Council Directive 2013/59/EuratomShow full title

ANNEX IV Justification of new classes or types of practices involving consumer products as referred to in Article 20

A. Any undertaking intending to manufacture or import into a Member State consumer products for which the intended use is likely to lead to a new class or type of practice, shall provide the competent authority of this Member State with all relevant information, as to the:

(1)

intended use of the product;

(2)

technical characteristics of the product;

(3)

in the case of products containing radioactive substances, information as to their means of fixation;

(4)

dose rates at relevant distances for the use of the product, including dose rates at a distance of 0,1 m from any accessible surface;

(5)

expected doses to regular users of the product.

B. The competent authority shall examine that information and in particular assess whether:

(1)

the performance of the consumer product justifies its intended use;

(2)

the design is adequate in order to minimise exposures in normal use and the likelihood and consequences of misuse or accidental exposures, or whether there should be conditions imposed on the technical and physical characteristics of the product;

(3)

the product is adequately designed to meet the exemption criteria, and, where applicable, is of an approved type and does not necessitate specific precautions for disposal when no longer in use;

(4)

the product is appropriately labelled and suitable documentation is provided to the consumer with instructions for proper use and disposal.