Act No. 153 / 2000 Coll.
Act on the treatment of genetically modified organisms and products and amending certain related laws
Valid
Law
Effective from 01.01.2001
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153
THE LAW
of 10 May 2000
on the management of genetically modified organisms and products and amending certain related laws
Parliament has decided on this law of the Czech Republic:
DISCLOSURE WITH GENETICALLY MODIFIED ORGANISMS AND PRODUCTS
INTRODUCTORY PROVISIONS
Subject matter of the regulation and scope of the law
(1) The Act lays down the obligations of persons and the powers of administrative authorities in the handling of genetically modified organisms and products.
(2) If the genetically modified organism or product is a medicinal product under a specific legislation, 1) it shall not be subject to the provisions of Section 9.
Basic concepts
For the purposes of this Act:
(a) organism - biological unit, cellular or non-cellular, capable of reproduction or transmission of hereditary material, including viruses, viroids and animal and plant cells in culture;
(b) hereditary material - deoxyribonucleic or ribonucleic acid,
(c) genetic modification - a targeted change in the genetic material of the organism in a way which does not achieve natural recombination by introducing foreign material into the genetic material of the organism or removing part of the genetic material of the organism;
(d) a genetically modified organism - an organism other than a man whose hereditary material has been altered by genetic modification; the technical solutions by which the genetically modified organism may be created and the technical solutions which do not lead to the creation of the genetically modified organism shall be laid down in implementing legislation,
(e) product - any item containing one or more genetically modified organisms which has been produced or otherwise obtained, irrespective of the degree of processing thereof, and is intended for circulation,
(f) the management of genetically modified organisms and products - any activity the object of which is genetically modified organisms or products from their origin by genetic modification until they lose their ability to reproduce or transmit the genetic material;
(g) user - a legal person or a natural person authorised to do business who is authorised to dispose of genetically modified organisms or products that have not been approved for putting into circulation in accordance with Article 9, or who requests such authorisation;
(h) enclosed space - space enclosed by physical barriers, where appropriate in combination with chemical or biological barriers which restrict the contact of genetically modified organisms and products with humans, animals and the environment, 2)
(i) the contained management of genetically modified organisms - the management of genetically modified organisms in a enclosed area, in particular their development by genetic modification, cultivation, storage and disposal;
(j) the introduction into the environment of genetically modified organisms - their deliberate introduction into the environment outside the enclosed area, for purposes other than putting into circulation;
(k) by putting into circulation genetically modified organisms and products - their surrender or offer for such transmission to another person for distribution or use; This does not apply to the procedure set out in Section 9 (2),
(l) assessment of the risk of the management of genetically modified organisms or products - written analysis defining the risk posed by the treatment of the genetically modified organism or product under consideration for human and animal health, the environment and biodiversity, 3) carried out on the basis of verified scientific knowledge, experience and risk prevention principles,
(m) risk category - classification of the management of a genetically modified organism or product on the basis of the result of the risk assessment of this activity set out in Annex 1 to this Act;
(n) accident - any event in the management of genetically modified organisms or products which has caused a serious adverse spill of genetically modified organisms, which may cause immediate or consequential risks to human and animal health, the environment and biodiversity.
GENERAL PROVISIONS
(1) When dealing with genetically modified organisms and products, everyone is obliged to protect human and animal health, the environment and biodiversity.
(2) The treatment of genetically modified organisms and products can be done by the following means:
(a) the contained treatment of genetically modified organisms (hereinafter referred to as "contained use");
(b) the placing into the environment of genetically modified organisms (hereinafter referred to as "placing into the environment");
(c) putting into circulation genetically modified organisms and products (hereinafter referred to as "putting into circulation").
(3) The authorisation to dispose of genetically modified organisms and products under this Act is subject to a decision on entry on the relevant list and shall cease to be withdrawn from that list, unless otherwise provided for in this Act (Section 7 (4)). These lists are:
(a) a list of persons authorised to handle genetically modified organisms and products (hereinafter referred to as "the List of Users"),
(b) a list of genetically modified organisms approved for contained uses (hereinafter referred to as the "List for contained uses"),
(c) the list of genetically modified organisms approved for placing in the environment (hereinafter referred to as the list for placing in the environment),
(d) List of genetically modified organisms and products approved for circulation in the Czech Republic (hereinafter referred to as "List for placing into circulation").
(4) The application for registration in the lists referred to in paragraph 3 shall be submitted by the user to the Ministry of the Environment (hereinafter referred to as "Ministry") in the Czech language in four copies, together with the technical medium of the data and, where appropriate, by e-mail.
(5) The Ministry shall send a single application to the Ministry of Health, the Ministry of Agriculture and the Czech Commission for the Management of genetically modified organisms and products (hereinafter referred to as the "Commission") immediately upon receipt of the application for registration in the lists referred to in paragraph 3. These ministries and commissions shall communicate their views in writing to the Ministry within 45 days of receipt of the request. Taking these opinions into account, the Ministry shall decide within 90 days of receipt of the request. If the application is incomplete, the Ministry shall request its completion and the procedure shall be interrupted. 4) If the proceedings are suspended, the time limit for the decision under this law shall not run. The decision will also be sent by the Ministry to the Ministry of Health, the Ministry of Agriculture and the Commission. The decision may be limited in time by the Ministry and, where justified, on the basis of the user's request, extended.
(6) In the decision, the Ministry shall lay down the treatment conditions arising from the ministerial and commission opinions referred to in paragraph 5.
(7) The user is obliged
(a) designate a competent and sound natural person to exercise professional control over the management of genetically modified organisms or products (hereinafter referred to as "expert advisor"); the condition of professional competence is the completed higher education of the relevant direction and at least 5 years of experience in the field, of which at least 2 years of work with genetically modified organisms; the detailed conditions of competence are laid down in the implementing legislation,
(b) keep documentation on the handling of genetically modified organisms and products for each site and keep it for at least 10 years after the end of such disposal; the manner and extent of the management of the dossier shall be determined by implementing legislation,
(c) forward to the Ministry, in writing or by electronic means, by 15 February of the calendar year, an overview of the genetically modified organisms and products, their quantities and their handling for the previous calendar year;
(d) send a report to the Ministry within 60 days of the end of the management of the genetically modified organism or product on the outcome of this activity, in particular with regard to risks to human and animal health, the environment and biodiversity;
(e) ensure that the risk assessment of the management of genetically modified organisms and products (hereinafter referred to as the "risk assessment") referred to in Article 4 is carried out and that the emergency plan referred to in Article 5 is prepared;
(f) ensure that the operating rules of the workplace in which genetically modified organisms or products are handled include the particulars listed in Annex 2 to this Act;
(g) to provide staff training prior to the start of the treatment of genetically modified organisms or products and their training in any change in working practices, or at least once a year, and to demonstrate to the staff that they are familiar with the working order of the workplace supplemented in accordance with point (f);
(h) notify the Ministry, the Ministry of Health and the Ministry of Agriculture without delay, but no later than 24 hours after the detection of any accident occurring, by telephone, in writing or, where appropriate, by e-mail, indicating the genetically modified organism or product concerned by the accident, and its quantity, the location where the accident occurred, the possible consequences of the accident, in particular the risks to human and animal health, the environment and biodiversity, and the manner in which they are removed;
(i) to provide administrative services pursuant to Sections 14, 17 to 19 with synergies in the control of premises and equipment intended for the handling of genetically modified organisms and products, to enable documentary checks and, where appropriate, free of charge, the collection of samples for control purposes;
(j) notify the Ministry of any change in the information contained in the application referred to in paragraph 4. The Ministry, after consulting the Ministry of Health and the Ministry of Agriculture, shall decide within 60 days of the submission of this notification whether a new application for entry in the lists referred to in paragraph 3 is necessary. The new application shall be submitted by the user within 30 days of the date on which the decision becomes final.
(8) Activities related to the use of live vertebrate animals, in particular those affecting their physiological functions or regulating their metabolic products, shall be considered as animal experiments under specific legislation. 5)
(9) The request submitted pursuant to paragraph 4 shall contain the opinion of the expert consultant.
(10) Where a genetically modified organism or product is entered in one of the lists referred to in points (b) to (d) of paragraph 3, no new application for inclusion in that list shall be required.
Risk assessment
(1) The user is obliged to submit a risk assessment to the Ministry
(a) as part of the application for registration in the lists referred to in Article 3 (3);
(b) regularly after 5 years from the date of the last risk assessment;
(c) within 20 days in the cases referred to in Article 6 (8).
The formalities and procedures for risk assessment shall be laid down in implementing legislation.
(2) The risk assessment must include an assessment of possible direct and indirect harmful effects on human and animal health, the environment and biodiversity, both immediate and subsequent, in particular:
(a) negative effects on humans,
(b) negative effects on animals and plants,
(c) limiting the possibility of treating the disease or ensuring effective prophylaxis due to antibiotic resistance;
(d) the establishment and distribution of the genetically modified organism in the environment;
(e) the natural transmission of inserted genetic material to other organisms.
(3) The user is obliged to ensure that risk assessment is used
(a) current scientific knowledge;
(b) verified experience with a genetically modified organism and related organisms;
(c) verified experience with the organism from which the hereditary material used for genetic modification originates, where genetic modification involves the introduction of foreign hereditary material;
(d) verified experience with the relevant genetic modification;
(e) verified experience with the relevant genetically modified organism or product;
(f) qualified estimates where verified scientific evidence is missing; the risk prevention principle must be applied in such cases,
(g) the opinion of the expert adviser.
(4) The user is required to ensure that the risk assessment for each genetically modified organism is carried out separately.
Emergency plan
(1) The emergency plan is a document describing the activities and measures carried out in the event of an accident which lead to the mitigation of its effects on human and animal health, the environment and biodiversity.
(2) The user is obliged to submit an emergency plan to the Ministry
(a) as part of the application for registration in the lists referred to in Article 3 (3);
(b) regularly after 5 years from the date of the last submission of the emergency plan;
(c) within 30 days of changing the facts which may have a serious impact on the measures provided for in the event of an accident.
(3) An emergency plan shall be submitted by the user prior to the start of the treatment of the genetically modified organism or product and within 15 days of any subsequent submission pursuant to paragraph 2 (b) and (c), also to the Ministry of Health, the Ministry of Agriculture and the relevant municipalities according to the place of disposal and, where appropriate, persons who may be affected by the accident.
(4) The emergency plan shall include all data concerning the potential threat to human and animal health and environmental and biodiversity damage resulting from the accident. The emergency plan shall include in particular:
(a) the name, surname, permanent residence, telephone number and, where appropriate, fax number and e-mail address of the expert consultant;
(b) a precise description of the premises and facilities where the genetically modified organisms and products where they are stored and where accidents may occur, indicating the location of the premises or facilities;
(c) the methods and procedures applicable to the detection and destruction of the genetically modified organisms and products concerned in accordance with specific legislation, 6)
(d) methods and procedures to protect human and animal health, the environment and biodiversity;
(e) the administrative authorities concerned referred to in Article 13, in accordance with their competence and the manner in which they are informed and, where appropriate, the way in which citizens are warned,
(f) the opinion of the expert adviser.
The requirements of the emergency plan shall be laid down in implementing legislation.
Writing to the User List
(1) The application for registration in the User List submitted by the user to the Ministry before the start of the treatment of a genetically modified organism or product must contain:
(a) the name, surname, permanent residence, citizenship, place of business, birth and identification number, if any, if it is a natural person authorised to do so;
(b) name (trade name), legal form, registered office and identification number, if applicable,
(c) the name, surname, permanent residence of the expert adviser and evidence of his integrity, competence and practice;
(d) an officially certified copy of the trade certificate, if it is for a natural person authorised to do business;
(e) an extract from the commercial register not more than 3 months old or an officially certified copy of the instrument of incorporation or of the instrument of incorporation, if it is a legal person;
(f) how the genetically modified organism or product is handled;
(g) the purpose and duration of the treatment of the genetically modified organism or product;
(h) the address and description of the workplaces or parcels on which the loading will take place;
(i) particulars of the organism that is genetically modified, including its origin;
(j) genetic modification data, including data enabling the identification of the changed hereditary material;
(k) particulars of the genetically modified organism or product;
(l) an indication of whether the genetically modified organism or product has already been approved in another State and for what purposes;
(m) the risk assessment referred to in Article 4, including the inclusion of the treatment of a genetically modified organism or product in the risk category;
(n) the emergency plan referred to in Article 5;
(o) a description of the management of the genetically modified organism or product in accordance with the risk assessment, including measures to protect human and animal health, the environment and biodiversity;
(p) details of the system for the control and disposal of genetically modified organisms in accordance with specific legislation, 6)
(q) a description of the management of waste, including hazardous waste, as well as of the waste water and waste gas residues in accordance with specific legislation. 7)
(2) Professional competence shall be demonstrated by evidence of completed higher education in the relevant field and by evidence certifying the required practice pursuant to Article 3 (7) (a); integrity shall be demonstrated by the presentation of an extract from the record of a criminal record of not more than 3 months of age certifying that a natural person has not been convicted of an intentional offence. Further requirements for the selected data specified in the application for each mode of loading shall be laid down in the implementing legislation.
(3) For a particular method of handling in the same risk category with several genetically modified organisms, the user may submit one joint application.
(4) The list of users contains:
(a) the user identification data specified in the application;
(b) the identification details of the expert adviser;
(c) the address of the workplace where the genetically modified organisms or products will be handled;
(d) the specification of the genetically modified organism or product or, where appropriate, several organisms referred to in paragraph 3;
(e) the method of handling the genetically modified organism or product; and
(f) the period of validity of the registration decision, if any.
(5) The user will be excluded from the User List on the background
(a) the expiry of the registration decision;
(b) the decision of the Ministry to withdraw from the User List pursuant to paragraphs 6 and 7;
(c) the winding up or termination of a legal person or the termination of an authorisation to conduct business of a natural person;
(d) the death of a natural person authorised to do business or his declaration of death.
The withdrawal from the List of Users shall not eliminate the obligations arising from the decision on entry into that list.
(6) If the user infringes the provisions of this Act or does not comply with the conditions laid down by the Ministry in the decision to enter the List of Users, the Ministry will decide on its removal from that list. A new application for registration in the User List may be submitted at least 5 years after the decision to withdraw from the User List.
(7) The Ministry may exclude users from the User List upon request or upon the creation of new facts which have changed the conditions under which the User List was registered.
(8) If the Ministry obtains new knowledge of the potential danger to human and animal health, the environment or biodiversity resulting from the treatment of the genetically modified organism or product in question, whether at the time of the examination of the application or after the user has been entered in the User List, it shall invite the user to invite, within 20 days of the date of receipt of the request at the latest:
(a) carry out a new risk assessment in accordance with Article 4;
(b) examine the measures referred to in the application referred to in paragraph 1 (o) and, where necessary, amend them to ensure the protection of human and animal health, the environment and biodiversity.
(9) The obligation to apply for entry in the List of Users shall not apply to the administrative offices referred to in Section 13 if they treat genetically modified organisms within the scope of their competence referred to in Sections 14 to 19 and to the legal person with whom the Ministry has concluded a cooperation agreement in the exercise of its competence under Section 14.
Closed use
(1) The user may only dispose of genetically modified organisms in a restricted area which complies with the closure and protection requirements laid down for the relevant or higher risk category. Where the risk assessment carried out pursuant to Article 4 has not led to a clear inclusion of the management of a genetically modified organism in a specific risk category, such treatment shall be assessed according to the requirements for the higher risk category. The requirements for enclosed space and protection measures for each risk category shall be laid down in implementing legislation.
(2) The application for registration in the User List in the case of contained use must contain the information referred to in Article 6 (1) and
(a) a description of the location of the premises for contained loading and a technical description of their facilities;
(b) an assessment of these premises and facilities, including their location, in accordance with the requirements for the closed area and the protection measures laid down for each risk category;
(c) the estimated quantity of genetically modified organisms to be used.
Further requirements for selected data specified in the application shall be laid down in the implementing legislation.
(3) As regards the contained use of the first risk category solely for the purposes of teaching or scientific research and development, the user shall indicate in the application for inclusion in the User List the organism or group of organisms and genetic modification to be used.
(4) In the case of closed use of the first and second risk categories, the user may start loading 90 days after the request has been made, unless the Ministry decides otherwise by the end of this period. In the case of contained use of the third and fourth risk categories, the user may only commence treatment with the consent of the Ministry.
(5) In the case of contained use of the first and second risk categories, the Ministry, together with the user entry in the User List, shall enter the genetically modified organism referred to in the application or, where applicable, the group of organisms referred to in paragraph 3 in the List of Concluded Use.
(6) In the case of contained use of the third and fourth risk categories, the user shall submit an application for the inclusion of the genetically modified organism in the restricted use list at the same time as the application for entry in the User List. The contained use of the third and fourth risk categories may only be initiated by the user once the decision on the inclusion of the genetically modified organism in the list of contained uses has become final.
(7) The application for the registration of a genetically modified organism in the List of Concluded Use shall contain the information referred to in Article 6 (1) (2) and
(a) an indication of the function of genetic modification;
(b) a description of the genetic modification and of the part of the modified deoxyribonucleic or ribonucleic acid allowing the unique identification of the genetically modified organism.
Further requirements for selected data specified in the application shall be laid down in the implementing legislation.
(8) The list of contained uses contains:
(a) the specification of the genetically modified organism and, where appropriate, the group of organisms referred to in paragraph 3;
(b) the specification of the genetic modification;
(c) risk category;
(d) the identification of the user handling the genetically modified organism;
(e) the purpose of the disposal; and
(f) the period of validity of the registration decision, if any.
(9) Where the Ministry receives new knowledge which could pose a risk caused by closed handling under the conditions laid down, it shall, within 60 days of the date of receipt of such knowledge, determine the new conditions of contained use and, where appropriate, the conditions for suspension or termination of contained use, including the disposal of genetically modified organisms. The Ministry, after consulting the Ministry of Health and the Ministry of Agriculture, may decide, on the basis of new knowledge, to change the risk category of the contained treatment of the genetically modified organism entered in the List of Concluded Carriage. In such a case, the user is obliged to ensure that the premises and facilities correspond to the modified risk category within the time limit set in the Ministry's decision and to implement the related measures. In the event that the user does not do so by the end of the prescribed period, the contained use shall not continue.
(10) The user shall, in the course of the contained use, check the enclosed space and the protection measures regularly in accordance with the operating rules and without delay in the case referred to in Section 6 (8), or where the Ministry has decided to change the classification of the risk category in accordance with paragraph 9.
Environment
(1) Only users registered in the User List shall be allowed to place genetically modified organisms in the environment, to the extent specified in that list.
(2) Only those genetically modified organisms that are listed in the List of Environmental Products may be placed in the environment, subject to all the conditions laid down in the decision on inclusion in that list.
(3) The application for registration of the genetically modified organism in the list for placing in the environment must contain the information referred to in Article 6 (1) and
(a) an indication of the function of genetic modification;
(b) a description of the genetic modification and of the part of the modified deoxyribonucleic or ribonucleic acid, allowing a clear identification of the genetically modified organism;
(c) the identification of the user or, where appropriate, of users who will carry out or participate in the placing in the environment, including documents or officially certified copies of requests to register such persons in the User List;
(d) the location and location of the genetically modified organism;
(e) the quantity of GMOs to be used and the size of the area on which the GMOs will be placed in the environment;
(f) measures to prevent the spread of genetically modified organisms during the period of introduction into the environment and their occurrence and spread at a given site after placing them into the environment,
(g) data on possible interactions between the genetically modified organism and the environment.
Further requirements for selected data specified in the application shall be laid down in the implementing legislation.
(4) As regards the placing in the environment of several genetically modified organisms falling within the first risk category during the same period and for the same purpose, for the sole purpose of teaching or scientific research and development, the user may submit a single joint application.
(5) The list for placing into the environment contains:
(a) the specification of the genetically modified organism;
(b) the specification and function of genetic modification;
(c) the outcome of the risk assessment;
(d) identification of the user who will handle the genetically modified organism;
(e) the purpose and place of placing in the environment; and
(f) the period of validity of the registration decision, if any.
(6) Where the Ministry has obtained new knowledge which could pose a risk to the environment under the conditions laid down, it shall, within 60 days of the date of receipt of such knowledge, determine the new conditions for placing in the environment and, where appropriate, the conditions for suspension or termination of disposal.
(7) The Ministry, after consulting the Ministry of Health and the Ministry of Agriculture, may decide, on the basis of new knowledge, to remove the genetically modified organism from the List of Environmental Products. In the Decision, the Ministry sets out the conditions for the cessation of introduction into the environment and the means of disposal of the genetically modified organisms used. The decision shall be published in the Journal of the Ministry and forwarded to the Ministry of Health and the Ministry of Agriculture.
Entry into circulation
(1) Only genetically modified organisms and products listed in the List for putting into circulation may be put into circulation, subject to all the conditions set out in the decision on entry into the list. The decision to put them into circulation under specific legislation8) is without prejudice to this provision.
(2) The provision of genetically modified organisms for scientific and control purposes, for teaching and for collections shall not be considered to be put into circulation. Genetically modified organisms which are so provided shall bear on their packaging a clear mark "GMO '.
(3) The application for the registration of a genetically modified organism or product in the List for putting into circulation shall contain the information referred to in Article 6 (1), and
(a) proof of user registration in the List of Users or an officially certified copy of the application for registration in that list;
(b) an indication of the function of genetic modification;
(c) a description of the genetic modification and of the part carried by the modified deoxyribonucleic or ribonucleic acid, allowing a clear identification of the genetically modified organism;
(d) the method of laboratory control of the presence of genetic modification;
(e) an indication of whether the genetically modified organism in question is included in the list for placing in the environment,
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Regulation Information
| Citation | Act No. 153 / 2000 Coll., on the Treatment of Genetically Modified Organisms and Products and on the Modification of Certain Related Acts |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.06.2000 |
|---|---|
| Effective from | 01.01.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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