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.
