1. Before placing a PPE model on the market, the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the competent authorities.
2. Prior to the series production of PPE other than those referred to in paragraph 3, the manufacturer or his authorized representative established in the Community shall submit a model for EC type-examination as referred to in Article 10.
3. EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time.
This category shall cover exclusively PPE intended to protect the wearer against:
mechanical action whose effects are superficial (gardening gloves, thimbles, etc.),
cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.),
risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50°C or to dangerous impacts (gloves, aprons for professional use, etc.),
atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.),
minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.),
sunlight (sunglasses).
4. Production of PPE shall be subject:
(a)according to the manufacturer’s choice, to one of the two procedures referred to in Article 11 in the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time. This category shall cover exclusively:
filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases,
respiratory protection devices providing full insulation from the atmosphere, including those for use in diving,
PPE providing only limited protection against chemical attack or against ionizing radiation,
emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature of 100°C or more and which may or may not be characterized by the presence of infra-red radiation, flames or the projection of large amounts of molten material,
emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of −50°C or less,
PPE to protect against falls from a height,
PPE against electrical risks and dangerous voltages or that used as insulation in high-tension work,
motor cycle helmets and visors;
(b)the EC declaration of conformity referred to in Article 12 for all PPE.
1. Each Member State shall inform the Commission and the other Member States of the approved bodies responsible for the execution of the certification procedures referred to in Article 8. For information purposes, the Commission shall publish in the Official Journal of the European Communities and keep up to date a list giving the names of these bodies and the distinguishing numbers it has assigned to them.
2. Member States shall apply the criteria laid down in Annex V in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonized standards shall be presumed to fulfil those criteria.
3. A Member State shall withdraw its approval from such a body if it establishes that the latter no longer satisfies the criteria referred to in Annex V. It shall inform the Commission and the other Member States of its action forthwith.