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PPE – Covid 19 Training

May 2020

Chris Smith & Vicki Burch

• Overview of the applicable PPE legislation and enforcement powers

• Understanding the current easements for PPE during Covid 19 pandemic by way of the EU Recommendation 2020/403 alongside the OPSS Guidance

• Practicalities on the ground:-

• How the easements affect Trading Standards enforcement & MS activities

• Identification and classification of applicable PPE products for Covid 19

• Relevant standards & alternative international standards

• Examples of good and bad PPE products and certification seen during Covid 19

• Tips and hints on identifying genuine and compliant PPE

• Emerging Issues

Course objectives for the second training section on PPE

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Legislation: Regulation EU 2016/425 –Personal Protective Equipment

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• Regulation (EU) No 2016/425

• UK Enforcement Regulations - The Personal Protective Equipment (Enforcement) Regulations 2018

• PPE Regulation (EU) 2016/425 applied from 21st April 2018 and repealed the Directive PPE Directive 89/686/EEC

• EC Type Certificates issued to Directive 89/686/EEC remain valid until 21st April 2023 unless they have an expiry date prior to this date

• Definition of PPE –

“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;

Definition of Risk – “a risk which may result in harm to the health or safety of persons, domestic animals or property, if personal protective equipment (“PPE”) is used in a normal and predictable manner”

• Brings in a number of important changes for actors in the supply chain

PPE Regulation Overview

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Categories of PPE:-

3 classes of PPE:- Categories 1, 2 and 3

Category is based upon the hazard being protected from, not the complexity of the PPE

• Category 1 - low risk PPE, manufacturers can self certify compliance e:g: sunglasses & oven gloves

• Category 2 - PPE not in Categories 1 or 3, product requires type approval but manufacturers self declare on production control. No NB number required on product. Examples: high viz jackets, protective gloves

• Category 3 - PPE where hazard may cause serious harm including biological agents. Products must be type approved and production control reviewed by NB through either audit or sample testing. Examples: hardhats, respirators.

All PPE for protection against Covid19 is Category 3

• Exemptions include:- Motor cycle helmets & PPE designed for private use to protect against;

• Atmospheric Conditions that are not of an extreme nature

• Damp and water during dishwashing

PPE Regulation Overview (cont’d)

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Article 14 Presumption of conformity of PPE

PPE which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.

Harmonised Standards

BS EN 149:2001+A1:2009

Previous standard was EN 149:2001

Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking

Three categories of masks - FFP3, FFP2 and FFP1.

The performance of filtering facepieces tested against requirement in this standard

Materials

Practical performance

Leakage

Flammability

Strength

Breathing resistance

Filter penetration

EN 149 - standard for testing respirator PPE

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Legislation:The Personal Protective Equipment (Enforcement) Regulations 2018

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• Reg 3 - Market Surveillance Responsibilities

Private use or consumption PPE

• GB:- LA Weights & Measures (TS) – within own area

• NI:- District councils – within own area

PPE designed for use or operation, whether exclusively or not, by persons at work

• GB:- the Health and Safety Executive

• NI:- the Health and Safety Executive for Northern Ireland

• Reg 4 – Creates the duty for MS Authorities to enforce EU 2016/425, EU 765/2008 (RAMS) applicable to PPE and the UK enforcement Regs.

• Reg 5 - Enforcement powers under the Consumer Protection Act 1987.

• Note:- Consumer Rights Act – has now been amended to include the new PPE Enforcement Regulations 2018.

The Personal Protective Equipment (Enforcement) Regulations 2018

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• Reg 7 - Offences – details those listed in the Articles of the Regulation EU 2016/425

• Reg 8 - Summary conviction offences

(a) In England and Wales, to a fine or imprisonment for a term not exceeding three months, or to both;

(b) in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding three months,

• Reg 11 - Time limits – 12 months from knowledge by Prosecutor and 3 years after commission

• Reg 9 - Due Diligence Defence

• Sch.1 - Lists the enforcement powers from the 1987 Consumer Protection Act

• Sch.4 - Brings in powers to issue enforcement notices for ‘non-compliant PPE’ - compliance, withdrawal and recall

The Personal Protective Equipment (Enforcement) Regulations 2018 (cont’d) - Offences

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Supply Chain Operators - Legal Obligations

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Regulation (EU) 2016/425 – Art. 13 Details the responsible persons in the supply chain – collectively termed as “economic operators”

This includes (but is not limited to) the following types of organisations;

Manufacturers – Art.8

Includes anyone who places on the market under their own name or trademark or modifies a product before bringing to the market PPE products

Authorised Representative – Art. 9

Someone acting on behalf of the manufacturer to provide specific tasks in relation to the PPE to the market by mandate

Importers – Art.10

Someone with responsibility of providing the PPE to the market from outside of the EU (3rd Country)

Distributors – Art.11

Anyone making PPE available to the market who is not a Manufacturer or Importer

Economic Operators in the Supply Chain

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• Has ultimate responsibility for legal compliance including processes carried out by other parties

• Must hold technical documentation demonstrating compliance (for 10 years) – Annex III

• Ensure PPE meets the EHSR’s

• Carry out applicable conformity assessment procedure:-

• Appoint a Notified Body to assess design to obtain the Module B EU Type Examination Certificate

• Appoint a Notified Body to Assess series production control (Module C2 or D)

• When designing & manufacturing PPE and drawing up the instructions, must envisage the reasonably foreseeable uses of the PPE

• Affix CE Mark & Notified Body number of the NB assessing production control

• Mark product with type/batch or serial number & Name and postal address,

• Draw up Declaration of Conformity – provide with PPE or via web address

• Ensure the PPE is accompanied by User Instructions

Manufacturer Obligations

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13

PPE Category PPE Directive 89/686/EEC PPE Regulation (EU) 2016/425

Category IManufacturers self-

declaration

Module A –

Internal Production Control

Category IIArticle 10 – EC Type

Examination

Module B –

EU Type Examination Plus

Module C –

Internal Production Control

Category III

Article 10 – EC Type

ExaminationModule B –

EU Type Examination plus either

Article 11A –ongoing

surveillance

through testing or

Module C2 –

Sample Testing

or

Article 11B – ongoing

surveillance

through factory auditing

Module D –

Production Quality Assurance

Compliance routes

Route to Conformity Assessment

A manufacturer may, by a written mandate, appoint an authorised representative.

• The obligations in Art. 8(1) and the obligation to draw up the technical documentation Art. 8(2) shall not form part of the authorised representative's mandate.

• An authorised representative shall perform the tasks specified in the mandate from the manufacturer.

• The mandate shall allow the authorised representative to do at least the following:

(a) keep the DoC and technical documentation for 10 years at the disposal of the competent authorities

(b) provide all the information and documentation necessary to demonstrate the conformity of the PPE to a reasoned request by a competent authority

(c) cooperate with the competent authorities, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative's mandate.

Authorised Representative

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• Assure themselves that product is compliant before placed on the market

• Confirm appropriate Conformity Assessment has been carried out

• Confirm Manufacturer has drawn up technical documentation, affixed CE mark and name and address

• Indicate their own name and address, trade mark (on product, packaging or document)

• Product is accompanied by user instructions in language of country product is available

• Obtain and keep a copy of the manufacturer’s Declaration of Conformity - 10 years

• Assure themselves that upon request manufacturers will supply technical documentation

Importer Obligations

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• When making PPE available on the market, distributors must act with due care in relation to the requirements of the Regulation

• Distributors shall verify that :-

• it bears the CE mark,

• is accompanied by the required instructions in a language understood by end-users in the country PPE is available

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

• Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with this Regulation shall withdraw it or recall it.

• Furthermore, where the PPE presents a risk, distributors shall immediately inform the competent national authorities giving details, in particular, of the non-conformity and of any corrective measures taken.

• Co-operate with reasoned request for documentation demonstrating conformity of PPE to MS Authority

Distributer Obligations

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EU Recommendation 2020/403 & UK Covid 19 Easements

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• Issued on the 13th March 2020 by the EU Commission –https://ec.europa.eu/newsroom/growth/item-detail.cfm?item_id=672953

• Guidance from the EC has been provided at the bottom of the above link

• Relates to specific PPE to be used by Healthcare workers involved in managing the Covid19 pandemic including

• Request NB to treat such work as a priority

• Encourages Technical Specifications based on existing standards as proof of conformity/suitability for healthcare use

• Compliance with existing PPE Regulation and/or Medical Devices Directive EHSR’s

EU Recommendation 2020/403

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Summary details from OPSS ‘Guidance to High Volume Manufacturers of PPE for Covid 19’ -https://www.gov.uk/guidance/opss-coronavirus-covid-19-guidance-for-business-and-local-authorities

Route 1 - PPE For NHS/Healthcare workers procured by Central Government ONLY:-

• Does not need a CE Mark

• Does not need to have started the conformity assessment procedure

• Does not need a Declaration of Conformity

• Must continue to meet the essential health and safety requirements – set out in Annex II of the Regulation.

• Must be manufactured to any of the following: -

❖ a relevant European Standard

❖ in accordance with a standard referenced in the WHO guidelines

❖ or to an alternative technical solution that delivers adequate safety

• Product procured in this way must be approved by the cross-Government Decision Making Committee (Incl. HSE, DHSC, MHRA & OPSS)

• Must not be offered to any other users/general public/retailers etc.

NB: This easement does not apply to Local Authority procurement.

2 Routes to Easement compliance - UK

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Large Scale Manufacture:-

Route 2 - PPE specifically needed for protection in context with Covid 19 to be placed on the market:-

1. Must meet the EHSR - set out in Annex II or WHO Referred Technical Specification

2. Must be assessed in line with the regulatory easements in EU Recommendation 2020/403

3. Must have started the conformity assessment procedure with a Notified Body AND gain assurance from NB that product has adequate level of H&S in accordance with ESHR’s

4. Must produce confirmation of point 3 above

5. Does not need to have a CE mark at this time

6. Does not need to have a DoC at this time – yet need to secure all applicable documentation at the end of the process

2 Routes to Easement compliance (cont’d)

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Small Scale Manufacture:-

Route 2 - PPE specifically needed for protection in context with Covid 19 to be placed on the market:-

1. Must meet the EHSR - set out in Annex II or alternative Technical Specification (US or referred in WHO Guidelines)

2. PPE needs to be assessed as safe

3. Start and obtain NB acceptance of PPE in the Conformity assessment procedure

4. Obtain NB agreement that PPE meets the EHSR’s

5. Must produce confirmation of points above

2 Routes to Easement compliance (cont’d)

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What does this all mean for Trading Standards?

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Product Examination

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• Main area of focus on non-compliant PPE - Face masks

• Highlighting increasing need for vigilance due to number of non-compliant products & fake documentation circulating within the Marketplace.

• What are we already contending with?

Areas of product safety concern – during & post Covid 19

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For CE Marked PPE – is it a genuine product?

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What regulation is being declared? Needs to be compliant with the Regulation

• It should be EU 2016/425. Reference to Directive 89/686/EEC (revoked) it may be more likely to be a fraudulent claim, particularly if it is dated 2020.

• If there is no visible NB number on the product, documentation or certificates then it either has not been through the correct process or it is lower grade PPE that is not intended for Covid 19 use.

• What standards are being declared in compliance with? Harmonised standards are listed here: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/personal-protective-equipment_en

• The Notified Body Number is it real, Is the NB approved for PPE? This can be checked here: https://ec.europa.eu/growth/tools-databases/nando/

• Is there a copy of the Manufacturers Declaration of Conformity? Remember it is a legal requirement for the Importer to hold a copy.

• Have you got a picture of the product and packaging? What is written on the PPE? Do they match ?

Types of FFP respiratory masks we may come across

• Detailed in En149 – Respiratory protective devices. Filtering half masks to protect against particles

• FFP = ‘Filtering Facepiece’ – designed for filtering out particles

➢ FFP 1 – Lowest level of protection – not recommended for Covid 19 protection

➢ FFP 2 – Filters 94% of airborne particles

➢ FFP 3 - Highest level of protection. Protects against Liquid & Solid aerosols. Filters 99% airborne particles

• PPE Respiratory Masks can have exhalation valves but not mandatory

For CE Marked PPE – is it a genuine product? (cont’d)

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What are we looking for?

• Different levels of marking and compliance dependent upon when the product was placed on the market, under which easement regime or none at all.

• Respiratory masks - Caught by PPE legislation only

• PPE must still meet essential health and safety requirements of the legislation

• No DoC or CE mark – so what documentation do they have to show they meet EHSR’s?

• Traceability evidence

• Must be accompanied by Instructions for use

• What assurances can you get from Notified Body?

For non - CE marked PPE – is it a genuine product made within the remit of Recommendation 403?

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Typical features – ‘Good’ example

Exhale valve

present (optional)

Nose clip (optional)

Two head straps,

can be one

continuous loop

Identification

markings

Manufacturers markings

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Typical features

Faceseal in

different materials

No facesealFoam seal around

nose area

Adjustable strapsNon-adjustable

straps

Identification markings

Example of what good looks like for product markings

Man. Product code European

Standard

Class of

respiratorConformity mark

and Notified Body

Markings3M 8835 EN149:2001 FFP3 CE0086

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‘Bad’ Examples - non-compliant masks

Claims to be

N95 but no details

of standard numbers

Incorrect CE marking,

should have 4-digit

number

representing notified

body

Ear Loops such as these are a quick indicator that the product is not made to EN149.

‘Bad’ Examples - non-compliant masks

Examples of Counterfeit respirators to

the NIOSH standard can be found

at https://www.cdc.gov/niosh/npptl/user

notices/counterfeitResp.html

Claims to be

N95 but gives details

of Chinese standard

Claims to be N95 and

FFP3. These are

not equivalent masks

so cannot be

the same

Note the shape of the mask and the holes

for the string.

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• EN 149-2001 for FFP2 class respirators – Europe

• N95 (US) - NIOSH-42CFR84 for N95 class respirators – equivalent to FFP2

• KN95 – GB2626-2006 (Chinese domestic standard) – are equivalent to FFP 2

GB2626 is almost equivalent of EN149. Difference is:- FFP2 is third party assessed, KN95 is self declaration only – not tested to technical standard

• AS/NZ 1716:2012 for P2 class respirators – Australia

• KMOEL - 2017-64 for 1st class respirators – Korea

• Japan JMHLW Notification 214, 2018 for DS class respirators – Japan

• GB 32610 – Chinese domestic standard for pollution barrier masks not MD or PPE

Note: GB does not stand for Great Britain. They are Chinese domestic standard numbers.

• Check Chinese Accredited Laboratories (CNAS):- https://www.cnas.org.cn/english/index.shtml

Masks: Equivalent standards throughout the world

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Medical Devices – face masks legislation crossover?

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Medical Devices Regulations 2002 (EU Directive 93/42/EEC) – transposing to – EU Regulation 2017/745

• W&M Authority has Duty to enforce re: Consumer Goods – as defined

• Essential Requirements - Annex I

• Class 1 Medical Devices

• Relevant EU Standard for surgical masks - BS EN 14683

2 Class types (Type I and Type II) – distinguished by level of bacterial filtration efficiency (BFE)

• Type I – General Use

• Type II or Type II R – Medical Staff & 'R' signifies splash resistance.

Mask Performance Requirements

• Type 1 - BFE > 95%

• Type II - BFE > 98%

• Type II R (Fluid Resistant Type surgical mask - FRSM) - BFE > 98%

NB – some medical devices may also be PPE and will be covered by both the PPE Regulation and The Medical Devices Regulation

Surgical Masks – Cont’d

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Class 1 Medical Device:-

Can be self certified and must be CE marked

Labelling Requirements

Sterile Masks:- Need NB involvement for sterile production control – do they have a QMS (ISO 9001/BS EN 13485)

Consider intended protection for whom/ what is being claimed

Surgical masks (not to be confused with a PPE FFP respirator masks)

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Certificate and Supporting Document Examination: Is it genuine?

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Lets look at some certificates – not genuine

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What are we looking for?

Check the ESF website below:-

Lists suspicious and known fake certificates & DoC’s

https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe

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Lets look at some certificates – non-compliant

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Lets look at some certificates

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Module B EU Type Examination Certificate

EU Type Examination Certificate

Certificate 00001001

PPE Suppliers Ltd100 The Street

Anytown

AB1 2DE

It is certified that the manufacturers technical files and the PPE

products detailed on this certificate have been assessed and found to

be in accordance with

PPE Regulation (EU) 2016/425Module B, EU type-examination

Date of Issue: 05 April 2020

Date of Expiry: 04 April 2025

FFP 2 Face Mask - 41235

It is certified that the manufacturer’s technical file and the

above mentioned PPE have been assessed and found to meet

the essential Health & Safety Requirements in Annex II of

Regulation (EU) 2016/425 Personal Protective Equipment

Certification is based on technical file reference ABC001 and test

results as detailed on following pages

This certificate remains the Property o we test to whom it must be

returned on request

01

01

Authorised byWe Test Labs

London

WA1 123

www.wetest.co.uk

Certificate Number

Manufacturer

name and

address

Approval to PPE

Regulation

Date of issue &

Date of Expiry

Product description and

coding

Notified Body Name and

number

Signature of

authorised person at

Notified Body

Name, address and

number of Notified

Body

Subsequent pages

with test details etc.

listed

WE

TE

ST

La

b

Declaration of Conformity

EU Declaration of Conformity No.

00123678This declaration of Conformity is issued under the sole responsibility of

the manufacturer:

PPE Suppliers Ltd

100 The Street

AnyTown

AB1 2DE

Luna FFP 2 Face Mask

Code: 41235 – Category III PPE

With valveVarious Batch Numbers apply

The product referenced in this Declaration satisfies the essential Health

& Safety requirements of Regulation (EU) 2016/425 Personal Protective

Equipment

The product referenced in this declaration is issued in compliance with

the following harmonised Standards

BS EN 149:2001+A1:2009– Respiratory Protective Devices

EU Module B Type Certificate number: 00001001 Refers

EU type Examinations by:

We Test Lab

London

WA1 123

Notified Body No: 0101

Module D QA Assessment by:

SAGA United LtdLondon

WA2 345

Notified Body No: 2222

Authorised and approved:

05/04/2020

Issued by:

Company

LogoTitle and Number of

D of CName and

Address of

manufacturer

Description & code

of PPE

Declaration of

Compliance with

PPE Regulation

Declaration of

Compliance with specific

Standards Details of Module

B Certificate(s)

Details of Notified

Body who issued

Module B

Certificate(s)

Details of Notified

Body who conduct QA

Module Assessment

Details of who (person)

issued D of C and date of

issue

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Product & Document Examination: Summary & Best Practice

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• Risk assess what you have

• Question the Traceability

• Start with the basics: N&A of Importer/MFR/Auth Rep

• Utilise available checklists (BSIF & Suffolk) & Essential Technical Specifications (MHRA & HSE)

• Consider the Importer/Distributer’s level of knowledge of PPE - What is their usual business activity?

• What standards are being claimed product is tested to? Is it correct?

• Does it meet the Easement requirements – started NB Conformity assessment procedure

• Where in the supply chain do products you are examining fit (Use at Work – LA Procurement - Consumer retail –B2B)

• What claims are being made on marketing material/social media or websites?

To Summarise:-

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Emerging issues:-

1) Face Coverings:- Are they PPE, Medical Devices or GPSR?

2) GPSD:- Art. 3 – conformity assessment:-https://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:011:0004:0017:en:PDF

“reasonable consumer expectations concerning safety”

3) Business Advice to employers that have supplied staff with the wrong level of PPE or fake PPE

4) Enforcement of Local Authority Procurement issues

And finally….

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• A number of checklists and useful documents are available for all participants

• Fast moving environment - Keep up to date with the Gov.uk website https://www.gov.uk/guidance/opss-coronavirus-covid-19-guidance-for-business-and-local-authorities

Checklists & Useful Reading Document Links

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