Marking g

An update to new legislative requirements

Alan Powell CE Marking Association www.cemarkingassociation.co.uk +44 (0)1527 595066

Content
A brief reminder of CE and accompanying product legislation Changes to the LV, EMC & Machinery Directives Changes to WEEE RoHS Batteries & WEEE, RoHS, EuP Directives Help & Support

A brief reminder of CE and accompanying product legislation

Harmony
489 million people 27 Member States

free movement of goods

free movement of labour

Safety

New Legislative Framework

New Approach is ending. New Legislative New Approach ending Framework begins 1st January 2010. Current New Approach Directives must be implemented by the nation state.

New Legislative Framework

Under the NLF these Directives will become Regulations, directly implemented! Aims to strengthen enforcement procedures and activity across EU. Seeks further harmonisation and consistency across directives- conformity procedures.

EUROPEAN DIRECTIVES
Machinery ATEX Low Voltage Pressure Equipt. Equipt EMC

21 New Approach Directives

CE Marking Harmonised Standards

General Products WEEE/RoHS/ WEEE/RoHS/EuP etc

CE Mark Directives
Low Voltage Simple Pressure Vessels Safety of toys Construction products Electromagnetic compatibility (EMC) Machinery Personal protective equipment (PPE) Non-automatic weighing instruments Active implantable medical devices p Appliances burning gaseous fuels Efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels
Energy using Products (EuP)

Explosives for civil uses Medical devices Equipment explosive atmospheres (ATEX) Recreational craft Lifts Pressure equipment In vitro diagnostic medical devices Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity Cableway installations designed to carry persons Measuring instruments

Related Directives but NOT CE Mark Directives

Packaging and packaging waste Interoperability of trans-European high-speed rail system Marine equipment Interoperability of trans-European conventional rail system ************************************** Energy efficiency requirements for gy y q household electric refrigerators, freezers and combinations thereof Transportable pressure equipment Noise emission in the environment by equipment for use outdoors Airborne noise emitted by household appliances General product safety Community postal services Restrictions on marketing and use of certain dangerous substances and preparations

Which Legislation Applies?

CE Mark Directives General Product Safety Directive Packaging Whole Vehicle Directive WEEE Directive RoHS Directive EuP etc

CE Marking Mandatory Dates

Machinery Directive will become 2006/42/EC on 29th December 2009. EMC Directive 2004/108/EC came into force 29th July 2009. LV Directive 2006/95/EC came into force 16th January 2009 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

CE Marking
Indicates compliance with any one, some, all, or more than the following:, g
EU EU EU EU Machinery (Safety) Directive Low Voltage Directive EMC Directive Pressure Equipment Directive

The CE Mark (on equipment) indicates compliance with ALL RELEVANT Directives

Guidelines Blue Book

Produced by the Commission ALL CE Directives Publicly available Not legally binding -enforcement authorities enforcement will take them into account Laws in Member States take precedence

Essential Requirements or Essential Provisions

Directives contain only those requirements that are necessary to allow free circulation Quality & reliability are excluded - except where they produce hazards Essential Requirements are mandatory q y must be met before placing the product on the market they vary according to the directive applied

Essential Requirements
IDEAL
CE Marking Directives Harmonised Standard(s)

ACCEPTABLE in EU
Directive Essential Requirements (EHSRs)

UNACCEPTABLE in EU
Do not fall below this line!

Harmonised Standards
There is a presumption of conformity with the requirements of most directives when the apparatus conforms to the relevant standards
http://ec.europa.eu/enterprise/newapproach/standardization/ harmstds/reflist.html

Harmonised Standards for

EN 693 Hydraulic presses EN 692 Mechanical presses EN 1760 Safety mats EN 61496 Light C rtains Curtains

Machinery Directive

EN 999 Positioning of protective equipment EN 1114 Rubber & plastics machinery

EN 983 Pneumatic controls

EN 982 Hydraulic controls

EN 811 Safe distances

EN ISO 14121-1 Risk assessment EN 294 Safe distances

EN 415 Packaging machinery y

EN 60204-1 Electrical equipment of machines EN ISO 13849 Safety l t d S f t related control systems

EN 953 Guards

EN ISO 12100 General Principles

EN 1088 Interlocking devices

EN 60947-5-3 Proximity devices

EN ISO 13850 Emergency stops

EN 574 2 hand controllers EN 1672 Food processing machinery

EN 60947-5-5 Mechanical latch E-Stops

EN 1037 Unexpected start-up EN 931 Footwear manufacturing machinery

EN 746 Thermo processing machinery

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Technical Documentation
N Now M d t Mandatory f th EMC di ti as well for the directive ll as the Machinery and LVD directives Formats of technical documentation vary with directives but there is a lot of common content Where several directives are applied to a product, a common Technical File can be used The technical documentation must be in an official EU language

Declaration of Conformity
The declaration of conformity must be signed by y g y a 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 and Authorised Representative established within the Community

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Who is a Responsible Person?

The Responsible Person would be a senior person in the Company (typically the MD or Technical Director) who is able to ensure that the documentation will be retained for at least 10 years after manufacture or the withdrawal of production of series manufacture. They must be satisfied that the documentation is y correct, the apparatus is legally CE Marked and every effort has been made to ensure the safety of the equipment.

CE Marking

All the directives require it to be not less than 5 mm high (Minimum waived for small scaled machinery)

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CE + CE
Be warned!:-

What the CE Mark indicates

The user The manufacturer

Hardcopy or software

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Enforcement

Health & Safety Executive- non domestic. 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 products or forfeit them them. HSW Act is significantly worse- Higher court unlimited fine and/or 2 years imprisonment.

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Enforcement Loss of Reputation & L fR t ti Market can outweigh Legal sanctions!

Changes to the LV Directive, Directive EMC Directive Machinery Directive

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Low Voltage Directive

73/23/EEC and amendments

is re-codified to

2006/95/EC
from 16th January 2007 No change to the Statutory Instrument Latest BERR Guidelines available

EMC Directive

89/336/EEC
Existing apparatus until 20th July 2009

2004/108/EC
from 20th July 2007 EMC Guidance Notes now available from BERR www.berr.gov.uk/files/file47539.pdf

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EMCD Major Changes

Distinction between and assessment procedures for apparatus and for fixed installations Definitions a e included for appa a us e o s are c uded o apparatus and fixed installations;

EMCD Major Changes

The conformity assessment procedure for apparatus has been simplified to a single procedure. There is no compulsory involvement of a third party,
the option of presenting a technical documentation to a Notified Body for assessment;

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EMCD Major Changes

When deviating from the European harmonised standards or not applying them fully,
the manufacturer has to perform an EMC assessment provide detailed documentary evidence that the apparatus complies with the protection requirements of the EMC Directive;

EMCD Major Changes

Fixed installations, although they must comply installations with the protection requirements, require neither an EC Declaration of Conformity (DofC) nor CE marking;
Responsible Person for Fixed Installations required Large Machines are considered apparatus; g pp ; Mobile installations are considered apparatus;

For apparatus, there are changes in the documentation and information requirements;

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EMCD Major Changes

Apparatus intended for a given fixed installation and not otherwise commercially available may be exempt from the requirements and procedures for apparatus (e.g. EC Declaration of Conformity and CE marking),
provided that certain documentation requirements are p q met precautions to be taken in order not to compromise the EMC characteristics of the fixed installation

EMCD Major Changes The regulatory role of Competent Bodies has been removed Now called N tifi d B di N ll d Notified Bodies

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EMC Transitional Arrangement 1

Apparatus When following the TCF route to compliance before 20th July 2007 can continue to be manufactured and placed on the market up to 20th July 2009 This has now passed. The new directive must be met in full.

EMC Transitional Arrangement 2

Apparatus when following the selfcertification route before 20th July 2007 can continue to be manufactured and placed on the market up to 20th July 2009 This has now passed. The new directive must be met in full.

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EMC Transitional Arrangement 3

. Fixed installations (as described in the new EMC Directive) put into service on or after 20th July 2007 will have to comply with the new EMC Directive.

GOOD & BAD NEWS

For further information contact: Kevin Lane, Directive Policy Advisor, BIS

EMCD Major Changes

CAUTION! - EU Guidance Notes The term fixed installation also applies to large machines if they meet the definition given for fixed installations, such as production lines. However: Large machines, in the usual sense of this term, 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 his authorised representative is established within the Community, the obligation to hold the EC declaration of conformity AND the technical documentation at the disposal of the competent authorities shall lie with the person who places the apparatus on the Community market.

EMCD Major Changes

Military Apparatus is NOT exempt from the regulations Treaty Article 296 states:
Derogation where there is need to protect Member States Security EMC Exempt? Not adversely affect competition where equipment is dual use EMC Compliant

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Automotive EMC

95/54/EEC
ESA equipment and accessories require to be e-marked.

2004/104/EC 00 / 0 / C
Non Immunity related ESA accessories have option to be e-marked or CE Marked. 1st July 2006

Automotive - note
Whole Body Vehicle Directive - 2007/46/EC N Now t i l d b to include buses, coaches, vans, t k t il h trucks, trailers and special purpose vehicles Timetable
29th April 2009 29th October 2010 29th October 2011 29th April 2012 29th October 2012 29th April 2013 29th October 2013 29th October 2014 Type approval available (voluntary) Minibuses, Buses and Coaches First Stage Multibuild Light Vans and Trucks Multistage Mini /Buses & Coaches Special purpose passenger Caravans Ambulances etc Caravans, Medium / Heavy Vans, Trucks and Trailers First Stage Multibuild Light Vans and Trucks - Multistage Trailers - Multistage 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/EC
comes into force on 29 December 2009
new directive can be downloaded: www.eur-lex.europa.eu/

UK Regulations
'The Supply of Machinery (Safety) The Regulations 2008 Statutory Instrument 2008/1597 are now pub s ed published
www.opsi.gov.uk/si/si2008/pdf/uksi_20081597_en.pdf

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MD Major Changes
Manufacturers of electrical machinery will no longer need to determine from the results of their risk assessment whether a machine falls under the LV Directive, or the new Machinery Directive. Clear differentiation between the two directives in the form of a list.

eg:

LV vis MD

6 Categories of electrical machinery are subject exclusively to the LVD

Household appliances, Audio Video, IT, Office Machinery, LV Switchgear, Electric Motors

All other Electrical Machinery - has to meet safety objecti es of LV and safet objectives Essential requirements for MD. Conformity against MD only

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New MD Exclusions
Safety Components as spare parts of the original equipment Weapons Transport & Networks by Road, Air, Rail, Water (not Seagoing) Mounted Machinery is included included. Temporary use in Research Laboratories Electrical Equipment as listed

MD Major Changes
The requirements for Risk Assessment have been made more explicit. Ergonomic requirements & Requirements on emissions have been made more precise.
Noise, EM fields, Exhaust, Substances.

Requirements like those concerning seating & lightning, have been moved to the general part of Annex I and thus apply to all machinery.

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MD Major Changes
Once the existing tractors directive 2003/37/EC has been amended to extend its coverage to the risks presently covered by the machinery directive, then the machinery directive should no longer apply at all to agricultural and forestry tractors. C Contrary Th N The New M di l Di Medical Directive i f i in force March 2010 will adopt the Machinery Directive EHSRs where not covered.

MD Major Changes
The scope of the directive has been defined 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)

impact machinery ( g cartridge-operated fixing p y (e.g. g p g machinery).

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

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MD Major Changes
Party completed machinery. machinery
the requirements for supplying a declaration of incorporation and assembly instructions with such machinery is clarified. These provisions will significantly reduce the various difficulties involved in the construction of machinery.

MD Major Changes
Conformity assessment procedures revised. Simpler if applying Harmonised Standards. A full quality assurance procedure has been introduced as an alternative to EC type examinations. Article 12 Internal checks - Annex VIII

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Annex IV
either
Internal checks if use Harmonised Standards
Caution Late availability of harmonised standards related to the new directive may affect those manufactures to certify this way!

EC Notified Body Full Quality Procedure

Useful Publication
Recommended by BIS The New Machinery Directive
A tool to uncover the changes introduced by the revised directive

www.kan.de/publikationen/bestellung.html

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WEEE & RoHS

Commission proposes revised laws for 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 UK SI 2007 2037 11th A August 2007 t 250,000 units per annum with significant environmental impact i.e. TVs, washing machines, lighting, PCs & Monitors, External PSUs etc Framework Directive setting out implementation measures 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 electric refrigerators, freezers and combinations thereof Directive 2000/55/EC - energy efficiency requirements for ballasts for fluorescent lighting

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Batteries & Accumulators

Directive 2006/66/EC ( NOT a CE Directive)
Ai d at B tt Aimed t Battery Producers, and P d P d d Producers of f Equipment with Batteries included
Material Prohibition of Mercury, Cadmium or Lead Labelling to aid Recycling Design for Battery removal

Apply to End-of Life Regulations Apply to WEEE Regulations Effective 26th September 2008 Further Consultation to Cover Recycling www.berr.gov.uk/files/file49478.doc

EDTCTechnologyGateway

Product Development Process

Concept Evaluation Competitor Analysis Technology Options Feasibility Studies Prototyping Product Design Product Compliance & Certification Manufacturing Technology

Materials Advice

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EDTCTechnologyGateway
Partnership with Wemtech since 2004 Seminar programme delivered across Scotland Wemtech Hotdesk at EDTC offices every month
Next hotdesk date 8th December 2008

Visit us at Stand G1

Help & Support

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Help & Support

CE Marking Association
6 months Trial; FREE via our website 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 g y courses available. 50% members discount on standard courses. TUV Rheinland endorsed

BSI standards discounts through Wemtech

Thank you

Any Questions?
These slides can be seen on our website for the next month. alan.powell@wemtech.co.uk alan powell@wemtech co uk www.cemarkingassociation.co.uk +44 (0) 1527 595066

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