the new ppe regulation (eu) 2016/425

1

The New

PPE Regulation (EU) 2016/425

Dave Tuplin

Certification Manager, BSI

Copyright © 2016 BSI. All rights reserved.

2

PPE Regulation (EU) 2016/425 changes

Agenda

• Who is BSI

• Landscape and timeframes

• Scope of the new PPE Regulation

• Categorisation under the PPE Regulation

• Modules under the PPE Regulation

• Module B

• Module C2

• Module D

• Kitemark and PPE Regulation

• Summary


3 Copyright © 2016 BSI. All rights reserved.

Who is BSI?

• Leading Global Standards Creation Body: British, European, ISO, Public, Private

• The UK National Standards Body: The source of British Standards

• Specialist Focus on Standards Creation, Training and Certification

• Experienced: The world’s first National Standards Body established in 1901 and a founding member of ISO

• Thought Leaders: Shaped the world’s most adopted standards, incl. ISO 9001, ISO 14001, OHSAS 18001

• Trusted: We’re a Royal Charter Company, reinvesting profits back into our business to improve our clients’ experience

• Global Network: 80,000 clients in 172 countries worldwide including governments, global brands and SME’s

4 Copyright © 2016 BSI. All rights reserved.

A truly global brand and network – trusted and recognized

4

80,000 clients

172 Countries

75 Offices

• Clients in 172 countries

• 75 offices worldwide

• 3 regional hubs in

UK, US and Hong Kong

5

Product Specification Standards

Over 100 years expertise shaping global standards to facilitate trade and improve business

• Beginning in 1901, initial Standards focused on product specifications to harmonize and facilitate commerce and reduce duplication

• Railroad gauges

• Steel specifications

• Construction standards

• Agricultural commodities

• Consumer and electrical products

• Personal safety equipment

• Medical devices

• Product Specification Standards remain relevant today driving interoperability and innovation in areas such as smart cities and regenerative medicine (e.g. stem cells)

• The next generation of standards focused on business processes to ensure consistent quality output

• BSI shaped the original standards for:

• Quality Management (ISO 9001)

• Information Security (ISO/IEC 27001)

• Environment Management (ISO 14001)

• Health & Safety (OHSAS 18000)

• IT Services Management (ISO/IEC 20000-1)

• Business Continuity (ISO 22301)

• Sustainable Events (ISO 20121)

• BSI’s new generation of Standards are centred around people behaviour and values to help organizations reach their full potential and protect their corporate reputation

• Key standards include:

• Anti-Bribery

• Corporate Social Responsibility

• Collaborative Business Relationships

• Cyber Security

• Customer Service

Founded 1901 1950

2000

5

Product Specification Standards Business Process Standards Business Potential Standards


6

The PPE Directive Landscape

One of the first new Approach Directives

Now almost 30 years old

New technologies need to be reflected

2015-16 development of Regulation and final adoption

12 February ‘16

2016-2017

Period of transition for Notified Bodies and Member States

2019 onwards New Regulation (EU) 2016/425 applies

Throughout 2018-9 12 months to work to either the old PPE Directive or new PPE Regulation


7

Timescales for implementation


8

Timescales for implementation

Key Dates

• PPE Directive 89/686/EEC is repealed with effect from 21 April 2018

• This PPE Regulation (EU) 2016/425 shall apply from 21 April 2018

• Member States shall not impede the making available on the market of products covered by the old PPE Directive 89/686/EEC before 21 April 2019

• EC type-examination certificates issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date


9

The new PPE Regulation (EU) 2016/425: scope

‘This Regulation applies to PPE’

Definitions;

'personal protective equipment' (PPE) means:

a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;

b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;

c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;


10

PPE Regulation (EU) 2016/425: exemptions

This Regulation does not apply to PPE:

(a) specifically designed for use by the armed forces or in the maintenance of law and order;

(b) designed to be used for self-defence, with the exception of PPE intended for sporting activities;

(c) designed for private use to protect against:

(i) atmospheric conditions that are not of an extreme nature,

(ii) damp and water during dishwashing;

(d) PPE use on seagoing vessels or aircraft

(e) helmets and their visors for drivers and passengers of motor cycles and mopeds.


11

Understanding the changes Who is now responsible for compliance?

Old PPE Directive

89/686/EEC

Manufacturers

Authorised Representatives

New PPE Regulation

(EU) 2016/425

Manufacturers

Authorised Representatives

Importers/Distributors


12

Obligations on Importers and Distributors

Article 10 and 11 • Importers and Distributors shall place only compliant PPE on the market

• Before placing PPE on the market, Importers and Distributors shall ensure that the appropriate conformity assessment procedures have been carried out by the manufacturer

• Where an Importers and Distributors considers or has reason to believe that PPE is not in conformity he shall not place it on the market. Furthermore, the importer shall inform the manufacturer and the market surveillance authorities to that effect

• Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity

• Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted


13

Documentation needed by Importers and Distributors

So what do you need?

• Copy of the Manufacturers Module B EU Type Examination Certificate AND (if applicable) a copy of the Module C or D certificate

• The Declaration of Conformity for the product you are handling

• Ensure the User Instructions are in the correct language

• Be prepared to hold records for at least 10 years


14

Understanding the changes Categorisation of PPE PPE Directive

89/686/EEC New PPE Regulation

(EU) 2016/425

Category I Simple PPE

Category II Intermediate PPE

Category III Complex PPE

Category I Simple PPE

Category II Intermediate PPE

Category III Complex PPE


15

Categorisation of PPE under Regulation (EU) 2016/425

Category definitions – Annex I

Category I - includes exclusively for minimal risks

Category II - risks other than those listed in Categories I and III

Category III - includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health


16

Categorisation of PPE

Category I - Simple PPE

• superficial mechanical action • minor impacts and lesions • contact with hot surfaces <50°C • atmospheric conditions that are

not exceptional • sunlight (sunglasses)

PPE Directive 89/686/EEC

• superficial mechanical injury • contact with hot surfaces <50°C • atmospheric conditions that are

not of an extreme nature • exposure to sunlight (not

observing the sun) • contact with cleaning materials

weak action or prolonged contact with water

New PPE Regulation (EU)

2016/425


17


Category II – Intermediate PPE


Category II includes risks other than those listed in

Categories I and III

Category II includes risks other than those listed in

Categories I and III


New PPE Regulation (EU)

2016/425

18


Category III - Complex PPE


• filtering respiratory devices • respiratory protective devices • PPE for chemical attack or ionizing

radiation • high-temp environments >100 °C • low-temp environments <-50 °C • Fall arrest • PPE against electrical risks

• substances & mixtures hazardous to health

• oxygen deficient atmospheres • harmful biological agents • ionising radiation • high- air temp environments >100°C • low-air temp environments <-50°C • falling from a height • electric shock and live working • drowning • cuts by hand-held chain-saws • high-pressure jets • bullet wounds or knife stabs • harmful noise


New PPE Regulation (EU) 2016/425

19

Categorisation of PPE under Regulation (EU) 2016/425

Significant changes

• Substances & mixtures hazardous to health (a catch all)

• Life Jackets moving from Category II to Category III

• Hearing protection moving from Category II to Category III

• Clarification and specific references in Category III for e.g.;

• PPE to protect against cuts by hand-held chain-saws

• PPE used high-pressure jet cutting operations

• bullet wounds or knife stabs


20

The PPE Regulation (EU) 2016/425 modules The Regulation changes from articles to modules and falls in line with terminology used in similar European legislation

PPE Category Activity Old PPE Directive 89/686/EEC

New PPE Regulation (EU) 2016/425

Cat I Simple PPE Placing product onto the market

Manufacturers self declaration

Module A (Annex IV) Manufacturers self

declaration

Both Cat II Intermediate PPE

and Cat III Complex PPE

Initial product approval Article 10 EC Type

Examination

Module B (Annex V) EU Type

Examination

Cat III Complex PPE only

On-going surveillance through testing

Article 11A Module C2 (Annex VII)

or

Cat III Complex PPE only

On-going surveillance through factory auditing

Article 11B Module D (Annex VIII)


21

The PPE Regulation (EU) 2016/425 modules

Module B – EU Type Examination (Annex V) Similar to current Article 10 process

EU type-examination is the part of a conformity assessment procedure in which a Notified Body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of this Regulation that apply to it.

On completion manufacturer is given EU Type examination which has a max 5 year validity

The Notified Body shall keep a copy of the documents for 5 years after the expiry of the certificate

The manufacturer shall keep a copy of the technical documentation for 10 years after the PPE has ceased production.


22


Module B (Annex V) – EU Type Examination certificate renewal

The manufacturer shall ensure that the PPE continues to fulfil the applicable essential health and safety requirements in light of the state-of-the-art.

The manufacturer shall ask the Notified Body to review the EU Type Examination certificate either:

(a) in the case of a modification to the product or documentation

(b) in the case of a change in standards, Essential Health & Safety Requirements or

state-of-the art

(c) at the latest, before the date of expiry of the certificate.

The manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU Type Examination certificate.


23


Module C2 (Annex VII) Similar to Article 11A

• The Notified Body shall carry out product checks in order to verify the consistency of production

• The product checks shall be carried out at least once a year and at random intervals

Where the C2 Notified Body is not the body that issued the relevant EU type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production

If the examination and testing reveal that the production is not consistent, the Notified Body shall take measures appropriate to the fault(s) recorded and inform the Notifying Authority


24

The PPE Regulation (EU) 2016/425 Modules

Module D (Annex VIII)

Similar to Article 11B The manufacturer shall maintain a documented quality system The manufacturer shall lodge an application for assessment of his quality system with a single Notified Body of their choice Similar activities are assessed by the Notified Body as current 11B during periodic audits, at least once a year


25

EU Declaration of Conformity for PPE Regulation (EU) 2016/425

Annex IX

The contents for the declaration of conformity is contained within Annex IX of the Regulation – Similar in structure to the old PPE Directive

Major change

The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the products user instructions and information or web link as to where EU declaration of conformity can be accessed


26

• PPE Regulation (EU) 2016/425 has now published. • Two years to transition • After three years PPE Regulation only

• Specific scope and exclusions • Now has provisions for distributors and importers • Changes to module names (OLD Article 10, 11A & 11B – NEW Modules B, C2 & D) • Changes is product categorisation; life jackets and hearing to Category III • Bespoke PPE covered by the Regulation • Declaration of Conformity (or web link) available with each product • 5 years validity for EU Type Examination certificates from April 2018

Summary

27

REMEMBER!


28

Use of the BSI Kitemark™

PPE Regulation & Differentiation

Chrishna Vaja,

Propositions Manager, BSI


29

We run PPE Kitemark schemes for industrial safety helmets, equestrian

helmets and safety eyewear.

Requirements are that a product is tested to and meets a ‘published

standard’ and the manufacturer has a quality system which meets the

requirements of ISO 9001.

Once a licence is issued there are regular on-going product testing and

factory assessments.

Use of the BSI Kitemark to meet PPE Regulation requirements


30

Use of the BSI Kitemark to meet PPE Regulation requirements

The activities manufacturers use to maintain their Kitemark

certificates can be used to maintain their legal regulatory

requirements


31

Why do more than CE marking?

BSI Kitemark goes beyond meeting minimum legal safety

requirements and delivers a reassurance of quality, trust and

safety to the end user.

Differentiation

Commercial

Advantage


32

Use of the BSI Kitemark to meet PPE Regulatory requirements


Activity PPE Regulation (EU) 2016/425

Kitemark process

Pre-market approval

Module B Type Test Test data can be used for both

On-going surveillance

Module C2

OR

Module D

Twice annual product audit test

AND

Continuing

Assessment Visit

Kitemark audit can be used for

Module C2

A CAV can be combined with

Module D

33

Initial Assessment

Type testing

Certification Evaluation

KM Award

Continuing Assessments

Audit Testing

Initial Assessment – Stage 1: Pre-Audit Visit of the Quality Management System Stage 2: Initial Assessment visit for QMS & Manufacturing processes Type testing Certification evaluation by BSI Certification Manager and recommendations made BSI’s Compliance and Risk Team review and if successful, award BSI Kitemark On-going continuing assessment visits On-going audit testing of products

BSI Kitemark™ a brief overview of BSI’s rigorous process

34

• Consistency of performance of products, independently tested by BSI against recognised industry standards

• Evidence of a manufacturer’s due diligence:

• Commitment to using current standards to benchmark their products

• On-going commitment to quality manufacturing, with samples tested annually

• Customer focused approach

• Reassurance of product quality

What reassurance will BSI Kitemark give you?


35

Clear choice for the end user

All Kitemark approved products are listed on

www.bsigroup.com/kitemark

How to be sure product is BSI Kitemark approved?


http://www.bsigroup.com/kitemark

36

How is BSI Kitemark valued? Our survey said…

• Consumers associate BSI Kitemark with rigour

• Consumers know that products and services displaying BSI Kitemark are tried and tested

• Consumers trust products and services displaying the BSI Kitemark

• 58% of consumers say BSI Kitemark is an indication of quality


37


38

Useful links

PPE Regulation webpage

BSI Kitemark information

Kitemark Directory – search for a BSI Kitemark approved product or service

Product Development and Manufacturing Seminar – 24 November, Hemel Hempstead

OHSAS 18001 information


http://www.bsigroup.com/en-GB/our-services/product-certification/industry-sector-schemes/personal-protective-equipment-ppe/PPE-regulation-revision-uk/PPE-revision-webinars/PPE-webinars-form/





http://www.bsigroup.com/en-GB/Product-Directory/









http://www.bsigroup.com/en-GB/our-services/events/2016/product-certification-event/




http://www.bsigroup.com/en-GB/ohsas-18001-occupational-health-and-safety/

39

Thank you

Any Questions?

If you want a copy of the slides please pass on your business card to us


the new ppe regulation (eu) 2016/425

Documents