How to get safetyfootwear CE

marked

The European Union and the UnitedStates of America are the worldslargest safety footwear markets. Bothhave comprehensive legislationcovering the workplace environmentand performance requirements forsafety footwear. Although other partsof the world have different legislation,the industrial hazards are generallyvery similar. Regardless of country,protective and safety footwear oftenincorporates similar features, such assafety toecaps and under-footprotection. More specialist footwearhas been developed to protect againstother physical risks, such as cutting bychainsaws, or environmental hazardsassociated with chemicals, heat andelectricity.The European Personal Protective

Equipment (PPE) Directive 89/686/EECdefines PPE as clothing and equipmentdesigned to be worn or held by anindividual for protection against one ormore health and safety hazards.

Since the Directive became part ofEuropean law in 1995, suppliers ofPPE in the European market have hadto follow the appropriate approvalprocedure to CE mark their products.SATRA is one of the leading Notified

Bodies for the CE marking of PPEintended for the European market andhas been influential in thedevelopment of PPE-related testmethods and safety standards. SATRAstesting and certification services covermost areas of PPE from headprotection to safety footwear, andnearly everything in between.

European Council Directive89/686/EECThe Directive covers a range ofproducts, which it divides into threecategories. These are based on therisk, consequences and severity ofinjury likely to occur to someone notwearing adequate PPE. The proceduresfor demonstrating compliance and theinvolvement of a Notified Body differfor each category.Simple design PPE covers products

that are claimed to provide protectionagainst minimal risks, with effects thatare gradual and can be safelyidentified by the user in good time.Products in this category (commonlycalled Category 1), washing-up glovesfor example, are listed in the Directive.Category 1 PPE can be self-certifiedby the manufacturer or Europeanimporter without the need for third-party verification. The involvement of aNotified Body is not required.However, an enforcement authoritywould expect to be able to examine atechnical dossier backed up byappropriate test reports. Therefore, itis recommended that records of sometesting carried out by an independenttest centre be kept, to providedocumentary evidence to support anyclaims made about the product.

Complex design PPE (Category 3)covers products claimed to provideprotection against risks of mortaldanger, or dangers that may seriouslyand irreversibly harm the health of theuser. Again, a list of such products isdetailed in the Directive. Theseproducts must be certified by aNotified Body and are subject to initialtype examination and continualproduction checks. This categoryincludes footwear for fire fighters, forprotection against molten metal infoundries or for high voltageprotection.All other products (neither simple

nor complex) fall into a third categoryoften called Intermediate design orCategory 2. These are productsclaimed to provide protection againstrisks of severe injury. A Notified Bodymust certify initial examples of suchproducts and any associateddocumentation. Most safety footwearfalls into this category.

European harmonised standardsAs the Directive is a piece of generallegislation, it includes health and safetyrequirements that must be taken intoaccount for all types of PPE. It doesnot, however, detail how particulartypes of product should be tested. Tosupport the Directive, the EuropeanUnion Commission has mandated thedevelopment of various product safetystandards through the Europeanstandards agency CEN (ComitEuropen de Normalisation). CEN hasconvened a technical committee,referenced CEN/TC 161, to develop aseries of harmonised Europeanstandards for use in testing andcertification of foot and leg protection.These European standards describe

in detail how a particular type ofproduct should be tested and whatperformance is required to achieve asatisfactory pass. The tests developed

An EC type examination certificate is requiredfor all types of safety footwear beforeproducts can be placed on the EU market

European Union regulations set thestandard for the performance of PersonalProtective Equipment (PPE) worldwide.

for the various standards are designedto assess products against therequirements of the PPE Directive for therisks of the particular activity for whichthey are to be used. The EuropeanCommission reviews these standardsand, if they are found suitable, theybecome officially harmonisedthroughout Europe, and receive apresumption of conformity for the partsof the Directive detailed in Annex ZA ofeach standard. The publication of thestandard is also mentioned in the officialjournal of the EU. Hence, when startingthe CE marking process, it is necessaryto review Annex ZA of any harmonisedstandard to be used, to ensure that allrelevant clauses of the Directive areaddressed.Harmonised standards are not the

only means of demonstratingcompliance with the PPE Directive. Amanufacturer can use any technicalspecification as long as it can beshown to satisfy the relevant basichealth and safety requirements (BHSR)of the PPE Directive. However, if aharmonised standard is available forthe particular product being examined,there should be a sound technicalargument if it is not used. In certainareas, such as niche or leading edgeproducts, there may still be noharmonised standards available. Insuch cases a technical specificationdetailing how compliance is to bedemonstrated must be produced andused. SATRA has certified a number ofproducts where harmonised standardsor satisfactory national standards donot exist and has produced a series ofSATRA specifications (referred to as MDocuments) to cover them.Typically the tests necessary to certify anitem of PPE cover all of the followingfour main categories:

1. Innocuousness:This is generally a subjective assessmentfor any parts of the product that maycause injury, such as sharp edges. Itusually also includes some quantitativetests, such as measuring the quantity oftrace toxic substances in the product orits raw materials.

2. Ergonomics:Usually a small-scale practical wear trialwhich involves the wearer carrying out arange of movements typical of normal

use and reporting any restrictions ordiscomfort caused by the PPE.

3. Protective coverage:Particularly important for products suchas impact protectors. Minimumdimensions are specified, which areusually dependent on the size of theintended wearers, and the area ofcoverage is often checked against astandard template.

4. Protective qualities:A range of physical laboratory tests tomimic accident scenarios, such asmeasurement of resistance to impact,penetration, cutting, burning and theflow of electricity.During the development of CEN standards(ENs), individual EU member states areprohibited from working on their ownstandards (this process is formally referredto as standstill). This ensures that all newstandards produced for products coveredby the PPE Directive do not differsignificantly between EU member states.For instance, safety footwear designedand sold in Germany should be tested tothe same standard as a similar productdesigned in France or the UK.CEN standards are achieving

widespread acceptance worldwide. Anumber of countries outside Europe havetaken advantage of the progress beingmade under the PPE Directive either byusing the relevant ENs or modifyingthem slightly to meet their own

requirements. Many European standardsalso form the basis of standardsproduced by the International StandardsOrganisation (ISO). Others aredeveloped jointly between CEN and ISOunder the Vienna Agreement, which isintended to help reduce duplication ofeffort. The current safety footwearstandards EN ISO 20344-7 are a goodexample of this.

The role of Notified BodiesNotified Bodies, such as SATRA, areEurope-based organisations that have

Footwear for use in foundry applications to protect aainst molten metals is in theComplex PPE category

Safety footwear is widely used in theconstruction industry

been appointed by Member StateGovernments and notified to theEuropean Commission on the basis oftheir ability to carry out theexaminations and tests required formarking of PPE. They must beindependent, impartial and have ahigh level of professional indemnityinsurance. There are currently around110 Notified Bodies throughoutEurope 105 in EU Member Statesand 5 in EFTA countries (all inSwitzerland and Norway). These areall subject to routine surveillance atregular intervals. It is possible toidentify which Notified Body hascertified a product as the bodysname, address and unique numbermust be displayed on theaccompanying user information.Representatives from the NotifiedBodies meet regularly to ensure thatstandards and legislation are applieduniformly across Europe. These groupsare usually referred to as Vertical andHorizontal Groups.

EC type examinationIt is mandatory for suppliers of Complexand Intermediate design PPE to haveinitial examples of their productsassessed by a European Notified Bodysuch as SATRA. This process, called ECtype examination, checks the design anddocumentation of a prototype or initialexample of an item of PPE to ensure it isfit for its intended use and satisfies theBHSR of the Directive. This assessment isbased on the claims made about the

product in the user information and isachieved by:

1. Examining the design documentation(referred to as the technical file) toensure first that the product satisfiesall the relevant sections from the listof basic health and safetyrequirements given in Annex II of thePPE Directive; and secondly, that theproduct is adequately describedthrough the use of diagrams and listsgiving the source of all materials.

2. Carrying out a series of tests andexaminations on the products toensure they meet the claimedperformance levels. This may becarried out to harmonised Europeanstandards or, if required, themanufacturer and Notified Body canuse an agreed technical specification.The test reports are then added to thetechnical file. If EC type examinationis successful, a certificate is issued bythe Notified Body to prove the itemsconformity. For intermediate products,this is effectively the end of the

Notified Bodys involvement and thecertificate holder becomes responsiblefor ensuring that subsequentproduction remains the same as themodel examined by the Notified Body.

Production checksIn addition to initial type examination ofthe prototype model, Complex designPPE is subject to checks by a NotifiedBody to ensure that production versionsof the item continue to comply with thesample that was approved by the ECtype examination. It should be noted,however, that the Notified Body thatcarries out the Article 11 assessmentneed not be the same as the NotifiedBody that carried out the original typeapproval. The manufacturer orauthorised representative can chooseone of two methods for the NotifiedBody to use when checking theconformity of ongoing production:

Article 11A (Product Monitoring) This involves the Notified Bodyselecting and removing randomsamples of manufactured items of

Safety footwear may be tested for contactheat resistance

A protective toecap being subjected to a compression test

PPE which are then tested by methodssuch as those used in the original ECtype examination to ensure continuingcompliance.

Article 11B (Quality SystemMonitoring) The Notified Body visitsthe manufacturing site to check thatthe quality systems used by themanufacturer are capable of enablingconsistent production of the certifiedproduct. SATRA uses qualitymanagement system auditorsregistered with the InternationalRegister of Certified Auditors (IRCA)for this work.

Both Article 11A and 11B assessmentsare carried out on a regular basis whilethat item of PPE remains in production.

Step by step guide to CE markingwith SATRA

1. It is essential that manufacturers haveaccess to copies of the standardsassociated with their particular productsand familiarise themselves with therequirements. If they dont, it is moredifficult to manufacture products that arelikely to be immediately suitable. Werecommend you obtain a copy of theNational Legislation that enacts theEuropean PPE Directive, as this is thelegislation that controls the placing ofPPE on the European Market. Copies ofdocuments can be purchased fromSATRA (email testmethods@satra.co.uk).

2. We recommend that products aredesigned taking into account therequirements of the product standard(s).This sounds obvious, but we still seemany instances where a product hasbeen made first and then legislativerequirements considered later. Withmany standards there are a number ofoptional properties, so it is important atthis stage to decide what category ofprotection is required. Manufacturersmay also wish to commission somelimited experimental tests to identify anypotential design problems.

3. Where the involvement of a NotifiedBody is required, the manufacturer orauthorised representative needs to makea formal application for EC typeexamination. Amongst other things, thiswill confirm the name of theorganisation the certificate should beissued to, the product identifiers and theproduct test specification. Ideally theapplication form should beaccompanied by the technical file andproduct samples. A basic template of atechnical file is available on request formember companies.

4. The Notified Body assessor will needto confirm that appropriate tests havebeen carried out. SATRA has some of themost extensive testing facilities in theworld and many clients also require usto test their products.

5. In addition to performance testingagainst the specific product standard, EC

type examination against the PPEDirective also requires an assessment ofinnocuousness confirmation that theproduct will not harm those who comeinto contact with it, including the wearer.At its simplest this may be a check thatthere are no sharp edges or points.European legislation also covers anumber of restricted chemical substances,therefore SATRA also needs to confirm theproduct does not contain any of thesebefore a certificate can be issued.

Restricted substance legislation includes:

EC Directive 2002/61/EC AzoColourants (Dyes)

EC Directive 1999/51/EC Pentachlorophenol (PCP)

EC Directive 94/27/EC Nickel

Products also need to be assessedagainst EN 340:2003 Generalrequirements for clothing; also seeAnnex 17 of REACh.Current guidance is understood to be

that the CE mark signifies compliance withall relevant legislation. Thereforecompliance with azo dye or PCP directives(via national legislation) is mandatory.

6. In addition to confirmation of theproducts physical attributes, EC typeexamination also includes assessmentof a technical dossier, called thetechnical file. This should include:

Name and address of themanufacturer.

EU authorised representative (ifrelevant).

Product specifications (drawings,photographs and constructiondetails).

Raw material specifications (includingthe full postal address of thesupplier).

Quality control and test facilitiesused at the manufacturing plant.

Product marking (artwork of theinformation to be affixed to theproduct).

Copy of user information sheet. Details of how the product complieswith Annex II of EC Directive89/686.

Details of how the certificate holderintends to comply with Article 11 ofEC Directive 89/686*.

Test reports (especially those beingused to support the EC typeexamination).

[* Complex design products only]

Resistance to radiant heat is an important property for some types of safety footwear

7. SATRA will assess the technical fileand if necessary, request any additionalinformation needed to satisfy theminimum requirements. When the file isconsidered to be satisfactory, an ECtype examination certificate isproduced.

8. SATRA returns the technical file (butkeeps a copy) together with the EC typeexamination certificate. These should bekept in a safe place (ideally in aEuropean office) as the relevantEuropean enforcement authorities mayneed to see them as part of anyinvestigations if there is a problem in thefuture.

9. The certificate holder must draw upan EC Declaration of Conformity; awritten commitment to manufacture theproducts in exactly the same way as themodel that was type approved. Anychanges to subsequent productionshould be discussed with and reviewedby the Notified Body, or the certificatemay no longer be valid.

10. Products can now be manufacturedand placed on the European marketprovided that:

The design remains unchanged. The products are marked inaccordance with the technical file.

The products are supplied with userinformation as detailed in thetechnical file.

11. In the case of complex designproducts, maintain ongoing compliancein accordance with one of the two Article11 routes.

It is important to remember that the ECtype examination certificate remains theproperty of the Notified Body. Althoughwe cannot prevent organisationssupplying product to the market, we canwithdraw the certificate if we havesufficient grounds to consider it is beingabused in some way.Notified Bodies such as SATRA carry

out a crucial role in assessing PPEproducts facilitating European tradeby ensuring safety and consistency ofapplication through harmonisedEuropean standards and the PPEDirective requirements. This providesconsumers with a measure ofconfidence that products have beenassessed against recognised standardsor other specifications by anindependent third party, which is itselfassessed for competence. It isimportant to remember that, with theexception of complex categoryproducts, where the same NotifiedBody has been nominated to carry outadditional responsibilities toperiodically assess ongoingproduction, a Notified Body does notsee the vast majority of PPE producedafter initial type examination.Responsibility for ensuring consistentproduction in accordance with the

initial type examination lies with thecertificate holder.

EN ISO 20345/6/7 Categories ofprotection

The current European footwearstandards are:

Safety footwear:EN ISO 20345:2004 (+ A1:2007)

Protective footwear:EN ISO 20346:2004 (+ A1:2007)

Occupational footwear:EN ISO 20347:2004 (+ A1:2007)

Forestry footwear:EN ISO 17249:2004 (+ A1:2007)

Footwear against chemicals:EN 13624

Firefighters footwear:EN 15090:2006

These all refer to EN ISO 20344 fordetails of the test procedure.The three main footwear product

standards (EN ISO 20345/6/7) include arange of optional tests each with anassociated marking code; see box. Thenumber of samples required to carry outtesting to these standards depends on anumber of factors, as test specimens mustbe cut from the upper/outsole/insolearea. Factors affecting how many samplesare required include the number of uppermaterials present and the shape and sizeof the various upper panels. However,provided the design of the upper isrelatively simple with only one upperThe trough test from ENO ISO 20344 assesses water resistance - marking code W R

Impact tests are carried out at 200J and100J energy (EN ISO 20345 and EN ISO20346 respectively

material and a limited number of seams,the following samples should besufficient: 4 pairs of footwear in the smallest sizefrom the range to be produced

4 pairs of footwear in the largest sizefrom the range to be produced

4 pairs of footwear of a size from themiddle of the size range

A4 cuttings of upper and liningmaterials.

For further information onCE certification pleasecontact DANIEL COTTER ondanielc@satra.co.uk

MARKING CODES

EN ISO 20345 SB Toe protection tested with 200 J impact and 15 kN compression force (includes oil-resistant outsole). EN ISO 20346 PB Toe protection tested with 100 J impact and 10 kN compression force (includes oil-resistant outsole). EN ISO 20347 OB No toe protection against mechanical hazards provided but must provide protection to one or more

of the categories P, C, A, E, CI, I, AN, WR or HI as described below.

CLASSIFICATIONS OF FOOTWEAR

Code I Footwear made from leather and other materials, excluding all-rubber or all-polymeric footwear.Code II All-rubber (i.e. entirely vulcanised) or all-polymeric (i.e. entirely moulded) footwear.

HRO Heat resistant outsole compound tested at 300C P Penetration resistant outsole tested at 1100 newtons A Electrical resistance between foot and ground of between 0.1 and 1000 Mega Ohms C Electrical resistance between foot and ground of less than 0.1 Mega Ohms I Electrically insulating (Code II products only) AN Ankle protection CR Cut resistant upper CI Insulation against the cold HI Insulation against heat E Energy absorption of the seat region tested at 20 joules WRU Water resistant upper leather WR Water resistant footwear M Metatarsal protection FO Oil-resistant outsole (applies to EN ISO 20347 only)

The following short codes are for commonly used combinations:

S1 Footwear made from leather and other materials excluding all-rubber or all-polymeric footwear+ closed seat region + SB + A + ES2 S1 + WRUS3 S2 + P + cleated outsolesS4 All-rubber (i.e. entirely vulcanised) or all-polymeric (i.e. entirely moulded) footwear + SB + A + ES5 S4 + P + cleated outsoles.

P1 Upper footwear made from leather and other materials excluding all-rubber or all-polymeric footwear+ closed seat region + PB + A + EP2 P1 + WRUP3 P2 + P + cleated outsolesP4 All-rubber (i.e. entirely vulcanised) or all-polymeric (i.e. entirely moulded) footwear + PB + A + EP5 P4 + P + cleated outsoles.

O1 Footwear made from leather and other materials excluding all-rubber or all-polymeric footwear+ closed seat + A + EO2 O1 + WRUO3 O2 + P + cleated outsolesO4 All-rubber (i.e. entirely vulcanised) or all-polymeric (i.e. entirely moulded) footwear OB + A + EO5 O4 + P + cleated outsoles.

SRA Slip resistance on ceramic tile floor with SLS* SRB Slip resistance on steel floor with glycerol SRC Slip resistance on ceramic tile floor with SLS* and on steel floor with glycerol.

*SLS = Sodium lauryl sulphate solution

Wyndham Way, Telford Way, Kettering,Northamptonshire, NN16 8SD, United Kingdom

Tel: +44 (0)1536 410000 Fax: +44 (0)1536 410626email: info@satra.co.uk www.satra.co.uk