The Personal Protective Equipment (EC Directive) (Amendment) Regulations 1994

Regulation 3(2)

SCHEDULEAMENDMENTS TO THE DIRECTIVE

In paragraphs 5 and 6, the words “Contracting Parties” are substituted for the word “Community” by virtue of paragraph 8 of Protocol 1 annexed to the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993(1).

1.  Throughout the text, the term “EC mark” is replaced by “CE marking”.

2.  In Article 4 the first paragraph is replaced by the following text:

“1.  Member States may not prohibit, restrict or hinder the placing on the market of PPE or PPE components which comply with the provisions of this Directive and which bear the CE marking attesting their conformity to all the provisions of this Directive, including the certification procedures in Chapter II.”.

3.  The following paragraph is added to Article 5:

“6.—(a) Where the PPE is subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the PPE is also presumed to conform to the provisions of the other Directives.

(b)However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity to the provisions only of those Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying such PPE.”.

4.  In Article 9 the first paragraph is replaced by the following:

“1.  Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 8 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.”.

5.  The introductory sentence of Article 12 is replaced by the following text:

“The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative established within the Contracting Parties:”.

6.  Article 13 is replaced by the following text:

“Article 13

1.  The CE conformity marking shall consist of the initials “CE” in the form shown in the specimen in Annex IV. In the event of the involvement of a notified body in the production control phase as indicated in Article 11, its identification number shall be added.

2.  The CE marking must be affixed to each piece of manufactured PPE so as to be visible, legible and indelible throughout the expected life of the PPE; however, if this is not possible in view of the characteristics of the product, the CE marking may be affixed to the packaging.

3.  The affixing of markings on the PPE which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the PPE or its packaging provided that the visibility and legibility of the CE marking is not thereby reduced.

4.  Without prejudice to Article 7:

(a)where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the Contracting Parties shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;

(b)where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.”.

7.  The following text is added to section 1.4 of Annex II:

“(h)where appropriate, the references of the Directives applied in accordance with Article 5(6)(b);

(i)the name, address and identification number of the notified body involved in the design stage of the PPE.”.

8.  Annex IV is replaced by the following text:

“ANNEX IVCE CONFORMITY MARKING AND INFORMATION

• The CE conformity marking shall consist of the initials “CE” taking the following form:

  

• If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

• The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm. This minimum dimension may be waived for small-scale PPE.

Additional information

• The last two digits of the year in which the CE marking was affixed; this information is not required in the case of the PPE referred to in Article 8(3).”