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
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
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
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
Article 18
Risk categories of PPE
Article 19
Conformity assessment procedures
CHAPTER V
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
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
Article 42
Delegated power
Article 43
Exercise of the delegation
Article 44
Committee procedure
CHAPTER VIII
Article 45
Penalties
Article 46
Repeal
Article 47
Transitional provisions
Article 48
Entry into force and application
ANNEX I
ANNEX II
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
ANNEX IV
(Module A)
2. Technical documentation
3. Manufacturing
4. CE marking and EU declaration of conformity
5. Authorised representative
ANNEX V
(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
(Module C)
2. Manufacturing
3. CE marking and EU declaration of conformity
4. Authorised representative
ANNEX VII
(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
(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
ANNEX X
Directive 89/686/EEC |
This Regulation |
Article 1(1) |
Articles 1 and 2(1) |
Article 1(2) and (3) |
Article 3 point (1) |
Article 1(4) |
Article 2(2) |
Article 2(1) |
Article 4 |
Article 2(2) |
Article 6 |
Article 2(3) |
Article 7(2) |
Article 3 |
Article 5 |
Article 4(1) |
Article 7(1) |
Article 4(2) |
— |
Article 5(1), (4), (5) |
— |
Article 5(2) |
Article 14 |
Article 6 |
Article 44 |
Article 7 |
Articles 37-41 |
Article 8(1) |
Article 8(2) first subparagraph |
Article 8(2)-(4) |
Articles 18 and 19 and Annex I |
Article 9 |
Articles 20, 24(1), 25, and 30(1) |
Article 10 |
Annex V |
Article 11(A) |
Annex VII |
Article 11(B) |
Annex VIII |
Article 12(1) |
Article 15 |
Articles 12(2) and 13 |
Articles 16 and 17 |
Article 14 |
— |
Article 15 |
— |
Article 16(1) first subparagraph and (2) |
— |
Article 16(1) second subparagraph |
Article 48(2) |
Annex I |
Article 2(2) |
Annex II |
Annex II |
Annex III |
Annex III |
Annex IV |
Article 16 |
Annex V |
Article 24(2)-(11) |
Annex VI |
Annex IX |