09 Nov Glasgow1

8/6/2019 09 Nov Glasgow1

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MarkinMarkinAn update to newlegislative requirements

Alan Powell

CE Marking Association

www.cemarkingassociation.co.uk

+44 (0)1527 595066


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Content

A brief reminder of CE andaccompanying product legislation

Changes to the LV, EMC & MachineryDirectives

, ,EuP Directives

Help & Support

accompanying product

legislation


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Harmony489 mi l l ion people

f ree

movement o f

f ree

movement o f

labour

goods

Safety


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New Legislative Framework

.Framework begins 1st January 2010.

Current New Approach Directives must beimplemented by the nation state.

New Legislative Framework

Regulations, directly implemented!

Aims to strengthen enforcement proceduresand activity across EU.

Seeks further harmonisation and consistency

across directives- conformity procedures.


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EUROPEAN DIRECTIVES

Machinery Low Voltage EMC

.

CE Mark ingCE Mark ing

GeneralGeneral

ProductsProducts

21 New Approach Directives

WEEE/WEEE/RoHSRoHS//EuPEuPet cet cHarmonisedHarmonised

StandardsStandards

CE Mark Directives

Low Voltage Explosives for civil uses

Simple Pressure Vessels

Safety of toys

Construction products

Electromagnetic compatibility (EMC) Machinery

Personal protective equipment (PPE)

Non-automatic weighing instruments

Active im lantable medical devices

Medical devices

Equipment explosive atmospheres(ATEX)

Recreational craft Lifts

Pressure equipment

In vitro diagnostic medical devices

Radio Equipment and

Appliances burning gaseous fuels

Efficiency requirements for new hot-water boilers fired with liquid orgaseous fuels

Energy using Products (EuP)

Telecommunications TerminalEquipment and the MutualRecognition of their Conformity

Cableway installations designed tocarry persons

Measuring instruments


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Related Directives but NOTCE Mark Directives

Packaging and packaging waste

Interoperability of trans-Europeanhigh-speed rail system

Marine equipment

Interoperability of trans-Europeanconventional rail system

**************************************

Ener efficienc requirements for

Airborne noise emitted by householdappliances

General product safety

Community postal services

Restrictions on marketing and use ofcertain dangerous substances andpreparations

household electric refrigerators,freezers and combinations thereof

Transportable pressure equipment

Noise emission in the environment byequipment for use outdoors

Which Legislation Applies?

General Product Safety Directive

Packaging Whole Vehicle Directive

WEEE Directive

RoHS Directive

EuP etc


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CE Marking Mandatory Dates

29th December 2009.

EMC Directive 2004/108/EC came into force 29th

July 2009.

LV Directive 2006/95/EC came into force 16th

Old directives no longer applicable; check your

Declarations of Conformity!

CE Marking Process

1 - Apply Appropriate Directives

2 - Meet the Essential Requirements

3 - Do Testing/Apply Standards

4 - Produce Technical Documentation

5 - Produce Declaration of Conformity

6 - Apply CE Mark


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CE MarkingInd ica tes compl iance w i th any one, some,

a l l , or more thant he fol low i n :-

EU Machinery (Safety) Direct ive

EU Low Vol tage Direct ive

EU EMC Directive=

EU Pressure Equipment Direc t ive

The CE Mark (on equipment) indicates compliance with

ALL RELEVANT Directives

Guidelines Blue Book

Produced by the Commission

ALL CE Directives Publicly available

-

will take them into account

Laws in Member States take precedence


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Essential Requirementsor Essential Provisions

Directives contain only those requirements that are

necessary to allow free circulation

Quality & reliability are excluded - except where theyproduce hazards

Essential Re uirements are mandator

must be met before placing the product on themarket

they vary according to the directive applied

Essent ia l Requi rement s

CE Marking DirectivesIDEAL

Directive EssentialRequirements (EHSRs)

Harmonised Standard(s)

UNACCEPTABLE

ACCEPTABLE in EU

in EUDo not fall below this

line!


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Harmonised Standards

with the requirements of most directives

when the apparatus conforms to therelevant standards

http://ec.europa.eu/enterprise/newapproach/standardization/

harmstds/reflist.html

Harmonised Standards forMachinery Directive

EN 61496i i

EN 692Mechanical presses

EN 693Hydraulic presses

EN ISO 12100GeneralPrinciples

EN ISO 13849

EN ISO 14121-1Risk assessment

EN 953Guards

EN 811Safe distances

EN 294Safe distances

EN 60947-5-3Proximity devices

EN 1760Safety mats

Positioning of protectiveequipment

ght urta ns

EN 415Packagingmachinery

EN 1114Rubber & plasticsmachinery

EN 60204-1Electrical equipment ofmachines

EN 982Hydraulic controls

EN 983Pneumatic controls

Safety relatedcontrol systems

EN ISO 13850Emergency stops

EN 1037Unexpected start-up

EN 1088Interlocking

devicesEN 60947-5-5Mechanical latchE-Stops

EN 5742 hand controllers

EN 1672Food processing

machinery

EN 746Thermo processingmachinery

EN 931Footwear manufacturing

machinery


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Technical Documentation

ow an a ory or e rec ve as weas the Machinery and LVD directives

Formats of technical documentation vary withdirectives but there is a lot of common content

Where several directives are applied to aroduct a common Technical File can be used

The technical documentation must be in anofficial EU language

Declaration of Conformity

The declaration of conformity must be signed bya responsible person

Keep DoC in Community at disposal of

authorities Can be one document for all directives

Use community language UK Manf. English

Name & address of Manufacturer andAuthorised Representative established withinthe Community


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Who is a Responsible Person?

The Responsible Person would be a senior person inthe Company (typically the MD or Technical Director)who is able to ensure that the documentation will beretained for at least 10 years after manufacture or thewithdrawal of production of series manufacture.

The must be satisfied that the documentation is

correct, the apparatus is legally CE Marked and everyeffort has been made to ensure the safety of theequipment.

CE Mark ing

All the directives require it to be not less than

(Minimum waived for small scaled machinery)


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CE + CE

Be warned!:-

=+

What t he CE Mark indic at es

The user

The manufacturer

Hardcopyor

software


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Enforcement

Health & Safety Executive- nondomestic.

Trading Standards Institute- domestic

Ofcom (R&TTE)

What if we dont comply?

Up to three months imprisonment

and/or a fine.

GPSD states max 20,000 fine. The authorities have the power to force

manufacturers to recall or replace faulty.

HSW Act is significantly worse- Higher courtunlimited fine and/or 2 yearsimprisonment.


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Enforcement

oss o epu a onMarket can outweigh

Legal sanctions!

Changes to the,

EMC Directive

Machinery Directive


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Low Voltage Directive

and amendmentsis re-codified to

2006/95/EC

No change to the Statutory Instrument

Latest BERR Guidelines available

EMC Directive

Existing apparatus until 20th July 2009

2004/108/EC

EMC Guidance Notes now available fromBERR www.berr.gov.uk/files/file47539.pdf


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EMCD Major Changes

procedures for apparatus and for fixedinstallations

Definitions are included for a aratusand fixed installations;

EMCD Major Changes

apparatus has been simplified to a single

procedure. There is no compulsory involvement of a

third party,

the option of presenting a technicaldocumentation to a Notified Body forassessment;


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EMCD Major Changes

and not otherwise commercially available may be

exempt from the requirements and proceduresfor apparatus (e.g. EC Declaration of Conformityand CE marking),

provided that certain documentation requirements are

met

precautions to be taken in order not to compromisethe EMC characteristics of the fixed installation

EMCD Major Changes

e regu a ory ro e oCompetent Bodies has been

removed

ow ca e o e o es


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EMC TransitionalArrangement 1

Apparatus When following the TCFroute to compliance before 20th July 2007can continue to be manufactured andplaced on the market up to 20th July 2009

This has now passed. The new directivemust be met in full.


Apparatus when following the self-certification route before 20th July 2007can continue to be manufactured andplaced on the market up to 20th July 2009

This has now passed. The new directivemust be met in full.


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. Fixed installations (as described in the new

EMC Directive) put into service on or after20th July 2007 will have to comply with thenew EMC Directive.

For further information contact: Kevin Lane, DirectivePolicy Advisor, BIS

EMCD Major Changes

CAUTION!- EU Guidance Notes

The term fixed installation also applies tolarge machines if they meet the definition

given for fixed installations, such asproduction lines.

However:

Large machines, in the usual sense of thisterm, are normally apparatus and have to be

treated as such.


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EMCD Major Changes

CAUTION!Directive Conformity Assessment

If neither the manufacturer nor hisauthorised representative is establishedwithin the Community,

the obligation to hold the EC declaration ofconformityAND the technical documentation

at the disposal of the competent authorities shalllie with the person who places the apparatuson the Community market.

EMCD Major Changes

the regulations

Treaty Article 296 states: Derogation where there is need to protect

Member States Security EMC Exempt?

Not adversely affect competition whereequipment is dual use EMC Compliant


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Automotive EMC

ESA equipment and accessories require tobe e-marked.

2004/104/ECNon Immunity related ESA accessories

have option to be e-marked or CEMarked. 1st July 2006

Automotive - note Whole Body Vehicle Directive - 2007/46/EC

ow o nc u e uses, coac es, vans, ruc s, ra ers

and special purpose vehicles

Timetable 29th April 2009 Type approval available (voluntary) 29th October 2010 Minibuses, Buses and Coaches First Stage Multibuild

29th October 2011 Light Vans and Trucks Multistage Mini /Buses & Coaches

th ,

29th October 2012 Medium / Heavy Vans, Trucks and Trailers First Stage Multibuild

29th April 2013 Light Vans and Trucks - Multistage

29th October 2013 Trailers - Multistage

29th October 2014 Medium and heavy trucks Multistage, other special vehicles

www.vca.gov.uk


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Machinery Directive

98/37/EEC

effective to 28th December 2009

2006/42/ECcomes into force on 29 December 2009

new directive can be downloaded: www.eur-lex.europa.eu/

UK Regulations

'Regulations 2008

Statutory Instrument 2008/1597 are nowublished

www.opsi.gov.uk/si/si2008/pdf/uksi_20081597_en.pdf


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MD Major Changes

longer need to determine from the results of

their risk assessment whether a machine fallsunder the LV Directive, or the new MachineryDirective.

Clear differentiation between the twodirectives in the form of a list.

eg: LV vis MD

subject exclusively to the LVD

Household appliances, Audio Video, IT, OfficeMachinery, LV Switchgear, Electric Motors

All other Electrical Machinery - has tomee sa e y o ec ves o anEssential requirements for MD.

Conformity against MD only


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New MD Exclusions

original equipment

Weapons

Transport & Networks by Road, Air, Rail,Water (not Seagoing) Mounted Machinery

. Temporary use in Research Laboratories

Electrical Equipment as listed

MD Major Changes

been made more explicit.

Ergonomic requirements & Requirements onemissions have been made more precise.

Noise, EM fields, Exhaust, Substances.

& lightning, have been moved to the generalpart of Annex I and thus apply to all

machinery.


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MD Major Changes

Once the existing tractors directive2003/37/EC has been amended to extend itscoverage to the risks presently covered by

the machinery directive, then the machinerydirective should no longer apply at all toagricultural and forestry tractors.

ContraryThe New Medical Directive in forceMarch 2010 will adopt the Machinery

Directive EHSRs where not covered.

MD Major Changes

more clearly (as has the terminology)

expanded to include construction-site hoists, to lifts speed < 0.15m/s(now outside scope of the lifts directive)

im act machiner e. . cartrid e-o erated fixinmachinery).

(now outside scope of 91/477/EEC, the Weapons Directive)


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WEEE & RoHS

http://ec.europa.eu/environment/waste/weee/index_en.htm

RoHS Directive Include Medical & Monitoring & Control Equipment

CE Marking, TCF and DofC of EEE

Additional hazardous substances ie REACH

WEEE Directive

Harmonisation of Registration and Reporting Changes to Collection and Recycling Targets

Energy Using Products EuP 2005/32/EC EuP Directive 10th August 2005

2007 2037 11 ugust 2007

250,000 units per annum with significant environmentalimpact i.e. TVs, washing machines, lighting, PCs &Monitors, External PSUs etc

Framework Directive setting out implementationmeasures current are: Directive 92/42/EEC - efficiency requirements for new hot-water boilers fired

with liquid or gaseous fuels

Directive 96/57/EC - energy efficiency requirements for household electricrefrigerators, freezers and combinations thereof

Directive 2000/55/EC - energy efficiency requirements for ballasts forfluorescent lighting


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Partnership with Wemtech since 2004

EDTCTechnology

Gateway

Seminar programme delivered across Scotland

Wemtech Hotdesk at EDTC offices every month Next hotdesk date 8thDecember 2008

Visit us at Stand G1

Help & Support


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Help & Support CE Marking Association

Knowledge & contacts throughout industry

Highly experienced at working with funding bodies Not-for-profit rates when working on funded projects

Work closely with the EDTC.

Training CE Essentials, Design for EMC, New Machinery & bespoke

courses available. 50% members discount on standardcourses.

TUV Rheinland endorsed

BSI standards discounts through Wemtech

Thank you

These slides can be seen on ourwebsite for the next month.

. . .

www.cemarkingassociation.co.uk

+44 (0) 1527 595066

09 Nov Glasgow1

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