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Art. 28 Mandatory licensing
A licence is required by anyone who: - a.
- handles radioactive substances or equipment and articles containing radioactive substances;
- b.
- manufactures, distributes, installs or uses installations and equipment capable of emitting ionizing radiation;
- c.
- administers ionizing radiation and radioactive substances to humans.
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Art. 29 Powers of the Federal Council
The Federal Council may: - a.
- subject other activities that may involve an ionizing radiation hazard to mandatory licensing;
- b.
- exempt activities specified in Article 28 letters a or b from mandatory licensing if an ionizing radiation hazard can be ruled out;
- c.
- specify the conditions under which certain types of articles, installations and equipment containing radioactive substances or capable of emitting ionizing radiation may, after testing of the standard model, be granted general approval or approval restricted to certain applications.
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Art. 30 Licensing authorities 22
The Federal Council shall designate the licensing authorities.
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Art. 31 Conditions
A licence shall be granted if: - a.
- the applicant or an expert appointed by the applicant (Art. 16) has the necessary qualifications;
- b.
- the enterprise has an appropriate number of experts at its disposal;
- c.
- the applicant and the experts ensure safe operation;
- d.
- the enterprise has adequate liability insurance;
- e.
- the installations and equipment are in accordance with the current state of science and technology with regard to radiological protection;
- f.
- radiological protection is assured in accordance with this Act and the implementing provisions.
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Art. 32 Licence holder and content
1 The licence shall only be valid for the designated enterprise or the designated person. 2 It shall contain a description of the licensed activity, including any requirements and stipulations, and give the names of the experts responsible for radiological protection. It shall be granted for a limited period. 3 The licensing authority may transfer the licence to a new holder, provided the latter meets the conditions specified in Article 31.
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Art. 33 Modification
The licence shall be modified: - a.
- at the holder’s request, if the proposed modification meets the conditions for the granting of a licence;
- b.
- automatically, where this is necessitated by changes in the actual or legal conditions specified in Article 31.
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Art. 34 Revocation and expiry
1 The licence shall be revoked: - a.
- if the conditions for granting it are not met or are no longer met;
- b.
- if a stipulation associated with the licence or a measure ordered has not been complied with despite notice being given.
2 The licence shall expire: - a.
- if it is duly relinquished by the holder;
- b.
- at the end of the specified term;
- c.
- if the holder dies or, in the case of legal persons and registered companies, the entry in the Commercial Register is deleted;
- d.
- if the enterprise is discontinued or ownership is transferred.
3 The licensing authority shall issue a decree declaring the licence to have expired, subject to the possibility of renewal or a transfer in accordance with Article 32 paragraph 3.
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Art. 35 Duties of notification and provision of information
1 The licence holder must notify the supervisory authority: - a.
- of any proposed modifications to the structure or operation of installations or equipment which could adversely affect operational safety;
- b.
- of any plans to use additional radioactive substances or to increase the activity of licensed radioactive substances.
2 The licence holder and persons working for the enterprise must provide information to the supervisory authority and its agents, allow them to consult documents and grant access to the premises insofar as this is necessary for the fulfilment of supervisory responsibilities. 3 If an inadmissible radiation exposure is suspected or known to have occurred, the licence holder or expert must notify the competent authorities immediately.
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Art. 36 Record-keeping requirements
1 Anyone who handles radioactive substances or equipment and articles containing radioactive substances is required to keep records thereof. 2 Reports are to be submitted regularly to the supervisory authority. 3 The Federal Council may waive the record-keeping requirements for low-level radioactive substances.
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Art. 37 Supervision
1 The Federal Council shall designate the supervisory authorities. 2 The supervisory authority shall issue the necessary decrees. If necessary, it may take protective measures at the expense of the party responsible. In particular, it may order the discontinuation of operations or the seizure of dangerous substances, equipment or articles. 3 It may engage third parties for the implementation of inspections. Their responsibilities under criminal and property law are defined by the Government Liability Act of 14 March 195823; with regard to duties of confidentiality and testimony, they are bound by the regulations applicable for federal officials.
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Art. 38 Removal of sources of risk
1 Once a licence is revoked or has expired, the sources of risk must be removed by the former licence holder or the party responsible for them. In particular: - a.
- radioactive substances are to be transferred to another licence holder or disposed of as radioactive waste;
- b.
- installations and equipment capable of emitting ionizing radiation are to be transferred to another licence holder or placed in a condition rendering unauthorised operation impossible.
2 If necessary, the federal authorities shall take over or seize substances, installations, equipment and articles and shall remove the sources of risk at the licence holder’s expense. 3 The licensing authority shall determine whether premises with contaminated or activated areas and their surroundings may be used for other purposes. 4 The licensing authority shall issue a decree declaring that the sources of risk have been duly removed.
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