Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC)

CHAPTER I U.K. SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT

Article 1 U.K.

1. This Directive applies to personal protective equipment, hereinafter referred to as ‘PPE’.

It lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.

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

PPE shall also cover:

(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.

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

4. This Directive does not apply to:

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

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

Article 2 U.K.

1. Member States shall take all appropriate measures to ensure that the PPE referred to in Article 1 may be placed on the market and brought into service only if it preserves the health and ensures the safety of users without prejudice to the health or safety of other individuals, domestic animals or goods, when properly maintained and used for its intended purpose.

2. This Directive shall be without prejudice to the right of Member States to lay down — in conformity with the Treaty — any requirements which they consider necessary to ensure user protection, provided that this does not give rise to modifications to PPE which could result in its non-conformity with the provisions of this Directive.

3. Member States shall not prevent the presentation at trade fairs, exhibitions and the like of PPE which is not in conformity with the provisions of this Directive, provided that an appropriate notice is displayed drawing attention to this fact and the prohibition on its acquisition and/or use for any purpose whatsoever until it has been brought into conformity by the manufacturer or his representative established in the Community.

Article 3 U.K.

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

Article 4 U.K.

[F1 1. Member States may not prohibit, restrict or hinder the placing on the market of PPE or PPE components which comply with the provisions of this Directive and which bear the CE marking attesting their conformity to all the provisions of this Directive, including the certification procedures in Chapter II.]

2. Member States shall not prohibit, restrict or impede the placing on the market of PPE components which do not bear the [F1 CE marking, and which are intended to be incorporated in PPE, provided that they are not essential to its satisfactory functioning.

Textual Amendments

F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

Article 5 U.K.

1. Member States shall regard as in conformity with the basic requirements referred to in Article 3 the PPE referred to in Article 8 (3) bearing the CE marking with respect to which the manufacturer is able to produce, on demand, the declaration of conformity referred to in Article 12.

2. Member States shall presume that the PPE referred to in Article 8 (2) satisfies the basic requirements referred to in Article 3 if it bears the CE marking with respect to which the manufacturer is able to produce, on demand, not only the declaration referred to in Article 12 but also the certificate issued by the body of which notification has been given in accordance with Article 9 attesting to their conformity to the relevant national standards, transposing the harmonized standards, assessed at the EC type examination level in accordance with the first indent of Article 10 (4) (a) and (b).

Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the certificate issued by the body of which notification has been given must state the conformity to the basic requirements in accordance with the second indent of Article 10 (4) (a) and (b).

F2 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. The Commission shall publish the references of the harmonized standards in the Official Journal of the European Communities.

Member States shall publish the references of the national standards transposing the harmonized standards.

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

[F3 6. (a) Where the PPE is subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the PPE is also presumed to conform to the provisions of the other Directives.

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

Textual Amendments

F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

F2 Deleted by Council Directive 93/95/EEC of 29 October 1993 amending Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE).

F3 Inserted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

Article 6 U.K.

F4 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F5 2. The Commission shall be assisted by the Standing Committee, set up by Article 6(2) of Directive 98/37/EC (1) , hereinafter referred to as ‘the Committee’.

It may be apprised, in accordance with the procedure referred to in this paragraph, of any matter to which the implementation and practical application of this Directive give rise.

Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC (2) shall apply, having regard to the provisions of Article 8 thereof.

The Committee shall adopt its rules of procedure.]

Textual Amendments

F4 Deleted by Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (Text with EEA relevance).

F5 Substituted by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty.

Article 7 U.K.

1. If a Member State discovers that PPE bearing the CE markingand used in accordance with its intended purpose could compromise the safety of individuals, domestic animals or property, it shall take all necessary measures to remove that equipment from the market and prohibit the marketing or free movement thereof.

The Member State concerned shall immediately inform the Commission of such action, indicating the reasons for its decision and, in particular, stating whether non-conformity is due to:

(a) failure to comply with the basic requirements referred to in Article 3;

(b) the unsatisfactory application of the standards referred to in Article 5;

(c) a shortcoming in the standards referred to in Article 5.

2. The Commission shall initiate discussions with the parties concerned as soon as possible. If, after such consultation, the Commission decides that the action taken was justified, it shall immediately inform the Member State concerned and all the other Member States to that effect. If, after such consultation, the Commission decides that the action taken was not justified, it shall immediately inform the Member State concerned and the manufacturer or his authorized representative established in the Community to that effect. If the decision referred to in paragraph 1 is in response to a shortcoming in the standards, the Commission shall refer the matter to the Committee referred to in Article 6 (1) if the Member State concerned intends to adhere to its decision and shall initiate the procedure referred to in Article 6 (2).

3. If PPE which is not in conformity with the relevant requirements bears the CE marking, the Member State concerned shall take the appropriate measures with regard to those responsible for affixing the mark and shall inform the Commission and the other Member States accordingly.

4. The Commission shall ensure that the Member States are kept informed of the progress and results of the procedure provided for in this Article.

Textual Amendments

F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

CHAPTER II U.K.

CERTIFICATION PROCEDURES U.K.

Article 8 U.K.

1. Before placing a PPE model on the market, the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the competent authorities.

2. Prior to the series production of PPE other than those referred to in paragraph 3, the manufacturer or his authorized representative established in the Community shall submit a model for EC type-examination as referred to in Article 10.

3. EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can 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.

This category shall cover exclusively PPE intended to protect the wearer against:

• mechanical action whose effects are superficial (gardening gloves, thimbles, etc.),

• cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.),

• risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 °C or to dangerous impacts (gloves, aprons for professional use, etc.),

• atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.),

• 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.),

• sunlight (sunglasses).

4. Production of PPE shall be subject:

(a) according to the manufacturer's choice, to one of the two procedures referred to in Article 11 in the case of PPE of complex design 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. This category shall cover exclusively:

• (a) filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases,

• respiratory protection devices providing full insulation from the atmosphere, including those for use in diving,

• PPE providing only limited protection against chemical attack or against ionizing radiation,

• emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature of 100 °C or more and which may or may not be characterized by the presence of infra-red radiation, flames or the projection of large amounts of molten material,

• emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of -50 °C or less,

• PPE to protect against falls from a height,

• PPE against electrical risks and dangerous voltages or that used as insulation in high-tension work,

• [F2 . . . . .]

(b) the EC declaration of conformity referred to in Article 12 for all PPE.

Textual Amendments

F2 Deleted by Council Directive 93/95/EEC of 29 October 1993 amending Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE).

Article 9 U.K.

[F1 1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 8 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

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

2. Member States shall apply the criteria laid down in Annex V in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonized standards shall be presumed to fulfil those criteria.

3. A Member State shall withdraw its approval from such a body if it establishes that the latter no longer satisfies the criteria referred to in Annex V. It shall inform the Commission and the other Member States of its action forthwith.

Textual Amendments

F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

EC TYPE-EXAMINATION U.K.

Article 10 U.K.

1. EC type-examination is the procedure whereby the approved inspection body establishes and certifies that the PPE model in question satisfies the relevant provisions of this Directive.

2. Application for EC type-examination shall be made by the manufacturer or his authorized representative to a single approved inspection body in respect of the model in question. The authorized representative shall be established in the Community.

3. The application shall comprise:

• the name and address of the manufacturer or his authorized representative and of the PPE production plant in question,

• the manufacturer's technical file referred to in Annex III.

It shall be accompanied by the appropriate number of specimens of the model to be approved.

4. The inspection body of which notification has been given shall conduct the EC type-examination in accordance with the undermentioned procedures:

(a) Examination of the manufacturer's technical file

• (a) It shall examine the manufacturer's technical file to establish its suitability with respect to the harmonized standards referred to in Article 5.

• Where a manufacturer has not applied, or has only partly applied, the harmonized standards or where there are no such standards, the body of which notification has been given must check the suitability of the technical specifications used by the manufacturer with respect to the basic requirements before examining the manufacturer's technical file to establish its suitability with respect to these technical specifications.

(b) Examination of the model

• (b) When examining the model, the inspection body shall 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.

• It shall conduct the necessary examinations and tests to establish the conformity of the model with the harmonized standards.

• Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the body of which notification has been given shall conduct the necessary examinations and tests to establish the conformity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to these basic requirements.

5. If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue and incorporate the descriptions and drawings necessary for the identification of the approved model.

The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, in response to a reasoned request, a copy of the manufacturer's technical file and the reports of the examinations and tests conducted.

The file shall be held at the disposal of the competent authorities for 10 years following the placing of the PPE on the market.

6. Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact. An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect. That Member State shall then inform the other Member States and the Commission, setting out the reasons for the decision.

CHECKING OF PPE MANUFACTURED U.K.

Article 11 U.K.

A. ‘EC’ quality control system for the final product

1. 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 this Directive.

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

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

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

5. The body of which notification has been given shall provide the manufacturer with a test report. If the report concludes that production is not homogeneous or that the PPE examined do not conform to the type described in the EC type-approval certificate or the relevant basic requirements, the body shall take measures appropriate to the nature of the fault or faults recorded and inform the Member State which gave notification thereof accordingly.

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

B. System for ensuring EC quality of production by means of monitoring

(1. The system

(a)

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

That application shall include:

• all the information relating to the category of PPE concerned, including, where appropriate, documentation relating to the model approved,

• documentation on the quality-control system,

• the undertaking to maintain the obligations arising from the quality-control system and to maintain its adequacy and efficiency.

(b)

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

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

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

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

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

(c)

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

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

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

(d)

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

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

(2. Supervision

(a)

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

(b)

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

• documentation on the quality-control system,

• technical documentation,

• quality control manuals.

(c)

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

(d)

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

(e)

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

EC DECLARATION OF PRODUCTION CONFORMITY U.K.

Article 12 U.K.

[F1 The EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative established within the Community:]

1.

draws up a declaration using the form laid down in Annex VI certifying that the PPE placed on the market are in conformity with the provisions of this Directive with a view to its submission to the competent authorities;

2.

affixes the CE marking]of conformity provided for by Article 13 to each PPE.

Textual Amendments

F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

CHAPTER III U.K. CE MARKING

[F1 Article 13 U.K.

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

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

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

4. Without prejudice to Article 7:

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

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

Textual Amendments

F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

CHAPTER IV U.K. FINAL PROVISIONS

Article 14 U.K.

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

Article 15 U.K.

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

[F6 Article 16 U.K.

1. Before 31 December 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof.

They shall apply the measures in question with effect from 1 July 1992.

2. Furthermore, Member States shall allow, for the period until 30 June 1995, the placing on the market and putting into service on PPE in conformity with the national regulations in force in their territory on 30 June 1992.

3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.]

Textual Amendments

F6 Substituted by Council Directive 93/95/EEC of 29 October 1993 amending Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE).

Article 17 U.K.

This Directive is addressed to the Member States.