CHAPTER VJUSTIFICATION AND REGULATORY CONTROL OF PRACTICES
SECTION 1 Justification and prohibition of practices
Article 19Justification of practices
1.
Member States shall ensure that new classes or types of practices resulting in exposure to ionising radiation are justified before being adopted.
2.
Member States shall consider a review of existing classes or types of practices with regard to their justification whenever there is new and important evidence about their efficacy or potential consequences or new and important information about other techniques and technologies.
3.
Practices involving occupational and public exposures shall be justified as a class or type of practice, taking into account both categories of exposures.
4.
Practices involving medical exposure shall be justified both as a class or type of practice, taking into account medical and, where relevant, associated occupational and public exposures, and at the level of each individual medical exposure as specified in Article 55.
Article 20Practices involving consumer products
1.
Member States shall require any undertaking intending to manufacture or import a consumer product for which the intended use is likely to be a new class or type of practice, to provide the competent authority with all relevant information, including that listed in Annex IV, Section A, so as to allow the implementation of the justification requirement in Article 19(1).
2.
On the basis of an assessment of this information, Member States shall ensure that the competent authority, as outlined in Annex IV, Section B, decides whether the intended use of the consumer product is justified.
3.
Without prejudice to paragraph 1, Member States shall ensure that the competent authority which has received information according to that paragraph, informs the point of contact for the competent authorities of other Member States of this receipt and, upon request, of its decision and the basis for that decision.
(4)
Member States shall prohibit the sale or the making available to the public of consumer products if their intended use is not justified or their use would not fulfil the criteria for exemption from notification under Article 26.
Article 21Prohibition of practices
1.
Member States shall prohibit the deliberate addition of radioactive substances in the production of foodstuffs, animal feeding stuffs, and cosmetics, and shall prohibit the import or export of such products.
2.
Without prejudice to the Directive 1999/2/EC, practices involving the activation of material resulting in an increase in activity in a consumer product, which at the time of placing on the market cannot be disregarded from a radiation protection point of view, shall be deemed not to be justified. However, the competent authority may evaluate specific types of practices within this class with regard to their justification.
3.
Member States shall prohibit the deliberate addition of radioactive substances in the manufacture of toys and personal ornaments and shall prohibit the import or export of such products.
4.
Member States shall prohibit practices involving the activation of materials used in toys and personal ornaments, resulting, at the time of the placing on the market of the products or of their manufacture, in an increase in activity, which cannot be disregarded from a radiation protection point of view, and shall prohibit the import or export of such products or materials.
Article 22Practices involving the deliberate exposure of humans for non-medical imaging purposes
1.
Member States shall ensure the identification of practices involving non-medical imaging exposure, in particular taking into account the practices included in Annex V.
2.
Member States shall ensure that special attention is given to the justification of practices involving non-medical imaging exposure, in particular:
(a)
all types of practices involving non-medical imaging exposure shall be justified before being generally accepted;
(b)
each particular application of a generally accepted type of practice shall be justified;
(c)
all individual non-medical imaging exposure procedures using medical radiological equipment shall be justified in advance, taking into account the specific objectives of the procedure and the characteristics of the individual involved;
(d)
the general and particular justification of practices involving non-medical imaging exposure, as specified in (a) and (b), may be subject to review;
(e)
circumstances warranting non-medical imaging exposures, without individual justification of each exposure, shall be subject to regular review.
3.
Member States may exempt justified practices involving non-medical imaging exposure using medical radiological equipment from the requirement for dose constraints according to point (b) of Article 6(1) and from the dose limits set out in Article 12.
4.
Where a Member State has determined that a particular practice involving non-medical imaging exposure is justified, it shall ensure that:
(a)
the practice is subject to authorisation;
(b)
requirements for the practice, including criteria for individual implementation, are established by the competent authority, in cooperation with other relevant bodies and medical scientific societies, as appropriate;
(c)
for procedures using medical radiological equipment
- (i)
relevant requirements identified for medical exposure as set out in Chapter VII are applied, including those for equipment, optimisation, responsibilities, training and special protection during pregnancy and the appropriate involvement of the medical physics expert;
- (ii)
where appropriate, specific protocols, consistent with the objective of the exposure and required image quality, are put in place;
- (iii)
where practicable, specific diagnostic reference levels are put in place;
(d)
for procedures not using medical radiological equipment, dose constraints are significantly below the dose limit for members of the public;
(e)
information is provided to and consent sought from the individual to be exposed, allowing for cases where the law enforcement authorities may proceed without consent of the individual according to national legislation;