Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March…

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)

regulation · European Union · 32016R0425

386 provisions in 1269 nodes · 14 provisions hand work to national law

Defined terms · All instruments · European standard · Internet · access to information · auditing · branch · competition · confidentiality · consumer

CHAPTER I GENERAL PROVISIONS

Article 1 Subject matter

Article 3 Definitions

Article 4 Making available on the market

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Article 5 Essential health and safety requirements

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Article 6 Provisions concerning the use of PPE

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Article 7 Free movement

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CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

Article 8 Obligations of manufacturers

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10.

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Article 9 Authorised representatives

Article 10 Obligations of importers

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Article 11 Obligations of distributors

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

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Article 13 Identification of economic operators

CHAPTER III CONFORMITY OF THE PPE

Article 14 Presumption of conformity of PPE

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Article 15 EU declaration of conformity

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Article 16 General principles of the CE marking

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Article 17 Rules and conditions for affixing the CE marking

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CHAPTER IV CONFORMITY ASSESSMENT

Article 18 Risk categories of PPE

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Article 19 Conformity assessment procedures

CHAPTER V NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 20 Notification

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Article 21 Notifying authorities

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Article 22 Requirements relating to notifying authorities

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Article 23 Information obligation on notifying authorities

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Article 24 Requirements relating to notified bodies

Article 25 Presumption of conformity of notified bodies

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Article 26 Subsidiaries of and subcontracting by notified bodies

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Article 27 Application for notification

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Article 28 Notification procedure

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Article 29 Identification numbers and lists of notified bodies

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Article 30 Changes to notifications

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Article 31 Challenge of the competence of notified bodies

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Article 32 Operational obligations of notified bodies

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Article 33 Appeal against decisions of notified bodies

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Article 34 Information obligation on notified bodies

Article 35 Exchange of experience

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Article 36 Coordination of notified bodies

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CHAPTER VI UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

Article 37 Union market surveillance and control of PPE entering the Union market

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Article 38 Procedure at national level for dealing with PPE presenting a risk

Article 39 Union safeguard procedure

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Article 40 Compliant PPE which presents a risk

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Article 41 Formal non-compliance

CHAPTER VII DELEGATED AND IMPLEMENTING ACTS

Article 42 Delegated power

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Article 43 Exercise of the delegation

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Article 44 Committee procedure

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CHAPTER VIII TRANSITIONAL AND FINAL PROVISIONS

Article 47 Transitional provisions

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Article 48 Entry into force and application

RISK CATEGORIES OF PPE

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

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1.1. Design principles

1.1.1. Ergonomics

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1.1.2. Levels and classes of protection

1.1.2.1. Optimum level of protection

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1.1.2.2. Classes of protection appropriate to different levels of risk

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1.2. Innocuousness of PPE

1.2.1. Absence of inherent risks and other nuisance factors

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1.2.1.1. Suitable constituent materials

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

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1.2.1.3. Maximum permissible user impediment

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1.3. Comfort and effectiveness

1.3.1. Adaptation of PPE to user morphology

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1.3.2. Lightness and strength

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

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1.3.4. Protective clothing containing removable protectors

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1.4. Manufacturer's instructions and information

2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL TYPES OF PPE

2.1. PPE incorporating adjustment systems

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

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2.3. PPE for the face, eyes and respiratory system

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2.4. PPE subject to ageing

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2.5. PPE which may be caught up during use

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2.6. PPE for use in potentially explosive atmospheres

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2.7. PPE intended for rapid intervention or to be put on or removed rapidly

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2.8. PPE for intervention in very dangerous situations

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

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

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2.11. PPE incorporating a fluid circulation system

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

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2.13. PPE capable of signalling the user's presence visually

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2.14. Multi-risk PPE

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3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR 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

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3.1.2. Falls

3.1.2.1. Prevention of falls due to slipping

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3.1.2.2. Prevention of falls from a height

3.1.3. Mechanical vibration

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

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3.3. Protection against mechanical injuries

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3.4. Protection in liquids

3.4.1. Prevention of drowning

3.5. Protection against the harmful effects of noise

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3.6. Protection against heat and/or fire

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3.6.1. PPE constituent materials and other components

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3.6.2. Complete PPE ready for use

3.7. Protection against cold

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3.7.1. PPE constituent materials and other components

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3.7.2. Complete PPE ready for use

3.8. Protection against electric shock

3.8.1. Insulating equipment

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3.8.2. Conductive equipment

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3.9. Radiation protection

3.9.1. Non-ionising radiation

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3.9.2. Ionising radiation

3.9.2.1. Protection against external radioactive contamination

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3.9.2.2. Protection against external irradiation

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

3.10.1. Respiratory protection

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3.10.2. Protection against cutaneous and ocular contact

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3.11. Diving equipment

TECHNICAL DOCUMENTATION FOR PPE

INTERNAL PRODUCTION CONTROL (Module A)

Passage

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2. Technical documentation

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3. Manufacturing

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4. CE marking and EU declaration of conformity

5. Authorised representative

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ANNEX V

EU TYPE-EXAMINATION (Module B)

3. Application for EU type-examination

4. EU type-examination

6. EU type-examination certificate

7. Review of the EU type-examination certificate

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (Module C)

3. CE marking and EU declaration of conformity

4. Authorised representative

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ANNEX VII

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS (Module C2)

3. Application for supervised product checks at random intervals

6. CE marking and EU declaration of conformity

7. Authorised representative

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ANNEX VIII

CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (Module D)

4. Surveillance under the responsibility of the notified body

5. CE marking and EU declaration of conformity

8. Authorised representative

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ANNEX IX

EU DECLARATION OF CONFORMITY No … It is optional for the manufacturer to assign a number to the declaration of conformity.