S.I. No. 457/1994:

EUROPEAN COMMUNITIES (PERSONAL PROTECTIVE EQUIPMENT) (CE MARKING) REGULATIONS, 1994.

EUROPEAN COMMUNITIES (PERSONAL PROTECTIVE EQUIPMENT) (CE MARKING) REGULATIONS, 1994.

I, RICHARD BRUTON, T.D., Minister for Enterprise and Employment, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Articles 7 and 14 of Council Directive 93/68/EEC of 22 July, 1993⁽¹⁾ amending Council Directive 89/686/EEC of 21 December, 1989⁽²⁾, on the approximation of the laws of the Member States relating to personal protective equipment, hereby make the following Regulations:

1. (1) These Regulations may be cited as the European Communities (Personal Protective Equipment) (CE marking) Regulations, 1994.

(2) These Regulations shall come into operation on the 1st day of January, 1995.

(3) The Principal Regulations, the European Communities (Personal Protective Equipment) (Amendment) Regulations, 1994 ( S.I. No. 13 of 1994 ), and these Regulations may be cited together as the European Communities (Personal Protective Equipment) Regulations 1993 to 1994 and shall be construed together as one.

2. (1) In these Regulations--

the "Principal Regulations" mean the European Communities (Personal Protective Equipment) Regulations, 1993 ( S.I. No. 272 of 1993 ).

(2) A reference in the European Communities (Personal Protective Equipment) Regulations 1993 to 1994 to a Chapter is a reference to a Chapter in the Directive.

⁽¹⁾ O.J. No. L220, 30.8.93, p. 1

⁽²⁾ O.J. No. L399, 30.12.89, p.18

(3) The "CE conformity marking" shall consist of the initials "CE" taking the form of the specimen given in Annex IV of the Principal Regulations as amended by these Regulations.

3. Regulation 2 (1) of the Principal Regulations is hereby amended by the substitution of the following definition for the definition of the Directive:

"the Directive" means Council Directive 89/686/EEC of 21 December, 1989, as amended by Council Directive 93/95/EEC of 29 October, 1993⁽¹⁾ and Council Directive 93/68/EEC of 22 July, 1993.

4. A reference to the "EC mark" in the Principal Regulations shall be construed as a reference to "CE marking" as defined in Regulation 15 as amended by these Regulations.

5. Regulation 4 of the Principal Regulations is hereby amended by the substitution therefor of the following Regulation:

"4. (1) ( a ) A person shall not place PPE on the market or bring PPE into service on or after the day on which these Regulations come into operation unless, when properly maintained and used for its intended purpose, it preserves the health and ensures the safety of users thereof without compromising the health or safety of individuals, domestic animals or goods, and complies with the basic health and safety requirements specified in Annex II.

( b ) PPE which complies with the marking requirements in force before 1 January, 1995 may continue to be placed on the market or brought into service until 1 January, 1997.

(2) PPE of simple design shall be presumed to be in conformity with these Regulations and the Directive if--

( a ) it bears CE marking, affixed in accordance with the procedures described in Regulation 15, and

⁽¹⁾ O.J. No. L276, 09.11.93, p.11

( b ) the manufacturer or the manufacturer's authorised representative is able to produce on demand, at the request of an approved body or an authorised officer, the declaration of conformity referred to in Regulation 14 in respect of the PPE in question.

(3) PPE other than PPE of simple design shall be presumed to satisfy these Regulations and the Directive if--

( a ) it bears CE marking, affixed in accordance with the procedures described in Regulation 15, and

( b ) the manufacturer or the manufacturer's authorised representative is able to produce, on demand, at the request of an approved body or an authorised officer, not only the declaration of conformity referred to in Regulation 14 but also where there are applicable harmonised standards, the certificate issued by the approved body attesting to the PPE's conformity to the relevant national standards transposing the harmonised standards.

(4) Where a manufacturer or the manufacturer's authorised representative has not applied or has only partly applied the harmonised standards or where there are no such standards, the certificate issued by the approved body must state the conformity of the PPE with basic requirements in accordance with Regulation 10(3) and 10(5).

(5) Notwithstanding the provisions of paragraphs (1) to (4) of this Regulation, these Regulations shall not operate to prevent the presentation at trade fairs, exhibitions and the like of PPE which is not in conformity with the provisions of this Regulation, provided that an appropriate notice is displayed drawing attention to this fact with the prohibition on its acquisition or use, or both for any purpose whatsoever until it has been brought into such conformity by the manufacturer or the manufacturer's authorised representative.

(6) ( a ) Where PPE is subject to other Directives concerning matters not governed by the Directive and which also provide for the affixing of the CE marking, such CE marking 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 any such 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.".

6. Regulation 5 of the Principal Regulations is hereby amended by the substitution therefor of the following Regulation:

"5. Nothing in these Regulations shall operate:

( a ) to prohibit, restrict or hinder the placing on the market of PPE or PPE components which comply with the provisions of the Directive and which bear the CE marking attesting their conformity to all the provisions of the Directive, including the certification procedures in Chapter II, or

( b ) to prohibit, restrict or impede the placing on the market of PPE components which do not bear the CE marking, and which are intended to be incorporated in PPE, provided that they are not essential to its satisfactory functioning.".

7. Paragraph (3) of Regulation 6 of the Principal Regulations is hereby amended by the substitution therefor of the following paragraph:

"(3) The Minister shall inform the Commission and the other Member States of the names of the approved bodies appointed under paragraph (1) 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.".

8. Regulation 15 of the Principal Regulations is hereby amended by the substitution therefor of the following Regulation:

"15. (1) The CE conformity marking shall consist of the initials "CE" in the form shown in the specimen in Annex IV. This CE marking shall be affixed to the PPE by the manufacturer or the manufacturer's authorised representative referred to in Regulation 14. In the event of the involvement of an approved body in the production control phase as indicated in Regulation 13, its identification number, as has been determined and published by the Commission, shall be added.

(2) The CE marking shall 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 by affixed to the PPE or its packaging provided that the visibility and legibility of the CE marking is not thereby reduced.".

9. Annex IV of the Principal Regulations is hereby amended by the substitution therefor of the following Annex:

"Annex IV

CE 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.

-- The CE marking shall include the last two digits of the year in which the CE marking was affixed; this information is not required in the case of PPE referred to in Regulation 3 (3).".

10. Paragraph (1) of Regulation 16 of the Principal Regulations is hereby amended by the substitution therefor of the following paragraph:

"16. (1) Where the Minister, the Director or the Authority is of the opinion that a person is placing or has placed on the market any PPE bearing the CE marking which, when used in accordance with its intended purpose, is likely to compromise the safety of persons, domestic animals or property or where the CE marking is affixed unduly in any other respect, the Minister, the Director or the Authority, as the case may be shall by direction in writing given to that person prohibit the person from placing or continuing to place on the market such PPE or if appropriate impose restrictions on the person's so doing, and where appropriate, require the person to take all practicable steps to withdraw from the market any such equipment already placed by the person on the market.".

11. The following text is added to paragraph 1.4 of Annex II of the Principal Regulations:

"( h ) where appropriate, the references of the Directives applied in accordance with paragraph 6 (b) of Regulation 4 of these Regulations;

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

GIVEN under my Official Seal, this 22nd day of December, 1994.

RICHARD BRUTON,

Minister for Enterprise and

Employment

EXPLANATORY NOTE.

These Regulations amend the European Communities (Personal Protective Equipment) Regulations, S.I. No. 272 of 1993 as amended by the European Communities (Personal Protective Equipment) (Amendment) Regulations, S.I. No. 13 of 1994 . They give effect to the European Communities Council Directive (93/68/EEC) of 22 July 1993 amending Council Directive (89/686/EEC) of 21 December 1989 as amended by Council Directive (93/95/EEC) of 29 October 1993, on the CE conformity marking and assessment procedures for the technical harmonisation of the laws of the Member States.

These Regulations require the manufacturer, or the manufacturer's authorised representative within the Community, to affix the revised CE conformity marking on personal protective equipment. The Regulations shall come into operation on 1 January 1995. Personal protective equipment complying with the marking arrangements in force before this date shall continue to be allowed to be placed on the market until 1 January 1997.

The Director of Consumer Affairs has powers of enforcement for these Regulations.