European Commission
PPE Regulation Guidelines
Guide to application of 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
1th edition - april 2018
TABLE OF CONTENTS
1. PREAMBLE TO THE PPE REGULATION - THE CITATIONS AND THE RECITALS
• 1.1. The citations
• 1.2. The legal basis of the PPE Regulation
• 1.3. The recitals
• 1.4. The previous PPE Directive
• 1.5. The "New Legislative Framework"
• 1.6. The scope and the objective of the PPE Regulation
• 1. 7. Exclusions from the scope
• 1.8. Responsibilities of economic operators
• 1.9. Responsibilities of manufacturers: conformity assessment
• 1.10. Res1lonsibilities of importers and distributors
• 1.11. Documentation to be provided by economie operators
• 1.12. Obligations of the manufacturer for economie operators
• 1.13. Information and traceability of PPE for market surveillance
• 1.14. Noise, vibrations and radiation
• 1.15. Use of PPE at the workplace
• 1.16. The EU dedaration of conformity
• 1.17. Technical documentation
• 1.18. The EU type-examination certificate
• 1.19. The CE marking
• 1.20. Conformity assessment procedures
• 1.21. Conformity assessment bodies: notified bodies
• 1.22. Compliance of products on the market and market surveillance
• 1.23. The safeguard clause procedure
• 1.24. Delegated and implementing powers and procedures
• 1.25. The PPE Committee
• 1.26. Implementing acts concerning measures on non-compliant products
• 1.27. Transitional provisions
• 1.28. Enforcement: penalties
• 1.29. Subsidiarity and proportionaliity
• 1.30. Repeal of Directive 89/686/EEC .
2. CHAPTER I - GENERAL PROVISIONS
• 2.1. Article 1 - Subject matter
• 2.2. Article 2 - Scope
• 2.3. Article 3 - Definitions
• 2.4. Article 4- Making available on the market
• 2.5. Article 5 - Essential health and safety requirements
• 2.6. Article 6 - Provisions concerning the use of PPE
• 2.7. Article 7 - Free movement
3. CHAPTER II- OBLIGATIONS OF ECONOMIC OPERATORS
• 3.1. Article 8- Obligations ofthe manifacturers
• 3.2. Article 9 - Authorised representatives
• 3.3. Article 10 - Obligations of impoirters
• 3.4. Article 11- Obligations of distributors
• 3.5. Article 12 - Cases in whieh obligations of manufacturers apply to importers and distributors
• 3.6. Article 13- Identification of economic operators
4. CHAPTER III - CONFORMITY OF THE PPE
• 4.1. Article 14 - Presumption of conformity of PPE
• 4.2. Article 15 - EU dedarntion of conformity
• 4.3. Article 16 - General principles of the CE marking
• 4.4. Article 17 - Rules and conditionts for affixing the CE marking
5. CHAPTER IV - CONFORMITY ASSESSMENT
• 5.1. Article 18 - Risk categories of PPE
• 5.2. Article 19 - Conformity assessment procedures
6. CHAPTER V - NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
• 6.1. Article 20- Notification
• 6.2. Article 21- Notifying authorities
• 6.3. Article 22 - Requfrements relatiing to notifying authorities
• 6.4. Article 2 3- Information obligation on notifying authorities
• 6.5. Article 24 - Requirements relating to notified bodies
• 6.6. Article 25 - Presumption of conformity of notified bodies
• 6.7. Article 26 - Subsidiaries of and subcontracting by notified bodies
• 6.8. Articles 27 and 28 - Application and procedures for notification
• 6.9. Article 29 - Identiflcation numbers and lists of notified bodies
• 6.10. Article 30 - Changes to notifications
• 6.11. Article 31- Challenge of the Competence of notified bodies
• 6.12. Article 32 - Operational obligations of notifled bodies
• 6.13. Article 33 - Appeal against decisions of notified bodies
• 6.14. Article 34 - Information obligation on notifled bodies
• 6.15. Article 35 - Exchange of experience
• 6.16. Article 36 - Coordination of notified bodies
7. CHAPTER VI - UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
• 7.1. Article 37 - Union market sunrveillance and control of PPE entering the Union market
• 7.2. Article 38 - Procedure at nationial level for dealing with PPE presenting a risk
• 7.3. Article 39 - Union safeguard procedure
• 7.4. Article 40 - Compliant PPE which presents a risk
• 7.5. Article 41 - Formal non-compliance
8. CHAPTER VII - DELEGATED AND IMPLEMENTING ACTS
• 8.1. Article 42 - Delegated power
• 8.2. Article 43 - Exercise of the delegation
• 8.3. Article 44 - Committee procedure
9. CHAPTER VIII - TRANSITIONAL AND FINAL PROVISIONS
• 9.1. Article 45 - Penalties
• 9.2. Article 46 - Repeal
• 9.3. Article 47 - Transitional provisions
• 9.4. Article 48- Entry into force and application
• 9.5. Legail value, direct applicability and signatories of the Regulation
10. ANNEX I- RISK CATEGORIES, OF PPE
• 10.1. Category I
• 10.2. Category II
• 10.3. Category III
11. ANNEX II- ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
• 11.1. Preliminary remarks
• 11.2. 1. General requirements applicable to all PPE
• 11.3. 1.1. Design principles
• 11.4. 1.2. Innocuousness of PPE
• 11.5. 1.3. Comfort and effectiveness
• 11.6. 1.4. Manufacturer's instructions and information
• 11. 7. 2. Additional requirements common to several types of PPE
• 11.8. 2.1. PPE incorporating adjustarnent sistems .
• 11.9. 2.2. PPE enclosing the parts of the body to be protected
• 11.10. 2.3. PPE for the face, eyes and respiratory system
• 11.11. 2.4. PPE subject to ageing
• 11.12. 2.5. PPE which may be caught up during use
• 11.13. 2.6. PPE for use in potentially explosive atmospheres
• 11.14. 2.7. PPE intended for rapid intervention or to be put on or removed rapidly
• 11.15. 2.8. PPE for intervention in very dangerous situations
• 11.16. 2.9. PPE incorporating components which can be adjusted or removed by the user
• 11.17. 2.10. PPE for connection to complementary equipment external to the PPE
• 11.18. 2.11. PPE incorporating a fluid circulation system
• 11.19. 2.12. PPE bearing one or more identification markings or indicators directly or indirectly relating to health and safety
• 11.20. 2.13. PPE capable of signalling the user's presence visually
• 11.21. 2.14. Multi-risk PPE
• 11.22. 3. Additional requirements specific to particular risks
• 11.23. 3.1. Protection against mechanical impact
• 11.24. 3.1.2. Falls
• 11.25. 3.1.3. Mechanical vibration
• 11.26. 3.2. Protection against static compression of a part of the body
• 11.27. 3.3. Protection against mechanical injuries
• 11.28. 3.4. Protection in liquids
• 11.29. 3.5. Protection against the harmful effects of noise
• 11.30. 3.6. Protection against heat and/or fire
• 11.31. 3.7. Protection against cold
• 11.32. 3.8. Protection against electric shock
• 11.33. 3.9. Radiation protection
• 11.34. 3.10. Protection against substances and mixtures which are hazardous to health and against harmful biological agents
• 11.35. 3.11. Diving equipment
12. ANNEX III - TECHNICAL DOCUMENTATION FOR PPE
13. ANNEX IV - INTERNAL PRODUCTION CONTROL (MODULE A)
14. ANNEX V - EU TYPE-EXAMINATION (MODULE B)
15. ANNEX VI - CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)
16. ANNEX VII - CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS (MODULE C2)
17. ANNEX VIII - CONFORlVIITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (MODULE D)
18. ANNEX IX - EU DECLARATION OF CONFORMITY
19. ANNEX X - CORRELATION TALBLE
20. APPENDIX: GUIDE FOR THE CATEGORISATION OF PERSONAL PROTECTIVE EQUIPMENT (PPE)
ORGANISATIONAL SCHEME FOR THE PPE REGULATION (EU) 2016/425
USEFUL WEBSITES AND LINKS
Fonte: ec.europa.eu