What is Act No. 78 / 2004 Coll.?

Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products — Act on the management of genetically modified organisms and genetic products.

When it became Act No. 78 / 2004 Coll. effectiveness?

Act No. 78 / 2004 Coll. became effective 25.02.2004.

Is Act No. 78 / 2004 Coll. still valid?

Yes, Act No. 78 / 2004 Coll. is still valid and effective.

Act No. 78 / 2004 Coll. - Act on the management of genetically mod...

78

THE LAW

of 22 January 2004

on the management of genetically modified organisms and genetic products

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

INTRODUCTORY PROVISIONS

§ 1

Subject matter

(1) This law implements the relevant European Union1), building on the directly applicable European Union21), and regulating the rights and obligations of persons and the powers of administrations in the management of genetically modified organisms and genetic products.

(2) This law does not apply to:

(a) the treatment of organisms derived from mutagenesis techniques or from cellular fusion or fusion of plant cell protoplasts of organisms for which genetic material exchanges may be achieved by traditional breeding methods, unless such techniques at the same time include the technical procedures referred to in point 1 of Annex 1 to this Act or the use of genetically modified organisms by such processes;

(b) the contained use of genetically modified organisms exclusively related to genetically modified micro-organisms which meet the safety criteria for human health, animal health, environmental compartments and biodiversity set out in Annex 2 thereto;

(c) the contained treatment of genetically modified organisms relating exclusively to genetically modified micro-organisms resulting from a cellular fusion or a fusion of prokaryonic cell protoplases which exchange genetic material known to be physiological processes, unless such fusion simultaneously involves the technical procedures referred to in point 1 of Annex 1 to this Law or the use of genetically modified organisms by such processes;

(d) the contained treatment of genetically modified organisms relating exclusively to genetically modified micro-organisms arising from the cellular fusion or the fusion of protoplastics of cells of eukaryonic species, including the formation of hybrids, provided that such fusion does not simultaneously include the technical procedures referred to in point 1 of Annex 1 to this Act or the use of genetically modified organisms by such processes.

(3) The Ministry of the Environment (hereinafter referred to as "the Ministry") decides in doubt whether it is an exemption from the scope of this Act under paragraph 2.

(4) Where a genetically modified organism or a genetic product is a medicinal product subject to registration in accordance with a directly applicable European Union regulation governing procedures for the authorisation of medicinal products for human and veterinary use and the supervision of them (2) or a plant protection product for which authorisation is granted under the directly applicable European Union regulation on the placing of plant protection products on the market (22), Article 11 and the provisions of Part Four of this Act shall not apply.

§ 2

Basic concepts

For the purposes of this Act:

(a) by an organism - a biological unit, including a microbiological unit, capable of reproducing or transmitting inherited material;

(b) hereditary material - deoxyribonucleic or ribonucleic acid,

(c) genetic modification - a targeted change of the hereditary material consisting of the introduction of foreign hereditary material into the hereditary material of the organism or the removal of part of the hereditary material of the organism in a manner which does not achieve natural recombination;

(d) a genetically modified organism - an organism, except for a man whose hereditary material has been altered by genetic modification carried out by one of the technical procedures laid down in point 1 of Annex 1 to this law;

(e) genetically modified micro-organism - a microbiological unit capable of reproducing or transmitting hereditary material, including viruses, viroids, animal and plant cells in a culture whose hereditary material has been altered by genetic modification;

(f) genetic 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 placing on the market,

(g) enclosed space - space enclosed by physical barriers, where appropriate in combination with chemical or biological barriers that restrict the contact of genetically modified organisms or genetic products with humans, animals and the environment, 3)

(h) monitoring - detection of the presence of genetic modification in the organism or product and monitoring of the effects of the genetically modified organism or genetic product on human health, animal health, environmental compartments and biodiversity.

§ 3

Management of genetically modified organisms and genetic products

(1) The treatment of genetically modified organisms and genetic products for the purposes of this Act means:

(a) contained use of genetically modified organisms (hereinafter referred to as "contained use") shall be considered to be any activity in which organisms are genetically modified or in which genetically modified organisms are grown, stored, transported, destroyed, disposed of or otherwise used in a restricted area, not involving genetically modified organisms approved for placing on the market pursuant to Article 23 (1);

(b) the placing into the environment of genetically modified organisms (hereinafter referred to as "placing into the environment") which is considered to be the placing into the environment of genetically modified organisms outside the enclosed area, not involving genetically modified organisms approved for placing on the market pursuant to Article 23 (1);

(c) the placing on the market of genetically modified organisms or genetic products (hereinafter referred to as "placing on the market"), which shall be considered to have been passed on to another person, whether or not for the sole purpose of being transferred, for the sole purpose of the contained use or placing into the environment of the person entitled to such disposal.

(2) Treatment of genetically modified organisms and genetic products shall not be considered to be handling them from the moment they lose their ability to reproduce or transmit genetic material.

(3) When dealing with genetically modified organisms and genetic products, everyone shall, in accordance with the precautionary principle, protect human health, animal health, environmental compartments and biodiversity (hereinafter referred to as "health and the environment ').

(4) Anyone who treats a genetically modified organism or genetic product must comply with the conditions indicated on the packaging or, where appropriate, with the accompanying sheet of the genetically modified organism or genetic product and treat it only for the purpose indicated therein.

(5) The use of live vertebrate animals in the handling of genetically modified organisms and genetic products is considered to be animal experiments under a specific legislation.4)

ČÁST DRUHÁ

GENERAL PROVISIONS

§ 4

Authorisation to handle genetically modified organisms and genetic products

(1) The treatment of genetically modified organisms and genetic products is subject to authorisation under this Act.

(2) The authorisation for the contained use is based on the authorisation for the contained use and, where appropriate, the notification. The conditions for this authorisation are specified in Sections 16 to 16c.

(3) The authorisation for placing in the environment is based on an authorisation for placing in the environment. Section 17 and 18 provide for closer conditions for the creation of this authorisation.

(4) The marketing authorisation shall be issued on the date on which the decision on the placing on the market of a genetically modified organism or a genetic product is taken to take effect by the competent authority of another Member State of the European Union (hereinafter referred to as "the Member State ') or by an authorisation pursuant to the directly applicable European Union Regulation on genetically modified food and feed (23). Article 23 to 24c provides for more detailed conditions for this authorisation.

§ 5

Procedure for granting authorisations for contained use, authorisations for placing in the environment and registration in the Marketing List

(1) The applicant shall submit an application for authorisation for contained use, for authorisation for placing in the environment or for registration in the Marketing List under this Act to the Ministry.

(2) The application may be made by means of a data box, in electronic form signed by a recognised electronic signature or in paper form, provided that it is simultaneously delivered on a technical medium or in electronic form via a public data network. Where standard data formats have been established pursuant to Regulation (EC) No 178 / 200231 of the European Parliament and of the Council, the application for authorisation for placing on the environment and the application for registration in the Marketing List shall be submitted in those formats.

(3) The applicant may refer in the application to data, information or results contained in previously submitted applications. The data, information or results contained in applications submitted by other applicants may be referred to only if such data, information or results are not subject to the protection provided for in Article 9 or if the applicant at whose request the reference is made has given written consent.

(4) The Ministry shall assess its completeness within 5 working days of receipt of the request. If the application does not contain any of the elements laid down in this Act, the Ministry shall invite the applicant to supplement it within that period. In the invitation, the Ministry shall indicate where the data provided were incomplete and shall set a time limit for supplementing them. This period shall not be less than 30 days from the date of receipt of the call. If the applicant fails to complete the application within the time limit set, the Ministry shall suspend the proceedings.

(5) If the application complies with all the requirements laid down in this Act, the Ministry shall, within five working days of the expiry of the period for assessing its completeness, send the application to the Ministry of Agriculture and the Ministry of Health (hereinafter referred to as "the Ministry concerned '), where appropriate from the date of receipt of the supplemented application referred to in paragraph 4. The Ministry shall publish the information on the initiation of an authorisation procedure for placing in the environment or registration procedure in the Marketing List in accordance with Section 10. A summary of the content of the application for authorisation for placing in the environment or for registration in the Marketing List shall be published by the Ministry in accordance with Section 10 (b). The details of the summary of the content of the application shall be laid down in the implementing legislation.

(6) The ministries concerned may make written observations on the application or make requests to supplement the application data to the Ministry within 30 days of its receipt. Where the Ministry concerned makes a request to supplement the information in the application, the Ministry shall, within 5 working days of the expiry of the period referred to in the first sentence, invite the applicant to be added. In the invitation, the Ministry shall indicate where the data provided were incomplete and shall set a time limit for supplementing them. This period shall not be less than 30 days from the date of receipt of the call. If the applicant fails to complete the requested information within the time limit set, the Ministry shall suspend the proceedings. The Ministry shall send the completed request to the ministries concerned, who may make their observations within 15 working days of the date of receipt. If the Ministry concerned does not comment within the above deadlines, it shall be deemed not to have any comments on the request.

(7) Any person may send his written observations to the Ministry within 30 days of the date of publication of the summary of the content of the request. Comments sent after the deadline by the Ministry shall not be taken into account.

(8) Where the Ministry has received the opposition referred to in paragraph 7 with the introduction of a genetically modified organism into the environment, or where appropriate with the placing on the market of a genetically modified organism or genetic product, which is in question by the results of the risk assessment or which is alleging a lack of protection of health and the environment, it shall ensure public consultation in accordance with Article 6 before deciding on the application.

(9) The Ministry shall decide on the application within 90 days of its receipt. The time limit for supplementing the application referred to in paragraphs 4 and 6 and the period for which the public consultation of the application pursuant to Article 6 takes place shall not be counted; the public consultation may not extend the period by more than 30 days.

(10) In its decision-making, the Ministry is also based on the observations of the ministries concerned and the public. The decision on the application shall always include a summary settlement of the observations submitted pursuant to paragraphs 6 and 7 and, in the case of a public consultation pursuant to paragraph 8, the conclusions of that discussion.

(11) Where, pursuant to paragraph 9, the Ministry decides to grant an authorisation or entry in the Marketing List, it shall at the same time lay down the conditions for the disposal of genetically modified organisms and genetic products.

(12) The decision referred to in paragraph 9 shall also be forwarded by the Ministry to the ministries concerned and published in accordance with Paragraph 10.

(13) The same status as the ministries concerned shall be established in accordance with paragraphs 5, 6, 10 and 12, Article 16c (4) and Article 18 (7) of the Regional Office, in whose administrative district the treatment or placing into the environment is to take place immediately.

§ 6

Public consultation

(1) The Ministry shall ensure, in the cases referred to in Article 5 (8), that the public consultation is held no later than 30 days after the expiry of the period for written observations referred to in Article 5 (7). The Ministry shall publish public consultation information covering the place and time of the public consultation in accordance with Section 10 at least 5 days before it takes place.

(2) In addition to the Ministry, applicants for authorisation for placing in the environment or for registration in the Marketing List are always present in public consultation. In the absence of the applicant, the Ministry may terminate the public consultation. In that case, the Ministry shall determine the place and time of the renegotiation at the applicant's expense. The new public consultation shall take place no later than 5 days after the date of conclusion of the public consultation in accordance with the second sentence. The Ministry shall inform the applicant of the location and time of the new public consultation.

(3) The Ministry makes a public record containing, in particular, information on the participation and conclusions of the discussion and a full phonogram. The Ministry shall send the minutes of the public consultation to the applicant within 5 working days of its termination and publish them in accordance with Section 10 (b).

(4) The right to information under special legislation5) is not affected by this law.

§ 7

Evaluation of the risk of the management of genetically modified organisms and genetic products

(1) The assessment of the risk of the management of genetically modified organisms and genetic products is a written analysis based on a comparison of the management of genetically modified organisms and genetic products with the management of genetically modified organisms and products under similar conditions, including the definition and assessment of possible direct and indirect, immediate and consequential harmful effects of such treatment, in particular:

(a) human health;

(b) effects on animals and plants,

(c) the establishment and distribution of the genetically modified organism in the environment;

(d) the natural transmission of the inserted genetic material to other organisms, in particular the transmission of the gene that makes the insensitivity to antibiotics and other means used to treat human or animal infections, where such gene or genes have been introduced into the genetically modified organism.

(2) The risk assessment is carried out by an expert consultant (Section 14).

(3) Risk assessments are required to be submitted to the Ministry

(a) the applicant as part of the application for authorisation and the application for registration in the Marketing List;

(b) a person submitting a notification pursuant to Article 16 (3) or Article 16a (5) as part of that notification;

(c) a person authorised under this Act to dispose of the first risk category in cases under Paragraph 16a (4);

(d) a person authorised under this Act to be used or placed in the environment and a person listed in the Marketing List in the cases referred to in paragraphs 2 and 3 of Section 8.

(4) In assessing the risk, they must be used

(a) current scientific knowledge;

(b) verified experience with a genetically modified organism and with 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 genetic product;

(f) qualified estimates where verified scientific evidence is missing; in such cases, it is necessary to base the precautionary principle.

(5) The protection of workers from the risks associated with the management of genetically modified organisms and genetic products at work is regulated by specific legislation. 6)

(6) The formalities and procedures for risk assessment are laid down in implementing legislation.

§ 8

New information

(1) Where a person authorised under this Act for the contained use or placing into the environment, a person registered in the Marketing List or a person requesting such authorisation or entry in the Marketing List is required to obtain new information concerning the risks of a genetically modified organism or a genetic product for health or the environment, he shall immediately:

(a) take the measures necessary to protect health and the environment; and

(b) provide the Ministry with new information in writing and notify it of the measures taken.

The Ministry shall communicate the information and notify the measures referred to in point (b) to the other administrative authorities concerned referred to in Section 27.

(2) Furthermore, the person referred to in paragraph 1 shall be required to carry out and submit a new risk assessment to the Ministry no later than 30 days after the date of receipt of the new information.

(3) Where the Ministry obtains new information concerning the risks of a genetically modified organism or a genetic product for health or the environment by any other means than those referred to in paragraph 1 (b), it shall transmit that information to the persons referred to in paragraph 1 and invite them to carry out and submit a new risk assessment to the Ministry no later than 30 days from the date of receipt of the call. At the same time, the Ministry shall notify new information to the other administrative authorities concerned referred to in Section 27.

(4) Where the new information referred to in paragraph 1 or 3 concerns a genetically modified organism or genetic product for which an application has been submitted for registration in the Marketing List, the Ministry shall immediately provide that information to the European Commission (the Commission) and to the competent authorities of the other Member States. If the registration has not yet been carried out, the Ministry may request further information from the applicant. Where new information is obtained only after the registration of the genetically modified organism or genetic product in question in the Marketing List, the Ministry shall, within 60 days of the date on which it received it, transmit to the Commission an evaluation report specifying whether and, where appropriate, how the registration must be amended or cancelled. If neither the Member States nor the Commission submit any reasoned objections within 60 days of the date on which the evaluation report was circulated by the Commission to the Member States, or if the points at issue are discussed within 75 days of the date of dispatch of the evaluation report, the Ministry shall decide to amend the minutes. The Ministry shall inform the Member States, the Commission and the ministries concerned of this decision within 30 days of its issue.

(5) If, on the basis of new information that may affect the risk assessment or on the basis of a re-evaluation of existing information in the context of new scientific knowledge, the Ministry obtains sufficient basis for the opinion that a genetically modified organism or genetic product for which written consent has been given by the competent authority of a Member State constitutes a risk to health or the environment, it may temporarily restrict or prohibit the handling of that genetically modified organism or genetic product, including its import and sale, under the same conditions as laid down in similar situations for a genetically modified organism or genetic product, which has been entered into the Marketing List under this Act. The decision will be published by the Ministry in accordance with Section 10.

(6) The Ministry shall immediately send a report to the Commission and the competent authorities of the Member States on the measures taken pursuant to paragraph 5. The report shall contain:

(a) the reasons for the action;

(b) new information on which the decision is based;

(c) whether or not the conditions of written consent need to be amended or the written consent withdrawn.

(7) The report referred to in paragraph 6 shall be published by the Ministry in accordance with Paragraph 10 (b). The Ministry shall publish new information and any related decisions pursuant to Paragraph 10.

§ 9

Request for confidentiality of certain data

(1) An applicant pursuant to Article 5 (1) or a notifier pursuant to Article 16 (3) or Article 16a (5) may request, at the same time as the application or notification is submitted, that certain information contained in the application or notification be treated as confidential.

(2) The information to be treated as confidential must be indicated in the application or notification. The request or notification shall be made in both a non-confidential and confidential language, where the non-confidential text must not contain data to be treated as confidential and must indicate the places where such data have been removed and the confidential version must contain all the data submitted, including data to be treated as confidential, which must be clearly indicated in the confidential version. The applicant or notifier shall demonstrate that the disclosure of data to be treated as confidential may significantly harm his interests; the reasons for confidentiality must be stated individually for each indication.

(3) In the application and notification referred to in Article 16 (3) and the notification referred to in Article 16a (5), the information to be treated as confidential cannot be identified as:

(a) a general description of the genetically modified organism or genetic product;

(b) the name or business name, the address of the registered office and, if assigned, the identification number of the person referred to in paragraph 1, if he is a legal person, or the name, business name, address of the registered office and, if assigned, the person referred to in paragraph 1, if he is a natural person authorised to do business;

(c) location and category of risk of contained use, requirements for restricted space and protective measures of the relevant category of risk of contained use;

(d) risk assessment; or

(e) an emergency plan.

(4) In the application for authorisation to place on the environment and in the application for registration in the Marketing List, the information to be treated as confidential may only be indicated:

(a) the information referred to in Article 39 (2) (a) to (c) of Regulation (EC) No 178 / 200231 of the European Parliament and of the Council), where relevant in view of the content of the application,

(b) information on deoxyribonucleic acid sequences, except those used for detection, identification and quantification of a transformation event; or

(c) breeding methods and strategies.

(5) The Ministry will assess the request for the treatment of identified data as confidential without delay. The Ministry shall decide which of the data that have been identified as confidential will be treated as confidential in the procedures and procedures under this Act; until the date of this Decision, the period referred to in Article 5 (5) shall not apply. The decision on which data will be treated as confidential shall be sent by the Ministry to the ministries concerned at the same time as the request under Article 5 (5).

§ 9a

Protection of data confidentiality

(1) The data decided by the Ministry to be treated as confidential are only accessible to:

(a) the administrative authorities referred to in Article 27;

(b) the Czech Commission on the Management of genetically modified organisms and genetic products,

(c) legal persons with whom the Ministry has concluded a contract pursuant to Paragraph 28 (1) (f);

(d) the competent authorities of the Member States; and

(e) the Commission.

(2) The Ministry is required to ensure the confidentiality of data which it has decided to treat as confidential. Such data may not be disclosed by the Ministry unless:

(a) urgent measures must be taken to protect human or animal health or the environment, in particular in emergency situations; or

(b) are part of the conclusions of scientific outputs issued by the Czech Commission for the Management of Genetically Modified Organisms and Genetic Products or by the European Food Safety Authority or the conclusions of assessment reports, and in so far as they concern foreseeable effects on human health, animal health or the environment.

(3) The data which the Ministry has decided to treat as confidential shall not be provided under the Freedom of Information Act and the Law on the right to information on the environment.

(4) The protection of confidentiality of data which the Ministry has decided to treat as confidential shall apply even if the applicant has withdrawn his application pursuant to Article 5 (1) or the notifier has notified the termination of the contained use of the first or second category of risk for which the authorisation under Article 16a (3) has been issued.

(5) The Ministry shall also ensure the protection of confidentiality of data, as provided for in paragraphs 2 and 3,

(a) which have been identified as confidential in the application or notification pending the decision of the Ministry pursuant to Article 9 (5);

(b) which the applicant has identified as being treated as confidential if the applicant has withdrawn his application pursuant to Article 5 (1) before the Ministry has decided whether such data will be treated as confidential; or

(c) which the notifier has identified as confidential data to be treated if the notifier has withdrawn its notification of the contained use of the second category before the expiry of the period referred to in Article 16a (3) or if the Ministry has issued one of the decisions referred to in Article 16b (1).

§ 10

Information to the public

Ministry ensures publication of information under this Act

(a) on the official plate of the Ministry,

(b) on its website,

(c) in at least one other appropriate way in the municipality and region in whose territory the use or disposal immediately takes place or is expected to take account of all circumstances.

§ 11

Labelling

(1) The person providing the genetically modified organism solely for the purposes of contained use or placing in the environment shall ensure that the words "Genetically modified organism 'are clearly indicated on the label or in the accompanying document of the genetically modified organism and that the designation of the genetically modified organism meets any additional labelling requirements resulting from the authorisation for contained use or placing in the environment.

(2) A person who, in the course of his business, places a genetically modified organism or a genetic product on the market must ensure that the words "This product contains genetically modified organisms" are indicated on the label or accompanying document of the genetically modified organism or genetic product. The designation of the genetically modified organism or genetic product shall also include:

(a) the trade name of the genetic product;

(b) the name of the genetically modified organism;

(c) the name and address of the registered office of the person established in the territory of one of the Member States responsible for marketing;

(d) an indication of where it is possible to obtain further publicly available information on this genetic product.

(3) In addition, the designation of a genetically modified organism or a genetic product placed on the market shall comply with any additional labelling requirements resulting from the entry in the Marketing List or written consent issued for placing on the market by the competent authority of another Member State or authorisation granted under the directly applicable European Union Regulation on genetically modified food and feed (23).

(4) For products for which random or technically unavoidable additives of genetically modified organisms approved for placing on the market pursuant to Article 23 (1) cannot be excluded, the Ministry shall, in accordance with European Union law, set a threshold for the presence of such additives by implementing legislation. If the values for the occurrence of additives in the product are lower than the threshold, the product may no longer be marked in accordance with paragraphs 2 and 3.

(5) The conditions for placing on the market and the requirements for packaging and labelling of products laid down in specific legislation (9) are not affected by this provision.

§ 12

Amendment and revocation of authorisations and registration in the Marketing List

(1) The Ministry may amend or revoke the valid authorisation or registration in the Marketing List,

(a) if there is a substantial change in the conditions under which the authorisation or registration has been issued;

(b) where it is demonstrated that the information submitted by the person who has been granted the authorisation or by a person entered in the Marketing List in the procedure for granting the authorisation or, where applicable, entry in the Marketing List or amendment thereto is incorrect; or

(c) if there is a serious or repeated breach of the obligations laid down in this law or determined pursuant to it by the person who has been granted the authorisation or, where appropriate, by the person entered in the Marketing List.

(2) The Ministry shall revoke the valid authorisation or registration in the Marketing List if the authorised person for the contained use or placing on the environment so requests, or if the person listed in the Marketing List so requests.

(3) Where necessary, the Ministry shall at the same time specify in the decision referred to in paragraph 1 or 2 the conditions for the cessation of the treatment of genetically modified organisms and genetic products, including any disposal thereof.

§ 13

Termination of authorisations to handle genetically modified organisms and genetic products

Authorisations for the treatment of genetically modified organisms and genetic products under this Act shall cease to exist

(a) the expiry of the period of authorisation or registration in the Marketing List;

(b) the loss of a business authorisation if the authorised person is the natural person authorised to do so;

(c) the death of an authorised person, if he is a natural person authorised to do business, or if he is a legal person,

(d) the date on which the decision to revoke the authorisation or to revoke the registration in the Marketing List was taken;

(e) the expiry of a period of time for which written consent to the placing on the market has been given by the competent authority of another Member State or for which authorisation has been granted pursuant to a directly applicable European Union Regulation governing genetically modified food and feed (23), or the withdrawal of such consent or authorisation;

(f) where the person entitled to the contained use does not submit a new notification in the cases referred to in Article 16b (2); or

(g) on the date of receipt of the notification of termination of the contained use of the first or second risk category to the Ministry.

§ 14

Expert adviser

(1) Only an upstanding and competent natural person may be designated by a professional adviser under this law.

(2) For the purposes of this Act, a person who has not been convicted of a criminal offence committed by negligence, the nature of which is linked to the management of genetically modified organisms and genetic products, or to an offence committed intentionally, shall be deemed to be righteous. The Ministry shall, in order to prove its integrity, request, in accordance with the special legislation, 9a) an extract from the Register of Penalties. An application for an extract from the Register of Penalties and an extract from the Register of Penalties shall be sent in electronic form in a way that allows remote access.

(3) The professional competence referred to in paragraph 1 shall be subject to higher education obtained by study in an accredited study programme10) in the field of medicine, veterinary medicine, biochemistry or microbiology for the management of genetically modified micro-organisms; natural sciences, agriculture or forestry for the management of genetically modified plants; or natural sciences, agriculture or veterinary medicine for the management of genetically modified animals and at least 5 years of experience in the field, of which at least 2 years of work with genetically modified organisms. The period of postgraduate or doctoral studies in the relevant area concerning the management of genetically modified organisms shall also be included in the required two-year experience.

ČÁST TŘETÍ

CLOSED TREATMENT AND ENVIRONMENT

HLAVA I

CLOSED DISCLOSURE

§ 15

(1) A risk assessment shall result in the inclusion of such treatment in one of the risk categories set out in Annex 3 to this Act in the case of contained treatment. Where the risk assessment has not led to a clear inclusion of the contained use in a specific risk category, it is necessary to assess such use according to the requirements for the risk category higher.

(2) Closed loading may only be carried out in a closed area which complies with the closure and protective measures laid down for the relevant or higher risk category. The requirements for enclosed space and protection measures for each risk category shall be laid down in implementing legislation.

(3) A person authorised under § 16 to 16c for contained use is required to check the enclosed space and protective measures regularly in accordance with the operating rules and immediately after obtaining new information pursuant to § 8 and keep records of the checks carried out.

§ 16

(1) Authorisations for the contained use may be granted only to a legal person or to a natural person authorised to do business.

(2) The authorisation for the contained use, which has been included in the first or second risk category on the basis of the outcome of the risk assessment provided for in Article 7, is a notification. The authorisation for the contained use, which, on the basis of the outcome of the risk assessment referred to in Article 7, has been placed in a third or fourth risk category, shall arise from the date on which the authorisation for the contained use is acquired.

(3) The notification or application for authorisation for contained use must be submitted to the Ministry before the first contained loading in a closed area pursuant to Paragraph 15 (2). The notification or application for authorisation for contained use may be submitted jointly for several enclosed spaces, if located in one building.

(4) The notification of the contained use of the first or second risk category and the application for authorisation for the contained use of the third or fourth risk category shall, in addition to the general requirements of the administrative rules, always contain:

(a) identification, contact and other details of the expert adviser and contact person at the workplace;

(b) information on genetically modified organisms;

(c) the purpose of the contained use;

(d) the address and description of the workplace on which the contained use will take place;

(e) an assessment of the premises and facilities of the workplace on which the contained use will be carried out with regard to compliance with the requirements for the closed space and protective measures laid down for the relevant risk category; and

(f) the opinion of the expert adviser.

(5) The application for authorisation for the contained use of a third or fourth risk category shall also include:

(a) a description of the contained use; and

Citation	Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products
Regulation Type	-
Author	-
Collection	Code of Laws

Date of Promulgation	25.02.2004
Effective from	25.02.2004
Effective until	-
Status	Valid

Act No. 78 / 2004 Coll.

Act on the management of genetically modified organisms and genetic products

Contents