The Personal Protective Equipment (EC Directive) Regulations 1992

Made: 10th December 1992

Laid before Parliament: 10th December 1992

Coming into force: 1st January 1993

Now, therefore, the Secretary of State in the exercise of the powers conferred on him by section 2(2) of that Act hereby makes the following Regulations:

Citation and commencement

1

These Regulations may be cited as the Personal Protective Equipment (EC Directive) Regulations 1992 and shall come into force on 1st January 1993.

Interpretation

2

In these Regulations—

• “the Directive” means Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment[^f00003], a copy of which is printed in the Schedule to these Regulations;

Scope, Placing on the Market and Free Movement

3

• (1) The Directive shall have effect within the United Kingdom for the purpose of laying down the conditions governing the placing of products to which the Directive applies on the market and their free movement within the Community and the basic safety requirements which such products must satisfy in order to ensure the health protection and safety of users.

• (2) For the purposes mentioned in paragraph (1) above—

• (a) section 13 of the Consumer Protection Act 1987[^f00004] (prohibition notices and notices to warn) shall (to the extent that it does not already do so) apply in relation to products to which the Directive applies as it applies in relation to relevant goods under that section;

• (b) these Regulations shall constitute safety provisions for the purposes of section 14 of that Act (suspension notices) and sections 16 and 17 of that Act (forfeiture); and

• (c) a weights and measures authority in Great Britain or a district council in Northern Ireland shall have the same duty to enforce these Regulations as it has in relation to Part II of that Act, and Part IV of that Act shall apply accordingly.

• (3) For the purposes of paragraph (2)(a) above any question as to whether products to which the Directive applies are unsafe shall be determined in accordance with the Directive.

• (4) Paragraph (2)(c) above is without prejudice to the duty of the Health and Safety Executive in relation to section 6 of the Health and Safety at Work etc. Act 1974[^f00005] or, in Northern Ireland, the duties of the Department of Economic Development and the Department of Agriculture in relation to Article 7 of the Health and Safety at Work (Northern Ireland) Order 1978[^f00006] (general duties of manufacturers as regards articles and substances for use at work); and no action shall be taken by virtue of that paragraph before 1st January 1994 unless it could have been taken otherwise than by virtue of these Regulations.

• (5) Nothing in any enactment or rule of law shall prevent the placing on the market of products to which the Directive applies in accordance with the Directive.

Certification and Monitoring Procedures

4

The Secretary of State shall, in accordance with the Directive, approve one or more bodies for the purposes of carrying out the certification and monitoring procedures laid down in the Directive and shall withdraw his approval from such a body if he establishes that the latter no longer satisfies the criteria set out in the Directive.

SCHEDULE — COUNCIL DIRECTIVE

of 21 December 1989

on the approximation of the laws of the Member States relating to personal protective equipment

(89/686/EEC)

The Council of the European Communities,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission[^f00007],

In co-operation with the European Parliament[^f00008]

Having regard to the opinion of the Economic and Social Committee[^f00009],

Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is guaranteed;

Whereas various Member States have, over recent years, adopted provisions covering numerous items of personal protective equipment with a view in particular to safeguarding public health, improving safety at work and ensuring user protection;

Whereas these national provisions are often very detailed as regards the requirements relating to the design, manufacture, quality level, testing and certification of personal protective equipment with a view to the protection of individuals against injury and illness;

Whereas, in particular, the national provisions relating to safety at work make the use of personal protective equipment compulsory; whereas many requirements oblige employers to make appropriate personal protective equipment available to their staff in the absence or inadequacy of priority public protection measures;

Whereas national provisions relating to personal protective equipment differ significantly from one Member State to another; whereas they may thus constitute a barrier to trade with direct consequences for the creation and operation of the common market;

Whereas it is necessary to harmonize these different national provisions in order to ensure the free movement of these products, without in any way reducing the valid levels of protection already required in the Member States, and to provide for any necessary increase therein;

Whereas the provisions governing the design and manufacture of personal protective equipment laid down in this Directive which are fundamental, in particular, to attempts to ensure a safer working environment are without prejudice to provisions relating to the use of such equipment and the organization of the health and safety of workers at the workplace;

Whereas this Directive defines only the basic requirements to be satisfied by personal protective equipment; whereas, in order to facilitate proof of conformity with those basic requirements, it is essential that harmonized European standards be available relating, in particular, to the design and manufacture of, and the specifications and test methods applicable to, personal protective equipment, since compliance therewith confers on these products a presumption of conformity with the abovementioned basic requirements; whereas such harmonized European standards are drawn up by private bodies and must retain the status of non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are the competent bodies which have been authorized to adopt harmonized standards in accordance with the general guidelines governing co-operation between the Commission and those two institutions ratified on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a text containing technical specifications (a European standard or a harmonization document) which has been adopted by one or both of the[^f00010], as amended by Directive 88/182/EEC[^f00011], and pursuant to the abovementioned general guidelines;

Whereas, pending the adoption of harmonized standards, which will be very numerous because of the broad scope of application and the preparation of which within the deadline set for the creation of the internal market will involve a great deal of work, it would be advisable to maintain, on a transitional basis and subject to the requirements of the Treaty, the status quo as regards conformity with existing national standards for personal protective equipment not covered by a harmonized standard at the date of adoption of this Directive;

Whereas, given the general and horizontal nature of the role played by the Standing Committee set up pursuant to Article 5 of Directive 83/189/EEC in Community standardization policy and, more particularly, its part in the preparation of standardization applications and the operation of the existing European standardization agreements, this Standing Committee is especially suited to the task of assisting the Commission in monitoring the conformity of harmonized standards throughout the Community;

Whereas compliance with these technical requirements must be monitored in order to ensure adequate user and third-party protection; whereas existing monitoring procedures may differ appreciably from one Member State to another; whereas, in order to avoid numerous checks which merely impede the free movement of personal protective equipment, provision should be made for the mutual recognition of inspections conducted by the Member States; whereas, in order to facilitate such recognition, it is necessary, in particular, to lay down harmonized Community procedures and to harmonize the criteria to be taken into account in selecting the bodies responsible for examination, monitoring and verification;

Whereas the legislative framework should be improved so that both sides of industry will make an effective and appropriate contribution to the process of standardization,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I — SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT

Article 1

1

This Directive applies to personal protective equipment, hereinafter referred to as `PPE'.

2

For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

3

Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure.

4

This Directive does not apply to:

• PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety,

• the PPE classes specified in the list of excluded products in Annex I, independently of the reason for exclusion mentioned in the first indent.

Article 2

Article 3

The PPE referred to in Article 1 must satisfy the basic health and safety requirements laid down in Annex II.

Article 4

Article 5

5

Member States shall ensure that by 30 June 1991 appropriate steps are taken to enable both sides of industry to have an influence at national level on the process of formulating the harmonized standards and keeping them under review.

Article 6

Article 7

CHAPTER II — CERTIFICATION PROCEDURES

Article 8

Article 9

EC TYPE-EXAMINATION

Article 10

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.

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.

CHECKING OF PPE MANUFACTURED

Article 11

‘EC’ quality control system for the final product

A

A body of which notification has been given, chosen by a manufacturer, shall carry out the necessary checks. Those checks shall be carried out at random, normally at intervals of at least one year.

An adequate sample of PPE taken by the body of which notification has been given shall be examined and appropriate tests defined in the harmonized standards or necessary to show conformity to the basic requirements of this Directive shall be carried out to check the conformity of PPE.

Where a body is not the body that issued the relevant EC type-approval certificate it shall contact the body of which notification has been given in the event of difficulties in connection with the assessment of the conformity of samples.

System for ensuring EC quality of production by means of monitoring

B

1

The system

• (a) Under this procedure the manufacturer submits an application for the approval of his quality-control system to a body of which notification has been given, of his choice.

• That application shall include: all the information relating to the category of PPE concerned, including, where appropriate, documentation relating to the model approved, documentation on the quality-control system, the undertaking to maintain the obligations arising from the quality-control system and to maintain its adequacy and efficiency.

• (b) Under the quality-control system, each PPE shall be examined and the appropriate tests referred to in Section A paragraph 3 shall be carried out to check their conformity to the relevant basic requirements of this Directive.

The documentation on the quality-control system shall in particular include an adequate description of:

• the quality objectives, the organization chart, the responsibilities of executives and their powers in respect of product quality,

• the checks and tests which must be carried out after manufacture,

• the means to be employed to check the efficient operation of the quality-control system.

• (c) The body shall assess the quality-control system to determine whether it satisfies the provisions referred to in paragraph 1(b). It shall assume that quality-control systems applying the relevant harmonized standard satisfy those provisions.

The body carrying out audits shall make all necessary objective evaluations of the components of the quality-control system and shall check in particular whether the system ensures conformity of PPE manufactured with the approved model.

The decision shall be communicated to the manufacturer. It shall include the conclusions of the check and the reasoned assessment decision.

• (d) The manufacturer shall inform the body which approved the quality-control system of any plan to alter the quality-control system.

The body shall examine the proposed changes and decide whether the altered quality-control system satisfies the relevant provisions. It shall communicate its decision to the manufacturer. The communication shall include the conclusions of the check and the reasoned assessment decision.

2

Supervision

• (a) The purpose of supervision is to ensure that a manufacturer correctly fulfils the obligations arising from the approved quality-control system.

• (b) The manufacturer shall authorize the body to have access, for purposes of inspection, to PPE inspection, testing and storage sites and shall provide the body with all requisite information, in particular:

• documentation on the quality-control system,

• technical documentation,

• quality control manuals.

• (c) The body shall periodically carry out audits to ensure that the manufacturer is maintaining and applying the approved quality-control system and shall provide the manufacturer with a copy of the audit report.

• (d) In addition, the body may make unnannounced visits to the manufacturer. In the course of such visits the body shall provide the manufacturer with a report of the visit and, if appropriate, with an audit report.

• (e) The manufacturer must be able to present, on request, the report of the body of which notification has been given.

EC DECLARATON OF PRODUCTION CONFORMITY

Article 12

The EC declaration of conformity is the procedure whereby the manufacturer:

CHAPTER III — EC MARK

Article 13

CHAPTER IV — FINAL PROVISIONS

Article 14

Any decision taken in implementation of this Directive and leading to restrictions on the marketing of PPE shall be accompanied by a detailed explanation of the grounds on which it is based. The interested party shall be notified of the decision without delay and informed of the possibilities for appeal under the legislation in force in the Member State concerned and of the deadlines for lodging such appeals.

Article 15

The Commission shall take the necessary steps to ensure that data concerning all the relevant decisions in connection with the management of this Directive are made available.

Article 16

Article 17

This Directive is addressed to the Member States.

Done at Brussels, 21 December 1989.

For the Council The President

E. CRESSON

Signed

Edward Leigh — Parliamentary Under-Secretary of State, — Department of Trade and Industry — 10th December 1992

Explanatory note

(This note is not part of the Regulations)

1 These Regulations implement Council Directive 89/686/EEC (OJ No L399, 30.12.89, p.18) on the approximation of the laws of the Member States relating to personal protective equipment.

2 They provide for the application of the powers to serve prohibition notices, notices to warn, suspension notices and forfeiture orders under the Consumer Protection Act 1987 and for enforcement by weights and measures authorities in Great Britain and district councils in Northern Ireland.

3 They provide for the approval and withdrawal of approval of bodies responsible for certification and monitoring.

4 They provide for the free movement of personal protective equipment and components in accordance with the Directive.

Footnotes

[^f00002]: 1972 c. 68.

[^f00003]: OJ No.L399, 30.12.89, p.18.

[^f00004]: 1987 c. 43.

[^f00005]: 1974 c. 37.

[^f00006]: S.I.1978/1039 (N.I.9).

[^f00007]: OJ No.C141, 30.5.1988, p.14.

[^f00008]: OJ No.C12, 16.1.1989, p.109, OJNo.C304, 4.12.1989, p.29.

[^f00009]: OJ No.C337, 31.12.1988, p.37.

[^f00010]: OJ No.L109, 26.4.1983, p.8.

[^f00011]: OJ No.L81, 26.3.1988, p.75.

[^f00012]: OJ No.L109, 26.4.1983, p.8.

[^f00013]: OJ No.L183, 29.6.1989, p.9.

[^f00014]: OJ No L 137, 24.5.1986, p.28.