The Personal Protective Equipment Regulations 2002

Regulations 2(1)(c)(iii) and 11(b) and (c)

SCHEDULE 7 ARTICLE 10 OF THE PPE DIRECTIVE

EC TYPE-EXAMINATION

1.  EC type-examination is the procedure whereby the approved inspection body establishes and certifies that the PPE model in question satisfies the relevant provisions of this Directive.

2.  Application for EC type-examination shall be made by the manufacturer or his authorised representative to a single approved inspection body in respect of the model in question. The authorised representative shall be established in the Community.

3.  The application shall comprise:

• the name and address of the manufacturer or his authorised representative and of the PPE production plant in question,

• the manufacturer’s technical file referred to in Annex III.

It shall be accompanied by the appropriate number of specimens of the model to be approved.

4.  The inspection body of which notification has been given shall conduct the EC type-examination in accordance with the undermentioned procedures:

(a) Examination of the manufacturer’s technical file

• It shall examine the manufacturer’s technical file to establish its suitability with respect to the harmonised standards referred to in Article 5.

• Where a manufacturer has not applied, or has only partly applied, the harmonised standards or where there are no such standards, the body of which notification has been given must check the suitability of the technical specifications used by the manufacturer with respect to the basic requirements before examining the manufacturer’s technical file to establish its suitability with respect to these technical specifications.

(b) Examination of the model

• When examining the model, the inspection body shall verify that it has been produced in accordance with the manufacturer’s technical file and can be used in complete safety for its intended purpose.

• It shall conduct the necessary examinations and tests to establish the conformity of the model with the harmonised standards.

• Where a manufacturer has not applied or has only partly applied the harmonised standards or where there are no such standards the body of which notification has been given shall conduct the necessary examinations and tests to establish the conformity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to these basic requirements.

5.  If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue and incorporate the descriptions and drawings necessary for the identification of the approved model.

• The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, in response to a reasoned request, a copy of the manufacturer’s technical file and the reports of the examinations and tests conducted.

• The file shall be held at the disposal of the competent authorities for 10 years following the placing of the PPE on the market.

6.  Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact. An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect. That Member State shall then inform the other Member States and the Commission, setting out the reasons for the decision.