Regulation on application and registration documents and on authorisation and registration procedures in accordance with the Gentechnikgesetz (Genechnik Procedure Regulation-GenTVfV)

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GenTVfV

Date of completion: 24.10.1990

Full quote:

" Genetic procedure Regulation as amended by the Notice of 4 November 1996 (BGBl. 1657), as last amended by Article 1 of the Regulation of 28 April 2008 (BGBl I). 766).

Status:	New by Bek. v. 4.11.1996 I 1657;
	Last amended by Art. 1 V v. 28.4.2008 I 766

For more details, please refer to the menu under Notes
This Regulation shall be used for the implementation of Commission Directive 97 /35/EC
of 18 June 1997 on the second adaptation of Directive 90 /220/EEC on the
Deliberate release into the environment of genetically modified organisms
technical progress (OJ C 327 EC No 72).

Footnote

(+ + + Text evidence from: 4.11.1990 + + +) 
  
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 ERL 35/97 (CELEX Nr: 397L0035)  V v. 10.12.1997 I 2884 + + +) 

  

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Content Summary

	1.	Section
		General
§ 1	Scope
§ 2	Advice
§ 3	Formal requirements
	2.	Section
		Requirements for documents
§ 4	Documents for genetic engineering, first-time or further genetic engineering work
§ 5	Documents in the case of releases
§ 6	Documents on the market
§ 7	Exceptions to information and measures
§ 8	Documents for enclosed decisions
	3.	Section
		Approval procedure
§ 9	Participation of other bodies
§ 10	Assessment report
§ 11	Simplified procedure for releases
§ 12	Form of decision, announcement
	4.	Section
		(dropped)
§ 13	(dropped)
§ 14	(dropped)
	5.	Section
		Final provision
§ 15	(dropped)
§ 16	(Entry into force)
Annex (to § 4)
	Information in the documents for genetic engineering or genetic engineering

Section 1
General

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§ 1 Scope

This Regulation lays down detailed rules for the procedure

1.

on the decision on the granting of a plant permit for

a)

the establishment and operation of genetically engineered plants to be carried out by genetic engineering at security level 2, 3 or 4, including the implementation of certain genetic engineering works in accordance with Article 8 (1) and (2) sentence 2 of the Genetic engineering law;

b)

the substantial change in the location, nature or operation of a genetic engineering plant of security level 2, 3 or 4 in accordance with § 8 (4) sentence 1 and sentence 3 in conjunction with Section 8 (1) of the Gentechnikgesetz (Genetic Engineering Act);

c)

the execution of further genetic engineering works, which are to be assigned to a higher security level than the work included in the plant approval pursuant to § 8 (1) sentence 2 or from the application in accordance with § 8 (2) sentence 1 of the Gentechnikgesetz, according to § § 8 (2) sentence 1 of the Gentechnikgesetz 9 (4) of the Gentechnikgesetz;

d)

(dropped)

2.

for a decision on the granting of a permit for

a)

the implementation of further genetic engineering works of security level 2, 3 or 4 according to § 9 para. 2 sentence 2 and section 3 of the Gentechnikgesetz;

b)

the release of genetically modified organisms in accordance with § 14 (1) sentence 1 no. 1 of the Gentechnikgesetz;

c)

the placing on the market of products containing or consisting of genetically modified organisms, in accordance with Section 14 (1) sentence 1 (2) of the Genetic Engineering Act;

d)

the placing on the market of products containing or consisting of genetically modified organisms for a different purpose than the intended use to date in accordance with Article 14 (1), first sentence, sentence 1, point 3, of the Gentechnikgesetz;

3.

to register

a)

the establishment and operation of genetic engineering plants to carry out genetic engineering work at security level 2, including the genetic engineering work provided for in Section 8 (2) sentence 1 of the Gentechnikgesetz;

b)

the substantial change in the situation, the nature or the operation of a genetic engineering plant of the security level 2 in accordance with § 8 (4) sentence 2 in conjunction with Section 8 (2) sentence 1 of the Gentechnikgesetz (Genetic Engineering Act)

(c) d)

(dropped)

4.

to display

a)

the establishment and operation of genetic engineering plants to carry out genetic engineering work in safety level 1, including the genetic engineering work envisaged in accordance with Article 8 (2) sentence 1 of the Gentechnikgesetz;

a1)

the substantial change in the situation, the nature or the operation of a genetic engineering plant at security level 1 in accordance with § 8 (4) sentence 2 in conjunction with Section 8 (2) sentence 1 of the Gentechnikgesetz;

b)

the implementation of further genetic engineering works of the security level 2 in accordance with § 9 paragraph 2 sentence 1 of the Gentechnikgesetz.

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§ 2 Consultation

As soon as the operator informs the competent authority of the proposed genetic engineering project, the operator shall advise him on the application or on a necessary notification or notification. Unofficial table of contents

§ 3 Forming provisions

The notification, registration or application for approval under the Genetic Engineering Act shall be submitted by the operator in writing in a number of copies to be determined by the approval authority. The competent authority may require the use of forms to be used for the notification, registration or application for authorisation and the documents.

Section 2
Requirements for documents

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§ 4 Documents for genetic engineering, first-time or further genetic engineering works

(1) The documents referred to in § 10 (2) and (3), § 12 (2) and Section 12 (2a) of the Gentechnikgesetz (German Genetic Engineering Act) for the notification of the application or the application for approval of a genetic engineering plant in which genetic engineering works are carried out , as well as for the purpose of displaying, registering or applying for the approval of further genetic engineering works,

1.

for the establishment and operation and for the substantial change in the location, nature or operation of a genetic engineering plant and for the work on genetic engineering in the case of safety level 1 in accordance with part Ia of the plant and, in the case of safety level 2, 3 or 4, in accordance with part Ib of the installation, unless the security level requires the information referred to in Part II or III of the Appendix;

2.

in the case of genetic engineering work at security level 2, where no authorisation is requested for that stage, in accordance with Part II of the Appendix;

3.

in the case of genetic engineering work in safety level 3 or 4 and 2, if a permit is requested for this stage, in accordance with Part III of the Appendix.

4.

(dropped)

(2) The information to be provided, descriptions, explanations, assessments and evidence must, as a whole, prove that the proposed transaction is subject to the requirements laid down in the Gentechnikgesetz (Genetic Engineering Act) and in the genetic engineering safety regulation in the individual regulated requirements. Risk assessment, safety classification, security measures as well as the expertise of the project manager and the authorized representative for biological safety. (3) Insofar as a hearing procedure is to be carried out in accordance with § 18 of the Gentechnikgesetz , the applicant shall have the competent authority in addition to the documents to provide, in accordance with paragraphs 1 and 2, a generally understandable brief description of the genetic engineering plant, which shall provide an overview of the installation, its operation and the work to be carried out, and the the probable impact on the legal goods referred to in § 1 No. 1 of the Gentechnikgesetz (Genetic Engineering Act). Unofficial table of contents

§ 5 Documents in the case of releases

(1) For the application for the authorisation of a release of genetically modified organisms, with the exception of plants, which belong to the taxonomic group of the Gymnosperms or the Gymnosperms, for the application of the application for the approval of the genetically modified organisms in § 15 (1) sentence 2 of the German Genetic Angiosperms (higher plants) are considered to be:

1.

proof of the material required in accordance with § 15 (1) sentence 2 in conjunction with § 10 para. 2 sentence 2 no. 2 of the Gentechnikgesetz (Genetic Engineering Act) of the project manager shall be carried out in accordance with § 15 of the genetic engineering safety regulations;

2.

proof of the material required pursuant to section 15 (1) sentence 2 in conjunction with § 10 (2) sentence 2 no. 3 of the German Genetic Engineering Act (Gentechnikgesetz) of the representative for the biological security shall be provided in accordance with § 17 of the genetic engineering safety regulations;

3.

the description of the safety-relevant properties of the organism to be released and of the conditions for survival, reproduction, and the conditions necessary for survival, in accordance with Article 15 (1) sentence 2, point 3, of the German Genetic Engineering Act (Genetic Engineering Act) and the dissemination of the organism shall be carried out in accordance with Annex III A No II of Directive 2001 /18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC (OJ L 134, 30.4.2001, p. EC No 1), as last amended by Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 (OJ L 284, 31.10.2003, p. EU No OJ L 268, p. 24);

4.

the risk assessment required pursuant to Article 15 (1), second sentence, No. 4 of the German Genetic Engineering Act, in accordance with Section 6 (1) of the German Genetic Engineering Act and the presentation of the security measures provided for shall be carried out in accordance with Annex II to Directive 2001 /18/EC, and the Commission Decision of 24 July 2002 laying down guidelines for supplementing Annex II to Directive 2001 /18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and on the Repeal of Council Directive 90 /220/EEC (OJ L 327, 30.4.1990 EC No 22) on the basis of the provisions laid down in Annex III (A) (No) II to IV of Directive 2001 /18/EC.

4a.

the plan to determine the effects of the organism to be released on human health and the environment, as required in accordance with Article 15 (1) sentence 2 (4a) of the Genetic Engineering Act, shall be determined in accordance with the relevant parts of Annex III in each case A Directive 2001 /18/EC should be drawn up;

5.

the description of the planned surveillance measures, as well as the information on emerging residues and their treatment as well as on contingency plans, as required in accordance with Article 15 (1) sentence 2 (5) of the German Genetic Engineering Act, shall be carried out in accordance with Annex III A (A) V of Directive 2001 /18/EC.

For the documents referred to in Article 15 (1), second sentence, of the Genetic Engineering Act concerning the application for the approval of a release of higher plants, the first sentence shall apply; in this case, Annex III A to Directive 2001 /18/EC shall be replaced by Annex III to Directive 2001 /18/EC B. (2) The safety-relevant properties of the released organism as defined in paragraph 1 (3) and its safety-related effects on the legal goods referred to in § 1 (1) of the Genetic Engineering Act referred to in paragraph 1 (4) shall be based on the to assess the experience gained in genetic engineering works in the closed system (3) § 4 (3) applies accordingly. (4) (omitted) Unofficial table of contents

§ 6 Documents on placing on the market

(1) For the following documents, referred to in § 15 (3) sentence 3 of the Gentechnikgesetz (Genetic Engineering Act), apply to the application for marketing authorization:

1.

the name required under Article 15 (3), third sentence, No. 2 of the Genetic Engineering Act, and the description of the product to be placed on the market in accordance with the state of the scientific community, with regard to the genetically modified specific properties pursuant to section A of Annex IV to Directive 2001 /18/EC;

2.

the description of the types of use to be expected and the planned spatial distribution required pursuant to Article 15 (3), third sentence, No. 3 of the Genetic Engineering Act shall be carried out in accordance with section A of Annex IV to Directive 2001 /18/EC;

3.

the risk assessment and the presentation of the potential adverse effects, as required by Article 15 (3), third sentence, of the Genetic Engineering Act, shall be carried out in accordance with Annex II to Directive 2001 /18/EC and to the Commission Decision of 24 July 2002 laying down guidelines for supplementing Annex II to Directive 2001 /18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC 1. EC No 22) on the basis of the information to be provided in accordance with Annex IV to Directive 2001 /18/EC;

4.

the description of the measures envisaged in accordance with Article 15 (3), third sentence, No. 5 of the Gentechnikgesetz, to control the further behaviour or quality of the organism or product to be placed on the market, the residual substances which are produced; and their treatment and contingency plans shall be made in accordance with Annex IV, Section B, to Directive 2001 /18/EC;

4a.

the monitoring plan required pursuant to Article 15 (3), third sentence, point (5a) of this Regulation shall be adopted in accordance with Annex VII to Directive 2001 /18/EC and to the Council Decision of 3 June 2001 on the application of October 2002 laying down guidelines for supplementing Annex VII to Directive 2001 /18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Directive 90 /220/EEC Council Regulation (EC) No EC No 27), and must include the indication of its duration;

5.

the description of special conditions for the handling of the product to be placed on the market and the proposal for its labelling and packaging, as required in accordance with Article 15 (3) sentence 3, sentence 3, point 3, of the Genetic Engineering Act, shall be made in accordance with Annex IV Section A (8) and (B) of Directive 2001 /18/EC.

(2) The safety-related effects, which may be caused by the placing on the market, on the legal goods referred to in § 1 No. 1 of the Gentechnikgesetz referred to in paragraph 1 (3), as well as the measures to control further behaviour and the quality of the goods in circulation (3) The applicant may, on request from the submission of documents, be able to assess the experience gained in the release of the genetically modified organism (3). over individual of the items listed in Annex IV, Section B to Directive 2001 /18/EC Requirements shall be exempted if, on the basis of the results of an approved release or scientific investigation, it is to be assumed that the placing on the market and use of a product as described in paragraph 1 (1) do not present any risk is linked to one of the legal goods referred to in Section 1 (1) of the Gentechnikgesetz (Genetic Engineering Act). Unofficial table of contents

Section 7 Exceptions to information and measures

If individual information and measures are not taken into consideration in accordance with § § 4 to 6 and the existing facilities on account of the nature of the individual case, this is to be noted in the documents. Where information on such information and measures is technically impossible or does not appear to be necessary, the reasons for such information shall be given in each case. Unofficial table of contents

§ 8 Documents for enclosed decisions

The nature and extent of the documents to be annexed to a request for the granting of a plant approval for the decisions taken by the authorities pursuant to Section 22 (1) of the Gentechnikgesetz (Genetic Engineering Act) shall be determined in accordance with the relevant applicable law. Legislation.

Section 3
Approval procedure

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Section 9 Participation of other bodies

(1) The competent authority shall forward the application for approval pursuant to § 1 (1) and (2) and the required documents for the genetic security assessment immediately to the bodies to be involved. (2) As far as one is concerned, the following shall be submitted to the competent authority. In accordance with Section 22 (1) of the Gentechnikgesetz (Gentechnikgesetz), the competent authority shall immediately forward the application and the documents necessary for the examination to the relevant competent authority. further to determine whether the conditions for the codecision decision have been met (3) Unless otherwise specified, the competent authority shall set a reasonable time limit for the authorities and the competent authorities concerned to submit their observations. If a body or authority concerned has not delivered an opinion by the end of the period, the approval authority may assume that the body or the specialised authority does not wish to comment. Unofficial table of contents

§ 10 Evaluation Report

The evaluation report according to § 16 (3) sentence 2 of the Gentechnikgesetz (Gentechnikgesetz) must be drawn up in accordance with Annex VI to Directive 2001 /18/EC. Unofficial table of contents

Section 11 Simplified procedure for releases

(1) Among the measures set out in points 2, 6 and 6.1 of 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 the Directive 90 /220/EEC (OJ L 327, 28.2.1990) EC No 31), the operator may apply for the authorisation of all releases issued within a work programme for releases of genetically modified plants. The authorisation shall be accompanied by the condition that the operator must report the subsequent releases following the first release to the approval authority referred to in point 7 of Decision 94 /730/EC, and that it shall be subject to the conditions referred to in point 7 of Decision 94 /730/EC. Requirements may be fulfilled. The provisions of Decision 94 /730/EC shall apply with regard to the procedure, in particular the information to be made when the application is submitted. (2) Under the conditions set out in points 1 and 2 of Decision 94 /730/EC, the operator may: request a uniform authorisation for multiple releases. The provisions of Decision 94 /730/EC shall apply in respect of the procedure, in particular the information to be made when the application is submitted. Unofficial table of contents

§ 12 Form of decision, announcement

(1) § 10 (7) and (8) of the Federal Immission Protection Act shall apply to the form of the decision and to its notification and notification. Authorisations for the establishment, operation or substantial modification of a genetic engineering plant, further genetic engineering works or releases which are granted without hearing in accordance with § 18 of the Gentechnikgesetz (Genetic Engineering Act) shall be subject to the provisions of § 10 Article 8 (2) to (5) of the Federal Immission Control Act (Federal Immission Protection Act). After the public notice, the notice of approval and its explanatory statement may be requested in writing by the interested parties until the expiry of the period of opposition; this shall also be indicated in the notice. (2) The Approval authority announcates decisions concerning the placing on the market in the Federal Gazette. Sentence 1 shall apply in accordance with decisions within the meaning of Section 14 (5) of the Gentechnikgesetz (Genetic Engineering Act); these decisions shall be accompanied by a German translation.

Section 4
(dropped)

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§ 13 (omitted)

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§ 14 (omitted)

-

Section 5
Final provision

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§ 15

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§ 16

(Entry into force) Unofficial table of contents

Annex (to § 4)
Information in the documents for genetic engineering or genetic engineering

(Fundstelle des Originaltextes: BGBl. I 2002, 3227-3228;
with regard to of the individual amendments. Footnote) Part Ia
For the establishment and operation and for the substantial modification of the location, nature or operation of a genetic engineering plant to be carried out in the genetic engineering work of safety level 1, and for the purposes of: At least the following information shall be required:

1.

the location of the genetic engineering plant;

2.

general description of the genetic engineering plant;

3.

Description of the nature of the proposed genetic engineering work;

4.

a summary of the risk assessment of genetic engineering work;

5.

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

6.

the name of the person responsible for the biosafety and the proof of the necessary expertise;

7.

Information on waste and waste water disposal.

Part Ib
For the establishment and operation and for the substantial modification of the location, nature or operation of a genetic engineering plant to be carried out in the genetic engineering works of security level 2, 3 or 4, and for the purposes of: At least the following information shall be required:

-

the location of the genetic engineering plant;

-

description of the parts of the genetic engineering plant;

-

a description of the nature of the genetic engineering work envisaged, including the risk assessment of the organisms used in the process;

-

the expected extent of the genetic engineering project;

-

Risk assessment of genetic engineering work;

-

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

-

the name of the person responsible for the biosafety and the proof of the necessary expertise;

-

Information on waste and waste water disposal.

Part II
In the case of genetic engineering work at security level 2, where no authorisation is requested for this stage, the information required in part Ib shall at least include the following information:

-

(r) or to use (s) recipient/donor and/or parent organism (s) or, where appropriate, used or used host vector system (s);

-

origin and intended functions of the genetic material, which is suitable for genetic modification;

-

the identity and characteristics of the genetically modified organism;

-

the purpose of the genetic engineering work, including the expected results;

-

cultural volumes to be used (if necessary) approximate value);

-

Description of the protection and containment measures.

Part III
In the case of genetic engineering work in safety level 3 or 4 and 2, where a permit is requested for this stage, the following information shall be required, in addition to the information required in Parts Ib and II:

-

information on accident prevention and emergency plans, where available;

-

specific hazards associated with the location of the installation;

-

contraceptive measures, such as safety equipment, warning systems and containment methods;

-

procedures and plans to verify the uninterrupted effectiveness of the containment measures;

-

description of the information given to the workers;

-

where appropriate, information required by the competent authority for the assessment of the emergency plans;

-

a comprehensive assessment of the potential risks and risks that could be caused by the proposed genetic engineering work.

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Appendix 2

(dropped) Unofficial table of contents

Appendix 3

(dropped)