Date: 2020-05-19Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2020/668 of 18 May 2020 on the harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council
Executive Summary:
This Commission Implementing Decision EU 2020/668 publishes harmonised standards for personal protective equipment (PPE) in support of Regulation EU 2016/425. It lists updated and revised standards, the references of which are published in the Official Journal of the European Union. It also withdraws references to superseded standards, with withdrawals taking effect on either 19 November 2020 or 19 November 2021 to allow manufacturers time to prepare for the updated standards.
Key Points / Main Content:
* **Purpose:** To establish harmonised standards for PPE that conform to the essential health and safety requirements of Regulation EU 2016/425.
* **Harmonised Standards Published:**
* The references of harmonised standards for PPE listed in Annex I are published in the Official Journal of the European Union.
* These standards include EN 343:2019, EN 358:2018, EN 388:2016A1:2018, EN 510:2019, EN 893:2019, EN 9431:2015A1:2019, EN 9432:2019, EN 10731:2016A1:2018, EN ISO 10819:2013/A1:2019, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-5:2019, EN ISO 11393-6:2019, EN 12277:2015/A1:2018, EN 13832-2:2018, EN 13832-3:2018, EN 14458:2018, EN 14594:2018, and EN 50321-1:2018/AC:201808.
* **Withdrawal of References:**
* The references of harmonised standards listed in Annex II are withdrawn from the Official Journal of the European Union.
* Withdrawal dates are either 19 November 2020 or 19 November 2021.
* Standards being withdrawn include EN ISO 10819:2013, EN 343:2003A1:2007/AC:2009, EN 358:1999, EN 381-5:1995, EN 381-7:1999, EN 381-9:1997, EN 381-11:2002, EN 388:2016, EN 943-1:2015, EN 12277:2015, EN 13832-2:2006, EN 13832-3:2006, EN 14594:2005/AC:2005 and EN 50321-1:2018.
* **Entry into Force:** The decision enters into force on the day of its publication in the Official Journal of the European Union.
Impact Analysis:
**Manufacturers of PPE:**
* *Impact:* Manufacturers must ensure their products comply with the updated harmonised standards to maintain presumption of conformity with Regulation EU 2016/425.
* *Action Required:* Adapt production and testing processes to meet the requirements of the new standards (e.g. EN 343:2019), and be aware of the withdrawal dates of the old standards.
**Importers/Distributors of PPE:**
* *Impact:* Importers and distributors must ensure that the PPE they place on the market complies with the updated harmonised standards.
* *Action Required:* Ensure PPE sourced from manufacturers complies with new standards and is appropriately certified.
**Users of PPE:**
* *Impact:* Users benefit from updated safety standards and improved PPE performance.
* *Action Required:* Ensure purchased PPE meets the most current standards for the intended application.
**European Standardisation Organisations (CEN/CENELEC):**
* *Impact:* CEN and CENELEC are responsible for drafting and revising harmonised standards based on the Commission's requests.
* *Action Required:* Continue to develop and update standards as requested by the Commission.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Parliament: One of the legislative bodies of the European Union. It is composed of Members of the European Parliament (MEPs) directly elected by EU citizens.
Council of the European Union: One of the legislative bodies of the European Union, composed of government ministers from each EU member state.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of the EU's powers.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's budget.
Ursula VON DER LEYEN: The President of the European Commission.
CEN: European Committee for Standardization
Cenelec: European Committee for Electrotechnical Standardization
19.5.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 156/13
COMMISSION IMPLEMENTING DECISION (EU) 2020/668
of 18 May 2020
on the harmonised standards for personal protective equipment drafted in support of Regulation
(EU) 2016/425 of the European Parliament and of the Council
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament
and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European
Parliament and of the Council(1), and in particular Article 10(6) thereof,
Whereas:
(1) In accordance with Article 14 of Regulation (EU) 2016/425 of the European Parliament and of the Council(2),
personal protective equipment that is in conformity with harmonised standards or parts thereof, the references of
which have been published in the Official Journal of the European Union, is to be presumed to be in conformity with
the essential health and safety requirements set out in Annex II to that Regulation covered by those standards or
parts thereof.
(2) By letter M/031, entitled βSTANDARDISATION MANDATE TO CEN/CENELEC CONCERNING STANDARDS FOR
PERSONAL PROTECTIVE EQUIPMENTβ, the Commission made a request to the European Committee for
Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to develop and
draw up harmonised standards in support of Council Directive 89/686/EEC(3).
(3) Directive 89/686/EEC was replaced by Regulation (EU) 2016/425 as from 21 April 2018, which brought only a
limited number of changes to the essential health and safety requirements set out in Annex II to Directive
89/686/EEC. The harmonised standards drafted on the basis of request M/031 have been drafted exclusively in
support of essential health and safety requirements, which have remained substantially unchanged following the
replacement of Directive 89/686/EEC by Regulation (EU) 2016/425.
(4) On the basis of the request M/031, CEN and Cenelec drafted the following harmonised standards: EN 893:2019 on
mountaineering equipment, EN 943-2:2019 on protective clothing against dangerous solid, liquid and gaseous
chemicals, EN 1073-1:2016+A1:2018 on protective clothing against solid airborne particles including radioactive
contamination and EN 14458:2018 on personal eye-equipment, in support of Regulation (EU) 2016/425.
(5) On the basis of the request M/031, CEN and Cenelec revised harmonised standards EN 343:2003
+A1:2007/AC:2009, EN 358:1999, EN 381-5:1995, EN 381-7:1999, EN 381-9:1997, EN 381-11:2002, EN
13832-2:2006, EN 13832-3:2006, EN 14594:2005, EN 388:2016, EN 943-1:2015 and EN 12277:2015, the
references of which are published in the C series of the Official Journal of the European Union(4). This resulted in
adoption of, respectively, harmonised standards EN 343:2019 for protective clothing against rain, EN 358:2018 for
belts and lanyards for work positioning or restraint, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-
5:2019 and EN ISO 11393-6:2019 for protective clothing for users of hand-held chainsaws, EN 13832-2:2018 and
EN 13832-3:2018 for footwear protecting against chemicals, EN 14594:2018 for respiratory protective devices, EN
388:2016+A1:2018 for protective gloves against mechanical risks, EN 943-1:2015+A1:2019 for protective
clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols and EN
12277:2015+A1:2018 for mountaineering equipment.
(1) OJ L 316, 14.11.2012, p. 12.
(2) 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 (OJ L 81, 31.3.2016, p. 51).
(3) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal
protective equipment (OJ L 399, 30.12.1989, p. 18).
(4) OJ C 113, 27.3.2018, p. 41.L 156/14 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 19.5.2020
(6) On the basis of request M/031, CEN and Cenelec amended harmonised standard EN ISO 10819:2013, the reference
of which is published in the C series of the Official Journal of the European Union(5). This resulted in adoption of an
amendment to that harmonised standard, EN ISO 10819:2013/A1:2019.
(7) The Commission together with CEN and Cenelec has assessed whether those standards comply with the request
M/031.
(8) The harmonised standards EN 893:2019, EN 943-2:2019, EN 1073-1:2016+A1:2018, EN 14458:2018, EN
343:2019, EN 358:2018, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-5:2019, EN ISO 11393-
6:2019, EN 13832-2:2018, EN 13832-3:2018, EN 14594:2018, EN 388:2016+A1:2018, EN 943-1:2015
+A1:2019, EN ISO 10819:2013 as amended by EN ISO 10819:2013/A1:2019, and EN 12277:2015+A1:2018
satisfy the requirements which they aim to cover and which are set out in Regulation (EU) 2016/425. It is therefore
appropriate to publish the references of those standards in the Official Journal of the European Union.
(9) CEN and Cenelec also drafted corrigendum EN 50321-1:2018/AC: 2018-08 correcting harmonised standard EN
50321-1:2018, the reference of which is published in the C series of the Official Journal of the European Union(6).
Due to the fact that this corrigendum introduces technical corrections and in order to ensure correct and consistent
application of harmonised standard EN 50321-1:2018, the reference of which was previously published, it is
appropriate to publish the reference of this harmonised standard together with the reference of the corrigendum in
the Official Journal of the European Union.
(10) It is therefore necessary to withdraw the references of harmonised standards EN 343:2003+A1:2007/AC:2009, EN
358:1999, EN 381-5:1995, EN 381-7:1999, EN 381-9:1997, EN 381-11:2002, EN 13832-2:2006, EN 13832-
3:2006, EN 14594:2005, EN 388:2016, EN 943-1:2015, EN ISO 10819:2013, EN 12277:2015 and EN 50321-
1:2018, from the C series of the Official Journal of the European Union, given that those standards have been revised,
amended or corrected. In order to give manufacturers more time to prepare for applying harmonised standards EN
343:2019 EN 358:2018, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-5:2019, EN ISO 11393-
6:2019, EN 13832-2:2018, EN 13832-3:2018, EN 14594:2018, EN 388:2016+A1:2018, EN 943-1:2015
+A1:2019, EN ISO 10819:2013 as amended by EN ISO 10819:2013/A1:2019, EN 50321-1:2018 as corrected by
EN 50321-1:2018/AC: 2018-08, and EN 12277:2015+A1:2018, it is necessary to defer the withdrawal of the
references of harmonised standards EN 343:2003+A1:2007/AC:2009, EN 358:1999, EN 381-5:1995, EN
381-7:1999, EN 381-9:1997, EN 381-11:2002, EN 13832-2:2006, EN 13832-3:2006, EN 14594:2005, EN
388:2016, EN 943-1:2015, EN ISO 10819:2013, EN 12277:2015 and EN 50321-1:2018.
(11) Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential
requirements set out in Union harmonisation legislation from the date of publication of the reference of such
standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its
publication,
HAS ADOPTED THIS DECISION:
Article 1
The references of harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425
listed in Annex I to this Decision are hereby published in the Official Journal of the European Union.
Article 2
The references of harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425
listed in Annex II to this Decision are hereby withdrawn from the Official Journal of the European Union as from the dates set
out in that Annex.
(5) OJ C 113, 27.3.2018, p. 41.
(6) OJ C 113, 27.3.2018, p. 41.19.5.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 156/15
Article 3
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
Done at Brussels, 18 May 2020.
For the Commission
The President
Ursula VON DER LEYENL 156/16 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 19.5.2020
ANNEX I
No Reference of standard
1. EN 343:2019
Protective clothing β Protection against rain
2. EN 358:2018
Personal protective equipment for work positioning and prevention of falls from a height β Belts and lanyards for
work positioning or restraint
3. EN 388:2016+A1:2018
Protective gloves against mechanical risks
4. EN 510:2019
Specification for protective clothing for use where there is a risk of entanglement with moving parts
5. EN 893:2019
Mountaineering equipment β Crampons β Safety requirements and test methods
6. EN 943-1:2015+A1:2019
Protective clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols β
Part 1: Performance requirements for Type 1 (gas-tight) chemical protective suits
7. EN 943-2:2019
Protective clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols β
Part 2: Performance requirements for Type 1 (gas-tight) chemical protective suits for emergency teams (ET)
8. EN 1073-1:2016+A1:2018
Protective clothing against solid airborne particles including radioactive contamination β Part 1: Requirements
and test methods for compressed air line ventilated protective clothing, protecting the body and the respiratory
tract
9. EN ISO 10819:2013
Mechanical vibration and shock β Hand-arm vibration β Measurement and evaluation of the vibration
transmissibility of gloves at the palm of the hand (ISO 10819:2013)
EN ISO 10819:2013/A1:2019
10. EN ISO 11393-2:2019
Protective clothing for users of hand-held chainsaws β Part 2: Performance requirements and test methods for leg
protectors (ISO 11393-2:2018)
11. EN ISO 11393-4:2019
Protective clothing for users of hand-held chainsaws β Part 4: Performance requirements and test methods for
protective gloves (ISO 11393-4:2018)
12. EN ISO 11393-5:2019
Protective clothing for users of hand-held chainsaws β Part 5: Performance requirements and test methods for
protective gaiters (ISO 11393-5:2018)
13. EN ISO 11393-6:2019
Protective clothing for users of hand-held chainsaws β Part 6: Performance requirements and test methods for
upper body protectors (ISO 11393-6:2018)
14. EN 12277:2015+A1:2018
Mountaineering equipment β Harnesses β Safety requirements and test methods19.5.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 156/17
No Reference of standard
15. EN 13832-2:2018
Footwear protecting against chemicals β Part 2: Requirements for limited contact with chemicals
16. EN 13832-3:2018
Footwear protecting against chemicals β Part 3: Requirements for prolonged contact with chemicals
17. EN 14458:2018
Personal eye-equipment β High performance visors intended only for use with protective helmets
18. EN 14594:2018
Respiratory protective devices β Continuous flow compressed air line breathing devices β Requirements, testing
and marking
19. EN 50321-1:2018
Live working β Footwear for electrical protection β Insulating footwear and overboots
EN 50321-1:2018/AC:2018-08L 156/18 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 19.5.2020
ANNEX II
No Reference of standard Date of withdrawal
1. EN ISO 10819:2013 19 November 2021
Mechanical vibration and shock β Hand-arm vibration β Measurement and evaluation
of the vibration transmissibility of gloves at the palm of the hand (ISO 10819:2013)
2. EN 343:2003+A1:2007 19 November 2021
Protective clothing β Protection against rain
EN 343:2003+A1:2007/AC:2009
3. EN 358:1999 19 November 2021
Personal protective equipment for work positioning and prevention of falls from a
height β Belts for work positioning and restraint and work positioning lanyards
4. EN 381-5:1995 19 November 2021
Protective clothing for users of hand-held chain saws β Part 5: Requirements for leg
protectors
5. EN 381-7:1999 19 November 2021
Protective clothing for users of hand-held chainsaws β Part 7: Requirements for
chainsaw protective gloves
6. EN 381-9:1997 19 November 2021
Protective clothing for users of hand-held chain saws β Part 9: Requirements for chain
saw protective gaiters
7. EN 381-11:2002 19 November 2021
Protective clothing for users of hand-held chainsaws β Part 11: Requirements for upper
body protectors
8. EN 388:2016 19 November 2021
Protective gloves against mechanical risks
9. EN 943-1:2015 19 November 2021
Protective clothing against dangerous solid, liquid and gaseous chemicals, including
liquid and solid aerosols β Part 1: Performance requirements for Type 1 (gas-tight)
chemical protective suits
10. EN 12277:2015 19 November 2021
Mountaineering equipment β Harnesses β Safety requirements and test methods
11. EN 13832-2:2006 19 November 2021
Footwear protecting against chemicals β Part 2: Requirements for footwear resistant to
chemicals under laboratory conditions
12. EN 13832-3:2006 19 November 2021
Footwear protecting against chemicals β Part 3: Requirements for footwear highly
resistant to chemicals under laboratory conditions19.5.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 156/19
13. EN 14594:2005 19 November 2021
Respiratory protective devices β Continuous flow compressed air line breathing
apparatus β Requirements, testing, marking
EN 14594:2005/AC:2005
14. EN 50321-1:2018 19 November 2020
Live working β Footwear for electrical protection β Insulating footwear and overboots