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Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

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  • Art. 3(2) words substituted by S.I. 2019/696 Sch. 35 para. 3(4)(a) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(a) substituted immediately before IP completion day by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4))
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  • Art. 3(5) substituted by S.I. 2019/696 Sch. 35 para. 3(4)(b) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1460, reg. 1(4), Sch. 3 para. 3)
  • Art. 3(5) words substituted in earlier amending provision S.I. 2019/696, Sch. 35 para. 3(4)(b) by S.I. 2020/852 reg. 4(2) Sch. 1 para. 1(u)(ii) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 1(u)(ii) omitted immediately before it comes into force by virtue of S.I. 2020/1460, regs. 1(3), Sch. 4 para. 1(3))
  • Art. 24(2A) inserted by S.I. 2024/504 reg. 17(b)

CHAPTER IU.K.GENERAL PROVISIONS

Article 1U.K.Subject matter

This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules [F1concerning] PPE in the [F2United Kingdom].

Textual Amendments

Article 2U.K.Scope

1.This Regulation applies to PPE.

2.This Regulation does not apply to PPE:

(a)specifically designed for use by the armed forces or in the maintenance of law and order;

(b)designed to be used for self-defence, with the exception of PPE intended for sporting activities;

(c)designed for private use to protect against:

(i)

atmospheric conditions that are not of an extreme nature,

(ii)

damp and water during dishwashing;

(d)for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in [F3the United Kingdom];

(e)for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

Textual Amendments

Article 3U.K.Definitions

For the purposes of this Regulation, the following definitions apply:

(1)

‘personal protective equipment’ (PPE) means:

(a)

equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;

(b)

interchangeable components for equipment referred to in point (a) which are essential for its protective function;

(c)

connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

(2)

‘making available on the market’ means any supply of PPE for distribution or use on the [F4market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge;

(3)

‘placing on the market’ means the first making available of PPE on the [F5market of Great Britain];

(4)

‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;

(5)

‘authorised representative’ means any natural or legal person established within the [F6United Kingdom] who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(6)

[F7importer” means a person who—

(a)

is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or

(b)

is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;]

(7)

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market;

(8)

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(9)

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;

(10)

F8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11)

F8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12)

F8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(13)

‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;

(14)

‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(15)

‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;

(16)

‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;

(17)

F9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(18)

F9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(19)

[F10‘approved body’ has the meaning given in Article 20;

(20)

‘designated standard’ has the meaning given in Article 7A;

(21)

‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390);

(22)

‘UK Marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;

(23)

‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;

(24)

‘Regulation 2016/425 (pre-exit)’ means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before IP completion day;

(25)

In this Regulation, references to “the market surveillance authority” are to be construed in accordance with regulation 3 of the Personal Protective Equipment (Enforcement) Regulations 2018.]

Textual Amendments

Article 4U.K.Making available on the market

PPE shall only be made available on the market if, where properly maintained and used for its intended purpose, it complies with this Regulation and does not endanger the health or safety of persons, domestic animals or property.

Article 5U.K.Essential health and safety requirements

PPE shall meet the essential health and safety requirements set out in Annex II which apply to it.

F11Article 6U.K.Provisions concerning the use of PPE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 7U.K.[F12Making available, putting into service and exhibition at trade fairs, etc]

1.[F13Nothing in this Regulation impedes], for the aspects covered by this Regulation, the making available on the market of PPE which complies with this Regulation.

2.At trade fairs, exhibitions and demonstrations or similar events, [F14nothing in this Regulation prevents] the showing of PPE which does not comply with this Regulation, provided that a visible sign clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.

During demonstrations, adequate measures shall be taken to ensure the protection of persons.

Textual Amendments

[F15Article 7AU.K.Designated standard

1.Subject to paragraphs 6 and 7, in this Regulation, a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body [F16or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

(b)designated by the Secretary of State, by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

2.For the purposes of paragraph 1, “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a)the characteristics required of a product, including—

(i)levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and

(ii)the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;

(b)production methods and processes relating to the product, where these have an effect on the characteristics of the product.

3.For the purposes of this Article, a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (Cenelec);

(c)the European Telecommunications Standards Institute (ETSI);

(d)the British Standards Institution (BSI).

[F173A.In this Article “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]

4.When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

5.Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F18such] technical specifications adopted by the other recognised standardisation bodies [F19or by international standardising bodies as the Secretary of State considers to be relevant].

6.The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b).

7.Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

8.In this Article, a reference to a “product” is a reference to PPE to which this Regulation applies.

9.The Secretary of State may, by regulations, amend paragraph 3 to reflect any changes in the name or structure of the recognised standardisation bodies.

10.Regulations made under paragraph 9 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

CHAPTER IIU.K.OBLIGATIONS OF ECONOMIC OPERATORS

Article 8U.K.Obligations of manufacturers

1.When placing PPE on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II.

2.Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out.

Where compliance of PPE with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, manufacturers shall draw up the F20... declaration of conformity referred to in Article 15 and affix the [F21UK] marking referred to in Article 16.

3.Manufacturers shall keep the technical documentation and the F22... declaration of conformity for 10 years after the PPE has been placed on the market.

4.Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in the design or characteristics of the PPE and changes in the [F23designated] standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by PPE, manufacturers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

5.Manufacturers shall ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or in a document accompanying the PPE.

6.Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and [F24the market surveillance authority].

7.Manufacturers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II [F25and that they are clear, legible and in easily understandable English].

8.The manufacturer shall either provide the F26... declaration of conformity with the PPE or include in the instructions and information set out in point 1.4 of Annex II the internet address at which the F26... declaration of conformity can be accessed.

9.Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the [F27enforcement authority] to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

10.Manufacturers shall, further to a reasoned request from [F28the enforcement authority], provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.

Textual Amendments

Modifications etc. (not altering text)

Article 9U.K.Authorised representatives

1.A manufacturer may, by a written mandate, appoint [F29a person established in the United Kingdom as their]F30... authorised representative.

The obligations laid down in Article 8(1) and the obligation to draw up the technical documentation referred to in Article 8(2) shall not form part of the authorised representative's mandate.

2.An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)keep the F31... declaration of conformity and the technical documentation at the disposal of the F31... market surveillance [F32authority] for 10 years after the PPE has been placed on the market;

(b)further to a reasoned request from [F33the enforcement authority], provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPE;

(c)cooperate with the [F34enforcement authority], at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative's mandate.

Textual Amendments

Article 10U.K.Obligations of importers

1.Importers shall place only compliant PPE on the market.

2.Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 19 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the [F35UK] marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 8(5) and (6).

Where an importer considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not place it on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the importer shall inform the manufacturer and the market surveillance [F36authority] to that effect.

3.Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted F37.... The contact details shall be in a language easily understood by end-users and market surveillance [F38authority].

[F39The obligation set out in this paragraph 3 to indicate information on the PPE does not apply where—

(a)either—

(i)it is not possible to indicate that information on the PPE, or

(ii)the importer has imported the PPE from an EEA state or Switzerland and places it on the market within the period of [F40seven years] beginning with IP completion day, and

(b)before placing the PPE on the market, the importer sets out the information referred to in this paragraph 3 on the packaging of the PPE or in a document accompanying the PPE.]

4.Importers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II [F41and that they are clear, legible and in easily understandable English].

5.Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.

6.When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

7.Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the [F42enforcement authority] to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

8.Importers shall, for 10 years after the PPE has been placed on the market, keep a copy of the F43... declaration of conformity at the disposal of the market surveillance [F44authority] and ensure that the technical documentation can be made available to [F45that authority], upon request.

9.Importers shall, further to a reasoned request from [F46the enforcement authority], provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.

Textual Amendments

Modifications etc. (not altering text)

Article 11U.K.Obligations of distributors

1.When making PPE available on the market, distributors shall act with due care in relation to the requirements of this Regulation.

2.Before making PPE available on the market, distributors shall verify that it bears the [F47UK] marking, is accompanied by the required documents and by the instructions and information set out in point 1.4 of Annex II [F48and that they are clear, legible and in easily understandable English] and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3) respectively.

Where a distributor considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not make the PPE available on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance [F49authority].

3.Distributors shall ensure that, while PPE is under their responsibility, its storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.

4.Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring it into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where the PPE presents a risk, distributors shall immediately inform the [F50enforcement authority] to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

5.Distributors shall, further to a reasoned request from [F51the enforcement authority], provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have made available on the market.

Textual Amendments

Modifications etc. (not altering text)

Article 12U.K.Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer set out in Article 8 where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that compliance with this Regulation may be affected.

Article 13U.K.Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance [F52authority]:

(a)

any economic operator who has supplied them with PPE;

(b)

any economic operator to whom they have supplied PPE.

Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the PPE and for 10 years after they have supplied the PPE.

Textual Amendments

CHAPTER IIIU.K.CONFORMITY OF THE PPE

[F53Article 14U.K.Presumption of conformity of PPE

1.PPE which is in conformity with a designated standard or part thereof shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by that standard or part thereof.

2.The presumption in paragraph 1 is rebuttable.]

Textual Amendments

Article 15U.K.F54... Declaration of conformity

1.The F55... declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex II has been demonstrated.

2.The F56... declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes IV, VI, VII and VIII and shall be continuously updated. It shall be [F57in English].

[F583.Where PPE is subject to more than one enactment requiring a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.]

4.By drawing up the F59... declaration of conformity, the manufacturer shall assume responsibility for the compliance of the PPE with the requirements laid down in this Regulation.

Textual Amendments

Article 16U.K.General principles of the [F60UK] marking

The [F61UK] marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Textual Amendments

Article 17U.K.Rules and conditions for affixing the [F62UK] marking

[F63A1. Paragraph 1 is subject to paragraph 1A.]

1.The [F64UK] marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packaging and to the documents accompanying the PPE.

[F651A.For a period of [F66seven years] months beginning with IP completion day, paragraph 1 does not apply where the UK marking is affixed to—

(a)a label affixed to the PPE; or

(b)a document accompanying the PPE.]

2.The [F64UK] marking shall be affixed before the PPE is placed on the market.

3.For category III PPE, the [F64UK] marking shall be followed by the identification number of the [F67approved] body involved in the procedure set out in Annex VII or VIII.

The identification number of the [F67approved] body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

4.The [F64UK] marking and, where applicable, the identification number of the [F68approved] body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.

F695.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

CHAPTER IVU.K.CONFORMITY ASSESSMENT

Article 18U.K.Risk categories of PPE

The PPE shall be classified according to the risk categories set out in Annex I.

Article 19U.K.Conformity assessment procedures

The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:

(a)

Category I: internal production control (module A) set out in Annex IV;

(b)

Category II: F70... type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;

(c)

Category III: F71... type-examination (module B) set out in Annex V, and either of the following:

(i)

conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;

(ii)

conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.

By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.

Textual Amendments

CHAPTER VU.K. [F72APPROVAL] OF CONFORMITY ASSESSMENT BODIES

[F73Article 20U.K.Approved bodies

1.An approved body is a conformity assessment body which—

(a)

has been approved by the Secretary of State pursuant to the procedure set out in Article 21 (approval of conformity assessment bodies); or

(b)

immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under Article 30 of Regulation 2016/425 (pre-exit), to suspend or withdraw the body's status as a notified body.

2.Paragraph 1 has effect subject to Article 30 (restriction, suspension or withdrawal of approval).

3.In this Chapter—

  • “notified body” means a body which—

    (a)

    the Secretary of State had, before IP completion day, notified to the European Commission and the member States of the European Union in accordance with Article 20 of Regulation 2016/425 (pre-exit); and

    (b)

    in respect of which no objections had been raised, as referred to in Article 28(5) of Regulation 2016/425 (pre-exit);

  • “approved body requirements” means the requirements set out in Article 24.]

Textual Amendments

[F74Article 21U.K.Approval of conformity assessment bodies

1.The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

2.A conformity assessment body qualifies for approval if the first and second conditions below are met.

3.The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent;

(iii)the category of PPE in respect of which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate; or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

4.The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

5.For the purposes of paragraph 4, the Secretary of State may accept an accreditation certificate provided in accordance with paragraph 3(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

6.When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

7.For the purposes of this Article, “accreditation certificate” means a certificate issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.]

Textual Amendments

[F75Article 22U.K.UK national accreditation body

The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements;

(b)monitoring approved bodies in accordance with Article 23; and

(c)compiling and maintaining the register of approved bodies, in accordance with Article 29.]

Textual Amendments

[F76Article 23U.K.Monitoring obligations

The Secretary of State must monitor each approved body with a view to verifying that the body—

The Commission shall make that information publicly available.

(a)continues to meet—

(i)the approved body requirements; and

(ii)any conditions set by the Secretary of State under Article 21(6)(b); and

(b)carries out its functions in accordance with this Regulation.]

Textual Amendments

Article 24U.K.[F77Approved body requirements]

1.For the purposes of [F78approval], a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2.A conformity assessment body shall be established [F79in the United Kingdom] and have legal personality.

3.A conformity assessment body shall be a third-party body independent of the organisation or the PPE it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of PPE which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, purchaser, owner, user or maintainer of the PPE which they assess, nor the representative of any of those parties. This does not preclude the use of assessed PPE that are necessary for the operations of the conformity assessment body or the use of such PPE for personal purposes.

A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, use or maintenance of PPE, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are [F80approved]. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes V, VII and VIII and in relation to which it has been [F81approved], whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind of PPE for which it has been [F81approved], a conformity assessment body shall have at its disposal the necessary:

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as [F82an approved body] and other activities;

(c)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the PPE technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7.The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been [F83approved];

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the applicable [F84designated] standards, and of the relevant provisions of [F85this Regulation and any other relevant United Kingdom legislation];

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8.The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9.Conformity assessment bodies shall take out liability insurance unless [F86the Secretary of State] is directly responsible for the conformity assessment.

10.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes V, VII and VIII or any provision of [F87United Kingdom] law giving effect to it, except in relation to the [F88enforcement authority]. Proprietary rights shall be protected.

11.Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of [F89any approved] body coordination group established [F90by the Secretary of State] and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Textual Amendments

[F91Article 25U.K.Presumption of conformity of approved bodies

1.Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such a standard), the Secretary of State must presume that the conformity assessment body meets the approved body requirements covered by that standard (or the part of that standard).

2.The presumption in paragraph 1 is rebuttable.]

Textual Amendments

[F92Article 26U.K.Subsidiaries of, and subcontracting by approved bodies

1.An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a)the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b)the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c)the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

2.The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

3.Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activity carried out by the subcontractor or subsidiary.

4.In this Article, “subsidiary” has the meaning given to it by section 1159 of the Companies Act 2006.]

Textual Amendments

F93Article 27U.K.Application for notification

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Textual Amendments

F94Article 28U.K.Notification procedure

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Textual Amendments

[F95Article 29U.K.Identification numbers and register of approved bodies

1.The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification numbers;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

2.The register referred to in paragraph 1 must be made publicly available.]

Textual Amendments

[F96Article 30U.K.Restriction, suspension or withdrawal of approval

1.Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in Article 21(6)(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under Article 21.

2.Where the Secretary of State determines that an approved body no longer meets a condition referred to in Article 21(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under Article 21.

3.In deciding what action to take under paragraph 1 or 2, the Secretary of State must have regard to the seriousness of the non-compliance.

4.Before taking action under paragraph 1 or 2, the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

5.Where the Secretary of State has taken action in respect of an approved body under paragraph 1 or 2, or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a)transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b)keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and market surveillance authority for a period of 10 years from the date they were created.

6.The activities undertaken as an approved body referred to in paragraph 5 include any activities that the body has undertaken as a notified body.]

Textual Amendments

F97Article 31U.K.Challenge of the competence of notified bodies

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Textual Amendments

Article 32U.K.Operational obligations of [F98approved] bodies

1.[F99Approved] bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes V, VII and VIII.

[F1001A.Subject to the terms of its appointment an approved body must carry out the conformity assessment activities and procedures, in respect of which—

(a)the body's approval was given under Article 21; or

(b)the body's notification as a notified body was made.]

2.Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the PPE technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the PPE with the requirements of this Regulation.

3.Where [F101an approved] body finds that the essential health and safety requirements set out in Annex II or the corresponding [F102designated] standards or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.

4.Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, [F103an approved] body finds that a PPE no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary.

5.Where corrective measures are not taken or do not have the required effect, the [F104approved] body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

Textual Amendments

Article 33U.K.Appeal against decisions of [F105approved] bodies

[F106Approved] bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.

Textual Amendments

Article 34U.K.Information obligation on [F107approved] bodies

1.[F108Approved] bodies shall inform the [F109Secretary of State] of the following:

(a)any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

(b)any circumstances affecting the scope of or conditions for [F110their approval];

(c)any request for information which they have received from [F111the market surveillance authority] regarding conformity assessment activities;

(d)on request, conformity assessment activities performed within the scope of their [F112approval] and any other activity performed, including cross-border activities and subcontracting.

2.[F113Approved] bodies shall provide [F114other approved bodies] under this Regulation carrying out similar conformity assessment activities covering the same kinds of PPE with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Textual Amendments

F115Article 35U.K.Exchange of experience

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Textual Amendments

F116Article 36U.K.Coordination of notified bodies

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Textual Amendments

Textual Amendments

CHAPTER VIU.K.[F117MARKET SURVEILLANCE AND CONTROL OF PPE ENTERING THE UNITED KINGDOM MARKET]

Article 37U.K.[F118Market surveillance and control of PPE entering the United Kingdom market]

[F119Articles 15(3), 16 to 22 and 26 to 29] of Regulation (EC) No 765/2008 shall apply to PPE covered by Article 2(1) of this Regulation.

Textual Amendments

Article 38U.K.Procedure F120... for dealing with PPE presenting a risk

1.Where the market surveillance [F121authority has] sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons, [F122the authority] shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance [F123authority] for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance [F124authority finds] that the PPE does not comply with the requirements laid down in this Regulation, [F125the authority] shall without delay require the relevant economic operator to take all appropriate corrective action to bring the PPE into compliance with those requirements, to withdraw the PPE from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as [F125the authority] may prescribe.

The market surveillance [F126authority] shall inform the relevant [F127approved] body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

F1282.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.The economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE concerned that it has made available on the market F129....

4.Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance [F130authority] shall take all appropriate F131... measures to prohibit or restrict the PPE being made available on [F132the market], to withdraw the PPE from that market or to recall it.

F133...

F1345.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1346.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1347.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1348.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F135Article 39U.K.Union safeguard procedure

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Textual Amendments

Article 40U.K.Compliant PPE which presents a risk

1.Where, having carried out an evaluation under Article 38(1), [F136the enforcement authority] finds that although PPE is in compliance with this Regulation, it presents a risk to the health or safety of persons, it shall require the relevant economic operator to take all appropriate measures to ensure that the PPE concerned, when placed on the market, no longer presents that risk, to withdraw the PPE from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

2.The economic operator shall ensure that corrective action is taken in respect of all the PPE concerned that he has made available on the market F137....

F1383.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1384.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1385.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 41U.K.Formal non-compliance

1.Without prejudice to Article 38, where [F139the enforcement authority] makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a)the [F140UK] marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 17 of this Regulation;

(b)the [F141UK] marking has not been affixed;

(c)the identification number of the [F142approved] body involved in the production control phase has been affixed in violation of Article 17 or has not been affixed;

(d)the F143... declaration of conformity has not been drawn up or has not been drawn up correctly;

(e)the technical documentation is either not available or not complete;

(f)the information referred to in Article 8(6) or Article 10(3) is absent, false or incomplete;

(g)any other administrative requirement provided for in Article 8 or Article 10 is not fulfilled.

2.Where the non-compliance referred to in paragraph 1 persists, the [F144enforcement authority] shall take all appropriate measures to restrict or prohibit the PPE being made available on the market or ensure that it is recalled or withdrawn from the market.

Textual Amendments

Textual Amendments

CHAPTER VIIU.K.DELEGATED AND IMPLEMENTING ACTS

[F145Article 42U.K.Regulation making powers

1.In order to take into account technical progress and knowledge or new scientific evidence with respect to the category of a specific risk, the Secretary of State may, by regulations, amend Annex I by reclassifying the risk from one category to another.

2.Regulations made under paragraph 1 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.

3.Any power to make regulations under this Article includes power to make—

(a)different provision for different purposes;

(b)consequential, supplementary, transitional or transitory provision or savings.]

Textual Amendments

F146Article 43U.K.Exercise of the delegation

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Textual Amendments

F146Article 44U.K.Committee procedure

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Textual Amendments

CHAPTER VIIIU.K.TRANSITIONAL AND FINAL PROVISIONS

F146Article 45U.K.Penalties

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Textual Amendments

F146Article 46U.K.Repeal

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Textual Amendments

[F147Article 47U.K.Transitional provision in relation to EU exit

1.In this Article, “pre-exit period” means the period beginning with 21 April 2018 and ending immediately before IP completion day.

2.Subject to paragraph 3, where PPE was made available on the market during the pre-exit period, despite the amendments made by Schedule 35 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under Regulation 2016/425 (pre-exit), continues to have effect as it did immediately before IP completion day, in relation to that PPE.

3.Paragraph 2 does not apply to—

(a)any obligation of the enforcement authority to inform the European Commission or the member States of any matter, or

(b)any obligation to take action outside of the United Kingdom in relation to that PPE.

4.Where during the pre-exit period—

(a)PPE has not been placed on the market; and

(b)a manufacturer has taken any action under Article 8(2) of Regulation 2016/425 (pre-exit) with respect to carrying out the applicable conformity assessment procedure referred to in Article 19 of that Regulation,

that action has effect as if it had been done under Article 8(2) of this Regulation (with respect to carrying out the applicable conformity assessment procedure referred to in Article 19 of this Regulation).

[F1485.Subject to paragraph 6, where before 11pm on 31st December 2024—

(a)PPE has not been placed on the market; and

(b)a manufacturer has taken any action under the conformity assessment procedure that applies to the PPE in accordance with Article 19 of Regulation 2016/425 (pre-exit)

that action has effect as if it had been done under the applicable conformity assessment procedure referred to in Article 19 of this Regulation.

6.Paragraph 5 does not apply—

(a)after the expiry of the validity of any certificate issued pursuant to the applicable conformity assessment procedure; and

(b)in any event, after 31st December 2027.]]

Textual Amendments

F149Article 48U.K.Entry into force and application

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Textual Amendments

F150...

F151...

F152...

Textual Amendments

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