Key Benefits:
The Prime Minister,
On the report of the Minister of Health, Youth and Sports,
Having regard to Council Regulation (EURATOM) No. 1493/93 of 8 June 1993 concerning the transfer of radioactive substances between Member States;
Having regard to Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 establishing general principles and general requirements of food legislation, establishing the European Food Safety Authority and establishing procedures for food safety;
In light of Council Directive 96/29/EURATOM of 13 May 1996 establishing the basic standards for the health protection of the population and workers against the dangers resulting from ionizing radiation, including articles 3 and 4;
In light of Council Directive 2003/122/EURATOM of 22 December 2003 on the control of high-level sealed radioactive sources and orphan sources;
Considering the Civil Aviation Code, including its article R. 330-1-1;
Considering the code of defence;
Considering the Customs Code;
Considering the environmental code;
Considering the Code of Criminal Procedure, including article 227;
Considering the Public Health Code;
Considering the mining code, including its article 83;
Considering the social security code, including its article R. 162-53;
Considering the labour code;
Having regard to Act No. 2000-321 of 12 April 2000 on the Rights of Citizens in Their Relations with Government;
Considering Law No. 2004-811 of 13 August 2004 on Civil Security Modernization;
Having regard to amended Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters;
Considering Decree No. 77-1133 of 21 September 1977 as amended for the application of Act No. 76-663 of 19 July 1976 on facilities classified for the protection of the environment;
Having regard to amended Decree No. 94-853 of 22 September 1994 on import, export, transit and exchange of radioactive wastes between member states of the Community with borrowing from the national territory;
Considering the opinion of the High Council of Public Health of 14 September 2007;
Considering the opinion of the Nuclear Safety Authority of 1 February 2007;
The State Council (Social Section) heard,
Decrete:
Title III of Book III of Part I of the Public Health Code is amended in accordance with Articles 2 to 32 of this Order.
Section R. 1333-2 is replaced by the following provisions:
"Art. R. 1333-2. - Any intentional addition of artificial and natural radionuclides, including when obtained by activation, in construction products, consumer goods and foodstuffs within the meaning of Regulation EC No. 178/2002 of the European Parliament and of the Council of 28 January 2002 establishing the general principles and general requirements of food legislation, establishing the European Food Safety Authority and establishing procedures for food safety. The prohibition does not involve radionuclides naturally present either in the original constituents used to manufacture construction products and consumer goods or in foodstuffs.
"It is also prohibited to import and export, if any, under any customs regime, as well as the placement in stores and temporary storage areas of such goods, products and commodities that would have been added. »
In R. 1333-3, the words: "An Order of Ministers Responsible for the Environment, Industry and Health" are replaced by the words: "A Decision of the Nuclear Safety Authority, approved by Ministers Responsible for Health, Industry and the Environment".
In article R. 1333-4, before the words "of the High Council of Public Health" are inserted the words "of the Nuclear Safety Authority and".
In article R. 1333-5, after the words: "A decree of ministers responsible for consumption, health and, if necessary, construction" are inserted the words: "taken after the opinion of the Nuclear Safety Authority".
Section R. 1333-6 is replaced by the following provisions:
"Art. R. 1333-6. - Manufacturers, suppliers and users of consumer goods and construction products with an exemption granted under section R. 1333-4 are subject to the provisions of section 3 of this chapter. »
Section R. 1333-7 is amended to read:
1° The words: "direct responsibility for the exercise" are replaced by the word "responsible";
2° The item is supplemented by the following paragraph:
"A decision of the Nuclear Safety Authority approved by the Minister for Health or, for activities and facilities relevant to the defence, of the delegate for nuclear safety and radiation protection referred to in section R. 1411-7 of the Defence Code, specifies as appropriate the terms and conditions for the application of this section, taking into account the risk to which the population is subject. »
Section R. 1333-10 is amended to read:
1° In the first paragraph, the words: "an order of ministers responsible for work and health, taken" are replaced by the words: "a decision of the Nuclear Safety Authority, approved by ministers responsible for health and work, taken";
2° In the last paragraph, the words "the Minister for Health" are replaced by the words "a decision of the Nuclear Safety Authority approved by the Minister for Health".
Section R. 1333-11 is replaced by sections R. 1333-11 and R. 1333-11-1 as follows:
"Art. R. 1333-11. - I. - The national network of environmental radioactivity measures is intended to contribute to the estimation of doses due to ionizing radiation to which the population is exposed and to public information.
"He gathers:
« 1° The results of environmental radioactivity measurements carried out either by the Institute of Radiation Protection and Nuclear Safety or by laboratories approved by the Nuclear Safety Authority for this type of measure;
« 2° Information material on the assessment of doses received by the population.
“II. - The results of measurements of the environmental radioactivity grouped within the network are those obtained:
« 1° As part of the implementation of legislative or regulatory provisions that contribute to the assessment of doses to which the population is exposed, in particular the results of monitoring the impact of nuclear activities on the environment;
« 2° By the Nuclear Safety Authority, by territorial authorities, state or public institutions that carry out measures by accredited laboratories or by the Institute of Radiation Protection and Nuclear Safety;
« 3° By any association or other private organization that conducts measurements by accredited laboratories or by the Nuclear Safety and Radiation Protection Institute as soon as the transmission of results to the network is requested by the organization holding these results. The results of measurements of environmental radioactivity made under the research, excluding those obtained under the 1° above, may be excluded from the network.
"III. - The objectives of the network of measures of environmental radioactivity are set by the Nuclear Safety Authority. The management of this network is provided by the Institute of Radiation Protection and Nuclear Safety.
"A decision of the Nuclear Safety Authority, approved by the Minister for Health, defines the modalities for the organization of the national network of measures for the radioactivity of the environment, the nature of the information transmitted to it and the manner in which such information is made available to the public.
"Art. R. 1333-11-1. - The application for approval or renewal of approval submitted by the laboratories referred to in Article R. 1333-11 shall be addressed to the Nuclear Safety Authority with a record including:
« 1° Information on the laboratory, its organization, its quality, its activity, the qualification of its personnel and its technical performance;
« 2° The list and results of inter-laboratory comparison tests to which the laboratory participated for the approval it requested.
"The file is deemed complete if, within three months of its receipt, the Nuclear Safety Authority has not requested the provision of additional information or documents. When the Authority requests additional information or documents, the deadline is suspended until such information or documents are received. The Nuclear Safety Authority, on the basis of this record, including the results of the laboratory at inter-laboratory comparison tests, publishes its decision within a maximum of eight months from the date on which the file is deemed complete. The absence of a response within this period is a rejection of the application.
"A decision of the Nuclear Safety Authority, approved by the Minister for Health, sets out the detailed list of information to be included in the application for approval, the qualification criteria to be met by the accredited laboratories and the terms and conditions for the issuance, renewal, control, suspension or withdrawal of such approval. »
Section R. 1333-12 is replaced by the following provisions:
"Art. R. 1333-12. - effluents and wastes contaminated by radionuclides, or likely to be contaminated by a nuclear activity, of any kind, must be collected, treated or disposed of, taking into account the characteristics and quantities of these radionuclides, the risk of exposure incurred and the exutories retained for their disposal. A decision of the Nuclear Safety Authority, approved by the Ministers responsible for health and the environment, sets out the technical rules to be followed by the disposal of effluents and wastes from:
« 1° Of all nuclear activities for medicine, human biology or biomedical research;
« 2° Any other nuclear activity, with the exception of:
“(a) In the basic nuclear facilities referred to in Article 28 III of Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters;
“(b) In nuclear facilities and activities relevant to the defence referred to in the III of Article 2 of the same Law;
"(c) In facilities classified for environmental protection subject to authorization pursuant to articles L. 511-1 to L. 517-2 of the Environmental Code;
"(d) In facilities subject to authorization pursuant to section 83 of the mining code.
"For the facilities mentioned in a to d of 2°, these rules are set by the specific regulations that apply to them.
"When nuclear activity is subject to authorization pursuant to the provisions of section 3 of this chapter, any proposed release of liquid and gaseous effluents and disposal of waste contaminated by radionuclides, or likely to be contaminated by nuclear activity, shall be subject to review and approval under the said authorization. The licensee shall make available to the public an inventory of the effluents and wastes disposed of, specifying the retained excutories. This inventory must be updated annually. »
Section R. 1333-13 is replaced by the following provisions:
"Art. R. 1333-13. - I. In accordance with the provisions of Article L. 1333-10 and subject to the provisions of the Labour Code relating to the protection of workers, the head of the company shall establish, for any professional activity whose characteristics meet one of the conditions defined below, a monitoring of exposure to ionizing radiation of natural origin and shall make an estimate of the doses to which persons are likely to be subjected by virtue of this activity. These include:
« 1° Occupational activities during which these people are subjected to internal or external exposure involving elements of the natural families of uranium and thorium;
« 2° Occupational activities involving the use or storage of unused materials due to their radioactive properties but naturally containing radionuclides;
« 3° Occupational activities leading to the production of residues naturally containing radionuclides.
"A decision of Ministers responsible for health and the environment taken after the advice of the Nuclear Safety Authority defines the categories of professional activities to which the provisions of this Article apply, taking into account the quantities of radionuclides held or levels of exposure that may be measured.
"For the occupational activities mentioned in 2° and 3°, the dose estimate is for the neighbouring population of the facilities as well as all persons mentioned in article R. 1333-8 when these activities produce consumer goods or construction products.
“II. - Preliminary studies necessary for the assessment of exposures to ionizing radiation of natural origin and the estimation of doses must be carried out within two years of the publication of the Order in paragraph 5 of I. They also include a study of the actions to be taken to reduce, if necessary, exposure of individuals. Based on the results, a decision by the Nuclear Safety Authority, approved by the Ministers responsible for health and the environment, sets out, by activity category, the monitoring and protection measures against ionizing radiation to be put in place. These measures cannot go beyond those imposed on nuclear activities under this Code and the Labour Code.
"III. - For professional activities under an authorization issued under Article L. 512-1 of the Environmental Code:
« 1° The impact assessment, when it contains an estimate of the doses that people are likely to be subjected to as a result of the activity, takes place in the studies referred to in II;
« 2° The monitoring measures for exposure to ionizing radiation of natural origin and, where appropriate, the protective measures contained in the authorization also take place monitoring and protection measures to be carried out under the II."
Section R. 1333-14 is amended to read:
1° After the word: "may", the words are inserted: ", after the opinion of the Nuclear Safety Authority",
2° The last sentence is deleted.
Section R. 1333-15 is replaced by the following provisions:
"Art. R. 1333-15. - In geographic areas where the natural radon is likely to be measured in high concentrations in places open to the public, the owners or, if not, the operators of these places are required, in accordance with the provisions of Article L. 1333-10, to carry out measures of the activity of the radon and its descendants in premises where the public is likely to stay for significant durations. These measures are carried out either by the Institute of Radiation Protection and Nuclear Safety or by bodies approved by the Nuclear Safety Authority. A decree of Ministers responsible for health, work, construction and the environment, taken after the advice of the Nuclear Safety Authority, defines:
« 1° The list of departments or parts of departments in which these measures must be carried out, taking into account the local geological context and the results of radon analyses available;
« 2° The categories of establishments concerned because of the public's foreseeable time in these places;
« 3° The levels of radon activity beyond which owners or operators are required to implement the actions necessary to reduce the exposure of individuals and the deadlines for their implementation.
"The conditions under which radon activity is measured, including sampling methods and methods for evaluating the measuring devices used, are defined by a decision of the Nuclear Safety Authority, approved by the Ministers responsible for health and construction.
"The measures of the activity of the radon and its descendants in the places defined under this section shall be carried out within two years of the date of publication of the order referred to in the first paragraph of this Article. These measures must be repeated every ten years and, where applicable, whenever work is done to alter the ventilation of the premises or the sealing of the premises in the radon.
"Art. R. 1333-15-1. - The application file for the approval of the bodies responsible for the measurement of radon exposures referred to in R. 1333-15 includes information on the organization, organization, quality, activity, qualification of its personnel and the methods and materials used by it. The file is deemed to be complete if, within three months of its receipt, the Nuclear Safety Authority has not requested the provision of additional information or documents. In the event of a request for additional information or documents, the deadline is suspended until the receipt of such information. The Nuclear Safety Authority shall issue its decision within a maximum period of six months from the date on which the record is deemed complete. The absence of a response within this period is a rejection of the application.
"A decision of the Nuclear Safety Authority, approved by the Ministers responsible for health, work and construction, defines, on the one hand, the detailed list of information to be included in the application for accreditation and the terms and conditions for the issuance, control and withdrawal of the approval, on the other hand, the criteria for the accreditation of the organizations as well as the objectives, duration and content of the training programs of the persons who carry out the measures. »
Section R. 1333-16 is replaced by the following provisions:
"Art. R. 1333-16. - The results of the radon measures carried out pursuant to section R. 1333-15 are communicated to the Chief of Institution, to staff representatives and to occupational doctors and prevention doctors when the building has work premises. They are brought to the attention of persons who attend the establishment. They are held at the disposal of the radiation protection inspectors referred to in Article L. 1333-17 and of the agents referred to in Article L. 1333-18, of the agents or services referred to in the first paragraph of Article L. 1312-1 and in the second paragraph of Article L. 1422-1, of the labour inspectors, of the hygiene and security inspectors and of the agents responsible for the prevention services of the social security agencies, of the body
"Agreed bodies for radon measurement shall communicate the results of the measures to a body designated by the Minister responsible for health after the advice of the Nuclear Safety Authority. A decision by the said authority, approved by the Minister for Health, sets out the terms and conditions for access to the information and the technical rules of their transmission. »
Section 3 is replaced by the following:
“Section 3
"Authority and declarations regime
"Subsection 1
" Scope of application
"Art. R. 1333-17. - I. - The following nuclear activities are subject to the authorization or declaration regime referred to in Article L. 1333-4, provided that they do not receive an exemption under Article R. 1333-18:
« 1° For radionuclides and containing products or devices:
“(a) Manufacturing;
“(b) Use or detention;
"(c) Distribution, import or export, whether or not these radionuclides, products or devices are held in the facility;
« 2° For accelerators of any type of particles and electrical appliances emitting ionizing radiation other than electronic microscopes:
“(a) Manufacturing;
“(b) Use or detention;
"(c) Distribution;
« 3° The irradiation of products of any kind, including food.
“II. - The carriage of radioactive material is subject to authorization or declaration under the conditions set out in R. 1333-44.
"III. - The authorizations for nuclear activities referred to in I, issued in accordance with the specific regulations applicable to them, shall be the authorization provided for in Article L. 1333-4 where such activities are carried out at the following facilities:
“(a) The basic nuclear facilities referred to in Article 28 III of Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters;
“(b) Nuclear facilities and activities referred to in Article 2 III of the Act;
"(c) Facilities classified for environmental protection subject to authorization pursuant to articles L. 512-1 of the Environmental Code;
"(d) Facilities subject to authorization pursuant to section 83 of the mining code.
"The authorizations for the distribution, import or export operations referred to in c of 1° of the I, carried out in a facility classified for the protection of the environment subject to authorization under Article L. 512-1 of the Environmental Code, shall be issued by the Nuclear Safety Authority.
"Art. R. 1333-18. - I. Are exempt from the authorization or declaration provided for in Article L. 1333-4:
« 1° Nuclear activities using radioactive sources referred to in 1° and 3° of I of Article R. 1333-17, if they meet one of the following two conditions:
“(a) The quantities of radionuclides present at any time in the place where practice is exercised do not exceed in total the exemption thresholds set out in Table A of Schedule 13-8, regardless of the value of the activity concentration of these substances;
“(b) The concentration per mass unit of radionuclides present at any time on the place where practice is exercised does not exceed the exemption thresholds set out in Table A of Appendix 13-8, provided that the masses of the substances involved are equal to one ton.
"For radionuclides not listed in Table A of Appendix 13-8, exemption values may be set, on a provisional basis, by a decision of the Nuclear Safety Authority, approved by the Ministers responsible for Health and Labour, following the advice of the Institute of Radiation Protection and Nuclear Safety.
« 2° The detention or use of electrical appliances referred to in 2° I of Article R. 1333-17 does not create, under normal conditions of use, at any point located at a distance of 0.1 m from its accessible surface, a dose equivalent flow greater than 1 μv.h-1 and meeting one of the following requirements:
“(a) The electrical appliance used is of a certified type conforming to the standards whose references are fixed by decision of the Nuclear Safety Authority approved by the Ministers responsible for health, labour and industry;
“(b) The aircraft is granted an exemption certificate issued by a decision of the Nuclear Safety Authority approved by the Ministers responsible for health and labour because, by design, it ensures effective protection of individuals and the environment from ionizing radiation under normal conditions of use;
"(c) The electrical appliance used is a cathodic tube intended for image display, or any other electrical apparatus operating under a potential difference of less than or equal to 30 kV;
« 3° The distribution and use of consumer goods and construction products that are exempted under section R. 1333-4;
« 4° The use, possession and distribution of any ionizing electrical appliances that operate under a potential difference of less than 5 kV.
“II. - Nuclear activities for medicine, dental art, human biology and biomedical research cannot be granted the exemption of authorization or declaration provided for in I.
"Subsection 2
“System of declarations
"Art. R. 1333-19. - The provisions of this subsection define the terms and conditions of declaration required under Article L. 1333-4 for the following nuclear activities:
« 1° The possession or use of electrical appliances generating X-rays for biomedical or medical, dental, forensic or veterinary purposes for the categories of devices listed by a decision of the Nuclear Safety Authority approved by the Minister for Health;
« 2° The possession or use of radionuclides in radioactive sources sealed in a quantity greater than the exemption thresholds defined in 1° of section R. 1333-18 for nuclear activities listed by a decision of the Nuclear Safety Authority approved by the Minister for Health;
« 3° The non-medical detention or use of electrical appliances generating X-rays that do not present at any point at a distance of 0.1 m from their surface accessible under normal conditions of use, as a result of their design, a dose equivalent flow greater than 10 μSv.h-1.
"The lists of nuclear activities or X-ray appliances mentioned in 1° and 2° are prepared taking into account the characteristics of the ionizing sources and the devices that contain them, their design, their conditions of use and the devices provided for the effective protection of people and the environment.
"Art. R. 1333-20. - The nuclear activities referred to in Article R. 1333-19 shall be reported to the Nuclear Safety Authority. However, the nuclear activities referred to in 2° and 3° of the same article, when carried out in an establishment where nuclear activities are licensed, are not reported. In this case, they are referred to in the application for authorization under section R. 1333-23.
"The list of documents to be attached to the declaration is established under the conditions set out in section R. 1333-43, taking into account the characteristics of ionizing sources of radiation, sheltering facilities and purpose of use.
"Art. R. 1333-21. - The Nuclear Safety Authority acknowledges receipt of the declaration filed by the natural or legal person responsible for nuclear activity, below referred to as "the declarant." The declaration is updated without delay by the declarant when the information contained therein is amended and, in particular, when the declarant ceases to operate.
"When the nuclear activities referred to in 1st of section R. 1333-19 take place at sites under the Minister of Defence, the declaration is filed with the service designated by the Minister. This service acknowledges receipt of the statement.
"Art. R. 1333-22. - In the case of mobile sources emitting ionizing radiation, the declarant shall make available to the Nuclear Safety Authority the list of places where the mobile source is used.
"Subsection 3
"Authority Plan
"Art. R. 1333-23. - The provisions of subsection 3 define the terms and conditions of authorization for nuclear activities defined in section R. 1333-17, where they do not benefit from the exemptions provided for in section R. 1333-18 and are not subject to declaration under section R. 1333-19.
"Art. R. 1333-24. - The application for authorization or renewal shall be submitted by the natural person or by the representative of the legal person who shall be the person responsible for the nuclear activity envisaged and co-signed by the head of establishment if it exists.
"This application indicates the name of the competent person in radiation protection who participated in the constitution of the file, in accordance with the provisions of Article R. 231-106 of the Labour Code.
"Art. R. 1333-25. - The application for authorization is accompanied by a supporting file containing general information on the establishment, the organization of radiation protection and detailed information on sources of ionizing radiation, the installation of them and the radiation protection equipment implemented. The content of this information is specified in the conditions provided for in Article R. 1333-43, taking into account the purposes and conditions of use or detention of sources.
"In the case where the application relates to the use, outside of any establishment, of sources of ionizing radiation, of products or devices in containers, the file contains a description of the conditions of their transport, use and storage.
"The Nuclear Safety Authority may request information on the rationale for the use of ionizing radiation sources, products or devices in containers. Where applicable, it may request that additional expertise, carried out at the applicant's expense, assess the relevance of this information.
"Art. R. 1333-26. - I. - In the case where the application relates to the use of ionizing radiation for medical purposes, the application file is supplemented by medical information on the justification of the new application and its possible consequences for the patient and the people around him.
"In the event that the application relates to the use of ionizing radiation for biomedical research purposes, the application file for authorization is supplemented by information on the terms and conditions under which the provisions of Article R. 1333-65 are applied.
“II. - When the application relates to the distribution, import or export of radioactive sources, products or devices in containers, the application for authorization file is supplemented by:
« 1° Additional information on the manufacturer, where appropriate, its agent and suppliers and, in the case of sealed radioactive sources, on the modalities for the recovery of sources and associated financial guarantees;
« 2° Manuals and manuals for use and maintenance;
« 3° The results of the tests performed to assess their performance and safety.
"The information referred to in 2° and 3° is also attached to any request for authorization to distribute electrical appliances emitting ionizing radiation.
"Art. R. 1333-27. - For the manufacture, distribution or importation for distribution of radiopharmaceutical drugs, generators or precursors as defined in section L. 5121-1, the application for authorization is accompanied by a document establishing that an application for authorization to open a pharmaceutical establishment has been filed in accordance with section L. 5124-3 or that the applicant has an authorization for a pharmaceutical establishment in force. Any issuance, modification, withdrawal, refusal or suspension of authorization under this Order must be made known to the author authority, as well as to the authority that authorized the pharmaceutical establishment.
"Art. R. 1333-28. - The application for authorization or renewal of authorization is sent, under recommended fold with request for notice of receipt, or filed against receipt to the Nuclear Safety Authority.
"The file is deemed complete if, within three months of its receipt, the Nuclear Safety Authority has not requested the provision of additional information or documents. Where the Nuclear Safety Authority requests additional information or documents, the time limit provided for in this Article shall be suspended until such information or documents are received.
"The Nuclear Safety Authority may, prior to the issuance of the authorization, seek advice from the Institute of Radiation Protection and Nuclear Safety, the French Health Safety Agency for Health Products or another body.
"Art. R. 1333-29. - The Nuclear Safety Authority shall notify its decision within a maximum period of six months from the date on which the record is deemed complete. The absence of a response within this period is a rejection of the application. Where the Nuclear Safety Authority requests additional information or documents necessary for the instruction of the application, the deadline provided for in this Article shall be suspended until such information or documents are received.
"Art. R. 1333-30. - The authorization granted under this section is granted to the natural or legal person responsible for the activity and is not transferable.
"The elements on which the requirements of the authorization are met shall be determined under the conditions laid down in Article R. 1333-43.
"Art. R. 1333-31. - For nuclear activities involving radionuclides in unsealed radioactive sources, the authorization under this section further stipulates:
« 1° Technical requirements for waste and effluent produced for disposal in authorized facilities;
« 2° If necessary, the frequency of an estimation of the doses to which the population is subject in accordance with the terms set out in articles R. 1333-10 and R. 1333-11.
"Art. R. 1333-32. - The facility is the subject of a reception on the part of the licensee during which the conformity of the premises where radionuclides, products or devices are received, stored and used, as well as the premises where devices emitting ionizing radiation shall be tested or used. This receipt may only take place after the manufacturer's control and verifications are carried out and, where applicable, by the authorization issued under this section.
"Art. R. 1333-33. - When high-level radioactive sources are implemented, the authorization imposes the obligation to establish an internal emergency plan as defined in section L. 1333-6. This plan takes into account the risks of internal and external exposure to ionizing radiation from all persons likely to be threatened. The characteristics of high-activity radioactive sources are defined in Appendix 13-8 to this code.
"Art. R. 1333-34. - The authorization is issued for a period not exceeding ten years. The duration of this period depends on the specificity of the establishment, installation, premises and characteristics of the ionizing sources of radiation or their conditions of use and the nature of nuclear activities. The authorization may be renewed upon request by the licensee, not later than six months before the expiry date. The application must mention the modifications made to the installation since the date of issue of the current authorization, be accompanied by the check reports made under the Labour Code and confirm the validity of the documents already transmitted, including in previous applications for authorization or, if not, include updated information. If, after the filing of this renewal application, the applicant is not notified of any decision or request for additional justification prior to the expiry date of the licence, the applicant shall be deemed to be renewed on that date, under conditions and for a period identical to that of the previous authorization.
"Art. R. 1333-35. - If a nuclear activity that has been authorized has not begun to be implemented within one year of the issuance of the authorization, it becomes obsolete. The Nuclear Safety Authority must be kept informed by the Institute of Radiation Protection and Nuclear Safety.
"Where the licensee does not comply with the provisions of this Code or the requirements notified to it, the authorization may be subject to a temporary or final withdrawal by the Nuclear Safety Authority, as defined in Article L. 1333-5. The temporary withdrawal cannot exceed ninety days.
"In the event of a final withdrawal, the Nuclear Safety Authority shall determine the conditions for the disposal of current or future sources and wastes at the expense of the licensee.
"Art. R. 1333-36. - In addition to the prohibitions that may be imposed pursuant to Article L. 1333-2, the Nuclear Safety Authority may review the authorization issued whenever new elements allow for a reassessment of the justification of the authorized nuclear activity. In the event that the authorization concerns a nuclear activity intended for medicine, dental art, human biology or biomedical research, the Nuclear Safety Authority shall inform the French Health Safety Agency of health products.
"For suppliers of sealed radioactive sources and of products or devices in containers, the withdrawal of the authorization to distribute does not exempt the supplier from taking the necessary measures to fulfil its obligations under section 4, including those relating to the recovery and disposal of the sources referred to in section R. 1333-52.
"Art. R. 1333-37. - Any refusal to submit the facility to the control referred to in R. 1333-95 may result in the withdrawal of the authorization granted under this section.
"Subsection 4
“Common provisions applicable to plans
authorization and declaration
"Art. R. 1333-38. - The person responsible for a nuclear activity declared or authorized under sections R. 1333-19 and R. 1333-23 shall present, as a natural or legal person, the qualifications or capacities required under section R. 1333-43.
"Art. R. 1333-39. - Any change in respect of the declarer or licensee, any change in the allocation of premises intended to receive radionuclides or ionizing radiation transmitters, any extension of the domain covered by the original authorization, any modification of the characteristics of a source of ionizing radiation held, used or distributed, shall be the subject of a new declaration or application for a security right in the case mentioned The failure to file a new application for authorization exposes the licensee to the immediate termination of the authorization, without prejudice to any prosecution under section L. 1337-5 of the Public Health Code.
"Art. R. 1333-40. - Any change in the person responsible for radiation protection, as well as any other changes in the technical equipment of the facilities where radionuclides and ionizing radiation transmitters are used, shall be the subject of information from the Nuclear Safety Authority.
"Art. R. 1333-41. - The cessation of a nuclear activity subject to declaration or authorization pursuant to Articles R. 1333-19 and R. 1333-23 shall be notified to the Nuclear Safety Authority at least six months before the scheduled date of such termination. The Nuclear Safety Authority shall notify the licensee of the authorization or the declarant of the measures to be implemented, including the recovery of sealed radioactive sources, the verification of the absence of radioactive contamination, the disposal of radioactive wastes and, where appropriate, the conduct of work to allow the reuse, for another purpose, of premises in which such nuclear activities are carried out.
"Art. R. 1333-42. - The licensee or the registrant is relieved of its obligations when it demonstrates that radionuclides and containing products or devices have been removed from the premises and that it has fulfilled all of its obligations under R. 1333-41. The Nuclear Safety Authority, as the case may be, shall notify the Authority of the decision to terminate the authorization or issue an attestation to it that it is exempt from its obligations.
"Art. R. 1333-43. - Decisions of the Nuclear Safety Authority approved by the Minister for Health define the modalities for the application of the provisions of subsections 2, 3 and 4, and in particular those relating to:
« 1° The qualifications and abilities of the persons referred to in Article R. 1333-38;
« 2° The detailed content of the information to be attached to the declarations or requests for authorization or renewal of authorization referred to in articles R. 1333-20, R. 1333-25 and R. 1333-30 respectively;
« 3° The elements on which the requirements of the authorization relate to the sources used and their conditions of employment and, as appropriate, the additional requirements for the organization of radiation protection in premises where sources are used or held;
« 4° The specific conditions of use applicable to certain ionizing sources of radiation, taking into account the modes of exposure and the characteristics of the ionizing sources;
« 5° The minimum technical requirements for design, operation and maintenance to be met by facilities in which nuclear activities are carried out or declared under this section are carried out.
"Decisions on the points mentioned in 1°, 3°, 4° and 5° are also approved by the Minister responsible for work.
"Subsection 5
"Authorisation or declaration of carriage
of Radioactive Material
"Art. R. 1333-44. - I. - Without prejudice to the regulations concerning the transport of dangerous goods, companies carrying out the transport of radioactive material are subject to a declaration or authorization of the Nuclear Safety Authority for the transport of radioactive material on the national territory. A decision of the Nuclear Safety Authority, approved by the Ministers responsible for nuclear safety and transport, sets out, among other things, the characteristics of radioactive material pertaining to either the authorization or the declaration, the composition of the application file for authorization and the elements attached to the declaration, the terms of instruction and the conditions of renewal, withdrawal and suspension.
"However, transport by vessels entering the territorial waters but not stopping in a French port is exempt from declaration and authorization.
“II. - The authorization for the air transportation of radioactive material issued pursuant to section R. 330-1-1 of the Civil Aviation Code shall be the authorization provided for in this section. »
In sections R. 1333-45, R. 1333-47, R. 1333-50, R. 1333-51 and R. 1333-53, the words "sealed or unsealed sources" are replaced by the words "radiological sources".
The second to eighth paragraphs of R. 1333-45 are replaced by the following:
"Not applicable to the provisions of this section:
« 1° Radioactive sources and containing products and devices listed in the first paragraph, where the holder is not subject to the declaration or authorization provided for in Article L. 1333-4;
« 2° Radioactive waste as defined by Decree No. 94-853 of 22 September 1994 on import, export, transit and exchange of radioactive wastes between member states of the Community with borrowing from the national territory;
« 3° Materials, equipment and products contaminated by a radioactive substance from a nuclear activity referred to in Article L. 1333-1;
« 4° Materials containing natural radionuclides not used for their radioactive, fissile or fertile properties referred to in Article L. 1333-10;
« 5° Nuclear substances defined under Article L. 1333-1 of the Defence Code, unless they are intended for the manufacture of radioactive sources or used as a radioactive source, as well as materials used as nuclear, irradiated or non-irradiated, nuclear fuels at basic nuclear facilities or facilities classified for the protection of the environment authorized for that purpose;
« 6° Radioactive or activated test specimens, which are intended to be characterized or analyzed, to produce radioactive sources or to be used for intercomparison measures, as long as these activities are described in the authorizations of these facilities;
« 7° Transactions related to the transport of radioactive materials.
"The authorizations listed in this section are either the authorizations issued under section 3 or the authorizations for:
“(a) The basic nuclear facilities referred to in Article 28 III of Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters;
“(b) Nuclear facilities and activities referred to in Article 2 III of the Act;
"(c) Facilities classified for environmental protection subject to authorization pursuant to articles L. 512-1 of the Environmental Code;
"(d) Facilities subject to authorization pursuant to section 83 of the mining code. »
Section R. 1333-46 is replaced by the following provisions:
"Art. R. 1333-46. - The assignment of radionuclides in the form of radioactive sources, of products or devices in containers to any person who does not have a receipt of declaration issued pursuant to R. 1333-20 or an authorization referred to in R. 1333-45 and the acquisition by the same persons of such radionuclides is prohibited. »
Section R. 1333-47 is amended to read:
Before the words: "Every assignment or acquisition of radionuclides", the words are inserted: "except in the cases defined by the decision provided for in 1° of Article R. 1333-54-1,".
Section R. 1333-48 is replaced by the following provisions:
"Art. R. 1333-48. - The declaration provided for in Article 4 of Council Regulation EURATOM No. 1493/93 of 8 June 1993 concerning the transfer of radioactive substances between the Member States is deposited with the Institute of Radiation Protection and Nuclear Safety. The statement of deliveries under section 6 of the Regulations is made at each transfer and deposited with the Institute of Radiation Protection and Nuclear Safety. »
Section R. 1333-49 is replaced by the following provisions:
"Art. R. 1333-49. - Any import or export of radionuclides in the form of radioactive sources, products or devices containing, from or to States not members of the European Community, must be previously registered with the Institute of Radiation Protection and Nuclear Safety. The exporter or importer shall complete and attach to the application for registration a form issued by the Institute, including the nature and quantities of radionuclides imported or exported. The form registered by the Institute of Radiation Protection and Nuclear Safety is submitted in support of the customs declaration. »
The second paragraph of section R. 1333-50 is replaced by the following:
"A quarterly statement of assignments and acquisitions must be sent by the supplier to the Institute of Radiation Protection and Nuclear Safety in the form that is notified to the supplier when the authorization is issued or after receipt of the declaration referred to in section 3.
"For the purpose of updating the inventory provided for in Article L. 1333-9, a copy of the receipt of the declarations and authorizations referred to in Articles R. 1333-20 and R. 1333-45 shall be transmitted to the Institute of Radiation Protection and Nuclear Safety by the authority that issued the authorization or received the declaration. A list of these authorizations and declarations is maintained by this authority and transmitted to the Institute of Radiation Protection and Nuclear Safety. »
Articles R. 1333-51, R. 1333-52 and R. 1333-53 are replaced by the following:
"Art. R. 1333-51. - Any appropriate action shall be taken to prevent unauthorized access to radioactive sources, their loss, theft or damage by the fire or water that they may suffer.
"After any event that may have damaged a source, including a fire or flood, the chief of establishment conducts an audit of the integrity of each source.
"Art. R. 1333-52. - I. - A sealed radioactive source is considered to have been outdated no later than 10 years after the date of the first registration affixed to the supply form or, if not, after the date of its first release on the market, except as extended by the competent authority.
"Any user of sealed radioactive sources is required to take back outdated sources or at the end of use by the supplier. However, as a derogatory, this obligation is not applicable where the characteristics of the sources allow a decay in the place of use. The deteriorated sources are taken under the same conditions without any derogation.
“II. - The supplier of sealed radioactive sources, of products or devices in containers, is under an obligation to recover, without condition and on a simple request, any sealed source that it has distributed, especially when that source is outdated or its holder has no use of it. When the source is used in a device or product, it is also required to resume it in full if the holder so requests.
"The supplier may either proceed or cause the removal of the sources in a licensed facility to do so or return them to the supplier or manufacturer. It must report to the Nuclear Safety Authority and the Institute of Radiation Protection and Nuclear Safety any sealed source, product or device in a container that would not have been returned to it within the required time frame.
"The supplier must have a storage site, in conditions consistent with the protection of health and the environment, with sufficient capacity to receive end-of-use sources during the period prior to disposal or recycling.
"III. - The decision under section R. 1333-54-1 sets out the conditions for the application of this section.
"Art. R. 1333-53. - Under this Article, the supplier shall be the one who:
« 1° Distributes sealed radioactive sources, products or devices in containers to a holder or end user;
« 2° Imports, for distribution to an end-user or end-user, or for its own use, sealed radioactive sources, products or devices in containers, acquired from a foreign company that has no authorization under section L. 1333-4 of the Public Health Code.
"Before any import, transfer between Member States of the European Community, or distribution of sealed radioactive sources or products or devices in containers, the supplier must be able to present the financial guarantee provided for in Article L. 1333-7. The terms and conditions for the implementation and acquittal of this guarantee shall be determined by the order provided for in section R. 1333-54-2, up to the amount fixed in accordance with section R. 1333-54.
"The supplier's obligation to present a financial guarantee under the conditions set out in the preceding paragraph remains notwithstanding the financial guarantee that these sources, products or devices could benefit from in another Member State of the European Community. »
Section 4 is supplemented by articles R. 1333-54, R. 1333-54-1 and R. 1333-54-2 as follows:
"Art. R. 1333-54. - The amount of the financial guarantee required under section R. 1333-53 is based on a national scale that defines, by family of sources, a cost of recovery of sealed radioactive sources and of products or devices containing them. Families of radioactive sources are determined by taking into account the nature of radionuclide, the initial activity of the source and the existence or absence of an elimination channel in France.
"When the supplier imports, transfers from another Member State or distributes a single family of sealed radioactive sources and containing products or devices, the amount of the financial guarantee required under Article R. 1333-53 is the cost of recovery set by the national scale for the family of sources considered multiplied by the number of radioactive sources that must be taken back to users.
"When the supplier imports, transfers from another Member State or distributes several families of radioactive sources and products or devices in containers, the amount of the financial guarantee is the sum of the products obtained under the preceding paragraph for each family of sources.
"The Nuclear Safety Authority shall implement the financial guarantee in the event of a supplier's failure in the performance of its obligation of recovery as provided for in the third paragraph of Article R. 1333-52.
"Art. R. 1333-54-1. - A decision of the Nuclear Safety Authority, approved by the Ministers responsible for health and the environment, defines the modalities for the application of the provisions of this section and in particular those relating to:
« 1° The registration of radionuclides and containing products or devices mentioned in articles R. 1333-47 to R. 1333-49;
« 2° The rules for monitoring radioactive sources and containing products or devices enacted in R. 1333-50, taking into account their characteristics and destination;
« 3° The general rules that the advertisement provided for in Article L. 1333-14 may be made as well as the minimum information that must be carried on packagings of radioactive sources and of products or devices in containers;
« 4° The technical criteria on which the extensions granted under Article R. 1333-52 are based;
« 5° Resuming and eliminating the sources provided for in Article R. 1333-52;
« 6° The identification and marking of high-activity sealed sources and the nature of the information on these sources that the holder must collect.
"Art. R. 1333-54-2. - A decree of Ministers responsible for health and the economy, taken after the advice of the Nuclear Safety Authority, the National Radioactive Waste Management Agency and the Nuclear Safety and Protection Institute, defines:
“(a) The modalities for calculating the national scale of the financial guarantee referred to in R. 1333-54;
“(b) The terms and conditions for the implementation and acquittal of this guarantee and the transitional conditions associated with the sources distributed prior to the date of publication of that order. »
Section 5, Control, becomes Section 7. It is amended in accordance with the provisions of articles 28 to 31.
Section 6, entitled "Protection of persons exposed to ionizing radiation for medical or forensic purposes", which includes sections R. 1333-55 to R. 1333-74, becomes section 5. It is amended to read:
1° In R. 1333-56, the words: "The National Health Accreditation and Assessment Agency" are replaced by the words: "the High Health Authority" and the word "benefit" is replaced by the word "benefit";
2° In section R. 1333-60, after the words: "by order of the minister responsible for health", the words are added: ", after notice of the Nuclear Safety Authority";
3° In R. 1333-64, the words: "Decision of the Minister for Health" are replaced by the words: "Decision of the Nuclear Safety Authority, approved by the Minister for Health";
4° In R. 1333-65, the word "benefit" is replaced by the word "benefit", the word "biomedical" is inserted after the word "research", the words "or medico-legal procedures" and the last paragraph are deleted;
5° In R. 1333-66, the words: "An order of the Minister for Health" are replaced by the words: "A decision of the Nuclear Safety Authority, approved by the Minister for Health";
6° In R. 1333-67, the words "in R. 1333-29" are replaced by the words "in R. 1333-38";
7° In R. 1333-70, the words: "the Minister responsible for health" are replaced by the words: "the Nuclear Safety Authority" and the words: "the National Health Accreditation and Assessment Agency" are replaced by the words: "the High Health Authority";
8° In article R. 1333-71, the second sentence is deleted;
9° In R. 1333-73, the words: "The National Health Accreditation and Assessment Agency" are replaced by the words: "the High Health Authority";
10° Section R. 1333-74 is replaced by the following provisions:
"Art. R. 1333-74. - A decision of the Nuclear Safety Authority, approved by the Minister for Health, determines the objectives, duration and content of the training programs for health professionals on the radiation protection of patients, as provided for in section L. 1333-11 and the modalities for recognition of equivalent training. »
Section 7 entitled "Rradiological emergency and sustainable exposure to ionizing radiation" becomes, with the same title, section 6 including sections R. 1333-75 to R. 1333-94. It is amended to read:
1° At the end of the article R. 1333-75, after the words: "as defined in articles R. 1333-76 and R. 1333-77", are added the words: "or when discovering an orphaned radioactive source";
2° In the first paragraph of section R. 1333-80, the words: "an order of the Minister for Health, after the advice of the Institute for Radiation Protection and Nuclear Safety" are replaced by the words: "a decision of the Nuclear Safety Authority approved by the Minister for Health, and taken after notice of the Institute for Nuclear Radiation Protection and Safety and the competent authority for nuclear activities and facilities relevant to the defence";
3° In the third paragraph of article R. 1333-80, after the words: "civil security" are added the words: ", after the opinion of the Nuclear Safety Authority",
4° In the second paragraph of article R. 1333-81, after the word "guardianship", the words ", and by the Nuclear Safety Authority" are added;
5° In the fifth paragraph of article R. 1333-81, after the word "radioprotection", the words "and the Nuclear Safety Authority" are inserted;
6° At the end of the second paragraph of Article R. 1333-82, the sentence is added: "These balances are transmitted for advice to the Nuclear Safety Authority. » ;
7° In section R. 1333-83, the words: "in section 10 of Act No. 87-565 of 22 July 1987, under the authority of the Director of Relief Operations, in particular under the ORSEC plans and emergency plans as defined by Decree No. 88-622 of 6 May 1988 on emergency plans taken under Act No. 87-565 of 22 July 1987 relating to the prevention of civil safety are replaced by the words: "by section 17 of Act No. 2004-811 of 13 August 2004 on Civil Security Modernization, under the authority of the Director of Emergency Operations, in particular under the emergency and relief plans provided for by this Act. » ;
8° In article R. 1333-88, after the words: "A decree taken by ministers responsible for health, work, internal affairs and civil security", are inserted the words: ", after the opinion of the Nuclear Safety Authority",
9° In the first paragraph of article R. 1333-90, after the words: "the prefect implements", are added the words: ", after the opinion of the Nuclear Safety Authority",
10° After the 4° of the article R. 1333-90, is added a 5° as follows:
"5° How to handle contaminated materials";
11° In the penultimate paragraph of Article R. 1333-90, after the words: "A decree of ministers responsible for health, agriculture and the environment" are inserted the words: ", after the opinion of the Nuclear Safety Authority",
12° In article R. 1333-91, after the word "guardianship", are added the words: "and by the Nuclear Safety Authority. » ;
13° Sub-section 4 "Different Provisions" of new section 6 becomes sub-section 5 and section R. 1333-93 becomes section R. 1333-94;
14° It is inserted after subsection 3 a sub-section 4 as follows:
"Subsection 4
« Orphaned radioactive sources
"Art. R. 1333-93. - In each department, the prefect, after the advice of the Nuclear Safety Authority and the National Agency for the Management of Radioactive Waste, determines the modalities for the management of orphaned radioactive sources that may be discovered therein and the actions to be taken to deal with radiological emergencies caused by these sources.
"The measures defined by the prefect must be consistent with the requirements of the national plan for the management of radioactive materials and wastes as established by the decree set out in Article L. 542-1-1 of the Environmental Code.
"After security of the site where an orphaned source was discovered, the prefect is seeking the identity of the final holder or supplier. Following the advice of the Nuclear Safety Authority and, where appropriate, of the competent authority for nuclear activities and facilities relevant to the defence, it organizes, as appropriate, the transfer of orphaned radioactive sources to an authorized body to collect them, and uses the advice and technical assistance provided to it by the competent ministerial departments and agencies of expertise under their supervision.
"The Prefect shall hold the Nuclear Safety Authority and, where appropriate, the competent authority for nuclear activities and facilities relevant to the defence informed of the actions it intends to take or has taken to ensure the security of the site. »
It is created a new section 7 entitled "Control". This section is organized in three subsections, including articles R. 1333-95 to R. 1333-97, R. 1333-98 to R. 1333-108 and R. 1333-109 to R. 1333-111 respectively.
Sub-section 1 is as follows:
"Subsection 1
“Control by accredited bodies
"Art. R. 1333-95. - Without prejudice to the internal controls provided for in section R. 1333-7 and the controls provided for in sections R. 231-84 and R. 231-85 of the Labour Code and, where applicable, those carried out pursuant to section L. 521-21 of the Environmental Code, the head of establishment is required to have the Institute of Radiation Protection and Nuclear Safety checked by a body approved by the Nuclear Safety Authority:
« 1° The effectiveness of the organization and the technical devices it has put in place pursuant to article R. 1333-7;
« 2° The rules that have been established pursuant to R. 1333-45 to R. 1333-54 to manage radioactive, sealed and unsealed sources, containing products or devices, as well as ionizing electrical appliances;
« 3° The technical rules to which the collection, processing and disposal of effluents and wastes contaminated by or likely to be contaminated by radionuclides as a result of a nuclear activity, as defined under section R. 1333-12.
"Art. R. 1333-96. - The controls carried out by the Institute of Radiation Protection and Nuclear Safety or the approved bodies referred to in section R. 1333-95 are the subject of written reports, indicating the date and nature of the audits, the names and qualities of the persons who have performed them and any non-conformities identified. These reports are forwarded to the licensee or the registrant of the controlled device or facility and to the registrant who keeps them for ten years. They are made available to labour inspectors and radiation protection inspectors.
"In the event of a finding of a non-compliance that may result in exposure of persons beyond the regulatory limits set out in section R. 1333-8 and sections R. 231-76 and R. 231-77 of the Labour Code, the body that has carried out the control must, without delay, transmit a reasoned recommendation to place the device or facility under control to the licensee or to the licensee of the facility. This recommendation is addressed by the Chief of Institution to the Labour Inspector, the Nuclear Safety Authority and the Prefect. The Chief of Institution specifies the measures it intends to take to remedy this non-compliance.
"Art. R. 1333-97. - A decision of the Nuclear Safety Authority approved by the Ministers responsible for health and work defines, for approved bodies:
« 1° The detailed list of information to be included in the application for approval referred to in Article R. 1333-95 and the terms and conditions for the accreditation of these organizations and the modalities and frequencies of the controls it performs;
« 2° The procedures for the suspension of the approvals of the inspection bodies referred to in R. 1333-95;
« 3° Cases of non-compliance referred to in R. 1333-96 and the terms and conditions of their declaration.
"The application file for the accreditation of the control bodies includes information on the body, its organization, its quality, its activity, the qualification of its personnel and the methods and materials used by it. The file is deemed to be complete if, within two months of its receipt, the Nuclear Safety Authority has not requested the provision of additional information or documents. When the Authority requests additional information or documents, this period is suspended until such information or documents are received. The Nuclear Safety Authority shall notify its decision within a maximum period of four months from the date on which the record is deemed complete. The absence of a response within this period is a rejection of the application. »
Sections R. 1333-54 to R. 1333-54-9 become sections R. 1333-98 to R. 1333-108 constituting subsection 2 "Risk Protection Inspectors". This subsection is amended to read:
1° Section R. 1333-54 is replaced by sections R. 1333-98 to R. 1333-100 as follows:
"Art. R. 1333-98. - Are responsible for the control of the application of the provisions of this chapter and of Annexes 13-7 and 13-8 of this Code, which define the technical terms and set the exemption thresholds for declaration or authorization, the radiation protection inspectors referred to in Articles L. 1333-17 and L. 1333-18.
"Art. R. 1333-99. - Radiation protection inspectors may, at their request, be communicated by the head of the establishment where, when prepared, manufactured, detained or used sources of ionizing radiation justifying an authorization or declaration referred to in section L. 1333-4, any useful information to justify the measures taken to implement the provisions of this chapter. A decision of the Nuclear Safety Authority, approved by the Ministers responsible for health and labour, defines the nature of the information to be transmitted to the radiation protection inspectors.
"Art. R. 1333-100. - I. - The Nuclear Safety Authority shall, by decision, designate among its agents, whether they are assigned or made available to it, the radiation protection inspectors mentioned in the 1st of Article L. 1333-17.
“II. - The Nuclear Safety Authority shall, by decision taken after notice by the Minister for Mines, designate the radiation protection inspectors referred to in 2° of section L. 1333-17. If the Minister fails to give notice within one month, the notice is deemed favourable.
"III. - The Nuclear Safety Authority shall, by decision taken after the Minister for Health, designate the radiation protection inspectors referred to in section 3 L. 1333-17. If the Minister fails to give notice within one month, the notice is deemed favourable. » ;
2° R. 1333-54-1 becomes R. 1333-101. In this article, the words: "The order referred to in R. 1333-54" are replaced by the words: "The decision referred to in R. 1333-100";
3° Article R. 1333-54-2 becomes article R. 1333-102;
4° Section R. 1333-54-3 becomes section R. 1333-103. It is thus modified:
(a) The words: "Requests for designation are forwarded for advice to the Director General of Nuclear Safety and Radiation Protection" are replaced by the words: "Requests for designation referred to in Article R. 1333-100 are forwarded for advice to the Nuclear Safety Authority";
(b) The words: "as mentioned in the 3rd of Article L. 1333-17" are deleted;
5° Section R. 1333-54-4, as R. 1333-104, is replaced by the following:
"Art. R. 1333-104. - Before making a designation, the authorities referred to in R. 1333-100 or R. 1333-102 shall verify that the professional experience and legal and technical knowledge of the Radiation Protection Officer in one or more areas referred to in R. 1333-101 are appropriate for the exercise of the duties entrusted to him.
"For this purpose, the officer shall produce in support of his or her application for designation all supporting evidence relevant to the assessment of his or her qualifications and skills, as well as the reasoned opinion of his or her chief of service regarding the necessity of the service to have an officer responsible for the inspection of radiation protection. Additional supporting documents or information may be requested by the competent authorities referred to in articles R. 1333-100 and R. 1333-102. » ;
6° Section R. 1333-54-5 is repealed. Article R. 1333-54-6 becomes article R. 1333-105. The second preambular paragraph is replaced by the following:
"The decision and the designation order referred to in sections R. 1333-100 and R. 1333-102 are notified to the interested party and published, as the case may be, to the Official Bulletins of the Nuclear Safety Authority, the Ministry of Health, the Ministry of Mining, the Ministry of Defence or the Ministry of Industry. » ;
7° Section R. 1333-54-7, which became section R. 1333-106, is replaced by the following provisions:
"Art. R. 1333-106. - The Nuclear Safety Authority shall issue to each designated officer pursuant to section R. 1333-100 a professional card specifying its jurisdiction. » ;
8° Article R. 1333-54-8 becomes article R. 1333-107;
9° Section R. 1333-54-9, which became section R. 1333-108, is replaced by the following provisions:
"Art. R. 1333-108. - The delegate for nuclear safety and radiation protection for nuclear defence activities and facilities shall issue to each designated officer pursuant to section R. 1333-102 a professional card specifying his or her area of competence. »
10° In R. 1333-100 to R. 1333-108, the reference: "R. 1333-54" is replaced by the reference: "R. 1333-100", the reference: "R. 1333-54-1" is replaced by the reference: "R. 333-101", the reference: "R. 1333-54-2" is replaced by the reference: "R. 1333-102", the reference:
Sub-section 3 is as follows:
"Subsection 3
“Events, Incidents and Accidents
"Art. R. 1333-109. - Pursuant to Article L. 1333-3, the person responsible for a nuclear activity shall declare to the Nuclear Safety Authority any events or incidents that have resulted or may result in individual or collective exposure to ionizing radiation greater than the limits prescribed by the provisions of this chapter or, in the case of exposure of patients for medical purposes, that have resulted in consequences for the health of the persons exposed. These events or incidents are described as significant events.
"The person responsible for a nuclear activity conducts an analysis of significant events to prevent future events, incidents or accidents.
"Art. R. 1333-110. - The loss or theft of radionuclides in the form of radioactive sources, containing products or devices, as well as any event likely to cause radioactive release, any incident or accident resulting in the unintentional exposure of a person or any event likely to have damaged a source must be immediately reported to the prefect of the department of the occurrence site by the head of establishment. It also indicates the measures it has taken to ensure the protection of persons. The prefect informs the Nuclear Safety Authority or the delegate to nuclear safety and radiation protection for activities and facilities relevant to the defence and the Institute of Radiation Protection and Nuclear Safety.
"Art. R. 1333-111. - A decision of the Nuclear Safety Authority, approved by the Minister of Health, specifies the criteria for considering an event or incident as a significant event. This decision specifies the terms and conditions of their declaration to the Nuclear Safety Authority and the modalities of their analysis. »
After section 7, is added a section 8 as follows:
“Section 8
“ Approval of technical decisions
Nuclear Safety Authority
"Art. R. 1333-112. - The approval of decisions of the Nuclear Safety Authority set out in this chapter shall be made under the following conditions.
"The President of the Nuclear Safety Authority shall address the decision to the Minister for Health who shall, if any, transmit it to the other Ministers concerned.
"Where the Minister for Health shall notify the Nuclear Safety Authority, within three months of the date of receipt of the decision, as the case may be, the Minister for Health shall notify the Nuclear Safety Authority, or the order made jointly with the other Ministers concerned, which shall approve the decision.
"When one of these Ministers refuses the registration, the Minister for Health shall notify the Nuclear Safety Authority, within the same time, of the decision to refuse the reasons.
"After the period mentioned above, the registration is deemed to be acquired in the absence of an order. »
Section 1 of Chapter I of Part I title II of Book III is amended as follows:
1° In section R. 1321-3, after the words: "fixed by order of the minister responsible for health" are added the words: ", after the opinion of the Nuclear Safety Authority. » ;
2° Section R. 1321-20 is replaced by the following provisions:
"Art. R. 1321-20. - An order of the Minister for Health made after the advice of the French Food Safety Agency determines the sampling conditions to be used to measure lead, copper and nickel parameters in water.
"The radionuclides to be taken into account in calculating the total indicative dose set out in the order referred to in section R. 1321-3 and the B of Schedule 13-1 and the methods used in this calculation shall be defined by an order of the Minister responsible for health taken after notice of the Nuclear Safety Authority".
Sections R. 1337-11, R. 1337-12, R. 1337-13 and R. 1337-14 are replaced by the following:
"Art. R. 1337-11. - Agents designated as radiation protection inspectors pursuant to section R. 1333-100 may be authorized, by the administrative authority that has the capacity to designate them, for the purposes of the search for and recognition of offences under section L. 1337-1-1 falling within their jurisdiction, as provided for in sections R. 1333-103 to R. 1333-106.
"Art. R. 1337-12. - The officers authorized under the conditions set out in section R. 1337-11 shall, before the High Court in whose jurisdiction their administrative residence is located, take the oath of good and faithfully perform their duties, observe in all the duties they impose on them and not reveal or use any information protected under the law brought to their knowledge in the course of the performance of their duties.
"The Clerk of the Court of Grand Instance refers to this oath, date and place on the professional card of the person concerned.
"Art. R. 1337-13. - Authorized and sworn agents exercise their prerogatives within the territorial limits of their service or establishment of assignment and, for agents belonging to the services of the central administration, throughout the territory of the national territory.
"Art. R. 1337-14. - The designations made pursuant to section R. 1333-100 shall cease from the date on which the officer ceases the duties that he exercised at the time of designation or by decision of the authority that designated him in the same forms as the designation.
"The officer who no longer has the status of an inspector of radiation protection or who, pursuant to section 227 of the Code of Criminal Procedure, is prohibited from temporarily or permanently exercising his or her functions as a judicial police officer is required to give his or her professional card to the authority that designated him without delay. »
Annex 13-7 is amended as follows:
1° The following definitions are inserted according to the alphabetical order:
"Failing: a supplier who is or has been the subject of a judicial liquidation and who, as a result, cannot meet the requirement for the resumption of sealed radioactive sources that are outdated or unused under sections L. 1333-7 and R. 1333-53-1. » ;
"Supplier: any person who provides or makes available sources of ionizing radiation. » ;
"Orphaned radioactive source: a source whose level of activity at the time of discovery is greater than the exemption thresholds defined in Annex 13-8 and which is no longer under the control of a person declared or authorized to hold it:
" - either because it was abandoned, lost, lost or stolen;
" - because it has never been the subject of such a declaration or authorization. » ;
"High Activity Radioactive Source: a sealed radioactive source containing a radionuclide whose activity at the time of manufacture or, if this time is not known, at the time of the first market release is equal to or greater than the level of activity defined in Table C of Appendix 13-8. » ;
2° In the definition of "effective dose", the words: "the intended order" are replaced by the words: "the intended decision";
3° The last paragraph of the definition "equivalent dose" is replaced by the following:
"In HT(t), t is indicated in years. If the value of t is not given, it is implicitly, for adults, fifty years and, for children, the number of years between the age at the time of incorporation and the age of 70 years. The equivalent dose unit is the sievert (Sv). »
Appendix 13-8 is amended to read:
1° The title is replaced by the following title: "Exemption thresholds for the application of section R. 1333-18 and activity levels defining a high activity sealed source for the application of section R. 1333-33";
2° Tables A and B are replaced by tables A and B in annex 1 to this decree;
3° Following Table B, Table C is added to the present Order in Council in Annex 2.
In article R. 1411-47 of the Public Health Code, the words: "the Director General of Nuclear Safety and Radiation Protection" are deleted and the words: "and the president of the College of the High Health Authority" are replaced by the words: "the president of the College of the High Health Authority and the president of the Nuclear Safety Authority".
Article 2 of the above-mentioned decree of 22 September 1994 is amended as follows:
In a, the words: "values listed in Appendix 2 to Chapter V-I of Title I of Book I of the Public Health Code" are replaced by the words: "values listed in Appendix 13-8 of Chapter III of Book III of Part I of the Public Health Code";
In b, the words: "a radiation source defined in the C of Schedule I to the above-mentioned Decree of 20 June 1966" are replaced by the words: "a sealed radioactive source defined in Schedule 13-7 of Chapter III of Book III of Part I of the Public Health Code."
In article R. 162-53 of the Social Security Code, the reference to article R. 43-17 becomes the reference to article R. 1333-19 and the reference to article R. 43-19 becomes the reference to article R. 1333-23.
The provisions of Article 15 of this Decree whose application is subject to the intervention of regulatory decisions of the Nuclear Safety Authority are applicable from the date of publication of the approved decisions.
The provisions of Articles 23 and 24 of this Order are applicable after six months from the date of publication.
Subject to the provisions of Article R. 1333-39 of the Public Health Code set out in Article 15 of this Decree:
1° The nuclear activities declared before the date of publication of this decree are exempted from the renewal of the declaration provided for in article R. 1333-19 of the Public Health Code;
2° The authorizations provided for in Article L. 1333-4 issued prior to the date of publication of the decisions referred to in the first paragraph shall remain valid until their expiry date and default, if they fall within section 3 of Chapter III of Title III of Book III of the Public Health Code, for a period of not more than five years from the publication of this Order;
3° Authorizations issued pursuant to chapter III, section 3, title III, of Book III of the Public Health Code before the date of publication of the decisions referred to in the first paragraph shall, if any, take place of the declaration provided for in article R. 1333-19 of the Public Health Code contained in article 15 of this Decree.
The Minister of State, Minister of Ecology, Development and Sustainable Development, the Minister of Economy, Finance and Employment, the Minister of Labour, Social Relations and Solidarity, the Minister of Health, Youth and Sports and the Minister of Housing and the City are responsible for the execution of this decree, which will be published in the Official Journal of the French Republic.
Table A
You can see the table in the OJ
n° 260 of 09/11/2007 text number 30
TABLE B
List of nuclides in secular balance
You can see the table in the OJ
n° 260 of 09/11/2007 text number 30
A N N E X E 2
TABLE C
Activity levels defining a sealed source
high activity
You can see the table in the OJ
n° 260 of 09/11/2007 text number 30
(a) Levels of activity include contributions from descending radionuclides whose period is less than 10 days, according to the following list:
Mg-28 Al-28;
Ca-47 Sc-47;
Ti-44 Sc-44;
Fe-52 Mn-52m;
Fe-60 Co-60m;
Zn-69m Zn-69;
Ge-68 Ga-68;
Rb-83 Kr-83m;
Sr-82 Rb-82;
Sr-90 Y-90;
Sr-91 Y-91m;
Sr-92 Y-92;
Y.-87 Sr-87m;
Zr-95 Nb-95m;
Zr-97 Nb-97m, Nb-97;
Mo-99 Tc-99m;
Tc-95m Tc-95;
Tc-96m Tc-96;
Ru-103 Rh-103m;
Ru-106 Rh-106;
Pd-103 Rh-103m;
Ag-108m Ag-108;
Ag-110m Ag-110;
Cd-115 In-115m;
In-114m In-114;
Sn-113 In-113m;
Sn-121m Sn-121;
Sn-126 Sb-126m;
Te-127m Te-127;
Te-129m Te-129;
Te-131m Te-131;
Te-132 I-132;
I.-135 Xe-135m;
Xe-122 I-122;
Cs-137 Ba-137m;
Ba-131 Cs-131;
Ba-140 La-140;
Ce-144 Pr-144m, Pr-144;
Pm-148m Pm-148;
Gd-146 Eu-146;
Dy-166 Ho-166;
Hf-172 Lu-172;
W-178 Ta-178;
W-188 Re-188;
Re-189 Os-189m;
Os-194 Ir-194;
Ir-189 Os-189m;
Pt-188 Ir-188;
Hg-194 Au-194;
Hg-195m Hg-195;
Pb-210 Bi-210;
Pb-212 Bi-212, Tl-208, Po-212;
Bi-210m Tl-206;
Bi-212 Tl-208, Po-212;
At-211 Po-211;
Rn-222 Po-218, Pb-214, At-218, Bi-214, Po-214;
Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Po-211, Tl-207;
Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212;
Ra-225 Ac-225, Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209;
Ra-226 Rn-222, Po-218, Pb-214, At-218, Bi-214, Po-214;
Ra-228 Ac-228;
Ac-225 Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209;
Ac-227 Fr-223;
Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212;
Th-234 Pa-234m, Pa-234;
Pa-230 Ac-226, Th-226, Fr-222, Ra-222, Rn-218, Po-214;
U-230 Th-226, Ra-222, Rn-218, Po-214;
U-235 Th-231;
Pu-241 U-237;
Pu-244 U-240, Np-240m;
Am-242m Am-242, Np-238;
Am-243 Np-239;
Cm-247 Pu-243;
Bk-249 Am-245;
Cf-253 Cm-249.
(b) Including beryllium neutronic sources.
(c) These values apply only to the following uranium forms: UF6, UO2F2 and UO2(NO3)2.
(d) These values apply only to the following uranium forms: UO3, UF4, UCl4 and hexavalent compounds.
(e) These values apply to all other forms of uranium than those specified in (d) and (e) above.
(f) This value applies only to non-irradiated uranium.
Done in Paris, November 7, 2007.
François Fillon
By the Prime Minister:
Minister of Health
youth and sports,
Roselyne Bachelot-Narquin
Minister of State, Minister of Ecology,
sustainable development and development,
Jean-Louis Borloo
Minister of Economy,
finance and employment,
Christine Lagarde
Minister of Labour, Social Relations
and solidarity,
Xavier Bertrand
Minister of Housing and City,
Christine Boutin
A N N E X E 1
