Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March... (32016R0425)
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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 (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)
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Subject matter
- Article 2
- Scope
- Article 3
- Definitions
- Article 4
- Making available on the market
- Article 5
- Essential health and safety requirements
- Article 6
- Provisions concerning the use of PPE
- Article 7
- Free movement
- CHAPTER II
- OBLIGATIONS OF ECONOMIC OPERATORS
- Article 8
- Obligations of manufacturers
- Article 9
- Authorised representatives
- Article 10
- Obligations of importers
- Article 11
- Obligations of distributors
- Article 12
- Cases in which obligations of manufacturers apply to importers and distributors
- Article 13
- Identification of economic operators
- CHAPTER III
- CONFORMITY OF THE PPE
- Article 14
- Presumption of conformity of PPE
- Article 15
- EU declaration of conformity
- Article 16
- General principles of the CE marking
- Article 17
- Rules and conditions for affixing the CE marking
- CHAPTER IV
- CONFORMITY ASSESSMENT
- Article 18
- Risk categories of PPE
- Article 19
- Conformity assessment procedures
- CHAPTER V
- NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
- Article 20
- Notification
- Article 21
- Notifying authorities
- Article 22
- Requirements relating to notifying authorities
- Article 23
- Information obligation on notifying authorities
- Article 24
- Requirements relating to notified bodies
- Article 25
- Presumption of conformity of notified bodies
- Article 26
- Subsidiaries of and subcontracting by notified bodies
- Article 27
- Application for notification
- Article 28
- Notification procedure
- Article 29
- Identification numbers and lists of notified bodies
- Article 30
- Changes to notifications
- Article 31
- Challenge of the competence of notified bodies
- Article 32
- Operational obligations of notified bodies
- Article 33
- Appeal against decisions of notified bodies
- Article 34
- Information obligation on notified bodies
- Article 35
- Exchange of experience
- Article 36
- Coordination of notified bodies
- 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
- Article 38
- Procedure at national level for dealing with PPE presenting a risk
- Article 39
- Union safeguard procedure
- Article 40
- Compliant PPE which presents a risk
- Article 41
- Formal non-compliance
- CHAPTER VII
- DELEGATED AND IMPLEMENTING ACTS
- Article 42
- Delegated power
- Article 43
- Exercise of the delegation
- Article 44
- Committee procedure
- CHAPTER VIII
- TRANSITIONAL AND FINAL PROVISIONS
- Article 45
- Penalties
- Article 46
- Repeal
- Article 47
- Transitional provisions
- Article 48
- Entry into force and application
- ANNEX I
- RISK CATEGORIES OF PPE
- Category I
- Category II
- Category III
- ANNEX II
- ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
- PRELIMINARY REMARKS
- 1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE
- 1.1. Design principles
- 1.1.1. Ergonomics
- 1.1.2. Levels and classes of protection
- 1.1.2.1. Optimum level of protection
- 1.1.2.2. Classes of protection appropriate to different levels of risk
- 1.2. Innocuousness of PPE
- 1.2.1. Absence of inherent risks and other nuisance factors
- 1.2.1.1. Suitable constituent materials
- 1.2.1.2. Satisfactory surface condition of all PPE parts in contact with the user
- 1.2.1.3. Maximum permissible user impediment
- 1.3. Comfort and effectiveness
- 1.3.1. Adaptation of PPE to user morphology
- 1.3.2. Lightness and strength
- 1.3.3. Compatibility of different types of PPE intended for simultaneous use
- 1.3.4. Protective clothing containing removable protectors
- 1.4. Manufacturer's instructions and information
- 2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL TYPES OF PPE
- 2.1. PPE incorporating adjustment systems
- 2.2. PPE enclosing the parts of the body to be protected
- 2.3. PPE for the face, eyes and respiratory system
- 2.4. PPE subject to ageing
- 2.5. PPE which may be caught up during use
- 2.6. PPE for use in potentially explosive atmospheres
- 2.7. PPE intended for rapid intervention or to be put on or removed rapidly
- 2.8. PPE for intervention in very dangerous situations
- 2.9. PPE incorporating components which can be adjusted or removed by the user
- 2.10. PPE for connection to complementary equipment external to the PPE
- 2.11. PPE incorporating a fluid circulation system
- 2.12. PPE bearing one or more identification markings or indicators directly or indirectly relating to health and safety
- 2.13. PPE capable of signalling the user's presence visually
- 2.14. Multi-risk PPE
- 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
- 3.1.2. Falls
- 3.1.2.1. Prevention of falls due to slipping
- 3.1.2.2. Prevention of falls from a height
- 3.1.3. Mechanical vibration
- 3.2. Protection against static compression of a part of the body
- 3.3. Protection against mechanical injuries
- 3.4. Protection in liquids
- 3.4.1. Prevention of drowning
- 3.4.2. Buoyancy aids
- 3.5. Protection against the harmful effects of noise
- 3.6. Protection against heat and/or fire
- 3.6.1. PPE constituent materials and other components
- 3.6.2. Complete PPE ready for use
- 3.7. Protection against cold
- 3.7.1. PPE constituent materials and other components
- 3.7.2. Complete PPE ready for use
- 3.8. Protection against electric shock
- 3.8.1. Insulating equipment
- 3.8.2. Conductive equipment
- 3.9. Radiation protection
- 3.9.1. Non-ionising radiation
- 3.9.2. Ionising radiation
- 3.9.2.1. Protection against external radioactive contamination
- 3.9.2.2. Protection against external irradiation
- 3.10. Protection against substances and mixtures which are hazardous to health and against harmful biological agents
- 3.10.1. Respiratory protection
- 3.10.2. Protection against cutaneous and ocular contact
- 3.11. Diving equipment
- ANNEX III
- TECHNICAL DOCUMENTATION FOR PPE
- ANNEX IV
- INTERNAL PRODUCTION CONTROL
- (Module A)
- 2. Technical documentation
- 3. Manufacturing
- 4. CE marking and EU declaration of conformity
- 5. Authorised representative
- ANNEX V
- EU TYPE-EXAMINATION
- (Module B)
- 3. Application for EU type-examination
- 4. EU type-examination
- 5. Evaluation report
- 6. EU type-examination certificate
- 7. Review of the EU type-examination certificate
- ANNEX VI
- CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
- (Module C)
- 2. Manufacturing
- 3. CE marking and EU declaration of conformity
- 4. Authorised representative
- ANNEX VII
- CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS
- (Module C2)
- 2. Manufacturing
- 3. Application for supervised product checks at random intervals
- 4. Product checks
- 5. Test report
- 6. CE marking and EU declaration of conformity
- 7. Authorised representative
- ANNEX VIII
- CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
- (Module D)
- 2. Manufacturing
- 3. Quality system
- 4. Surveillance under the responsibility of the notified body
- 5. CE marking and EU declaration of conformity
- 8. Authorised representative
- ANNEX IX
- EU DECLARATION OF CONFORMITY No …
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- ANNEX X
- CORRELATION TABLE
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