78/2004 Coll.
LAW
of 22 March. January 2004
on the management of genetically modified organisms and genetic products
Change: 78/2004 Coll.
Change: 346/2005 Sb.
Change: 78/2004 Coll.
Change: 124/2008 Sb.
Change: 227/2009 Sb.
Change: 281/2009 Sb.
Modified: 18/2012 Sb.
Change: 279/13 Sb.
Parliament has passed the following Act of the Czech Republic:
PART THE FIRST
INTRODUCTORY PROVISIONS
§ 1
The subject of the law
(1) the law lays down, in accordance with the law of the European communities "^ 1") rights and
obligations of the parties and the scope of the administrative authorities in the handling of genetically
genetically modified organisms and genetic products.
(2) this Act does not apply to
and) handling technique or technology obtained by mutagenesis
cell fusion or protoplast fusion of plant cells of organisms, for which
Exchange of genetic material can be achieved by traditional
breeding methods, if these techniques at the same time do not include
technical procedures referred to in point 1 of annex 1 to this Act or the
the use of genetically modified organisms resulting from these procedures,
(b)) the contained use of genetically modified organisms on
exclusively of genetically modified micro-organisms which meet the criteria
the safety for human health, animal health, environmental
and biodiversity as laid down in annex 2 to this Act,
(c)) the contained use of genetically modified organisms on
exclusively of genetically modified micro-organisms resulting from cellular merger
or merger of prokaryotic cells species protoplast fusion, which Exchange
genetic material by known physiological processes, if this merger
at the same time does not include the technical procedures referred to in point 1 of the annex No. 1 to the
This law or the use of such genetically modified organisms
procedures incurred,
(d)) the contained use of genetically modified organisms on
exclusively of genetically modified micro-organisms resulting from cellular merger
or merger protoplasts of cells eukaryotic species, including the creation of
hybridomas, if this merger at the same time does not include the technical procedures under the
point 1 of annex 1 to this Act or the use of genetically
modified organisms resulting from these procedures.
(3) in doubt, whether it is an exception from the scope of this Act pursuant to
paragraph 2 shall be decided by the Ministry of the environment (hereinafter referred to as
"the Ministry").
(4) If a genetically modified organism or a gene product
the medicinal product or plant protection product are subject to
registration under special legislation, ^ 2) do not apply to him,
the provisions of this law on the procedure for registration in the list of the genetically
modified organisms and genetic products approved for marketing
into circulation (hereinafter referred to as "the list for the putting into circulation") and about his change.
The decision on the authorisation of the medicinal product, or
a plant protection product into circulation under the special rule
the prescription shall not be issued before the Ministry shall issue an opinion on
containing the specific risk assessment of the medicinal product, or
the plant protection product for the environment. The Ministry is
obliged to issue an opinion within 15 days from the date of receipt of the relevant
administrative authority.
§ 2
The basic concepts
For the purposes of this Act, means the
-biological organism) unit, including the unit of microbiological,
capable of reproduction or transmission of hereditary material
(b)), the hereditary material-deoxyribonukleová or ribonucleic acid,
(c)) genetic modification-targeted change of the hereditary material consisting of
in the case of cizorodého of hereditary material to the hereditary material
the organism or the exclusion of part of the hereditary material of the organism in a way
which attains a natural recombination,
(d)) of the genetically modified organism-organism, except man,
the hereditary material has been altered through genetic modification made
some of the procedures laid down in point 1 of Annex No. 1 to the
This law,
genetically modified micro-organism)-microbiology unit
capable of reproduction or transmission of hereditary material, including viruses,
viroids, animal and plant cells in culture, whose hereditary
material has been altered through genetic modification,
f) genetic product-any thing that contains one or more
genetically modified organisms, which have been manufactured or otherwise
obtained, regardless of the degree of processing and is intended to be placed in the
circulation,
g) closed space-space bounded by physical barriers,
where appropriate, in combination with chemical or biological barriers, which
limit contact of genetically modified organisms or genetic
products with people, animals and the environment, ^ 3)
h) monitoring-detect the presence of genetic modification in
the organism or product and the monitoring of effects of genetically modified
the organism or gene product on human health, animal health,
components of the environment and biological diversity.
§ 3
Use of genetically modified organisms and genetic products
(1) the Use of genetically modified organisms and genetic
products for the purposes of this Act, means the
and the contained use) genetically modified organisms (hereinafter referred to as
"contained use"), which is considered to be any activity in which they are
organisms, genetically modified or in which they are genetically
modified organisms cultured, stored, transported, destroyed,
disposed of or used in any other way in a closed
the area is about genetically modified organisms authorised for the
putting into circulation referred to in section 23, paragraph. 2,
(b)) the marketing of genetically modified organisms into the environment
(hereinafter referred to as "placing into the environment"), which is considered to be
the marketing of genetically modified organisms into the environment outside the
an enclosed space, unless the approved genetically modified organisms
for putting into circulation referred to in section 23, paragraph. 2,
(c)), the marketing of genetically modified organisms or genetic products
into circulation (hereinafter referred to as "putting into circulation"), which is considered to be their
in return for payment or transfer to another person, unless it is a transmission of exclusively
for the purpose of the contained use or putting into the environment
person authorised to this method of treatment.
(2) for the use of genetically modified organisms and genetic
products shall not be dealing with them from the moment they lose
ability of reproduction or transmission of hereditary material.
(3) the use of genetically modified organisms and genetic
everyone is obliged to products in accordance with the precautionary principle, the
to protect human health, animal health, environmental and
biological diversity (hereinafter referred to as "health and environment").
(4) every person who is treated with a genetically modified organism, or
the genetic product, is obliged to comply with the conditions indicated on the packaging,
the accompanying document, where appropriate, a genetically modified organism, or
the genetic product and treat it only for the purpose stated there.
(5) the use of Live vertebrate animals in the handling of genetically modified
organisms and genetic products is considered animal experiments
under special legislation. ^ 4)
PART THE SECOND
GENERAL PROVISIONS
§ 4
Permission to use of genetically modified organisms and
genetic products
(1) to dispose of genetically modified organisms and genetic
products can only be on the basis of permission under this Act.
(2) Permission for contained use arises on the basis of the authorisation to
contained use, where appropriate, of the notification. For more terms and conditions of this
provides section 16 permission.
(3) permission to entry into the environment arises on the basis of
authorisation for placing into the environment. More conditions
This privilege provides section 17 and 18.
(4) permission to the circulation is formed on the basis of the registration of genetically
the modified organism or gene product whose marketing
This is the list for putting into circulation. For more terms and conditions of this
provides permissions section 23 and 24, or on the basis of written consent or
authorisation for putting into circulation, issued by the competent authority of another
of the Member State.
§ 5
The procedure for granting permits for contained use, the authorisation for the placing
into the environment and to write to the list, for putting into circulation
(1) an application for the granting of permits for contained use, the authorization for the
entry into the environment (hereinafter referred to as "permits") or write to
List for circulation under this Act, the applicant shall
Ministry in four copies of the documentary, and at the same time
technical data medium or by electronic mail. The request contains the name,
where appropriate, the name, last name, business name, address of place of residence, place of
business and the identification number of the person (hereinafter referred to as "identification number"),
If it has been assigned, if the applicant is a natural person authorised to
business, or the name or business name, registered office and identification number,
If it has been assigned, if the applicant is a legal person, the name and, where applicable,
name, surname and the address of the place of residence of a vocational Adviser. Other essentials
the application needed to assess the handling of genetically modified
organism or genetic product in terms of ensuring the protection of
health and the environment, lays down implementing legislation.
(2) the applicant may appeal to the information in the request, the information, or
the results, which are the contents of previously filed applications submitted by other
the applicant, if these data, information and results are not subject to
protection under section 9 or, if the person concerned to have their written
the consent.
(3) the Ministry within 5 working days from the receipt of the request referred to in paragraph
1 assess its completeness. If the application does not contain any of the
the requirements laid down by this law, the Ministry will invite in this
the applicant within the time limit for its completion. In the invitation, the Ministry shall, in what
the data provided were incomplete, and at the same time provides for the addition to the
the time limit. This time limit shall not be shorter than 30 days from the date of receipt of the request.
If the applicant's request within the prescribed period, the Department of management of the phrase
stops.
(4) if the application complies with all the requirements set out under this
the law, the Ministry within 5 working days from the date of expiry of the time limit to
assessment of its completeness, or from the date of receipt of the application, accompanied by the
pursuant to paragraph 3 shall send one copy of the application in paper
the form and also the Ministry of agriculture and Ministry of electronically
Health (hereinafter referred to as "the Ministry concerned") and at the same time in a way
under section 10 (a). (b) shall publish a summary of the content of the application) and information about the
initiation of the procedure, information about the initiation of the proceedings shall be published also in a way
under section 10 (a). and (c))). A summary of the content of the application provides Essentials
the implementing legislation.
(5) the Ministry Concerned may communicate in writing their observations to the application
or raise the requirements for data requests to the Ministry within 30
days from the date of receipt of the request. Raises the requirement to the concerned Ministry
to supplement the information in the request, the Ministry within 5 working days from the date of
the expiry of the period referred to in the first sentence prompts to complete the applicant. In the call
the Ministry shall indicate in what way the data provided were incomplete, and at the same time for
In addition to setting a deadline. This time limit shall not be shorter than 30 days
from the date of receipt of the request. If the applicant has the required information within the
the time limit, the Department of management of the phrase. Together with the request
the Ministry will send the interested ministries, which can make their
comments within 15 working days from the date of receipt of the request. Fails to
the concerned Ministry within the above time limit, it shall be deemed that the
the application does not have comments.
(6) Each can send their written comments to the Ministry within 30 days from the date of
the publication of a summary of the content of the application. The expression sent after the deadline
the Ministry is not obliged to take into account.
(7) if the Ministry in case of a request for the grant of authorisation for
entry into the environment or on the list for entry into
circulation received dissenting comments in accordance with paragraph 6, indicating the
genetically modified organism into the environment, where appropriate, with
indication of the genetically modified organism or a gene product
in circulation, which are the results of the risk assessment or
which argues inadequate to ensure protection of health and the
environment, will ensure in a manner pursuant to section 6 public hearing before
about the applications.
(8) the Ministry is obliged to decide on the application within 90 days from the date of
the date of its receipt. In this period, not the period to supplement the
the request referred to in paragraphs 3 and 5, and the period during which the public is in progress
examination of the application under section 6; a public hearing shall not extend the time limit
more than 30 days.
(9) in its decision, the Ministry is based on the observations of the interested
the ministries and the public. Part of the decision on the request is always
Summary of settlement observations submitted under paragraphs 5 and 6, and in the case of
public consultation in accordance with paragraph 7 of the conclusions from this discussion also.
(10) if the Ministry decides pursuant to paragraph 8 of the authorisation
or write to the list for the putting into circulation in
the decision at the same time the conditions for the use of genetically modified
organisms and genetic products.
(11) the decision referred to in paragraph 8, the Ministry shall send also concerned
Government departments and publish in the manner referred to in section 10.
(12) in the same position as the Ministry concerned, in accordance with paragraph 4,
5, 9 and 11, § 16. 10, and section 18, paragraph. 7 region, on the territory of the
occurs immediately before loading or placing in the
environment.
§ 6
The public consultation
(1) the Ministry shall ensure that in the cases referred to in § 5 (3). 7 the venue of public
discuss the latest within 30 days after the expiry of the deadline for written comments
under section 5 (3). 6. Information on the public consultation involving the location and
public consultation the Ministry of time shall be published in the manner referred to in section 10
at least 5 days prior to its holding.
(2) the public consultation in addition to participating in the Ministry always the applicant for
the granting of authorisation for the placing into the environment or write to
List for circulation. In the case of non-participation of the applicant can
the Ministry of public discussion to end. In such case shall lay down the
the Ministry at the expense of the applicant, the time and location of the new public
consultation. New public consultation shall be held not later than 5 days from the date of
their public consultation pursuant to the second sentence. About the place and time of the new
the public consultation, the Ministry informs the applicant.
(3) the Ministry of the public discussion takes the minutes containing the
in particular, the data on the participation and the conclusions of the consultation and the full sound recording.
The Ministry is obliged to send the minutes of the public hearing into 5
working days of its termination of the applicant and publish it under section 10
(a). (b)).
(4) the right to information in accordance with the specific legislation of this ^ 5)
without prejudice to the law.
section 7 of the
Risk evaluation of the use of genetically modified organisms and
genetic products
(1) risk assessment, use of genetically modified organisms and
genetic analysis of the products is written based on the comparison of the
use of genetically modified organisms and genetic products with
management of genetically non-GMOs and products for
similar conditions, including defining and assessing potential direct
and indirect, immediate and subsequent harmful effects of this
waste, and in particular
and the effects on human health),
(b)) effects on animals and plants,
(c) the establishment and extension of) the genetically modified organisms in the
environment,
(d)) of the natural transfer of inserted genetic material to other
organisms, especially podmiňujícího numbness on gene transfer
antibiotics and other resources used to treat infections of people or animals
in the event that such a gene or genes were injected into the genetically
the modified organism.
(2) the risk assessment processes Professional Adviser (§ 14).
(3) the risk assessment are required to submit to the Ministry of
and) the applicant as part of the application for the grant of the authorisation and the application for registration to the
The list for the putting into circulation,
(b) the person submitting the notification under) § 16. 2 or 3 as part of the
This notice,
(c)), the person authorized under this Act or for contained use
entry into the environment and the person registered in the list for entry into
in the cases referred to in § 8 paragraph. 2 and 3,
(d)), the person authorized under this Act or for contained use
entry into the environment and the person registered in the list for entry into
the circulation regularly every 5 years from the date of the last submission.
(4) when the guest risks must be used
and) current scientific knowledge,
(b)) proven experience with the organism that is genetically modified, and
organisms,
(c)) proven experience with the organism from which the hereditary material
used in the genetic modification, where the genetic modification involves
in the case of cizorodého of hereditary material
(d)) with appropriate experience verified through genetic modification,
(e)) with the proven experience of genetically modified organisms
or genetic product,
f) qualified estimates in cases where lack of verified scientific
knowledge; in these cases, it is necessary to be based on the principle of preliminary
the precautionary principle.
(5) the assessment of the risk the applicant or a person referred to in paragraph 3 shall
kept for at least 10 years since the submission of the request and it
provide the administrative authorities referred to in section 27.
(6) the protection of workers from the risks related to the management of genetically
genetically modified organisms and genetic products in work regulates the
special legislation. ^ 6)
(7) the Requirements and procedures of risk assessment lays down detailed legal
prescription.
§ 8
New information
(1) If a person gets authorized under this Act to the contained use
or putting into the environment, a person entered in the list for the
putting into circulation or the person about the emergence of such permission or
write to the list for the putting into circulation of requests, new information relating to the
risks of the genetically modified organism or a gene product for
health or the environment, shall forthwith
and) take measures necessary to protect health and the environment and
(b)) to provide in writing to the Ministry of the newly acquired information and notify
the measures taken.
The Ministry of information and shall notify the measures referred to in point (a) (b))
the other concerned the administrative authorities referred to in section 27.
(2) a person referred to in paragraph 1 is also obliged, no later than within 30 days
the date when the new information received, make and submit to the Ministry of
the new risk assessment.
(3) If the Ministry gets new information regarding the risks of genetically
the modified organism or gene product for health or
the environment any way other than in accordance with paragraph 1 (b). (b)), shall transmit to the
This information to the interested parties referred to in paragraph 1 and shall invite them to
at the latest within 30 days from the date of receipt of the invitation carried out and submitted to the
the Ministry of the new risk assessment. At the same time, the Ministry shall notify the new
information to other administrative authorities concerned referred to in section 27.
(4) if the new information referred to in paragraph 1 or 3 of the genetically
the modified organism or gene product, for which the
request for entry on the list for putting into circulation, Ministry of
This information shall promptly provide to the European Commission (hereinafter referred to as "the Commission")
and the competent authorities of the other Member States of the European communities
(hereinafter referred to as the "Member States"). If the entry has not yet executed, can
the Ministry from the applicant's request for more information. If you are new
information obtained after registration of the genetically modified
the organism or gene product in the list for putting into circulation, is
the Ministry is obliged within 60 days from the date when it is received, to the Commission
the evaluation report, in which it will be determined whether and, if applicable, must be
write changed or canceled. If the Member States nor the Commission does not submit a
no reasoned objections within 60 days from the date on which the assessment report
The Commission sent to the Member States, or if they are disputed points to 75
days from the date of circulation of the assessment report discussed, Ministry of
Decides to change the minutes. About this Ministry of the decision within 30 days from the
his release shall inform the Member States, the Commission and the Ministry concerned.
(5) if the Ministry gets, on the basis of new information
may affect the assessment of the risk, or on the basis of a reassessment of
existing information in connection with the new scientific knowledge
sufficient basis for the view that the genetically modified organism, or
the genetic product, whose circulation was given consent or
authorisation by the competent authority of the Member State, constitutes a risk for the
health or the environment, it may provisionally restrict or decision
disable the handling of this genetically modified organism, or
the genetic product, including its importation and sale under the same conditions,
What provides in similar situations for genetically modified
an organism or a gene product that was entered in the list for the
putting into circulation under this Act. The decision of the Ministry shall publish
pursuant to section 10.
(6) on the measures taken in accordance with paragraph 5, the Ministry required to
without delay, send a message to the Commission and the competent authorities of the Member States.
The report must include
and the reasons for the measures)
(b)) the new information, of which the decision is based,
(c)) whether or how it is necessary to change the conditions granted to
consent or authorization, or whether it should be granted the authorization or consent of the
Remove.
(7) the report referred to in paragraph 6, the Ministry shall publish pursuant to section 10 (a). (b)).
New information and any related decision, the Ministry shall publish
pursuant to section 10.
§ 9
Some of the data protection
(1) the applicant under section 5 (3). 1 or the notifier pursuant to section 16. 2 or
3 may in the application, where appropriate, indicate the information in the notification, the
the publication would harm competition for commercial
the secret ^ 7). The person referred to in the first sentence is required in the application, where appropriate, in
notification of demonstrably prove that marked her are her
trade secret.
(2) trade secrets cannot be under this law mark
and a general description) of the genetically modified organism or genetic
of the product,
(b)) the name or business name, registered office and identification number, if
granted, the person referred to in paragraph 1 is a legal person, or the name,
where appropriate, the name, last name, business name, business address and
identification number, if any, of the person referred to in paragraph 1, if the
a natural person authorised to business,
(c)) and the risk category instead of the contained use, the requirements for a closed
space and appropriate protective measures in risk category closed
waste management,
(d) the place and the purpose of marketing) into the environment or the purpose of putting into
circulation,
e) risk assessment,
(f) an emergency plan).
(3) the data designated as trade secrets have access only
and the administrative authorities) referred to in section 27,
(b)) the Czech Commission for the use of genetically modified organisms and
genetic products
(c)) of a legal person, which has concluded a contract under section 28 of the Ministry
paragraph. 1 (a). (f)),
(d)), the competent authorities of the Member States,
(e)).
(4) unless otherwise provided in this Act, shall be in
the collection, storage, disclosure and other processing of personal
data carried out in connection with the use of genetically modified
organisms and genetic products in accordance with a special law ^ 8).
§ 10
Informing the public
The Ministry shall ensure publication of the information under this Act,
and on the official notice board of the Ministry),
(b)) through the internet,
(c)), at least one other in an appropriate way in the municipality and region, on the
the territory immediately occurs to contained use or putting into
of the environment or of such waste with a view to all
in the circumstances it is expected.
§ 11
Labelling
(1) the person placing the genetically modified organism or genetic
product into circulation, as well as the person providing the genetically modified
the body solely for the purpose of the contained use or the putting into
the environment is required to ensure that the packaging of the genetically
the modified organism or gene product was visible
the site stated a clear designation of "genetically modified organism",
or "this product contains genetically modified organisms"
or "this product contains genetically modified organisms"; This
the designation must be indicated in the accompanying documents and in all stages of the
the process of processing the product. The Ministry, in a statement on the decision
the grant of authorisation to provide for additional labelling requirements.
(2) the person placing the genetically modified organism or genetic
product into circulation within your business is required to
ensure that the packaging or, if this is not possible, in the accompanying worksheet
the genetically modified organism or a gene product were
also given the following data
and the trade name of the product),
(b)) name of a genetically modified organism,
(c) the name, if applicable) name, last name, business name, business address and
identification number, if any, of the person registered for this
a genetically modified organism or a gene product in the list for
putting into circulation, if the natural person authorized to conduct business, or
the name or business name, registered office and identification number, if
granted, if the person is a legal,
(d) the conditions for and the purpose of the treatment) with a genetically modified organism, or
the genetic product referred to in the minutes to the list for putting into circulation,
(e) lessons learned about how to obtain) additional information content
registration in the list for the putting into circulation, under this Act,
(f)) for information on safety at work and the personal protective
the resources in those cases, when working with genetically modified
organisms or genetic products requires the means or measures
beyond the commonly used.
The Ministry may in the minutes to the list for the putting into circulation and
additional marking requirements. If marketed genetically
modified organism or gene product, for which it was issued
written consent or authorisation for putting into circulation by the competent authority
another Member State, the person is that it puts into circulation within their
business activities required to ensure that the labelling and packaging of
suit and the relevant requirements specified in the consent, or
the authorization.
(3) for the products for which you cannot rule out adventitious or technically
the inevitable ingredients of genetically modified organisms authorised for
putting into circulation referred to in section 23, paragraph. 2, the Ministry in accordance with the
the law of the European communities ^ 8a) implementing law
the threshold limit of occurrence of these additives. If the value of the occurrence of the
impurities in the product are lower than the threshold limit, this product has
need not be marked in accordance with paragraphs 1 and 2.
(4) the conditions for marketing and packaging and labelling requirements
the products, which lays down specific legal provisions, ^ 9) are not
without prejudice to the provisions.
§ 12
Change and cancellation of the authorisation and registration in the list for putting into circulation
(1) the Ministry may permit or valid entry in the List for marketing
to change or cancel the circulation, and it
and) if there is a material change in the conditions under which authorisation was granted
or the entry is made,
(b)) if it is proved that the information submitted by the person to whom the authorization was
granted, or a person registered in the list for the putting into circulation in the
the granting of authorisation, or entry in the list for the putting into circulation, or
of their change is incorrect, or
(c)) if there is a serious or repeated breach of the obligations
laid down in this law or laid down by him in person, which
the authorization was granted, where appropriate, by the person enrolled in the list for marketing
into circulation.
(2) the Ministry of the valid permit or registration in the list for entry into
circulation cancels, if the person entitled to on the basis of the closed
loading or placing into the environment, where appropriate, the person registered
in the list for the putting into circulation of requests.
(3) if necessary, the Ministry shall determine in the decision referred to in paragraph
1 or 2 at the same time the conditions for their use of genetically modified
organisms and genetic products, including their eventual disposal.
section 13
The demise of the permission to the use of genetically modified organisms and
genetic products
Permission to use of genetically modified organisms and
genetic products under this act ceases to exist
and the date of expiry) which has been granted a permit or an entry
in the list for putting into circulation,
(b)) the demise of the business, if the person is a natural person
authorized to do business,
(c) upon the death of the person) If a natural person authorised to
business, or its termination, if the person is a legal,
(d)) on the date of the decision on the revocation of the authorisation or cancellation of the registration in the
The list for the putting into circulation,
(e)) the expiry of the period for which it was issued the written consent or authorization to
putting into circulation by the competent authority of another Member State, or
the abolition of this consent or authorization.
§ 14
Expert Advisor
(1) the consultant pursuant to this Act may only be determined
unblemished and professionally capable natural person.
(2) For integrity, for the purpose of this Act, the person shall be deemed to
has not been sentenced for an offence committed through negligence,
the merits related to the handling of genetically modified
organisms and genetic products, or for an offence committed
intentionally. The Ministry's integrity in order to authenticate the requests referred to in
^ special legal regulation 9a) an extract from the criminal register.
Request for the release of the statement from the criminal register and the extract from the register
Criminal record shall be transmitted in electronic form, and the way
enabling remote access.
(3) the condition of professional competence referred to in paragraph 1 is higher
education gained in an accredited study programme ^ 10) area
medicine, veterinary medicine, biochemistry or microbiology for
use of genetically modified micro-organisms; natural sciences,
agriculture or forestry for the use of genetically modified
plants; or natural sciences, agriculture and veterinary
medicine for the use of genetically modified animals and at least
5 years of experience in the field, of which at least 2 years of work with genetically
genetically modified organisms. By the time the two-year practice
i counted the time of postgraduate or doctoral studies in the
relevant areas relating to the use of genetically modified
organisms.
PART THE THIRD
CLOSED LOADING AND PLACING INTO THE ENVIRONMENT
TITLE I OF THE
THE CONTAINED USE
§ 15
(1) as a result of the risk assessment in the case of contained use
the inclusion of this waste to one of the categories of risk referred to in
Annex No. 3 to this Act. If the risk assessment does not lead to
the clear inclusion of contained use in certain categories of risks,
This treatment must be assessed according to the requirements for the category of risk
higher.
(2) it's close to dispose only in such an enclosed space, which
meets the requirements for the conclusion of the protective measures provided for
the appropriate risk category or higher. Enclosed space requirements and
protective measures for each risk category, lays down the detailed
legal prescription.
(3) a person authorized under section 16 for contained use is required in the
during the check the enclosed area and protective measures regularly
According to the rules, as well as immediately after, when new
the information referred to in section 8, and the result of the checks carried out records.
section 16 of the
(1) Permission for contained use may give rise to legal
a person or a natural person authorised to do business.
(2) in the event that the result of the risk assessment pursuant to § 7 is the inclusion of
the contained use in a first category of risk, it may be the person referred to in
paragraph 1 start, if this treatment delivers the Ministry of
the notification. The notification for the first category of risk is served in paper
the form and at the same time on the technical data medium or by electronic mail and
contains the name or name, last name, business name, address,
place of residence, place of business and identification number, if assigned,
If Notifier is a natural person authorized to conduct business, or the name of the
or business name, registered office and identification number, if assigned,
If the notifier, and the name of the legal person, where appropriate, the name, surname
and the address of the place of residence of a vocational Adviser. Other essentials reporting
necessary for an assessment of the contained uses in terms of ensuring
protection of health and of the environment lays down detailed legal prescription.
(3) in the event that the result of the risk assessment pursuant to § 7 is the inclusion of
the contained use in a second category of risk and the person referred to in paragraph 1
delivers the notification to the Ministry about this treatment, treatment may start
After a period of 45 days from the delivery, if her Ministry in this period
to communicate that to the loading permit to the closed
loading. The treatment can be instituted with the consent of the Ministry even before
the expiry of the time limit. The announcement for the second category of risk is served in
the documentary form, and at the same time on a technical or an electronic data medium
mail and contains the elements referred to in paragraph 2, second sentence. For more
notification requirements needed for the assessment of the contained uses
to ensure protection of health and the environment provides for the
the implementing legislation.
(4) the Department is authorized to request from the notifier within 30
days from the receipt of the notification referred to in paragraph 2 or 3, for more information or
specification of the data referred to in the notice.
(5) the Ministry may, on the basis of a submitted notification, additional information
or clarifications of the data referred to in paragraph 4 or new information under section 8
Save the notifier to modify the conditions of management referred to in
the notification, if it is necessary from the point of view of the protection of health and the
environment. In this case, cannot be used in the treatment to continue before the
the Ministry will grant approval. The Ministry will grant consent as soon as
the conditions of loading adapted in accordance with its requirements. Appeal
against the decision, which was to make an adjustment to the notifier are saved
the conditions of the waste referred to in the notice, does not have suspensory effect.
(6) establishing permissions for contained use under paragraph 2 or 3
the Ministry will issue the request legitimate confirmation.
(7) the contained use of third or fourth risk category can be initiated
only on the basis of a permit for the contained use, and only to the extent and for the
the conditions laid down herein.
(8) in proceedings for the grant of authorisation for contained use,
According to § 5.
(9) permits for contained use contains
and, where applicable, names) the name, last name, business name, address of domicile,
place of business and identification number, if any, authorised,
If a natural person is entitled to the business, or the name or business
name, registered office and identification number, if any, authorised,
If the person is a legal,
(b)) the specification of the genetically modified organism,
c) specification of the genetic modification,
(d) waste management, taking into account the requirements of) the conditions for the protection of the health and
of the environment,
(e)), for which a risk category has been granted,
(f) the purpose of the loading)
(g)) any additional marking requirements (section 11 (1)),
(h) the period of validity of the permit).
(10) the validity of permits for contained use must be limited.
The Ministry may, on the basis of the request, no later than
60 days before the date of expiry of the permit, and after consultation with the
the ministries concerned to extend the period of validity of the permit. Authorized
a person may, on the basis of the applications submitted in accordance with the second sentence of the resume
contained use, in accordance with the conditions laid down in the authorization, up to
the issue of a decision on its extension. The decision, the Ministry shall send the
Government departments concerned and published in accordance with § 10.
(11) the authorisation for contained use is non-transferable to other persons.
TITLE II
ENTRY INTO THE ENVIRONMENT
§ 17
(1) the placing of genetically modified organisms into the environment
only a legal person or a natural person authorized to
a business that has been granted authorisation for placing into the
environment, and only to the extent and under the conditions provided for therein.
(2) a person referred to in paragraph 1 is required to ensure that no material
derived from a genetically modified organism, which
the environment has not been put into circulation, if it is not in the
accordance with the provisions of section 23.
section 18
(1) in proceedings for the grant of authorisation for putting into the environment,
in accordance with § 5, unless otherwise specified.
(2) the applicant is required to provide the Ministry or his designated
a legal person, to which the Ministry has concluded a cooperation agreement
in the exercise of its jurisdiction under section 28 paragraph. 1 (a). (f)), at the same time
application or at the latest within 10 days of the filing of a sample of
the genetically modified organisms for control purposes.
(3) if it is the same marketing into the environment of genetically
the GMO on different locations, or a combination of genetically
GMOs on the same site or on different sites for the
the same purpose, the applicant may submit a joint application.
(4) the Ministry within 30 days from the receipt of the request for the grant of authorisation for
entry into the environment will provide a summary of the content of the application under section
5 (3). 4 the Commission. The Ministry will provide on request to the competent authority
the Member State and the Commission a full copy of the application.
(5) in a decision on a request for the grant of authorisations for the placing on the
the Environment Ministry also will take into account the opinions of the
the competent authorities of the Member States, if they are submitted within 60 days from the
provide a summary of the content of the application to the Commission pursuant to paragraph 4.
(6) the authorisation for the placing into the environment contains
and, where applicable, names) the name, last name, business name, address of domicile,
place of business and identification number, if any, authorised,
If a natural person is entitled to the business, or the name or business
name, registered office and identification number, if any, authorised,
If the person is a legal,
(b)) the specification of the genetically modified organism,
c) specification of the genetic modification,
(d) waste management, taking into account the requirements of) the conditions for the protection of the health and
of the environment,
(e)) the purpose of the management,
(f)) any additional marking requirements (section 11 (1)),
(g)), the place where will be putting into the environment,
including a clear identification of the parcel,
(h) monitoring and) the requirements for the reporting of its results,
and the period of validity of the permit).
(7) the validity of the authorisation for placing into the environment must be
limited. The Ministry may, on the basis of the request of an authorized person,
submitted no later than 60 days before the date of expiry of the permit, and
after consultation with the concerned ministries of the period of validity of the permit
extended. The authorized person may, on the basis of a request submitted according to the sentence
the other continue putting into the environment, in accordance with the
the conditions laid down in the permit until the release of the decision of its
the extension. The decision, the Ministry shall send the affected ministries and
published in accordance with § 10.
(8) the authorisation for the placing into the environment is non-transferable on the
the other person.
(9) a person that has been granted authorisation for placing into the
environment, is required to ensure the implementation of the monitoring and reporting of
its results in accordance with the requirements laid down in the authorisation.
TITLE III
COMMON PROVISIONS FOR CONTAINED USE AND THE PLACING INTO THE
ENVIRONMENT
§ 19
The obligations of the persons authorized for contained use and the persons authorized to
entry into the environment
The person authorized under this Act to the contained use and the person
authorized under this Act to putting into the environment,
required to
and secure professional performance) checks on the management of genetically
modified organisms Professional Advisor does not satisfy the conditions for itself
under section 14,
(b)) lead the documentation about the use of genetically modified organisms
for each workplace and retain it for at least 10 years from the termination of the
This waste; the method and extent of the guidance documentation provides detailed
legislation,
(c)) to pass to the Ministry in paper and electronic form to 15.
February calendar year overview of genetically modified organisms,
data on the quantity and the type of treatment with them for the past
the calendar year,
(d) to send to the Ministry) within 60 days after their treatment with genetically
modified organisms the final report about the course and consequences of this
activities, in particular with regard to the risk to health and the environment
environment,
(e) ensure the implementation of the risk assessment) the handling of genetically
modified organisms referred to in section 7,
(f)) to ensure that the operational rules of the workplace, where it is treated with genetically
modified organisms, contain the particulars referred to in annex No 4
to this Act,
(g) ensure training of staff) before starting treatment with genetically
genetically modified organisms and their training at each change
working practices, but at least once a year, and employees
proven to be familiar with the operational regulations of the workplace,
(h)) to provide administrative authorities pursuant to section 28 and section 31 to 33 synergies when
the control of land, premises and equipment intended for the treatment of genetically
modified organisms or land, premises and equipment in which
This loading occurs or may occur, including the provision of
documents and not tolerating the samples for control purposes.
section 20
Emergency plan
(1) emergency plan is a document that describes the activities and measures
carried out in the formation of the accident (section 21), which lead to the mitigation or
the Elimination of its consequences for health and the environment for the use of
all available measures.
(2) to handle the emergency plan and submit it to the Ministry are required to
and as part of the application) the applicant for the grant of authorisation,
(b) the person submitting the notification under) § 16. 2 or 3 as part of the
This notice,
(c)), the person authorized under this Act or for contained use
entry into the environment every 5 years from the date of its
the last submission,
(d)), the person authorized under this Act or for contained use
entry into the environment when the facts change, which may have
a significant effect on the measures laid down in case of an accident, and within 30 days
the date of this change.
(3) the emergency plan are on the applicant and the persons referred to in paragraph 2 shall
submit before loading and, in the cases referred to in paragraph 2 (a).
(c)), and (d)) also to the relevant municipalities in whose territory the waste
genetically modified organisms takes place, to the competent territorial
the most well-liked Relief Corps region, the regional office and, on request, and
persons who may be directly affected by the accident. For the municipality in accordance with
space management for the purposes of this paragraph shall not be considered a municipality, through the
whose territory the only takes place continuous transport of genetically
the modified organism.
(4) the emergency plan contains the name or name, last name, business
the company, the address of the place of residence, place of business, the identification number, if
granted, the telephone number and fax number, and, where appropriate, the address of the
e-mail of the person referred to in paragraph 2, if a person physical or
the name or business name, registered office and identification number, if
granted, as well as the phone number, and fax number and, where appropriate, the address of the
the statutory body of the e-mail, if a person is legal.
The emergency plan also contains the name or name, last name, address,
of residence, telephone number and fax number, and, where appropriate, the address of the
e-mail vocational Advisor and persons responsible for disposal
crash. Other essentials emergency plan lays down detailed legal
prescription.
(5) information on the plan, the Ministry shall publish pursuant to section 10 (a).
(b)), and (c)). The scope of these information, the detailed legal prescription.
(6) the Ministry shall provide information about the plan to the competent
authority of the Member State which could be affected by the accident.
section 21
Measures of the accident
(1) the Accident for the purposes of this Act, means any event when
contained use or putting into the environment, in which
an accidental leak of genetically modified organisms, or
that such leakage is imminent, if it can cause
immediate or consequential risk to health or the environment.
(2) in the event of an accident is the person entitled to the contained use or the
entry into the environment shall immediately thereafter, when it
learns to perform in accordance with the emergency plan measures to eliminate or
alleviate its harmful consequences.
(3) the person referred to in paragraph 2 is further required to every crash
immediately notify by telephone and in writing or by electronic mail
the Ministry stating the
and) type and quantity of the genetically modified organism, which
crash covers,
(b) the circumstances of the accident,)
(c)) of the place where the accident occurred,
(d) the potential consequences of an accident), in particular, of the risks to health and the
environment,
e) of the measures adopted and the next steps towards the elimination or
mitigate the effects of the accident.
(4) the Resulting crash is a person referred to in paragraph 2 shall immediately
notify other administrative authorities also referred to in section 27, in their
jurisdiction.
(5) the Ministry is obliged to immediately after, when on the origin of the crash
learned,
and inform the administrative authorities) referred to in section 27,
(b) to publish the information about the crash) in the manner referred to in section 10 (b). (b)), and (c)),
(c) the competent authority of the Member) to warn the State that could be an accident
hit,
(d) notify the Commission, resulting from the crash); part of the information referred to in the notice are
of paragraph 3.
(6) Ministry is also required to handle the analysis resulting from the crash,
including the findings of its causes and determining the recommendations aimed at
limitations of accidents and their prevention in the future.
(7) an analysis of the accident referred to in paragraph 6, the Ministry shall provide to the Commission.
section 22
Register of authorised genetically modified organisms and the registry
users
(1) the Ministry maintain a register of genetically modified organisms, for
that permit was granted (hereinafter referred to as the "register of authorised genetically
modified organisms ").
(2) the register of authorised genetically modified organisms with leads
separately for contained use and for placing in the environment.
(3) The register of authorised genetically modified organisms
the information contained in the written authorization referred to in section 16. 9 and § 18 paragraph. 6 with
the exception data, which shall be regarded as confidential (§ 9).
(4) the Department also keeps a register of persons to whom a permit has been granted
under this Act, or who was the permission to the closed
the management on the basis of a notification under section 16. 2 or 3 (hereinafter referred to as
"register user").
(5) the user in the registry is written to the
and, where applicable, names) the name, last name, business name, business address and
the identification number, if assigned, the persons entitled to the closed
loading or placing into the environment, is a natural person
authorized to do business, or its name or business name, registered office and
the identification number, if assigned, if the person is a legal,
b) genetically modified organisms, for which the authorisation to the user
granted, where appropriate, the type of organisms referred to in the notice,
(c)) date of permission for contained use or putting into
the environment, and this permission on the basis of the authorisation,
the period of validity of the authorisation.
(6) If a person referred to in paragraph 5 in the case of contained use
entitled to dispose of the genetically modified organisms on the basis of the
the notice under section 16(1). 2 or 3, entered in the register of users
also the purpose of the waste and the risk category.
(7) the Ministry is required to enter the particulars referred to in paragraphs 3, 5 and 6 to
a register of authorised genetically modified organisms and the registry
the users not later than within 15 days from the date of the decision of the
the granting of authorisation, or amendment, as appropriate, from the date of inception of the permission to
contained use, on the basis of the notification under section 16. 2 or 3.
(8) the Ministry is obliged to indicate in the register of authorised genetically
GMOs and the registry users permission (section sunset date
13) not later than 15 days from the date of the decision on the abolition of
authorization or from the day when the powers that permission.
(9) the data entered in the register of authorised genetically modified
organisms and the registry, users are kept and are accessible to the public
at least for a period of 5 years from the date of dissolution of the permissions.
(10) the register of authorised genetically modified organisms and the registry
users shall be published pursuant to section 10 (a). (b)).
PART THE FOURTH
PUTTING INTO CIRCULATION
section 23
(1) cancelled
(2) the genetically modified organism or a gene product can be
placing into circulation only if it has been entered in the List for entry into
circulation, or if he was to put into circulation has given consent or authorization
the competent authority of the Member State and complies with the requirements of
regulations of the European communities.
(3) every person who grows genetically modified organisms authorised for the
putting into circulation referred to in paragraph 2, is required to provide the Ministry of
written information about the location of their cultivation, and no later than 60 days
from the start of their cultivation, in the event that it has not made in accordance with
other legislation ^ 20). The Ministry of type exposes the growing space
genetically modified organisms pursuant to section 10 (a). (b)).
(4) a person registered in the list for the putting into circulation is required to ensure
the implementation of the monitoring and reporting of its results in accordance with the
the requirements laid down in writing. The Ministry is entitled to on the basis of the
These messages after the first monitoring period the requirements on monitoring
specify. The results of the monitoring of the Department available to the public
under section 10 (a). (b)).
(5) reports on the results of the monitoring referred to in paragraph 4 passes
the Department of the Commission and the competent authorities of the Member States.
section 24
(1) in proceedings for the registration to the list for the putting into circulation of the
According to § 5, unless otherwise specified. The application for registration may be made by
the only legal person or natural person authorised to do business.
(2) If, on the basis of the results of the previous entry into the
environment or on the basis of relevant scientific knowledge, the applicant
considers that the putting into circulation and use of genetically modified
the organism or gene product poses no risk for
health and the environment, the Ministry before the application
propose that certain data are not required. The Ministry in such
the case shall inform the applicant of its opinion, after consultation with the relevant
ministries, within 30 days after receipt of the proposal. The procedure laid down in this
paragraph shall not apply the administrative code.
(3) the applicant shall provide the Ministry or entity with which
the Ministry has concluded a cooperation agreement in the exercise of its competence
According to § 28 paragraph. 1 (a). (f)), at the same time with the application or at the latest within 10
days of the filing of a sample of the genetically modified organism, or
the genetic product for control purposes.
(4) the Ministry without undue delay after receipt of the request, the
a summary of the content of the application, pursuant to section 5 (3). 4 the Commission and the competent authorities of the
of the Member States. A copy of the full application, the Ministry shall provide the Commission
no later than simultaneously with the evaluation report referred to in paragraph 5.
(5) taking into account the opinions of the ministries concerned shall draw up
Ministry within 90 days from the date of receipt of the application and the assessment report
send it to the applicant within that period and concerned ministries. In the period of 90
days not hours, after which the Ministry is waiting for information from the
the applicant under section 5 (3). 3 or 5. Ministry of an evaluation report
publish in the manner referred to in section 10 (b). (b)). The assessment report shall be
stated that the
and) the genetically modified organism or gene product should be
put into circulation and under what conditions, or
(b)) the genetically modified organism or gene product should not
be put into circulation.
(6) in the case referred to in paragraph 5 (a). the Ministry will send an evaluation)
report within 90 days of receipt of the request, whether or not the Commission. In the case referred to in
paragraph 5 (a). (b) the Ministry shall forward the evaluation report) to the Commission
no later than 105 days after receipt of the request. For the calculation of time limits
It shall apply the provisions of paragraph 5, second sentence.
(7) If the Commission or the competent authority of the Member State within a period of 90
days from the date on which the Commission sent to the assessment report referred to in paragraph 5
(a). and requests for more information), or submit comments or
the reasoned objections to the marketing of genetically modified
the organism or gene product into circulation, Ministry of such
information and comments or reservations with the Commission or the competent
authority of the Member State shall consult within 45 days from the expiry of that period.
(8) the Department is authorized to request, on the basis of the request, comments
or the reservations submitted pursuant to paragraph 7 the applicant for more information.
In this case, the period for which it is waiting for a response from the applicant,
not counted in the period 45 days referred to in paragraph 7.
(9) If, in the case referred to in paragraph 5 (a). the Commission does not submit)
the Ministry in the period of 90 days referred to in paragraph 7 is no reasoned
comments or reservations, or if it was reached within 45
days referred to in paragraph 7, the Ministry shall decide on the implementation of the registration to the
List for circulation. The Ministry about this decision within 30 days
Since its release, inform the Commission and the competent authorities of the Member States.
(10) If there was no consensus within 45 days pursuant to paragraph 7,
the result of the Ministry in accordance with the procedure laid down for such cases
the law of the European communities, within 30 days from the notification of the results of the
Decides to write to the list for putting into circulation or the
rejection of the application of this decision and shall inform the Commission and the competent
the authorities of the Member States. 45 days to the deadline referred to in the first sentence is not counted
the period for which it is waiting for a response from the applicant in accordance with paragraph 8.
(11) If the Ministry decides to perform the write to the list, for
putting into circulation, performs this registration not later than 15 days from the date of
the decision.
(12) in the case referred to in paragraph 5 (a). (b) the Ministry shall decide by 15)
days after sending the assessment report referred to in paragraph 6 about the rejection of the application.
(13) the list for the putting into circulation contains
and, where applicable, names) the name, last name, business name, address of domicile,
place of business and identification number, if any, of the person who
filed an application for registration, a natural person is entitled to the business,
or the name or business name, registered office and identification number, if
granted, the person who filed the application for registration, if the person is a legal,
(b)) the specification of the genetically modified organism or genetic
of the product,
c) specification of the genetic modification,
(d) the results of the risk assessment)
(e) the conditions for and the purpose of the placing) genetically modified organism, or
the genetic product into circulation, including any specific conditions
the use, handling and packaging, and the conditions for protection of certain
ecosystems, environments or geographical areas,
(f)) any additional marking requirements (section 11 (2)),
(g)) the way the laboratory checks the presence of the genetic modification, including
description of the changed deoxyribonucleic acid or ribonukleové
enabling unique identification of genetically modified
the organism, and, where appropriate, in accordance with international rules,
(h) provision of control samples) conditions of the competent administrative authority,
I) requirements for the monitoring and reporting of the results,
(j) the period of validity of the registration).
(14) the validity of the registration into the list for the putting into circulation may be
fixed a maximum of 10 years from the implementation of the registration. The validity of the registration cannot be
extended.
(15) in the case of a genetically modified organism, in which it is assumed
trading only with his seed according to the relevant laws and regulations
Of the European communities, expire the registration referred to in paragraph 14 of the
no later than the expiry of 10 years from the date of first registration of the first plant
varieties containing genetically modified organism into the list of varieties
the plant, in accordance with the relevant legislation of the European
the community. In the case of forest reproductive material shall expire
the registration referred to in paragraph 14 on the expiry of 10 years from the date of the deposit of the basic
material containing the GMO on an official
National Register of the basic material in accordance with the relevant
legal regulation of the European communities.
(16) the list for the putting into circulation in a manner referred to in section 10 of the published
(a). (b)).
(17) the elements of the assessment report referred to in paragraph 5 lays down the detailed
legal prescription.
PART THE FIFTH
THE IMPORT, EXPORT AND TRANSIT OF GENETICALLY MODIFIED ORGANISMS AND GENETIC
PRODUCTS
§ 25
Import and export of genetically modified organisms and genetic products
(1) cancelled
(2) the import or export of ^ 12) can only be genetically modified organisms
or genetic products entered into the list for the putting into circulation, or
for which consent has been granted, or the authorisation for putting into circulation
the competent authority of the Member State.
(3) a person entitled to the contained use (§ 16) is entitled to import
or export of genetically modified organisms, to which this
permissions if they are intended exclusively for contained use.
(4) a person that has been granted authorisation for placing into the
environment (section 18), is authorized to import or export a genetically
modified organisms to which the permit applies if you are
intended exclusively for marketing into the environment.
(5) a person who intends to import or export the genetically modified
organisms referred to in paragraph 3 or 4, is required to the Ministry not later than 5
days prior to import or export, provide information about the nature and
the quantity of genetically modified organisms, which are imported or
exported, and about the presumed place of entry or exit to or from
the territory of the Czech Republic.
(6) the importer or exporter of genetically modified organism, or
the genetic product is obliged to inform immediately the competent Customs Office, in
the case of food and raw material for food purposes and State agricultural
and food inspection, in the case of plant protection products and
Central control and testing Institute of agriculture (hereinafter referred to as "the Institute") and in
the case of medicinal products for human use and the State Institute for drug control, and in the
the case of veterinary drugs and the Institute for State control of veterinary
Biologicals and medicaments for the arrival of such goods to the point of entry,
allow the implementation of control and provide the authorities carrying out the check
the necessary synergies.
(7) the importer or exporter of genetically modified organism, or
the genetic product is required to submit to the Office of the movement
the documentation, which includes
a) specification of the genetically modified organism or genetic
of the product,
(b) information on the quantities transported),
(c) the name, if applicable), name, last name, business name, business address and
identification number, if any, of the importer or exporter, if the
a natural person authorized to conduct business, or the name or business name
and the identification number, if any, of the importer or exporter, if the
a legal person,
(d) the name, if applicable), name, last name, business name, business address and
identification number, if any, of the carrier, as well as persons
responsible for carriage a consignment, if a natural person authorised to
business, or the name or trade name and identification number,
If it was allocated, the carrier, as well as the person responsible for the carriage
the consignment, if a person is legal.
(8) in the case of imports or exports of genetically modified organism
or genetic product intended exclusively for contained use or
entry into the environment is the importer or exporter shall also
submit to the Office of
and a certified copy of the authorization) for contained use, or permit to
putting into the environment, where appropriate, the certificate referred to in section 16. 6,
(b)) a copy of the emergency plan.
(9) persons who import, export or provážejí genetically
genetically modified organisms or genetic products, are required to the applicable
the facts referred to in paragraphs 1 to 8 to declare to the Customs authorities in
the submission of the customs declaration.
(10) after the implementation of the control of the Customs Office
and imported or exported) have released genetically modified organism
or genetic product into the proposed customs procedure are met.
the conditions for the release of goods laid down by this law and by a special
laws, regulations, or
(b) imported or exported) releases the genetically modified organism
or genetic product into the proposed customs procedure after previous
the Ministry of information and the Czech environmental inspection and
any consultation with them, the conditions are not fulfilled for the release
goods provided for by this law and by a special legislation.
(11) Imported or exported a genetically modified organism, or
the genetic product cannot be released into the proposed customs procedure
If
and is not fulfilled any of) the requirements laid down in paragraphs 1 to 6,
(b)) the consignment containing the genetically modified organism or genetic
the product is not accompanied by the accompanying documents referred to in paragraphs 7 and 8,
(c)) the accompanying documents referred to in paragraphs 7 and 8 is incomplete, or
(d)) are grounds for reasonable doubts about the origin or identity of the genetically
the modified organism or gene product.
section 26
The transit of genetically modified organisms and genetic products
(1) the transit of ^ 12) genetically modified organisms or genetic
products through the territory of the Czech Republic from the point of entry to the place of the output is
can only take place in means of transport, secure against
the accidental escape of genetically modified organisms or genetic
products into the environment or their loss or theft with
regard to possible risks to health and the environment.
(2) the genetically modified organism or a gene product may not be
the Customs transit regime, if there is no requirement under the
of paragraph 1.
PART SIX
THE PERFORMANCE OF STATE ADMINISTRATION
section 27 of the
The administrative authorities on the use of genetically modified organisms
and genetic products
The administrative authorities on the use of genetically modified
organisms and genetic products are under this Act
and Ministry)
(b)), the Ministry of health,
(c)), the Ministry of agriculture,
(d)) the Czech environmental inspection (hereinafter referred to as "the inspection"),
(e)), the Customs authorities,
f) veterinary authorities,
(g)),
h) State Institute for drug control,
I) Institute for State control of veterinary Biologicals and medicaments,
(j)) of the State agricultural and food inspection,
k) public health authorities.
§ 27a
(1) the Ministry of the Interior or the police of the Czech Republic provides administrative
authorities on the use of genetically modified organisms and
genetic products
and data from Basic) reference population register,
(b)) the data from the agendového information system of the population register,
(c)) the data from the agendového information system for foreigners.
(2) Information Provided pursuant to paragraph 1 (b). and) are
and, where applicable, names) the name, surname,
(b)) of the date, place and County of birth; for the data subject, who was born in
abroad, the date, the place and the State where he was born,
(c)) date and place of death; in the case of the death of the data subject outside the territory of the Czech
Republic, the date of death, place and the State on whose territory the death occurred;
If the decision of the Court on the declarations for the dead, the day which is in
decision given as the day of death or the day that the data subject
declared dead survived, and the date of the entry into force of this
the decision,
(d) the address of the place of stay)
e) citizenship, or more of State citizenship.
(3) Provided the information referred to in paragraph 1 (b). (b))
and, where applicable, names) the name, surname, maiden name,
(b)) of the date, place and County of birth; for the data subject, who was born in
abroad, the date, the place and the State where he was born,
(c) the social security number),
(d) the address of the place of residence),
e) citizenship, or more of State citizenship.
(4) the information Provided under paragraph 1 (b). (c))
and, where applicable, names) the name, surname, maiden name,
(b)) of the date, place and County of birth; for the data subject, who was born in
abroad, the date, the place and the State where he was born,
(c)), or more citizenship nationality,
(d)) kind of place of residence and address,
(e)) the beginning of the stay, where appropriate, the date of their stay.
(5) data that are kept as reference in the principal registry
the population recovered from the agendového information system registration
of the population or agendového information system for foreigners only if they are
in the shape of the previous status quo.
(6) the data provided can be used in a particular case only
such information, which are necessary to fulfil that task.
section 28
The Ministry of
(1) the Ministry of
and is the central administrative authority) in the area of environmental impact assessment of genetically
modified organisms and genetic products on environmental
environment and biodiversity,
(b)) performs State supervision in the area of the upper management of genetically
genetically modified organisms and genetic products in terms of the protection
of the environment and biological diversity,
(c) establishes the Czech Commission for the) use of genetically modified
organisms and genetic products as its advisory body,
(d)) performs the function of the administrative authority for the international exchange of information in
the field of genetically modified organisms and genetic products
e) shall decide on the appeal against the decision issued by the inspection,
(f)) concluded cooperation agreements in the exercise of its powers relating to
the laboratory determination of the presence of genetically modified organisms
with the laboratories, which have introduced the quality system according to ČSN EN ISO/IEC
posouzený 17025, accrediting by the person who under the Special
legislation, ^ 13)
(g)) leads the list for putting into circulation,
h) carries out the scope of the focal point and the competent administrative authority
According to the directly applicable European Community regulation on the
the cross-border movement of genetically modified organisms ^ 13a).
(2) the Chairman and members of the Czech Commission for the handling of genetically
genetically modified organisms and genetic products called with their
the agreement and dismissed by the Minister of the environment after consultation with the
the Ministers of health and Agriculture of the experts nominated by the administrative
the authorities referred to in section 27, the Academy of Sciences of the Czech Republic, universities
and specialised research institutes. The Czech Commission for the management of
genetically modified organisms and genetic products in the performance
their activities governed by the rules of procedure, issued by the Ministry.
section 29
The Ministry of health
The Ministry of health
and evaluation procedures to the Ministry) suggests health risks for
a man associated with the handling of genetically modified organisms and
genetic products
(b)) is expressed in terms of its scope of applications under section 5.
section 30
The Ministry of agriculture
The Ministry of agriculture
and evaluation procedures to the Ministry) suggests the risks associated with the management
genetically modified organisms and genetic products in terms of
Agriculture,
(b)) is expressed in terms of its scope of applications under section 5.
section 31
Inspection
(1) Inspection
and) controls alone or in cooperation with the administrative authorities of the
referred to in section 27 of the protection of the environment, as they are
legal persons and natural persons in compliance with the provisions of
the rules and conditions laid down in the decisions of the Ministry, which is
involve the use of genetically modified organisms or genetic
products,
(b) legal persons) stores and individuals corrective measures (section 34)
and fines for violation of the obligations under this Act (section 35).
(2) Inspectors shall exercise control activities demonstrate card
the inspection, which is at the same time proof of their credentials for review.
§ 32
The Customs authorities of the
The Customs authorities of the
and check whether the imported), balanced or transiting consignments
When layoffs are in the customs regime declared as genetically
genetically modified organisms or genetic products are equipped with
relevant documents referred to in section 25 and the specific legislation or
the international conventions for the transport, export, import and transit,
(b) in the case of goods) shall ensure the detection of infringements of this law or in the
the case of a suspected violation of this Act, and shall immediately inform the
the Ministry, inspection, in the case of plant protection products and the State
plant protection management and in the case of foodstuffs and raw materials for the
Food and the State agricultural and food inspection;
before decide according to § 25 paragraph. 10, the Customs authorities may request the
Ministry or the inspection, in the case of plant protection products and
The Institute and, in the case of food and raw material for food purposes and State
agricultural and food inspection for technical assistance,
(c)) shall keep a register of all imported, exported and provážených shipments
genetically modified organisms and genetic products, including
shipments released across national boundaries. This registration will allow
the Ministry of personnel, inspection, in the case of products for the protection of
plants and the Institute and, in the case of food and raw material for food purposes
and personnel of the State agricultural and food inspection,
take from her statements, copies, copy, including, where appropriate, allow the
remote data transmission through the General Directorate of customs.
section 33
Other administrative authorities
(1) the veterinary authorities, State agriculture and food
inspection, the Institute, the State Institute for drug control, and the Department of State
control of veterinary Biologicals and medicaments
and professional control over) the management of genetically
genetically modified organisms and genetic products, inspection and testing
genetically modified organisms and genetic products in the framework of its
the scope of and in accordance with the specific legislation, ^ 14)
(b) in the case of finding an infringement) of this law shall be submitted to the inspection initiative
the initiation of administrative proceedings and inform the Ministry.
(2) the officials of the administrative authorities referred to in paragraph 1 shall be
the performance of the control activities of the competent administrative card show
the authority, which is at the same time proof of their credentials for review.
(3) supervision of the protection of the health of workers in workplaces, on which
treated with genetically modified organisms and genetic products
carried out by public health authorities, governing specific legal
legislation. ^ 15)
(4) State administration, compliance with the prohibition of bacteriological and Toxin
weapons under a special legal regulation 16) ^ ^ National Office
for nuclear safety.
PART SEVEN
CORRECTIVE MEASURES AND PENALTIES
§ 34
Measures to remedy the
(1) if the inspection finds that there has been or there is the handling of genetically
genetically modified organisms and genetic products in violation of this
law or in conflict with the decisions issued by him, the more
handling according to the seriousness of the breach of the obligation, to suspend or even
Disable. The appeal against the decision referred to in the first sentence does not have suspensory
effect.
(2) if appropriate, the inspection may be a person who disposes of or handling
genetically modified organisms or genetic products in
contrary to this Act or in contravention of decisions by
issued, save the obligation to undertake in due time on their
the costs of reasonable measures to remedy the situation. If this person will remain idle,
carry out corrective measures inspections on its costs.
(3) If a person referred to in paragraph 2 of the known or available and is threatened with injury
to human health or to the environment, the inspection measures to
the remedy itself.
(4) the inspection authority may for the implementation of measures to remedy the decision to save the
duty and other legal person or natural person authorised to
the business, which is to implement the measures to rectify the professionally and technically
eligible. A participant in the proceeding in this case is just such a person. The person
According to the first sentence has the implementation of the corrective measures shall be entitled to reasonable
financial compensation.
(5) the owner of the property may in connection with the inspection measures referred to in
paragraph 2, save the obligation to tolerate the extent and after the necessary
for its normal use. Compensation for any damage by
incurred shall be borne by the owner, as a result of the unlawful activity was
corrective measures imposed. If this is not the person identified by the damage
State. If this person is detected Additionally, and the State has already paid the damage,
against the person entitled to damages.
(6) Inspection of the decision referred to in paragraph 1, where appropriate, imposing a
measures to remedy shall promptly inform the Ministry.
(7) the Ministry shall immediately thereafter, when powers of the management with
genetically modified organisms or genetic products without
permission, shall inform the Commission, the competent authorities of the
the Member States and the public under section 10 (a). (b)), and (c)).
section 35
The fine
(1) a fine of up to CZK 50,000 can save the inspection, who
and does the risk assessment) for at least 10 years from its
the submission and on-demand does not provide it or the administrative authorities referred to
in section 27, even though to do so under section 7. 5 shall,
(b)), as the person entitled to fail to provide under this Act to the closed
loading or person authorized under this Act to the putting into
of the environment, to make the rules of operation of the workplace, which is treated with
genetically modified organisms, contained all the elements
listed in annex 4 to this Act [section 19 (b), (f))],
(c)), as the person entitled to fail to provide under this Act to the closed
loading or placing in the environmental training of employees
before starting the use of genetically modified organisms, or
their training at each change of working procedures, at least
Once a year, or ascertains the employee with a proven
regulations of the workplace [section 19 (b), (g))].
(2) a fine of up to $ 500 can save the inspection, who
and does not follow the treatment) of the genetically modified organism, or
genetic conditions marked on the product packaging or accompanying document
or treated for other purpose than stated (§ 3 (4)),
(b) does not submit a new Ministry) risk assessment containing elements
under this Act, not later than 5 years from the date of the submission of the last
Guest, even though it is under section 7 (2). 3 (b). (d)) shall,
(c)) is going as a person entitled under this law to the closed
loading or placing in the environmental performance of the expert inspection
over the handling of genetically modified organisms, consultant,
does not satisfy the conditions laid down in article 14 itself [§ 19)],
(d)) shall, as a person entitled under this law to the closed
waste or putting into the environment, forged in the
the documentation referred to in section 19 (a). (b)) or in the final report referred to in section 19
(a). (d)),
(e)) will not pass as a person entitled under this law to the closed
loading or placing into the Environment Ministry Overview
genetically modified organisms, information on the quantity or
the method of dealing with them for the past calendar year [section 19 (b), (c))],
(f)) has not sent to the Ministry as a person entitled under this law to
contained use or putting into the environment, the final
a report on the progress and implications of this activity [section 19 (b), (d))],
(g) does not process or does not submit to the Ministry) emergency plan that includes
under this law, though it is referred to in section 20 (2). 2 (a).
(c)) shall,
h) grown genetically modified organisms approved for entry into
circulation and the Ministry does not provide timely written information about their place of
cultivation, though is referred to in section 23, paragraph. 3 shall,
I) fails to comply with the conditions for the export, import or other cross-border movement of
genetically modified organisms provided for section 25 and the competent directly
the applicable law of the European communities ^ 16a).
(3) a fine of up to Czk 1 0000 0000 inspections can save it, who
and the new Ministry) do not submit risk assessment containing elements
under this law, though it is under section 8 (2). 2 obligation to him
It was pursuant to section 8 (2). 3 stores
(b)) as the person authorized does not check under this Act to
contained use enclosed area and protective measures in accordance with the
the requirements of section 15(2). 3 or does not lead on the examinations, records
(c)), as the person entitled to fail to provide under this Act to the putting into
of the environment, to ensure that no material derived from GMOs
modified organism, which gives to the environment, was not
put into circulation when it is not in accordance with the provisions of section 23 (section 17
paragraph. 2) d) does not, as a person entitled under this law to
contained use or person authorized under this Act to the placing
to environmental documentation on the management of genetically
modified organisms pursuant to section 19 (a). (b)) or it does for
at least 10 years from the end of the treatment,
(e)) when you change the facts which may have a significant effect on the measures
provided for the case of an accident, or fails to submit to the Ministry does not
emergency plan for containing the requirements under this Act, although it is
under section 20 (2). 2 (a). (d)) shall,
(f)) does not, as a person included in the list for putting into circulation
monitoring or does not pull reports on its results in accordance with the requirements
set out in writing to the list for the putting into circulation (article 23, paragraph 4)
or fails to comply with the conditions for putting into circulation or the conditions for granting
samples provided in the minutes to the list for putting into circulation,
(g)) does not ensure that the genetically modified organism or genetic
the product is labelled in accordance with the requirements of § 11 (1). 1 and 2, and the competent
directly applicable European Community regulation ^ 16b),
(h) fails to comply with the requirements for backward) traceability and labelling of products
consisting of or containing genetically modified organisms
genetically modified organisms, as laid down in the regulation directly applicable
Of the European communities ^ 16 c),
I) gets as person entitled under this law to the closed
loading or placing into the environment or as a person registered
in the list for the putting into circulation of new information concerning the risks
the genetically modified organism or a gene product for health
or the environment, and the Ministry does not, or does not accept the
measures necessary to protect health and the environment (section 8, paragraph 1),
(j)) does not provide the administrative authorities pursuant to section 28 and section 31 to 33 as a person
authorized pursuant to this Act for contained use or for entry into
environmental cooperation in the control of land, premises and
equipment intended for the use of genetically modified organisms, or
of land, premises and equipment in which this treatment occurs, or
You may experience [§ 19 h)],
to fail as a person authorized) under this Act to the closed
loading loading conditions laid down in the authorisation for the closed
waste management,
l) locks as a person entitled under this law to the putting into
environment the implementation of monitoring and reporting on its
the results in accordance with the requirements laid down in the authorisation for the placing on the
the environment or fails to comply with the conditions set out in the management
the authorisation for putting into the environment,
m) does not, as a person entitled under this law to the closed
loading or placing into the environment in the event of an accident
immediately after it learns, measures to eliminate or mitigate the
its harmful consequences (section 21 (2)),
n) notifies the person entitled under this law to the closed
loading or placing into the environment without delay resulting from the
the crash of the Ministry (article 21 (3)).
(4) a fine in the amount of up to Eur 1 500 0000 inspections can save legal person
or a natural person authorized under this Act to the closed
the waste that's close in space, which does not meet the requirements of the
on the conclusion of the protective measures laid down for the category
risk (section 15 (2)).
(5) a fine in the amount of up to 5 0000 0000 Czk inspection may save whomsoever
treated with genetically modified organisms or genetic products
without appropriate permission or without exiting the management in accordance with the
the conditions laid down in the decision referred to in section 12, paragraph. 3.
(6) when considering whether and to what extent will the fine imposed, the inspection
account shall be taken in particular of the seriousness of the breach of the obligation, the duration of the
the infringement and to the harmful effects of the infringement,
incurred or threatened.
(7) if at the time of 1 year from the date of the entry into force of the decision on
the imposition of fines for infringement of the same obligations again, which was
the fine imposed by the decision, or if within the time limit laid down by the inspection
done specified measures to remedy, the upper limit of the fines according to the rates
paragraphs 1 to 5 shall be increased to double the amount.
(8) the procedure for the imposition of fines can be initiated within 5 years from the date when the
breach of an obligation has occurred. A fine can be imposed not later than 6 years after the date
the date on which the infringement occurred.
(9) the financial penalty is payable within 30 days from the date of the entry into force of the decision,
in which it was stored.
(10) the Fines collected by the inspection. The fine is the income of the State Fund of the
the environment of the Czech Republic.
(11) the inspection keeps records of persons who have been referred to in paragraphs 1 to 5
fined. The record of the imposition of a fine, from the evidence clears after
the expiry of 1 year from the date when the decision on the imposition of fines has acquired the
to be able to, if the fine has been paid.
(12) a register of the persons referred to in paragraph 11 cannot be used for purposes other than
It is the assessment of liability referred to in paragraph 6, or for the recovery of stored
the fines.
section 36
Relationship to the administrative regulations
Unless otherwise provided in this Act, applies to decisions
under this Act, the administrative procedure code.
PART EIGHT
TRANSITIONAL AND FINAL PROVISIONS
§ 37
(1) the decision on registration in the user list, the list for closed
loading List for putting into the environment, and the list for the
putting into circulation, issued pursuant to Act No. 153/2000 Coll., on the management of
genetically modified organisms and products, and change some
related laws, shall cease to have effect not later than 17 May. October
2006.
(2) after 31 December 2006. December 2004 shall not be placed in circulation a genetically
modified organisms containing genes introduced by genetic modification
contingent upon the numbness on the antibiotics used to treat infections of the people
or animals.
(3) after 31 December 2006. December 2008 shall not be placed in the environment
genetically modified organisms containing the genetic modification
the transferred genes contingent upon the numbness on the antibiotics used to treat
infections of people or animals.
(4) the proceedings initiated before the entry into force of this law shall be completed
According to the existing legislation. ^ 18)
(5) when saving increased fines, fines imposed by the existing
^ law 18) shall be considered as a fine imposed under this Act.
section 38
The Ministry, in agreement with the ministries concerned, shall lay down the implementing
legal regulation
and the requirements of the request for grant) the authorisation and the requirements for an application for the registration of
in the list for putting into circulation (article 5 (1)),
(b) a summary of the content of the application) the formalities (article 5 (4)),
(c) the requirements and procedures) risk assessment (section 7 (7)),
(d) the threshold limit of occurrence of admixture) (section 11 (3)),
e) enclosed space requirements and protective measures in the case of
contained use (section 15 (2)),
(f) requirements for notification) the contained use of first and second category
risk (section 16 (2) and (3)),
(g) the manner and scope of leadership) documentation (section 19 (b)),
h) Essentials emergency plan (section 20 (4)) and the scope of the Ministry of
the information published on the plan (section 20 (5)),
I) particulars of the assessment report (section 24, paragraph 17),
j) requirements of proof of a reasoned order.
section 39
No act is repealed. 153/2000 Coll., on the management of genetically
genetically modified organisms and products and amending some related
laws.
section 40
The effectiveness of the
(1) this law shall enter into force on the date of its publication, with the exception of the
the provisions of § 8 paragraph. 4 to 7 of section 9 (2). 3 (b). (d)), and (e)), section 18, paragraph. 4 and
5, section 20 (2). 6, § 21. 5 (a). (c)), and (d)), § 21. 7, section 23, paragraph. 2
and (5), section 24, paragraph. 4 to 10, section 24, paragraph. 12, 15 and 17, § 25 paragraph. 2 and section 34
paragraph. 7, which shall take effect on the date of the accession treaty
The Czech Republic to the European Union.
(2) the entry into force of the Treaty of accession of the Czech Republic to the European Union in
the validity of the void provisions § 23 paragraph. 1 and § 25 paragraph. 1.
(3) the provisions of § 24 of the paragraph. 18 expires on 18. April 2007.
Zaorálek in r.
Klaus r.
Spidla in r.
Annex 1
The technical procedures that may arise genetically modified
the organism, and the technical procedures for the creation of a genetically
GMO do not
1. the genetically modified organisms can arise when using
and recombinant nucleic acid techniques) that creates a new combination
hereditary material by the insertion of a stretch of nucleic acids prepared
in any way out of the body into any virus, bacterial
plasmid or other vector system and its subsequent incorporation into the
of the recipient organism, in which it normally does not occur, but in which it is
capable of continued propagation;
(b)) the techniques of misleading hereditary material prepared in any way
outside the organism directly into the recipient organism, including mikroinjekce,
makroinjekce, biolistické methods of microencapsulation and artificial chromosomes,
or
(c)) cell fusion techniques, including protoplast fusion or hybridization
the cells, which are the merger of two or more cells by means of
viable cells with new combinations of heritable material,
methods or devices, which do not occur naturally.
2. the genetically modified organisms cannot lead
the following technical procedures, if at the same time do not include the use of
recombinant hereditary material techniques referred to in point 1 of this
the annex or the use of such genetically modified organisms
techniques, incurred
and in vitro fertilization),
(b)) of the bacterial conjugation, transformation, transduction and similar natural
processes,
(c) induction of polyploidy and haploidie).
Annex 2
Criteria for the safety of the genetically modified micro-organisms
To meet the requirements on safety, health and the environment
According to § 1 (1). 2 (a). (b)) must the contained use of genetically
modified micro-organism comply with the following criteria
and genetically modified micro-organism) must be clearly defined,
the identity of the strain must be determined and verified, the modification must be known and
verified,
(b)) must be provided with evidence of the safety of the organism, and accompanied by the necessary
documentation,
(c)) must be demonstrated genetic stability, if the instability
could adversely affect the safety,
(d) genetically modified micro-organism) may not be able to cause
disease or injury to a healthy human, plant or animal; because
pathogenicity includes both toxinogenitu and allergenicity not genetically
the modified micro-organism
1. create increased toxinogenitu as a result of the genetic modification
or may not be known toxigenic properties
2. create increased allergenicity as a result of the genetic modification,
must not be a known allergen,
(e)) shall not in itself contain the harmful adventitious agents, such as
other micro-organisms, active or latent, existing alongside or
inside of the genetically modified micro-organism and which could
harm the health of people, animals, the environment or
biodiversity,
(f)) is his modified genetic material transferred may not invoke
damage or may not be autoinfekční or portable with greater frequency than
the other genes of the recipient or parental micro-organism,
(g)) may not have immediate or subsequent adverse effects on the
the environment or biodiversity in the event of escape
genetically modified organism into the environment.
Annex 3
Categories of risks of the contained use
The result of the evaluation of the risk of the contained use of a certain
genetically modified organism is the inclusion of this activity to one of the
the following categories of risk
I. the first category represents the activity without risk or
a negligible risk of harmful effects on health and the
environment; i.e.. activities in which to preserve the health of the
humans and animals, the environment or biodiversity,
will the level of containment and protective measures provided for in this Act for
the first category of risk.
II. The second category represents a low-risk of malicious activity
effects on health and the environment, which can be easily
removed generally known measures; i.e.. activities in which the
in order to safeguard human and animal health, the environment or
biological diversity, the level of containment and protective measures
provided for in this Act for the second category of risk.
III. The third category represents the activity with the risk of such harmful
effects on health and the environment, which can be removed only
intensive interventions; i.e.. activities in which to preserve
human and animal health, the environment or biodiversity,
will the level of containment and protective measures provided for in this Act for
the third category of risk.
IV. The fourth category represents the activities with a high risk of malicious
effects on health and the environment in which to do so, in order to
preserve human and animal health, the environment or biological
diversity is a necessary level of containment and protective measures provided for in
This law for the fourth category of risk.
Annex 4
The elements of the operating regulations of the workplace, which is treated with genetically
modified organisms
The rules of operation of the workplace, which is treated with a genetically modified
organisms, must contain the following particulars
and, where applicable, names) the name, last name, business name, business address and
the identification number, if it has been allocated, the authorized person, if the physical
the person entitled to the business,
(b)) the name or business name, registered office and identification number, if
granted, the person is a legal person, as well as the name,
where appropriate, the name, surname and the address of the place of residence of the statutory authority
the authorised person,
(c) the name, if applicable) name, surname and the address of the place of residence of the owner of the building
or, if the owner is not the same as the authorised person, if it is
a natural person, or the name or business name, registered office and
the identification number, if assigned, as well as the name or names,
the last name and the address of the place of residence of the statutory body, if the legal
person,
(d) the name or names), surname, home address, telephone number,
also, if applicable, the fax number and electronic mail address of the expert advisor,
(e) risk management category) genetically modified organisms,
that may be carried out at the workplace, in the case of a closed
waste management,
(f) the name or names), surname, home address, telephone number,
also, if applicable, the fax number and electronic mail address of the person responsible for the
operation of the workplace,
(g)) the character, purpose, description of the technical elements that ensure the conclusion of the
area, if this is a contained use,
h) list and description of mandatory work procedures used to
workplace,
even the list of workers trained for) work at the workplace,
j) enumeration and the approximate amount of genetically modified organisms,
which will be treated in the workplace,
to organizational and technological) security of the workplace,
l) measures in case of accident or fire, including the emergency plan referred to in
section 20,
m) the duties of workers at work (compliance with working procedures,
How to reassemble the space and equipment for their work activities,
the decontamination procedure tools, personal protective equipment and clothing),
n) system, and the frequency of checks of the space, equipment and protective measures,
about) the obligations of workers in the maintenance of equipment,
p) principles of safety and hygiene of work in accordance with the provisions of the
special legislation,
q) method of waste management and contaminated materials and articles
in particular, the procedures for the disposal of genetically modified organisms and the way
monitoring of their effectiveness,
r) list of personal protective equipment and other AIDS
that the employer shall, in accordance with the particular legal
Regulation, ^ 19) indicating the activities which must be used,
with the banned activities in the workplace),
t) the principles of operation of the recording equipment, carried out sanitization and
checks of security elements,
u) measures to prevent the entry of unauthorised persons,
in the case of the placing in) of genetically modified organisms into the environment
the environment on
1. the means of transport on land, including security measures,
2. location and method of storage of genetically modified organisms before
putting into the environment, and after closure, including the
packaging and labelling,
an indication of the possible) time limits the validity of the operating system.
The rules of operation must include the certified number of parties; is prohibited from
It cut or damage the individual sheets and must be kept
under section 19 (a). (b)).
Selected provisions of the novel
Article. VII of Act No. 279/13 Sb.
The transitional provisions of the
Check initiated before the date of entry into force of this law shall be completed
According to the existing legislation.
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.
for example, 2) Act No. 79/1997 Coll., on pharmaceuticals and on changes and additions to the
some related laws, as amended, law No.
147/1996 Coll., on phytosanitary care and amendments to some related
laws, as amended.
3) Law No 17/1992 Coll., on the environment, as amended
regulations.
4) of Act No 246/1992 Coll., on the protection of animals against cruelty, as amended by
amended.
5) Law No. 123/1998 Coll., on the right to information on the environment, in
amended by Act No. 132/2000 Sb.
Act No. 106/1999 Coll., on free access to information in the text of the
amended.
6) for example, Act No. 258/2000 Coll., on the protection of public health and the
changes to some related laws, as amended.
7) commercial code.
8) Law No. 101/2000 Coll., on protection of personal data and on amendments to certain
laws, as amended.
8A) Article. 21. 2 of European Parliament and Council Directive 2001/18/EC, in
the text of the regulation of the European Parliament and of the Council (EC) 1830/2003 of 22 July 2003.
September 2003 concerning the traceability and labelling of genetically
modified organisms and the traceability of food and feed
produced from genetically modified organisms and amending Directive
2001/18/EC.
for example, 9) Act No. 110/1997 Coll. on foodstuffs and tobacco
products and amending and supplementing certain related laws, as amended by
amended, law No 91/1996 Coll., on feedstuffs, as amended by
amended, law No 219/2003 Coll. on the putting into circulation of the seed and
seed grown plants and on the amendment of certain laws (law on the circulation of
seeds and seedlings), law No. 147/1996 Coll., as amended,
Act No. 167/1999 Coll., on health care and on changes of some
related laws (health law), as amended,
and Act No. 79/1997 Coll., as amended.
9A) Law No. 269/1994 Coll., on criminal records, as amended
regulations.
10) section 44 of the Act No. 111/1998 Coll., on universities and amending and supplementing
other laws (the law on universities).
11) for example, Act No. 110/1997 Coll., as amended,
Act No. 91/1996 Coll., as amended, law No. 147/1996
Coll., as amended, law No 166/1999 Coll., as amended by
amended, and Act No. 79/1997 Coll., as amended
regulations.
11A) Article. 47 European Parliament and Council Regulation (EC) 1829/2003 of the day
22 September 2003 on genetically modified food and feed. Article.
12A of the European Parliament and Council Directive 2001/18/EC, as amended by regulation
The European Parliament and of the Council (EC) 1829/2003 of 22 July 2003. September 2003 on
genetically modified food and feed.
12) Act No. 13/1993 Coll., the Customs Act, as amended.
13) section 15 of Act No. 22/1997 Coll., on technical requirements for products and
amending and supplementing certain acts, as amended by law No 71/2000 Sb.
13A) Article. 17 regulation of the European Parliament and of the Council (EC) no 1946/2003 of
July 15, 2003 on transboundary movements of genetically modified
organisms.
for example, law No 14) 219/2003 Coll., Act No. 147/1996 Coll., as amended by
amended, law No 166/1999 Coll., as amended
legislation, law No 146/2002 Coll., on the State agricultural and food
inspection and amending certain related laws, as amended
regulations.
15) Act No. 20/1966 Coll., on the health care of the people, as amended
regulations.
Act No. 258/2000 Coll., as amended.
16) Act No. 281/2002, on certain measures connected with the
the prohibition of Bacteriological (Biological) and Toxin Weapons and on an amendment
the Trade Licensing Act.
16A) the regulation of the European Parliament and of the Council (EC) no 1946/2003 of 15 July.
July 2003 on transboundary movements of genetically modified
organisms.
16B) Article. 4 (4). 6 regulation of the European Parliament and of the Council (EC) 1830/2003
of 22 March. September 2003 concerning the traceability and labelling of genetically
modified organisms and the traceability of food and feed
produced from genetically modified organisms and amending Directive
2001/18/EC.
16 c) Article. 4 (4). 1 to 4 of the regulation of the European Parliament and of the Council (EC)
1830/2003 of 22 July 2003. September 2003.
17) Act No. 337/1992 Coll., on administration of taxes and fees, in the text of the
amended.
18) Law No 153/2000 Coll., on the use of genetically modified
organisms and products and amending certain related laws.
19) Government Regulation No 495/2001 Coll., laying down the scope and more
the conditions for the provision of personal protective equipment, washing machines,
cleaning agents and disinfectants.
20) Law No. 252/1997 SB., about agriculture, in wording of later regulations.
