Advanced Search

Decree No. 2011 - 1177 23 September 2011 On The Contained Use Of Genetically Modified Organisms

Original Language Title: Décret n° 2011-1177 du 23 septembre 2011 relatif à l'utilisation confinée d'organismes génétiquement modifiés

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Learn more about this text...

Information on this text

Keywords

FINAL STATEMENT , RESEARCH , ENVIRONMENT , CODE OF ENVIRONMENT , GENETICAL RESEARCH , ORGANISM GENETIQUEMENT MODIFY , GMO , USE CONFINAL , INSTALLATION , PRODUCTION


JORF n°0223 of 25 September 2011 page 16243
text No. 21



Decree No. 2011-1177 of 23 September 2011 on the confined use of genetically modified organisms

NOR: ESRR1111752D ELI: https://www.legifrance.gouv.fr/eli/decret/2011/9/23/ESRR1111752D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2011/9/23/2011-1177/jo/texte


Publics concerned: any operator of a facility in which a confined use of genetically modified organisms must be implemented.
Subject: procedure for declaration and registration of confined use of genetically modified organisms for research, development, teaching and industrial production.
Entry into force: the text comes into force on the day after its publication; the approvals that are valid on the date of entry into force of this Order shall remain valid under the conditions and until the time limit set out in the decision to approve.
Explanatory note: the decree contains the following measures:
― making available to the public a record of information by the operator when the registration for the confined use of genetically modified organisms concerns the first use of such organisms in a facility;
- the conditions for the implementation of genetically modified organisms in the field of industrial production;
― the classification criteria for confined uses of genetically modified organisms based on the genetically modified organism group and the characteristics of the operation;
- criteria for establishing the safety of genetically modified organisms for the environment and public health;
― the conditions for the licensing of the facility operator by the administrative authority.
References: the environmental code and the Public Health Code, as amended by this decree, may be consulted, in their drafting, on the website Légifrance (http://www.legifrance.gouv.fr). This decree is taken for the application of articles 11 and 13 of Act No. 2008-595 of 25 June 2008 genetically modified organisms.
The Prime Minister,
On the report of the Minister of Ecology, Sustainable Development, Transport and Housing and the Minister of Higher Education and Research,
Considering Directive 2009/41/EC of the European Parliament and the Council of 6 May 2009 on the confined use of genetically modified microorganisms;
Vu le Criminal codeincluding its article R. 610-1;
Considering the environmental code, including article L. 120-1 and titles I and III of his book V;
Vu le Defence codeincluding articles R. 2311-1 to D.* 2311-12;
Vu le Public Health Codeincluding article R. 1125-1;
Vu la Act No. 2000-321 of 12 April 2000 the rights of citizens in their relations with administrations;
Based on the advice of the Local Finance Committee (the Standards Assessment Advisory Board) dated 9 September 2010;
Considering the opinion of the Higher Council for the Prevention of Technological Risk of 27 October 2010;
Considering the advice of the High Council of Biotechnology of 18 January 2011;
The State Council (section of public works) heard,
Decrete:

Article 1 Learn more about this article...


Section 4 of Chapter V of Book V title I of the Environmental Code (regulatory part) is amended as follows:
1° Article R. 515-32 is amended as follows:
(a) In the first paragraph, after the word "acceptance", the words "or statement" are added;
(b) It is inserted after the second preambular paragraph, a paragraph, as follows:
"The provisions relating to the confined use of genetically modified organisms for industrial production are set out in Chapter II of Title III of this book. » ;
(c) The last two paragraphs are deleted;
2° Sections R. 515-33 to R. 515-35 are repealed.

Article 2 Learn more about this article...


Section 1 of Chapter I of Title III of Book V of the Environmental Code is amended as follows:
1° Articles D. 531-4 to D. 531-6 are repealed;
2° Section D. 531-3 is replaced by the following provisions:
"Art. D. 531-3.-The techniques and definitions referred to in articles D. 531-1 and D. 531-2 are interpreted and implemented according to the evolution of scientific knowledge in the field of genetic engineering, molecular genetics and cell biology. »

Article 3 Learn more about this article...


Chapter II of title III of Book V of the Environmental Code is replaced by the following:


“Chapter II



« Confined use
genetically modified organisms



“Section 1



“General provisions


"Art. R. 532-1.-The provisions of this chapter do not apply to genetically modified organisms used only in a confined manner whose safety for public health and the environment was established by application of the criteria listed in Part B of Schedule II to Directive 2009/41/EC of the European Parliament and the Council of May 6, 2009 on the confined use of genetically modified microorganisms.
"Art. D. 532-2.-The group classification, as provided for in section L. 532-1, of organisms, in particular micro-organisms, genetically modified based on the risks to public health or the environment, shall meet the following criteria:
« 1° Group I includes organisms, in particular micro-organisms, genetically modified with the following conditions:
“(a) The organism, in particular the micro-organism, receptor or parent, is not likely to cause disease in humans, animals or plants or cause adverse environmental effects;
“(b) The vector and insert are of such nature that they cannot equip the organism, including the micro-organism, genetically modified with a phenotype that could cause disease in humans, animals or plants or cause adverse effects on the environment;
"(c) The genetically modified organism, in particular the microorganism, is not likely to cause disease in humans, animals or plants or cause adverse effects on the environment;
« 2° Group II includes biological agents that can cause disease in humans and constitute a danger to workers, or cause adverse environmental effects. Their spread in the community is unlikely and there is usually effective prophylaxis or treatment;
« 3° Group III includes biological agents that can cause serious illness in humans and pose a serious danger to workers, or cause adverse environmental effects. Their spread in the community is possible but there is usually effective prophylaxis or treatment;
« 4° Group IV includes biological agents that cause serious illness in humans and constitute a serious danger to workers, or cause adverse environmental effects. The risk of their spread in the community is high and there is usually no prophylaxis or effective treatment.
"Art. D. 532-3.-The classification, as provided for in section L. 532-1, of confined uses of organisms, in particular of micro-organisms, genetically modified in containment classes according to the group of the body defined in section D. 532-2 and the characteristics of the operation, shall be as follows:
« 1° Containment Class 1 consists of operations that implement genetically modified organisms of Group I and whose risk to human health and the environment is zero or negligible;
« 2° Containment Class 2 consists of operations that implement genetically modified organisms in Group II and whose risk to human health and the environment is low;
« 3° Containment Class 3 consists of operations that implement genetically modified organisms in Group III and whose risk to human health and the environment is moderate;
« 4° Containment Class 4 consists of operations that implement genetically modified organisms of Group IV and whose risk to human health or the environment is high.
"These containment classes correspond to the containment levels 1.2.3 and 4 defined in Appendix IV of Directive 2009/41/EC of the European Parliament and the Council of May 6, 2009 on the confined use of genetically modified microorganisms.
"If the characteristics of the operation require a level of containment different from that of this classification, the use of a genetically modified organism can be ranked on the advice of the High Council of Biotechnology in another class of containment than that provided by the said classification.
"Art. R. 532-4.- Confined uses of organisms, especially micro-organisms, genetically modified in confinement classes 2 to 4 are subject to approval. These rows in containment class 1 are subject to declaration.
"However, where confined use in containment class 2 is to be implemented in a facility where the use of genetically modified organisms of the same containment class or upper class has already been approved, this use is reported.


“Section 2



" Provisions relating to confined uses of genetically modified organisms for research, development or teaching purposes


"Subsection 1



" Provisions relating to the approval of use


"Art. R. 532-5.-The approval of use under section R. 532-4 shall be issued for a period not exceeding five years by order of the Minister for Research who shall inform the Minister for the Environment. It may be renewed under the same conditions.
"Art. R. 532-6.-The application for approval of use, together with the payment referred to in section L. 532-6, is addressed to the Minister for Research.
"It is established by the operator of the facility in which the use must be implemented.
"It indicates:
« 1° If it is a natural person, his or her name, first name and domicile and, if it is a legal person, his or her name or social reason, legal form, address of his or her head office and the quality of the signatory of the application;
« 2° The address of the facility in which the application will be used;
« 3° The nature of the use the applicant proposes to exercise;
« 4° Genetically modified organisms that will be used and the containment class for use;
« 5° Where applicable, genetically modified organisms whose use is already declared or approved and the containment class of which it reports;
« 6° The name and qualifications of the user;
« 7° The financial capacities of the private person operating a facility under a containment class 3 or 4;
« 8° Internal procedures to temporarily suspend use or cease activity.
"The application file also includes a technical file, the content of which is set by joint decree of the ministers responsible for research and the environment, respectively.
"Art. R. 532-7.-In its application, the operator of the facility may indicate the information other than the information referred to in Article L. 532-4-1 that the operator wishes not to be disclosed to third parties and provides the elements that justify the confidential nature of the information. The Minister for Research, after consultation with the applicant in the event of a discrepancy, decides information that is kept confidential. The approval refers to this decision.
"Art. R. 532-8.-The application for approval of a confined use of genetically modified containment classes 3 or 4 includes an emergency plan.
"This plan sets out the organizational arrangements, methods of intervention and the means necessary, including in the area of alert and information, that the facility operator is implementing to ensure the protection of personnel and the population.
"It is amended whenever the conditions for the implementation of genetically modified organisms make it necessary to update it, and when the licence is renewed.
"A copy of the emergency plan is:
« 1° Available permanently in the facility where the confined use is implemented;
« 2° Transmitted by the Minister responsible for research to the mayor of the commune or district in which the confined use must be implemented that transmits it to the other authorities that may be required to take action in the event of an accident.
"The same applies to changes in this emergency plan.
"Art. R. 532-9.-The Minister for Research shall issue to the applicant an acknowledgement of receipt of the application for approval of use record stating its date of receipt. If the file is incomplete or irregular, it invites the applicant to complete or regulate the application and informs the applicant that the time limit in which it is to be decided on the application is suspended until the response and that in the absence of a response within a time limit that the application is to be deemed abandoned.
"As soon as the application for approval of use is complete, the Minister for Research shall forward the application to the High Council of Biotechnology for notice and notify the interested party of the date on which, in the absence of an express decision, the application shall be deemed to be rejected or, pursuant to the fourth paragraph of section R. 532-11, granted.
"The Minister for Research may at any time, at the request of the High Council for Biotechnology, invite the applicant to provide additional information by informing him that the time limit on the application is suspended until the response and that in the absence of a response within two months the application will be deemed to be rejected. Upon receipt of the response, the Minister shall notify the applicant of the new date on which, in the absence of an express decision, the application shall be deemed to be rejected or, pursuant to the fourth paragraph of section R. 532-11, granted.
"In reviewing the application for approval of use, the High Council for Biotechnology may hear the applicant. It may also delegate, as necessary, one or more of its members to visit the facility.
"Art. R. 532-10.-The High Council of Biotechnology shall transmit its opinion to the Minister for Research within thirty-five days.
"This deadline is extended to seventy-five days in the event of a first application for confined use of genetically modified containment class organisms 3 or 4.
"It is suspended during the same period as the period in which it must be decided on the application for approval of use in the event of the implementation of the third paragraph of section R. 532-9.
"Art. R. 532-11.-The Minister for Research shall rule on the application by order notified to the applicant within forty-five days of the date of receipt of the file.
"This period is ninety days in the event of a first application for confined use of genetically modified containment class organisms 3 or 4.
"The order issuing the approval mentions that it is only valid for the registered use.
"In the absence of a decision to the contrary by the Minister responsible for research, the use of a genetically modified containment class organism 2 whose approval is first sought by the individual may be undertaken after the expiry of a period of forty-five days.
"If, after receiving the advice of the High Council for Biotechnology, the Minister for Research considers that the intended use is not subject to the legislative provisions of this title or chapter, or is subject to a declaration of use, the Minister shall notify the applicant within forty-five days after the receipt of the application. This period is ninety days in the event of a first application for registration of containment class 3 or 4.
"Art. R. 532-12.-The user approval may be accompanied by special requirements, especially if, in the same facility, it is used genetically modified organisms of different containment classes. In this case, the requirements applicable to the highest containment class may be required for all uses implemented in this facility.
"Art. R. 532-13.-I. ― Where the licence relates to the first confined use of genetically modified containment class 3 or 4 organisms as defined in section D. 532-3, the application also includes a public information record.
"This file includes:
« 1° The information cannot be considered confidential under Article L. 532-4-1;
« 2° The address of the High Council for Biotechnology, to whom the public can make its observations known.
"It is added to this file after the grant of approval any useful information on the classification of genetically modified organisms that may be implemented in the facility as well as on containment measures, means of response in the event of a disaster and the technical requirements to which the approval is subordinated.
“II. ― Upon issuance of the approval, the operator shall forward the information package to the public to the mayor of the municipality or district where the facility is located and to the prefect of the department.
"III. ― A notice to the public is posted in town hall for one month, at the expense of the facility operator and by the mayor's care, within eight days of receiving the file at the city hall.
"IV. ― This notice mentions the genetically modified organism used and the address of the facility in which the use must be made; it indicates that the information file is available on site and the days and hours of consultation. The completion of this display is certified by the mayor of the commune.


"Subsection 2



" Provisions relating to the declaration of use


"Art. R. 532-14.-In the cases provided for in section R. 532-4, the person responsible for the facility in which the use is to be implemented shall forward to the Minister responsible for the research a statement of use for a period not exceeding five years.
"The statement states:
« 1° If the applicant is a natural person, its name, first name and domicile and, if it is a legal person, its name or social reason, its legal form, the address of its head office and the quality of the signatory of the application;
« 2° The address of the facility in which the application will be used;
« 3° The nature of the use the applicant proposes to exercise;
« 4° Genetically modified organisms that will be used and their containment class;
« 5° Where applicable, genetically modified organisms whose use is already declared or approved and their containment class;
« 6° The name and qualifications of the user;
« 7° Internal procedures to temporarily suspend use or cease activity.
"This statement is accompanied by a technical record, the content of which is set by joint decree of ministers responsible for the environment and research, respectively.
"The operator of the facility may indicate in his statement the information other than the information referred to in Article L. 532-4-1 that he wishes not to be disclosed to third parties under the conditions provided for in Article R. 532-7.
"Art. R. 532-15.-If the declaration of use file is incomplete, the Minister for Research invites the applicant to complete it.
"As soon as the file is complete, it forwards it to the High Council of Biotechnology for information and delivers it to the applicant received from its declaration of use.
"The use of the body can be undertaken upon receipt of the receipt.
"The receipt of a declaration of use mentions that it is only valid for the intended confined use.
"The Minister for Research may at any time invite the applicant to provide additional information.
"Art. R. 532-16.-The Minister of Research shall, at the same time as the recipient, issue the general requirements applicable to the declared use, as set out in section R. 532-17. If the facility operator has already obtained one or more approvals for the confined use of genetically modified organisms in the same facility, these requirements indicate the level of containment that must be met for all declared or approved uses.


"Subsection 3



"Common provisions for approval and declaration of use


"Art. R. 532-17.-General technical requirements, applicable to confined uses of genetically modified organisms, may be determined by joint decree of ministers responsible for the environment and research, respectively, after the advice of the High Council for Biotechnology.
"Art. R. 532-18. -In the event of a change in the operator of the facility or in charge of the confined use of genetically modified organisms approved or declared, the new operator of the facility or the new owner of the use shall promptly inform the Minister responsible for the research.
"Art. R. 532-19.-The operator of the facility may request the Minister responsible for research to amend certain of the requirements applicable to the use or conditions for the implementation of approved or declared uses. The Minister shall rule within forty-five days in accordance with the procedure provided for in sections R. 532-9 to R. 532-11.
"Art. R. 532-20.-If the operator wishes to continue the confined use for which the operator has an approval or receipt of a declaration, a new application for approval or a new declaration of use shall be addressed to the Minister responsible for the research at least forty-five days before the expiry of the period provided for by the approval or the receipt of a declaration.
"A new application must be made in the event of a noticeable change in the conditions of the use of genetically modified organisms that have been the subject of the approval or declaration of use, particularly in the event of a change in the class of containment of the use or aggravation of the risk presented by the registered or declared use.
"Art. R. 532-21. -In the event that, following the issuance of the registration or receipt of a declaration, the operator of the facility is aware of new information that may alter the assessment of hazards or inconveniences to public health or the environment, the operator shall promptly inform the Minister responsible for research.
"Art. R. 532-22.-I. ― The facility operator shall inform the ministers responsible for health, research and the environment, respectively, the department's prefect and the mayor of the municipality and the Director General of the Regional Health Agency of any accident, i.e., any incident that causes, during the confined use, a significant and involuntary release of organisms, in particular of micro-organisms, genetically modified, that may present the public health
"This information is about:
« 1° The circumstances of the accident;
« 2° The designation of genetically modified organisms released;
« 3° Quantities of genetically modified organisms released;
« 4° any information necessary to assess the impact of the accident on public health or the environment;
« 5° Emergency measures taken.
“II. ― The Minister for Research shall inform the European Commission of any accident as soon as it has been informed. It indicates the circumstances of the accident, the designation of genetically modified organisms released, the quantities of genetically modified organisms released, the circumstances of the accident, the measures taken, and an analysis of the accident with recommendations to limit the consequences of the accident and to prevent such accidents from happening again.
"Art. R. 532-23.-In accordance with section L. 532-5, the Minister for Research may, by order, suspend or withdraw the approval or suspend the effects of the declaration or terminate the declaration in the event of the failure of the operator to comply with its obligations, after having, unless urgently required, the person concerned to comply with his obligations and having given him the opportunity to be heard.
"Art. D. 532-24.-When genetically modified organisms are made available to third parties for confined use, they are labelled or accompanied by a document indicating:
« 1° The name of the genetically modified organism;
« 2° The name and complete address of the person responsible for the disposition;
« 3° A specific mention: " Contains genetically modified organisms".
"If applicable, the approval specifies that this labelling must be completed under the conditions set out in Annex IV, Appendix IV, 7 to the March 12, 2001 directive on the voluntary release of genetically modified organisms into the environment.


“Section 3



" Provisions relating to the confined use of organisms
genetically modified for industrial production


"Art. R. 532-25.-The provisions of Sections 1 and 2 apply to confined uses of genetically modified organisms for industrial production subject to the modifications provided for in this section.
"The Prefect is the competent authority.


"Subsection 1



" Accreditation Provisions


"Art. R. 532-26.-By derogation from Article R. 532-5, the approval provided for in Article R. 532-4 shall be issued without condition of duration.
"For the purposes of section R. 532-6, the accreditation file consists of the elements defined in 1° to 6° of section R. 532-6 as well as the following elements derived from the application file for approval under classified facilities, if any updated on the day the application for approval is filed:
« 1° The financial capacities of the private person operating a facility under a containment class 3 or 4;
« 2° Internal procedures to temporarily suspend use or cease activity;
« 3° In the event of confined use of genetically modified containment class 3 or 4 organisms, the internal operating plan defined in section R. 512-29, which is an emergency plan.
"The application for approval of use is accompanied by a technical record, the content of which is set by joint decree of ministers responsible for the environment and research, respectively.


"Subsection 2



" Provisions relating to the declaration of use


"Art. R. 532-27.-In the cases provided for in Article R. 532-4, the declaration made in accordance with Article R. 512-47, supplemented by the elements referred to in Article R. 532-14, place of declaration of use.
"Art. R. 532-28.-By derogation from article R. 512-51, first paragraph, of general technical requirements, applicable to confined uses of genetically modified organisms, may be fixed by prefectural order, after the advice of the High Council of Biotechnology.


"Subsection 3



"Common provisions for approval and declaration of use


"Art. R. 532-29.-Without prejudice to the application of R. 512-33 and R. 512-54, the assessment of confined uses, containment measures and other protective measures are reviewed by the operator at least every five years. If substantial changes are identified, the operator shall inform the prefect as soon as possible, including when one or more of the following conditions are met:
« 1° It is aware of new information that may alter the assessment of hazards or disadvantages to public health or the environment;
« 2° The risk of use is aggravated;
« 3° Containment measures are no longer appropriate or the class assigned to confined uses has changed;
« 4° Conditions of use are significantly modified.
"The Prefect assesses whether a new application must be addressed to the Prefect and informs the operator of the request.
"Art. R. 532-30.-The operator of the facility shall inform the prefect of any accident under the conditions defined in R. 512-69. It includes the circumstances of the accident, the designation of genetically modified organisms released, the quantities of genetically modified organisms released, the measures taken, and an analysis of the accident with recommendations to limit its consequences and to prevent such accidents from happening again. The Prefect transmits this information to the regional health agency and the Minister responsible for the environment who informs the European Commission.
"Art. R. 532-31.-If the operator of the classified facility has already obtained, for the same classified facility, one or more approvals or one or more declarations for the confined use of genetically modified organisms under this section, the prefect specifies the level of containment that must be respected for all declared or approved uses.


“Section 4



“Special provisions on national defence


"Art. R. 532-32. -The provisions of section 2 apply to confined uses of genetically modified organisms for research, development or teaching purposes subject to the modifications provided for in this section when they are implemented:
« 1° be in institutions dependent on the Ministry of Defence;
« 2° Either, at the request of this department, by public institutions or private bodies, as long as these uses are covered in whole or in part by the secret of national defence, or require the use of information covered by this same secret.
"The Minister of Defence is the competent authority to make the decisions referred to in section 2 and to issue the receipt of the declaration.
"Art. R. 532-33.-The application file for approval or declaration referred to in R. 532-6 and R. 532-14 shall be addressed to the Minister of Defence.
"The information covered in whole or in part by the national defence secrecy contained in the application for approval or in the declaration of use file is reported in accordance with Articles R. 2311-3 and R. 2311-4 of the Defence Code. This information is disjointed from the file transmitted to the mayor.
"The consultation procedures for the collection of opinions are carried out in accordance with the above-mentioned provisions of Defence code.
"Art. R. 532-34. -The members of the High Council of Biotechnology exercise their right to field visits in the establishments mentioned in article R. 532-32 within the limits of the competences recognized in this high council by this title.
"Only members of the High Council of Biotechnology entitled to know information or materials protected by the secrecy of national defence, Articles R. 2311-8 and R. 2311-9 of the Defence Code, may sit or exercise a right of visit under Article R. 532-9 when the file contains such information or media. »

Article 4 Learn more about this article...


Sub-section 1 of Chapter VI, Chapter VI, Title III of Book V of the Environmental Code (regulatory part) is amended as follows:
1° In paragraph 1, entitled: " Confidential use of genetically modified organisms for research, development or teaching purposes":
(a) Section R. 536-1 is replaced by the following provisions:
"Art. R. 536-1.-An order of the Minister for Research empowers, among the officials and agents under his or her authority or with research bodies, referred to in Article L. 536-1, after the advice of the High Council for Biotechnology and the Attorney of the Republic to the Court of Grand Instance of their administrative residence, persons who may seek and report on the offences provided for in sections L. 536-6-11.
"These individuals must have a PhD or equivalent degree or be a Category A official and have the scientific, technical and legal knowledge necessary for their mission.
"The order referred to in the first paragraph specifies the purpose of the authorization, its duration and the geographic exchange in which the authorized person can search for and determine the offences. » ;
(b) After the article R. 536-4, an article R. 536-4-1 is added as follows:
"Art. R. 536-4-1.-If an employee or officer has already sworn in in the same forms for an authorization to inspect facilities classified under section R. 514-2, the initial oath is an oath under section R. 536-3. Mention is carried on the professional card by the clerk of the court of large instance. » ;
2° In paragraph 2, entitled: "In confined use of genetically modified organisms for industrial production", section R. 536-5 is replaced by the following provisions:
"Art. R. 536-5.-People referred to in articles R. 514-2 and R. 514-3 may, in accordance with Article L. 536-1, seek and observe offences under articles L. 536-3 to L. 536-6 and R. 536-11. » ;
3° Paragraph 3, entitled: “Special provisions for national defence” is amended to read:
(a) Section R. 536-6 is replaced by the following provisions:
"Art. R. 536-6.-In respect of the confined use of genetically modified organisms in the context of national defence, the competent minister referred to in sections R. 536-1 to R. 536-4 is the Minister of Defence. » ;
(b) After the article R. 536-6, an article R. 536-6-1 is added as follows:
"Art. R. 536-6-1. -In the matter of confined use of genetically modified organisms within the framework of national defence, the persons referred to in Articles R. 536-1 and R. 536-2 shall be empowered in accordance with Articles R. 2311-8 to R. 2311-9 of the Defence Code for information or materials protected by the secret of national defence. »

Article 5 Learn more about this article...


Section 2 of Chapter VI of Title III of Book V of the Environmental Code is replaced by the following:


“Section 2



“Sanctions


"Art. R. 536-11.-I. ― Is punished by the fine provided for the contraventions of the third class any operator of a facility in which is implemented a confined use of genetically modified containment class organisms 3 or 4, as defined in section D. 532-3, which did not proceed to the filing of an information record at the municipality or settlement area of the facility,
“II. ― shall be punished by the fine provided for the contraventions of the fifth class by any operator of a facility in which a confined use of genetically modified organisms is implemented that would not inform the competent administrative authority of an accident that would affect the environment or public health that occurred during use, in accordance with section R. 532-22.
"III. ― shall be punished by the fine provided for the contraventions of the fifth class by any operator of a facility in which a confined use of genetically modified organisms subject to declaration is implemented without having made the declaration under the conditions set out in R. 532-4 and R. 532-14. »

Article 6 Learn more about this article...


The first paragraph of section R. 1125-1 of the Public Health Code is replaced by the following:
"The application package under section R. 1123-30 also includes the classification of the genetically modified organism after the advice of the High Council for Biotechnology and the approval of the Minister for Research or the receipt of a statement to that Minister as referred to in section L. 532-3 of the Environmental Code. »

Article 7 Learn more about this article...


The approvals that are valid on the date of entry into force of this Order remain valid under the conditions and until the time limit set out in the decision to approve.

Article 8 Learn more about this article...


The Minister of Defence and Veterans Affairs, the Minister of Ecology, Sustainable Development, Transport and Housing, the Guard of Seals, Minister of Justice and Freedoms, the Minister of Labour, Employment and Health and the Minister of Higher Education and Research are responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.


Done on 23 September 2011.


François Fillon


By the Prime Minister:


Minister of Higher Education

and research,

Laurent Wauquiez

Minister of Defence

and veterans,

Gérard Longuet

The Minister of Ecology,

Sustainable Development,

Transport and housing,

Nathalie Kosciusko-Morizet

The guard of the seals,

Minister of Justice and Freedoms,

Michel Mercier

The Minister of Labour,

employment and health,

Xavier Bertrand


Download the document in RTF (weight < 1MB) Extrait du Journal officiel électronique authentifié (format: pdf, weight : 0.39 Mo) Download the document in RDF (format: rdf, weight < 1 MB)