Decree No 341 / 2019 Coll.
Decree amending Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products, as amended
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20.12.2019
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341
DECLARATION
of 11 December 2019
amending Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products, as amended
According to Article 38 of Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, as amended by Act No. 346 / 2005 Coll. and Act No. 371 / 2016 Coll., ("the Act '):
Decree No. 209 / 2004 Coll., on Closer Conditions for the Treatment of Genetically Modified Organisms and Genetic Products, as amended by Decree No. 86 / 2006 Coll., Decree No. 29 / 2010 Coll. and Decree No. 372 / 2016 Coll., is amended as follows:
1. At the end of footnote 1, the sentence "Commission Directive (EU) 2018 / 350 of 8 March 2018 amending Directive 2001 / 18 / EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms is added to the separate line. '.
In Section 2, points (f) and (h) are deleted.
Point (g) shall be renumbered (f) and points (i) to (k) shall be renumbered (g) to (i).
2. In Article 2 (g), the word "design 'is replaced by" insert' and the word "construct 'is replaced by the word" insert'.
3. In Article 2 (h), the word "design 'is replaced by" insert'.
4.
"Requirements and procedures for risk assessment
(Paragraph 7 (6) of the Law)
(1) The effects of the management of a genetically modified organism or genetic product may be:
(a) direct - primary effects on human, animal, plant or environmental health directly linked to a genetically modified organism or genetic product;
(b) indirect effects on the health of humans, animals, plants or the environment arising from the causal sequence of events, for example through interaction with other organisms, transfer of inherited material or changes in the manner of disposal; indirect effects may occur with delay,
(c) immediate - those observed during the treatment of a genetically modified organism or genetic product; immediate effects may be direct and indirect;
(d) late - those which may not be observed during the treatment of a genetically modified organism or genetic product but may be detected as direct or indirect effects after the end of the treatment of a genetically modified organism or genetic product; or
(e) cumulative long-term effects - the cumulative effects of the management of genetically modified organisms or genetic products on human, animal, plant and environment health.
(2) The placing on the market of genetically modified organisms or genetic products shall also take into account long-term effects - those resulting either from delayed reaction of organisms or their offspring to long-term or chronic exposure to the genetically modified organism or from the extensive use of genetically modified organisms over time and space.
(3) In identifying and evaluating the long-term adverse effects of GMOs on human health and the environment, account shall be taken of:
(a) long-term interactions between the genetically modified organism and the receiving environment;
(b) the characteristics of the genetically modified organism which will become significant in the long term;
(c) data obtained from the repeated placing on the environment or on the market of the genetically modified organism for a long time.
(4) The identification and evaluation of cumulative long-term effects shall also take into account genetically modified organisms put into the environment or on the market in the past.
(5) In the risk assessment, the intended and unintended changes resulting from genetic modification shall be identified and their potential adverse effects on human health and the environment evaluated. The intended change resulting from genetic modification is a change to be made that meets the original goal of genetic modification. The unintended change resulting from genetic modification is a consistent change that goes beyond the intended change. Intended and unintended changes may have direct or indirect effects on human health and the environment, either immediately or in time.
(6) The risk assessment shall take into account the characteristics of:
(a) the consignee or, where appropriate, the parent organism;
(b) the donor organism, if the donor organism is used during genetic modification;
(c) vector and embedded hereditary material, including signal and selection genes, if used;
(d) the resulting genetically modified organism,
(e) the location, manner and extent of handling of the genetically modified organism or genetic product;
(f) the environment at the place where the genetically modified organism or genetic product is handled; and
(g) the interaction of these elements.
(7) The risk assessment shall also take into account relevant information from previous placing of the same or similar genetically modified organisms and organisms with similar characteristics in the environment or on the market, their interactions with similar receiving environments, including information obtained through monitoring of those organisms.
(8) Harmful effects on human health, animals, plants or the environment may in particular include:
(a) effects on the dynamics of populations of species in the receiving environment and on the genetic diversity of those populations which could lead to a potential decrease in biodiversity;
(b) altered susceptibility to pathogens to facilitate the spread of infectious diseases;
(c) the limited effectiveness of prophylactic or therapeutic human or veterinary treatment, or, where appropriate, the effectiveness of plant treatment, for example, by transferring genes that cause resistance to antibiotics used in human or veterinary medicine;
(d) effects on soil biochemical processes, including carbon and nitrogen circulation, resulting in changes in the soil degradation process of organic materials;
(e) diseases affecting humans, including allergic or toxic reactions,
(f) diseases affecting animals or plants, including toxic and allergic reactions in animals. "
5. The following Sections 5a to 5c are inserted after Section 5, including footnotes 2 and 10:
(1) The risk assessment shall be carried out for each area referred to in Article 5b in the following successive steps:
(a) the definition of the problem, including the identification of a hazard for which any changes in the properties of the organism associated with genetic modification will be identified; any potential harmful effects associated with such changes shall be further identified, regardless of the likelihood with which they may occur,
(b) the characterisation of a hazard for which the scope of any potential harmful effect is assessed, provided that it occurs,
(c) a characterisation of the exposure for which the likelihood of each identified potential adverse effect is assessed;
(d) an estimate of the risk posed by each of the identified harmful effects on the basis of the assessment of the likelihood that this effect will occur and the severity of that effect, if any; for each identified risk, the level of uncertainty shall also be expressed;
(e) where risks have been identified requiring certain risk reduction or exposure measures, a risk management strategy shall be proposed; the proposed measures must be proportionate to the intended risk reduction, the extent and conditions of use and the level of uncertainty in the case in question,
(f) the overall risk assessment and conclusions made with regard to the risk estimation, the proposed risk management strategy and the associated uncertainty levels; specific requirements for the monitoring plan, including how to monitor the effectiveness of the proposed risk management measures, shall also be proposed in cases of environmental or marketing as part of the overall risk assessment.
(2) The risk assessment in the case of contained use also takes into account:
(a) the characteristics of the environment likely to be affected by the release of the genetically modified organism from a enclosed area;
(b) the nature and extent of the contained use; and
(c) any non-standard activities carried out during the contained use, such as vaccination of animals with genetically modified micro-organisms or the operation of equipment which may generate aerosols.
(3) All steps of the procedure referred to in paragraph 1 shall be documented in writing and, where possible, documented by references to scientific literature, protocols from experimental studies and, where appropriate, documentation on the previous management of genetically modified organisms or genetic products. The relevant European Union legislation, guidelines issued by the European Food Safety Authority or the European Medicines Agency and international or national classification systems, including new scientific and technical knowledge, shall also be used for risk assessment.
(4) In the case of the contained treatment of genetically modified organisms, the classification of biological agents according to the specific legislation10) or classification systems applicable to plant and animal pathogens 1a may also be used for risk assessment.
(5) The outcome of the risk assessment of the contained use shall be the inclusion of such treatment in one of the risk categories listed in Annex 3 to the Act. Only genetically modified organisms for which only genetically modified organisms may be included in the first risk category of contained use
(a) it is unlikely that the recipient or the parental organism will cause disease to humans, animals or plants;
(b) the nature of the vector and insert is such that they cannot make the phenotype of the genetically modified organism subject to which it could cause human, animal or plant disease or which could have harmful effects on the environment;
(c) the genetically modified organism is unlikely to cause diseases in humans, animals or plants or to have harmful effects on the environment; and
(d) any non-standard activities carried out during the contained use, in particular the vaccination of animals with genetically modified micro-organisms or the operation of equipment which may generate aerosols.
(3) All steps in the procedure referred to in paragraph 1 shall be documented and documented in writing by references to scientific literature, if available, protocols from experimental studies, and, where appropriate, documentation on the previous management of genetically modified organisms or genetic products. The relevant European Union legislation, guidelines issued by the European Food Safety Authority or the European Medicines Agency and international or national classification systems, including new scientific and technical knowledge, shall also be used for risk assessment.
(1) The specific areas for which a risk assessment is carried out in cases where GMOs other than a higher plant are placed in the environment or on the market are:
(a) the likelihood of a genetically modified organism becoming more resistant or more invasive than the recipient or the parent organism in its natural habitat under conditions of introduction into the environment;
(b) any selective advantage or disadvantage resulting from genetic modification and the likelihood that such an advantage or disadvantage will manifest itself under conditions of introduction into the environment;
(c) the possibility of transferring material to other species under conditions of introduction into the environment and any selective advantage or disadvantage which may be transferred in such a way;
(d) possible immediate or delayed environmental effects caused by direct or indirect interactions between the genetically modified organism and the target organism, if the target organism exists;
(e) possible immediate or delayed environmental effects caused by direct or indirect interactions between the genetically modified organism and non-target organisms, including impact on the level of populations of competitors, prey, symbiotes, predators, parasites and pathogens;
(f) the possible immediate or delayed effects on human health resulting from possible direct or indirect interactions between the genetically modified organism and persons in contact with it;
(g) the possible immediate or delayed effects on animal health and the consequences on food chains resulting from the consumption of a genetically modified organism or genetic product intended for use as feed;
(h) possible immediate or delayed effects on biochemical processes resulting from possible direct and indirect interactions between the genetically modified organism and the target and non-target organisms in the environment; and
(i) possible immediate or delayed direct and indirect effects on the environment as a result of the use of specific techniques for the management of genetically modified organisms, where such techniques differ from those commonly used in the management of the corresponding non-modified organisms.
(2) The risk assessment for placing genetically modified organisms in the environment for the purpose of the clinical trial of medicinal products also contains:
(a) a description of the ways in which the genetically modified organism or its functional parts can spread from the tested body (human or animal) to the environment;
(b) the indication of the inclusion and elimination criteria for the selection of clinical trial subjects and the environmental risk impact of those criteria; and
(c) the identification and evaluation of potential harmful effects in the event of an interaction of the genetically modified organism with humans not subject to a clinical trial.
(3) The specific areas for which a risk assessment is carried out in the case of the placing on the environment or on the market of a genetically modified higher plant are:
(a) persistence and invasiveness of a genetically modified higher plant, including the transfer of genes from plant to plant;
(b) the transfer of genes from a genetically modified higher plant to micro-organisms;
(c) interactions between genetically modified higher plants and target organisms;
(d) interactions between genetically modified higher plants and non-target organisms;
(e) the effects of specific cultivation, agrotechnology and harvesting methods;
(f) effects on biochemical processes; and
(g) effects on human and animal health.
(1) The applicant shall provide evidence of the application for registration in the Marketing List,
(a) where toxicological studies have been carried out to ensure that such studies have been carried out in establishments which comply with the requirements of another legislation2), or where toxicological studies have been carried out outside the European Union that the establishments comply with the principles of the Organisation for Economic Cooperation and Development for Good Laboratory Practice;
(b) where non-toxicological studies have been carried out, that such studies have been carried out in accordance with the principles of good laboratory practice laid down by other legislation (m2) or that they have been carried out by organisations accredited to the relevant International Organisation for Standardisation (ISO) standard or, in the absence of the relevant standard, that they have been carried out in accordance with internationally recognised standards.
(2) The information on the studies referred to in paragraph 1 shall include unprocessed data in an electronic format suitable for statistical or other analysis.
(3) In the case of an application for the placing on the market of a genetically modified organism containing a combined transformation event or a genetic product containing such an organism, it is necessary to carry out a risk assessment for each single transformation event or a reference must be made to previous marketing applications concerning the relevant simple transformation events. In assessing the risk of a genetically modified organism containing combined transformation events, it is necessary to assess:
(a) stability of transformation events;
(b) expression of transformation events; and
(c) potential additive, synergistic or antagonistic effects arising from a combination of transformation events.
(4) Where the progeny of that genetically modified organism may contain different sub-combinations of transformation events, the applicant shall be required to provide relevant experimental data for those sub-combinations, unless it is sufficiently justified that it is not necessary to provide experimental data for the sub-combinations concerned.
(5) The assessment of the risk of a genetic product containing several different genetically modified organisms must include an assessment of the relevant data for each of these organisms.
2) Act No. 350 / 2011 Coll., on chemicals and chemical mixtures and on the amendment of certain laws (chemical law), as amended.
10) Government Regulation No. 361 / 2007 Coll., laying down conditions for health protection at work. '
6. in Article 10 (e), the words "put into circulation" shall be replaced by the words "to the market."
7. In Annex 2, the introductory part, including the title, reads:
"Models of applications for authorisation for placing in the environment
(1) The provision of a particular sub-set of information set out in the model application for authorisation for placing in the environment shall not be required unless it is relevant or necessary for the purpose of risk assessment in relation to a particular application, in particular with regard to the characteristics of the genetically modified organism or the extent and conditions of placing in the environment. The appropriate level of detail for each sub-set of information may also vary depending on the nature and extent of the proposed placing in the environment.
(2) For each sub-set of information, summaries and results of quoted studies, including, where appropriate, an explanation of their relevance to environmental risk assessment,
(3) Documents marked (+) must be attached as a separate annex
(4) The information summarising the content of the request for publication is underlined in the model application. "
8. In Annex 2, Part B, including the title:
MODEL REQUEST FOR GRANTING ENVIRONMENTAL PERFORMANCE FOR THE PURPOSES OF CLINICAL EVALUATION OF MEDICINAL PRODUCTS
Date of administration
1. Project name
1.1. Unique identifier of the clinical trial if known at the time of application
2. Applicant
2.1. Name or name or business name if the applicant is a natural person authorised to do business
2.2. Name or business name and legal form if the applicant is a legal person
2.3. Citizenship (for natural persons)
2.4. Address of residence and address of residence (for natural persons)
2.5. IČO (if assigned)
2.6. Names of persons who are members of the statutory body of the applicant, if the applicant is a legal person, indicating the manner in which the applicant is represented
2.7. Telephone
2.8. E-mail
3. Expert Advisor
(+) Evidence of educational attainment and the length of professional experience (if professional education or practice has been acquired in another Member State by a national of a Member State, this document means a decision on the recognition of professional qualifications under another legislation)
3.1. Name, title
3.2. Employment, possibly employer and function
3.3. Education
3.4. Professional courses
3.5. Practice
3.6. Address of residence
3.7. Telephone
3.8. E-mail
4. Information on the place where the placing into the environment will take place
4.1. Workplace at which the environment will be put into operation
4.2. Address of the workplace
4.3. The contact person at the workplace if different from the expert consultant
4.3.1. Name, title
4.3.2. Telephone
4.3.3. Email
(+) Test methodology
(+) Emergency plan according to Annex 5 to this Decree
(+) Operating Regulations of the Institute according to Annex 4 to the Act
(+) Scheme of the workplace on which the placing into the environment will take place
5. Clinical trial contractor (if different from the applicant)
5.1. Name or business name and legal form
5.2. Address of the seat
5.3. IČO (if assigned)
5.4. Contact person (if different from expert advisor), name, title
5.5. Telephone
5.6. E-mail
6.
6.1.
6.1.1. Medicinal product for gene therapy
6.1.2. Vaccines for human use
6.1.3. Other type of medicinal product
6.2.
6.2.1. consists of genetically modified cells which do not contain any other genetically modified organism;
6.2.2. consists of cells that contain a genetically modified micro-organism,
6.2.3. contains a genetically modified organism other than genetically modified cells. The genetically modified organism in the medicinal product is:
6.2.3.1. virus
6.2.3.2. bacteria
6.2.3.3. other organism (please specify)
6.3. Labelling of the investigational medicinal product
7. Characteristics of the management of the genetically modified organism
7.1. Purpose of introduction into the environment - objective of clinical trial
7.2. Planned number of subjects in the clinical trial
8. Time of introduction into the environment
8.1. Total duration of introduction of the genetically modified organism into the environment and date of anticipated initiation of clinical trial
8.2. Binding schedule (breakdown of individual stages, date of their envisaged start and duration)
9. Does the applicant plan to place the same genetically modified organism in the environment in or outside a Member State of the European Union? If yes, please indicate:
9.1. the State in which the applicant plans to enter the environment
9.2. Estimated start and duration of placing in the environment
10. Has the applicant submitted an application for placing the same genetically modified organism into the environment in another Member State of the European Union?
If yes, please indicate:
10.1. State of application
10.2. date of submission and number or other indication of the application
10.3. the date and designation of the permit if issued
10.4. the period covered by the authorisation
11. Has the applicant submitted an application for placing the same genetically modified organism in the environment or on the market outside the European Union?
If yes, please indicate:
11.1. State of application
11.2. date of submission and number or other indication of application
11.3. the date and designation of the permit, if issued
11.4. Period covered by authorisation
12. Evaluation of the risk of placing a genetically modified organism in the environment
(+) Risk assessment according to § 7 of the Act and § 5 to 5b
12.1. Summary of risk assessment
13. Data on the recipient, where applicable, of the parent organism
13.1. The recipient or, where appropriate, the parent organism is:
13.1.1. virus
13.1.2. bacteria
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Regulation Information
| Citation | Decree No. 341 / 2019 Coll., amending Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.12.2019 |
|---|---|
| Effective from | 01.01.2020 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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