S.I. No. 136/2018 - European Union (Personal Protective Equipment) Regulations 2018

• (a) the day next following the day on which the contravention notice is confirmed or varied on final appeal,

• (b) the day next following the day on which the appeal is discontinued, or

• (c) the day specified in the contravention notice.

• (6) Subject to paragraph (7), in the case of PPE which the Authorised Officer does not consider to present a serious risk requiring rapid intervention under Article 20 of Regulation (EC) No. 765/2008, the intended recipient of a contravention notice that includes a direction referred to in Regulation 34(2)(d)(ii), (iii), (iv) or (v) shall have the opportunity to make representations to a market surveillance authority within 10 working days of first being advised of the Authorised Officer’s intention to serve a contravention notice on that person.

• (7) Where an opportunity to make representations referred to in paragraph (6) is not possible because of the urgency of the measure directed in the contravention notice as referred to in the said paragraph (6), as justified by health or safety requirements or other grounds relating to public interests, the market surveillance authority shall give the recipient of the notice the opportunity to be heard as soon as possible after the service of the notice on that person and the service of the notice shall be reviewed promptly thereafter.

Prohibition notice — PPE presenting a serious risk

• (2) For the avoidance of doubt, where PPE does not have any marking (on its packaging or otherwise) or document required under the PPE Regulation or these Regulations, an Authorised Officer may form an opinion referred to in paragraph (1).

• (3) A prohibition notice shall—

• (a) state that the Authorised Officer is of the opinion referred to in paragraph (1),

• (b) specify the grounds for the opinion,

• (c) where in the opinion of the Authorised Officer there is or is likely to be a contravention of any provision of the PPE Regulation or these Regulations, specify every such provision (including the particular paragraph and subparagraph of such provision as appropriate),

• (d) prohibit any activity of the economic operator that results in the PPE referred in paragraph (1) being placed on the market or made available on the market,

• (e) inform the person on whom the prohibition notice is served that he or she may appeal the notice to the District Court in accordance with Regulation 37,

• (f) state that if the person on whom the prohibition notice is served fails to comply with the notice, that person commits an offence, and

• (g) be signed and dated by the Authorised Officer.

• (4) A prohibition notice may include—

• (a) directions as to the measures to be taken by the economic operator to stop the activity referred to in paragraph 3(d), to remedy any contravention of the PPE Regulation or these Regulations or any matter to which the prohibition notice relates, or to otherwise comply with the notice, including directions to do one or more of the following regarding the PPE referred to in paragraph (1):

• (i) refrain from placing on the market the PPE;

• (ii) refrain from making available on the market the PPE;

• (iii) withdraw the PPE from the market;

• (iv) recall the PPE;

• (v) dispose of the PPE;

• (vi) destroy the PPE;

• (b) directions to bring the prohibition notice to the attention of any person who may be affected by it, or to the attention of the public generally,

and

• (c) any other requirement that the Authorised Officer considers appropriate.

• (5) Subject to Regulation 37(9), a prohibition notice shall take effect immediately at the time the notice is received by the person on whom it is served.

• (6) A person on whom a prohibition notice has been served under paragraph (1) shall comply with the notice.

• (7) A person on whom a prohibition notice has been served who is of the opinion that the notice has been complied with, shall confirm such compliance in writing to the Authorised Officer.

• (8) Where a person on whom a prohibition notice has been served confirms in accordance with paragraph (7), the Authorised Officer, on being satisfied that the person has complied with the notice, shall within one month of receipt of such confirmation give notice to the person of compliance with the prohibition notice.

• (9) An Authorised Officer may at any time withdraw a prohibition notice if—

• (a) the Authorised Officer is satisfied that the PPE to which the prohibition notice relates no longer gives rise to a serious risk to health or safety of persons, or

• (b) the Authorised Officer is satisfied that the prohibition notice was issued in error or is incorrect in some material respect.

Appeal against prohibition notice

• (2) A person who appeals under paragraph (1) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence at the hearing of the appeal.

• (3) Where a decision is made under paragraph (1), any person aggrieved by that decision may, within 7 days beginning on the day on which the decision was made, appeal it to the Circuit Court in the circuit in which the prohibition notice was served and in determining the appeal, the court may, if it considers it appropriate to do so, confirm the decision of the District Court, vary it or allow the appeal.

• (4) A decision under paragraph (3) shall be final, save that, by leave of the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (5) Subject to paragraph (6), the bringing of an appeal against a prohibition notice shall not have the effect of suspending the operation of the notice.

• (6) Where a person brings an appeal under this Regulation, the appellant may apply to the court determining the appeal (being the District Court, Circuit Court or High Court) to have the operation of the prohibition notice suspended until the determination or discontinuation of the appeal before that court and, on such application, the court may, if it thinks proper to do so, grant the application.

• (7) Where, on the hearing of an appeal under this Regulation, a prohibition notice is not cancelled, notwithstanding paragraph (6), the judge by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the judge considers appropriate.

• (8) A person who applies for the suspension of the operation of a prohibition notice shall at the same time notify the market surveillance authority of the application and the grounds for the application.

• (9) Where an appeal is brought under this Regulation and the court (being the District Court, Circuit Court or High Court) has granted a suspension on the operation of the prohibition notice, the prohibition notice shall take effect on the later of—

• (a) the day next following the day on which the notice is confirmed or varied on final appeal,

• (b) the day next following the day on which the appeal is discontinued, or

• (c) the day next following the expiration of the period of final suspension.

Order of High Court to direct compliance of prohibition notice

• (2) The High Court may, upon an application under this Regulation, if satisfied that the person on whom the prohibition notice is served has failed to comply with the notice, grant an order referred to in paragraph (1).

Seizure notice — seizure and disposal of PPE presenting a serious risk

• (2) The Authorised Officer may require the economic operator relating to the PPE referred to in paragraph (1), where known, to reimburse the cost or any portion of the cost of any measure taken under that paragraph.

• (3) An Authorised Officer who has seized, or intends to seize, PPE under paragraph (1) shall serve a seizure notice on the economic operator relating to the PPE, which seizure notice shall—

• (a) state that the PPE has been or is intended to be seized and that it is intended to destroy or dispose of the PPE,

• (b) specify the grounds for the seizure and intended destruction or disposal of the PPE,

• (c) where in the opinion of the Authorised Officer there is or is likely to be a contravention of any provision of the PPE Regulation or these Regulations, specify every such provision (including the particular paragraph and subparagraph of such provision as appropriate),

• (d) inform the person on whom the seizure notice is served that he or she may appeal the notice to the District Court in accordance with this Regulation,

and

• (e) be signed and dated by the Authorised Officer.

• (4) A person on whom a seizure notice is served may, within 21 days beginning on the day on which the seizure notice is served on him or her, appeal against the notice to the appropriate court (as defined in paragraph (17)) and in determining the appeal, the court may, if it considers it appropriate to do so, confirm, vary or cancel the notice or make any other order as it considers appropriate.

• (5) An appeal under paragraph (4) shall state the grounds on which the appeal is made and shall be made by written notice, which notice shall be lodged with the office of the appropriate court.

• (6) A person who appeals under paragraph (4) shall at the same time furnish a copy of the notice referred to in paragraph (5) to the appropriate market surveillance authority and the authority shall be entitled to appear, be heard and adduce evidence at the hearing of the appeal.

• (7) If, during the hearing of an appeal under paragraph (4) to the District Court, that court forms the opinion that the value of the PPE the subject of the appeal exceeds that court’s jurisdiction in tort, it may, if it so thinks fit, transfer the appeal to the Circuit Court or the High Court, whichever it considers appropriate having regard to its opinion of the value of the PPE.

• (8) If, during the hearing of an appeal under paragraph (4) to the Circuit Court, that court forms the opinion that the value of the PPE, the subject of the appeal, exceeds that court’s jurisdiction in tort, it may, if it so thinks fit, transfer the appeal to the High Court.

• (9) Paragraphs (7) and (8) are without prejudice to the jurisdiction of a court (being either the District Court or the Circuit Court) to determine an appeal under paragraph (4) in relation to which it was, at the time of the hearing of the appeal, the appropriate court.

• (10) Where a decision is made under paragraph (4), any person aggrieved may, within 21 days beginning on the day on which the decision was made, appeal the decision to the following court:

• (a) where the decision under paragraph (4) was made by the District Court, the Circuit Court;

• (b) where the decision under paragraph (4) was made by the Circuit Court, the High Court;

• (c) where the decision under paragraph (4) was made by the High Court, the Court of Appeal.

• (11) On hearing an appeal under paragraph (10), the court may, if it considers it appropriate to do so, confirm the decision of the appropriate court, vary it or allow the appeal.

• (12) A decision under paragraph (11) of the Circuit Court shall be final, save that, by leave of the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (13) A decision under paragraph (11) of the High Court shall be final, save that, by leave of the Court of Appeal, an appeal from the decision shall lie to the Court of Appeal on a specified question of law.

• (14) An appeal under paragraph (4) to the District Court shall be determined by a judge of the District Court for the District Court district in which the PPE the subject of the appeal was placed on the market or the appellant ordinarily resides.

• (15) An appeal under this Regulation (whether under paragraph (4) or (10)) to the Circuit Court shall be determined by a judge of the Circuit Court for the circuit in which the PPE the subject of the appeal was placed on the market or the appellant ordinarily resides.

• (16) Where an appeal is made under paragraph (4), the PPE the subject of the appeal shall not be destroyed or disposed of until at least the day following the determination or discontinuation of the final appeal.

• (17) In this Regulation “appropriate court” means—

• (a) in any case where the estimated value of the PPE the subject of the appeal does not exceed €15,000, or such other amount as may stand specified for the time being by law as that Court’s jurisdiction in tort, the District Court,

• (b) in any case where the estimated value of the PPE referred to in subparagraph (a) exceeds the jurisdiction of the District Court in tort but does not exceed €75,000, or such other amount as may stand specified for the time being by law as that Court’s jurisdiction in tort, the Circuit Court,

and

• (c) in any case not coming within subparagraph (a) and (b), the High Court.

• (18) In this Regulation “dispose” includes any manner of disposal which in the opinion of the Authorised Officer will least endanger the public and includes surrender of the PPE to a member of the Garda Síochána or to any other competent agency or organisation for its destruction, or the certified return of the PPE to the economic operator relating to the PPE, in order to remove it from the market, at the expense of the economic operator, manager, or person having lawful possession of the PPE at the time of seizure, where known.

Forfeiture order

• (2) An application under paragraph (1) shall be made to the appropriate court.

• (3) Upon hearing an application under paragraph (1), the appropriate court may, if it considers it appropriate to do so, grant a forfeiture order.

• (4) The appropriate court may order that the person against whom a forfeiture order is sought pay the costs of seizure and destruction or disposal of the PPE the subject of the order.

• (5) A forfeiture order granted under paragraph (3) may contain such provision as appears to the court to be appropriate for delaying the coming into force of the order pending the making and determination of any appeal.

• (6) If, during the hearing of an application under paragraph (1) to the District Court, that court forms the opinion that the value of the PPE the subject of the appeal exceeds that court’s jurisdiction in tort, it may, if it so thinks fit, transfer the appeal to the Circuit Court or the High Court, whichever it considers appropriate having regard to its opinion of the value of the PPE.

• (7) If, during the hearing of an application under paragraph (1) to the Circuit Court, that court forms the opinion that the value of the PPE, the subject of the appeal, exceeds that court’s jurisdiction in tort, it may, if it so thinks fit, transfer the appeal to the High Court.

• (8) Paragraphs (6) and (7) are without prejudice to the jurisdiction of a court (being either the District Court or the Circuit Court) to determine an application under paragraph (1) in relation to which it was, at the time of the hearing of the application, the appropriate court.

• (9) Where a decision is made under paragraph (3), any person aggrieved may, within 21 days beginning on the day the decision was made, appeal the decision to the following court:

• (a) where the decision under paragraph (3) was made by the District Court, the Circuit Court;

• (b) where the decision under paragraph (3) was made by the Circuit Court, the High Court;

• (c) where the decision under paragraph (3) was made by the High Court, the Court of Appeal.

• (10) On hearing an appeal under paragraph (9), the court may, if it considers it appropriate to do so, confirm the decision of the appropriate court, vary it or allow the appeal.

• (11) A decision under paragraph (10) of the Circuit Court shall be final, save that, by leave of the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (12) A decision under paragraph (10) of the High Court shall be final, save that, by leave of the Court of Appeal, an appeal from the decision shall lie to the Court of Appeal on a specified question of law.

• (13) An application under paragraph (1) to the District Court shall be determined by a judge of the District Court for the District Court district in which the PPE the subject of the order sought was placed on the market or the person against whom the order is sought ordinarily resides.

• (14) An application under paragraph (1) to the Circuit Court and any appeal under paragraph (9) to the Circuit Court shall be determined in the circuit in which the PPE the subject of the application under paragraph (1) was placed on the market or the person against whom the order was sought in an application under paragraph (1) ordinarily resides.

• (15) Where a forfeiture order is granted and there is no stay on the coming into force of the order, the PPE the subject of the forfeiture order may be seized on behalf of the market surveillance authority by an Authorised Officer and destroyed, disposed of or released as the Authorised Officer considers appropriate.

• (16) In this Regulation—

(a)“appropriate court” has the meaning assigned to it under Regulation 39(17); and

(b)“dispose” has the meaning assigned to it under Regulation 39(18).

Information notice

• (2) An information notice shall—

• (a) inform the person on whom the information notice is served that he or she may appeal the notice to the District Court in accordance with this Regulation,

• (b) state that if the person on whom the information notice is served fails to comply with the notice, that person commits an offence, and

• (c) be signed and dated by the Authorised Officer.

• (3) The period specified in the information notice referred to in paragraph (1) may be extended at the discretion of the market surveillance authority or Authorised Officer on the written application of the person on whom the notice is served or at the volition of the authority or Authorised Officer issuing the notice.

• (4) A person on whom an information notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the District Court district in which the notice was served and in determining the appeal the judge may, if he or she considers it appropriate to do so, confirm, vary or cancel the notice.

• (5) A person who appeals under paragraph (4) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence at the hearing of the appeal.

• (6) Where a decision is made under paragraph (4), any person aggrieved by that decision may, within 7 days beginning on the day on which the decision was made, appeal it to the Circuit Court in the circuit in which the information notice was served and in determining the appeal, the court may, if it considers it appropriate to do so, confirm the decision of the District Court, vary it or allow the appeal.

• (7) A decision under paragraph (6) shall be final, save that, by leave of the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (8) Where, upon the hearing of an appeal under this Regulation (whether under paragraph (4), (6) or (7)), an information notice is not cancelled by the court, the judge by whom the appeal is heard may, on the application of the appellant, suspend the operation of the information notice for such period as in the circumstances of the case the judge considers appropriate.

• (9) Subject to paragraph (10), a person on whom an information notice is served shall comply with the notice before the later of—

• (a) the expiration of the period to comply specified in the information notice, or

• (b) where the period referred to in subparagraph (a) is extended under paragraph (3), the expiration of that extended period.

• (10) Where an appeal is brought under this Regulation, the person on whom the information notice is served shall comply with the notice before—

• (a) the day next following the day on which the information notice is confirmed or varied on final appeal,

• (b) the day next following the day on which the appeal is discontinued,

• (c) the expiration of the period to comply specified in the information notice,

or

• (d) where the operation of the information notice has been suspended, the expiration of the period of final suspension,

whichever occurs latest.

Publication of information

• (2) The market surveillance authority may, in the interest of the protection of health or safety, take such measures as it considers appropriate to bring to the attention of the public any other matter of concern arising from the requirements of the PPE Regulation or these Regulations.

Sharing information on application of PPE Regulation

• (2) A market surveillance authority may provide information to any European Union information network, the European Commission or a market surveillance authority of another Member State for the purpose of sharing information related to the application of the PPE Regulation and shall also raise any concern it may have of the type referred to in Article 42(2) of the PPE Regulation in accordance with that Article.

PART 7 Offences and Penalties

Offences

• (a) Articles 8, 9, 10, 11, 13, 15, 17 of the PPE Regulation, or

• (b) Regulations 5(1), 5(2) 6, 7, 8, 9, 11, 17(5), 27(2), 27(6), 29(2) of these Regulations,

commits an offence.

• (2) A person who fails to comply with any requirement of a notice served on him or her under Regulation 34, 36 or 41 or any term of a forfeiture order granted under Regulation 40 that is required to be complied by him or her commits an offence.

• (3) A person who, in relation to CE marking, other marking or any document required for the purposes of the PPE Regulation or these Regulations does one or more of the following commits an offence:

• (a) forges or counterfeits any such document;

• (b) gives or signs a document knowing it to be false in any material particular or makes a marking knowing it to be false in any material particular;

• (c) knowingly uses a marking or document that is forged or counterfeited, or that is false in any material particular;

• (d) knowingly uses as applying to any person or PPE a marking or document which does not so apply;

• (e) knowingly connives at any such forging, counterfeiting, giving, signing, or using referred to in subparagraphs (a) to (d);

• (f) knowingly makes a false entry in any such document that is so required to be kept, served or sent;

• (g) knowingly uses any false entry referred to in subparagraph (f);

• (h) knowingly and without lawful authority has in his or her possession one or more of the following:

• (i) a forged marking;

• (ii) a forged document;

• (iii) an altered marking;

• (iv) an altered document.

• (4) Any person who obstructs or interferes with an Authorised Officer or a member of the Garda Síochána in the course of exercising a power conferred on him or her by these Regulations or by a warrant under Regulation 32(6) or who impedes or prevents the exercise by the Authorised Officer or member, as the case may be, of such power, or fails or refuses to comply with a request or requirement of, or to answer a question asked by, an Authorised Officer or such a member pursuant to a power conferred by these Regulations, or in purported compliance with such request or requirement or answer to such question asked, gives information to the Authorised Officer or member that he or she knows to be false or misleading in any material respect, commits an offence.

• (5) A person who falsely represents himself or herself to be an Authorised Officer commits an offence.

• (6) A person who, at any time during the period of 3 months immediately following the affixing of a notice in accordance with Regulation 48(1)(e) removes, alters, damages or defaces the notice without lawful authority commits an offence.

• (7) A person who states to a market surveillance authority that another person has committed an offence under this Regulation or has failed to comply with a provision of these Regulations, knowing the statement to be false, commits an offence.

• (8) A person who, in purported compliance with a requirement in an information notice, furnishes information to a market surveillance authority that he or she knows to be false or misleading in a material respect, commits an offence.

• (9) A person who prevents or attempts to prevent any person from answering any question to which an Authorised Officer may require an answer under Regulation 32, commits an offence.

• (10) A person who fails to comply with a bona fide request, instruction or direction from an Authorised Officer in the exercise of his or her functions under these Regulations, commits an offence.

• (11) Where an offence under a provision of these Regulations is committed by reason of a failure to do something at or within a time fixed by or under that provision, the offence shall be deemed to continue until that thing is done.

Penalties

• (a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 6 months or both, or

• (b) on conviction on indictment, to a fine not exceeding €500,000 or imprisonment for a term not exceeding 2 years or both.

• (2) Where a person is convicted of an offence under these Regulations in proceedings brought by a market surveillance authority, or instituted following an investigation by or on behalf of the authority, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the authority the costs and expenses, measured by the court, incurred by the authority in relation to the investigation, detection and prosecution of the offence, including the costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisers engaged by the authority.

Offences by bodies corporate

Prosecution of offences

• (2) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act 1851 and section 5(4) of the European Communities (Amendment) Act 1993, summary proceedings for an offence under Regulation 44 may be instituted at any time within 3 years from the date on which the offence was committed or alleged to have been committed.

PART 8 Miscellaneous

Service of notices, directions etc

• (a) delivering it to the person;

• (b) leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address;

• (c) sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address;

• (d) where there is a facility for receiving the text of the notice by electronic means at the address at which the person carries on business or ordinarily resides, transmitting the text of the notice by such means to such address, provided that the notice is also delivered in any of the other ways referred to in this paragraph; or

• (e) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the notice being served relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises.

• (2) Where a direction, notice or other measure under Regulation 33, 34, 36, 39, or 41 is to be served on a person who is the owner or occupier of land or property and the name of the person cannot be ascertained by reasonable inquiry, it may be addressed to the person by using the words “the owner” or, as the case may require, “the occupier”.

• (3) For the purposes of these Regulations, a company within the meaning of the Companies Acts 2014 shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

Immunity

Indemnification

Restriction on disclosure of information

• (2) Without prejudice to the generality of the foregoing, business, professional and trade secrets shall be treated as confidential unless the disclosure of such information is for one or more of the following reasons:

• (a) for the purpose of the discharge of functions under these Regulations;

• (b) required to be provided by law;

• (c) made with the consent of the person to whom the information applies;

• (d) for the purposes of—

• (i) any legal proceedings (including by means of a report to a coroner holding an inquest under the Coroners Acts 1962 and 2005 on the body of a person whose death may have been caused through personal injury), or

• (ii) any investigation or special report under section 70 of the Act of 2005;

• (e) necessary in order to protect the health or safety of persons;

• (f) required by a provision or provisions of the PPE Regulation or these Regulations;

• (g) ordered by a court of law.

Transitional provisions

• (2) Any EC type-examination certificate or approval decision issued under the Directive shall remain valid until 21 April 2023 unless it expires before that date.

Revocation

Regulations 13 and 17

SCHEDULE 1 Text of Annex I to the PPE Regulation

RISK CATEGORIES OF PPE

This Annex lays down the categories of risk against which PPE is intended to protect users.

Category I

Category I includes exclusively the following minimal risks:

• (a) superficial mechanical injury;

• (b) contact with cleaning materials of weak action or prolonged contact with water;

• (c) contact with hot surfaces not exceeding 50 °C;

• (d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);

• (e) atmospheric conditions that are not of an extreme nature.

Category II

Category II includes risks other than those listed in Categories I and III;

Category III

Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:

• (a) substances and mixtures which are hazardous to health;

• (b) atmospheres with oxygen deficiency;

• (c) harmful biological agents;

• (d) ionising radiation;

• (e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;

• (f) low-temperature environments the effects of which are comparable to those of an air temperature of –50 °C or less;

• (g) falling from a height;

• (h) electric shock and live working;

• (i) drowning;

• (j) cuts by hand-held chainsaws;

• (k) high-pressure jets;

• (l) bullet wounds or knife stabs;

• (m) harmful noise.

Regulations 6, 8, 9, 12, 15 and 23

SCHEDULE 2 Text of Annex II to the PPE Regulation

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

PRELIMINARY REMARKS

PPE must provide adequate protection against the risks against which it is intended to protect.

1.1. Design principles

1.1.1. Ergonomics

PPE must be designed and manufactured so 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 level possible.

1.1.2. Levels and classes of protection

1.1.2.1. Optimum level of protection

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 the normal performance of the activity.

1.1.2.2. 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 inherent risks and other nuisance factors

PPE must be designed and manufactured so as not to create risks or other nuisance factors under foreseeable conditions of use.

1.2.1.1. Suitable constituent materials

The materials of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users.

1.2.1.2. Satisfactory surface condition of all PPE parts in contact with the user

Any part of the PPE that is in contact or is liable to come into contact with the user when the PPE is worn must be free of rough surfaces, sharp edges, sharp points and the like which could cause excessive irritation or injuries.

1.2.1.3. Maximum permissible user impediment

Any impediment caused by PPE to the actions to be carried out, the postures to be adopted and sensory perceptions shall be minimised. Furthermore, use of the PPE must not engender actions which might endanger the user.

1.3. Comfort and effectiveness

1.3.1. Adaptation of PPE to user morphology

PPE must be designed and manufactured in such a way as to facilitate its correct positioning on the user and to remain in place for the foreseeable period of use, bearing in mind ambient factors, the actions to be carried out and the postures to be adopted. For this purpose, it must be possible to adapt the PPE to fit the morphology of the user by all appropriate means, such as adequate adjustment and attachment systems or the provision of an adequate range of sizes.

1.3.2. Lightness and strength

PPE must be as light as possible without prejudicing its strength and effectiveness.

PPE must satisfy the specific additional requirements in order to provide adequate protection against the risks for which it is intended and PPE must be capable of withstanding environmental factors in the foreseeable conditions of use.

1.3.3. Compatibility of different types of PPE intended for simultaneous use

If the same manufacturer places on the market several PPE models of different types in order to ensure the simultaneous protection of adjacent parts of the body, they must be compatible.

1.3.4. Protective clothing containing removable protectors

Protective clothing containing removable protectors constitutes PPE and shall be assessed as a combination during conformity assessment procedures.

1.4. Manufacturers instructions and information

In addition to the name and address of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on:

• (a) instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions;

• (b) performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE;

• (c) where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts;

• (d) where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use;

• (e) where applicable, the month and year or period of obsolescence of the PPE or of certain of its components;

• (f) where applicable, the type of packaging suitable for transport;

• (g) the significance of any markings (see point 2.12);

• (h) the risk against which the PPE is designed to protect;

• (i) the reference to this Regulation and, where applicable, the references to other European Union harmonisation legislation;

• (j) the name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE;

• (k) references to the relevant harmonised standard(s) used, including the date of the standard(s), or references to the other technical specifications used;

• (l) the internet address where the EU declaration of conformity can be accessed.

The information referred to in points (i), (j), (k) and (l) need not be contained in the instructions supplied by the manufacturer if the EU declaration of conformity accompanies the PPE.

2.1. PPE incorporating adjustment systems

If PPE incorporates adjustment systems, the latter must be designed and manufactured so that, after adjustment, they do not become undone unintentionally in the foreseeable conditions of use.

2.2. PPE enclosing the parts of the body to be protected

PPE must be designed and manufactured in a way that perspiration resulting from use is minimised. Otherwise it must be equipped with means of absorbing perspiration.

2.3. PPE for the face, eyes and respiratory system

Any restriction of the users face, eyes, field of vision or respiratory system by the PPE shall be minimised.

The screens for those types of PPE must have a degree of optical neutrality that is compatible with the degree of precision and the duration of the activities of the user.

If necessary, such PPE must be treated or provided with means to prevent misting-up.

Models of PPE 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 performance of new PPE may be significantly affected by ageing, the month and year of manufacture and/or, if possible, the month and year of obsolescence must be indelibly and unambiguously marked on each item of PPE placed on the market and on its packaging.

If the manufacturer is unable to give an undertaking with regard to the useful life of the PPE, his instructions must provide all the information necessary to enable the purchaser or user to establish a reasonable obsolescence month and year, taking into account 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 marking 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. Where such a marking is not affixed, the manufacturer must give that information in his instructions.

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 be designed and manufactured in such a way that a constituent part will break or tear, thereby eliminating the danger.

2.6. PPE for use in potentially explosive atmospheres

PPE intended for use in potentially explosive atmospheres must be designed and manufactured in such a way 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 rapid intervention or to be put on or removed rapidly

Those types of PPE must be designed and manufactured in such a way as to minimise the time required for putting on and removing the equipment.

Where PPE comprises fixing systems enabling the PPE to be maintained in the correct position on the user or removed, it must be possible to operate such systems quickly and easily.

2.8. PPE for intervention in very dangerous situations

The instructions supplied by the manufacturer with PPE for intervention in very dangerous situations must include, in particular, data intended for competent, trained persons who are qualified to interpret them and ensure their application by the user.

The instructions must also describe the procedure to be adopted in order to verify that PPE is correctly adjusted and functional when worn by the user.

Where PPE incorporates an alarm which is activated in the absence of the level of protection normally provided, the alarm must be designed and placed so that it can be perceived by the user in the foreseeable conditions of use.

2.9. PPE incorporating components which can be adjusted or removed by the user

Where PPE incorporates components which can be attached, adjusted or removed by the user for replacement purposes, such components must be designed and manufactured so that they can be easily attached, adjusted and removed without tools.

2.10. PPE for connection to complementary equipment external to the PPE

Where PPE incorporates a connexion system permitting its connection to other complementary equipment, the means of attachment must be designed and manufactured in such a way as to enable it to be mounted only on appropriate equipment.

2.11. PPE incorporating a fluid circulation system

Where PPE incorporates a fluid circulation system, the latter must be chosen or designed and placed in such a way as to permit adequate fluid renewal in the vicinity of the entire part of the body to be protected, irrespective of the actions, postures or movements of the user under the foreseeable conditions of use.

2.12. PPE bearing one or more identification markings or indicators directly or indirectly relating to health and safety

Where PPE bears one or more identification markings or indicators directly or indirectly relating to health and safety, those identification markings or indicators must, if possible, take the form of harmonised pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, those markings must be complete, precise and comprehensible so as to prevent any misinterpretation. In particular, where such markings include words or sentences, the latter must be written in a language easily understood by consumers and other end-users, as determined by the Member State where the PPE is made available on the market.

Where PPE is too small to allow all or part of the necessary marking to be affixed, the relevant information must be mentioned on the packaging and in the manufacturers instructions.

2.13. PPE capable of signalling the users presence visually

PPE intended for foreseeable conditions of use in which the users presence must be visibly and individually signalled must have one (or more) judiciously positioned means or devices for emitting direct or reflected visible radiation of appropriate luminous intensity and photometric and colorimetric properties.

2.14. Multi-risk PPE

PPE intended to protect the user against several potentially simultaneous risks must be designed and manufactured in such a way as to satisfy, in particular, the essential health and safety requirements specific to each of those risks.

3.1. Protection against mechanical impact

3.1.1. Impact caused by falling or ejected objects and collisions of parts of the body with an obstacle

PPE intended to protect against 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 means of shock-absorption would preclude effective use of the PPE for the foreseeable period of wear.

3.1.2. Falls

3.1.2.1. Prevention of falls due to slipping

The outsoles of protective footwear intended to prevent slipping must be designed and manufactured or equipped with additional means so as to ensure adequate grip, having regard to the nature or state of the surface.

3.1.2.2. Prevention of falls from a height

PPE intended to prevent falls from a height or their effects must incorporate a body harness and a connexion system which can be connected to a reliable external anchorage point. It must be designed and manufactured so that, under the foreseeable conditions of use, the vertical drop of the user is minimised to prevent collision with obstacles while the braking force does not attain the threshold value at which physical injury or the opening or breakage of any PPE component which might cause the user to fall can be expected to occur.

Such PPE must also ensure that, after braking, the user is maintained in a correct position in which he may await help if necessary.

The manufacturers instructions must specify, in particular, all relevant information relating to:

• (a) the characteristics required for the reliable external anchorage point and the necessary minimum clearance below the user;

• (b) the proper way of putting on the body harness and of attaching the connexion system to the reliable external 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.

3.2. Protection against static compression of a part of the body

PPE designed to protect a part of the body against static compressive stress must be sufficiently capable of attenuating its effects so as to prevent serious injury or chronic complaints.

3.3. Protection against mechanical injuries

PPE constituent materials and other components designed to protect all or a part of the body against superficial injuries, such as abrasion, perforation, cuts or bites, must be chosen or designed and incorporated so as to ensure that those types of PPE provide sufficient resistance to abrasion, perforation and gashing (see also point 3.1) under the foreseeable conditions of use.

3.4. Protection in liquids

3.4.1. Prevention of drowning

PPE designed to prevent drowning must be capable of returning to the surface as quickly as possible, without danger to health, a user who may be exhausted or unconscious after falling into a liquid medium, and of keeping the user afloat in a position which permits breathing while awaiting help.

PPE may be wholly or partially inherently buoyant or may be inflated by gas which can be manually or automatically released, or inflated orally.

Under the foreseeable conditions of use:

• (a) 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;

• (b) 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:

• (a) they must have all the inflation devices referred to in the second subparagraph, and/or a light or sound- signalling device;

• (b) they must have a device for hitching and attaching the body so that the user may be lifted out of the liquid medium;

• (c) they 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 the users immersion in it.

3.4.2. Buoyancy aids

Clothing intended to ensure an effective degree of buoyancy, depending on its foreseeable use, shall be safe when worn and afford positive support in the liquid medium. In foreseeable conditions of use, this PPE must not restrict the users freedom of movement but must enable the user, in particular, to swim or take action to escape from danger or to rescue other persons.

3.5. Protection against the harmful effects of noise

PPE intended to prevent the harmful effects of noise must be capable of attenuating the latter so that the exposure of the user does not exceed the limit values laid down by Directive 2003/10/EC of the European Parliament and of the Council⁵

Each item of PPE must bear labelling indicating the noise attenuation level provided by the PPE. Should that 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 a part of the body against the effects of heat and/or fire must possess thermal insulation capacity and mechanical strength appropriate to the foreseeable conditions of use.

3.6.1. PPE constituent materials and other components

Constituent materials and other components intended 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 external surface of those materials and components must be reflective, the reflective power must be appropriate to the intensity of the heat flux due to radiation in the infrared 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 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 the PPE.

PPE materials and other components which may be splashed by hot products must also possess sufficient mechanical-impact absorbency (see point 3.1).

PPE materials and other components which may accidentally come into contact with flame and those used in the manufacture of industrial or fire-fighting equipment must also possess a degree of non-flammability and thermal or arc heat protection 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:

• (a) 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;

• (b) 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, the design of such devices 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, that device must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.

The manufacturers instructions accompanying PPE intended for brief use in high-temperature environments must, in particular, provide all relevant data for the determination of the maximum permissible 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 a 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 intended.

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 cold products must also possess sufficient mechanical-impact absorbency (see point 3.1).

3.7.2. Complete PPE ready for use

Under the foreseeable conditions of use, the following requirements apply:

• (a) 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;

• (b) 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, that device must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.

The manufacturers instructions accompanying PPE 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

3.8.1. Insulating equipment

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 those types of PPE must be chosen or designed and incorporated so 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, in any event, below a maximum conventional permissible 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 or corresponding operating voltage, their serial number and their date of manufacture. A space must also be provided outside the protective 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 manufacturers instructions must indicate, in particular, the exclusive use for which those PPE types are intended and the nature and frequency of the dielectric tests to which they are to be subjected during their useful life.

3.8.2. Conductive equipment

Conductive PPE intended for live working at high voltages shall be designed and manufactured in such a way as to ensure that there is no difference of potential between the user and the installations on which he is intervening.

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 visible spectrum, the perception of contrasts and the ability to distinguish colours where required by the foreseeable conditions of use.

To that end, eye protective equipment must be designed and manufactured so as to possess, for each harmful wavelength, a spectral transmission factor such that the radiant-energy illumination density capable of reaching the users eye through the filter is minimised and under no circumstances exceeds the maximum permissible exposure value. PPE designed to protect the skin against non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths.

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 manufacturers instructions must indicate, in particular, how to select the appropriate PPE taking into account the relevant conditions of use such as the distance from the 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 eye protective equipment by the manufacturer.

3.9.2. Ionising radiation

3.9.2.1. Protection against external radioactive contamination

PPE constituent materials and other components designed to protect all or a part of the body against radioactive dust, gases, liquids or mixtures thereof must be chosen or designed and incorporated so 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 reuse during the foreseeable useful life of those types of equipment.

3.9.2.2. 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 types of PPE must be chosen or designed and incorporated so 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 point 1.3.2).

PPE must bear a mark indicating the type and equivalent thickness of the constituent material(s) suitable for the foreseeable conditions of use.

3.10. Protection against substances and mixtures which are hazardous to health and against harmful biological agents

3.10.1. Respiratory protection

PPE intended for the protection of the respiratory system must make it possible to supply the user with breathable air when exposed to a polluted atmosphere and/or an atmosphere having an inadequate oxygen concentration.

The breathable air supplied to the user by PPE must be obtained by appropriate means, for example after filtration of the polluted air through PPE or by supply from an external unpolluted source.

The constituent materials and other components of those types of PPE must be chosen or designed and incorporated so 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 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 details of the specific characteristics of the equipment which, in conjunction with the instructions, enable a trained and qualified user to employ the PPE correctly.

In the case of filtering equipment, the manufacturers instructions must also indicate the time limit for the storage of new filters 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 substances and mixtures which are hazardous to health or with harmful biological agents must be capable of preventing the penetration or permeation of such substances and mixtures and agents through the protective integument under the foreseeable conditions of use for which the PPE is intended.

To this end, the constituent materials and other components of those types of PPE must be chosen or designed and incorporated so 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 substances and mixtures which are hazardous to health or harmful biological 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 their performance. PPE which is considered to be in conformity with the test specifications must bear a marking indicating, in particular, the names or, in the absence of the names, the codes of the substances used in the tests and the corresponding standard period of protection. The manufacturers instructions 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. Diving 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.

Where the foreseeable conditions of use so require, the diving equipment must comprise the following:

• (a) a suit which protects the user against cold (see point 3.7) and/or pressure resulting from the depth of immersion (see point 3.2);

• (b) an alarm designed to give the user prompt warning of an approaching failure in the supply of breathable gaseous mixture (see point 2.8);

• (c) a lifesaving device enabling the user to return to the surface (see point 3.4.1).

Regulation 6

SCHEDULE 3 Text of Annex III to the PPE Regulation

TECHNICAL DOCUMENTATION FOR PPE

The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the PPE with the applicable essential health and safety requirements referred to in Article 5 and set out in Annex II. The technical documentation shall include at least the following elements:

• (a) a complete description of the PPE and of its intended use;

• (b) an assessment of the risks against which the PPE is intended to protect;

• (c) a list of the essential health and safety requirements that are applicable to the PPE;

• (d) design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits;

• (e) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE;

• (f) the references of the harmonised standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied;

• (g) where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements;