Genetic Engineering Act (Gentechnikgesetz-GenTG)

Unofficial table of contents

GenTG

Date of completion: 20.06.1990

Full quote:

" Genetic law in the version of the notice of 16 December 1993 (BGBl. 2066), as last amended by Article 2 (27). Article 4 (14) of the Law of 7 August 2013 (BGBl. I p. 3154).

Status:	New by Bek. v. 16.12.1993 I 2066;
	Last amended by Art. 2 (27) and Art. 4 (14) G v. 7.8.2013 I 3154

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 24.6.1990 + + +) 
(+ + + Changes due to EinigVtr cf.  § 41a + + +) 

  

The Act as Article 1 G 2121-60-1 v. 20.6.1990 I 1080 (GenTRG) was approved by the Bundestag with the consent of the Bundesrat; the G was announced on 23.6.1990. Rules d. G who authorise the adoption of legal regulations and general administrative provisions shall act in accordance with the provisions of this Regulation. Art. 8 sentence 1 shall enter into force on the day after the announcement. In other respects, d. G gem. Article 8, second sentence, G v. 20.6.1990 I 1080 in force on 1 July 1990. Unofficial table of contents

Content Summary

Part one
	General provisions
§ 1		Purpose of the law
§ 2		Scope
§ 3		Definitions
§ 4		Commission for Biological Safety
§ 5		Duties of the Commission
Section 5a		(dropped)
§ 6		General due diligence and recording obligations, risk prevention
Part two
	Genetic engineering work in genetic engineering plants
§ 7		Security levels, security measures
§ 8		Approval, notification and registration of genetic engineering plants and first-time genetic engineering
§ 9		Other genetic engineering works
§ 10		Approval procedure
§ 11		Approval requirements
§ 12		Display and login procedures
§ 13		(dropped)
Part Three
	Release and marketing
§ 14		Release and marketing
§ 15		Marketing authorisation application for release and placing on the market
§ 16		Authorisation for release and placing on the market
§ 16a		Location register
§ 16b		Handling of products placed on the market
§ 16c		Observation
§ 16d		Decision of the Authority on the marketing of
§ 16e		Derogations for non-labelling seed
Fourth part
	Common rules
§ 17		Use of documents
§ 17a		Confidentiality of information
Section 17b		Marking
§ 18		Consultation procedure
§ 19		Subsidiary provisions, post-posterior requirements
§ 20		Cessation
Section 21		Participation obligations
Section 22		Other regulatory decisions
Section 23		Exclusion of private defense claims
§ 24		Fees, expenses and expenses
Section 25		Monitoring, Arrival, Duty to Dult
Section 26		Government orders
§ 27		Deletion of authorisation, Uneffective notification of the application
§ 28		Information propagation
Section 28a		Information to the public
§ 28b		Method Collection
§ 29		Evaluation and provision of data
§ 30		Adoption of legal regulations and administrative provisions
Section 31		Competent authority and competent federal authority
Fifth Part
	Liability rules
Section 32		Liability
§ 33		Maximum Liability
Section 34		Presumption of reason
§ 35		Claims of the injured party
§ 36		Coverage
§ 36a		Claims in case of use impairments
Section 37		Liability under other legislation
Sixth Part
	Criminal and penal rules
§ 38		Fines
§ 39		Criminal provisions
Seventh Part
	Transitional and final provisions
§ 40		(dropped)
Section 41		Transitional arrangements
§ 41a		(dropped)
§ 42		Applicability of the provisions applicable to the other States Parties to the Agreement on the European Economic Area

Part one
General provisions

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§ 1 Purpose of the Law

The purpose of this law is to:

1.

Taking into account ethical values, life and health of people, the environment in their impact, animals, plants and materials against the harmful effects of genetic engineering and products, and the provision of protection against the emergence of human beings, of such dangers,

2.

to ensure that products, in particular food and feed, can be produced and marketed conventionally, ecologically or with the use of genetically modified organisms,

3.

to provide the legal framework for research, development, use and promotion of the scientific, technical and economic possibilities of genetic engineering.

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§ 2 Scope

(1) This Act shall apply to:

1.

genetically engineered plants,

2.

Genetic engineering,

3.

Releases of genetically modified organisms and

4.

the placing on the market of products containing or consisting of genetically modified organisms; animals shall be considered as products within the meaning of this Act.

(2) The Federal Government shall be empowered to implement the decisions or decisions of the European Communities or the European Union referred to in Article 21 of Council Directive 90 /219/EEC of 23 April 1990 on the application of genetically modified organisms (genetically modified organisms) Micro-organisms in closed systems (OJ L 327 EC No 1), as last amended by Commission Decision 2005 /174/EC of 28 February 2005 (OJ L 117, 5.5.2005, p. EU No 20), to Annex II, Part C, after consultation of the Commission by means of a regulation with the consent of the Federal Council, by genetic engineering works with types of genetically modified micro-organisms, in whole or in part, by the provisions of this Act to be excluded. § § 32 to 37 shall remain unaffected. The legal regulation is intended to include a reporting obligation to the competent authority, which is limited to the type of genetically modified micro-organism used, the place where it is worked, and the person responsible for the purpose. . The competent authority is to keep a register and evaluate it at regular intervals. (2a) The Federal Government is authorised, after consultation of the Commission, by means of a legal regulation with the consent of the Federal Council. work with types of genetically modified organisms which are not micro-organisms and are safe for human health and the environment in accordance with the criteria for human health and the environment referred to in Annex II, Part B of Directive 90 /219/EEC; Installations in which containment measures are to be used which are suitable for: To limit contact between the organisms used with humans and the environment, in whole or in part, to be excluded from the provisions of the second and fourth parts of this law. (3) This Act does not apply to the application of genetically modified organisms to humans. (4) This Act permits further requirements for the placing on the market of products by other means. Legislation is unaffected. Unofficial table of contents

§ 3 Definitions

Within the meaning of this Act,

1.

organisers of any biological entity capable of proliferating or transferring genetic material, including micro-organisms,

1a.

microorganism viruses, viroids, bacteria, fungi, microscopically small single-cell or multicellular algae, lichens, other eukaryotic single-cell or microscopically small animal multicellular organisms as well as animal and plant cell cultures,

2.

Genetic engineering

a)

the production of genetically modified organisms;

b)

the reproduction, storage, destruction or disposal of genetically modified organisms as well as their use in another way, in so far as no authorisation for release or placing on the market is not yet carried out for the purpose of: the subsequent discharge into the environment has been granted,

3.

genetically modified organism, with the exception of humans, the genetic material of which has been altered in such a way that it does not occur under natural conditions by crosses or natural recombination; Genetically modified organism is also an organism which is caused by crossing or natural recombination between genetically modified organisms or with one or more genetically modified organisms or by other species of the genetically modified organism. Reproduction of a genetically modified organism shall be carried out if the the genetic material of the organism has properties that are due to genetic engineering works,

3a.

Methods of alteration of genetic material in this sense are in particular:

a)

Nucleic acid recombination techniques in which the introduction of nucleic acid molecules produced outside of an organism into viruses, viroids, bacterial plasmids or other vector systems, new combinations of genetic material and these are introduced into a host organism in which they do not occur under natural conditions,

b)

processes in which an organism is directly introduced into an organism which has been produced outside the organism and is naturally not present in it, including microinjection, macro-injection and microencapsulation,

c)

Cell fusions or hybridization methods in which living cells with new combinations of genetic material, which does not occur under natural conditions, by the fusion of two or more cells by means of methods , which do not occur under natural conditions,

3b.

shall not be considered as a method of modification of genetic material

a)

In vitro fertilisation,

b)

natural processes such as conjugation, transduction, transformation,

c)

polyploidic induction,

unless genetically modified organisms are used or recombinant nucleic acid molecules produced within the meaning of points 3 and 3a. Furthermore, genetic material is not considered to be a method of change

a)

mutagenesis and

b)

Cell fusion (including protoplast fusion) of plant cells of organisms capable of exchanging genetic material by means of conventional breeding techniques;

Unless genetically modified organisms are used as donors or recipients,

3c.

in the absence of a project of release or placing on the market and unless genetically modified organisms are used as donors or recipients, the modification of genetic modification shall not be considered to be a method of change Materials

a)

Cell fusion (including protoplast fusion) of prokaryotic species, which exchange genetic material via known physiological processes,

b)

Cell fusion (including protoplast fusion) of cells of eukaryotic species, including the production of hybridomas and the fusion of plant cells,

c)

Self-cloning of non-pathogenic, naturally occurring organisms, consisting of

aa)

the removal of nucleic acid sequences from cells of an organism,

bb)

the re-introduction of the whole or part of the nucleic acid sequence (or a synthetic equivalent) in cells of the same species or in cells of phylogenetically closely related species, the genetic material by natural physiological processes , and

cc)

any preceding enzymatic or mechanical treatment.

For self-cloning, the use of recombinant vectors can also count if they have been applied safely in this organism for a long time,

4.

Genetic engineering equipment in which genetic engineering works within the meaning of point 2 are carried out in the closed system and in which specific containment measures are used to establish contact between the organisms used and human beings, and to limit the environment and to ensure a level of safety appropriate to the hazard potential,

5.

-release the targeted delivery of genetically modified organisms to the environment where no marketing authorisation has yet been granted for the purpose of later release into the environment,

6.

Placing on the market the supply of products to third parties, including the provision for third parties, and the transfer to the scope of the law, in so far as the products are not intended for genetic engineering work in genetic engineering plants or for approved Releases are determined; however,

a)

transit traffic carried out under customs control,

b)

The provision for third parties, the delivery and the transfer to the scope of the law for the purpose of an approved clinical trial

not as placing on the market

6a.

Handling of genetically modified organisms ' application, reproduction, cultivation, storage, transport and disposal, and consumption and other use and handling of products authorised for placing on the market, which are genetically modified organisms contain or consist of

6b.

Risk management of the risk assessment process of weighing alternatives in the prevention or control of risks,

7.

Operator of a legal or natural person or association of persons who, under its name, establishes or operates a genetic engineering plant, carries out genetic engineering work or releases, or products which are genetically engineered contain or consist of modified organisms for the first time; if an authorisation has been granted in accordance with § 16 para. 2, which, according to § 14 para. 1 sentence 2, also the placing on the market of the offspring or the propagating material , in so far as only the marketing authorisation holder is operator,

8.

Project manager, a person carrying out, in the course of their professional duties, the direct planning, management or supervision of a genetic engineering work or release,

9.

A person or a majority of persons (Biological Safety Committee) who is responsible for verifying the performance of the tasks of the project manager and advising the operator,

10.

Safety level groups of genetic engineering work according to their hazard potential,

11.

laboratory safety measures or production safety measures, and a set of equipment for the production of genetic engineering,

12.

biological safety measures, the use of recipient organisms and vectors with certain risk-reducing properties;

13.

Vector a biological carrier, which introduces nucleic acid segments into a new cell.

13a.

A legal or natural person, or a non-fierce association of persons, which has the right to dispose of genetically modified organisms and to have effective jurisdiction over an area for cultivation.

14.

The employees according to § 2 para. 2 of the German Occupation Protection Act are equal to students, students and other persons carrying out genetic engineering work.

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§ 4 Commission for Biosafety

(1) Under the heading "Central Commission for Biological Safety" (Commission), a Commission of Experts shall be established with the competent authority of the Federal Republic of Germany. The Commission is composed of:

1.

Twelve experts who have experience in the fields of microbiology, cell biology, virology, genetics, plant breeding, hygiene, ecology, toxicology and safety engineering as well as international experience in the fields of microbiology, cell biology, ecology, toxicology and safety engineering; at least seven in the field of the recombination of nucleic acids; each of the said areas shall be represented by at least one expert, the field of ecology shall be represented by at least two experts;

2.

In each case, a competent person from the fields of trade unions, occupational safety and health, the economy, agriculture, environmental protection, nature protection, consumer protection and research-promoting organisations.

For each Member of the Commission, an alternate member shall be appointed from the same area. In so far as it is necessary for the tasks to be carried out properly, the Commission may, after consulting the Commission, appoint up to two experts as additional alternates. (2) The members of the Commission shall: , the Federal Ministry of Food, Agriculture and Consumer Protection, in agreement with the Federal Ministries of Education and Research, the Federal Ministry of Economics and Technology, for Labour and Social Affairs, for Health and for the Environment, Nature Conservation and Reactor safety for a period of three years. Revocation shall be admissible. (3) The members and the alternates shall be independent in their activities and shall not be bound by instructions. (4) The Commission reports annually to the public in general about its work. (5) The Federal Government is empowered to act with the consent of the Federal Council with the consent of the Federal Council for further information on the to regulate the appointment and procedure of the Commission, the use of external experts and the cooperation of the committees with the authorities responsible for the enforcement of the law. By means of a legal regulation with the consent of the Federal Council, it may also be determined that the appeal decision in accordance with paragraph 2 is to be taken in consultation with the national governments. Unofficial table of contents

§ 5 Tasks of the Commission

The Commission examines and evaluates safety-related questions in accordance with the provisions of this law, provides recommendations and advises the Federal Government and the Länder on safety-related issues concerning genetic engineering. In its recommendations, the Commission should also take appropriate account of the state of international development in the field of genetic safety. The Commission publishes general opinions on frequently carried out genetic engineering work, with the underlying criteria of comparability in the Federal Gazette. As far as the general opinions on occupational safety and health are concerned, the Committee on Biological Agents has previously been consulted in accordance with Article 17 of the Biosubstance Regulation. Unofficial table of contents

§ 5a (omitted)

- Unofficial table of contents

§ 6 General due diligence and recording obligations, risk prevention

(1) Anyone who constructs or operates genetic engineering plants, carries out genetic engineering works, releases genetically modified organisms, or products that contain or consist of genetically modified organisms, as an operator in transport , the risks related to the legal goods referred to in Article 1 (1) shall be assessed in advance (risk assessment) and shall be subject to periodic review of this risk assessment and security measures and, where appropriate, in accordance with the examination result is necessary to revise, but without delay, if:

1.

the security measures applied are no longer appropriate, or the security level assigned to the genetic engineering work is no longer appropriate; or

2.

there is a reasonable assumption that the risk assessment no longer corresponds to the latest scientific and technical knowledge.

In the case of the risk assessment by the competent federal authority, use of antibiotic resistance markers in genetically modified organisms, resistance to antibiotics used in medical or veterinary treatment is , with a view to identifying and phasing out the use of antibiotic resistance markers in genetically modified organisms which have harmful effects on human health or the environment , for the placing on the market until 31 December 2004 and for the release of by 31 December 2008. (2) In accordance with the results of the risk assessment, the operator must take the necessary measures in accordance with the state of science and technology and adapt them without delay in order to comply with the provisions of § 1 no. 1. to protect these legal goods against possible dangers and to prevent the emergence of such hazards. The operator must ensure that even after an operating setting of the installation, no risks can arise for the legal goods referred to in § 1 (1). (3) The operator has to carry out genetic engineering work and releases. keep records and submit them to the competent authority in response to their request. The Federal Government, with the consent of the Federal Council, shall, after consulting the Commission, regulate the details of the form and content of the records and the storage and presentation obligations. (4) Those who work on genetic engineering or Releases shall be obliged to appoint project managers as well as representatives or committees for biosafety.

Part two
Genetic engineering work in genetic engineering plants

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§ 7 Security levels, security measures

(1) Genetic works are classified in four levels of safety:

1.

Safety level 1 shall be assigned to genetic engineering works in which, according to the state of science, there is no risk to human health and the environment.

2.

Safety level 2 is to be classified as genetic engineering, where, according to the state of the art, there is a low risk to human health or the environment.

3.

Safety level 3 shall be classified as genetic engineering, where, according to the state of science, a moderate risk to human health or the environment is to be considered.

4.

Safety level 4 shall be assigned to genetic engineering works in which, according to the state of the art, there is a high risk or reasonable suspicion of such a risk to human health or the environment.

The Federal Government is authorized, after consultation of the Commission by means of a regulation with the consent of the Federal Council, to assign certain types of genetic engineering work to the safety levels with the consent of the Federal Council for the purposes of Article 1 (1). rules. The assignment takes place on the basis of the risk potential of the genetic engineering work, which is determined by the properties of the recipient and donor organisms, the vectors as well as the genetically modified organism. In this context, consideration should be given to possible effects on employees, the population, livestock, crops and the other environment, including the availability of appropriate countermeasures. (1a) Doubts exist as to which If the safety level is appropriate for the proposed genetic engineering work, then the genetic engineering work must be assigned to the higher safety level. On a case-by-case basis, the competent authority may, on request, allow a lower level of safety, provided that adequate protection is provided for human health and the environment. (2) When carrying out the application of genetic engineering Certain security measures must be taken into consideration. The Federal Government, after consulting the Commission, shall, by means of a regulation with the consent of the Federal Council, regulate the security measures necessary for the laboratory for the different safety levels in accordance with the state of the art and technology. and production sector, for animal husks and greenhouses, as well as the requirements for the selection and safety assessment of the recipient organisms and vectors used in genetic engineering work. Unofficial table of contents

§ 8 Approval, notification and registration of genetic engineering plants and first-time genetic engineering works

(1) Genetic engineering works may only be carried out in genetic engineering plants. The establishment and operation of genetically engineered plants, which are intended to carry out genetic engineering work at security level 3 or 4, require approval (plant approval). The authorisation is authorised to carry out the genetic engineering work mentioned in the notice of approval. (2) The establishment and operation of genetically engineered plants, which are intended to carry out genetic engineering work at security level 1 or 2, and the intended first-time genetic engineering work shall be carried out by the operator of the competent authority prior to the intended start of the installation or, if the installation is already in place, before the intended start of the operation in the case of the To view security level 1 and to log in to security level 2. By way of derogation, the operator of a plant in which a safety level 2 is to be carried out may apply for a plant authorisation in accordance with the second sentence of paragraph 1. (3) The authorisation may be granted on request for:

1.

the establishment of a genetic engineering plant or part of such an installation, or

2.

the establishment and operation of a part of a genetic engineering plant (partial authorisation).

(4) The essential change in the location, nature or operation of a genetic engineering plant to be carried out in the genetic engineering works of security level 3 or 4 requires a plant permit. Paragraph 2 shall apply mutagenic to any significant changes in the location, nature or operation of a genetic engineering plant in which the operations of the safety level 1 or 2 are to be carried out by genetic engineering. Unofficial table of contents

§ 9 Further genetic engineering works

(1) Further genetic engineering works of safety level 1 can be carried out without any indication. (2) Further genetic engineering works of safety level 2 shall be carried out by the operator with the competent authority before the intended start of the work. . By way of derogation from the first sentence, the operator may apply for a permit. (3) Further genetic engineering works of the safety level 3 or 4 require a permit. (4) Further genetic engineering works which are to be assigned to a higher safety level than The works included in the approval pursuant to § 8 (1) sentence 2 or from the advertisement or notification pursuant to § 8 (2) sentence 1 may only be granted in accordance with their security level pursuant to a new authorisation pursuant to Section 8 (1) sentence 2 or a new Registration in accordance with § 8 (2) sentence 1 are carried out. (4a) Should an already indicated, declared or -the genetic engineering work of safety levels 2 and 3 in another approved or approved genetic engineering plant of the same operator in which the appropriate genetic engineering works may be carried out shall be carried out; to communicate to the competent authority prior to the commending of the work by the operator. (5) Other genetic engineering works of safety level 2, 3 or 4, which are carried out by an international filing body for the purpose of meeting the requirements of the Budapest Treaty of 28 April 1977 on the international recognition of the Deposit of microorganisms for the purposes of patent procedures (BGBl. 679), the competent authority must be notified immediately after the commencement of the work by the operator. (6) Further genetic engineering work, on the initiative of the competent authority, for the development of the Sample testing required detection methods or for the examination of a sample within the framework of the monitoring in accordance with § 25 may be carried out by way of derogation from paragraph 2. Unofficial table of contents

§ 10 Approval Procedure

(1) The authorisation procedure requires a written application. (2) A request for approval of a genetic engineering plant shall be accompanied by the documents which are to be submitted for examination of the conditions of the approval, including the requirements of § 22 (1). co-operating decisions are required. The documents shall, in particular, contain the following information:

1.

the location of the genetic engineering plant and the name and address of the operator,

2.

the name of the project manager and proof of the necessary expertise,

3.

the name of the person or agent responsible for the biological safety and the proof of the necessary expertise,

4.

a description of the existing or planned genetic engineering plant or plant and its operation, in particular the facilities and arrangements relevant to safety and health and safety at work;

5.

the risk assessment in accordance with Article 6 (1) and a description of the genetic engineering works provided for, from which the properties of the donor and recipient organisms used or of the initial organisms or, where appropriate, used Host vector systems as well as the vectors and the genetically modified organism with regard to the required safety level as well as their possible safety-related effects on the legal goods referred to in § 1 No. 1 and the the necessary facilities and arrangements, in particular those relating to the protection of employed persons,

6.

a description of the techniques available for the detection, identification and monitoring of the genetically modified organism;

7.

information on the number and training of personnel, contingency plans and information on measures to prevent accidents and malfunctions;

8.

Information on waste and waste water disposal.

(3) A request for authorisation to carry out further genetic engineering works shall be accompanied by the documents necessary for the examination of the conditions of approval. The documents shall, in particular, contain the following information:

1.

a description of the proposed genetic engineering work in accordance with the second sentence of the second sentence of paragraph 2,

1a.

a description of the techniques available for the detection, identification and monitoring of the genetically modified organism;

2.

a statement by the project manager as to whether and, where appropriate, how the information referred to in the second sentence of paragraph 2 has changed,

3.

Date and reference number of the approval certificate for the establishment and operation of the genetic engineering plant or the receipt of receipt of the application pursuant to § 12 para. 3,

4.

a description of necessary changes to the safety-related facilities and arrangements, in particular the measures to protect employees;

5.

Information on waste and waste water disposal.

(4) The competent authority shall immediately confirm in writing to the applicant the receipt of the application and the documents annexed thereto, and shall examine whether the application and the documents are sufficient for the examination of the conditions for approval. If the application or documents are not complete or do not allow them to be assessed, the competent authority shall, without delay, request the applicant to supplement the application or documents within a reasonable time. (5) A request pursuant to section 8 (1) sentence 2, second sentence 2, sentence 2, para. 3 or 4 or § 9 para. 4 shall be decided in writing within a period of 90 days. The competent authority shall, in the case of the authorisation of a genetic engineering plant in which the genetic engineering works of safety level 2 are to be carried out, decide on the application without delay, at the latest after 45 days, when the The genetic engineering work of a genetic engineering work already classified by the Commission is comparable; paragraph 7, sentences 1 to 4, does not apply. If the establishment or operation of the genetic engineering plant, which is to be carried out in the genetic engineering work of the security level 2, requires further administrative decisions pursuant to § 22 para. 1, the time limit referred to in sentence 2 shall be extended to 90 days. The time limits shall rest as long as a hearing procedure is carried out in accordance with Article 18 (1) or the authority is awaiting the addition of the application or documents, or until the Commission's required opinion on the safety classification of the (6) In the case of a request pursuant to § 9 para. 2 sentence 2 or para. 3, a written decision must be made within a period of 45 days. The competent authority shall, in the case of the authorisation of other genetic engineering works, have to decide on the application without delay of the application, at the latest after 45 days, if the genetic engineering work of a Member State already classified by the Commission has been completed. Paragraph 7, sentences 1 to 4, shall not apply. The time limit shall be fixed as long as the Authority is awaiting the addition of the application or documents, or until the necessary Commission opinion on the safety classification of the proposed genetic engineering works and the necessary technical requirements for the (7) Before deciding on a permit, the competent authority shall, through the competent authority of the federal authority, obtain an opinion from the Commission on the safety classification of the intended Genetic engineering work and the necessary safety technology Measures. The Commission shall deliver its opinion without delay. The opinion shall be taken into account in the decision. If the competent authority departs from the opinion of the Commission in its decision, it shall state the reasons for its decision in writing. The competent authority shall also seek the opinions of the authorities whose remit is affected by the project. (8) Before an administrative action is brought, a decision on the request for authorisation of the establishment shall be made. and the operation of a genetic engineering plant shall not be subject to a pre-trial procedure provided that a consultation procedure has been carried out in accordance with Section 18. Unofficial table of contents

Section 11 Approval requirements

(1) The approval for the establishment and operation of a genetic engineering plant shall be granted where:

1.

there are no facts which raise concerns about the reliability of the operator and of the persons responsible for the establishment and management and supervision of the operation of the installation,

2.

ensure that the project manager, as well as the person responsible for the biosafety, possess the necessary expertise to carry out their tasks, and that they are able to meet the obligations of the project,

3.

ensure that the applicant complies with the obligations of Article 6 (1) and (2) and the legal regulations pursuant to section 30 (2), (2), (4), (4), (5), (5), (6) and (9) for the implementation of the proposed genetic engineering works,

4.

ensure that the necessary safety level is provided with the necessary facilities in accordance with the state of the art and technology, and that precautions are taken and, therefore, harmful effects on the the legal goods are not to be expected,

5.

there are no facts to which the prohibitions laid down in Article 2 of the Law of 21 February 1983 on the Convention of 10 April 1972 on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons as well as on the destruction of such weapons (BGBl. 132) and the provisions on the prohibition of biological and chemical weapons in the Implementing Act to Article 26 (2) of the Basic Law (Law on the Control of War Weapons in the Version of the Notice of 22 November 1990 (BGBl). 2506), as last amended by Article 17 of the Law of 21 December 1992 (BGBl I). 2150)), and

6.

Other public-law provisions and concerns relating to the protection of workers do not preclude the establishment and operation of the genetic engineering plant.

(2) The partial authorisation in accordance with Article 8 (3) shall be granted if a preliminary examination shows that the conditions set out in paragraph 1 are to be met with a view to the establishment and operation of the entire genetic engineering plant and that a justified (3) The approval pursuant to § 9 para. 2 sentence 2 or para. 3 shall be granted if the conditions set out in paragraph 1 (1) to (5) for the implementation of the other genetic engineering works provided for exist. Unofficial table of contents

§ 12 Display and registration procedures

(1) Display and registration must be given in writing. (2) On display of an installation in which the genetic engineering works of the security level 1 are to be carried out:

1.

the documents referred to in Article 10 (2), second sentence, no. 1 to 3 and 8,

2.

a general description of the genetic engineering plant,

3.

a summary of the risk assessment in accordance with section 6 (1),

4.

a description of the nature of the proposed genetic engineering works.

In the case of notification of an installation in which a genetic engineering work of the security level 2 is to be carried out, the documents must be submitted in accordance with § 10 (2) sentence 2 no. 1 to 8. (2a) When further genetic engineering work is displayed, the safety level 2 in accordance with Section 9 (2):

1.

a summary of the risk assessment in accordance with section 6 (1) and a description of the genetic engineering work provided for in accordance with § 10 (2) sentence 2 no. 5,

2.

a statement by the project manager as to whether and how the information has changed in accordance with § 10 (2) sentence 2 Nos. 1 to 3 and 6,

3.

the file number and date of the approval certificate for the establishment and operation of the genetic engineering plant or the confirmation of receipt of the application in accordance with section 12 (3),

4.

a description of the necessary changes to the safety-related facilities and arrangements;

5.

Information on waste disposal.

(3) The competent authority shall immediately confirm, in writing, the receipt of the notification and of the documents attached to the applicant and shall examine whether the application and the documents are sufficient for the assessment of the application. If the application or documents are not complete or do not allow them to be assessed, the competent authority shall immediately request the notifier to supplement the application or documents within a reasonable period. Sentences 1 and 2 shall apply to the notification accordingly. (4) In the case of security level 2, the competent authority shall obtain a Commission opinion on the safety classification of the designated competent authority. If the genetic engineering work is not comparable to a genetic engineering work already classified by the Commission, it will be necessary to carry out the necessary safety measures. The Commission shall deliver its opinion without delay. The opinion shall be taken into account in the decision. If the competent authority departs from the opinion in the event of a decision, it shall state the reasons for that decision in writing. (5) In the case of safety level 2, the operator may be responsible for the establishment and operation of the genetic engineering plant and with the implementation of the first-time genetic engineering work 45 days after the notification has been received by the competent authority or with the consent of the competent authority, even earlier. The expiry of the period shall be deemed to consent to the establishment and operation of the genetic engineering plant and to the execution of the genetic engineering work. The time limit shall be fixed as long as the Authority is awaiting the completion of the dossier or until the necessary Commission opinion on the safety classification of the proposed genetic engineering work and on the necessary (5a) The operator may be involved in the establishment and operation of the genetic engineering plant and with the implementation of the first-time genetic engineering work in the case of safety level 1 as well as with the implementation of Further genetic engineering work in the case of safety level 2 immediately after receipt of the display at the competent authority. The competent authority may provisionally carry out, or continue to carry out, the genetic engineering work up to the end of 21 days after receipt of the supplementary documents requested in accordance with paragraph 3 or the opinion of the competent authority referred to in paragraph 4 of this Article. Commission shall prohibit, to the extent necessary to ensure the purposes referred to in Article 1 (1). (6) The competent authority may make the carrying out of the indicated or notified work of genetic engineering subject to conditions, for a limited period or subject to conditions, to the extent that this is necessary in accordance with § 1 (7) The competent authority may prohibit the carrying out of the indicated or notified works of genetic engineering if the requirements referred to in Article 11 (1) (1) to (5) of this Regulation are fulfilled. are not or are no longer being complied with or are contrary to the interests of occupational safety and health. The decision shall require the written form. Unofficial table of contents

§ 13

(dropped)

Part Three
Release and marketing

Unofficial table of contents

Section 14 Release and placing on the market

(1) Approval of the competent federal authority shall be required.

1.

release of genetically modified organisms,

2.

bring products containing or consisting of genetically modified organisms into the market;

3.

products containing, or consisting of, genetically modified organisms for a purpose other than the intended use to date,

4.

Products placed on the market which have been obtained from or produced from released genetically modified organisms for which there is no authorization as specified in point 2.

The authorisation for release or placing on the market may also include the offspring and the propagating material of the genetically modified organism. The marketing authorisation may be limited to certain uses. The change of a release does not require approval if the competent federal authority determines that the change does not have a significant effect on the assessment of the conditions pursuant to § 16 para. 1. (1a) A marketing authorisation does not require the placing on the market of products containing or consisting of genetically modified organisms, the products which are

1.

have been manufactured in accordance with Article 3 (3) (c), and

2.

shall be placed in an installation in which containment measures shall be applied in accordance with the provisions of sentence 2.

3.

(dropped)

The containment measures must be appropriate to limit the contact of products with humans and the environment and to ensure a level of safety appropriate to the hazard potential. The containment measures should also comply with the security measures provided for in Article 7 (2) in conjunction with the legal regulation referred to therein. In so far as the products referred to in the first sentence do not require a marketing authorization, the other provisions of this Act and the provisions of the law on placing on the market adopted pursuant to this Act shall not apply. (2) Insofar as the The placing on the market shall be governed by legislation governing the provisions of this Act and of the legal provisions adopted pursuant to this Act concerning risk assessment, risk management, labelling, monitoring and information of at least equivalent to the general public, the rules shall apply of the third part, with the exception of § § 16a and 16b as well as § 17b (1) and § 20 (2) not. (2a) to (2d) (omitted) (3) A permit can be applied to the release of a genetically modified organism or a combination of genetically modified organisms. modified organisms at the same site or at different sites, provided that the release takes place for the same purpose and within a period of time specified in the permit. (4) The Federal Government may decide to implement the decision Commission Decision 94 /730/EC of 4 November 1994 laying down simplified procedures for the deliberate release of genetically modified plants in accordance with Article 6 (5) of Council Directive 90 /220/EEC (OJ L 206, 22.7.1990, p. EC No 31), after consulting the Commission, by means of a regulation with the consent of the Bundesrat, it shall determine that a simplified procedure deviating from the proceedings of the third part of this Act shall apply to the release, to the extent that: (4a) The Federal Government may decide to implement the decisions or decisions of the European Communities or of the European Communities, or the European Communities, or the European Union, to ensure that they have sufficient experience in the field of protection. Union pursuant to Article 7 (3) in conjunction with Article 30 (2) of Directive 2001 /18/EC Consultation of the Commission by means of a regulation with the consent of the Federal Council shall determine that:

1.

for the approval of the release, a simplified procedure deviating from the proceedings of the third part of this Act shall apply,

2.

to the authorisations referred to in point 1 of paragraph 3,

as far as sufficient experience has been gained with the release of organisms in view of the conditions laid down in Article 16 (1). In the case of the legal regulation, in particular the provisions of Section 18 (2) sentence 1 and (3), including in connection with the provisions of the law referred to therein, derogations may be made by way of the hearing. (5) The authorization of the placing on the market by the competent federal authority shall be the same as authorisations granted by the authorities of other Member States of the European Union or of other States Parties to the Agreement on the European Economic Area, in accordance with the provisions of the Directive implementing the Directive Directive 2001 /18/EC has been granted. The Federal Government is empowered to adopt, by means of a regulation with the consent of the Federal Council, provisions concerning the notification of authorisations equivalent to that laid down in the first sentence. Unofficial table of contents

Section 15 Authorisation application for release and placing on the market

(1) The application for the approval of a release shall be accompanied by the documents necessary for the examination. The documents must contain, in addition to the information described in section 10 (2), second sentence, no. 2 and 3, the following information:

1.

the name and address of the operator;

2.

the description of the release project in respect of its purpose and location, the time and period,

3.

the description of the safety-relevant properties of the organism to be released and of the circumstances relevant to the survival, reproduction and distribution of the organism, as appropriate to the state of the scientific community; documents shall be accompanied by previous work in a genetic engineering plant and on releases;

4.

a risk assessment pursuant to section 6 (1) and a presentation of the security measures provided for;

4a.

a plan to determine the impact of the organism to be released on human health and the environment;

5.

a description of the planned surveillance measures, as well as information on emerging residues and their treatment, as well as on contingency plans,

6.

a summary of the application documents in accordance with Council Decision 2002/813/EC of 3 June 2002 1 October 2002 laying down, in accordance with Directive 2001 /18/EC of the European Parliament and of the Council, the scheme for the summary of the information on the notification of a deliberate release into the environment of genetically modified organisms a purpose other than that of placing on the market (OJ C EC No L 280 p. 62).

(2) (omitted) (3) Anyone who makes an application for a marketing authorisation must be established in a Member State of the European Union or appoint a representative established there. The application shall be accompanied by the documents necessary for the examination of the conditions of approval. The documents shall, in particular, contain the following information:

1.

the name and address of the operator;

2.

the name and a description of the product to be placed on the market as regards the genetically modified specific properties; documents relating to previous work in a genetic engineering Annex and on releases shall be accompanied by:

3.

a description of the types of use to be expected and the planned spatial distribution;

3a.

information on the period of validity of the authorisation requested,

4.

a risk assessment in accordance with Article 6 (1), including a presentation of the potential adverse effects;

5.

a description of the measures envisaged to control the further behaviour or quality of the product to be placed on the market, the remaining substances and their treatment, and the contingency plans;

5a.

an observation plan, taking into account the observation obligation in accordance with § 16c, including the information on its duration,

6.

a description of specific conditions for the handling of the product to be placed on the market and a proposal for its labelling and packaging;

7.

a summary of the application documents in accordance with Council Decision 2002/812/EC of 3 December 2002 1 October 2002 laying down, in accordance with Directive 2001 /18/EC of the European Parliament and of the Council, the nomenclature for the summary of the information on the placing on the market of genetically modified organisms as products or in products (OJ L 327, 22.12.2001, p. EC No L 280 p. 37).

(4) The application for renewal of the marketing authorisation shall be submitted no later than nine months before the expiry of the authorisation (exclusion period). The application shall be accompanied by the documents necessary for the examination. The documents shall, in particular, contain the following information:

1.

a copy of the marketing authorisation;

2.

a report on the results of the observation,

3.

new information which goes beyond the report referred to in point 2 and which has become known to the applicant in respect of the risks arising from the product in respect of the legal goods referred to in Article 1 (1).

If, on the basis of the findings available to it, the applicant considers that a change in the substance of the authorisation to date, in particular as regards the observation plan or the period of validity of the authorisation, is necessary, the applicant shall, in the application, request: . Unofficial table of contents

Section 16 Authorisations for release and placing on the market

(1) The authorisation for a release shall be granted if:

1.

the conditions are in accordance with Article 11 (1) (1) and (2);

2.

ensures that all the necessary safety precautions are taken in accordance with the state of science and technology;

3.

in accordance with the state of the art in relation to the purpose of the release, unreasonably harmful effects on the legal goods referred to in § 1 (1) are not to be expected.

(2) The marketing authorisation shall be granted or extended if, in accordance with the state of the scientific community in relation to the purpose of the placing on the market, undue harmful effects on the legal goods referred to in § 1 (1) do not apply are to be expected. In the event of an application for renewal of the marketing authorisation, the placing on the market shall be deemed to be provisional until the administrative procedure has been completed, provided that such a request has been made in good time. (3) The application for a release is to be made in writing within 90 days of receipt of the application. Before deciding on an application for marketing authorisation, an evaluation report shall be drawn up and notified to the applicant within 90 days of receipt of the application by the competent authority of the Federal Republic of Germany; The application shall be made without delay after the conclusion of the procedure laid down in Articles 14, 15 and 18 of Directive 2001 /18/EC (EU participation procedure), but at the latest within 30 days. The time limits laid down in the first and second sentences shall rest as long as the competent authority of the federal authority has requested further information, documents or samples requested by the applicant; a public participation in accordance with section 18 (2) shall be extended, extended the period of time during which the hearing is carried out, but not more than 30 days. Before deciding on an application for an extension of the marketing authorisation, an evaluation report shall be drawn up by the competent federal authority and shall be notified to the applicant; the application shall be immediately after completion the procedure provided for in Article 17 of Directive 2001 /18/EC, but at the latest within 30 days in writing. (4) The decision on release shall be taken in consultation with the Federal Agency for Nature Conservation and the Robert Koch Institute as well as the Federal Institute for Risk Assessment; a prior opinion of the Julius Kühn Institute, Federal Research Institute for Cultural Plants, and, as far as genetically modified vertebrate animals or genetically modified microorganisms which are used in vertebrate animals, are affected, including the Friedrich-Loeffler-Institut (Friedrich-Loeffler-Institut) Prior to the granting of a permit for a release, an opinion shall be obtained from the competent State authority. Decisions on the granting or renewal of the marketing authorisation, including the submission of evaluation reports and opinions on evaluation reports of competent authorities of other Member States, shall be taken in consultation with with the Federal Agency for Nature Conservation, the Robert Koch Institute and the Federal Institute for Risk Assessment; previously, a statement by the Julius Kühn Institute, Federal Research Institute for Cultural Plants, and, as far as genetically modified vertebrates are concerned, or genetically modified micro-organisms on vertebrate animals , the Friedrich-Loeffler-Institut and the Paul-Ehrlich-Institute are to be collected. (5) Before granting the permit, the Commission shall examine and assess the application for possible risks for those referred to in § 1 no. 1 , in the cases referred to in paragraph 1, taking into account the security arrangements envisaged, and shall make recommendations on this subject. (5a) The provisions of a marketing authorisation shall also be taken into account by the other parties to the placing on the market of the product or the handling of those persons, insofar as they relate to the marketing of the product or to the handling of such products. Use or handling of the product, in particular its application, transport or storage, if the permit has been made public. (6) The Federal Ministry of Food, Agriculture and Consumer Protection will authorized, by means of a regulation with the consent of the Federal Council, the procedure of Participation of the European Commission and of the Member States of the European Union and of the other States Parties to the Agreement on the European Economic Area in the context of the release of genetically modified organisms and the The placing on the market of products containing or consisting of genetically modified organisms and the obligation of the competent authority, observations of the Member States of the European Union and of the other States Parties to the Agreement on the European Economic Area, or to implement decisions or decisions of the European Commission in so far as this is necessary for the implementation of the Council Directive on the deliberate release into the environment of genetically modified organisms, as amended in each case is required. The legal regulation referred to in the first sentence may provide for authorisation to be granted or to be refused, even by way of derogation from the provisions of this Act, in so far as this is in a decision or in a decision of the European (7) In the case of a decision on the application, the Commission shall, in accordance with Section 20 (2) and an understatement in accordance with Article 26 (5), sentence 3. Authorisation of a release shall not take place in advance, provided that a hearing procedure in accordance with § 18 was carried out. Unofficial table of contents

§ 16a Location Register

(1) For the purpose of monitoring any effects of genetically modified organisms on the legal goods and concerns referred to in Article 1 (1) and (2), and for the purpose of informing the public, the information to be communicated in accordance with paragraph 2 shall be: on the release of genetically modified organisms and the information to be provided in accordance with paragraph 3 on the cultivation of genetically modified organisms in a federal register. The register shall be kept by the competent federal authority and shall record the data reported in accordance with paragraph 2 or paragraph 3 for the entire Federal territory. The register shall be generally accessible in accordance with paragraph 4. (2) The operator shall have the actual implementation of the approved release of genetically modified organisms no later than three working days prior to the release of the competent authority. to be notified to the Federal Supreme Authority. The communication shall include the following information:

1.

the name of the genetically modified organism,

2.

its genetically modified properties,

3.

the plot of the release as well as the size of the release area,

4.

the release period.

(3) The cultivation of genetically modified organisms shall be notified by the person who farmed the land at the latest three months before the cultivation of the to the competent federal authority. The communication shall include the following information:

1.

the name and the specific identification marker of the genetically modified organism,

2.

its genetically modified properties,

3.

the name and address of the person who manages the area;

4.

the plot of the cultivation as well as the size of the area.

Any changes to the information shall be notified immediately. (4) The generally accessible part of the register shall include:

1.

the name and the specific identification marker of the genetically modified organism,

2.

its genetically modified properties,

3.

the land of the release or cultivation as well as the area size.

Information from the generally accessible part of the register will be supplied via the Internet via the automated call. (5) The competent federal authority shall also provide information from the non-generally accessible part of the register on the Internet. Personal data, insofar as the applicant has a legitimate interest and there is no reason to believe that the person concerned has an overriding interest in the exclusion of the information. (5a) The Execution of this law competent authority of a country may be used for the purpose of monitoring to retrieve the data stored in the non-generally accessible part of the register in the automated procedure, in so far as a lot of land is affected, which is situated in its area of responsibility; § 10 (2) to (5) of the Federal Data Protection Act (Bundesdatenschutzgesetz (6) The competent federal authority shall take appropriate measures to ensure data security and data protection, in particular the integrity of the data and the confidentiality of the data in the relevant state of the art, in order to ensure data security and data protection. ensure that the register of data is not generally accessible to the public; in the case of the use of publicly available data networks for information referred to in paragraph 5, encryption procedures shall apply. The data of the Federal Register will be deleted after the expiration of 15 years after its first storage. (7) § 19 of the Federal Data Protection Act shall apply to legal entities accordingly. (8) (omitted) Unofficial table of contents

§ 16b Handling of products placed on the market

(1) Those products authorised to be placed on the market, containing or consisting of genetically modified organisms, shall be further processed, processed, in so far as they are animals, or economically, commercially or in the form of a commercial or commercial product. in a comparable manner, provision has to be made for the legal goods and concerns referred to in § 1 (1) and (2) to be brought into circulation by the transfer of properties of an organism based on genetic engineering works by means of: Admixture or other entries of genetically modified organisms not essential shall be affected. He does not have to comply with this obligation with regard to the matters referred to in Section 1 (2) in relation to another insofar as he waived his protection by written agreement with him or, on request, he waived the protection for his protection. does not provide the necessary information within one month and the obligation in each individual case is solely for the protection of the other. In the written agreement or the request, the other person shall be informed about the legal consequences of the agreement or the non-communication of the information and must point out that he has to observe the rights of third parties to be protected. The permissible deviation from the requirements of good professional practice shall be notified to the competent authority in good time before sowing or planting. (1a) The managing authority shall supplement the information in accordance with § 16a (3) sentence 2

1.

the fact of concluding an agreement within the meaning of the second sentence of paragraph 1, or

2.

the fact that the neighbour has not been informed of a request within the meaning of the second sentence of paragraph 1, in so far as it intends to depart from the requirements of good professional practice on the basis of a lack of information,

to notify the competent authority of the competent federal authority not later than one month before the cultivation, under the name of the land concerned. The generally accessible part of the register in accordance with § 16a (1) sentence 1 shall comprise, in addition to the claim in accordance with § 16a (4) sentence 1, No. 3, the indication referred to in the first sentence of the first sentence of the first sentence. In addition, § 16a applies accordingly. (2) In the cultivation of plants, in other dealings with plants and in the keeping of animals, the obligation of care as referred to in paragraph 1 is fulfilled by the observance of good professional practice. (3) To the good professional practice, in so far as this is necessary for the purpose of fulfilling the obligation of advance referred to in paragraph 1, in particular:

1.

in the handling of genetically modified organisms, compliance with the provisions of the marketing authorisation pursuant to Article 16 (5a),

2.

in the cultivation of genetically modified plants and in the production and application of fertilisers containing genetically modified organisms, measures to prevent entry into other land and to cross-crossings into other crops to avoid adjacent areas and the proliferation of wild plants,

3.

in the case of the keeping of genetically modified animals, the prevention of the escape from the area provided for and the entry of other animals of the same species in this area,

4.

in the case of the transport, storage and processing of genetically modified organisms, the prevention of losses and of mixtures and mixtures with other products.

(4) Anyone who deals with products containing or consisting of genetically modified organisms for commercial, commercial or comparable purposes must possess the reliability, knowledge, skills and equipment to which they are: (5) If products containing or consisting of genetically modified organisms are placed on the market, a product information item containing the provisions of the authorisation shall be supplied to the extent that: these relate to the handling of the product, and it is clear from the the obligations under paragraphs 1 to 3 can be fulfilled. (6) The Federal Government is empowered to comply with the principles of good professional practice within the meaning of paragraph 3, including the Information exchange with neighbours and authorities, the suitability of the person and equipment referred to in paragraph 4 and the content of the product information referred to in paragraph 5. Unofficial table of contents

§ 16c Observation

(1) Anyone who, as an operator, places on the market products consisting of or containing genetically modified organisms, has to observe them in accordance with the authorisation, in order to have any effect on the effects on the products referred to in § 1 (1) of this Regulation. (2) The aim of the observation is to:

1.

to confirm that there is an acceptance of the occurrence and effect of any harmful effect of a genetically modified organism or its use in the risk assessment (case-specific observation), and

2.

identify the occurrence of harmful effects of the genetically modified organism or its use on human health or the environment, which have not been foreseen in the risk assessment (general observation).

(3) The Federal Government is empowered, with the consent of the Federal Council, to regulate the general principles of the observation of genetically modified organisms by the operator in a legal regulation, in particular as regards the definition of the minimum standards of observation, the involvement of third parties and the involvement of federal observation activities. Unofficial table of contents

Section 16d Decision of the Authority on placing on the market

(1) The competent authority of the federal authority shall decide on the marketing authorisation for a product containing or consisting of genetically modified organisms, by way of:

1.

the intended use,

2.

the special conditions for the handling of the product and its packaging,

3.

the conditions for the protection of particular ecosystems, environmental conditions or geographical areas;

4.

the marking,

5.

the requirements for the details of the observation based on the risk assessment, the duration of the monitoring plan,

6.

the obligation to provide control samples.

(2) The marketing authorisation shall be granted for a maximum period of ten years. An extension of the permit shall be made for ten years. The extension may, for specific reasons, be issued for a shorter or longer period. In the case of a genetically modified organism which is to be placed on the market solely as a seed or propagating material, the period referred to in the first sentence shall begin with the notification of the registration of the first such organism in accordance with Council Directive 2002/53/EC of 13 June 2002 on a common catalogue of plant varieties for agricultural plant species (OJ L 327, 22.12.2002, p. EC No 1), as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 (OJ L 284, 31.10.2003, p. EU No 1), and to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 327, 31.12.2002, p. EC No 33), as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 (OJ L 284, 31.10.2003, p. EU No L 268 p. 1). Where the placing on the market of forest reproductive material is authorised, the period referred to in the first sentence shall begin with the notification of the registration in an official national register of raw materials, in accordance with Council Directive 1999 /105/EC of 22 December 1999 on the marketing of forest reproductive material (OJ C 327, 28.12.1999, p. EC 2000 No 11 p. 17). The operator must immediately inform the competent federal authority of the announcement of the registration pursuant to sentence 3 and 4. (3) The competent authority of the federal authority may, insofar as this is intended to prevent the state of the scientific community, in relation to the purpose of the The placing on the market of undue harmful effects on the legal goods referred to in paragraph 1 (1) is required to alter the decision taken in accordance with the first sentence of paragraph 1, point 5, in so far as this is necessary for the adaptation of the monitoring methods, the Methods of sampling or analysis to the state of science or to the Consideration of knowledge gained in the course of the observation is required. § § 48 and 49 of the Administrative Procedure Act remain unaffected. Unofficial table of contents

Section 16e Exceptions to seed not subject to labelling

§ § 16a and 16b are not to be applied to seed, provided that the seed does not indicate the genetic engineering of seed on the basis of a threshold value established in legislative acts of the European Union and its implementation by Article 17b (1) sentence 2. Change must be identified or, if it were to be placed on the market, should be labelled.

Fourth part
Common rules

Unofficial table of contents

§ 17 Use of documents

(1) Documents pursuant to § 10 (2) sentence 2 no. 5, subsection 3 sentence 2 no. 4, also in conjunction with § 12 paragraph 2, pursuant to § 12 para. 2a sentence 2 Nos. 1 and 4, § 15 para. 1 sentence 2 Nos. 2 and 4, subsection 3 sentence 2 Nos. 2, 4 and 5 are not required, insofar as the competent The Authority shall have sufficient knowledge. The operator may also refer to documents which he or a third party submitted in a previous procedure, unless it is confidential documents of the third party and the third party has its consent to use it is not granted. Where evidence of animal testing comes from a third party ' s dossier, the competent authority shall inform the applicant and the notifier of the documents of the third party to be used for the benefit of the applicant or the applicant. , as well as the name and address of the other. Where animal testing is not a condition, the written consent of a third party shall be required for the use of confidential documents. Sentences 3 and 4 shall not apply if the application or authorisation is longer than ten years. (2) The third party may, in the case of the third sentence of paragraph 1, use his documents within 30 days of receipt of the notification in accordance with , paragraph 1, sentence 3. In the event of an objection, the notification or approval procedure shall be suspended for a period of five years from the date of notification or status of the application for approval, but not later than ten years after the notification or the date of expiry of the notification. Approval of the third party. If the applicant or applicant would require a shorter period of time for the submission of his/her own documents, the notification or approval procedure shall be suspended only for that period. Prior to the suspension of the notification or approval procedure, the applicant or the applicant and the third party shall be heard. (3) In the case of paragraph 2, an application shall be made or a permit shall be issued before the expiry of ten years from the date of notification; or In order to grant the authorization of the third party using his/her documents, he shall be entitled, against the applicant or the applicant, to a remuneration of 50% of the remuneration saved by the applicant or the applicant by the use of the document. Expenses. The third party may prohibit the applicant or applicant from being placed on the market as long as he or she has not paid the remuneration or has lodged a reasonable amount of security for it. (4) Are at the same time a number of applicants or applicants. shall submit the same documents to a competent authority which requires animal testing, the competent authority shall inform the notifying parties or applicants of which documents are to be submitted jointly, as well as the names and addresses of the other parties concerned. The competent authority shall give the notifying parties or the notifiers concerned the opportunity to agree within a time limit to be determined by the competent authority, who shall submit the documents. In the event of an agreement not being reached, the competent authority shall decide and immediately inform all parties concerned. If they do not withdraw their application or their application, or if they do not fulfil the conditions of their notification obligation or their application, they are obliged to pay the pro rata expenses to the person who has submitted the documents. They shall be liable as a full debtor. Unofficial table of contents

§ 17a Confidentiality of information

(1) Information which constitutes an operational or commercial secret shall be identified by the operator as confidential. It shall state the reasons for the fact that the disclosure of business and commercial secrets could damage him or her business or business. If the competent authority considers the marking to be unauthorised, it shall consult the applicant and inform the applicant of its decision before deciding which information shall be treated confidentially. Personal data are the same as business and business secrets and must be treated confidentially. (2) Do not fall within the scope of business and business secrets within the meaning of paragraph 1

1.

general characteristics or description of the genetically modified organisms;

2.

the name and address of the operator;

3.

the place of genetic engineering or release and the purpose of release,

3a.

intended use,

4.

security level and security measures,

5.

methods and plans for the monitoring of genetically modified organisms and for emergency response,

6.

Risk assessment.

(3) Where a consultation procedure is to be carried out in accordance with § 18, the contents of the documents shall be the content of the documents, insofar as the information contains operational or business secrets or personal data and insofar as it is done without the disclosure of these protected data. may be presented in such detail that it is possible for third parties to assess whether and to what extent they are affected by the effects of the project. (4) The applicant or the applicant shall return the application or the application for authorisation, , the competent authorities shall maintain confidentiality. Unofficial table of contents

§ 17b Labelling

(1) Products containing or consisting of or consisting of genetically modified organisms shall be placed on a label or in an accompanying document in accordance with the provisions adopted pursuant to Article 30 (2) (14) of this Directive on: Labelling with the reference "This product contains genetically modified organisms". The Federal Government may, with the consent of the Federal Council, to implement a threshold value for the marking established pursuant to Article 21 (2), second sentence, in conjunction with Article 30 (2) of Directive 2001 /18/EC, by means of a regulation of the law with the consent of the (2) Genetically Modified Organisms (GMOs), which cannot be excluded from genetically modified organisms. (2) genetically modified organisms, which are the other ingredients of the Genetic engineering works in genetic engineering plants, for work in plants within the meaning of § 14 (1a) or to be made available for a release shall be indicated by the reference "This product contains genetically modified organisms". The provisions adopted pursuant to Article 30 (2) (14) concerning the labelling of genetically modified organisms shall apply mutagenic to the extent to which they are applicable to organisms as defined in the first sentence of the nature of the object. The Federal Government may, in accordance with Article 26 (2) in conjunction with Article 30 (2) of Directive 2001 /18/EC, after consulting the Commission, implement the implementing rules of the European Community or the European Union in accordance with Article 30 (2) of Directive 2001 /18/EC (3) The rules for the labelling and packaging of products approved for the placing on the market of genetically modified organisms (genetically modified organisms) modified organisms, or consisting of such organisms, shall not apply to products which are intended for direct processing and whose share of approved genetically modified organisms is not higher than 0.9 per cent, provided that this proportion is adventitily or technically not to be avoided. The Federal Government may set a lower threshold defined in accordance with Article 21 (3) in conjunction with Article 30 (2) of Directive 2001 /18/EC with the consent of the Federal Council. Unofficial table of contents

Section 18 Hearing procedure

(1) Prior to the decision on the establishment and operation of a genetic engineering plant to carry out genetic engineering work of safety stages 3 or 4 for commercial purposes, the competent authority shall have a hearing procedure , A consultation procedure shall be carried out for the approval of genetically engineered plants for the purpose of carrying out genetic engineering work of the safety level 2 for commercial purposes, provided that an authorisation procedure in accordance with § 10 of the Federal Immission Protection Act would be required. In the case of Section 8 (4), a hearing procedure shall be omitted if it is not to be provided that additional or other risks to the legal goods referred to in § 1 (1) are to be expected as a result of the amendment. (2) Prior to the decision on the authorisation a consultation procedure shall be carried out. § 14 (4a) sentence 2 remains unaffected. (3) The hearing procedure regulates the Federal Government by means of a regulation with the consent of the Federal Council. The procedure must comply with the requirements of Section 10 (3) to (8) of the Federal Immission Protection Act. In the case of proceedings pursuant to paragraph 2, Section 10 (4) (3) and (6) of the Federal Immission Control Act shall not apply; objections against the project may be made in writing or in writing within one month after the expiry of the period of interpretation of the project. the approval authority or the body in which the application and documents are designed for inspection. Unofficial table of contents

§ 19 By-law, subsequent conditions

The competent authority may provide its decision with secondary provisions to the extent that this is necessary to ensure the conditions of approval. In particular, certain procedures or safety precautions, or a certain nature or equipment of the genetic engineering plant, may be arranged by means of conditions. The subsequent inclusion of secondary provisions or conditions shall be permitted under the conditions set out in the first sentence. Unofficial table of contents

Section 20 Cessation of incitation

(1) If the conditions for the continuation of the operation of the genetic engineering plant, the genetic engineering work or the release are subsequently omitted, the authorisation may be replaced by a withdrawal or withdrawal of the authorisation in accordance with the provisions of the (2) If the placing on the market is granted, even one in accordance with § 14 (2) shall be placed on the market. (2) After the granting of a marketing authorisation, the operator shall also be required to comply with the conditions laid down in Article 14 (2). (5), on the basis of new or additional information, effects on risk assessment, or on the basis of a re-evaluation of the available information on the basis of new or additional scientific evidence, an justified reason to believe that the genetically modified In the event of a risk to human health or the environment, the competent national authority may, pending a decision or pending a decision of the European Communities or of the European Union, in accordance with Article 23, in Connection with Article 30 (2) of Directive 2001 /18/EC the resignation of the authorisation in whole or in part. Unofficial table of contents

Section 21 Duty of notification

(1) The operator shall have any change in the assignment of the project manager, the biosafety officer or a member of the Biological Safety Committee of the persons responsible for a notification, the granting of the authorisation and the to the competent authority responsible for the monitoring. In the event of an unforeseen change, the notification shall be made without delay. (1a) (1b) If the operator intends to put an end to the operation of an installation, it shall indicate the date of the adjustment of the competent authorities responsible for the supervision of the plant. to inform the Authority without delay. The notification shall be accompanied by documents relating to the measures to be taken by the operator in order to comply with the obligations arising from the second sentence of Article 6 (2). (2) Furthermore, any intention to amend the safety-related facilities shall be notified. Provisions of a genetic engineering plant, even if the modification of the genetic engineering plant continues to meet the requirements of the safety level required for the implementation of the notified, notified or approved work. (2a) The competent federal authority is any intended or known (3) The operator has the responsibility for the notification, the notification, the approval and the for the The competent authority shall immediately notify the competent authority of any incident which does not correspond to the expected course of the work of genetic engineering or to the release or placing on the market, and which is suspected of being in danger of being exposed to the risks referred to in Article 1 (1) shall be made up. All information necessary for the safety assessment as well as planned or taken emergency measures must be communicated. (4) The operator has the results of the release after the completion of a release of the competent federal authority. , in so far as these findings can be taken from a risk to the legal goods referred to in § 1 (1). This shall also apply to risks arising from a placing on the market if it is intended. The duration of the notification requirement shall be decided upon in the permit. Decisions or decisions of the European Communities or of the European Union referred to in Article 10 in conjunction with Article 30 (2) of Directive 2001 /18/EC, which determine the form of the communications referred to in paragraph 4 and which shall be adopted by the Federal Ministry for food, agriculture and consumer protection in the Federal Gazette (Bundesanzeiger), must be taken into account in the preparation of the communications. (4a) The operator has the competent authority responsible for monitoring the placing on the market in accordance with the following conditions: Report on the conditions of the marketing authorisation. (5) The operator shall immediately inform the competent authority of any new information on risks to human health or the environment. (5a) The operator shall provide new information on the risks to be provided for the purposes of Article 1 (1) (1) and (2). If the release and the placing on the market are concerned, it shall immediately inform the competent authority of the law and interests of the goods and interests. (6) A communication under paragraphs 5 and 5a may not be used for the criminal prosecution of the contributor or of a procedure under the law. on administrative offences against the co-participant. Unofficial table of contents

Section 22 Other administrative decisions

(1) The approval of the plant shall include other official decisions relating to the genetic engineering plant, in particular public service authorisations, authorisations, distributors, permits and permits, with the exception of regulatory authorities. Decisions on the basis of nuclear regulations. (2) Regulations which grant public-law authorisations, authorisations, distributors, licences and authorisations shall apply to genetic engineering installations subject to a notification procedure. in accordance with this law, as well as to genetic engineering Work, release or placing on the market which are subject to notification or approval under this Act, in so far as the protection against the specific risks of genetic engineering is concerned; provisions relating to: The placing on the market according to § 14 para. 2 shall remain unaffected. (3) § 35 of the Federal Nature Protection Act shall remain unaffected. Unofficial table of contents

Section 23 Exclusion of private legal defence claims

The cessation of the operation of the genetic engineering plant, which is based on private law, which is not based on specific titles, for the purpose of repelling the adverse effects of a plot of land on an adjacent plot of land cannot be established. to work on genetic engineering or to terminate a release, the authorisation of which is unquestionable and for which a consultation procedure has been carried out in accordance with Article 18; only provisions which may be required for the less-favoured Exclude effects. Insofar as such arrangements are not practicable or economically unjustifiable according to the state of the art, only compensation for damages can be required. Unofficial table of contents

§ 24 Fees, expenses and expenses

(1) Charges and levies shall be charged for individually attributable public services in accordance with this Act and the legislation adopted for the implementation of this Act. In addition to the legal entities referred to in § 8 (1) and 2 of the Federal Law on Fees, the payment of fees and charges exempts the non-profit-making research institutions. (2) The Federal Ministry of Food, Agriculture and Rural Development and consumer protection is authorized, in agreement with the Federal Ministry of Health and the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, by means of a regulation without the consent of the Federal Council, the chargeable Facts and fees due to fixed rates, framework rates, or the value of the (3) Land law shall apply to the costs to be borne by the countries; the second sentence of paragraph 1 shall apply accordingly. The countries will have to reimburse the costs incurred by the Commission in the context of the notification, notification and authorisation procedures. The expenses shall be fixed on a case-by-case basis and may be based on fixed rates or framework rates determined according to the average personnel and material costs. (4) In the case of the fulfilment of information and duty obligations in the framework of the of the operator's own expense arising from notification and approval procedures and supervision shall not be reimbursed. Unofficial table of contents

Section 25 Monitoring, information, duty obligations

1. The competent authorities shall have the implementation of this law, of the legal regulations adopted pursuant to this Act, of acts directly applicable to the European Communities or of the European Union within the scope of this (2) The operator, the responsible persons within the meaning of § 3 nos. 8 and 9 and any person who contains products containing genetically modified organisms (GMOs) or consist of such, economically, industrially or in in a comparable manner, the competent authority shall, on request, immediately provide the information necessary for monitoring and make available the necessary tools, including control samples, within the limits of their availability. (3) The persons responsible for monitoring shall be empowered to:

1.

to enter and visit land, business premises and operating rooms at the operating and business hours,

2.

carry out all the tests necessary for the performance of their tasks, including the taking of samples,

3.

to consult the documents required for the performance of their duties and to make them out of any such documents or copies thereof.

In order to prevent urgent threats to public safety and public order, measures in accordance with the first sentence may also be taken in living quarters and at any time of day and night. The operator and any person who deals economically, commercially or in a comparable manner with products containing or consisting of genetically modified organisms shall be obliged to take measures in accordance with the provisions of the first and second sentences of 1 and 2 of this Regulation. and the second sentence, to assist the persons responsible for monitoring, as far as is necessary for the performance of their duties, and to provide the necessary business documentation. The fundamental right of inviolability of the home (Article 13 of the Basic Law) is restricted to this extent. (4) Persons who are responsible for providing information may refuse to provide information on such questions, the answers to which they themselves or one of their answers in § 383 (1) 1 to 3 of the Code of Civil Procedure would expose the persons concerned to the risk of persecution for an offence or offence. (5) The persons concerned in the fulfilment of an obligation to provide information or duty under this Act or any of them pursuant to this Act. Personal information collected by the law may only be used to the extent that this is necessary for the implementation of this law or for the prosecution of a criminal offence or for the defence of a danger to public safety. (6) The competent authority shall be the risk assessment at the request of the competent authority. pursuant to Article 6 (1). (7) By way of derogation from paragraph 1, authorities which carry out statutory audits on genetically modified plants authorised for the placing on the market or have them carried out, have themselves to ensure compliance with the Provisions of this Act, which are adopted pursuant to this Act legal regulations and directly applicable acts of the European Communities or of the European Union within the scope of this Act. This only applies to the municipalities and municipal associations, insofar as they have been assigned this task by national law. Unofficial table of contents

§ 26 Authorities

(1) The competent authority may, on a case-by-case basis, take the orders which are intended to eliminate or prevent future infringements of this law, against the legal regulations adopted pursuant to this Act, or against the immediate applicable legislation of the European Communities or of the European Union in the field of application of this Act. In particular, it may prohibit, in whole or in part, the operation of a genetic engineering plant or of genetic engineering work if:

1.

the required notification or notification has not been obtained, the necessary authorisation or consent is not available,

2.

a reason for the withdrawal or revocation of a permit under the administrative procedure laws,

3.

is to be infringed against secondary provisions or subsequent conditions pursuant to section 19,

4.

the existing safety-related facilities and arrangements are not or are no longer sufficient.

(2) If the operator of a genetic engineering system is subject to a requirement, a fully-fleable retrospective arrangement or an obligation under a legal regulation in accordance with § 30, the obligation, the order or the obligation shall be the subject of the obligation. The competent authority may prohibit the holding, in whole or in part, from the condition or operation of the genetic engineering plant until the condition is fulfilled, the order or the obligation arising from a legal regulation pursuant to § 30. (3) The competent authority shall: Authority may order that a genetic engineering plant without the necessary notification or Authorisation shall be set up, operated or substantially amended, in whole or in part, to be shut down or disposed of. It shall order total or partial disposal if the legal goods referred to in Article 1 (1) cannot be adequately protected in any other way. (4) The competent authority shall prohibit a release to the extent that: The conditions laid down in the second sentence of paragraph 1 (2) and (2) It may prohibit a release in so far as the conditions set out in the second sentence of paragraph 1 (2) and (4) are fulfilled. (5) The competent authority shall prohibit the placing on the market if the necessary authorisation is not available. It shall provisionally prohibit the placing on the market of a decision of the European Communities or of the European Union, pursuant to Article 23, in conjunction with Article 30 (2) of Directive 2001 /18/EC, until such time as the decision has been taken or pending a decision by the European Communities or the European Rest of the permit has been ordered. It may provisionally prohibit the placing on the market or up to this decision, in whole or in part, if there is sufficient suspicion that the conditions for placing on the market are not available. The competent authority shall refrain from arrangements provided for in the first sentence if the product containing genetically modified organisms not authorised to be placed on the market is intended for direct processing and shall ensure that the product is not in unprocessed food or feed, the genetically modified organisms are destroyed after processing and do not have any harmful effects on the legal goods referred to in § 1 (1). Unofficial table of contents

§ 27 Erasing of the authorisation, Uneffective notification of the application

(1) The authorisation shall be issued if:

1.

within a time limit set by the approval authority, which may not exceed three years, with the establishment or operation of the genetic engineering plant or the release, or

2.

a genetic engineering plant has not been operated for a period of more than three years.

(2) The authorisation, except in the cases of § 8 (2) sentence 2, shall also be issued in so far as the approval requirement is repealed. (3) The approval authority may, on request, by no more than one year from the time limits set out in paragraph 1. if this does not endanger the purpose of the law. (4) The application of an installation in which the genetic engineering works of the security level 1 or 2 are to be carried out shall be ineffective if:

1.

not started within three years with the establishment or operation of the genetic engineering plant, or

2.

the genetic engineering plant has not been operated for a period of more than three years.

(5) (dropped) Unofficial table of contents

Section 28 Information forwarded

(1) The competent authorities shall immediately inform the competent authority of the competent authority of the competent authority

1.

the decisions taken in the enforcement of this Act, if they are relevant to the Federal Supreme Authority,

2.

findings and incidents which may have an impact on the legal goods and concerns referred to in § 1 (1) and (2);

3.

Infringements or suspicions of infringements of the provisions of this Act and of acts adopted pursuant to this Act, acts directly applicable to the European Communities or the European Union as well as against authorisations and obligations within the scope of this Act.

(2) The competent authority of the federal authority shall announce its findings, insofar as they may be relevant to law enforcement, to the competent authorities. Unofficial table of contents

Section 28a Information to the public

(1) The competent authority shall inform the public of arrangements in accordance with Section 26, provided that it has become indisputable or has been ordered immediately to complete its enforcement, including the precautionary measures ordered. Personal data may only be published in so far as this is necessary for the security. (2) The competent authority shall inform the public about

1.

the reasonable suspicion of a risk to the legal goods referred to in § 1 (1), including the precautions to be taken,

2.

the results of the monitoring of the placing on the market in a general manner.

Personal data may only be published in the cases of sentence 1, in so far as the person concerned has consented or the protection-worthy information interest of the public has the legitimate interest of the person concerned in the exclusion of the person concerned. Publication outweighs publication. The person concerned must be consulted prior to the decision on publication. (3) Information referred to in paragraph 2 may not be published,

1.

in so far as the disclosure of the information may affect the confidentiality of the deliberations of the authorities or cause a significant risk to public security,

2.

for the duration of a judicial procedure, criminal investigation, disciplinary proceedings, procedural violation of the data which are the subject of the proceedings,

3.

in so far as the protection of intellectual property, in particular copyrights, is contrary to the right to information, or

4.

in so far as the information reveals operational or trade secrets or information which is relevant to competition, which is equivalent to the nature of trade secrets, unless certain information has to be provided in the light of the information provided by the total circumstances shall be published in order to ensure the protection of the safety and health of the population, with a weighing in accordance with the second sentence of paragraph 2.

The persons concerned shall be consulted prior to the decision on publication in the cases referred to in sentence 1 (3) or (4). Where information has been published as an operational or commercial secret, the competent authority shall, in case of doubt, be deemed to have been affected by the characterizing point. (4) The public authority shall inform the public of the information provided by the Authority. , the Authority shall inform the public thereof in the same manner in which the information in question has previously been reproduced as incorrect or the circumstances in which it is based as incorrect or incorrect. has been announced. Unofficial table of contents

§ 28b Method Collection

(1) The competent federal authority shall publish in consultation with the authorities responsible for food and feed legislation an official collection of sampling and testing procedures for samples to be carried out in the context of the monitoring (2) The procedures shall be carried out with the assistance of experts from the fields of the Monitoring, science and the economy involved. The collection must be kept up-to-date. Unofficial table of contents

§ 29 Evaluation and provision of data

(1) The competent authority of the federal authority shall have data pursuant to § 28 which has been levied or levied by him or her in connection with the establishment and operation of genetically engineered plants, the performance of genetic engineering works, or with a placing on the market. shall be processed and used for the purpose of observation, collection and evaluation of facts which may have an impact on the legal goods and concerns referred to in Article 1 (1) (2) and (2). It may provide data on Commission opinions on the safety classification and safety measures of genetic engineering work and on the decisions taken by the competent authorities to the competent authorities for use within the framework of Submit notification and approval procedures. The recipients may use the transmitted data only for the purpose to which they have been transmitted. (1a) The establishment of an automated retrieval procedure shall be permitted. The competent federal authority and the competent authorities shall lay down the nature of the data to be transmitted and the technical and technical data required in accordance with section 9 of the German Federal Data Protection Act (Bundesdatenschutzgesetz) in the establishment of the automated retrieval procedure. organizational measures in writing. The establishment of the automated retrieval procedure requires the approval of the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry for Economic Affairs and Technology. The Federal Commissioner for Data Protection shall be informed of the establishment of the retrieval procedure in the light of the provisions of the second sentence of sentence 2. The recipient shall bear the responsibility for the admissibility of the individual call. The competent federal authority shall examine the admissibility of the calls only if there is reason to do so. It has to ensure that the transmission of the data can be established and verified. (2) The legislation on confidentiality shall remain unaffected. The transmission of factual knowledge within the meaning of Section 17a to the services of the European Union and the authorities of other States may only be carried out if the requesting body states that it provides for the protection of operations and services. (3) Personal data may only be used by the competent authority of the Federal Republic of Germany. (3) Personal data may only be used by the competent authority of the Federal Republic of Germany. shall be processed and used to the extent that this is necessary for the assessment of the reliability of The operator, the project manager, the person responsible for the biosafety or the assessment of the expertise of the project manager or of the person responsible for the biosafety is required. (4) The nature and extent of the Data is regulated by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry of Economics and Technology by means of a legal regulation with the consent of the Federal Council. Unofficial table of contents

§ 30 Decree of laws, regulations and administrative provisions

(1) The Federal Government, after consulting the Commission, shall, by means of a regulation with the consent of the Federal Council, determine, in order to achieve the purposes set out in Article 1 (1), the responsibility and the required expertise of the project manager, in particular: with regard to the need for and scope of knowledge in classical and molecular genetics, practical experience in dealing with micro-organisms and the knowledge required, including the Labour protection legislation on work in a genetic engineering plant. (2) The The Federal Government is authorized, after consulting the Commission, to determine, by means of a regulation with the consent of the Federal Council, the achievement of the purposes set out in Article 1 (1) of this Regulation,

1.

how the workplace, the operating facilities and the technical equipment must be procesed, set up and operated at the individual levels of safety, in order to ensure that the safety, occupational health, hygiene and safety requirements are guaranteed, and meet other scientific findings which are necessary to protect employees and which are necessary to ensure that the work is done in a humane manner;

2.

the necessary operational measures, in particular:

a)

the way in which the working method must be designed so that the employees are not put at risk by genetic engineering or by a release,

b)

how the areas of work need to be monitored in order to identify contamination by genetically modified organisms,

c)

the way in which genetically modified organisms must be kept within the company and the hazards which need to be identified so that the employees are not at risk from unsuitable storage and the risks associated with them are not endangered by the risk of such storage. organisms emerging from organisms;

d)

what measures need to be taken to ensure that genetically modified organisms do not get into the hands of unauthorised persons or else they will be lost,

e)

which personal protective equipment must be made available and used by the employees in accordance with the intended purpose,

f)

that the number of workers who deal with genetically modified organisms is limited and that the duration of such employment can be limited,

g)

how employees have to behave so that they do not endanger themselves and others, and what measures are to be taken,

h)

the circumstances under which access restrictions for the protection of employees must be provided;

3.

that and how many commissioners for the biological safety of the operators has to order, which check the performance of the tasks of the project manager and which the operator and the responsible persons in all questions of biological safety , how these tasks are to be carried out in detail, what kind of expertise for biological security is to be demonstrated, and in which way the agent or the agents responsible for the biological safety, with the participation of the company, are to be considered. , or to appoint a staff council;

4.

which knowledge and skills must be provided and which evidence must be provided on the basis of genetic engineering works or a release;

5.

how and at what intervals the employees are to be informed of the risks and measures to be used for their use and how the content of the provisions to be applied in the establishment is carried out in an activity-related instruction manual under to take account of safety advice;

6.

what arrangements should be made to prevent accidents at work and operational disruptions, and to limit their impact on workers and what measures should be taken to organise the first aid;

7.

that and which supervisors are responsible for the supervision of genetic engineering works and releases, as well as other work in the field of danger, and which powers must be assigned to them in order to ensure that the occupational safety and health tasks are carried out can be fulfilled;

8.

that, with regard to the protection of employees, a risk assessment must be carried out by the operator and a security plan should be drawn up, which documents must be drawn up, and that these documents shall be used for the purpose of verifying the security of the operator. the risk assessment and the security plan must be kept ready for inspection by the competent authority;

9.

that the employees are to be provided with occupational health care and that they are to be kept informed, and for this purpose,

a)

the operator may be required to have a medical examination of the work carried out by genetic engineering or by a release,

b)

the physician responsible for carrying out a screening study has to comply with certain obligations in connection with the findings of the investigation, in particular with regard to the contents of a certificate and of the information to be issued by him, and Advice on the outcome of the investigation,

c)

the competent authority shall decide if findings of the doctor are deemed to be inaccurate,

d)

the data to be recorded shall be transmitted to the institutions of the statutory accident insurance or to a body designated by them for the purpose of determining work-related health hazards or occupational diseases;

9a.

the activities of which employees must be able to carry out subsequent investigations;

10.

that the employer must inform the operational or staff council of operations which he/she must experience in order to be able to carry out his/her duties;

11.

the competent authorities are empowered to adopt, for the purposes of the implementation of legal regulations, arrangements in individual cases also against supervisors and other employees, in particular in the event of a risk of default;

12.

that certain precautions must be taken in the event of the termination of a genetic engineering work or of a release;

13.

that the transport of genetically modified organisms should be subject to compliance with certain precautionary measures;

14.

that, as well as the order of transport and the handling of products containing or consisting of genetically modified organisms, the products must be packaged and labelled, in particular those relating to the genetic engineering of genetically modified organisms; To the extent that this is necessary for the protection of the user, changes and the justifiable harmful effects within the meaning of section 16 (2) shall be made;

15.

what content and form the display, registration and application documents must have in accordance with § 10 (2) and (3), § 12 (2) and (2a) and § 15, in particular on which criteria the risk assessment is to be aligned and which criteria during the production process of the monitoring plan, as well as the details of the notification, notification and approval procedures;

16.

that in the event of an accident in a genetic engineering plant,

a)

the competent authority shall, on the basis of documents to be supplied by the operator, draw up non-operational contingency plans, draw up and implement them with the competent authorities of the Member States of the European Union or the other Member States to coordinate and inform the public about security measures of the Agreement on the European Economic Area, which may be affected by an accident,

b)

to notify the operator of the circumstances of the accident and of the measures taken by the competent authority,

c)

the competent authority shall notify the competent authority of the competent authority to the competent authority to forward it to the European Commission, which shall be forwarded to the European Commission by the Member States of the European Union and the other States Parties to the Agreement on the European Union (a) to inform the authorities designated by the Economic Area as far as these States may be affected by the accident and to take all the emergency measures and other necessary measures.

(3) (4) Due to the requirements of paragraphs 1 and 2, notices of expert opinion may be made available to the public, where:

1.

indicate in the regulation the date of the contract notice and identify the reference source,

2.

Establish the notice to the competent authority of the Federal Supreme Authority in the form of an archive and draw attention to this in the legal regulation.

(5) The Federal Government may, after consulting the Commission with the consent of the Federal Council, adopt general administrative provisions for the implementation of this Act and of the legal regulations adopted pursuant to this Act. Unofficial table of contents

Section 31 Competent authority and competent federal authority

The authorities responsible for the implementation of this law shall determine the competent authority in accordance with national law, in the absence of such a provision, the Land Government; this authority may further transfer the authority. The competent federal authority is the Federal Office of Consumer Protection and Food Safety.

Fifth Part
Liability rules

Unofficial table of contents

§ 32 Liability

(1) Where a person is killed, his body or his health is injured or a cause is damaged as a result of properties of an organism based on genetic engineering, the operator shall be obliged to cause the damage resulting therefrom to be caused by the damage caused by the damage caused by the damage caused by the damage (2) If several operators are obliged to pay compensation for the same damage, they shall be liable as the total debtor. In the proportion of the persons liable to each other, unless otherwise specified, the obligation to replace and the extent of the replacement shall depend on the extent to which the damage is mainly caused by the one or the other part § § 426 (1) sentence 2 and (2) of the Civil Code. (3) If the injured party was responsible for the loss of damage, § 254 of the Civil Code shall apply; in the case of damage caused by the damage caused by the damage caused by the damage caused by the damage caused by the damage caused by the damage caused by the damage caused by the damage to the victim's property. the damage to the property is the fault of the person who is responsible for the actual violence is the same as the fault of the injured party. The liability of the operator shall not be reduced if the damage has been caused at the same time by the act of a third party; the second sentence of paragraph 2 shall apply accordingly. (4) In the case of the killing, replacement of the costs of the attempted healing and of the The loss of assets suffered by the person killed by the fact that during the illness his earning capacity was cancelled or reduced or that his needs were increased. In addition, the person liable shall reimburse the costs of the funeral to the person who has to bear the costs. Status of the person killed at the time of the injury to a third party in a relationship from which he was subject to the law or could be subject to maintenance obligations and the third party is entitled to maintenance as a result of the killing. , the liable person shall pay compensation to the third party in so far as the person who has been killed would have been obliged to provide the maintenance during the presumed period of his life. (5) In the event of injury to the body or health, compensation for the costs of the healing and of the asset disadvantage is to be paid by the third party. (5) In case of injury to the body or health, the costs of the healing and the property disadvantage must be paid. The injured person suffers from the fact that, as a result of the injury, his earning capacity is temporarily or permanently cancelled or diminished or a multiplication of his or her needs has occurred. Because of the damage, which is not property damage, a cheap compensation in money can also be demanded. (6) The damages due to cancellation or reduction of the earning capacity and because of increased needs of the injured as well as the after The third and fourth sentences of a third party to be awarded to a third party shall be made for the future by means of a financial pension. Section 843 (2) to (4) of the Civil Code shall be applied accordingly. (7) If the damage to a cause is also an impairment of nature or landscape, it shall be the case where the injured party is in the condition that it exists; if the impairment did not occur, Article 251 (2) of the Civil Code should be applied, subject to the proviso that expenses for the restoration of the previous condition are not disproportionate to the value of the previous state. Significantly higher than that. The Schädiger shall have to pay the necessary advance for the necessary expenses. (8) The limitation period shall apply to the provisions of the Civil Code applicable to unauthorised acts. Unofficial table of contents

§ 33 Liability limit

If damage has been caused as a result of properties of an organism based on genetic engineering, the operator shall, in the case of § 32, be liable to the injured party up to a maximum amount of 85 million euros. If the number of compensation to be paid under the same damage event exceeds the maximum amount referred to in the first sentence, the individual compensation shall be reduced in proportion to the total amount. Unofficial table of contents

§ 34 Reason for reason

(1) If the damage has been caused by genetically modified organisms, it is suspected that it has been caused by the properties of these organisms based on genetic engineering work. (2) The presumption is debilitated when it is it is probable that the damage is based on other characteristics of these organisms. Unofficial table of contents

Section 35 The claims of the injured party

(1) In the case of facts which justify the assumption that a person or property damage is based on the genetic engineering work of an operator, he/she shall, at the request of the injured party, be obliged to take account of the nature and the sequence of the activities in the genetic engineering sector. To the extent that this is necessary to determine whether a claim is in accordance with § 32, to provide information on the genetic engineering work on which it is based or to release it. § § § 259 to 261 of the Civil Code shall be applied accordingly. (2) A claim for information shall also be subject to the conditions set out in the first sentence of paragraph 1 also to the authorities who are responsible for the notification, the granting of a permit or the (3) The claims referred to in paragraphs 1 and 2 do not exist in so far as the transactions are kept secret due to legal regulations or the secrecy is of overriding interest to the operator or to a third party. . Unofficial table of contents

§ 36 Cover provision

(1) The Federal Government shall, with the consent of the Federal Council, determine in a regulation with the consent of the Federal Council that the person who carries out a genetic engineering plant should be carried out in the genetic engineering work of the safety stages 2 to 4, or the It is obliged to take precautions to cover the damage caused by the properties of an organism which is based on genetic engineering works (security of the cover). The scope of the financial security for a genetic engineering plant shall take into account the nature and extent of the work carried out in the plant, and this shall apply in accordance with the requirements of the releases. The legal regulation also needs to lay down more detailed rules on the powers of supervision of the financial security of the financial services. The Federal Ministry of Justice can, in agreement with the Federal Ministry of Economics and Technology, the Federal Ministry of Food, Agriculture, and the Federal Ministry of Economics and Technology, Consumer protection, the Federal Ministry of Education and Research, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, and the Federal Ministry of Health, the amount of the financial security cover, with due regard for the insurance market. (2) The provision of cover may in particular: be provided

1.

in the case of insurance undertakings authorised to operate within the scope of this Act, by insurance or

2.

by an exemption or warranty obligation of the federal government or of a country.

The legal regulation referred to in paragraph 1 may also allow other types of financial security, in particular the exemption or guarantee obligations of credit institutions, provided that they have comparable collateral arrangements, such as a financial guarantee. in accordance with the first sentence. (3) The obligation to provide financial security shall be exempt from the obligation to provide

1.

the Federal Republic of Germany,

2.

the countries and

3.

legal persons under public law.

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§ 36a Claims in case of impairment of use

(1) The transfer of properties of an organism based on genetic engineering, or other entries of genetically modified organisms, constitute a significant impairment within the meaning of Section 906 of the Civil Code, if, contrary to the intention of the person entitled to use, products, in particular, products,

1.

may not be placed on the market or

2.

in accordance with the provisions of this Act or in accordance with other provisions, may be placed on the market only with reference to the modification of genetic engineering; or

3.

should not be placed on the market by means of a marking which would have been possible in accordance with the legislation applicable to the production method.

(2) Compliance with the good professional practice according to § 16b (2) and (3) shall be considered as economically reasonable within the meaning of Section 906 of the Civil Code. (3) For the assessment of the local practice within the meaning of § 906 of the Civil Code, it shall come to an end. does not indicate whether the production of products with or without genetically modified organisms is carried out. (4) In the light of the actual circumstances of the individual case, a number of neighbours are considered to be the polluter and cannot be identified as to who of have caused them to be affected by their action, so everyone is responsible for the Impairment is responsible. This shall not apply if each has caused only a part of the impairment and a division of the compensation on the polluters is possible in accordance with § 287 of the Code of Civil Procedure. Unofficial table of contents

§ 37 Liability under other legislation

(1) Where a medicinal product intended for use in humans has been applied to the consumer within the scope of the Medicines Act and is subject to the obligation to be authorised, or by means of a legal regulation from the § § 32 to 36 shall not apply. (2) The same shall apply if products containing or consisting of genetically modified organisms are to be found on the basis of a Approval pursuant to Section 16 (2) or of an authorisation or approval pursuant to other Legislation within the meaning of Section 14 (2) shall be placed on the market. In this case, the liability of the manufacturer who has been granted the marketing authorisation or the marketing authorisation shall not apply if the product defect is based on genetic engineering works, Section 1 (2) (5) of the Product Liability Act (Product Liability Act). (3) Liability on the basis of other provisions shall remain unaffected.

Sixth Part
Criminal and penal rules

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Section 38 Penal rules

(1) Contrary to the law, those who intentionally or negligently act

1.

Contrary to § 6 (1) sentence 1 in conjunction with a legal regulation pursuant to § 30 para. 2 no. 15, a risk assessment for a further genetic engineering work of security level 1 does not, not properly, does not carry out in full or in time,

1a.

Contrary to § 6 (3) sentence 1, records are not kept,

2.

, contrary to § 8 (1) sentence 1, carries out genetic engineering work,

3.

shall set up a genetic engineering plant without authorisation pursuant to Article 8 (1) sentence 2,

4.

contrary to § 8 (2) sentence 1, also in connection with paragraph 4, sentence 2, the establishment or operation or a substantial change in the location, the condition or the operation of a genetic engineering plant or genetic engineering work, not correct or does not display or report in time,

5.

the situation, the nature or the operation of a genetic engineering plant substantially changes without the authorisation pursuant to Article 8 (4) sentence 1,

6.

Contrary to § 9 para. 2 sentence 1, an advertisement is not reimbursed, not correct or not reimbursed in time,

6a.

carry out further genetic engineering work without authorisation pursuant to section 9 (3),

6b.

carry out further genetic engineering work, contrary to Section 9 (4),

7.

, without authorisation pursuant to Article 14 (1), first sentence, No. 2 or 3 products containing or consisting of genetically modified organisms, shall be placed on the market,

7a.

who, contrary to § 16c (1), does not observe a product or does not observe correctly,

8.

shall be contrary to a fully-enforceable requirement pursuant to § 16d (3) sentence 1 or § 19 sentence 2 or a enforceable order pursuant to § 26,

9.

contrary to § 9 (4a) or (5), § 16a (2) sentence 1 or 3 or (3) sentence 1 or 3 or § 21 (1) sentence 1 or 2 in conjunction with sentence 1, paragraph 1b, sentence 1, paragraph 2 in conjunction with paragraph 1 sentence 1, paragraph 3, 4 sentence 1 or subsection 5 or 5a sentence 1 or 2, one sentence 1 or 2 Communication not, not correct or not timely,

10.

Contrary to Section 25 (2), no information is provided, not in time, in full or in the right place, or does not provide an aid,

11.

the obligation referred to in Article 16 (5a) or section 25 (3) sentence 3;

11a.

Contrary to Article 25 (6), the risk assessment is not presented or not presented in due time

12.

a legal regulation in accordance with § 2 para. 2 sentence 3, also in conjunction with paragraph 2a sentence 2, § 6 para. 3 sentence 2, § 7 para. 2 sentence 2 or § 30 para. 2 nos. 1 to 14, insofar as it refers to this fine for a certain amount of facts.

(2) The administrative offence may be punishable by a fine of up to fifty thousand euros. (3) As far as this law is executed by federal authorities, the administrative authority shall be the administrative authority within the meaning of Section 36 (1) (1) of the Law on Administrative Offences. in accordance with national law. Unofficial table of contents

Section 39 Criminal Code

(1) A custodial sentence of up to one year or a fine shall be punishable by a person who is contrary to a legal regulation in accordance with § 36 (1) sentence 1, insofar as it refers to that penal code for a particular offence. (2) With imprisonment up to three years or with a fine shall be punished, who

1.

Release of genetically modified organisms without authorisation pursuant to section 14 (1) sentence 1 no. 1

2.

operates a genetic engineering plant without authorization pursuant to Section 8 (1) sentence 2.

(3) A term of imprisonment of three months to five years shall be punishable by the person referred to in paragraph 2 or by an act referred to in paragraph 38 (1) (2), (8), (9) or (12) of another, foreign property of an important value or component of the (4) In the cases referred to in paragraphs 2 and 3, the attempt shall be punishable. (5) Those who act negligently in the cases referred to in paragraph 2 shall be punishable by imprisonment of up to one year or with a fine. (6) If, in the cases referred to in paragraph 3, the risk is caused by negligence, it shall be punishable by imprisonment (7) Anyone who acts negligently in the cases referred to in paragraph 3 and who is at risk of negligence shall be punished with imprisonment of up to three years or a fine.

Seventh Part
Transitional and final provisions

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§ 40

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Section 41 Transitional regime

(1) For genetic engineering work which, on the entry into force of the provisions of this Act, on notifications and authorisation requirements in accordance with the "Guidelines for protection against risks arising from in-vitro combined nucleic acids" (Gen-Guidelines) in accordance with the provisions of this Act, the registered gene laboratory may be carried out only in approved or registered genetic engineering facilities, must be notified or require authorisation, the following shall apply: Registration as done or granted as granted; for genetic engineering § 9 is applicable in such plants. (2) A permit which has been granted prior to the entry into force of the provisions of this Act concerning notifications as well as permit obligations under the Federal Immission Control Act shall be considered to be valid in the past. Registration or approval in accordance with this law. § 19 shall apply. (3) (omitted) (4) The provisions of the Second Law amending the Gentechnikgesetz of 16 August 2002 (BGBl I) shall apply to the proceedings initiated up to the date of entry into force of this Act. 3220), provided that complete application documents are available. This does not apply to the approval of further work of the security stages 3 and 4 in accordance with § 9 para. 3. (5) (omitted) (6) marketing authorisations granted before the 17. were granted on 17 October 2002. October 2006, if an extension has not been requested until 17 January 2006. (7) Until the adoption of a regulation pursuant to § 14 (4), but not later than 31 December 2008, shall be replaced by this law, even in so far as this law applies to these With regard to the procedure and the scope of authorisation, reference is made to the provisions of Commission Decision 94 /730/EC of 4 November 1994 laying down simplified procedures for the deliberate release of genetically modified organisms (genetically modified organisms) Modified plants referred to in Article 6 (5) of Council Directive 90 /220/EEC (OJ L 206, 22.7.1990. EC No 31). (8) Up to the Commission's education in accordance with § 4, their respective tasks shall be exercised by a special committee, which shall:

1.

in accordance with the rules applicable to the Central Commission for Biological Safety on 3 February 2005, and

2.

the tasks shall be carried out in accordance with the rules referred to in paragraph 1.

(9) By way of derogation from the other provisions of this Act,

1.

the Genetic Engineering Procedural Regulation as amended by the Notice of 4 November 1996 (BGBl. 1657), as last amended by Article 2 of the Law of 16 August 2002 (BGBl I). 3220),

2.

the Genetic Engineering Participation Ordinance of 17 May 1995 (BGBl. 734), as amended by Article 1 (2) of the Law of 22 March 2004 (BGBl I). 454),

up to 1. The Commission shall, without consulting the Commission, be amended in accordance with § 4 or a committee in accordance with § § 5 and 5a once. Unofficial table of contents

§ 41a

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§ 42 Applicability of the provisions applicable to the other States Parties to the Agreement on the European Economic Area

Upon the entry into force of the Agreement on the European Economic Area, the provisions providing for the participation of the Member States of the European Union shall also apply to the participation of the other States Parties to the Agreement on the European Economic Area. European Economic Area as from 1 January 1995.