European Communities (Personal Protective Equipment) Regulations, 1993.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Communities (Personal Protective Equipment) Regulations, 1993.
2 Interpretation.
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paragraphs: (1) In these Regulations—
"appropriate fee" means the fee referred to in Regulation 7;
"approved body" means—
( a ) an approved body in the State, being a body approved by the Minister under Regulation 6, or
( b ) a body approved by a Member State (other than the State) to exercise the functions of an approved body notified by that Member State under Article 9 of the Directive and which meets the criteria specified in Annex V;
"approved body in the State" shall be construed in accordance with Regulation 6;
"approved model" means a model of a PPE in respect of which an EC type-examination certificate has been granted pursuant to Regulation 11 by an approved body;
"authorised officer" means a person appointed under Regulation 18 to be an authorised officer for the purposes of these Regulations;
"authorised representative" means an authorised representative established within the Community;
"basic requirements" mean basic health and safety requirements specified in Annex II;
"bring into service" means the first use of PPE to which the Directive applies;
"the Community" means the European Economic Community;
"the Commission" means the Commission of the European Communities;
"the Directive" means Council Directive 89/686/EEC of 21st December, 1989;
"the Director" means the Director of Consumer Affairs;
"the Authority" means the National Authority for Occupational Safety and Health;
"EC mark" means the mark referred to in Regulation 15, a specimen of which is given in Annex IV;
"EC type-examination certificate" means a certificate issued by an approved body which has established that the PPE model referred to in the certificate has satisfied the relevant provisions of the Directive and the Regulations;
"EC declaration of production conformity" has the meaning assigned to it in Regulation 14;
"harmonised standard" means a technical specification adopted by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation;
"Member State" means a Member State of the Community;
"the Minister" means the Minister for Enterprise and Employment;
"place on the market" means—
( a ) import,
( b ) sell (whether by wholesale or retail),
( c ) offer or expose for such sale,
( d ) distribute free of charge, or
( e ) supply by a manufacturer for any of those purposes, and cognate words shall be construed accordingly;
"PPE" means Personal Protective Equipment to which the Directive applies as defined by Regulation 3;
"PPE of simple design" has the meaning assigned to it by Regulation 3 (3);
"PPE of complex design" has the meaning assigned to it by Regulation 3 (4);
"national standard" means the national standard of any Member State applicable to the PPE in question incorporating the harmonised standards whose references have been published in the Official Journal of the European Communities.
(2) ( a ) A reference in these Regulations to a Regulation is to a Regulation of these Regulations.
( b ) A reference in these Regulations to a paragraph is to the paragraph of the Regulation in which the reference occurs.
(3) A word or expression that is used in these Regulations, and is also used in the Directive, has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.
(4) A reference in these Regulations to an Annex is a reference to an Annex in these Regulations.
3 Scope.
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paragraphs: (1) In these Regulations, 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 risks.
(2) PPE shall also include:
( a ) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks;
( b ) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity;
( c ) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment; and
( d ) a system which is placed on the market in conjunction with a PPE unit for its connection to an external additional device shall be treated as integrally combined with the unit notwithstanding that it is not designed to be worn or held permanently by the user for the entire period of exposure to a risk.
(3) PPE of simple design means PPE whose designer assumes the user can for 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 being PPE which is intended to protect the wearer against:
( a ) mechanical action whose effects are superficial (gardening gloves, thimbles, etc.),
( b ) cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.),
( c ) risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 degrees centigrade or to dangerous impacts (gloves, aprons for professional use, etc. ),
( d ) atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.),
( e ) 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.), or
(f) sunlight (sunglasses).
(4) PPE of complex design means PPE 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, being:
( a ) any device of a filtering respiratory nature for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases,
( b ) any respiratory protection device providing full insulation from the atmosphere, including those for use in diving,
( c ) PPE which provide only limited protection against chemical attack or against ionizing radiation,
( d ) emergency equipment for use in high-temperature environments, the effects of which are comparable to those of an air temperature of 100 degrees centigrade or more and which may or may not be characterised by the presence of infrared radiation, flames or the projection of large amounts of molten material,
( e ) emergency equipment for use in low-temperature environments, the effects of which are comparable to those of an air temperature of minus 50 degrees centigrade or less,
( f ) PPE which protects against falls from a height,
( g ) PPE which protects against electrical risks and dangerous voltages or that used as insulation in high-tension work,
( h ) motor cycle helmets and visors.
(5) These Regulations do not apply to:
( a ) PPE covered by another Directive designed to achieve the same objectives as these Regulations with regard to placing on the market, free movement of goods and safety,
( b ) the classes of PPE specified in the list of excluded products in Annex I, independently of the reason for exclusion mentioned in sub-paragraph (a) of this paragraph.
4 Safety requirements for PPE.
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paragraphs: (1) 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.
(2) PPE of simple design shall be regarded as being in conformity with these Regulations and the Directive if—
( a ) it bears the EC mark, affixed in accordance with the procedures described in these Regulations and the Directive, and
( b ) the manufacturer is able to produce on demand, at the request of the approved body or the 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 the EC mark, affixed in accordance with the procedures described in Regulation 15, and
( b ) the manufacturer is able to produce, on demand, 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 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), inclusive, 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 his representative.
5 Free movement.
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paragraphs: Nothing in these Regulations shall operate:
( a ) to prohibit, restrict or hinder the placing on the market of PPE or PPE components which satisfy the provisions of the Directive and which bear the EC mark, or
( b ) to prohibit, restrict or impede the placing on the market of PPE components which do not bear the EC mark, and which are intended to be incorporated in PPE, provided that they are not essential to its satisfactory functioning.
6 Appointment of approved bodies in the State.
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paragraphs: (1) The Minister may appoint one or more persons to exercise in the State (whether individually or, where more than one person is so appointed and the Minister so directs, together with one or more of the other persons so appointed) the functions specified in the Directive of an approved inspection body referred to as "approved bodies" in Article 9 of the Directive and references in these Regulations to an approved body in the State shall be construed as references to each person so appointed or, as the case may be, to such of the persons so appointed as are the subject of an aforesaid direction.
(2) In making an appointment under paragraph (1), the Minister shall take into account the minimum conditions to be fulfilled by approved bodies, which said conditions are specified in Annex V, and the Minister may, in making such an appointment, attach such conditions thereto as he thinks fit.
(3) The Minister shall inform the Commission and the other Member States of the names of the approved bodies appointed under paragraph (1).
(4) An appointment under paragraph (1)—
( a ) may be for a fixed or indefinite time;
( b ) may be revoked by the Minister at any time; and
( c ) shall be revoked by the Minister if he has reason to believe that the approved body in the State does not meet, or has ceased to meet, the conditions referred to in paragraph (2).
(5) The Minister may amend or revoke any or all of the conditions (if any) attached under paragraph (2) to an appointment under paragraph (1) or attach additional conditions from time to time to such appointment for the efficient and proper functioning of the body in question.
(6) Where an appointment has been revoked under paragraph (4) (b) the Minister shall so inform the Commission and the other Member States.
7 Fees.
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paragraphs: (1) An approved body in the State may charge a fee (the "appropriate fee") which shall be equal to the costs which the body estimates it will incur in, or in connection with, carrying out or causing to be carried out the functions referred to in these Regulations in respect of the application concerned.
(2) Where the costs actually so incurred are greater than the appropriate fee, the difference between those costs and that fee shall be payable by the manufacturer or his authorised representative to the approved body in the State, and where those costs are less than the appropriate fee, the difference between those costs and that fee shall be repayable by the body to the manufacturer or his authorised representative, as the case may be.
8 Obligations on manufacturers — certification procedures.
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paragraphs: (1) Before placing a PPE model on the market, the manufacturer or his authorised representative shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the Minister, the Director or the Authority.
(2) Prior to the series of PPE other than those referred to in Regulation 3 (3), the manufacturer or his authorised representative shall submit a model for EC type-examination in accordance with Regulation 9.
(3) PPE products of complex design shall, according to the manufacturer's choice, be subject to the following:
( a ) one of the two procedures referred to in Regulation 13, and
( b ) the EC declaration of production conformity referred to in Regulation 14.
(4) EC type-examination shall not be required in the case of PPE models of simple design. PPE products of simple design shall be subject to the EC declaration of production conformity.
9 Application for an EC type-examination certificate.
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paragraphs: (1) A manufacturer of PPE (other than PPE of simple design), or his authorised representative shall apply to an approved body for an EC type-examination of the relevant PPE model.
(2) An application made under paragraph (1) shall be made in writing and shall contain such information and be supported by such documents as the approved body may reasonably require, including;
( a ) a description of the PPE,
( b ) the name and address of the manufacturer or his authorised representative, and of the PPE production plant in question, and
( c ) the manufacturer's technical file referred to in Annex III.
The application shall be accompanied by the appropriate number of specimens of the model to be approved.
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paragraphs: (1) The approved body shall conduct an EC type-examination comprising an examination of the manufacturer's technical file and examination of the model.
(2) The examination of the manufacturer's technical file shall be conducted so as to establish its suitability with respect to the harmonised standards referred to in Regulation 2.
(3) Where a manufacturer has not applied, or has only partly applied, the harmonised standards or where there are no such standards, the approved body must check the suitability of the technical specifications used by the manufacturer with respect to the basic requirements referred to in Annex II before examining the manufacturer's technical file to establish its suitability with respect to these technical specifications.
(4) The examination of the model of the PPE in question shall be conducted so as—
( a ) to 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, and
( b ) to establish the conformity of the model with the harmonised standards by means of the necessary examination and tests.
(5) Where a manufacturer has not applied or has only partly applied the harmonised standards or where there are no such standards, the approved body shall conduct the necessary examinations and tests to establish the conforminity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to the basic requirements referred to in Annex II.
(6) The approved body shall retain its file for a period not less than 10 years following the placing of the PPE on the market and the PPE shall, for the purposes of this Regulation, be deemed to be placed on the market when the examination to be conducted under paragraphs (2) to (5) inclusive, of this Regulation has been completed.
11 Granting of EC type-examination certificate.
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paragraphs: (1) Where an approved body to which an application has been made to it under Regulation 9, has carried out or caused to be carried out on its behalf the procedures described in Regulation 10, and has been paid the appropriate fee, and is satisfied that the PPE model satisfies the relevant provisions, it shall grant an EC type-examination certificate subject to such conditions as it thinks fit and shall so inform the applicant. 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.
(2) The approved body shall, if so requested, provide to the Commission, or to an approved body of or the competent authorities of another Member State, a copy of the EC type-examination certificate and, on receipt of a reasoned request by any of those bodies or authorities, a copy of the manufacturer's technical file included in the application for EC type-examination and reports of the examinations and tests conducted.
12 Refusal or withdrawal of EC type-examination certificate.
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paragraphs: (1) Where an approved body in the State having carried out the procedures referred to in Regulation 10 refuses to grant an EC type-examination certificate in respect of a PPE model, it shall so inform the applicant and the other approved bodies in all Member States. The applicant shall be given a detailed explanation of the grounds on which a decision to refuse an EC type-examination certificate was based. He shall also be advised of his right to appeal under Regulation 17 and of the time limit for bringing such an appeal.
(2) Where an approved body in the State withdraws an EC type-examination certificate it shall inform the person to whom it was granted, the Member State which granted it and the Minister to this effect, setting out the reasons for its decision.
(3) On receipt of a notice of withdrawal from an approved body in another Member State, the Minister shall inform the other Member States and the Commission setting out the reasons for the decision.
13 Checking of manufactured PPE and "EC" quality control system for the final product.
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paragraphs: (1) A person shall not produce PPE of complex design unless according to the manufacturer's choice, one of the two procedures referred to in paragraphs (2) to (7) and (8) to (11) respectively has been complied with in respect of that PPE.
A. General Provisions
(2) A manufacturer shall take all steps necessary to ensure that the manufacturing process, including the final inspection of PPE and tests, ensures the homogeneity of production and the conformity of PPE with the type described in the EC type-approval certificate and with the relevant basic requirements of the Directive.
(3) The approved body, 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.
(4) An adequate sample of PPE taken by the approved body shall be examined and appropriate tests defined in the harmonised standards, or necessary to show conformity to the basic requirements of the Directive, shall be carried out.
(5) Where the approved body is not the approved body that issued the relevant EC type-approval certificate, it shall contact the latter approved body in the event of difficulties in connection with the assessment of the conformity of samples.
(6) The approved body shall provide the manufacturer with a test report. If the report concludes that production is not homogeneous or that the PPE examined does not conform to the type described in the EC type-approval certificate or the relevant basic requirments, the approved body shall take measures appropriate to the nature of the fault or faults recorded and inform the Member State which gave notification thereof, accordingly.
(7) The manufacturer shall, on request being made in that behalf by an authorised officer, present the report of the approved body to an authorised officer.
B. Assessment of Quality Controls
(8) Under this procedure (namely the system for ensuring EC quality of production by means of monitoring) the manufacturer shall submit an application for the approval of his quality-control system to an approved body of his choice and that application shall include:
( a ) all the information relating to the category of PPE concerned, including, where appropriate, documentation relating to the model approved,
( b ) documentation on the quality-control system,
( c ) an undertaking to maintain the obligations arising from the quality-control system and to maintain its adequacy and efficiency.
(9) Under the quality-control system, each item of PPE shall be examined and the appropriate tests referred to in paragraph (4) shall be carried out to check its conformity to the relevant basic requirements of the Directive.
The documentation on the quality-control system shall in particular include an adequate description of:
(i) the quality objectives, the organisation chart, the responsibilities of executives and their powers in respect of product quality,
(ii) the checks and tests which must be carried out after manufacture,
(iii) the means to be employed to check the efficient operation of the quality-control system.
(10) The approved body shall assess the quality-control system to determine whether it satisfies the provisions referred to in Regulation 13 (9) and it shall assume that quality-control systems applying the relevant harmonised standard satisfy those provisions.
The approved 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.
(11) The manufacturer shall inform the approved body which approved the quality-control system of any plan to alter the quality-control system.
The approved 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.
C. Supervision to ensure that Quality Control Systems are properly applied
(12) ( a ) There shall be such supervision of the quality control systems to which these Regulations relate and the purpose of supervision shall be to ensure that a manufacturer correctly fulfils the obligations arising from his approved quality-control system.
( b ) The manufacturer shall authorise the approved body to have access, for purposes of inspection, to PPE inspection, testing and storage sites and shall provide the approved body with all requisite information, in particular:
(i) documentation on the quality-control system,
(ii) technical documentation,
(iii) quality-control manuals.
( c ) The approved 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 approved body may make unannounced visits to the manufacturer and shall provide the manufacturer with a report of any such visit and, if appropriate, with an audit report in respect of any such visit.
( e ) The manufacturer shall, on request being made in that behalf by an authorised officer, present the report of the approved body to an authorised officer.
(13) The manufacturer shall take all necessary steps to cooperate with an approved body for the purposes of this Regulation.
14 EC declaration of production conformity.
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paragraphs: A manufacturer of PPE which conforms to the provisions of these Regulations and the Directive or his authorised representative shall prepare an EC Declaration of Production Conformity. This is the procedure whereby the manufacturer or his authorised representative:
( a ) draws up a document using the format laid down in Annex VI, certifying that the PPE placed on the market is in conformity with the provisions of these Regulations and the Directive, and
( b ) affixes the EC mark in accordance with Regulation 15.
15 EC Mark.
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paragraphs: (a) The manufacturer referred to in Regulation 14 or his authorised representative shall affix the EC mark, in the form specified in Annex IV, to PPE and its packaging so as to be visible, legible and indelible throughout the foreseeable useful life of the PPE.
( b ) The EC mark shall consist of the letters "CE" followed by the last two digits of the year in which the mark was affixed, and in the event of the involvement of an approved body having carried out an EC examination of the type referred to in Regulation 10, the distinguishing number of such approved body shall also be added.
16 Prohibitions on marketing.
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paragraphs: (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 EC mark which, when used in accordance with its intended purpose, is likely to compromise the safety of persons, domestic animals or property, the Minister, the Director or the Authority, as the case may be shall by direction in writing given to that person prohibit him from placing or continuing to place on the market such PPE, or if appropriate impose restrictions on his so doing, and where appropriate, require him to take all practicable steps to withdraw from the market any such equipment already placed by him on the market.
(2) Where the Minister, the Director or the Authority gives a direction under paragraph (1), the Minister, the Director or the Authority, as the case may be, shall immediately inform the Commission of the fact indicating the reasons for the giving of the direction and, in particular, stating whether non-conformity is due to:
( a ) failure to comply with the basic requirements;
( b ) the unsatisfactory application of the standards referred to in Regulation 4;
( c ) a shortcoming in the standards referred to in Regulation 4.
(3) A direction given under paragraph (1) may be withdrawn by the Minister, the Director or the Authority, as the case may be, who has given the direction.
(4) Any trader or importer who is affected by a direction given under paragraph (1) may appeal to the High Court against the direction and the Court, as it thinks proper, may annul, vary or confirm the direction.
(5) Any document purporting to be a direction given by the Minister, the Director or the Authority under paragraph (1) shall be received in evidence and deemed to be such a direction without further proof unless the contrary is shown.
(6) No person shall place on the market PPE in contravention of a direction under this Regulation.
(7) A manufacturer shall take all reasonable steps to withdraw or cause to be withdrawn from the market PPE where he is required to do so by a direction under this Regulation.
17 Review.
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paragraphs: (1) Any person aggrieved by a decision of an approved body under Regulation 12 (1) or 12 (2) may, by notice in writing given to the Minister not later than 14 days after the receipt by that person of notice of that decision, appeal to the Minister against the decision and the Minister, having considered any submissions made to him by the person, the approved body in the State and any other interested parties and the report of any inquiry held under paragraph (2) in relation to the appeal or of any assessor appointed under paragraph (3) in relation thereto, may uphold, vary or reverse the decision of the approved body.
(2) The Minister may appoint an officer to hold an inquiry in connection with an appeal under this Regulation and to report to the Minister on the findings and result of the inquiry.
(3) The Minister may appoint an assessor to assist the Minister and to make a report to him in relation to an appeal under this Regulation or to assist an officer of the Minister in relation to an inquiry being held by him under paragraph (2).
18 Powers of authorised officers.
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paragraphs: (1) ( a ) The Minister and the Director may appoint such and so many officers of the Minister as the Minister or the Director thinks fit to be authorised officers for the purposes of these Regulations.
( b ) The Authority may appoint such and so many officers as the Authority thinks fit to be authorised officers for the purposes of these Regulations.
(2) An authorised officer shall be furnished with a warrant of his appointment as an authorised officer. An authorised officer may, on production of his authorisation if so required by any person affected, for the purposes of these Regulations and of the Directive—
( a ) at all reasonable times enter any premises or place in which he has reasonable grounds for believing that there is PPE, or PPE is being manufactured, or any premises or place that are part of the undertaking engaged in the manufacture of PPE,
( b ) at such premises or place, inspect and take copies of, or extracts from, any books, records or other documents which he finds in the course of his inspection,
( c ) carry out or have carried out such examinations, tests, inspections and checks of the place and any equipment, machinery or plant in or at the place as he reasonably considers to be necessary for the purposes of his functions under these Regulations or the Directive,
( d ) require any person at the premises or place and the owner or person in charge and any person employed in connection therewith to give him such information and to produce to him such books, documents and other records which are in that person's power or procurement as he may reasonably require for the purposes of his functions under these Regulations or the Directive, and
( e ) take possession of and remove for examination and checking PPE or any part thereof, and retain such PPE or part thereof for such time as he considers reasonable for the purposes of his functions under these Regulations or the Directive.
19 Offences.
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paragraphs: Any person who—
(1) ( a ) obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by these Regulations or impedes the exercise by the officer of such power or fails or refuses to comply with a request made by, or to answer a question asked by, an authorised officer pursuant to these Regulations or in purported compliance with such request or in answer to such question, gives information to an officer that he knows to be false or misleading in a material respect, or
( b ) affixes an EC mark to PPE which is not in conformity with the relevant requirements of the Regulations or the Directive, or
( c ) affixes to PPE a mark or inscription which is likely to be confused with the EC mark, or
( d ) contravenes Regulation 4 (1), 8 (1), 8 (2), 13 (1), 13 (12), 13 (13), 14, 15, 16 (6) or 16 (7), shall be guilty of an offence.
(2) Where an offence under these Regulations has been committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person being a director, manager, secretary or other officer of the body corporate, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentioned offence.
(3) A person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding £1,000 or to imprisonment for a term not exceeding six months or to both such fine and such imprisonment.
(4) The Minister shall inform the Commission of any offences which in the opinion of the Minister have been committed under paragraph 1 (b) and of the action taken.
20 Prosecution of offences.
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paragraphs: Proceedings for an offence under these Regulations may be brought and prosecuted by the Minister, the Director or the Authority.