S.I. No. 272/1993 - European Communities (Personal Protective Equipment) Regulations, 1993.
S.I. No. 272 of 1993.
EUROPEAN COMMUNITIES (PERSONAL PROTECTIVE EQUIPMENT) REGULATIONS, 1993.
I, RUAIRI QUINN, TD, 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 Council Directive 89/686/EEC of 21st December, 1989(1), on the approximation of the laws of the Member States relating to personal protective equipment hereby make the following Regulations:
(1)O.J. No. L399/18, 30.12.1989, P.18.
1 Citation and Commencement.
1. These Regulations may be cited as the European Communities (Personal Protective Equipment) Regulations, 1993.
2. (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. (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.
4. (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.
5. 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.
6. (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. (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.
8. (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.
9. (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.
10. (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.
11. (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.
12. (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.
13. (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.
14. 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.
15. (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.
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 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. (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.
18. (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. 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.
20. Proceedings for an offence under these Regulations may be brought and prosecuted by the Minister, the Director or the Authority.
GIVEN under my Official Seal, this 22nd day of September, 1993.
Minister for Enterprise and Employment.
Exhaustive List of PPE Classes not covered by this Directive
1. PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.).
2. PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.).
3. PPE designed and manufactured for private use against:
—adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.).
—damp and water (dish-washing gloves, etc.).
—heat (gloves etc.).
4. PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time.
5. Motor cycle helmets and visors.
Basic Health and Safety Requirements
1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE
PPE must provide adequate protection against all risks encountered.
1.1. Design principles
PPE must be so designed and manufactured that in the foreseeable conditions of use for which it is intended the user can perform the risk-related activity normally whilst enjoying appropriate protection of the highest possible level.
1.1.2. Levels and classes of protection
188.8.131.52. Highest level of protection possible
The optimum level of protection to be taken into account in the design is that beyond which the constraints imposed by the wearing of the PPE would prevent its effective use during the period of exposure to the risk or normal performance of the activity.
184.108.40.206 Classes of protection appropriate to different levels of risk
Where differing foreseeable conditions of use are such that several levels of the same risk can be distinguished, appropriate classes of protection must be taken into account in the design of the PPE.
1.2. Innocuousness of PPE
1.2.1. Absence of risks and other "inherent" nuisance factors
PPE must be so designed and manufactured as to preclude risks and other nuisance factors under foreseeable conditions of use.
220.127.116.11 Suitable constituent materials
PPE materials and parts, including any of their decomposition products, must not adversely affect user hygiene or health.
18.104.22.168. Satisfactory surface conditions of all PPE parts in contact with the user
Any PPE part in contact or in potential contact with the user when such equipment is worn must be free of roughness, sharp edges, projections and the like which could cause excessive irritation or injuries.
22.214.171.124. Maximum permissible user impediment
Any impediment caused by PPE to movements to be made, postures to be adopted and sensory perception must be minimized; nor must PPE cause movements which endanger the user or other persons.
1.3. Comfort and Efficiency
1.3.1. Adaptation of PPE to user morphology
PPE must be so designed and manufactured as to facilitate correct positioning on the user and to remain in place for the foreseeable period of use, bearing in mind ambient factors, movements to be made and postures to be adopted. For this purpose, it must be possible to optimize PPE adaptation to user morphology by all appropriate means, such as adequate adjustment and attachment systems or the provision of an adequate size range.
1.3.2. Lightness and design strength
PPE must be as light as possible without prejudicing design strength and efficiency.
Apart from the specific additional requirements which they must satisfy in order to provide adequate protection against the risks in question (see 3), PPE must be capable of withstanding the effects of ambient phenomena inherent under the forseeable conditions of use.
1.3.3. Compatibility of different classes or types of PPE designed for simultaneous use
If the same manufacturer markets several PPE models of different classes or types in order to ensure the simultaneous protection of adjacent parts of the body against combined risks, these must be compatible.
1.4. Information supplied by the manufacturer
In addition to the name and address of the manufacturer and/or his authorised representative established in the Community, the notes that must be drawn up by the former and supplied when PPE is placed on the market must contain all relevant information on:
( a ) storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on PPE or users when applied in accordance with the relevant instructions;
( b ) performance as recorded during technical tests to check the levels or classes of protection provided by the PPE in question;
( c ) suitable PPE accessories and the characteristics of appropriate spare parts;
( d ) the classes of protection appropriate to different levels of risk and the corresponding limits of use;
( e ) the absolescence deadline or period of obsolescence of PPE or certain of its components;
( f ) the type of packaging suitable for transport;
(g) the significance of any markings (see 2.12).
These notes, which must be precise and comprehensible, must be provided at least in the official language(s) of the Member State of destination.
2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE
2.1 PPE incorporating adjustment systems
If PPE incorporates adjustment systems, the latter must be so designed and manufactured as not to become incorrectly adjusted without the user's knowledge under the foreseeable conditions of use.
2.2. PPE "enclosing" the parts of the body to be protected
As far as possible, PPE "enclosing" the parts of the body to be protected must be sufficiently ventilated to limit perspiration resulting from use; if this is not the case, it must if possible be equipped with devices which absorb perspiration.
2.3. PPE for the face, eyes and respiratory tracts
Any restriction of the user's field of vision or sight by PPE for the face, eyes or respiratory tract must be minimised.
The degree of optical neutrality of the vision systems of these PPE classes must be compatible with the type of relatively meticulous and/or prolonged activities of the user.
If necessary, they must be treated or provided with facilities to prevent moisture formation.
PPE models intended for users requiring sight correction must be compatible with the wearing of spectacles or contact lenses.
2.4. PPE subject to ageing
If it is known that the design performances of new PPE may be significantly affected by ageing, the date of manufacture and/or, if possible, the date of obsolescence, must be indelibly inscribed on every PPE item or interchangeable component placed on the market in such a way as to preclude any misinterpretation; this information must also be indelibly inscribed on the packaging.
If a manufacturer is unable to give an undertaking with regard to the useful life of PPE, his notes must provide all the information necessary to enable the purchaser or user to establish a reasonable obsolescence date, bearing in mind the quality level of the model and the effective conditions of storage, use, cleaning, servicing and maintenance.
Where appreciable and rapid deterioration in PPE performance is likely to be caused by ageing resulting from the periodic use of a cleaning process recommended by the manufacturer, the latter must, if possible, affix a mark to each item of PPE placed on the market indicating the maximum number of cleaning operations that may be carried out before the equipment needs to be inspected or discarded; failing that, the manufacturer must give this information in his notes.
2.5. PPE which may be caught up during use
Where the foreseeable conditions of use include in particular the risk of the PPE being caught up by a moving object thereby creating a danger for the user, the PPE must possess an appropriate resistance threshold above which a constituent part will break and eliminate the danger.
2.6. PPE for use in explosive atmospheres
PPE intended for use in explosive atmospheres must be so designed and manufactured that it cannot be the source of an electric, electrostatic or impact-induced arc or spark likely to cause an explosive mixture to ignite.
2.7. PPE intended for emergency use or rapid installation and/or removal
These PPE classes must be so designed and manufactured as to minimise the time required for attachment and (or) removal.
Any integral systems permitting correct positioning on, or removal from, the user must be susceptible of rapid and easy operation.
2.8. PPE for use in very dangerous situations
The information notes supplied by the manufacturer together with PPE for use in the very dangerous situations referred to in Article 8 (4) (a) must include, in particular, data intended for the exclusive use of competent trained individuals who are qualified to interpret them and ensure their application by the user.
They must also describe the procedure to be adopted in order to verify that PPE is correctly adjusted and functional when worn by the user.
If PPE incorporates an alarm which is activated in the absence of the level of protection normally provided, this must be so designed and accommodated as to be perceived by the user in the conditions of use for which the PPE is marketed.
2.9. PPE incorporating components which can be adjusted or removed by the user
Any PPE components which can be adjusted or removed by the user for the purpose of replacement must be so designed and manufactured as to facilitate adjustment, attachment and removal without tools.
2.10. PPE for connection to another, external complementary device
If PPE incorporates a system permitting connection to another, complementary, device, the attachment mechanism must be so designed and manufactured as to enable it to be mounted only on appropriate equipment.
2.11. PPE incorporating a fluid circulation system
If PPE incorporates a fluid circulation system, the latter must be so chosen, or designed, and incorporated as to permit adequate fluid renewal in the vicinity of the entire part of the body to be protected, irrespective of user gestures, posture or movement under the foreseeable conditions of use.
2.12. PPEbearing one or more identification or recognition marks directly or indirectly relating to health and safety
The identification or recognition marks directly or indirectly relating to health and safety affixed to these types or classes of PPE must preferably take the form of harmonised pictograms or ideograms and must remain perfectly legible throughout the foreseeable useful life of the PPE. In addition, these marks must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such marks incorporate words or sentences, the latter must appear in the official language(s) of the Member State where the equipment is to be used.
If PPE (or a PPE component) is too small to allow all or part of the necessary marking to be affixed, the relevant information must be mentioned on the packing and in the manufacturer's notes.
2.13. PPE in the form of clothing capable of signalling the user's presence visually
PPE in the form of clothing intended for foreseeable conditions of use in which the user's presence must be visibly and individually signalled must have one (or more) judiciously positioned means of or devices for emitting direct or reflected visible radiation of appropriate luminous intensity and photometric and colorimetric properties.
2.14. "Multi-risk" PPE
All PPE designed to protect the user against several potentially simultaneous risks must be so designed and manufactured as to satisfy, in particular, the basic requirements specific to each of those risks (see 3).
3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS
3.1. Protection against mechanical impact
3.1.1. Impact caused by falling or protecting objects and collision of parts of the body with an obstacle
Suitable PPE for this type of risk must be sufficiently shock-absorbent to prevent injury resulting, in particular, from the crushing or penetration of the protected part, at least up to an impact-energy level above which the excessive dimensions or mass of the absorbing device would preclude effective use of the PPE for the foreseeable period of wear.
126.96.36.199. Prevention of falls due to slipping
The outsoles for footwear designed to prevent slipping must be so designed, manufactured or equipped with added elements as to ensure satisfactory adhesion by grip and friction having regard to the nature or state of the surface.
188.8.131.52. Prevention of falls from a height
PPE designed to prevent falls from a height or their effects must incorporate a body harness and an attachment system which can be connected to a reliable anchorage point. It must be designed so that under the foreseeable conditions of use the vertical drop of the user is minimised to prevent collision with obstacles and the braking force does not, however, attain the threshold value at which physical injury or the tearing or rupture of any PPE component which might cause the user to fall can be expected to occur.
It must also ensure that after braking the user is maintained in a correct position in which he may await help if necessary.
The manufacturer's notes must specify in particular all relevant information relating to:
— the characteristics required for the reliable anchorage point and the necessary minimum clearance below the user,
— the proper way of putting on the body harness and of connecting the attachment system to the reliable anchorage point.
3.1.3. Mechanical vibration
PPE designed to prevent the effects of mechanical vibrations must be capable of ensuring adequate attenuation of harmful vibration components for the part of the body at risk.
Under no circumstances must the effective value of the accelerations transmitted to the user by those vibrations exceed the limit values recommended in the light of the maximum foreseeable daily exposure of the part of the body at risk.
3.2. Protection against (static) compression of part of the body
PPE designed to protect part of the body against (static) compressive stress must be sufficiently capable of attenuating its effects to prevent serious injury or chronic complaints.
3.3. Protection against physical injury (abrasion, perforation, cuts, bites)
PPE constituent materials and other components designed to protect all or part of the body against superficial injury caused by machinery, such as abrasion, perforation, cuts or bites, must be so chosen or designed and incorporated as to ensure that these PPE classes provide sufficient resistance to abrasion, perforation and gashing (see also 3.1) under the foreseeable conditions of use.
3.4. Prevention of drowning (lifejackets, armbands and lifesaving suits)
PPE designed to prevent drowning must be capable of returning to the surface as quickly as possible, without danger to his health, a user who may be exhausted or unconscious after falling into a liquid medium, and of keeping him afloat in a position which permits breathing while awaiting help.
PPE may be wholly or partially inherently buoyant or may be inflated either by gas which can be manually or automatically released or orally.
Under the foreseeable conditions of use:
— PPE must, without prejudice to its satisfactory operation, be capable of withstanding the effects of impact with the liquid medium and the environmental factors inherent in that medium.
— inflatable PPE must be capable of inflating rapidly and fully.
Where particular foreseeable conditions of use so require, certain types of PPE must also satisfy one or more of the following additional requirements:
— it must have all the inflation devices referred to in the second subparagraph, and/or a light or sound-signalling device,
— it must have a device for hitching and attaching the body so that the user may be lifted out of the liquid medium,
— it must be suitable for prolonged use throughout the period of activity exposing the user, possibly dressed, to the risk of falling into the liquid medium or requiring his immersion in it.
3.4.1. Buoyancy aids
Clothing which will ensure an effective degree of buoyancy, depending on its foreseeable use, which is safe when worn and which affords positive support in water. In foreseeable conditions of use, this PPE must not restrict the user's freedom of movement but must enable him, in particular, to swim or take action to escape from danger or rescue other persons.
3.5. Protection against the harmful effects of noise
PPE designed to prevent the harmful effects of noise must be capable of attenuating the latter to such an extent that the equivalent sound levels perceived by the user do not under any circumstances exceed the daily limit values laid down by Council Directive 86/188/EEC of 12 May 1986 on the protection of workers from the risks related to exposure to noise at work.(1)
All PPE must bear labelling indicating the noise attenuation level and the value of the comfort index provided by the PPE; should this not be possible, the labelling must be fixed to the packaging.
3.6. Protection against heat and/or fire
PPE designed to protect all or part of the body against the effects of heat and/or fire must possess thermal insulation capacity and mechanical strength appropriate to forseeable conditions of use.
3.6.1. PPE constituent materials and other components
Constituent materials and other components suitable for protection against radiant and convective heat must possess an appropriate coefficient of transmission of incident heat flux and be sufficiently incombustible to preclude any risk of spontaneous ignition under the foreseeable conditions of use.
Where the outside of these materials and components must be reflective, its reflective power must be appropriate to the intensity of the heat flux due to radiation in the infra-red range.
Materials and other components of equipment intended for brief use in high-temperature environments and of PPE which may be splashed by hot products such as large quantities of molten material must also possess sufficient thermal capacity to retain most of the stored heat until after the user has left the danger area and removed his PPE.
PPE materials and other components which may be splashed by large amounts of hot products must also possess sufficient mechanical-impact absorbency (see 3.1).
PPE materials and other components which may accidentally come into contact with flame and those used in the manufacture of fire-fighting equipment must also possess a degree of non-flammability corresponding to the risk class associated with the foreseeable conditions of use. They must not melt when exposed to flames nor contribute to flame propagation.
3.6.2. Complete PPE ready for use
Under the foreseeable conditions of use:
1. the quantity of heat transmitted by PPE to the user must be sufficiently low to prevent the heat accumulated during wear in the part of the body at risk from attaining, under any circumstances, the pain or health impairment threshold;
2. PPE must if necessary prevent liquid or steam penetration and must not cause burns resulting from contact between its protective integument and the user.
If PPE incorporates refrigeration devices for the absorption of incident heat by means of liquid evaporation or solid sublimation, their design must be such that any volatile substances released are discharged beyond the outer protective integument and not towards the user.
If PPE incorporates a breathing device, the latter must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.
The manufacturer's notes accompanying each PPE model intended for brief use in high-temperature environments must in particular provide all relevant data for the determination of the maximum permissable user exposure to the heat transmitted by the equipment when used in accordance with its intended purpose.
3.7. Protection against cold
PPE designed to protect all or part of the body against the effects of cold must possess thermal insulating capacity and mechanical strength appropriate to the foreseeable conditions of use for which it is marketed.
3.7.1. PPE constituent materials and other components
Constituent materials and other components suitable for protection against cold must possess a coefficient of transmission of incident thermal flux as low as required under the foreseeable conditions of use. Flexible materials and other components of PPE intended for use in a low-temperature environment must retain the degree of flexibility required for the necessary gestures and postures.
PPE materials and other components which may be splashed by large amounts of cold products must also possess sufficient mechanical-impact absorbency (see 3.1).
3.7.2. Complete PPE ready for use
Under the foreseeable conditions of use:
1. the flux transmitted by PPE to the user must be sufficiently low to prevent the cold accumulated during wear at any point on the part of the body being protected, including the tips of fingers and toes in the case of hands or feet, from attaining, under any circumstances, the pain or health-impairment threshold;
2. PPE must as far as possible prevent the penetration of such liquids as rain water and must not cause injuries resulting from contact between its cold protective integument and the user.
If PPE incorporates a breathing device, this must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.
The manufacturer's notes accompanying each PPE model intended for brief use in low-temperature environments must provide all relevant data concerning the maximum permissible user exposure to the cold transmitted by the equipment.
3.8. Protection against electric shock
PPE designed to protect all or part of the body against the effects of electric current must be sufficiently insulated against the voltages to which the user is likely to be exposed under the most unfavourable foreseeable conditions.
To this end, the constituent materials and other components of these PPE classes must be so chosen or designed and incorporated as to ensure that the leakage current measured through the protective integument under test conditions at voltages correlated with those likely to be encountered in situ is minimised and, at all events, below a maximum conventional permissable value which correlates with the tolerance threshold.
Together with their packaging, PPE types intended exclusively for use during work or activities in electrical installations which are or may be under tension must bear markings indicating, in particular, their protection class and (or) corresponding operating voltage, their serial number and their date of manufacture; a space must also be provided outside the prjotective integument of such PPE for the subsequent inscription of the date of entry into service and those of the periodic tests or inspections to be conducted.
The manufacturer's notes must indicate, in particular, the exclusive use for which these PPE types are intended and the nature and frequency of the dielectric tests to which they are to be subjected during their useful life.
3.9. Radiation protection
3.9.1. Non-ionising radiation
PPE designed to prevent acute or chronic eye-damage from sources of non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths without unduly affecting the transmission of the innocuous part of the visable spectrum, the perception of contrasts and the ability to distingush colours where required by the foreseeable conditions of use.
To this end, protective glasses must be so designed and manufactured as to possess, for each harmful wave, a spectral transmission factor such that the radiant-energy illumination density capable of reaching the user's eye through the filter is minimised and, under no circumstances, exceeds the maximum permissible exposure value.
Furthermore, the glasses must not deteriorate or lose their properties as a result of the effects of radiation emitted under the foreseeable conditions of use and all marketed specimens must bear the protection-factor number corresponding to the spectral distribution curve of their transmission factor.
Glasses suitable for radiation sources of the same type must be classified in the ascending order of their protection factors and the manufacturer's notes must indicate, in particular, the transmission curves which make it possible to select the most appropriate PPE bearing in mind such inherent factors of the effective conditions of use as distance to source and the spectral distribution of the energy radiated at that distance.
The relevant protection-factor number must be marked on all specimens of filtering glasses by the manufacturer.
3.9.2. Ionising radiation
184.108.40.206. Protection against external radioactive contamination
PPE constituent materials and other components designed to protect all or part of the body against radioactive dust, gases, liquids or mixtures thereof must be so chosen or designed and incorporated as to ensure that this equipment effectively prevents the penetration of the contaminants under the foreseeable conditions of use.
Depending on the nature or condition of these contaminants, the necessary leak-tightness can be provided by the impermeability of the protective integument and/or by any other appropriate means, such as ventilation and pressurisation systems designed to prevent the back-scattering of these contaminants.
Any decontamination measures to which PPE is subject must not prejudice its possible re-use during the foreseeable useful life of these classes of equipment.
220.127.116.11. Limited protection against external irradiation
PPE intended to provide complete user protection against external irradiation or, failing this, adequate attenuation thereof, must be designed to counter only weak electron (e.g. beta) or weak photon (e.g. X, gamma) radiation.
The constituent materials and other components of these PPE classes must be so chosen or designed and incorporated as to provide the degree of user protection required by the foreseeable conditions of use without leading to an increase in exposure time as a result of the impedance of user gestures, posture or movement (see 1.3.2).
PPE must bear a mark indicating the type and thickness of the constituent material(s) suitable for the foreseeable conditions of use.
3.10. Protection against dangerous substances and infective agents
3.10.1. Respiratory protection
PPE intended for the protection of the respiratory tract must make it possible to supply the user with breathable air when the latter is exposed to a polluted atmosphere and/or an atmosphere having inadequate oxygen concentration.
The breathable air supplied to the user by the PPE must be obtained by appropriate means, for example after filtration of the polluted air through the protective device or appliance or by a piped supply from an unpolluted source.
The constituent materials and other components of these PPE classes must be so chosen or designed and incorporated as to ensure appropriate user respiration and respiratory hygiene for the period of wear concerned under the foreseeable conditions of use.
The leak-tightness of the facepiece and the pressure drop on inspiration and, in the case of the filtering devices, purification capacity must be such as to keep contaminant penetration from a polluted atmosphere low enough not to be prejudicial to the health or hygiene of the user.
The PPE must bear the manufacturer's identification mark and details of the specific characteristics of that type of equipment which, in conjunction with the instructions for use, will enable a trained and qualified user to employ the PPE correctly.
The manufacturer's notes must also in the case of filtering devices, indicate the deadline for the storage of filters as new and kept in their original packaging.
3.10.2. Protection against cutaneous and ocular contact
PPE intended to prevent the surface contact of all or part of the body with dangerous substances and infective agents must be capable of preventing the penetration or diffusion of such substances through the protective integument under the foreseeable conditions of use for which the PPE is placed on the market.
To this end, the constituent materials and other components of these PPE classes must be so chosen, or designed and incorporated as to ensure, as far as possible, complete leak-tightness, which will allow where necessary prolonged daily use or, failing this, limited leak-tightness necessitating a restriction of the period of wear.
Where, by virtue of their nature and the foreseeable conditions of their use, certain dangerous substances or infective agents possess high penetrative power which limits the duration of the protection provided by the PPE in question, the latter must be subjected to standard tests with a view to their classification on the basis of effeciency. PPE which is considered to be in conformity with the test specifications must bear a mark indicating, in particular, the names or, failing this, the codes of the substances used in the tests and the corresponding standard period of protection. The manufacturer's notes must also contain, in particular, an explanation of the codes (if necessary), a detailed description of the standard tests and all appropriate information for the determination of the maximum permissible period of wear under the different foreseeable conditions of use.
3.11. Safety devices for diving equipment
1. Breathing equipment
The breathing equipment must make it possible to supply the user with a breathable gaseous mixture, under foreseeable conditions of use and taking account in particular of the maximum depth of immersion.
2. Where the foreseeable conditions of use so require, the equipment must comprise:
( a ) a suit which protects the user against the pressure resulting from the depth of immersion (see 3.2) and/or against cold (see 3.7);
( b ) an alarm designed to give the user prompt warning of an approaching failure in the supply of breathable gaseous mixture (see 2.8);
( c ) a life-saving suit enabling the user to return to the surface (see 3.4.1).
Technical Documentation Supplied by the Manufacturer
The documentation referred to in Article 8(1) must comprise all relevant data on the means used by the manufacturer to ensure that a PPE complies with the basic requirements relating to it.
In the case of PPE models referred to in Article 8 (2), the documentation must comprise in particular:
1. the manufacturer's technical file consisting of:
( a ) overall and detailed plans of the PPE accompanied, where appropriate, by calculation notes and the results of prototype tests in so far as necessary for the verification of compliance with the basic requirements;
( b ) an exhaustive list of the basic safety requirements and of the harmonised standards or other technical specifications referred to in Articles 3 and 5, taken into account in the design of the model;
2. a description of the control and test facilities to be used in the manufacturer's plant to check compliance of production PPE with the harmonised standards or other technical specifications and to maintain quality level;
3. a copy of the information notice referred to in Annex II, 1.4.
EC Mark of Conformity
The EC mark of conformity consists of the symbol shown below.
The vertical dimensions of the different components of the EC mark must be perceptibly the same and not less than 5 mm.
(1)) As provided in Article 13 (1) the mark may also include the distinguishing number of the approved inspection body referred to in Article 9 (1).
(2)Year in which the mark was affixed.
Conditions to be fulfilled by the bodies of which notification has been given
(Article 9 (2))
The bodies designated by the Member States must fulfil the following minimum conditions:
1. availability of personnel and of the necessary means and equipment;
2. technical competence and professional integrity of personnel;
3. independence, in carrying out the tests, preparing the reports, issuing the certificates and performing the surveillance provided for in the Directive, of staff and technical personnel in relation to all circles, groups or persons directly or indirectly concerned with PPE;
4. maintenance of professional secrecy by personnel:
5. subscription of a civil liability insurance unless that liability is covered by the State under national law.
Fulfilment of the conditions under 1 and 2 shall be verified at intervals by the competent authorities of the Member States.
Model EC Declaration of Conformity
The manufacturer or his authorised representative established in the Community (1):
............................................................ ............................................................ ............................................................ .........
............................................................ ............................................................ ............................................................ .........
............................................................ ............................................................ ............................................................ ........
declares that the new PPE described hereafter (2)
............................................................ ............................................................ ............................................................ ........
............................................................ ............................................................ ............................................................ ........
is in conformity with the provisions of Council Directive 89/686/EEC and, where such is the case, with the national standard transposing harmonised standard No........................ (for the PPE referred to in Article 8 (3))
is identical to the PPE which is the subject of EC certificate of conformity No............ issued by (3) (4).................
is subject to the procedure set out in Article 11 point A or point B (4) of Directive 89/686/EEC under the supervision of the notified body(3) ............................................................ ............................................................ ..................................................
Done at ............................................................ ........., on .............................................
(1) Business name and full address; authorised representatives must also give the business name and address of the manufacturer.
(2) Description of the PPE (make, type, serial number, etc.)
(3) Name and address of the approved body.
(4) Delete whichever is inapplicable.
(5) Name and position of the person empowered to sign on behalf of the manufacturer or his authorised representative.
These Regulations, which came into operation on the making thereof, implement Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE). They provide that PPE may not be placed on the market or brought into service unless it complies with basic health and safety requirements. PPE is deemed to be in conformity with the Regulations if it bears the CE mark.