On The Conditions Of Use Of Genetically Modified Organisms

Original Language Title: o podmínkách nakládání s geneticky modifikovanými organismy

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=57807&nr=209~2F2004~20Sb.&ft=txt

209/2004 Coll.



The DECREE



of 15 July. April 2004



the closer the terms of use of genetically modified organisms and

genetic products



Change: 86/2006 Sb.



Modified: 29/2010 Sb.



The Ministry of the environment, in agreement with the Ministry of health

and the Ministry of agriculture lays down, pursuant to section 38 of the Act No. 78/2004 Coll., on

use of genetically modified organisms and genetic products

(hereinafter referred to as "the Act") for the implementation of § 5 (3). 1 and 4, § 7 (2). 7, section 11 (2).

3, § 15 paragraph. 2, § 16. 2 and 3, section 19 (e). (b)), section 20 (2). 4 and § 24

paragraph. 17:



§ 1



The subject of the edit



This Decree lays down, in accordance with the law of the European Communities ^ 1)

more detailed conditions for the use of genetically modified organisms and

genetic products, and that the particulars of applications for an authorisation to

contained use of genetically modified organisms, of particulars

the application for the grant of authorisation for the marketing of genetically modified organisms

to the environment, the requirements for an application for entry in the List

genetically modified organisms and genetic products approved

for putting into circulation, the particulars of the notification on the contained use of

genetically modified organisms, the first and second categories of risk,

a summary of the content of the application formalities, requirements and evaluation procedures

the risk threshold limit of occurrence of admixture, enclosed space requirements

and protective measures for each risk category when closed

use of genetically modified organisms, method and scope management

documentation, requirements and emergency plan evaluation

the message.



§ 2



The basic concepts



For the purposes of this Ordinance means



and recipient organism), in which the hereditary material, genetic

modification of hereditary material, bringing the foreign



(b) donor organism-organism), from whose hereditary material

the hereditary material in the vnesený comes from the genetic material of the recipient,



(c) parental organism-organism), from whose hereditary material

genetic modification has been excluded part of the hereditary material,



(d)) the target organism-organism, whose effect on genetically

modified organism to be affected by the genetic modification,



e) vector-nebuněčný Department containing hereditary material and able

bring this hereditary material together with an embedded cizorodým hereditary

material into the cells of the recipient,



(f)) insertem-foreign hereditary material embedded in the hereditary material

the recipient,



(g)) konstruktem-artificially modified nucleic acid molecule,



h) signal, gene-gene construct is contained in and easily

identified property of cells or organism containing functional

construct,



I) selective gene-gene construct is contained in and specifying the numbness to

specific to the substance or to the impact of preventing proliferation of cells this gene

do not include,



j) higher plant-plants of the gymnosperms (Gymnospermae) and flowering plant

(Angiospermae).



§ 3



Particulars of the application for the grant of authorisation for contained use with

genetically modified organisms, the formalities of the application

authorisation for the marketing of genetically modified organisms into the environment

environment, the requirements for an application for registration in the list of the genetically

modified organisms and genetic products approved for marketing

the circulation and the formalities of the notification on the contained use of first and second

risk category



(Section 5, paragraph 1, and article 16, paragraph 2 and 3 of the law)



(1) Requirements



and on contained use) notification of genetically modified organisms

(hereinafter referred to as "closed treatment") the first and second categories of risk are

listed in part A of annex 1 to this notice,



(b) applications for the grant of authorisation) for contained use are listed in the

part B of annex 1 to this notice,



(c) the application for the grant of authorisation) for the marketing of genetically modified

organisms into the environment (hereinafter referred to as "placing into the

environment ") are listed in annex 2 to this Decree, or



(d)) in the list of applications for the registration of genetically modified organisms and

genetic products approved for the putting into circulation (hereinafter "List

for putting into circulation ") are listed in annex 3 to this notice.



(2) the notification or the request referred to in paragraph 1 must be made in the Czech

the language breakdown set out in annexes 1 to 3 of this order and,

If the request is served on a technical data medium or by electronic

by post, text documents in the format of "Rich Text Format (.RTF),

graphic documents (plans, map, scanned documents, etc.) in the format

JPEG (JPG extension); in both cases it is possible to use the format "Portable

Document Format "(PDF extension).



(3) If the documents are to notice or application required by this

by Decree in a language other than English, it shall be submitted in an officially certified

translation.



(4) if the request for the grant of authorisation is made for more genetically

modified organisms (article 18, paragraph 3, of the Act), it should be noted

all the required information for each genetically modified

the organism.



§ 4



A summary of the content of the application requirements, which is the Web page



(article 5, paragraph 4, of the Act)



Summary of the essentials, content of the application for individual ways of dealing with the

genetically modified organisms and genetic products are

indicated in annexes 1 to 3 to this notice.



§ 5



Formalities and procedures of risk assessment



(§ 7 paragraph 7 of the law)



(1) when assessing the risk, account shall be taken of all the potential

harmful effects of the use of genetically modified organisms and

genetic products, regardless of the probability with which you can

occur, and compared against the harmful effects of waste by the consignee,

where appropriate, parental organism or organisms related. The effects of the

the handling of genetically modified organisms or genetic

the product can be



and direct-the primary effects) on human health, animals, plants, or

the environment, which is directly linked to genetically modified

organism or genetic product,



(b) indirect effects on)-the health of humans, animals, plants or the

environment, which occurs when a causal sequence of events, for example,

through interactions with other organisms, transfer of hereditary

material or changes in the way of loading; indirect effects are

can occur even with a delay,



(c)), instant-are observed during treatment with genetically

genetic modified organism or product; immediate effects

may be direct or indirect,



(d)) late-which may not be observed during treatment with

genetically modified organism, or the genetic product, but may

be identified as direct or indirect effects after their treatment with

genetically modified organism, or the genetic product, or



e) cumulative long-term effects-cumulative effects management

genetically modified organisms or genetic health products

people, animals, plants and the environment.



(2) the harmful effects on the health of humans, animals, plants or the

environment may occur



and employment or the extension) of the genetically modified organism in

environment, for example, his influence on the dynamics of populations of species in the

the receiving environment or genetic diversity of some of

them,



(b) the natural transfer of inserted) hereditary material to other organisms,

that can result in, for example, reduce the potential for prophylaxis or

treatment in the field of medical, veterinary or plant health, for example,

the transmission of genes enhancing the pathogenicity, virulence, or toxinogenitu

organisms or transfer of antibiotic-resistance genes

used in medicine or veterinary medicine,



(c) the phenotypic or genetic instability) of the genetically modified

the organism,



d) interactions of the GMO to other organisms,

or



e) differences between the handling of genetically modified organism, or

genetic and management with the recipient, where appropriate, the parental

the organism, including possible different agrotechnických procedures

can lead to differences in biochemical processes in the soil, such as

the decomposition of organic matter and carbon and nitrogen.



(3) in the assessment of risk, it is necessary to identify potential

harmful effects in conjunction



and with the beneficiary)



(b)) with embedded hereditary material (originating from the donor organism),



(c)) with the vector,



(d)) with the donor organism (if the donor organism during

genetic modification used)



(e)) with pasting the construct,



(f)), the key and the s genes,



g) with insertem,



(h)) with the exclusion of part of the hereditary material (if the genetic modification

includes)



I) with the resulting genetically modified organisms,



(j)) and the scope of management of genetically modified organism

or genetic product,



k) with the environment at the place of management of genetically modified

organism or genetic product and



l) with possible interactions between genetically modified organism, or

the genetic product and the environment at the place of treatment.



(4) the assessment of the risk severity assessment always includes every possible
a harmful effect, and the likelihood that this effect occurs

and when over the way management on a given site or location

putting into the environment, and under conditions which they are to be navozeny

or that may occur. The risk assessment must also take into account the

the characteristics of the activities and the resulting dangers.



(5) the first stage of the risk assessment is the identification of the contained use

the potential harmful effects referred to in paragraph 3 (b). and to i).) To the first

contained use of risk category in accordance with Annex No 3 to the Act can be

include only the genetically modified organisms for which the



and) it is unlikely that the recipient or parental organism causes

disease to humans, animals or plants,



(b) the nature of the vector and insertu) is such that it cannot make the phenotype

genetically modified organism that could cause disease

humans, animals or plants, or which could have adverse effects on

the environment, and



(c)) is not likely, that the genetically modified organism will cause

disease to humans, animals or plants, or that will have detrimental effects on

the environment.



(6) the assessment of the risks in the case of contained use takes into account whether or not



and environmental characteristics) that could be affected when

escape of genetically modified organism from the confined space,



(b)) the nature and extent of the contained use and



(c) any non-standard operations carried out) in the course of their

waste (for example, the vaccination of animals genetically modified

micro-organisms or the operation of the equipment, which may generate aerosols).



These facts are also considered in the classification of the contained use

to the relevant risk categories according to annex No 3 to the Act.



(7) the procedure for risk assessment includes



and the identification of all the possible harmful) effects in accordance with paragraphs 1 to 6 and

assess their seriousness,



(b) evaluation of the consequences of each harmful) effect, if it occurs,



(c) the evaluation of the likelihood that) harmful effects under given conditions

occurs,



(d) an estimate of the risk to health) of the people and the environment represented by the

each of the identified harmful effects on the basis of the assessment

the likelihood that the effect will occur, and the severity of that effect,

If it occurs,



(e) the comparison of the collected data with) the relevant data for the donor

the body, the recipient or parental organism, under comparable

conditions,



(f)) in the case of summary of the results, the classification of the contained use activities

to the relevant risk categories according to annex No 3 to the Act.



(8) all steps of the procedure referred to in paragraph 7 shall be in writing

documented and, where possible, documented scientific references

literature, protocols of experimental studies and, where appropriate,

documentation on the previous use of genetically modified

organisms. This analysis is part of the documentation referred to in § 19

(a). (b)) of the Act. To obtain the information necessary to carry out the evaluation

the risk to make use of the relevant Community legislation, international

or national classification systems, including new scientific and

technical knowledge. For the classification of the contained use of genetically

modified organisms into risk categories according to annex No 3 to the

the law can also use the classification of biological agents into four groups

According to the degree of risk of infection under section 36 and annex 7 of the Government Regulation No.

361/2007 Coll., or classification systems relating to plant

and animal pathogens ^ 1a).



(9) the assessment of the risks in the case of the placing of genetically modified

organisms other than higher plants to environmental

contains



and the likelihood of it) for the conditions of entry into the environment

become the genetically modified organism or significantly more invasive

than the recipient or parental organism in its natural habitat,



(b) selective advantage) or disadvantage arising from the genetic modification

and the likelihood that the advantage or disadvantage of the effect, under the conditions

putting into the environment,



(c) the possibility of the transmission of hereditary material) to other species under conditions of

entry into the environment and any selective advantage or disadvantage

that may be so transferred,



(d)) possible immediate and/or delayed effects on the environment caused by

direct and indirect interactions between the GMO

organism and the target organism (if the target organism exists),



e) possible immediate and/or delayed effects on the environment caused by

direct and indirect interactions between the GMO

organisms and non-target organisms, including impact on population levels

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



f) possible immediate and/or delayed effects on human health resulting from the

potential direct and indirect interactions between the GMO

the organism and by persons coming into contact with him,



g) possible immediate and/or delayed effects on animal health and consequences for the

feed/food chain resulting from consumption of genetically modified

the organism or gene product, which is intended for use as

feed,



h) possible immediate and/or delayed effects on biogeochemical processes

resulting from potential direct and indirect interactions of the

the GMO and target and non-target organisms in the vicinity

the marketing of a genetically modified organism into the environment, and



I) can be immediate or delayed the direct and indirect effects on the

the environment as a result of the use of specific techniques for dealing with

in the case of genetically modified organisms, that these different techniques

from techniques commonly used in the handling of the relevant

non-GMOs.



(10) the assessment of risk in the case of the placing of genetically modified

higher plants into the environment or into circulation if they are

genetically modified higher plants marketed as seed, or

sprout, ^ 2) must contain the following information



and the likelihood of it) for the conditions of entry into the environment

genetically modified higher plants become more resilient than the recipient

or parental organism in the agricultural environment, or more

invasive in natural environment,



(b) each additional selective advantage) or disadvantage arising from genetic

modification of, i.e.. the selective advantage of the genetically modified organism in the

compared to the recipient or parental organism



(c) the possibility of the transmission of hereditary material) on the same or a different kind of a

conditions of cultivation of genetically modified higher plants, and each

the selective advantage or disadvantage that may be transferred,



(d)) possible immediate and/or delayed effects on the environment caused by

by direct or indirect interactions between genetically modified higher

plant and target organisms (if the target organism exists),



e) possible immediate and/or delayed effects on the environment caused by

by direct or indirect interactions between genetically modified higher

plant and non-target organisms, including impact on population levels

of competitors, herbivores, symbionts where applicable, parasitů and pathogens,



f) possible immediate and/or delayed effects on human health resulting from the

potential direct and indirect interactions between genetically modified

higher plant and the persons coming into contact with her,



g) possible immediate and/or delayed effects on animal health and consequences for the

feed/food chain resulting from consumption of genetically modified higher

plants or gene product, which is intended for use as

feed,



h) possible immediate and/or delayed effects on biogeochemical processes

resulting from potential direct and indirect interactions of the

the GMHP and target and non-target organisms in the vicinity

the cultivation of genetically modified higher plants and



I) can be immediate or delayed the direct and indirect effects on the

environment from the use of the specific cultivation, crop or

processing techniques for the genetically modified plant, if applicable

These techniques differ from techniques commonly used in the treatment of

corresponding non GM higher plants.



(11) risk assessment the genetic product, in which is contained the more

a variety of genetically modified organisms, must also include an assessment of the

the relevant data for each of these organisms.



§ 6



The threshold limit of occurrence of admixture



(Section 11, paragraph 3, of the Act)



Genetic products, which may not be in accordance with § 11 (1). 3 of the law

identified by means of genetic products intended for direct processing,

which do not contain more than 0.9% of the admixture of genetically modified

organisms approved for putting into circulation referred to in section 23, paragraph. 1 or 2

the law, if these ingredients are random or they cannot be technically

prevent.



section 7 of the



Enclosed space requirements and safeguards for the individual

risk category in contained use



(Section 15, paragraph 2, of the Act)



(1) the requirements for a closed space and protective measures for closed
loading are given in annex 4 to this decree by type

the workplace and the risk category in which it was contained use

classified (section 15 (1) of the Act).



(2) part of the protective measures is also the compliance with the rules

workplace, work hygiene and safety policy work and ensure

training and retraining of employees [section 19 (b), (f) and (g))) of the Act].



(3) the provisions of paragraphs 1 and 2 are without prejudice to the special legislation

governing the work and correct laboratory practice. ^ 3)



§ 8



The method and extent of the guidance documentation



[To section 19 (b)) of the Act]



(1) documentation of the use of genetically modified organisms (hereinafter referred to

only the "documentation"), pursuant to section 19 (a). (b)) of the Act shall include the



and a copy of the submitted application for) the granting of permits for contained use, the

authorisation for placing into the environment or on the list for

putting into circulation, filed pursuant to section 5 (3). 1 of the Act, where appropriate, a copy of the

the notice filed under section 16(1). 2 or 3 of the Act,



(b) the decision to grant) issued permits for contained use, the

authorisation for placing into the environment (section 5 of the Act) and the

extension (section 16 paragraph 10 and § 17 paragraph 7 of the law), amendment or

cancellation (section 12 of the Act) of the authorization, the decision, which uu

modification of the conditions imposed to the notifier the management referred to in

notification (article 16, paragraph 5, of the Act), of a decision under section 34 of the Act, as well as

decision on the imposition of a fine pursuant to section 35 of the Act, where appropriate, certified

copies of these decisions,



(c) the assessment of the risk management) genetically modified organisms (7

of the Act),



(d) the operational rules of the workplace) [section 19 (b), (f)) of the Act],



e) emergency plan (section 20 of the Act),



(f)), the methodology of activities related to the management of genetically

modified organisms, where they are processed (e.g. standard

operating procedures) and not to the content of the application or notification in accordance with

(a)),



g) operational journals,



h) partial report [for example, a message containing the information referred to in section 19 (a).

(c)) of the Act and section 25, paragraph. 5 of the Act],



I) records of inspections carried out pursuant to § 15 paragraph. 3 of the Act and their

the results,



j) the final report referred to in section 19 (a). (d)) of the Act,



the records of employee training), their retraining and familiarisation with the

the operating regulations of the workplace under section 19 (a). g) of the Act, and



l) records of inspections, the presence of genetically modified organisms out of

enclosed space or land, on which it takes place, or was

use of genetically modified organisms, and their results, and

records of checks carried out by the administrative authorities, including the protocols of the

inspection findings.



(2) the dossier is based, and shall keep in paper and electronic

the form so that it could lead to the loss, damage or theft of the

content and to ensure its tidy and easy

availability if necessary.



(3) the operating journal that leads over the handling of genetically

modified organisms, contains



description of the waste) of genetically modified organisms,



(b)) information about the use of genetically modified organisms,

in particular, any difference from the description referred to in point (a)),



c) primary data obtained during the use of genetically modified

organisms,



(d) the minutes of any) carried out inspections, controls and their

the results,



(e)) the minutes of any incidents and accidents,



(f) the date of each record) name and signature of the person who has carried out.



(4) in the case of longer term projects is possible, where appropriate,

divide the use of genetically modified organisms on several

stages, i.e.. period aimed to obtain the partial results. For each of the

the stage is in this case can lead a separate operating journal.



(5) If during the use of genetically modified organisms to

the change compared with the description of the waste, it should be noted in the production of the journal reason

the changes and the date when the change was decided or when. Professional

Advisor in the documentation to confirm that the change was announced.



(6) any information about the use of genetically modified

organisms must a person, that is, to write records immediately, accurately and

legibly. In the record name must be specified, where appropriate, the name, surname and

the signature of the person who made the record, and the record date. Any changes in the

the original data on the results of observation, measurement and registration parameters

subscribing to read the original record, in this case, you must

be connected reason for change data, name, names, forenames and, where appropriate,

the signature of the person who decided about the change and that change has carried out, and the date,

where appropriate, the time to make a change.



(7) the data stored in the electronic form to back up. Amendments and corrections

These data shall be marked with the indication of the name or names and income

a person who changes and repairs carried out. Records on fotocitlivém paper

or other materials with a limited shelf life, it is necessary to pass on the

durable record.



(8) the documentation of the use of genetically modified organisms

closes the final report [section 19 (b), (d)) of the Act] positively posouzenou

Expert Advisor. The final report contains, in particular,



and waste management) the objective of the genetically modified organisms



(b)) the data referred to in the valid permits for contained use or marketing

into the environment, reference number and date of this permit, the

where appropriate, the date of submission of the notification, if it is a closed waste first

or other risk categories,



(c) the address of the workplace, where appropriate) the location and description of the land where the waste

This was done,



(d) the start and end date) the handling of genetically modified

with the organism,



(e) the information clearly identifying) genetically modified organisms,

that's close, treated or which have been placed into the

environment,



f) isolated hereditary material is disposed of, where appropriate, ways of

genetic modification, if it was carried out,



g) description of the use of genetically modified organisms, including the date,

Description and evaluation of all incidents and accidents,



h) description and date of disposal used genetically modified

organisms, as well as to verify the effectiveness of the liquidation, including the name, where applicable,

name and surname (or company name) of the person for the person

entitled to waste disposal of genetically modified organisms

carry out or verify its effectiveness, if not do the following activities

the person itself,



I) the results of the use of genetically modified organisms and their

the assessment, including the results of ongoing monitoring,



(j) ensure the subsequent monitoring) with a description of the premises and land after their

use of genetically modified organisms, and the name or names

first and last name (or company name) of the person for the person

to be entitled to the treatment monitoring carried out, if it is not justified

person alone,



to the vocational Advisor,) his signature and date of signature.



(9) specific legislation ^ 4) concerning the conduct of documentation remain

intact.



§ 9



Essentials emergency plan and the scope of the Ministry published

information about the plan



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



(1) emergency plan contains in addition to the data referred to in section 20 (2). 4 of the law

the following additional requirements:



the address of the workplace, and)



(b) the exact designation of the land) ^ 5) space and the equipment in which it is with genetically

modified organisms treated, along with a precise indication of the place where the

such land, premises or equipment,



(c)) the plan with the designation of sites of significant workplace for the limitation of the consequences

crash (the main drivers of the energy supply and ancillary media, places

storage of genetically modified organisms, safety elements

the conclusion of the space, if it is a contained use, etc.); When

transport description to ensure against leakage of genetically modified organisms,



d) description of the accident, which may arise in the premises or at the place where the

ongoing use of genetically modified organisms,



(e) an overview of the potential consequences of an accident) on the health of people, animals, the

environment and biodiversity, including ways to detect these

the consequences and effective protection against them,



(f) the validated detection procedures) the presence of genetically modified

organisms,



g) validated methods and procedures applicable to the disposal of genetically

GMOs and to decontaminate the affected area,



h) methods of isolation facilities affected by the accident, including the methods of

checks on the effectiveness of the insulation,



I) description and sketch rendering applicable to save resources

disposal of genetically modified organisms and the decontamination of the affected

space,



j) procedures to protect the health of people, animals, the environment and

biological diversity in the case of 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 the Special

the legislation, a ^ 6)



description of the procedure to ensure the subsequent) monitoring space and land after the

their clearance,



l) community, where appropriate, the persons to whom the emergency plan is presented under section

20 (2). 3 of the Act,
m) way of notification to the administrative authorities referred to in section 27 of the Act in the case of

the crash, as well as a way to alert citizens, depending on the location of the accident

and its possible consequences,



n) representation of a vocational Adviser, his signature and date of signature.



(2) information about the plan, pursuant to section 20 (2). 5 of law means

the information referred to in paragraph 1 (b). and), d), (e)), h), (j)) and m).



§ 10



The elements of the evaluation report



(Section 24, paragraph 17 of the Act)



The evaluation report referred to in section 24, paragraph. 5 of the Act contains the following

information:



and the identification of the properties of the recipient), which are for the guest

the use of genetically modified organisms or genetic

essential products and the identification of any known risks to

health and the environment resulting from the marketing of non-modified

the recipient into the environment or into circulation,



(b) a description of the result of the genetic modification) in genetically modified

the organism,



(c)) the assessment of whether the genetic modification for the purposes of risk assessment in

Applications characterized by sufficient,



(d) the identification of risks for the health) of people, animals, plants and the

environment that may result from the handling of the genetically

modified organism or genetic product in comparison with the

management of the corresponding unmodified organism or a product,

based on the assessment of the risk carried out in accordance with section 7 of the Act,



e) conclusion on whether the genetically modified organism, or

gene product may be put into circulation and under what conditions, or

whether the genetically modified organism or a gene product should

not be put into circulation, or whether the views of other

the administrative authorities, the European Commission or the committees referred to in the relevant

the legislation of the European Community to certain specific points

the risk assessment. Relevant aspects should be specified. The conclusion of the

contains a clear statement to the proposed use, to control the risks

and to the proposed monitoring plan. In the case of the genetically

modified organism or a gene product should not be placed in the

circulation, the conclusion contains the reasons for this position.



§ 11



Cancellation provisions



Shall be repealed:



1. Decree No. 372/2000 Coll., laying down technical solutions, using

which may result in a genetically modified organism, and the technical

solutions to the creation of a genetically modified organism.



2. Decree No. 373/2000 Coll., laying down the requirements for the closed

space and protective measures for each risk category in the

the contained use of genetically modified organisms.



3. Decree No 374/2000 Coll., on closer terms with management

genetically modified organisms and products.



§ 12



The effectiveness of the



This Decree shall take effect on the date of its publication.



Minister:



RNDr. Ambrozek in r.



Annex 1



Essentials reporting on the contained use of first and second category

the risks and requirements for an application for the grant of authorisation for contained use



Data marked



(+)

It is necessary to substantiate the original document or a certified copy



All relevant documents must be labeled with the name, or names, and

the last name, or the name (business name) of the applicant



The data, which consists of a summary of the contents of the request for publication, are

underlined



PART AND



ESSENTIALS REPORTING ON THE CONTAINED USE OF FIRST AND SECOND CATEGORY

The RISK of



Part 1



THE GENERAL REQUIREMENTS OF THE NOTIFICATION



Date of submission



1. The person submitting the notice (hereinafter the "notifier")



(+) Extract from the commercial register (not older than 3 months), or

officially certified copies of business license or of the incorporation

document



1.1. Name, where applicable, the name, and last name (business name), if

Notifier means any natural person authorized to do business



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

legal person



1.3. Citizenship (for physical persons)



1.4. Registered office (for legal entities), or place of business, and address

place of residence (for physical persons)



1.5. COMPANY REGISTRATION NUMBER (if assigned)



1. the 6. VAT NUMBER (if assigned)



1.7. The subject of activity (according to the document of the incorporation or registration in the

the commercial register)



1.8. Name, where applicable, the name and surname of the persons who constitute the statutory

authority of the notifier, with an indication of the way in which the name of the notifier

acting (for legal persons).



2. the expert advisor



(+) Extract from the criminal record, or other appropriate

document under special legislation. ^ 7)



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

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

a Member State, means in this document the decision on the recognition of professional

qualifications under special legislation ^ 7)).



2.1. Name, or name, last name, title



2.2. Profession, or the employer and the function



2.3. Education



2. the 4. Vocational courses



2.5. The current practice



2.6. Address of residence



2.7. Contact address



2.8. Phone



2.9. Fax



2.10. Email



Part 2



ADDITIONAL REQUIREMENTS IN THE CASE OF NOTIFICATION THE NOTIFICATION FOR THE FIRST CATEGORY

The RISK of



1. The purpose and duration of the contained use



1.1. The purpose of the contained use-the nature of the work, which will be provided by the notifier

to perform (e.g. research, teaching, laboratory inspection, production)



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

the projected start



2. Risk assessment



(+) A summary of the risk assessment referred to in section 7 of the Act for that kind of

the organism (species)



2.1. The result of the risk assessment



3. the site where the contained use will be



(+) The rules of operation of the workplace according to annex No. 4 of the Act



(+) Emergency plan referred to in section 20 of the Act



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

legal regulation in the case of breeding facilities for animals ^ 8)



3. the 1. The address of the workplace



3.2. The nature of the workplace



-microbiological laboratory



-demonstration



-production equipment



-greenhouse/culture room



-breeding animals



-other (uniquely identifying description of the workplace)



3.3. A description of the location of the space for the contained use, and a description of their

the most important device



(+) Map of the area and the location of the most important equipment



3.4. Assessment of the premises and facilities of the workplace and its location by

requirements for a closed space and trade measures laid down for the first

the risk category of the annex No 4 to this notice



4. The types and quantities used, and used genetic organisms

the modification, including named validated methods for the detection of

the presence of genetically modified organisms



5. data on waste management for individual departments (waste water,

waste gas pollutant, other and hazardous waste)



Part 3



ADDITIONAL REQUIREMENTS IN THE CASE OF NOTIFICATION THE NOTIFICATION FOR THE SECOND CATEGORY

The RISK of



1. The purpose and duration of the contained use



1.1. The purpose of the contained use-the nature of the work, which will be provided by the notifier

to perform (e.g. research, teaching, laboratory inspection, production)



1.2. The expected result of the contained use



1.3. The total duration of the contained use, and the date of its anticipated

the launch, if it is a closed management divided into intermediate stages also time

their duration and the date envisaged for the commencement of their



2. Risk assessment



(+) The risk assessment under section 7 of the Act for each of the processed genetically

modified organism separately



2.1. The result of the risk assessment



3. the site where the contained use will be



(+) The rules of operation of the workplace according to annex No. 4 of the Act



(+) Emergency plan referred to in section 20 of the Act



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

legal regulation in the case of breeding facilities for animals ^ 8)



3. the 1. The address of the workplace



3.2. The nature of the workplace



-microbiological laboratory



-demonstration



-production equipment



-greenhouse/culture room



-breeding animals



-other (uniquely identifying description of the workplace)



3.3. A description of the location of the space for contained use and technical description

their equipment



(+) Maps of the location of the space and the most important equipment



3.4. Assessment of the premises and facilities of the workplace and its location by

requirements for a closed space and trade measures laid down for the second

the risk category of the annex No 4 to this notice



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

laid down in annex 4 to this Decree and the actual equipment

the workplace



4. the genetically modified organism



4. the 1. Unlike data on organism, including its origin



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



4.3. The vector data, including its origin



4.4. Information about insertu



4.5. Add method insertu



4.6. Information relating to the GMO



4.6. 1. Specification of the resulting genetically modified organism



4.6. 2. Function brought by or exempted genes



4.6. 3. the method of detection and control of the presence of the genetic modification,
including the unique identification of a genetically validated methods

modified organisms



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

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



4.8. Information about whether the genetically modified organism has already been

approved in another State and for what purposes



5. Description of the handling of genetically modified organism



5.1. In the case of imports or exports of genetically modified organism

intended for contained use



5.1. 1. the State of origin, or destination



5.1. 2. the importer or exporter



5.1. 3. The maximum quantity of genetically modified organism, which has

be imported or exported



5.1. 4. Means of transport



5.1. 5. the method of packaging and labelling



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

risk evaluation



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

biological diversity



5.4. The frequency and method of carrying out the checks occurrence of genetically

GMOs both inside and outside the enclosure



5.5. Method of disposal of genetically modified organisms and control

its effectiveness



5.6. Description of the waste management (waste water, waste gas

harmful pollutants and hazardous wastes, other)



6. additional information



6.1. Instead of keeping the documentation on the use of genetically modified

organisms by § 19 (f). (b)) of the Act



6.2. Staff training plan before beginning treatment with genetically

genetically modified organisms and their subsequent training



6.3. Validated methods to detect the presence of genetically

in the case of GMOs and also the determination of the micro-organism

their quantity



PART (B)



PARTICULARS OF THE APPLICATION FOR THE GRANT OF AUTHORISATION FOR CONTAINED USE



Date of submission



1. the applicant shall



(+) Extract from the commercial register (not older than 3 months), or

officially certified copies of business license or of the incorporation

document



1.1. Name, where applicable, the name, and last name (business name), if

applicant means a natural person authorized to do business



1.2. The name (business name) and the legal form if the applicant is a legal

the person



1.3. Citizenship (for physical persons)



1.4. Registered office (for legal entities), or place of business, and address

place of residence (for physical persons)



1.5. COMPANY REGISTRATION NUMBER (if assigned)



1. the 6. VAT NUMBER (if assigned)



1.7. The subject of activity (according to the document of the incorporation or registration in the

the commercial register)



1.8. Name, where applicable, the name and surname of the persons who constitute the statutory

the applicant authority, indicating the manner in which they are acting on behalf of the applicant (for the

legal persons).



2. the expert advisor



(+) Extract from the criminal record, or other appropriate

document under special legislation. ^ 7)



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

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

a Member State, means in this document the decision on the recognition of professional

qualifications under special legislation ^ 7))



2.1. Name, or name, last name, title



2.2. Profession, or the employer and the function



2.3. Education



2. the 4. Vocational courses



2.5. The current practice



2.6. Address of residence



2.7. Contact address



2.8. Phone



2.9. Fax



2.10. Email



3. The purpose and duration of the contained use



3. the 1. The purpose of the contained use-the nature of the work, the applicant will be

to perform (e.g. research, teaching, laboratory inspection, production)



3.2. The expected result of the contained use



3.3. The total duration of the contained use, and the date of its anticipated

the launch, if it is a closed management divided into intermediate stages also time

their duration and the date envisaged for the commencement of their



4. Risk assessment



(+) The risk assessment under section 7 of the Act for each of the processed genetically

modified organism separately



4. the 1. The result of the risk assessment



5. the site where the contained use will be



(+) The rules of operation of the workplace, supplemented by Annex No. 4 of law



(+) Emergency plan referred to in section 20 of the Act



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

the law ^ 8)



5.1. The address of the



5.2. The nature of the workplace



-microbiological laboratory



-demonstration



-production equipment



-greenhouse/culture room



-breeding animals



-other (uniquely identifying description of the workplace)



5.3. A description of the location of the space for contained use and technical description

their equipment



(+) Maps of space and the location of the device



5.4. Assessment of the premises and facilities of the workplace and its location by

requirements for a closed space and trade measures laid down for the

the individual risk categories annex No 4 to this notice



(+) Comparative table of the requirements for the category of risks set out

Annex No 4 to this Decree and the actual equipment in the workplace



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

applicable) (C) the parent organism



(A) the donor organism



(B) the recipient,



(C) parental organism



6.1. The organism is



-minimum



-RNA virus



-DNA virus



-bacteria



-the sponge (fibrous mikromyceta, Candida)



-higher plant



-animal



-other (specify)



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

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

patovaru)



6.3. Origin (collection, collection number, supplier)



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

(alive or inanimate, including extra-cellular products). If Yes, please indicate

whether due to people, animals, plants or otherwise. Harm always

clearly identify the



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If Yes, clearly identify the possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals



-other (unique characteristics)



6.5. The natural occurrence of the organism,



6.6. Information about whether there is a natural exchange of hereditary material

between the donor and recipient organism



7. Information on the genetic modification



7.1. A type of genetic modification



-in the case of cizorodého of hereditary material



-the exclusion of hereditary material



-combination of exemption and, in the case of hereditary material



-cell fusion



-other (clearly identify)



7.2. The intended result of the genetic modification



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

used (+ genetic map of the vector)



7.3. 1. information on whether the vector wholly or partially present in the

the resulting genetically modified organism



7.3. 2. The type of the vector



-plasmid



-a Bacteriophage



-virus



-cosmid



-phasmid



-transposon



-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



-resistance to antibiotics (indicate the exact name of the medicinal substances)



-resistance to heavy metals



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



-the resistance of the other (clearly identify)



7.3. 6. methods of introducing vector into the recipient organism



-transformation



-elektroporace



-makroinjekce



-mikroinjekce



-biolistický transfer



-infection (agrobakteriální, viral)



-other (clearly identify)



7.3. 7. Partial fragments of the vector, and their presence in the resulting

genetically modified organism



7.4. If not in the genetic modification used vector method

introducing the insertu into the recipient organism



-transformation



-mikroinjekce



-microencapsulation



-makroinjekce



-biolostický transfer



-other (clearly identify)



8. insertu data (the data 8. 1. up to 8. 3. it is possible to summarize in the table and

attach a genetic map insertu)



8.1. The composition of insertu



8.2. The source of each part of the insertu



8.3. The intended function of each component part of the insertu in the resulting genetically

modified organism



8.4. Location of insertu in the final GMO



-on the free plasmid



-insert integrated into the chromosome



-other (Please specify)



8.5. Information about whether the insert contains a part of, the products or

features are not known



8.6. Information about 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. Genetic characteristics and phenotypic characteristics of the recipient or

parental organism which have been 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 or speed

the reproduction of the



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 genetically modified organism



9.4. Indicate whether the GMO pathogenic or

Another way malicious (alive or inanimate, including extra-cellular

products). If Yes, please indicate whether the given to people, animals, plants

or otherwise. The perniciousness of always clearly identify the



9.5. Description of identification and detection methods of genetically modified

organisms



9.5. 1. Data to allow the unambiguous identification of the modified section

hereditary material



9.5. 2. the procedures for detecting the presence of genetically modified

organisms, including validated methods for their unambiguous identification of



10. Description of the contained use



10.1. In the case of imports or exports of genetically modified organism

intended for contained use



10.1. 1. the State of origin, or destination



10.1. 2. the importer or exporter



10.1. 3. The maximum quantity of genetically modified organism, which has

be imported or exported



10.1. 4. Means of transport



10.1. 5. the method of packaging and labelling



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

risk evaluation



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

biological diversity



10.4. The protection of the health of workers at work, in accordance with the specific

^ 9 legislation)



10.5. Information on the system of carrying out checks on the presence of genetically

modified organisms



10.5. 1. The method and frequency of the controls inside the enclosure



10.5. 2. the method and frequency of carrying out checks on the outside of the enclosure



10.6. Method of disposal of genetically modified organisms and control

its effectiveness



10.7. Description of the waste management (waste water, waste gas

harmful pollutants and hazardous wastes, other)



11. additional information



11.1. Instead of keeping the documentation on the use of genetically modified

organisms by § 19 (f). (b)) of the Act



11.2. Staff training plan before beginning treatment with genetically

genetically modified organisms and their subsequent training



Part (C)



THE COMMON REQUIREMENTS FOR NOTIFICATION AND REQUEST



Comments, date and signature of the professional advisor------------



Date, stamp and signature of the applicant (notifier)------------



Annex 2



Particulars of the application for the grant of authorisation for placing into the environment



Data marked



(+)

It is necessary to substantiate the original document or a certified copy



All relevant documents must be labeled with the name, or names, and

the last name, or the name (business name) of the applicant



The data, which consists of a summary of the contents of the request for publication, are

underlined



part and



General requirements for an application



Date of submission



1. Project name



2. the applicant



(+) Extract from the commercial register (not older than 3 months), or

officially certified copies of business license or of the incorporation

document



2.1. Name, where applicable, the name, and last name (business name), if

applicant means a natural person authorized to do business



2.2. The name (business name) and the legal form if the applicant is a legal

the person



2.3. Citizenship (for physical persons)



2. the 4. Registered office (for legal entities), or place of business, and address

place of residence (for physical persons)



2.5. COMPANY REGISTRATION NUMBER (if assigned)



2.6. VAT NUMBER (if assigned)



2.7. The subject of activity (according to the document of the incorporation or registration in the

the commercial register)



2.8. Name, where applicable, the name and surname of the persons who constitute the statutory

the applicant authority, indicating the manner in which they are acting on behalf of the applicant (for the

legal persons).



3. Expert Advisor



(+) Extract from the criminal record, or other appropriate

document under special legislation. ^ 7)



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

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

a Member State, means in this document the decision on the recognition of professional

qualifications under special legislation ^ 7))



3. the 1. Name, or name, last name, title



3.2. Profession, or the employer and the function



3.3. Education



3.4. Vocational courses



3. the 5. The current practice



3.6. Address of residence



3.7. Contact address



3.8. Phone



3.9. Fax



3.10. Email



4. Characteristics of the handling of genetically modified organism



4. the 1. The purpose of putting into the environment, where appropriate, the name and designation of the

the project, the contracting authority (the purpose of marketing including all potential benefits

for the environment, which is to be expected)



4.2. The expected result of entry into the environment



5. the period of entry into the environment



5.1. The total time of the marketing of a genetically modified organism into the

the environment and the date envisaged for the commencement of his



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

their anticipated start and their duration)



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

into the environment in a Member State of the European

the community or outside its territory?



If Yes, please indicate:



-the State in which the applicant plans to put into the environment



-estimated time of commencement and duration of entry into the environment



7. the applicant Filed the application for the marketing of the same GM

the organism into the environment in a Member State of the European

the community?



If Yes, please indicate:



-the State in which the application was made



-the date of filing and the application number or other designation



-the date of the authorisation and labelling, it was granted



-the period to which the permit applies



8. the applicant Filed the application for the marketing of the same GM

the organism into the environment or into circulation outside the territory of the European

the community?



If Yes, please indicate:



-the State in which the application was made



-the date of filing and the application number or other designation



-the date of the authorisation and labelling, it was granted



-the period to which the authorisation applies.



9. the assessment of risk in the marketing of genetically modified organisms

of the environment



(+) The risk assessment under section 7 of the Act, including the documentation of results

previous entry into the environment, especially in terms of

different scope of activities and the various recipient ecosystems



9.1. A summary of the risk assessment



PART (B)



ADDITIONAL REQUIREMENTS FOR GENETICALLY MODIFIED ORGANISMS OTHER THAN

HIGHER PLANTS



1. Characteristics of the genetically modified organism



1.1. A genetically modified organism is:



-minimum



-RNA virus



-DNA virus



-bacteria



-the sponge (fibrous mikromyceta, Candida)



-Another micro-organism



-animal



-mammal



-insects



-fish



-another animal (indicate class)



-other (Please specify)



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

the organism with the precision specifying the race (breed, forms, strain, cell lines,

patovaru)



1.3. Genetic stability



1.3. 1. Measures to ensure genetic stability, factors that the

the stability of affect



1.3. 2. genetic stability of the authentication methods



1.3. 3. Description of inherited properties to exclude or restrict the

the extension of the genetic material



2. The recipient information, or (where applicable) parent

the organism



Characteristics of the recipient or parental organism



2.1. The organism is



-minimum



-RNA virus



-DNA virus



-bacteria



-the sponge (fibrous mikromyceta, Candida)



-animal (indicate class)



-other (Please specify)



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

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



2.3. Origin (collection, collection number, supplier)



2. the 4. Plasmids (in the case of micro-organisms)



2.5. Bakteriofágy (in the case of micro-organisms)



2.6. Phenotypic and genetic marker characters



2.7. Degree of relatedness between donor and recipient organism



2.8. Occurrence and living conditions



2.8. 1. Geographic distribution



-the original or established in the Czech Republic



-the original or established in the countries of the European Community



If the organism is original in the Czech Republic or in the countries of the European

of the community, indicate the ecosystem in which it is located:



-the Atlantic



-Mediterranean



-Boreal



-alpinský



-Continental



-another (uniquely identify)



2.8. 2. the organism Is commonly used in the Czech Republic?



2.8. 3. an organism commonly kultivován (present) in the Czech Republic?



2.8. 4. Habitat (natural birds) of the organism



-water environment



-land, wild



-land in conjunction with the root system of the plant



-in connection with the above-ground parts of the plants



-in conjunction with the animals
-other (clearly identify)



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

the ecosystem.



2.9. Methods for the identification and detection of the organism



2.9. 1. Detection methods, including data on their sensitivity, reliability,

and specificity



2.9. 2. Identification methods, including data on their sensitivity,

reliability and specificity



2.10. Is the organism classified under existing legislation

CR ^ 9) or the EC concerning the protection of the health of employees at work? If

Yes, indicate the classification and the relevant legislation.



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

(alive or inanimate, including extra-cellular products). If Yes, please indicate

whether due to people, animals, plants or otherwise. Harm always

clearly identify the



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If Yes, clearly identify the possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals



-other



2.12. Reproduction



2.12. 1. the generation time in the natural environment,



2.12. 2. Generation time in the ecosystem, in which genetically

modified organism is placed



2.12. 3. method of reproduction (sexual, asexual)



2.12. 4. the specific factors affecting reproduction (if

There are)



2.13. The ability of survival



2.13. 1. The ability to create durable surviving forms



-seeds



-endospóry



-cysts



-sclerotia



-asexual spores (fungi)



-the sexual spores (fungi)



-eggs



-hoods



-larvae



-other (clearly identify)



2.14. The spread in the environment



2.14. 1. the method and scope of the dissemination



2.14. 2. the specific factors affecting dissemination, if any



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

hosts



2.16. Other potential interactions with other organisms



2.16. 1. Other specific factors allowing survival



2.16. 2. The ability to survive in different seasons



2.17. Possible mezibuněčný transfer of genetic material between donor

(parental organism) and other organisms



2.17. 1. How to transfer (with the plasmid, bakteriofágem, otherwise)



2.17. 2. Organisms with which a natural exchange of genetic

material



2.18. Verification of the genetic stability of the organisms and factors that

the stability of affect



2.19. Involvement in environmental processes



-primary production



-the conversion of nutrients (consumer, predator)



-decomposition of organic matter



-other (clearly identify)



2.20. Custom vector organism



2.20. 1. The sequence of the vector



2.20. 2. the frequency of mobilization of the vector



2.20. 3. The specificity of the vector



2.20. 4. the presence of the genes causing the resistance of the vector



2.21. Previous genetic modification of the recipient or parental

body authorised in the Czech Republic (including date and number of the authorisation)



3. Information on the genetic modification



3. the 1. A type of genetic modification



-in the case of cizorodého of hereditary material



-the exclusion of hereditary material



-combination of exemption and, in the case of hereditary material



-cell fusion



-other (clearly identify)



3.2. The intended result of the genetic modification



3.3. When the genetic modification used vector?



If the vector was not used, continue, point 3. 4.



3.3. 1. Is the vector wholly or partially present in the resulting genetically

modified organism?



If the vector is not even partially present, proceed to point 3. 5.



3.3. 2. The type of the vector



-plasmid



-a Bacteriophage



-virus



-cosmid



-phasmid



-transposon



-another object (clearly identify) (vector + map)



3.3. 3. The identity of the vector (origin)



3.3. 4. Host range vector



3.3. 5. the presence of the vector sequence that passes the selection

(a selectable) or identifiable phenotype



-resistance to antibiotics (indicate the exact name of medicinal substances)



-resistance to heavy metals



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



-other (clearly identify)



3.3. 6. Partial fragments of the vector, and their presence in the resulting

genetically modified organism



3.3. 7. methods of introducing vector into the recipient organism



-transformation



-elektroporace



-makroinjekce



-mikroinjekce



-infection



-other (Please specify)



3.3. 8. Information about how far the vector is limited to the sequence

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

the sequence whose product or function are not known



3.4. If not in the genetic modification used vector method

introducing the insertu into the recipient organism



-transformation



-mikroinjekce



-microencapsulation



-makroinjekce



-other (clearly identify)



3. the 5. Methods and criteria used for the selection of



4. information on the insertu



4. the 1. Information about each section of insertu, where appropriate, on each set aside part of the

hereditary material, with particular reference to any known harmful

sequences



4. the 1. 1. The size of the



4. the 1. 2. Sequence



4. the 1. 3. The origin of the



4. the 1. 4. Functional characteristics



4.2. The location of the insertu in the body of the recipient



-on the free plasmid



-insert integrated into the chromosome



-other (clearly identify)



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

?



If Yes, please specify



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

acid, needed to ensure the intended function



4.5. Information about whether the sequence contained in the insertu involved

in any way on the pathogenic or harmful characteristics

the donor organism or vector



4.6. 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



4.7. In the case of exclusion of part of the hereditary material (deletions) size and

the function of the section exempted nucleic acid



4.8. The number of copies of the hereditary material embedded



4.9. Stability of the inserted material and its hereditary stability of the location



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

derived)



5.1. The donor organism is



-minimum



-RNA virus



-DNA virus



-bacteria



-the sponge (fibrous mikromyceta, Candida)



-Another micro-organism



-animal (indicate class)



-other (Please specify)



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

by specifying the precise cultivar (variety, race, breed, lineage, forms,

the hybrid, strain, patovaru)



5.3. Indicate whether the donor organism pathogenic or otherwise

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

indicate whether the given to people, animals, plants or otherwise.

The perniciousness of always clearly identify the



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If Yes, clearly identify the possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals-other



5.4. Is the donor organism classified under existing laws,

the laws of the CZECH REPUBLIC ^ 9) or the EC concerning the protection of the health of workers in

work?



If Yes, indicate the classification and the prescription



5.5. Exchange recipient and the donor organism's genetic material

the natural way?



6. information on the final GMO



6.1. Description of heritable characteristics and phenotypic characters that have been

changed as a result of the genetic modification



6.1. 1. the genetically modified organism differs from the beneficiary in

survival skills?



If Yes, clearly identify the



6.1. 2. Different genetically modified organism from the beneficiary in

method or the speed of reproduction?



If Yes, clearly identify the



6.1. 3. Different genetically modified organism from the beneficiary in

ability to spread?



If Yes, clearly identify the



6.1. 4. Different genetically modified organism from the beneficiary in

patogenicitě?



If Yes, clearly identify the



6.2. Genetic stability of the genetically modified organism



6.3. The properties of the genetically modified organism, that have an impact on the

his survival, reproduction and dissemination in the environment



6.4. Known or predicted environmental conditions which may

affect survival, multiplication and dissemination (wind, water, soil,

temperature, pH, etc. )



6.5. Sensitivity to specific substances (resources)
6.6. Indicate whether the GMO pathogenic or

Another way malicious (alive or inanimate, including extra-cellular

products). If Yes, please indicate whether the given to people, animals, plants

or otherwise. The perniciousness of always clearly identify the



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If Yes, clearly identify the possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals



-other (unique characteristics)



6.7. Description of identification and detection methods of genetically modified

the organism



6.7. 1. The methods used for the detection of genetically modified organisms,

including certified detection methodology



6.7. 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



6.7. 3. Data to allow the unambiguous identification of the modified section

hereditary material



6.8. Embedded expression of hereditary material



6.8. 1. The speed and level of expression of inserted hereditary material,

the life cycle of dependency, where the expression



6.8. 2. Description of the methods of measurement with an indication of their sensitivity



6.8. 3. Stability of expression



6.9. The expressed proteins



6.9. 1. The activity of the expressed protein



6.9. 2. Description of the methods for the identification and detection of the expressed proteins with

an indication of their sensitivity, specificity and reliability



6.10. The previous management of genetically modified organism



7. Information about the entry into the environment and the land on which the

will run



7.1. Instead of marketing to different environment from the ecosystem, in

where the recipient or parental organism usually occur, or

they are grown or cultured? If Yes, please specify



7.2. The workplace and the land on which the marketing environment

the environment take place



(+) The methodology of the trials



(+) Emergency plan referred to in section 20 of the Act



(+) The rules of operation of the workplace according to annex No. 4 of the Act



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

into the environment and the clear plan specifying the use of

the surrounding land, including the type of crop



7.3. The owner of the land, if it is not identical to the person who served

the application for the marketing of genetically modified organisms into the environment

environment, and the contractual relationship between the owner and the person



7.4. Specification of the land



7.4. 1. Region 7. 4.2. Village



7.4. 3. The name of the cadastral territory and reference number (+ location area

the cultivation of a genetically modified organism on the land and its size

indicate on the map on an appropriate scale)



7.4. 4. The identification number of the soil block and possibly part of the soil

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

special legal regulation ^ 10)



7.5. The total area of the desktop, which are putting into the environment

the environment has to be effected (m2))



-the current area you try to



-size of the experimental land (including the insulation and the like)



7.6. The distance of the experimental plot of land from a specific territory (in metres

or kilometres)



7.6. 1. Specially protected territory ^ 11)



7.6. 2. Dwelling, mansion



7.6. 3. Protection of water resources



7.6. 4. water flows, water tank



7.6. 5. The territory of the farm in organic agriculture ^ 12)



7.6. 6. Other



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

land (indicate in the plan)



7.8. Flora and fauna, including crops, livestock and

migrant species, which could come into contact with genetically

modified organism



7.9. Methods of entry into the environment, and the quantity used

genetically modified organisms



7.9. 1. The approximate amount of genetically modified organisms

to be used



7.9. 2. How to land security



-against unauthorized persons



-animals



-anti splachu



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

the cultivation of genetically modified organisms



7.9. 4. Other methods of elimination or minimization of the spread of the

modified organisms off the experimental plot



7.9. 5. A brief description of typical weather conditions



7.9. 6. Description of the ecosystem at the point of entry into the environment and to

It involved interference



-soil type



-water including irrigation mode



-climatic conditions



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

genetically modified organism into the environment, if the

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

people and animals, the environment and biodiversity



7.11. Description of the ecosystems which could be affected by the



7.12. Comparison of the natural habitat of the recipient, where appropriate, the parental

the organism with the proposed site marketing into the environment.



7.13. Any planned changes in land use in the vicinity of the place of

putting into the environment, which could be of importance for the operation of

genetically modified organisms into the environment



8. Description of the use of genetically modified organisms



8.1. Use of genetically modified organisms before their

putting into the environment (contained use, transport)



8.2. The procedure, which will be put into genetically modified organisms

of the environment



8.3. The approximate number of genetically modified organisms (per m2,

or m3)



8.4. Preparation and presentation of the plot before the genetically

modified organisms



8.5. Method of transport of genetically modified organisms



8.6. Way to protect the health of workers in the course of management of genetically

genetically modified organisms in accordance with the specific legislation ^ 9)



8.7. The method of cultivation of genetically modified organisms



8.8. Description of the further use of genetically modified organisms,

including their disposal



8.9. The term and the way to evaluate the marketing of genetically modified

organisms into the environment



9. Information on the interactions between the GMOs and

the environment, and their possible effect on the environment



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

There, with the precision specifying the cultivar (variety, race, breed, lineage,

forms, hybrid strain, patovaru)



9.2. Anticipated mechanism and result of interaction between the genetically

modified organism reported to the environment and the target

the organism



9.3. Anticipated mechanism and result of interaction with the other

organisms in the environment, which may be significant



9.4. It is likely that the selection occurs after the entry into the

environment, such as. increased competitiveness or invasiveness

genetically modified organism?



9.5. The possibility of a sharp increase in the population of genetically modified

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

the increase could be



9.6. The way biological dispersal of genetically modified organism

known or potential modes of interaction with the extension agents



9.7. Types of ecosystems, in which genetically modified organism

can extend from the place of entry into the environment and in which

can settle



9.8. The Czech and Latin name (genus and species name with the precision specifying the

cultivar-variety, race, breed, lineage, forms, hybrid, strain,

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

the receiving environment may be damaged by the marketing of genetically

modified organism into the environment



9.9. The presumed mechanism identified adverse interaction between

genetically modified organisms and non-target organisms including

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

pathogens



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



9.10. 1. The possibility of the transmission of hereditary material from a genetically

modified organism to another organism after the introduction of the genetically

modified organism into the environment and the consequences of such

transmission



9.10. 2. The possibility of the transmission of hereditary material from naturally

the outturn of the organism to the genetically modified organism

the placing of a GMO into the environment and

the consequences of such transfer



9.11. The results of the studies of the behaviour and characteristics of the genetically modified

organisms and their ecological impact carried out in simulated

the natural environment



9.12. Known or predicted involvement in biogeochemical processes



9.13. Other possible effects on the environment and biodiversity

Diversity (clearly identify)



10. Monitoring of the incidence and effects of genetically modified organisms



10.1. Method of detecting the presence of genetically modified organisms
10.2. Specificity of the methods for the identification of genetically modified

the organism and differentiation of genetically modified organism from the donor

the organism, the recipient, where appropriate, the parental organisms; the sensitivity and

the reliability of these methods



10.3. The methods of monitoring the effects on the ecosystem



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

on other organisms



10.5. The area, which will be monitoring implemented (m2))



10.6. The duration of the monitoring



10.7. The frequency of monitoring



11. Information on the measures after the attempt and on the management of waste



11.1. Description of the measures after the end of the experiment



11.2. Method of disposal of genetically modified organisms and control

its effectiveness



11.3. Plan of checks and surveillance



11.4. Types of waste generated and their estimated quantity



11.5. Possible risks arising from the treatment of waste



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



12. the provision of samples of genetically modified organisms



12.1. The amount and method of transmission of samples provided by § 18 paragraph.

2 of the Act



13. 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 considered putting into circulation)



13.1. State of origin, or destination



13.2. The importer or exporter



13.3. The maximum amount of genetically modified organisms, which has

be imported or exported



13.4. Transport method



13.5. Packaging and labelling



14. Instead of storing documentation on the use of genetically modified

organisms by § 19 (f). (b)) of the Act



15. staff training plan before beginning treatment with genetically

genetically modified organisms and their subsequent training



PART (C)



ADDITIONAL REQUIREMENTS FOR GENETICALLY MODIFIED HIGHER PLANTS



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

the organism



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

by specifying the cultivar (variety, line, hybrid)



1.2. Origin (collection, collection number, supplier)



1.3. Reproduction



1.3. 1. method of reproduction



1.3. 2. the specific factors affecting reproduction (if

There are)



1.3. 3. Generation time



1.3. 4. Sexual compatibility with other cultivated or wild species

and the expansion of these compatible species in the Czech Republic



1.4. The ability of survival



1.4. 1. The ability to create structures that allow the survival or

dormancy, and the length of the possible survival or dormancy,



1.4. 2. Other specific factors allowing survival, if there are



1.5. The spread of plants in the environment



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

Depending on the distance from the source, the force and direction of the wind, the flow of water and

other factors)



1.5. 2. the specific factors affecting dissemination, if any



1. the 6. Geographical distribution of plants



1.7. If the plant is not cultivated in the Czech Republic, including the description of the Habitus do information

about natural konzumentech, patogenech, parasites, competitors and

symbionts



1.8. Other possible relevant interactions of plants with other organisms in the

the ecosystem in which the plant is usually grown



1. the 9. Effects on the health of humans, animals and the environment.



-toxicity



-alergennost



-other (clearly identify)



2. information on the genetic modification and the GMHP



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

higher plants, with the precision specifying the cultivar (variety, line, hybrid)



2.2. Description and characteristics of hereditary properties that were inserted

or changed, including signal and marker genes and the previous

modifications and a description of their phenotypic expressions



2.3. A type of genetic modification



2.3. 1. In the case of cizorodého of hereditary material



2.3. 2. The exclusion of hereditary material



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



2.3. 4. Cell fusion



2.3. 5. Other (clearly identify)



2. the 4. Characteristics and origin of used vector (the vector has been in

genetic modification used)



(vector + map)



2.5. Information about each part of a stretch of DNA that has been entered into the organism

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

material)



2.5. 1. the origin of (Czech and Latin genus and species name of donor

the organism by specifying the precise cultivar-variety, race, breed, lineage,

forms, hybrid strain, patovaru)



2.5. 2. Functional characteristics



2.5. 3. The size of the



2.5. 4. Position-if integrated



2.5. 5. The sequence of



2.6. If it is the exclusion of part of the hereditary material (deletion),

the size and function of the exempted section



2.7. Description of the methods used for the genetic modification



2.8. If the recipient or parental organism of forest tree species,

describe the methods of dissemination and the specific factors affecting dissemination



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

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



2.10. The number of copies of the hereditary material embedded



2.11. Stability of the inserted material and its hereditary stability

the location of the



2.12. Methods for the determination of the data



2.13. The information about the embedded expression of hereditary material



2.13. 1. The place, where in the plant to the expression of inserted genes (e.g..

the roots, the leaves. the leaves, pollen, etc.)



2.13. 2. Changes of expression depending on the life cycle of plants



2.13. 3. Stability of expression



2.13. 4. The methods used for the characterisation of the expression



2.14. Information allowing the unique identification of a genetically

genetically modified higher plants



2.14. 1. Description of the altered DNA



2.14. 2. Methods for detection and identification of genetically modified higher

plants and their proven methodology



2.15. The behavior of the inserted genes



2.15. 1. the hybridization with the same kind of



2.15. 2. the hybridization with remote types



2.16. Clear information about what are genetically modified higher

the plant differs from the recipient or parental organism



-the method and rate of reproduction



-spreading in the environment



-the ability to survive



-effects on the health of humans, animals and the environment



-other (Please specify)



2.17. Phenotypic stability of genetically modified higher plants



2.18. Any change in the ability of genetically modified higher plants

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

the modification of the



2.19. Information about each of the possible harmful effects of genetically

genetically modified higher plants on human health caused by the genetic

modification of the



2.20. Data on the safety of genetically modified higher plants for

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

genetic modification, if it has to be genetically modified higher

plants used as animal feed



2.21. The mechanism of interaction between the genetically modified higher

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



2.22. Potential changes in the interactions of the GMHP

with non-target organisms resulting from the genetic modification



2.23. The possible interaction of genetically modified higher plants with artificial

the components of the environment



3. Data on the quantity of genetically modified higher plants, which has

be used, and the total area of the land



3. the 1. The approximate amount of genetically modified higher plants,

that has to be placed into the environment



3.2. The total area of the areas for which they are to be genetically modified

higher plants grown



4. The workplace and the land on which it will be put into the environment

take place



(+) Emergency plan referred to in section 20 of the Act



(+) The rules of operation of the workplace according to annex No. 4 of the Act



(+) A copy of the cadastral maps showing land and clear the map with

showing the crops grown on the surrounding grounds



4. the 1. The purpose of entry into the environment (including all relevant

the information available at this stage), such as agronomic purposes,

tests of hybridization, change the ability of survival or propagation, detection

the effects on the target or non-target organisms



4.2. The location of the land



4.2. 1. Region



4.2. 2. The municipality



4.2. 3. The name of the cadastral territory and reference number



4.2. 4. The identification number of the soil block and possibly part of the soil

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

special legal regulation ^ 10)



4.3. Plot size



4.3. 1. The location of the cultivation of genetically modified higher plants on the

the land and its size (m2)) (the map on an appropriate scale)



4.3. 2. Size (m2)) and how to use the isolation zone around the areas

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



4.4. The use of surrounding land



4.5. The distance from the specific land area (in metres or

km)



4.5. 1. Specially protected territory ^ 11)



4.5. 2. Protection of water resources



4.5. 3. water flows, water tank



4.5. 4. The territory of the farm in organic agriculture ^ 12)



4.5. 5. Other



4.6. Security land



4.6. 1. the land Security against unauthorized persons



4.6. 2. Security of land animals



4.6. 3. The security of the land against the splachu
4.7. The description of the ecosystem in the place of the land



4.7. 1. Type of soil



4.7. 2. mode of water including irrigation



4.7. 3. Climatic conditions



4.7. 4. Flora including agricultural crops



4.7. 5. the Fauna, including economic and migratory animals



4.8. The presence of sexually compatible wild or cultivated

plants on land and in its surroundings



4.9. 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



5. Description of the use of genetically modified higher plants



5.1. Use of genetically modified higher plants before

their putting into the environment (contained use, transport)



5.2. The procedure, which will be genetically modified higher plants

placed into the environment



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



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

modified higher plants



5.5. Method of transport of genetically modified higher plants



5.6. Way to protect the health of workers in the course of management of genetically

modified higher plants in accordance with specific legal

^ regulations 9)



5.7. The method of cultivation of genetically modified higher plants on the

plot of land



5.8. How to harvest of genetically modified higher plants



5.9. Description of the further use of genetically modified higher

plants



5.10. The term and the way to evaluate the marketing of genetically modified

higher plants into the environment



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

biodiversity and waste management



6.1. The distance of the area of cultivation of genetically modified higher

the plants from the wild or grown sexually compatible species

plant



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

If they are used



6.3. Description of the methods for the adjustment of the land after the end of the experiment



6.4. Description of the methods for the transport and processing of genetically modified

higher plants



6.5. Control and monitoring of the incidence and effects of genetically modified

higher plants



6.5. 1. methods of detecting the presence of genetically modified higher

plants and the monitoring of their effects on the ecosystem



6.5. 2. Specificity of methods of identification of genetically modified

higher plants and the differentiation of genetically modified plants from

the donor organism, the recipient or parental organism

the sensitivity and the reliability of these methods



6.5. 3. Techniques (methods) detection of embedded transmission of hereditary

material to other organisms



6.5. 4. the area that will be monitoring conducted



6.5. 5. The duration of the monitoring



6.5. 6. Frequency of monitoring



6.6. Waste management including disposal of genetically modified,

higher plants



6.7. Summary of protective measures



7. 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 people, animals and life

environment



PART (D)



THE COMMON NEED FOR ALL APPLICATIONS



Comments, date and signature of the professional advisor-----------------



Date, signature and stamp of the applicant-----------------



Annex 3



The elements of the request for entry on the list for putting into circulation



The information marked (+) is necessary to substantiate the original document or officially

certified copy of the



All relevant documents must be labeled with the name, or names, and

the last name, or the name (business name) of the applicant



The data, which consists of a summary of the contents of the request for publication, are

underlined.



PART AND



GENERAL REQUIREMENTS FOR AN APPLICATION



Date of submission



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



2. the applicant



(+) Extract from the commercial register (not older than 3 months), or

officially certified copies of business license or of the incorporation

document



2.1. Name, where applicable, the name, and last name (business name), if

applicant means a natural person authorized to do business



2.2. The name (business name) and the legal form if the applicant is a legal

the person



2.3. Citizenship (for physical persons)



2. the 4. Registered office (for legal entities), or place of business, and address

place of residence (for physical persons)



2.5. COMPANY REGISTRATION NUMBER (if assigned)



2.6. VAT NUMBER (if assigned)



2.7. The subject of activity (according to the document of the incorporation or registration in the

the commercial register)



2.8. Name, where applicable, the name and surname of the persons who constitute the statutory

the applicant authority, indicating the manner in which they are acting on behalf of the applicant (for the

legal persons).



2.9. The applicant is a



-domestic manufacturer



-importer



-other (Please specify)



2.10. In the case of imports



-name, where applicable, the name, and last name (business name) of the manufacturer, if the

a natural person, or the name (business name), if a person

legal



-the address of the manufacturer



3. Expert Advisor



(+) Extract from the criminal record, or other appropriate

a document issued under special legislation. ^ 7)



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

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

a Member State, means in this document the decision on the recognition of professional

qualifications under special legislation ^ 7))



3. the 1. Name, or name, last name, title



3.2. Profession, or the employer and the function



3.3. Education



3.4. Vocational courses



3. the 5. The current practice



3.6. Address of residence



3.7. Contact address



3.8. Phone



3.9. Fax



3.10. Email



4. Characteristics of the genetically modified organism contained in

gene product



The name, origin and characteristics of each genetically modified organism

contained in the genetic product



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

the genetic product into circulation



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

the product into circulation



5.2. The date envisaged for the commencement of marketing of the genetically modified

the organism or gene product into circulation and its binding timetable

(breakdown of the different intermediate stages, their presumed date

initiation and their duration)



5.3. The estimated amount of the genetically modified organism, or

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

specify whether to act on the production from the territory of the CZECH REPUBLIC, where appropriate,

Of the European communities or of imports



6. The risk evaluation of the marketing of a genetically modified organism, or

the genetic product into circulation



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



PART (B)



ADDITIONAL REQUIREMENTS FOR GENETICALLY MODIFIED ORGANISMS OTHER THAN

A HIGHER PLANT, OR FOR GENETIC PRODUCTS OTHER THAN CONTAINING

GENETICALLY MODIFIED HIGHER PLANTS



1. General description of the genetically modified organism or genetic

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

gene product



1.1. The type of the genetically modified organism or a gene product

(intended use of the genetically modified organism, or

gene product)



1.2. The genetic composition of the product



1.3. Specificity (diversity) of the genetic product (in comparison with the same

type of product free of genetically modified organisms)



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

consumers)



1.5. The terms of use, in particular the differences between the management of genetically

modified organism or genetic product and management

similar non-GMOs or products containing

modified organisms



1. the 6. Where appropriate, unambiguous definition of the geographical area in the EU, to which the

to be the marketing of a genetically modified organism or genetic

the product into circulation limited



1.7. The type of environment in which the use of the genetically modified

the organism (gene product) inappropriate



1.8. Estimated annual demand



-in the Czech Republic



-in the European Union



-on export markets



1. the 9. The unique identification code of the genetically modified organism

or genetically modified organisms contained in genetic

product



1.10. A request was made for marketing the same genetically modified

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 the State in which it was filed



If no, 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, point 9 of Annex No. 2 to this notice)



1.11. At the same time, the applicant shall request for the placing of the same genetically

the modified organism or gene product into circulation in one

EU Member State?



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

was made
1.12. He was a product of the same genetically modified organism

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

Other EU applicant?



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

It was issued and the period for which it was granted.



1.13. Information about whether the request was made (notification) for marketing

of the same GMO or the genetic product

into circulation in another State outside the EU



If Yes, please indicate the State in which the application was filed (notification)

number or other indication of the application (date and designation of the authorisation, if

issued), the applicant, purpose and period of circulation



1.14. A summary of the data obtained from past or ongoing cases

the placing of the same GMOs or the same

the combination of genetically modified organisms into the environment for

different conditions representing the different environments in which can be

genetically modified organism used



1.15. The proposed guidelines and recommendations relating to the use, transport,

storage and further treatment of the genetically modified organism

(genetic), including any limitations that are

proposed as a condition of authorization requested



1.16. The proposed method of packing a genetically modified organism, or

gene product



1.17. The proposed way of tagging beyond what is provided by law



1.18. The measures, to be taken in the event of an accident or

unauthorized use of genetically modified organisms, or

genetic products



1.19. The treatment of waste, including disposal of waste containing

genetically modified organisms



2. The recipient information, or (where applicable) parent

the organism



2.1. The Czech and Latin genus and species name of the recipient or

parental organism, with the precision specifying the race (breed, forms, strain,

cell line, patovaru)



2.2. Origin (collection, collection number, supplier)



2.3. Phenotypic and genetic characteristics



2. the 4. For micro-organisms own plasmids, bakteriofágy and other vectors

the organism



2. the 4. 1. The sequence of the vector



2. the 4. 2. the frequency of mobilization of the vector



2. the 4. 3. The specificity of the vector



2. the 4. 4. the presence of genes which confer resistance to vector

antibiotics



2.5. Degree of relatedness between donor and recipient organism



2.6. Occurrence and living conditions



2.6. 1. Geographic distribution



2.6. 2. the Habitat (natural birds) of the organism



2.6. 3. Natural predators, prey, competitors, parasites and symbiotes

and hosts



2.6. 4. Other potential interactions with other organisms



2.7. Genetic stability and factors affecting it



2.8. Possible transmission of hereditary mezibuněčný material between donor

(parental organism) and other organisms



2.8. 1. How to transfer (with the plasmid, bakteriofágem, otherwise)



2.8. 2. Organisms with which a natural exchange of hereditary

material



2.8. 3. The consequences of such transfer



2.9. Reproduction



2.9. 1. method of reproduction



2.9. 2. the specific factors affecting reproduction (if

There are)



2.9. 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



2.10. The ability of survival



2.10. 1. The ability to survive in different seasons



2.10. 2. The ability to create durable surviving forms (e.g. spores,

sclerotia)



2.10. 3. Other specific factors allowing survival, if there are



2.11. The spread in the environment



2.11. 1. the method and scope of the dissemination



2.11. 2. the specific factors affecting dissemination, if any



2.12. Host range including non-target organisms



2.13. Interaction with the environment



2.14. Involvement in environmental processes



-primary production



-the conversion of nutrients (consumer, predator)



-decomposition of organic materials



-other (clearly identify)



2.15. Methods of detection



2.15. 1. Description of the methods



2.15. 2. Sensitivity, reliability (in quantitative terms) and specificity of the methods



2.16. Identification methods



2.16. 1. Description of the methods



2.16. 2. Sensitivity, reliability (in quantitative terms) and specificity of the methods



2.17. The classification of the organism in accordance with the specific legislation and ČR9)

EC relating to the protection of the environment or human health



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

(alive or inanimate, including extra-cellular products) due to the people,

animals, plants, or otherwise. If Yes, clearly identify the

possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals



-other



2.19. Nature and description of known genetic particle extrachromozomálních



2.20. Description of previous genetic modifications of the organism



3. Information on the genetic modification



3. the 1. A type of genetic modification



-in the case of cizorodého of hereditary material



-the exclusion of hereditary material



-combination of exemption and, in the case of hereditary material



-cell fusion



-other (clearly identify)



3.2. Description of the methods used for the genetic modification



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



3.3. 1. The type of the vector



3.3. 2. identity of the vector (origin)



3.3. 3. A description of the structure of the vector



(+ genetic map and, where appropriate, restriction map of the vector)



3.3. 4. vector Sequences



3.3. 5. Information about how far the vector is limited to the sequence

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

the sequence whose product or function are not known



3.3. 6. The ability to vector to transmit the hereditary material



3.3. 7. Frequency of mobilisation of the vector



3.3. 8. information on whether the vector wholly or partially present in the

the resulting genetically modified organism



3.3. 9. Host range vector



3.3. 10. the presence of a sequence in the vector that passes

Select (a selectable) or identifiable phenotype



-resistance to antibiotics (indicate the exact name of medicinal substances)



-resistance to heavy metals



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



-other (clearly identify)



3.3. 11. The method of introducing vector into the recipient organism



4. information on the insertu



4. the 1. If not in the genetic modification used vector method

introducing the insertu into the recipient organism



4.2. The methods used for the construction of insertu



4.3. Restriction sites



4.4. Sequence insertu



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

hereditary material, with particular reference to any known harmful

sequences



4.5. 1. The origin of the



4.5. 2. Functional characteristics



4.5. 3. The size of the



4.5. 4. The position of the



4.5. 5. The sequence of



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

acid, needed to ensure the intended function



4.7. Information about whether the insert contains a part of, the products or

features are not known



If Yes, clearly identify the



4.8. Location of insertu in the final GMO



-on the free plasmid



-integrated into the chromosome



-other (clearly identify)



4.9. The number of copies of the hereditary material embedded



4.10. Stability of the inserted material and its hereditary stability

the location of the



5. Information about, unlike the body (the donor organisms)



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

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

patovaru)



5.2. Indicate whether the donor organism pathogenic or otherwise

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

indicate whether the given to people, animals, plants or otherwise.

The perniciousness of always clearly identify the



Concerning pathogenic or harmful properties of sequences used in the

genetic modification?



If Yes, clearly identify the possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals



-other



5.3. Classification in accordance with the applicable laws of the donor organism

the laws of the CZECH REPUBLIC ^ 9) and EC relating to the protection of the environment or

the health of the people



5.4. Information about whether the donor and recipient organism between runs

or maybe a natural exchange of genetic material



6. information on the final GMO (genetically

modified organism contained in the gene product)



6.1. Description of heritable characteristics and phenotypic characters, if they are

different from the recipient or parental organism
6.2. Genetic stability of the genetically modified organism, if

different from the stability of the recipient or parental organism



6.3. Embedded expression of hereditary material



6.3. 1. The speed and level of expression of inserted hereditary material,

the life cycle of dependency, where the expression



6.3. 2. Stability of expression



6.3. 3. A description of the measurement methods with an indication of their sensitivity



6.4. The expressed proteins



6.4. 1. The activity of the expressed protein



6.4. 2. Description of the methods of detection and identification of the expressed protein with

an indication of their sensitivity, specificity and reliability



6.5. Methods and criteria used for the selection of the resulting genetically

modified organism



6.6. Methods for detection of genetically modified organisms in the

environment, if different from the detection of the recipient or parental

the organism



6.7. Identification methods to distinguish genetically modified

the organism from the recipient or parental organism



6.7. 1. Description of the methods for detecting the presence of genetic modification,

including validated methods of sampling and sample preparation



6.7. 2. information on specificity, sensitivity, and reliability

(kvantifikovaně) these methods



6.7. 3. A description of the modified nucleic acid to enable clear

the identification of genetically modified organism



6.8. Effects on health



6.8. 1. Toxic or allergenic effects of the genetically modified

the organism and its metabolic products, if different from the effects

the recipient or parental organism



6.8. 2. genetic Risk product



6.8. 3. comparison of the modified organism to the donor

the organism, the recipient or parental organism (s) in terms of

pathogenicity



6.8. 4. The ability of the colonization, if different from consignee or

the parent organism



6.8. 5. If a genetically modified organism is more pathogenic than

the recipient or parental organism for immunocompetent human

an individual, please give the



-diseases that can be caused by genetically modified organisms and

mechanism of pathogenicity including invasiveness and virulence,



-communicability,



-infectious dose,



-host range, possibility of alteration,



-possibility of survival outside of human host,



-the presence of vectors or means of dissemination,



-the rate of biological stability,



-the characteristics of antibiotic resistance,



-allergenicity of



-availability of appropriate therapies.



6.8. 6. Information on the possible harmful effects of genetically

the modified organism or gene product on human health

caused by the genetic modification. Possible harmful effects always

clearly identify.



6.8. 7. information on the safety of the genetically modified organism, or

the genetic product for animal health, in particular with regard to any

the harmful effects caused by the genetic modification, if it has to be genetically

modified organism or genetic product used as part of

feed, veterinary medicine, etc.



6.9. Interactions of the GMO with the

environment



6.10. The ability of the survival, reproduction and dissemination of genetically

the GMO in the environment, if it is different from the

the ability of the recipient or parental organism



6.11. The effects of GMOs on the environment,

If they are different from the effects of the recipient or parental organism, and

their possible consequences



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

If there is, with the precision specifying the cultivar (variety, race, breed,

the line forms, hybrid strain, patovaru)



6.13. The mechanism of interaction between the genetically modified organism

or genetic product and the target organism, if the target organism

There is a



6.14. Potential changes in the interactions of the GMO

or genetic product with non-target organisms resulting from the genetic

the modification of the



6.15. Potential changes in the interactions of the GMO

or the genetic product with artificial components of the environment,

arising from the genetic modification



6.16. The stability of the genetically modified organism according to the hereditary

properties



6.17. Information about the genetically modified organism different from the

the recipient or parental organism. The differences clearly

identify.



-the method and rate of reproduction, the generation time



-spreading in the environment



-the ability to survive



-the effects on the health of people, animals, and other organisms



-other



6.18. The ability of genetically modified organism transfer genetic

material to other organisms, and the implications of such a transfer



7. the expected behavior of the genetic product, if it is different from the

the behavior of the recipient or parental organism



8. Information about the preceding entry into the environment in the Czech

Republic (if applicable)



8.1. Authorized person



8.2. The date and number of the permit



8.3. The place of entry into the environment



8.4. The purpose of entry into the environment



8.5. Duration of putting into the environment, its start date and

their



8.6. The focus and duration of monitoring



8.7. The conclusions of the monitoring



8.8. The results of putting into the environment, taking into account any

the risk for human and animal health, the environment and biodiversity

the diversity of the



9. information on the preceding entry into the environment or into the

circulation in other countries



9.1. Authorized person



9.2. The date of the designation and authorization



9.3. State



9.4. The responsible administrative authority



9.5. Place, date of commencement and their entry into the environment



9.6. Duration, start date, and their monitoring



9.7. The focus of the monitoring



9.8. The conclusions of the monitoring



9.9. The results of putting into the environment, where appropriate in the

taking into account any risk to the health of people and animals, the

environment and biodiversity



10. information on previous treatment (research, development, use of) relevant for the

the risk assessment



11. the monitoring plan



11.1. The identified characters, properties and uncertainties in relation to the

the genetically modified organism or genetic product or

their interactions with the environment, on which he had a plan

monitoring of focus



11.2. Security, the extent and the way of monitoring the effects of the

the modified organism or gene product on human health,

the animals, the environment and biodiversity (monitoring

the genetically modified organism or a gene product),



11.3. Security, the way and the frequency of sampling and analysis of samples after putting

the genetically modified organism or a gene product into circulation



12. Details of provision of reference samples of the genetically modified

the organism or gene product and store them for administrative authority

or by legal persons



12.1. Specification and quantity of the sample provided with the application at the same time

under section 24, paragraph. 3 of the law



12.2. The frequency and method of transmission of samples after the grant of authorisation for

putting into circulation



PART (C)



ADDITIONAL REQUIREMENTS FOR GENETICALLY MODIFIED HIGHER PLANTS,

WHERE APPROPRIATE, GENETIC PRODUCTS CONTAINING GENETICALLY MODIFIED HIGHER

PLANTS



1. General description of the genetically modified higher plants, or genetic

the product and the genetically modified higher plants, which is the content of the

gene product



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

by specifying the cultivar (variety, line, hybrid)



1.2. The form, which should not be genetically modified higher

a plant or a genetic product put into circulation (seeds, cut flowers,

the vegetative parts, etc. ), as the proposed condition of putting into circulation



1.3. The intended use of genetically modified higher plants, or

gene product and the target group of consumers



1.4. The terms of use, in particular the differences between the management of genetically

genetically modified higher plants, or a genetic product and management

similar non-GMOs or products containing

unmodified organisms, including mandatory restrictions as proposed

the conditions for putting into circulation



1.5. Where appropriate, unambiguous definition of the geographical area in the European Union,

that has to be the marketing of genetically modified higher plants, or

the genetic product into circulation limited



1. the 6. The type of environment in which is the use of genetically modified higher

plants (genetic) inappropriate



1.7. The proposed method of packing genetically modified higher plants

or genetic product



1.8. The proposed way of tagging beyond the law



1. the 9. Estimated annual demand



-in the Czech Republic



-in the European Union



-on export markets



1.10. The unique identification code of the genetically modified higher

plants



1.11. 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 of the

EU Member State?



If Yes, please provide the applicant, the number or other indication of the application (date of

and the designation of the permit, if issued) and the State in which it was filed



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 on the

the environment (part A, point 9 of Annex No. 2 to this notice)



1.12. At the same time, the applicant shall request for placing the same genetically

genetically modified higher plants, or of the same genetic product into circulation

in another Member State of the EU?



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

was made



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 on the

the environment (part A, point 9 of Annex No. 2 to this notice)



1.13. Or the application is made (notification) for placing the same

genetically modified higher plants, or of the same genetic

the product into circulation in another State outside the EU?



If Yes, please provide the applicant, the number or other indication of the application (date of

and the designation of the permit, if issued), the State in which it was made and the period

on which the application is made (the period for which the licence was granted).



1.14. Has previously made an application for placing the same genetically

genetically modified higher plants, or of the same genetic product into circulation

in the EU?



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

was made



1.15. The measures, to be taken in the event of an accident or

unauthorized use of genetically modified higher plants, or

genetic products



1.16. The treatment of waste, including disposal of waste containing

genetically modified organisms



1.17. A summary of the data obtained from past or ongoing cases

the placing of the same GMOs or the same

the combination of genetically modified organisms into the environment for

different conditions representing the different environments in which can be

genetically modified organism used



2. the data about the recipient or parental organism



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

by specifying the cultivar (variety, line, hybrid)



2.2. Origin (collection, collection number, supplier)



2.3. Reproduction



2.3. 1. method of reproduction



2.3. 2. the specific factors affecting reproduction (if

There are)



2.3. 3. Generation time



2.3. 4. Sexual compatibility with other cultivated or wild species

and the expansion of these compatible species in the Czech Republic



2. the 4. The ability of survival



2. the 4. 1. The ability to create structures that allow the survival or

dormancy, and the length of the possible survival or dormancy,



2. the 4. 2. Other specific factors allowing survival, if there are



2.5. The spread in the environment



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

Depending on the distance from the source, the force and direction of the wind, the flow of water and

other factors)



2.5. 2. the specific factors affecting dissemination, if any



2.6. Geographical extension



2.7. If it is not higher plant grown in the Czech Republic, a description of the Habitat, including

information on natural konzumentech, patogenech, parasites,

competitors and symbionts



2.8. Other possible relevant interaction with other higher plants

organisms in the ecosystem in which the higher plant usually grown,



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

(alive or inanimate, including extra-cellular products) due to the people,

animals, plants, or otherwise. If Yes, clearly identify the

possible characteristics:



-pathogenicity: infectivity, virulence, case fatality ratio



-allergenic effects



-toxic effects



-carrier of the pathogen,



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



-the possibility of activation of latent viruses (proviruses)



-the ability to penetrate into other organisms or to colonize other organisms



-antibiotic resistance, and potential use of these antibiotics

for the prophylaxis and treatment of diseases in humans and animals



-other



2.10. Significant phenotypic and genetic characteristics



3. Information on the genetic modification



3. the 1. A type of genetic modification



-in the case of cizorodého of hereditary material



-the exclusion of hereditary material



-combination of exemption and, in the case of hereditary material



-cell fusion



-other (clearly identify)



3.2. Description of the methods used for the genetic modification



3.3. Characteristics and origin of used vector (the vector has been in

genetic modification used)



(+ genetic map of the vector)



3.4. Information about each part of a stretch of DNA that is to be included in the organism

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

material)



3.4. 1. The size of the



3.4. 2. The position of the



3.4. 3. The sequence



3.4. 4. the origin of (Czech and Latin genus and species name of donor

the organism with the precision specifying the cultivar-variety, race, breed, lineage,

forms, hybrid strain, patovaru)



3.4. 5. Functional characteristics



4. the data of the GMHP



4. the 1. Description and characteristics of hereditary properties that were inserted

or changed, including signal and marker genes and the previous

modifications and a description of their phenotypic expressions



4.2. Data on a stretch of DNA that was included or excluded



4.2. 1. the structure and size of the embedded section of DNA, including information on each

a section of the vector, which was inserted into genetically modified higher

plants, or of any transportation or foreign DNA remaining in the

the GMHP



4.2. 2. In the case of exclusion of part of the hereditary material (deletions) size and

the function of each part of the exempted section of nucleic acid



4.2. 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



4.2. 4. The number of copies of the hereditary material embedded



4.2. 5. The stability of the inserted material and its hereditary stability

the location of the



4.2. 6. In the case of other genetic modifications than the insert or the exclusion

part of the hereditary material, describe the function of the modified hereditary

the material before and after the modification and further describe the direct changes in the

the expression of genes resulting from the modification of the



4.3. The information about the embedded expression of hereditary material



4.3. 1. the Expression of hereditary material inserted and the methods used for

her characterization of the



4.3. 2. The place, where in the plant to the expression of inserted genes (e.g..

the roots, stem, leaves, pollen and the like)



4.3. 3. Changes of expression depending on the life cycle of plants



4.3. 4. Stability of expression



4.4. Information about the genetically modified higher plants differ

from the recipient or parental organism (always unambiguously

identify)



4.4. 1. The method and speed of propagation



4.4. 2. The dissemination in the environment



4.4. 3. The ability of survival



4.4. 4. Effects on the health of people, animals, and other organisms



4.4. 5. Impact on non-target organisms



4.4. 6. More



4.5. The ability of the GMHP to transfer

the genetic material to other organisms, and the implications of such a transfer



4.6. Information about the possible harmful effects of genetically modified

higher plants on human health caused by the genetic modification. Possible

the harmful effects of always clearly identify.



4.7. Data on the safety of genetically modified higher plants for

animal health, if it is to be a genetically modified higher plants

used as animal feed, if the safety of genetically modified higher

plants different from the recipient or parental organism



4.8. The mechanism of interaction between the genetically modified higher

plant and target organisms (if there is a target organism),

If the mechanism of the interaction of genetically modified higher plants

different from the recipient or parental organism



4.9. Potential changes in the interactions of the GMO and

the genetic product with non-target organisms resulting from the genetic

the modification of the



4.10. Information allowing the unique identification of a genetically

genetically modified higher plants



4.10. 1. Description of the altered DNA



4.10. 2. Methods for detection and identification of genetically modified higher

the plant, certified methodology of collection and editing samples



4.11. The behavior of the inserted genes



4.11. 1. the hybridization with the same kind of



4.11. 2. the hybridization with remote types



4.12. Phenotypic stability of genetically modified higher plants



5. information on the possible effects on the environment resulting from

use of genetically modified higher plants (the possible effects

always uniquely identify the)



5.1. The possible effect on the environment resulting from the marketing of a genetically

genetically modified higher plants for circulation



5.2. The possible effect on the environment resulting from the interaction between the

genetically modified higher plants and the target organism (if the

There are), if different from the interaction of the recipient, where appropriate, the parental

the organism



5.3. 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



5.3. 1. the effects on biodiversity in the place of cultivation



5.3. 2. Effects on biodiversity in other environments
5.3. 3. Effects on Pollinator



5.3. 4. Effects on endangered species



5.3. 5. Possible interaction with inanimate components of the environment



6. information on previous cases, the marketing of genetically modified higher

the plants into the environment



6.1. Previous entry into the environment carried out by the applicant in

The Czech Republic



6.1. 1. The date and number of the permit



6.1. 2. The conclusions of the monitoring



6.1. 3. the results of putting into the environment, where appropriate in the

taking into account any risk to the health of people and animals, the

environment and biodiversity



6.2. Previous cases of entry into the environment or into circulation

carried out by the applicant in other countries



6.2. 1. the State of



6.2. 2. the Responsible administrative authority



6.2. 3. the date the authorisation and labelling of



6.2. 4. The place of entry into the environment



6.2. 5. The purpose of entry into the environment



6.2. 6. Duration of entry into the environment



6.2. 7. The duration of the monitoring



6.2. 8. The focus of the monitoring



6.2. 9. The conclusions of the monitoring



6.2. 10. the results of putting into the environment, where appropriate, into circulation

with regard to any risk to the health of people and animals, the

environment and biodiversity.



7. the monitoring plan



7.1. 1. The identified characters, properties and uncertainties in relation to the

the GMHP or genetic product or

their interactions with the environment, on which he had a plan

monitoring of focus



7.1. 2. Security, scope and method of monitoring the effects of the

genetically modified higher plants, or the genetic product on human health and the

the animals, the environment and biodiversity (monitoring

the genetically modified organism or a gene product).



7.1. 3. Security, method and frequency of sampling and analysis of samples after

putting genetically modified higher plants or gene product

into circulation



If the product contains multiple, genetically modified organisms,

necessary to handle the part (B), or (C) for each of the genetically modified

the body separately



PART (D)



THE COMMON NEED FOR ALL APPLICATIONS

Comments, date and signature of the professional advisor-----------



Date, signature and stamp of the applicant----------



Annex 4



Part a: requirements for the enclosure and protection measures for the

microbiological laboratory



Inspecting the loop means the entry to laboratory via separate

spaces, the "clean" side must be separated from the lab

security doors, dressing room to Exchange clothes and shower.



Standard operating procedure means a procedure to allow for the safe

the transfer of material to the sterilizer out of the laboratory and to ensure that the same

the level of protection which secures the laboratory.



Protective clothing, for example, means working the cotton sheath, protective

the apron of PVC, protective apron, jumpsuit of rubber textile special

polyethylene, a protective suit pressure, protective coat with

warm lined, protective linings of the coat with a hood, a protective cloak

waterproof, work pants, work pants, cotton net

head caps. Protective footwear shall mean, for example, rubber boots,

galoshes rubber work boots, closed-type shoes, sandals with

closed toe sandals, health.



Personal protective equipment shall mean, for example, cotton

gloves, latex gloves, disposable polyethylene gloves,

gloves, nitrile, or request to the sterility of gloves-

disposable vinyl gloves, protective glasses, protective glasses

dust-proof, protective shield, lícnicová part of the filtration material

against particles (ústenka), filtering half masks with filter against solid

particles (with or without exhalation valve), filter half mask, or

čtvrtmaska with filter, face mask with filter (to be given subject

filtration), insulating the non-autonomous unit (hose), the autonomous

breathing apparatus.



For the category of risk



I. II. III. IV.

------------------------------------------------------------ --------------------------------------------------------------- -------------------------------

Closed space

------------------------------------------------------------ --------------------------------------------------------------- -------------------------------

1 the Department inside the building or the Department is not required inside the building Department inside the building required

the location of the building in a special location in the Special building



2 Seal for gas sterilization is not required not required required required

Device



3 easy to clean surfaces required for the required for the required for the required for the

resistant to water, acids, work work work work

alkalines, solvents; desktop, desktop, floor and wall surface area,

enabling effective disinfection and the floor and walls, the floor and the walls of the floor, walls and ceiling

decontamination



4 entrance to the work area is not required, only requested if resulting from the required required

health risk assessment through the loop



5 Reduced pressure due to the pressure is not required required required

the immediate surroundings of the required



6 the input and output of air through not required not required required for the output required; where it works

aerosol filter (HEPA) with viruses, required

Special

measures against the spread of the virus



7 Sterile box-separate is not required, only requested if resulting from required required

room risk assessment



8 Pressure steam sterilizer is required that is required that must be sought that is required that must be

must be located in the building to be located in the building and to meet must be located in an enclosed in a laboratory; must be inserted between the

the conditions of the area of "clean" and "unclean" part

compliance with the standard operating

procedure (see above)

------------------------------------------------------------ --------------------------------------------------------------- -------------------------------

Work mode

------------------------------------------------------------ --------------------------------------------------------------- -------------------------------

9 restricted access is required required required required



10 Mark "danger-biological not required required required required

the risk of "^ 13) on entry



11 of the special measures for the restriction is not required required required * must spread the spread required to prevent the spread of

the spread of aerosol



12 Shower not required required required required

in the building



13 protective clothing and protective footwear required suitable required suitable protective clothing required suitable protective required protective clothing and protective

protective clothing (specific type and frequency of exchange of clothing and protective footwear footwear (a specific type of results from

(the specific type and result from the risk assessment), (type and frequency of specific risk assessment)

rate of exchange of protective footwear required only if an exchange of the full result from the exchange of linen, clothing and footwear

result from the evaluation results of the risk assessment the risk assessment) before entering the confined space and

the output from the risk) (a way of dealing with

clothing, linen and footwear collection

results of the risk assessment)



14 personal protective required only if required required required protective gloves, protective

resources resulting from the evaluation (specific type and frequency of exchange of gloves and other personal protective goggles and other personal protective

the risks arising from the risk assessment) protective equipment according to the

resources according to risk assessment

risk assessment (exchange rate resulting from the evaluation of the

(rate of exchange of results)

of the risk assessment)



15 effective control and exclusion required required required required

vectors of genetically

modified organisms (eg.

insects and rodents)



------------------------------------------------------------ --------------------------------------------------------------- -------------------------------

Waste

------------------------------------------------------------ --------------------------------------------------------------- -------------------------------
16 of the inactivation of the required only if required required required

modified organisms thus arises from the evaluation

in the runoff of the washbasins, sinks, risks

showers and other waste

the waters of the



17 of the inactivation of the required required required required, včetnědezinfekce

GMOs on the protective clothing including disinfection disinfection of protective clothing, including

material used and in hard protective clothing, footwear and footwear and other personal protection

the waste in accordance with specific other personal resources

the law ^ 14) protective equipment

Other measures



18 Laboratory has its own required required required required

equipment



19 observation window installed Is required only if required to do so only if the resulting from the required required

or other device, so that the results of the evaluation of the risk assessment

workers in the laboratory were the risks

see



20 rest room is not required, only requested if resulting from the required required

outside the workspace of the risk assessment

------------------------------------------------------------ --------------------------------------------------------------- -------------------------------



Part b: requirements for enclosed space and protective measures for greenhouses

and the culture room



The greenhouse or the culture room means an enclosed space

bounded by the walls, the floor and the roof (the ceiling), which is designed and

mainly used for growing plants. If treated in the greenhouse and

with other genetically modified organisms than are plants, must

greenhouse meet and the conditions laid down for the workplace

(for example, part A of this annex, if it is a genetically

genetically modified micro-organisms, or part C of this annex, if it is

about genetically modified organisms).



Inspecting the loop means the entry into a greenhouse or culture

the room through the separate areas, whose "pure" party is from

laboratories separated by security doors, wardrobe for clothes and Exchange

shower.



Standard operating procedure means a procedure to allow for the safe

the transfer of material to the sterilizer out of the greenhouse or the culture room

and to ensure the same level of protection as those spaces.



Protective clothing, for example, means working the cotton sheath, protective

the apron of PVC, protective apron, jumpsuit of rubber textile special

polyethylene, a protective suit pressure, protective coat with

warm lined, protective linings of the coat with a hood, a protective cloak

waterproof, work pants, work pants, cotton net

head caps.



Protective footwear shall mean, for example, rubber boots, galoshes rubber,

work shoes closed-type shoes, sandals with a closed toe,

Health sandals.



Personal protective equipment shall mean, for example, cotton

gloves, latex gloves, disposable polyethylene gloves,

gloves, nitrile, or request to the sterility of gloves-

disposable vinyl gloves, protective glasses, protective glasses

dust-proof, protective shield, lícnicová part of the filtration material

against particles (ústenka), filtering half masks with filter against solid

particles (with or without exhalation valve), filter half mask, or

čtvrtmaska with filter, face mask with filter (to be given subject

filtration), insulating the non-autonomous unit (hose), the autonomous

breathing apparatus.

For the category of risk

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

I. II. III. IV.

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

Closed space

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

1 greenhouse or the culture room is not required required required required

they are resistant to extremes of weather

in a given region



2 the Department inside the building or is not required, only requested if required only if so required will come from a specific location

the location in a special building arises from the risk assessment the risk assessment of building



3 Seal for gas sterilization is not required not required required required

Device



4 access to the workspace through not required required required entry through hygiene required input through

a separate room with two loop health loop

by interlocking doors



5 Reduced pressure due to pressure in not required not required required required

the immediate surroundings



6 the input and output of air through not required not required required required output

aerosol filter (HEPA)



7 Pressure steam sterilizer is required that is required that must be required that must be required that must

must be located in the premises be in the building to be located in the building and for the fulfilment of the be in the confined space;

the conditions must be inserted between "clean" and

standardníhooperačního procedure (see "impure" part

the above)

------------------------------------------------------------ --------------------------------------------------------------- ---------------------------------------

Work mode

------------------------------------------------------------ --------------------------------------------------------------- ---------------------------------------

8 limited access is not required required required required



9 Mark "danger-biological not required required required required

the risk of "^ 13) on entry



10 Shower not required required required required

in the building



11 protective clothing and protective footwear required required required suitable vhodnýochranný clothing suitable protective clothing and required protective clothing and

protective clothing (a specific type of afrekvence (a specific type of protective footwear and protective footwear (konkrétnítyp

(a specific type of Exchange will result from evaluation of the frequency of replacement will result from the results of the risk assessment)

Exchange rate risk), protective footwear risk assessment) the complete Exchange of clothing and footwear

from guest only required, if so before entering the closed

risks) resulting from the assessment of the risk area and output it

(how the treatment of clothing and

footwear collection arising from the

risk assessment)



12 personal protective required only if required required required protective gloves and protective gloves,

resources will come from the guest (a specific type of afrekvence other personal protective work and other personal protective

the risk of the exchange of results assessment of resources from work equipment according to the

risk) risk rating (rate of exchange of the risk assessment

results of the risk assessment) (frequency of exchange of vyplynez

risk assessment)

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

Waste

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

13 of the inactivation of the required only if required required required

modified organisms in the runoff so arises from the evaluation

from wash basins, sinks, showers and the risk

other waste waters

in accordance with specific legal

Regulations ^ 14)



inactivation of the 14 required required required required including disinfection,

GMOs on the protective clothing including disinfection of protective clothing, including protective disinfection

material used and in solid footwear and other personal protection clothing, footwear and other personal

waste of funds in accordance with specific protective equipment

the law ^ 14)

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------
Other measures

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

15 undesirable Restrictions required required required required to prevent the occurrence of the prevention of the occurrence of the

animals, insects, rodents, etc.

preventing access and regular

treatment

premises and equipment, effective

resources



16 greenhouse or cultivation required required required required

has its own equipment



17 Runoff water into the waste, where the only required only if the required limits runoff outside the required prevent runoff outside the required preventing runoff

inactivation occurs according to the point resulting from the evaluation of the waste to a minimum the waste out of waste

13 risk



18 treatment of soil is not required, only requested if required required

in an autoclave or hot-air resulting from the risk assessment

the steriliser



19 How the movement of organisms to the restrictions required required required spread outside the required spread

other devices must be able to prevent the spread of the smallest šířenímimo space, a space in which the organism outside the space in which it is

control over the dissemination of genetically possible outside in which the organism is an organism relocated relocated

modified organisms, in which space is relocated

the organism moved under



20 rest room is not required, only requested if required required

results from the evaluation of the risk

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------



Part c: requirements for enclosed space and protection measures for the

user equipment for animals



If the user devices for animals treated with other

genetically modified organisms, must comply with the terms of the greenhouse

established for the relevant departments (for example, part A of this annex,

If this is a genetically modified micro-organisms, or parts of the (B)

of this annex, if it is a genetically modified plants).



In the case of clinical trials of medicinal products for human or veterinary

containing genetically modified organisms, the requirements apply to the

closed areas and safeguard measures in accordance with specific legal

regulations ^ 15)



Zvířetníkem means a separate building or Department inside the building

including spaces for animals and other auxiliary spaces (e.g., warehouse

feed, bedding, equipment), including facilities for the staff (e.g., dressing room,

showers, sterilizers, spaces for the storage of food, etc.).



Space for the animals means the specialised facilities and equipment

According to the type of animals for their breeding and implementation of experimental procedures.



Insulator means transparent container, in which they are kept small

animals; for larger animals are more convenient isolated room.



Protective clothing, for example, means working the cotton sheath, protective

the apron of PVC, protective apron, jumpsuit of rubber textile special

polyethylene, a protective suit pressure, protective coat with

warm lined, protective linings of the coat with a hood, a protective cloak

waterproof, work pants, work pants, cotton net

head caps.



Protective footwear shall mean, for example, rubber boots, galoshes rubber,

work shoes closed-type shoes, sandals with a closed toe,

Health sandals.



Personal protective equipment shall mean, for example, cotton

gloves, latex gloves, disposable polyethylene gloves,

gloves, nitrile, or request to the sterility of gloves-

disposable vinyl gloves, protective glasses, protective glasses

dust-proof, protective shield, lícnicová part of the filtration material

against particles (ústenka), filtering half masks with filter against solid

particles (with or without exhalation valve), filter half mask, or

čtvrtmaska with filter, face mask with filter (to be given subject

filtration), insulating the non-autonomous unit (hose), the autonomous

breathing apparatus.



In addition to the requirements of the specific legislation of the ^ 16) must

user equipment for animals must meet the following requirements:



For the category of risk

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

I. II. III. IV.

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

1 Zodiac is a separate unit required only if required required required

thus arises from the

the risk assessment



2 Spaces for animals separate required only if required required required

closable doors so arises from the

the risk assessment



3 spaces for animals and helper required required required required

devices made to be

easy to clean and decontaminate

(materials impermeable to water, easily

to clean and disinfect)



4 floor and walls of the room easily if requested požadovánopro floor required for the floor and required for the floor and walls

washable so will come from the walls of the

the risk assessment



5 animals are kept within reasonable required required required required

barrier devices, as they are breed

containers, boxes or containers



6 filters at izolátorech or isolated požadovánojen is not required, if the results required required

the rooms of the risk assessment



7 in the case of the use of animal products required required required required

the origin of the creation of the conditions for the control of

(e.g., veterinary health control)



8 Shower not required required required required

in the building



9 protective clothing and protective footwear required suitable suitable protective clothing required required required protective clothing suitable protective and

protective clothing (konkrétnítyp and frequency of exchange of clothing and protective footwear protective footwear (a specific type of

(the specific type and result evaluation of risks), (specific type and resulting from the assessment of the risk)

rate of exchange of protective footwear required, the frequency of the resulting Exchange only the full exchange of clothing and footwear

result from the evaluation of the if resulting from the evaluation of the risk assessment) before entering the closed

risk) risk area and output it

(how the treatment of clothing and

footwear collection arising from the

risk assessment)

10 personal protective equipment required only if required required required protective gloves, protective

so will come from (konkrétnítyp and frequency of exchange of gloves and other personal and other personal protective

assessment of the risks arising from the risk assessment) protective equipment according to the

resources according to risk assessment

assessment of the risk (arising from the exchange rate

(rate of exchange of results of the risk assessment)

of the risk assessment)



11 rest room is not required požadovánojen where results required required

of the risk assessment

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

In the case of user equipment for aquatic animals

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

12 the inactivation of the organisms in waste water required required required required



13 Construction of the room such that the required escape požadovánopro escape of organisms required required

in the case of rupture, leakage or escape of organisms for water to leak water

overflow tanks for aquatic animals

prevent leakage into sewers,

surface water or groundwater

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------
Part D: requirements for enclosed space and other protective measures for

other activities (for example, manufacturing operations, demonstration)



Closed system means a device permanently fitted in the closed

the space intended for the possession and cultivation of genetically modified

organisms, usually in larger volumes.



Inspecting the loop means the entrance to the confined space through

separate spaces, whose "pure" party is from the enclosure

separate security doors, dressing room to Exchange clothes and shower.



Protective clothing, for example, means working the cotton sheath, protective

the apron of PVC, protective apron, jumpsuit of rubber textile special

polyethylene, a protective suit pressure, protective coat with

warm lined, protective linings of the coat with a hood, a protective cloak

waterproof, work pants, work pants, cotton net

head caps.



Protective footwear shall mean, for example, rubber boots, galoshes rubber,

work shoes closed-type shoes, sandals with a closed toe,

Health sandals.



Personal protective equipment shall mean, for example, cotton

gloves, latex gloves, disposable polyethylene gloves,

gloves, nitrile, or request to the sterility of gloves-

disposable vinyl gloves, protective glasses, protective glasses

dust-proof, protective shield, lícnicová part of the filtration material

against particles (ústenka), filtering half masks with filter against solid

particles (with or without exhalation valve), filter half mask, or

čtvrtmaska with filter, face mask with filter (to be given subject

filtration), insulating the non-autonomous unit (hose), the autonomous

breathing apparatus.



Risk category



------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

I. II. III. IV.

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

Closed system

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

1 Viable organisms shall be required only if required required required

maintained in a closed system, which arises from the

It is separated from the surrounding risk assessment



2 the security and control of the spread is not required required required to prevent the spread of the restrictions required to prevent the spread of

aerosols from outgoing from the closed low spread

System



3 security and control of the spread of required only if requested to limit the spread of the required prevention required to prevent the spread of

aerosols during sampling or so will come from the smallest possible spread

adding material to a closed risk assessment

system or transmission of the material to

another system



4 Inactivation of the medium before the necessary inactivation required physical inactivation or inactivation needed physical inactivation required physical or

removing or discharge of a closed physical or chemical method or chemical method of chemical method with a proven 100%

the system of chemical method with a proven 100% effective

efficiency



5 Construction seals and seals required required required required constraint

to prevent the spread of organisms spread on the smallest of the full spread of the full spread of the full spread

from the closed system possible

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

Other requirements for enclosed space

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

6 Waste tank for culturing required only if required required required

the device must accommodate the total volume thus arises from the

closed system, if an evaluation of the risk

the leak



7 Seal for gas sterilization is not required, only requested if the results required only if so required

from the assessment of the risk arising from the risk assessment



8 Input via the health loop not required not required required only if so required

results from the evaluation of the risk



9 easy to clean surfaces, required for the required for the desktop, requested for the work required for the desktop,

water, acids, alkalines, desktop, floor and wall area, floor and walls of the floor, walls and ceiling

solvents enabling the effective floor and walls

disinfection and decontamination



10 Special equipment for ventilation is required only if required to do so only if the results required required

in order to reduce the contamination of the air on the way from the risk assessment resulting from the

minimum risk assessment



11 Maintaining the lower air pressure than not required not required required required

the pressure is in the immediate vicinity



12 input and output of air through the HEPA is not required not required required for output, for required for input and output

filter input required only,

If it arises from the

the risk assessment

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

Work mode

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

13 the entire closed system is located is not required, only requested if the results required required

in the enclosed space of the risk assessment



14 limited access required required required required



15 Mark "danger-biological not required required required required

the risk of "^ 13) on entry



16 before leaving the confined space is not required not required required required

workers must take a shower



17 protective clothing and protective footwear required suitable required suitable protective clothing required suitable protective required protective clothing and protective

protective clothing (specific type and frequency of exchange of clothing and protective footwear footwear (a specific type of results from

(the specific type and result from the risk assessment), (type and frequency of specific risk assessment)

the frequency of the exchange of trade, exchange of obuvpožadována only will result from the full exchange of linen, clothing and

result from the evaluation of the if resulting from the evaluation of the risk assessment) footwear before entering the closed

risk) risk area and exit from it (the way

treatment of laundry, clothing aobuví

in the collection of results from the evaluation of

the risk)



18 personal protective equipment required only if required required required protective gloves, protective

so will come from (specific type and frequency of exchange of gloves and other personal and other personal protective

assessment of the risks arising from the risk assessment) protective equipment according to the

resources according to risk assessment

assessment of the risk (arising from the exchange rate

(rate of exchange of results of the risk assessment)

------------------------------------------------------------ --------------------------------------------------------------- ---------------------------------------- z hodnocení rizika)

Waste

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

19 Inactivation of genetically modified required only if required required required

organisms in the runoff of basins, arising from the

sinks, showers, etc. the risk assessment



20 Disinfection work clothing, work required only if required required required

individual protective footwear and so resulting from the

resources after the use of risk assessment



21 the inactivation of genetically modified the necessary inactivation required physical inactivation or inactivation needed physical inactivation required physical or
organisms on the material used and the method of physical or chemical or a chemical method of chemical method with a proven 100%

in liquid and solid wastes in the chemical method with a proven 100% effective

during the process, in accordance with the effect

special legislation ^ 14)

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

Other measures

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------

22 the rest room is not required, only requested if the results required required

of the risk assessment

------------------------------------------------------------ --------------------------------------------------------------- ----------------------------------------



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

the environment and repealing Council Directive 90/220/EEC.



Council Directive 90/219/EEC of 23 July. April 1990 on the contained use of

genetically modified micro-organisms.



Council Directive 98/81/EC of 26 April 1999. October 1998, amending Directive

90/219/EEC on the contained use of genetically modified

micro-organisms.



1A) of section 7 to 30 of Act No 326/2004 Coll., on phytosanitary care, as amended by

Act No. 137/2006 Coll., Act No. 249/2008 Coll. and Act No. 291/2009 Sb.



Act No. 167/1999 Coll., on health care and on the amendment of certain

related laws (health law), as amended.



Annex No 1 and 2 of Decree No 215/2008 Coll., on measures against the introduction into the

and the dissemination of harmful organisms of plants or plant products,

as amended.



Decree No 356/2004 Coll., on monitoring (monitoring) of zoonoses and zoonotic

zoonoses and amending Decree No. 299/2003 Coll., on measures for the prevention of

and control of diseases and diseases transmissible from animals to humans.



Decree No 474/2002 Coll., implementing Act No. 281/2002 Coll., on

some of the measures related to the prohibition of Bacteriological

(Biological) and Toxin Weapons and on the change of the Trade Licensing Act.



2) Law No 219/2003 Coll., on marketing of seeds and plants grown

plants and amending some laws (law on the circulation of seed and propagating material).



for example, 3) Government Decree No. 178/2001 Coll., laying down the conditions

protection of the health of workers at work, as amended by Decree-Law No.

523/2002 Sb.



Decree No. 472/2000 Coll., laying down good clinical practice and

closer to the conditions of a clinical trial of medicinal products, as amended by Decree No.

301/2003 Coll.



Decree No 504/2000 Coll., laying down good laboratory practice in

the area of pharmaceuticals,



Decree No. 311/1997 Coll., on the breeding and use of experimental animals.



§ 5, paragraph 5). 1 of law no 344/1992 Coll., on the Czech real estate

Republic of (Land Registry Act), as amended by law No. 89/1996 Coll., and act

No 120/2000 Sb.



6) for example, Act No 353/1999 Coll., on the prevention of major accidents

caused by selected hazardous chemical substances and chemical

products and amending Act No. 425/1990 Coll., on district offices, edit

their scope and on certain other related measures,

as amended (the law on the prevention of major accidents), in

the text of Act No. 258/2000 Coll. and Act No. 320/2002 Coll.



Act No 246/1992 Coll., on the protection of animals against cruelty, as amended by law

No 162/1993 Coll., Act No. 193/1994 Coll., Act No. 243/1997 Coll. and

Act No. 30/1998 Coll.



Act No. 167/1999 Coll. on veterinary care and related

laws (health law), as amended by Act No. 29/2000 Coll., Act No.

154/2000 Coll., Act No. 102/2001 Coll., the Act No. 76/2002 Coll., Act No.

120/2002 Coll., Act No. 320/2002 Coll., Act No. 131/2003 Coll. and act

No 309/2003 Coll.



Act No. 185/2001 Coll., on waste and on amendments to certain other laws,

as amended by Act No. 477/2001 Coll., the Act No. 76/2002 Coll., Act No.

275/2002 Coll., Act No. 320/2002 Coll. and Act No. 356/2003 Coll.



Law No. 147/1996 Coll., on phytosanitary care and amendments to certain

related laws, as amended by law no 409/2000 Coll., Act No.

314/2001 Coll. and Act No. 320/2002 Coll.



7) section 20 of Act 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

change some of the laws (law on the recognition of professional qualifications)



section 15, paragraph 8). 2 and § 23 paragraph. 1 (a). and) Act No 246/1992 Coll.



for example, 9) Government Decree No. 178/2001 Coll., as amended by Decree-Law No.

523/2002 Sb.



10) Law No. 252/1997 SB., on agriculture, as amended by Act No 62/2000

Coll., Act No. 308/2000 Coll. and Act No. 128/2003 Coll.



11) Act No 114/1992 Coll., on nature and landscape protection, as amended by law

347/1992 Coll., Act No. 289/1992 Coll., the finding of the Constitutional Court

published under no. 3/1997 Coll., Act No. 16/1997 Coll., Act No.

123/1998 Coll., Act No. 161/1999 Coll., Act No. 238/1999 Coll., Act No.

132/2000 Coll., the Act No. 76/2002 Coll. and Act No. 320/2002 Coll.



12) Act No. 242/2000 Coll., on organic farming and on the amendment of the Act

No 368/1992 Coll., on administrative fees, as amended,

as amended by Act No. 320/2002 Coll.



13) Government Decree No. 11/2002 Coll., laying down the appearance and location of the

safety signs and signals the introduction of



14), for example, Act No. 185/2001 Coll., as amended



15) for example, Act No. 79/1997 Coll., on pharmaceuticals and on changes and additions to the

some related laws, as amended by Act No. 149/2000 Coll., Act

No 153/2000 Coll., Act No. 258/2000 Coll., Act No. 102/2001 Coll., Act

No 138/2002 Coll., Act No. 309/2002 Coll., Act No. 320/2002 Coll., Act

No 129/2003 Coll., and Act No. 274/2003 Coll., Decree No. 472/2000 Coll., on the

the texts of Decree No. 301/2003 Coll.



16), for example, Act No 246/1992 Coll., as amended,

Decree No. 311/1997 Coll., Act No. 167/1999 Coll., as amended

legislation, Act No. 20/1966 Coll., on the health care of the people, as amended by law

No 210/1990 Coll., Act No. 425/1990 Coll., Act No. 548/1991 Coll., Act

No. 550/1991 Coll., Act No. 588/1992 Coll., Act No. 15/1993 Coll., Act

No 161/1993 Coll., Act No. 308/1993 Coll., Act No. 60/1995 Coll., Act

No 206/1996 Coll., the Act No. 14/1997 Coll., Act No. 79/1997 Coll., Act

No. 110/1997 Coll., Act No. 83/1998 Coll., Act No. 167/1998 Coll., Act

No 71/2000 Coll., Act No. 121/2000 Coll., Act No. 132/2000 Coll., Act

No 149/2000 Coll., Act No. 258/2000 Coll., Act No. 164/2001 Coll., Act

No 260/1991 Coll., Act No. 285/2002 Coll., Act No. 290/2002 Coll., Act

No. 320/2002 Coll., Act No. 130/2003 Coll., Act No. 274/2003 Coll. and

Act No. 356/2003 Coll.