8.19. the method of waste management, including the disposal of waste containing

genetically modified organisms



9. the data about the recipient, or, where applicable, the parent

the organism



9.1. The Czech and Latin genus and species name the recipient or parental

the organism, with accurate race (breed, forms, strain, cell

line, patovaru)



9.2. Origin (collection, collection number, vendor)



9.3. Phenotypic and genetic characteristics



9.4. For micro-organisms own plasmids, phages and other vectors

the organism



9.4.1. The sequence of the vector



9.4.2. the frequency of mobilization of the vector



9.4.3. The specificity of the vector



9.4.4. the presence of genes which confer resistance to vector

antibiotics



9.5. the degree of relatedness between donor and recipient organism



9.6. Occurrence and living conditions



9.6.1. Geographic distribution



9.6.2. Habitat (natural birds) of the organism



9.6.3. Natural predators, prey, parasites and competitors, symbionts and

hosts



9.6.4. Other potential interactions with other organisms



9.7. Genetic stability and factors affecting it



6.1. Possible transmission of hereditary material from the mezibuněčný donor

(parental organism) and other organisms



9.8.1. the method of transfer (with the plasmid, bakteriofágem, otherwise)



9.8.2. Organisms with which is the natural replacement of hereditary

material



9.8.3. The consequences of such transfer



6.2. Reproduction



9.9.1. method of reproduction



9.9.2. Specific factors affecting reproduction (if

There are)



9.9.3. Generation time in the natural environment, and generation time in the

the ecosystem into which it is to be a genetically modified organism is placed



9.10. Survivability



9.10.1. Survivability in the different seasons of the year



9.10.2. Ability to create durable surviving forms (e.g. spores,

sclerotia)



9.10.3. additional specific factors allowing survival, if there are



9.11. The dissemination in the environment



9.11.1. method and the extent of the spread of



9.11.2. Specific factors affecting dissemination, if any



9.12. Host range including non-target organisms



9.13. Interactions with the environment



9.14. Involvement in environmental processes:



-primary production



-the conversion of nutrients (consumer, predator)



-decomposition of organic materials



-other (clearly identify)



9.15. Detection methods



9.15.1. Description of the methods



9.15.2. Sensitivity, reliability (in quantitative terms) and specificity of the methods



9.16. Methods of identification



9.16.1. Description of the methods



9.16.2. Sensitivity, reliability (in quantitative terms) and specificity of the methods



9.17. the classification of the organism under other legislation of the Czech Republic

relating to the protection of the environment or human health



9.18. Indicate whether the organism pathogenic or harmful in any other way

(alive or inanimate, including extra-cellular products) for people,

animals, plants, or otherwise.



If so, clearly identify the possible characteristics:



9.18.1. pathogenicity: infectivity, infectivity, virulence



9.18.2. allergenic effects



9.18.3. toxic effects



9.18.4. carrier of the pathogen



9.18.5. possible vectors, host range including non-target organism



9.18.6. the possibility of activation of latent viruses (proviruses)



9.18.7. ability to penetrate into other organisms or to colonize other

organisms



9.18.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



9.18.9. other



9.19. the nature and description of known genetic particle extrachromozomálních



9.20. The description of the earlier genetic modifications of the organism



10. information on the genetic modification



10.1. The type of genetic modification:



10.1.1. the introduction of extraneous hereditary material



10.1.2. the exclusion of part of the hereditary material



10.1.3. the combination of exemption and, in the case of hereditary material



10.1.4. cell fusion



10.1.5. any other (clearly identify)



10.2. a description of the methods used for the genetic modification



10.3. data on the vector, if one was used when the genetic modification



10.3.1. A vector type



10.3.2. The identity of the vector (origin)



10.3.3. Description of the structure of the vector



(+) Genetic map and, where appropriate, restriction map vector



10.3.4. The sequence of the vector



10.3.5. Details on how far the vector is limited to the sequence

nucleic acid needed to ensure the intended function, and whether it contains

a sequence whose product or function are not known



10.3.6. the ability to vector to transmit hereditary material



10.3.7. frequency of mobilisation of the vector



10.3.8 recommended. information on whether the vector is present in whole or in part

the final GMO



10.3.9. Host range vector



10.3.10. the presence of the vector sequence that passes the selection

(a selectable) or identifiable Phenotype:



10.3.10.1. resistance to antibiotics (indicate the exact name of the active substance)



10.3.10.2. resistance to heavy metals



10.3.10.3. resistance to pesticides (indicate the exact name of the active substance)



10.3.10.4. another (uniquely identify)



10.3.11. method of injecting the vector into the recipient organism



11. information on insertu



11.1. If no genetic modification used vector method

injecting insertu into the recipient organism



11.2. The methods used for the construction of insertu



11.3. Restriction sites



11.4. Sequence insertu



12.5. details of any part of the insertu, where appropriate, on each set aside part of the

the hereditary material, with particular reference to any known harmful

sequences



11.5.1. the origin of



11.5.2. Functional characteristics



11.5.3. Size



11.5.4.



11.5.5. Sequence



7.2. information about how far the insert is limited to a sequence of nucleic

acids, needed to ensure the thoughtful features



7.3. information on whether the insert statement contains a section, whose products or

features are not known



If so, clearly identify the



7.3. The location of insertu on the final GMO:



11.8.1. free plasmid



11.8.2. integrated into the chromosomes



11.8.3. other (clearly identify)



7.4. The number of copies of the inserted hereditary material



11.10. the hereditary stability of the inserted material and its stability

the location of the



12. Information about, unlike the body (the donor organisms)



12.1. The Czech and Latin genus and species name of the organism, with the exact

by specifying the cultivar (variety, race, breed, lineage, the forms of hybrid, strain,

patovaru)



12.2. Indicate whether the donor organism pathogenic ie or otherwise

malicious (alive or inanimate, including extra-cellular products).



If Yes, please indicate whether for people, animals, plants or

otherwise.



Always uniquely identify the harm.



Familiar with pathogenic or harmful properties of sequences used in the

genetic modification?



If so, clearly identify the possible characteristics:



12.2.1. pathogenicity: infectivity, infectivity, virulence



12.2.2. allergenic effects



12.2.3. toxic effects



12.2.4. carrier of the pathogen



12.2.5 update. possible vectors, host range including non-target organism



12.2.6. the possibility of activation of latent viruses (proviruses)



12.2.7. the ability to penetrate into other organisms or to colonize other

organisms



12.2.8. antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of diseases in humans and animals



12.2.9. any other.



12.3. The classification of the donor organism under other legislation

relating to the protection of the environment or people's health



12.4. Details about whether the donor and recipient organism between runs

or maybe a natural exchange of genetic material



13. information on the final GMO (genetically

contained in the genetic modified organism product)



8.1. Description of heritable genetic and phenotypic characters, if they are

different from the recipient or parental organism




13.2. Genetic stability of the GMO, if

different from the stability of the recipient or parental organism



13.3. the embedded Expression of hereditary material



13.3.1. The speed and level of expression of inserted original material,

the life cycle of dependency, where the expression of



13.3.2. stability of expression



13.3.3. Description of the methods of measurement with an indication of their sensitivity



13.4. The expressed protein



13.4.1. Activity of the expressed protein



13.4.2. Description of the methods of detection and identification of the expressed proteins with

an indication of their sensitivity, specificity and reliability



13.5. The methods and criteria used for the selection of the resulting genetically

modified organism



8.5. Methods for detection of genetically modified organisms in the

environment, if different from the recipient or parental detection

the organism



8.5. Methods of identification to distinguish genetically modified

the body of the recipient or parental organism



13.7.1. Description of the methods for detecting the presence of genetic modification,

including validated methods of sampling and sample preparation



13.7.2. details on specificity, sensitivity, and reliability

(quantified) these methods



13.7.3. Description of the nucleic acid modified section allowing for unambiguous

identification of a genetically modified organism



8.6. effects on health



13.8.1.. Toxic or allergenic effects of the genetically modified

the organism and its metabolic products, if it is different from the effects

recipient or parental organism



13.8.2. genetic Risk product



13.8.3. comparison of the modified organism to the donor

the organism, by the recipient or parental organism in terms of

pathogenicity



13.8.4.. the colonization Ability, if different from consignee or

parental organism



13.8.5. If a genetically modified organism is more pathogenic than

the recipient or parental organism for immunocompetent human

individual, please indicate:



13.8.5.1. of disease which can be caused by genetically modified

the organism and mechanism of pathogenicity including invasiveness and virulence



13.8.5.2. infectivity



13.8.5.3. infectious dose



13.8.5.4. host range, possibility of alteration



13.8.5.5. the possibility of survival outside of human host



13.8.5.6. the presence of vectors or means of dissemination



13.8.5.7. the degree of biological stability



13.8.5.8. characteristics of antibiotic resistance



13.8.5.9. allergenicity



13.8.5.10. availability of appropriate therapies



13.8.6. Information about the possible harmful effects of genetically

the modified organism or gene product on human health

due to the genetic modification



Possible harmful effects always uniquely identify.



13.8.7. data relating to the safety of the genetically modified organism, or

the genetic product for animal health, in particular with regard to any

harmful effects caused by the genetic modification, where the genetically

genetically modified organism or product used in particular as

part of the feed



13.9. Interactions of the GMO with the

environment



13.10. The ability of the survival, reproduction and dissemination of genetically

the GMO in the environment, if different from the

ability of recipient or parental organism



13.11. the effects of GMOs on the environment,

If they are different from the effects of the recipient or parental organism, and

their possible consequences



13.12. The Czech and Latin genus and species name of the target organism,

If it exists, with accurate cultivar (variety, race, breed,

the line forms, hybrid, strain, patovaru)



13.13. Mechanism of interaction between the genetically modified organism

or genetic product and the target organism, if the target organism

There is a



13.14. potential changes in the interactions of the GMO

or genetic product with non-target organisms resulting from the genetic

modification



13.15. potential changes in the interactions of the GMO

or inanimate product of the genetic components of the environment,

arising from the genetic modification



13.16. The stability of the genetically modified organism according to the hereditary

the properties of the



13.17. An indication as to what is a genetically modified organism different from the

recipient or parental organism



Differences clearly identify:



13.17.1. route and rate of reproduction, the generation time



13.17.2. the dissemination in the environment



13.17.3. survivability



13.17.4. effects on the health of humans, animals, and other organisms



13.17.5. other



13.18. The ability of the genetically modified organisms to transfer genetic

material to other organisms, and the implications of such a transfer



14. the expected behavior of the genetic product, if it is different from the

the behavior of the recipient or parental organism



14.1. the effects of the product on the environment



14.2. the effects of the product on human health



15. information on the preceding entry into the environment in the Czech

Republic, if applicable



15.1. The person entitled



15.2. The date and number of the permit



15.3. The place of entry into the environment



15.4. The purpose of entry into the environment



15.5. The duration of the putting into the environment, its start date and

their



15.6. The focus and duration of monitoring



9.8. The conclusions of the monitoring



9.8. the results of putting into the environment, taking into account any

risks to human and animal health, the environment and biodiversity

the diversity of the



16. information on the preceding entry into the environment or on the

the market in other countries



16.1. The person entitled



16.2. The date the authorisation and labelling of



10.1. the State



10.2. the competent administrative authority



10.3. Place, date of commencement and termination of entry into the environment



10.3. duration, start date, and end the monitoring



10.4. The focus of the monitoring



10.4. The conclusions of the monitoring



10.5. the results of putting into the environment, where appropriate, on the market,

taking into account any risks to human and animal health, the

environment and biodiversity



17. data on previous treatment (research, development, use) relevant for the

the risk assessment



18. the monitoring plan



18.1. The identified characters, properties, and lack of clarity in relation to the

the genetically modified organism or genetic or

their interactions with the environment, on which he had a plan

monitoring of focus



18.2. Security, scope and monitoring the effects of the

the modified organism or gene product on human health,

animals, environment and biodiversity (monitoring

a genetically modified organism or a gene product)



18.3. Security, method and frequency of sampling and analysis of samples after putting

a genetically modified organism or a gene product on the market



19. data relating to the provision of reference samples of the genetically modified

organism or gene product and store them for administrative authority

or his representative of a legal person



19.1. The specifications and quantities of the sample provided with the application at the same time

According to § 24 para. 5 of law



19.2. the frequency and method of transmission of samples after the grant of authorisation for the placing

on the market



20. the observations of the expert advisor



PART (B)



MODEL APPLICATION FOR A GENETICALLY MODIFIED ORGANISM, WHICH IS HIGHER

THE PLANT, OR A GENETIC PRODUCT CONTAINING A GENETICALLY MODIFIED

HIGHER PLANT



[To section 24, paragraph 3, of the Act)]



Date of submission



1. name of the genetic product (commercial name and other names)



2. the applicant



2.1. name or company name or business, when the applicant is a natural

a person authorized to do business



2.2. The name or business name and legal form, when the applicant is

legal person



2.3. nationality (for natural persons)



2.4. Registered address (for legal entities), or place of business, and address

place of residence (for natural persons)



2.5. IDENTIFICATION NUMBER (if assigned)



2.6. the names of the persons who are members of the statutory body of the applicant, if

the applicant legal person, with an indication of the way in which the applicant shall represent the



2.7. the applicant is:



2.7.1. the domestic manufacturer



2.7.2. the importer



2.7.3. other (Please specify)



2.8. in the case of importation:



2.8.1. the name or business name of the manufacturer, if the physical

the person, or the name or trade name, if the person is a legal



2.8.2. registered address and home address (for natural persons) manufacturer



3. the expert advisor



(+) Proof of education and length of professional experience (if the professional

education or experience obtained in another Member State, a national of the

Member State, it is understood that document the decision on the recognition of professional

qualification under another law ^ 7))



3.1. Name, academic title



3.2. Occupation or employer, and job title



3.3. Education



3.4. Training courses



3.5. the current practice



3.6. Address of residence



3.7. the phone



3.8. E-mail



4. the contact person at the workplace, if different from the professional advisor



4.1. Name, academic title



4.2. the phone



4.3. E-mail



5. purpose of and the procedure for the marketing of a genetically modified organism, or

the genetic product on the market



5.1. The purpose of the marketing of a genetically modified organism or genetic

product on the market



5.2. the date envisaged for the commencement of marketing of the genetically modified


organism or gene product on the market and its schedule (schedule

each of the intermediate stages, the date envisaged for the commencement and duration of

their duration)



5.3. The estimated amount of genetically modified organism, or

the genetic product, which will be used at each stage, including

specify whether it will be a production of the territory of the Czech Republic,

where appropriate, the European Union, or on the importation of



6. The risk evaluation of the marketing of a genetically modified organism, or

the genetic product on the market



(+) The risk assessment under section 7 of the Act



If the product contains more genetically modified higher plants,

processed sections 7 through 10 for each of the genetically modified plant

separately.



7. General description of the genetically modified higher plants, or genetic

a product containing genetically modified higher plant



7.1. The Czech and Latin genus and species name of the recipient or parental

the plant, with accurate cultivar (variety, line, hybrid)



7.2. the function of the genetic modification



7.3. the Form in which it should not be the GMHP

or genetic product placed on the market (especially the seeds or vegetative

section), as the proposed condition of placing on the market



7.4. The thoughtful use of genetically modified higher plants, or

gene product and the target group of consumers



7.5. The conditions of treatment, in particular the differences between the treatment of genetically

modified higher plants, or a genetic product and waste management

similar non-GMOs or products containing

unmodified organisms, including mandatory restrictions suggested as

conditions for the placing on the market



4.7. where appropriate, a clear definition of the geographical area in the European Union,

you want to be the marketing of genetically modified higher plants, or

the genetic product on the market shall be limited



7.7. The type of environment in which is the use of genetically modified higher

plants (genetic) inappropriate



4.8. the proposed packing method of genetically modified higher plants

or genetic product



4.9. the proposed way of tagging beyond the directly

the applicable provisions of the European Union ^ 14)



7.10. the estimated annual demand:



7.10.1. in the Czech Republic



7.10.2. in the European Union



7.10.3. on export markets



7.11. unique identification code genetically modified higher

plants



7.12. A request was made for marketing the same genetically modified

higher plants or genetically modified higher plants, which is

the content of the genetic product, into the environment in one

Member State of the European Union?



If Yes, please provide the applicant, the number or other indication of the application (date of

and labelling authorisation has been issued) and State in which it was submitted.



If no, indicate the risk assessment of genetically modified higher

the plants according to the requirements of the request for the grant of authorisation for placing into

the environment (part A, point 10 of annex 2 to the Ordinance).



7.13. the applicant Served at the same time a request for marketing the same genetically

the GMHP or the same genetic product on the market in

another Member State of the European Union?



If Yes, please indicate the number or other indication of the application and the State in which the

It was submitted.



If no, indicate the risk assessment of genetically modified higher

the plants according to the requirements of the request for the grant of authorisation for placing into

the environment (part A, point 10 of annex 2 to the Ordinance)



7.14. Or the application is made (notification) for marketing the same

genetically modified higher plants, or of the same genetic

product on the market in another country outside the European Union?



If Yes, please provide the applicant, the number or other indication of the application (date of

and labelling authorisation has been issued), the State in which it was filed and the

the period for which aid is requested (the period for which the licence was granted).



7.15. Was previously submitted for marketing the same genetically

the GMHP or the same genetic product on the market in

The European Union?



If Yes, please indicate the number or other indication of the application and the State in which the

has been made



7.16. the measures to be taken in the event of an accident or

unauthorized use of genetically modified higher plants, or

gene product



7.17. method of waste management, including the disposal of waste containing

genetically modified organisms



7.18. The summary of the data obtained from past or ongoing cases

placing the same genetically modified higher plants, or the same

a combination of genetically modified higher plants to environmental

environment under different conditions representing the different environments

which may be genetically modified higher plants used



8. the data about the recipient, where appropriate, the parental plant



8.1. The Czech and Latin genus and species name of the plant, with the exact

by specifying the cultivar (variety, line, hybrid)



8.2. The origin (collection, collection number, vendor)



8.3. the Reproduction



8.3.1. method of reproduction



8.3.2. The specific factors affecting reproduction (if

There are)



8.3.3. Generation time



8.3.4. Sexual compatibility with other cultivated or wild species and

the expansion of these compatible species in the Czech Republic



8.4. Survivability



8.4.1. The ability to create structures that allow survival or

dormancy, and the length of the possible survival or dormancy



8.4.2. other specific factors allowing survival, if there are



8.5. The dissemination in the environment



8.5.1. the method and scope of dissemination (decrease quantity of pollen and seeds in

According to the distance from the source, the force and direction of the wind, the flow of water and

other factors)



8.5.2. Specific factors affecting dissemination, if any



5.3. Geographical expansion



8.7. If not higher plant grown in the Czech Republic, a description of the

Habitat, including information on natural konzumentech, pathogens.

parasites, competitors and symbionts



5.5. Other possible relevant interaction with other organisms of higher plants

in the ecosystem, in which the higher plant usually grown



8.9. Indicate whether the given to people, animals or other organisms has

plant



8.9.1. allergenic effects



8.9.2. toxic effects



8.9.3. other harmful effects



8.10. significant phenotypic and genetic characteristics



9. information on the genetic modification



9.1. Type of genetic modification:



9.1.1. the introduction of extraneous hereditary material



9.1.2. the exclusion of part of the hereditary material



9.1.3. the combination of exemption and, in the case of hereditary material



9.1.4. cell fusion



9.1.5. another (uniquely identify)



9.2. Description of the methods used for the genetic modification



9.3. The properties and origin of the vector (used if the vector when you

genetic modification used)



(+) A genetic map of the vector



5.8. details of any part of a stretch of DNA that is to be introduced into the body

the recipient (if the genetic modification involves the injecting of hereditary

material)



9.4.1. The size of the



9.4.2. The position of the



9.4.3. Sequence



9.4.4. the origin (the Czech and Latin genus and species name of donor

the organism with accurate cultivar-varieties, race, breed, lineage,

forms of hybrid, strain, patovaru)



9.4.5. Functional characteristics



10. Details of the GMHP



10.1. Description and characteristics of inheritable properties that are inserted

or changed, including signaling and selection genes and the previous

modifications and a description of their phenotypic manifestations



10.2. data on a stretch of DNA that was introduced or deleted



10.2.1. the structure and size of the embedded section of DNA, including details of any

a section of the vector that was inserted into genetically modified higher

plants, or of any transportation or foreign DNA remaining in the

the GMHP



10.2.2. In the case of exclusion of part of the hereditary material (deletion) size and

the function of each part of the exempted section of nucleic acid



10.2.3. The location of the inserted material in the plant cell, hereditary

(inserted into the chromosome, chloroplasts, or in a non-integrated form), and

methods for the determination of these data



10.2.4. The stability of the inserted material and the stability of its hereditary

the location of the



10.2.5. in case of other than genetic modification is the insertion or removal,

part of the hereditary material, describe the function of the modified original

the material before and after the modification and further describe the direct changes in the

the expression of genes resulting from modification



10.3. Data on the expression of hereditary material embedded



10.3.1. the embedded Expression of hereditary material and methods used for its

the characterization of the



10.3.2. Location where in the plant to the expression of inserted genes (e.g..

roots, stem, leaves, pollen, and so on)



10.3.3. changes of expression depending on the life cycle of plants



10.3.4. The stability of expression



10.4. Information about what are the GMHP is different

from the recipient or parental plants (always unambiguously

identify)



10.4.1. Route and rate of reproduction



10.4.2. The dissemination in the environment



10.4.3. Survivability



10.4.4. the effects on the health of humans, animals, and other organisms



10.4.5. The impact on non-target organisms



10.4.6. More



10.5. the ability of the GMHP to transfer


the genetic material to other organisms, and the implications of such a transfer



6.6. Information about the possible harmful effects of genetically modified

higher plants on human health caused by the genetic modification. Possible

harmful effects always uniquely identify.



10.7. Data on the safety of genetically modified higher plants for

animal health, if it is to be the GMHP

used as animal feed, if the safety of genetically modified higher

plants differ from the recipient or parental organism



10.8. Mechanism of interaction between the genetically modified higher

the plant and target organisms (if there is a target organism),

If the mechanism of interaction of genetically modified higher plants

different from the recipient or parental organism



10.9. Potential changes in the interactions of the GMHP with

non-target organisms resulting from the genetic modification



10.9.1. Description of DNA modified section



10.9.2. Methods for detection and identification of genetically modified higher

the plant, certified methodology of collection and edit patterns



10.10. The behavior of the inserted genes:



10.10.1. the hybridization with the same kind of



10.10.2. when hybridization with distant species



10.11. Phenotypic stability of the GMHP



11. information on the possible effects on the environment resulting from

the marketing of genetically modified higher plants on the market (possible effects always

uniquely identify)



11.1. The possible effect on the environment resulting from the marketing of a genetically

on the market of genetically modified higher plants



11.2. The possible effect on the environment resulting from the interaction between the

genetically modified higher plants and the target organism (if the

There is one), if different from the interaction of the recipient, where appropriate, the parental

the organism



11.3. The possible effect on the environment resulting from the interaction between the

genetically modified higher plants and non-target organisms, if

differs from the interaction of the recipient or parental organism



11.3.1. the effects on biodiversity in the place of cultivation



11.3.2. the effects on biodiversity in other environments



11.3.3. effects on pollinators



11.3.4. effects on endangered species



11.3.5. Potential interactions with inanimate environmental compartments



12. information on previous cases, the marketing of genetically modified higher

the plants into the environment or on the market



12.1. The previous entry into the environment carried out by the applicant in

The Czech Republic



12.1.1. Date and number of the permit



12.1.2. The conclusions of the monitoring



12.1.3. the results of putting into the environment, where appropriate on the market

taking into account any risks to human and animal health, the

environment and biodiversity



12.2. the previous cases of entry into the environment or on the market

carried out by the applicant in other countries



12.2.1. the State



12.2.2. the competent administrative authority



12.2.3. the date the authorisation and labelling of



12.2.4. Place of entry into the environment



12.2.5 update. purpose of entry into the environment



12.2.6. duration of entry into the environment



12.2.7. The duration of the monitoring



12.2.8. The focus of the monitoring



12.2.9. The conclusions of the monitoring



12.2.10. the results of putting into the environment, where appropriate, on the market,

taking into account any risks to human and animal health, the

environment and biodiversity



13. the monitoring plan



13.1. The identified characters, properties, and lack of clarity in relation to the

the GMHP or genetic or

their interactions with the environment, on which he had a plan

monitoring of focus



8.2. Security, scope and method of monitoring the effects of the

the GMHP or genetic product on human health and the

animals, environment and biodiversity (monitoring

a genetically modified organism or a gene product)



13.3. Security, method and frequency of sampling and analysis of samples after putting

genetically modified higher plants or gene product on the market



14. observations of the expert advisor



Appendix 4 to the Decree No 209/2004 Coll.



Enclosed space requirements and safeguards for closed

loading



(Article 15, paragraph 2, of the Act)



PART AND



ENCLOSED SPACE REQUIREMENTS AND PROTECTIVE MEASURES FOR MICROBIOLOGICAL

LAB



For the purposes of this part of the annex shall mean the



1. access to the laboratories of the health circle over the separate areas,

the "clean" side must be separated from the laboratory safety

doors, closet for clothes and shower, Exchange



2. the standard operating procedure for the safe transmission of

material outside the lab in the steriliser and ensuring the same level of

protection which secures the laboratory,



3. protective clothing, in particular cotton coat, protective apron of

PVC, rubber textile protective apron, a special jumpsuit made of polyethylene,

overpressure protective clothing, protective coat with liner,

the protective linings of hooded coat, waterproof protective sheath,

cotton work trousers, work trousers, reticle on the head, hat,



4. the protective footwear in particular, rubber boots, rubber galoshes, closed

work footwear-type shoes, sandals with a closed toe, health

Sandals,



5. personal protective equipment, in particular, cotton gloves,

latex gloves, disposable polyethylene gloves, nitrile

gloves, or a request to the sterility of gloves-disposable

Vinyl gloves, protective glasses, protective goggles, protective anti-dust

shield, lícnicová part of the particulate filter material (ústenka)

filtering half masks with filter against solid particles (with expiratory

with or without valve), filter half mask, or čtvrtmaska with a filter

face mask with filter (must include the subject of filtering), insulation

respiratory unit non-Autonomous (hose), a self-contained breathing apparatus.

I-----I----------------------I-------------------------------------------------------------------------------I

I I I for the category of risks and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I. (I) (II). AND (III). AND (IV). (I)

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even I enclosed space I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 1. Even the Department inside and is not required and the Department both inside and odděleníuvnitř as well as required and

(I) the building or the location and even the building and the building and the location in the I

And even in a special building and I I I a special building and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

2. As well as Sealing for I is not required and not required as well as required and requested I

And even gas sterilization I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I I I Equipment I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

3. As well as easy to clean as well as required for (I) required for (I) required for (I) required for (I)

Even the surfaces resistant to even the desktop, the desktop, and pracovníplochu, as well as the desktop, and

And even water, acids, and the floor and the walls and the floor and the walls and the floor and the walls and floor, wall and I

Even alkalis, I I I I the ceiling and

And solvents; I I I I I

Even allowing for the effective I I I I I

And even disinfecting and I I I I I

I I I I I I decontamination even

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

4. I enter the work and is not required and requested, and only required and ordered

I I I I if through space so the results I I I

I I I I the health loop from the reviews I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

(I) 5. And Reduced pressure is not required and not required as well as required and requested I

And also because of the pressure in the I I I I I

(I) the immediate vicinity of I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

6. As well as input and output and is not required and is not required to (I) required for (I) required; There, I

I I I I I air through the output and where I

I I I I I the aerosol filter viruses, also required

Even I (HEPA) I I I I I a special measure

I I I I I I against the spread of the virus and


I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

7. Even Sterile box-I is not required and requested, and only required and ordered

And also a separate room and even shows I I I

I I I I I I I from the evaluation

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

8. Even the pressure steam I required, I required, I required, I required, I

I I I the sterilizer must (I) that is a must and the must and the must (I)

I I I be on building and be located in the building and also be in nacházetv and

I I I I I and subject to a closed and laboratory; must I

I I I I the conditions and space be inserted between (I)

I I I I I I compliance with the "clean" and I

I I I I I I standard "impure" part I

I I I I I I I operating

I I I I the procedure (see I I I

I I I I výše) I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I work mode I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 9. Also a limited access is not required and the required and requested and required

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

10. And the tag "danger-I is not required and the required and requested and required

And even biological risk "I I I I I

I I ^ 15) on input I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

11. And special measures and also requested is not required and the required and requested I

And also for limiting the spread of and minimize and prevent the spread of zabránitšíření and I

I I I I spread the aerosol I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

12. And a shower and is not required and requested in I requested and required

I I I I I I I building

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

13. And protective clothing and also required suitable required suitable required suitable required even

(I) safety boots and protective clothing and protective clothing and full protective suit and even protective clothing and even

I I I (a particular type and a particular type of (and even ochrannáobuv and protective shoes and

I I I the frequency of exchanges and exchange rate (the concrete type and I (specific type I

I I I will result from both result from and replacement frequency and results from (I)

I I I the risk evaluation) as well as reviews and vyplynouz and risk assessment) and

I I I I), protective and risk assessment) and with the full Exchange and

I I I I I I laundry required shoes, clothing and even

I I I I only if and and footwear before and

I I I I I I will come from entering and

I I I I I I a closed risk assessment and

I I I I I I area and I

I I I I I I the output from the

I I I I I I (method of treatment and

I I I I I I with clothing, linens and

I I I I I I and footwear for the collection and

I I I I I I will result from (I)

I I I I I I risk assessment) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 14. And personal protective and required only, and required and requested and required, even

I I work and if so I will follow (the concrete type and ochrannérukavice and trade (I)

I I I the frequency of exchanges, and other personal and gloves, and

I I I I I will result from ochrannépracovní and protective glasses and even

I I I I) risk assessment and resources from other personal and

I I I I I the risk assessment and protective and

I I I I I (replacement frequency and means as I

I I I I I I will come from risk assessment and

I I I I I I (risk assessment) and exchange rate

I I I I I I I will come from

I I I I I I risk assessment) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

15. (I) effective control and even required required required required and even

(I) the exclusion of the vectors I I I I I

Even genetically I I I I I

I even modified I I I I I

And even organisms (eg. I I I I I

And even insects and rodents) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I I I Wastes And

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 1. I also required inactivation of the just, and also required required required and

I even modified even if results so I I I I

Even in the outflow from the and from the reviews I I I I

I even wash basins, sinks, and the risks I I I I

Even the showers and other I I I I I

(I) effluents I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 17. And the inactivation of the required and requested, including even required including even required, including (I)

I I I I I modified disinfection disinfection and disinfection and

I I I I on protective clothing and protective clothing, protective clothing, and

I also used material and even shoes and other shoes and other (I)

And even in solid waste in the I I I the personal and personal and

And also comply with the other I I I I I trade trade

I I I I I legislation, resources and funds, and the

I I ^16) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

And other measures I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

18. And the laboratory has its own and required required required required and even

I even own the equipment I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 19. I just installed and required, and required only, and required and ordered

Even the viewing window, or even if it emerges and if so will result I I I

And other equipment to and from the reviews even from reviews I I I

Even workers at risk and the risks I I I

(I) the laboratory were I I I I I

And I see I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

20. Even the rest room and it is not required and requested, and only required and ordered

And even outside of work and even shows I I I

And space and even from reviews I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I



PART (B)



ENCLOSED SPACE REQUIREMENTS AND SAFEGUARDS FOR GREENHOUSES AND

CULTURE ROOM



For the purposes of this part of the annex shall mean the



1. the greenhouse or the culture room enclosed area bordered by

walls, floors and roof (the ceiling), which is designed and mostly

used for growing plants. If treated in the greenhouse as well as with other

genetically modified organisms are plants, the greenhouse

comply with the conditions set out for the site (for example, parts of the

Of this annex, if it is a genetically modified micro-organisms,

or part C of this annex, if it is a genetically modified

animals),



2. hygiene loop entry to the greenhouse or the culture room through


separate spaces, the "clean" side is separated by a safety

doors, closet for clothes and shower, Exchange



3. the standard operating procedure for the safe transmission of

material into the sterilizer out of greenhouse or cultivation and

to ensure the same level of protection as those spaces,



4. protective clothing, in particular cotton coat, protective apron of

PVC, rubber textile protective apron, a special jumpsuit made of polyethylene,

overpressure protective clothing, protective coat with liner,

the protective linings of hooded coat, waterproof protective sheath,

cotton work trousers, work trousers, reticle on the head, hat,



5. protective footwear in particular, rubber boots, rubber galoshes, closed

work footwear-type shoes, sandals with a closed toe, health

Sandals,



6. personal protective equipment, in particular, cotton gloves,

latex gloves, polyethylene disposable gloves, nitrile

gloves, or a request to the sterility of gloves-disposable

Vinyl gloves, protective glasses, protective goggles, protective anti-dust

shield, lícnicová part of the particulate filter material (ústenka)

filtering half masks with filter against solid particles (with expiratory

with or without valve), filter half mask, or čtvrtmaska with a filter

face mask with filter (must include the subject of filtering), insulation

respiratory unit non-Autonomous (hose), a self-contained breathing apparatus.

I-----I----------------------I-------------------------------------------------------------------------------I

I I I for the category of risks and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I. (I) (II). AND (III). AND (IV). (I)

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even I enclosed space I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 1. Even greenhouse or even is not required and the required and requested and required

Even the culture room I I I I I

And also are resistant to I I I I I

Even the weather extremes in the I I I I I

I I the region I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

2. Even the Department inside and is not required and requested, and only required only, and required

And even a building or location even if results and if so will result in the location and

And even in a special building and also from the reviews even from reviews and specific building and

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

3. As well as Sealing for I is not required and not required as well as required and requested I

And even gas sterilization I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I I I Equipment I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

4. I enter the work and is not required and requested and required input and required the input and

I I I I I space via over hygiene despite the health and

I I I I I a separate room loop and loop (I)

Even with two mutually I I I I I

I also blocked the door I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

(I) 5. And Reduced pressure is not required and not required as well as required and requested I

And also because of the pressure in the I I I I I

(I) the immediate vicinity of I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

6. As well as input and output and is not required and is not required to (I) required for (I) required

(I) air through I I I I I output

(I) the aerosol filter I I I I I

I I (HEPA) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

7. Even the pressure steam I required, I required, I required, I required, I

I I I the sterilizer must (I) that is a must and the must and the must (I)

I I I be on site or be located in the building and the nacházetv building and reside in and

I I I I I I and subject to a closed and

I I I I I the conditions and space; must I

I I I I I I be inserted between the compliance and

I I I I I standard as well as a "clean" and I

I I I I I I "impure" operating part I

I I I I I the procedure (see I I

I I I I I výše) I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I work mode I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

8. Also a limited access is not required and the required and requested and required

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 9. And the tag "danger-I is not required and the required and requested and required

And even biological risk "I I I I I

I I ^ 15) on input I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

10. And a shower and is not required and requested in I requested and required

I I I I I I I building

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

11. And protective clothing and also required suitable required suitable required suitable required even

(I) safety boots and protective clothing and protective clothing and full protective suit and even protective clothing and even

I I I (a particular type and a particular type of (and even ochrannáobuv and protective shoes and

I I I the frequency of exchanges and exchange rate (the concrete type and I (specific type I

I I I will result from both result from and replacement frequency and results from (I)

I I I the risk evaluation) as well as reviews and vyplynouz and risk assessment) and

I I I I), protective and risk assessment) and with the full Exchange and

I I I I I I needed shoes, clothing and footwear and

I I I I only, if so I I before entering and

I I I I I I will come from a closed and

I I I I I I area of risk assessment and

I I I I I I the output from the

I I I I I I (method of treatment and

I I I I I I with clothing and footwear as well as

I I I I I I I will result in the collection of

I I I I I I from reviews and

I I I I I I risks) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

12. And personal protective and required only, and required and requested and required, even

I I work and if so I will follow (the concrete type and even ochrannérukavice and protective gloves and

I I I the frequency of exchanges, and other personal and other personal and

I I I I I I ochrannépracovní of protective and

I I I I risk assessment) and means as well as resources and

I I I I I I risk assessment risk assessment and

I I I I I I (exchange rate (the frequency of the exchanges

I I I I I will come from even arising from (I)

I I I I I risk assessment) and risk assessment) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I I I Wastes And

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

13. I also required inactivation of the just, and also required required required and

I even modified even if results so I I I I

Even in the outflow from the and from the reviews I I I I

I even wash basins, sinks, and the risks I I I I


Even the showers and other I I I I I

I even waste water in a I I I I I

And also comply with the other I I I I I

(I) the legislation I I I I I

I I ^16) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 14. And the inactivation of the required and requested, including even required including even required, including (I)

I I I I I modified disinfection disinfection and disinfection and

I I I I on protective clothing and protective clothing, protective clothing, and

I also used material and even shoes and other shoes and other (I)

And even in solid waste in the I I I the personal and personal and

And also comply with the other I I I I I trade trade

I I I I I legislation, resources and funds, and the

I I ^16) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

And other measures I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

15. (I) reduction of required and even required and requested and required

I I I I I preventing adverse as well as preventing and

(I) animals, insects, and even the occurrence of even the occurrence of even

And even rodents, etc. I I I I I

(I) preventing access I I I I I

And I and a regular I I I I I

And treatment space and I I I I I

I I effective device I I I I I

I I resources I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 16. I the greenhouse, or even required, and also required required required and

Even the culture room I I I I I

And even has its own I I I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 17. And the draining of water only and required only, and also required required required and

(I) waste, where will take place even if results and reduction of run-off and prevent runoff and prevent runoff and

And even as I of the inactivation of the reviews even outside the waste on the outside and out waste and scrap

Even I, point 13 and risks as well as a minimum I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

18. (I) treatment of waste and it is not required and requested, and only required and ordered

(I) soil in an autoclave I I I I

I I or hot-air and even so, deriving from the I I I

I I I I the steriliser risk assessment I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 19. And the way the movement and also required required required required

And even to other organisms and to limit the spread and control of the spread and prevention of the proliferation and spread of even

(I) the device must, even the lowest possible even outside the space, to even out the space in the outside space, the I

I even allow control and peace in and outside which is which is which is also

And even over the proliferation of space, to the organism and body and organism and

I I I which is genetically and moved and moved and moved and

I even modified organism and I I I I

I also moved the organisms I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

20. Even the rest room I is not even required, and only required and ordered

And even outside of work and required even if results so I I I

And space and even from reviews I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I



PART (C)



ENCLOSED SPACE REQUIREMENTS AND SAFEGUARDS FOR THE USER

EQUIPMENT FOR ANIMALS



1. If the user devices for animals treated with other

genetically modified organisms, the device must comply with the terms and conditions

established for the other departments (for example, part A of this

the annex, if it is a genetically modified micro-organisms, or

part B of this annex, if it is a genetically modified

plants).



2. In the case of clinical trials of medicinal products for human or veterinary

containing genetically modified organisms, they are applied to requests

closed areas and safeguard measures in accordance with other legal

regulations ^ 17).



3. for the purposes of this part of the annex shall mean the



and zvířetníkem) separate building or Department inside the building including

spaces for animals and other ancillary areas (for example, warehouse feed

litter, AIDS), including facilities for the staff (e.g., changing rooms,

showers, sterilizers, spaces for the storage of food,



(b)) space for animals according to specialized facilities and equipment

the species of animals for their breeding and the implementation of experimental procedures,



c) insulator translucent container, in which small animals are kept; for

larger animals are more convenient isolated room,



d) protective clothing, in particular cotton coat, protective apron of

PVC, rubber textile protective apron, a special jumpsuit made of polyethylene,

overpressure protective clothing, protective coat with liner,

the protective linings of hooded coat, waterproof protective sheath,

cotton work trousers, work trousers, reticle on the head, hat,



(e) protective footwear in particular) rubber boots, rubber galoshes, closed

work footwear-type shoes, sandals with a closed toe, health

Sandals,



f) personal protective equipment, in particular, cotton gloves,

latex gloves, polyethylene disposable gloves, nitrile

gloves, or a request to the sterility of gloves-disposable

Vinyl gloves, protective glasses, protective goggles, protective anti-dust

shield, lícnicová part of the particulate filter material (ústenka)

filtering half masks with filter against solid particles (with expiratory

with or without valve), filter half mask, or čtvrtmaska with a filter

face mask with filter (must include the subject of filtering), insulation

respiratory unit non-Autonomous (hose), a self-contained breathing apparatus.



4. in addition to the requirements of other legislation) must be the user ^ 18

equipment for animals must meet the following requirements:

I-----I----------------------I-------------------------------------------------------------------------------I

I I I for the category of risks and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I. (I) (II). AND (III). AND (IV). (I)

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 1. Even the Zodiac is also required, and only required and requested and required

(I) a separate unit and if so will result I I I I

I I I the reviews I I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

2. I also only required spaces, and also required required required and

Even animals separated even if results so I I I I

Even lockable by and from the reviews I I I I

I I door I risk I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

3. I also ordered spaces required and requested and required

Even animals and a helper I I I I I

I even made the device I I I I

Even so, that I I I I I

And even easy to clean and I I I I I

And even decontaminate I I I I I

I I (materials I I I I I

I also impermeable to I I I I I

And water, easily I I I I I

Even washable and I I I I I

I also disinfect) I I I I I


I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

4. Even the floors and walls and required only, and required both for and required for (I) required for (I)

And even the rooms easily even if it emerges and the floor and the floor and the walls and the floor and walls and

Even washable and from the reviews I I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

(I) 5. Even the animals are kept and also required required required required and even

And even reasonable I I I I I

Even barrier I I I I I

And even devices like I I I I I

And I are the breeding container, I I I I I

And even the boxes or the tank I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

6. Filters and is not required and requested, and only required and ordered

I I I I if izolátorech or so shows I I I

I even isolated even from reviews I I I

I I the rooms I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

7. Even if the use of both required and requested and required and the required

Even products of animal I I I I I

And even the origin of the creation of the I I I I I

(I) the conditions for the I I I I I

I even check (eg. I I I I I

I I I I I I animal health and

And even health control) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

8. And a shower and is not required and requested in I requested and required

I I I I I I I building

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 9. And protective clothing and even required required required required

And even protective footwear and suitable suitable suitable protective and

I I I the protective clothes and protective clothing and full protective suit and even clothing and protective and

I I I (a particular type and a particular type of (and even ochrannáobuv and shoes (specific and

I I I the frequency of exchanges and exchange rate (the concrete type and even the type of results from (I)

I I I will result from both result from and replacement frequency and risk assessment) and

I I I the risk evaluation) as well as reviews and vyplynouz and with the full Exchange and

I I I I), protective and risk assessment) and clothing and footwear as well as

I I I I I I needed shoes before entering and

I I I I only, if so I closed and

I I I I I I will come from space and even

I I I I I I risk assessment output from it even

I I I I I I (method of treatment and

I I I I I I with clothing and footwear as well as

I I I I I I I will result in the collection of

I I I I I I from reviews and

I I I I I I risks) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

10. And personal protective and required only, and required and requested and required, even

I I work and if so I will follow (the concrete type and even ochrannérukavice and protective gloves and

I I I the frequency of exchanges, and other personal and other personal and

I I I I I I ochrannépracovní of protective and

I I I I risk assessment) and means as well as resources and

I I I I I I risk assessment risk assessment and

I I I I I I (exchange rate (the frequency of the exchanges

I I I I I will come from even arising from (I)

I I I I I risk assessment) and risk assessment) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

11. Even the rest room and it is not required and requested, and only required and ordered

I I I I if so shows I I I

I I I I I I I from the evaluation

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even if the user device for aquatic animals and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

12. And the inactivation of the animals and also required required required required and even

And even in effluents I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

13. Even the design of the room I requested for and required for (I) required for (I) required for (I)

(I) such that the escape of organisms and organisms and the leakage water leakage and the leakage of water and

And I cracked, I I I I I

And even leaks or I I I I I

I I overflow tank for the I I I I I

(I) aquatic animals I I I I I

(I) prevent leakage to the I I I I I

And also, I I I I I

(I) surface water or I I I I I

And even ground water I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I



PART (D)



ENCLOSED SPACE REQUIREMENTS AND OTHER PROTECTIVE MEASURES FOR OTHER

ACTIVITIES (FOR EXAMPLE, MANUFACTURING PLANTS, DEMONSTRATION)



For the purposes of this part of the annex shall mean the



1. closed system device permanently placed in an enclosed space,

intended for the possession and cultivation of genetically modified organisms,

as a rule, in large volumes,



2. hygiene loop input in a confined space through separate

spaces, the "clean" side is separated by a safety doors,

dressing room to Exchange clothing and shower,



3. protective clothing, in particular cotton coat, protective apron of

PVC, rubber textile protective apron, a special jumpsuit made of polyethylene,

overpressure protective clothing, protective coat with liner,

the protective linings of hooded coat, waterproof protective sheath,

cotton work trousers, work trousers, reticle on the head, hat,



4. the protective footwear in particular, rubber boots, rubber galoshes, closed

work footwear-type shoes, sandals with a closed toe, health

Sandals,



5. personal protective equipment, in particular, cotton gloves,

latex gloves, polyethylene disposable gloves, nitrile

gloves, or a request to the sterility of gloves-disposable

Vinyl gloves, protective glasses, protective goggles, protective anti-dust

shield, lícnicová part of the particulate filter material (ústenka)

filtering half masks with filter against solid particles (with expiratory

with or without valve), filter half mask, or čtvrtmaska with a filter

face mask with filter (must include the subject of filtering), insulation

respiratory unit non-Autonomous (hose), a self-contained breathing apparatus.

I-----I----------------------I-------------------------------------------------------------------------------I

I I I for the category of risks and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I. (I) (II). AND (III). AND (IV). (I)

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I even closed system I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 1. And Viable and required only, and also required required required and

And even organisms must be even if it emerges I I I I

I even kept even from reviews I I I I

Even a closed system, and the risks I I I I

And even that is separated from the I I I I I

And I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

2. And security and it is not required and the required and requested and required

(I) the regulation of the distribution and limit the spread of the prevention of the proliferation and spread of even


I even spray I I I I I a minimum

And even departing from I I I I I

I even closed system I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

3. And security, and even required, and only required and requested and required

(I) the regulation of the proliferation and if so will follow and limit the spread of the prevention of the proliferation and spread of even

I also spray during and from reviews and the lowest possible I I I

And even the taking of samples or even risk and peace I I I

I add material I I I I I

And even in a confined I I I I I

(I) system or the transmission I I I I I

(I) the material to another I I I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

4. I also needed the inactivation of Inactivation required and the necessary inactivation and inactivation required inactivation and

Even the culture medium and the physical or physical or physical or physical or

Even before removing or even chemical and chemical and chemical and chemical method and

Even the deletion of I I I with evidence and with proven and

I I I I I a closed system 100% and 100% efficiency and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

(I) 5. And seal designs and even required and required the full and complete required and required the full and

And even closures to prevent and limit the spread of the prevention of the proliferation and spread of prevention of spread and

And even the spread of organisms out of even the lowest possible I I I I

Even a closed system and peace I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

And other requirements on the I I I I I

Even I enclosed space I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

6. And the trap for the I, I only required required required required and even

And even culture and if so will result I I I I

(I) the device must, even from reviews I I I I

I also hold the total risks I I I I

Even the volume of the closed I I I I I

And even if the system I I I I I

I I to escape I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

7. As well as Sealing for I is not required and requested, and only required only, and required

(I) gas sterilization and if so will result even if it emerges I I

I I I I from the reviews even from reviews I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

8. I enter through and it is not required and not required and requested, I just ordered

I I I I I the health loop if so shows I I

I I I I I I I from the evaluation

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 9. As well as easy to clean as well as required for (I) required for (I) required for (I) required for (I)

Even the surfaces resistant to even the desktop, the desktop, and pracovníplochu, as well as the desktop, and

And even water, acids, and the floor and the walls and the floor and the walls and the floor and the walls and floor, wall and I

Even alkalis, I I I I the ceiling and

And solvents; I I I I I

Even allowing for the effective I I I I I

And even disinfecting and I I I I I

I I I I I I decontamination even

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

10. As well as special equipment and required only, and required only, and required and ordered

And also for ventilation in order to even if it emerges and if so will result I I I

I also limit the contamination and from the reviews even from reviews I I I

Even the air to a minimum, and the risks and the risks I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

11. As well as keeping lower and is not required and not required as well as required and requested I

And even air pressure than I I I I I

(I) the pressure is on I I I I I

(I) the immediate vicinity of I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

12. As well as input and output and is not required and is not required to (I) required for (I) required for (I)

I I I I I air through the output, for both the input and the input and output as well as

(I) the aerosol filter I I I I I required

(HEPA) I I I I I only, if so I I

I I I I I I I will come from

I I I I I I I risk assessment

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I work mode I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

13. The closed system also is not required and requested, and only required and ordered

I I is located in the I I if so shows I I I

And even an enclosed area and also from the reviews I I I

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 14. Even limited access as well as required and requested and required and the required

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

15. And the tag "danger-I is not required and the required and requested and required

And even biological risk "I I I I I

I I ^ 15) on input I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 16. Even before leaving and it is not required and not required as well as required and requested I

And even an enclosed space I I I I I

And workers must I I I I I

I take a shower I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I 17. And protective clothing and also required suitable required suitable required suitable required even

(I) safety boots and protective clothing and protective clothing and full protective suit and even protective clothing and even

I I I (a particular type and a particular type of (and even ochrannáobuv and protective shoes and

I I I the frequency of exchanges and exchange rate (the concrete type and I (specific type I

I I I will result from both result from and replacement frequency and results from (I)

I I I the risk evaluation) as well as reviews and vyplynouz and risk assessment) and

I I I I), protective and risk assessment) and with the full Exchange and

I I I I I I laundry required shoes, clothing and even

I I I I only if and and footwear before and

I I I I I I will come from entering and

I I I I I I a closed risk assessment and

I I I I I I area and I

I I I I I I the output from the

I I I I I I (method of treatment and

I I I I I I with linens, clothing and

I I I I I I and footwear for the collection and

I I I I I I I will come from

I I I I I I risk assessment) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

18. And personal protective and required only, and required and requested and required, even

I I work and if so I will follow (the concrete type and even ochrannérukavice and protective gloves and

I I I the frequency of exchanges, and other personal and other personal and


I I I I I I ochrannépracovní of protective and

I I I I risk assessment) and means as well as resources and

I I I I I I I score reviews

I I I I I (frequency and risk (frequency and

I I I I I arises from the Exchange and the exchange of results from (I)

I I I I I risk assessment) and risk assessment) and

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

I I I I I I Wastes And

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 19. I also required inactivation of the just, and also required required required and

I even modified even if results so I I I I

Even in the outflow from the and from the reviews I I I I

I even wash basins, sinks, and the risks I I I I

And even showers, etc. I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

20. And Disinfection and required only, and also required required required and

I I work clothes, even if it results in I I I I

I I work shoes and even from reviews I I I I

And even individual risks I I I I

I I trade I I I I I

I I resources I I I I I

Even I use I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 21. I also needed the inactivation of the inactivation of the needed and necessary inactivation and inactivation required inactivation and

I even modified as well as physical or physical or physical or physical or

And even organisms on the chemical and even chemical and chemical and chemical method and

I also used material and I I I with evidence and with proven and

And even in the liquid and I I I 100% efficient and 100% efficiency and

Even and solid waste in the I I I I I

Even during the process of v I I I I I

And also comply with the other I I I I I

(I) the legislation I I I I I

I I ^16) I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

And other measures I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I

Even 22. Even the rest room and it is not required and requested, and only required and ordered

I I I I if so shows I I I

I I I I I I I from the evaluation

I I I I I I I

I-----I----------------------I-------------------I-------------------I-------------------I-------------------I



7) Law No 18/2004 Coll., on the recognition of professional qualifications and other

eligibility of nationals of the Member States of the European Union and the

amendments to certain laws (law on the recognition of professional qualifications), as amended by

amended.



8) Act No 246/1992 Coll., on the protection of animals against cruelty, as amended by

amended.



9) Act No. 258/2000 Coll., on the protection of public health and amending

some related laws, as amended.



Act No. 309/2006 Coll., to regulate for more safety requirements and

health at work in labor relations and to ensure

safety and health activities or the provision of services outside the

labor relations (the law on ensuring safety and other conditions

health at work), as amended.



10) Government Decree No. 361/2007 Coll., laying down the conditions of protection

health at work, as amended.



11) Law No 249/1997 Coll., on agriculture, as amended.



12) Act No. 114/1992 Coll., on nature and landscape protection, as amended by

amended.



13) Act No. 242/2000 Coll., on organic farming and on the amendment of the Act

No 368/1992 Coll., on administrative fees, as amended,

in the wording of later regulations.



14) 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.



15) Government Decree No. 11/2002 Coll., laying down the appearance and location of the

the introduction of the safety signs and signals.



16) for example, Act No. 185/2001 Coll., on waste and amending certain

other acts, as amended.



17 for example, Act No.) 378/2007 Coll., on pharmaceuticals and on changes of some

related laws, as amended, Decree No.

226/2008 Coll., on good clinical practice and detailed the conditions of clinical

evaluation of medicinal products.



18) for example, Act No 246/1992 Coll., as amended,

Decree No. 419/2012 Coll., on the protection of experimental animals, as amended by Decree

No 299/2014 Coll., Act No. 167/1999 Coll. on veterinary care and amending

certain related laws (health law), as amended

legislation, Act No. 258/2000 Coll., on the protection of public health and amending

some related laws, as amended, regulation

No 27/2002 Coll., laying down the method of organizing work and

working practices, which the employer is obliged to arrange at work

related to the rearing of animals. ".



25. After annex No 4, the following appendix 5, which including notes below

footnote # 19 and 20 read as follows:



' Annex No. 5 to Decree No 209/2004 Coll.



Patterns of the emergency plan



(Section 20, paragraph 4, of the Act)



Documents marked with



(+)

It is necessary to attach as a separate attachment



All relevant documents must be identified by name or title

(trade name) of the applicant



The data that form the Ministry of information made available about the accident

plan under section 20 (2). 5 of the Act, are flagged with a



PART AND



THE PATTERN OF EMERGENCY PLAN FOR CONTAINED USE



1. the user (the person authorized for dealing with GMOs)



1.1. The name or business name, if the user of the physical

a person authorized to do business



1.2. The name or business name and legal form, if the user

legal person



1.3. Registered address



1.4. COMPANY REGISTRATION NUMBER (if assigned)



For individuals below:



1.5. the address of the residence or address for service



1.6. the phone



1.7. E-mail



2. the members of the Board (for legal persons)



2.1. Name, academic degree, function



2.2. Address of residence



2.3. Address for service



2.4. the phone



2.5. Email



3. the expert advisor



3.1. Name, academic title



3.2. Address of residence



3.3. the phone



3.4. Email



4. The person responsible for the liquidation of accident



4.1. Name, academic title



4.2. Home address



4.3. the phone



4.4. E-mail



5. Workplace



5.1. workplace Address



5.2. the precise designation of premises and equipment



(+) Site plan with the designation of places relevant to the limitation of the consequences of

crash (in particular, the main driver of energy supply and its supporting media,

the place of storage of genetically modified organisms, safety features

the conclusion of the space or save rendering resources applicable to

liquidation of the accident)



6. the transport of genetically modified organisms (if the waste

genetically modified organisms covers their transport out of the

listed site)



6.1. Description of the method of transportation, ensure genetically modified

organisms against leakage



7. Description of the accident, which may arise in areas where

use of genetically modified organisms



8. An overview of the potential consequences of an accident on human health, animal health

the environment and biodiversity, including methods of detection

These consequences and effective protection from them



9. Methods for detection of the presence of genetically modified organisms



10. procedure in the event of a disaster



10.1. Rendering resources applicable to the disposal of genetically

GMOs and the decontamination of the affected area and place

save them



10.2. The methods and procedures applicable to the disposal of genetically modified

organisms and to decontaminate the affected area



10.3. the methods of isolation of premises and equipment affected by the accident, including

methods for testing the effectiveness of insulation



10.4. the procedures for the protection of the health of humans, animals, the environment and

biological diversity in the case of an unwanted influence resulting from the

accidents; where appropriate, the disposal or remediation methods, plants and animals,

that were in the area at the time of the accident, in accordance with other


the Law ^ 19)



10.5. Ensure the subsequent monitoring of the premises and land after their

redevelopment of the



11. The municipalities, or persons to whom the emergency plan is presented pursuant to section

20 (2). 3 of the law



12. the method of notification to the administrative authorities referred to in section 27 of the Act in

event of an accident, or a way of warning for citizens



13. the observations of the expert advisor



PART (B)



THE PATTERN OF EMERGENCY PLAN FOR ENTRY INTO THE ENVIRONMENT



1. the user (the person authorized for dealing with GMOs)



1.1. The name or business name, if the user of the physical

a person authorized to do business



1.2. The name or business name and legal form, if the user

legal person



1.3. Registered address



1.4. COMPANY REGISTRATION NUMBER (if assigned)



For individuals below:



1.5. the address of the residence or address for service



1.6. the phone



1.7. E-mail



2. the members of the Board (for legal persons)



2.1. Name, academic degree, function



2.2. Address of residence



2.3. Address for service



2.4. the phone



2.5. Email



3. the expert advisor



3.1. Name, academic title



3.2. Address of residence



3.3. the phone



3.4. Email



4. The person responsible for the liquidation of accident



4.1. Name, academic title



4.2. Home address



4.3. the phone



4.4. E-mail



5. Workplace and land



5.1. workplace Address



5.2. the precise designation of the land ^ 20), or the space and equipment to

storage



(+) Map showing land and clear the map on an appropriate scale with the

showing the experimental areas and crops grown on the surrounding grounds



(+) Alternatively, a plan departments marked with places significant for restrictions

the consequences of the accident (in particular, the place of storage of genetically modified

organisms or saving the rendering resources applicable to the disposal of

the crash)



6. the transport of genetically modified organisms



6.1. Description of the method of transportation, ensure genetically modified

organisms against leakage



7. Description of accidents which may arise



8. An overview of the potential consequences of an accident on human health, animal health,

the environment and biodiversity, including methods of detection

These consequences and effective protection from them



9. Methods for detection of the presence of genetically modified organisms



10. procedure in the event of a disaster



10.1. Rendering resources applicable to the disposal of genetically

GMOs and the decontamination of the affected area and place

save them



10.2. The methods and procedures applicable to the disposal of genetically modified

organisms and to decontaminate the affected land



10.3. the procedures for the protection of the health of humans, animals, the environment and

biological diversity in the case of an unwanted influence resulting from the

accidents; where appropriate, the disposal or remediation methods, plants and animals,

that were in the area at the time of the accident, in accordance with other

the Law ^ 19)



10.4. Ensure the subsequent monitoring of the land after their redevelopment



11. The municipalities, or persons to whom the emergency plan is presented pursuant to section

20 (2). 3 of the law



12. the method of notification to the administrative authorities referred to in section 27 of the Act in

event of a disaster



13. the observations of the expert advisor



19), for example, Act No 246/1992 Coll., as amended,

Act No. 167/1999 Coll., as subsequently amended, Act No. 185/2001

Coll., as subsequently amended, Act No. 147/1996 Coll., on

plant health care and certain related laws, changes in the

as amended.



20) section 8 (a). a) and b) of Act No. 256/2013 Coll., on the real estate register

(Act), as amended. ".



Article II



The effectiveness of the



This Decree shall enter into force on 1 January 2000. January 2017.



Minister:



Mgr. Vratislav Brabenec in r.