CE Marking and European Environmental Directives Presentation.pdf

7/27/2019 CE Marking and European Environmental Directives Presentation.pdf

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• CE Marking and EuropeanEnvironmental Directives

• (WEEE/RoHS and EuP)

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EU Environmental Directives

• Restriction of Hazardous Substances Directive (RoHS)(2002/95/EC)

• Waste of Electrical and Electronic Equipment Directive(WEEE) (2002/96/EC)

• Ecodesign requirements for Energy Using Products (EuP)(2005/32/EC)

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CE Mark--Introduction

• Basis for free movement of goods in the EU

• Provides for minimum threshold of worker safety forproducts circulating in the EU

• CE mark allows companies to sell in any of the 27 EUcountries (plus EEA and Turkey) without making

modifications for each Member State

• CE mark is mandatory to sell products in the EU which arecovered by a CE mark directive

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CE Mark – New Approach

• New Approach Directives – horizontal, covers a whole category of products like machinery,electronics, personal protective equipment, not

specific products like a computer or conveyor

• Development of European Standards by

European standards bodies CEN, CENELEC andETSI were key in shaping CE mark program

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• Directive – EU law

• Commission proposes

• Parliament reviews

• Council of Ministers approves

• Member States usually transpose Directives intoMember State law 18 months after the Counciladopts the Directive

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• List of Most Asked for CE Mark Directives

--Machine Safety Directive (98/37/EC)

--Electromagnetic Compatibility Directive (2004/108/EC)

--Low Voltage Equipment Directive (2006/95/EC)

--Medical Device Directive (93/42/EEC)

--Active Implantable Medical Device Directive (90/385/EEC)--In Vitro Diagnostic Medical Device Directive (98/79/EC)

--Toy Directive (88/378/EEC)

--Pressure Equipment Directive (97/23/EC)

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List of CE Mark Directives (cont.)

--Recreational Craft (2003/44/EC)--Radio and Telecommunications Terminal Equipment (99/5/EC)

--Construction Products (89/106/EEC)

--Equipment for Use in Potentially Explosive Atmospheres

(94/9/EC)

--And others

EU Website ( www.newapproach.org) lists 22New Approach Directive

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General Product Safety Directive

• CE marking is mandatory to sell products in theEU, if the product is covered by a CE mark directive

• Not all products are covered by the CE mark.Examples—furniture, playground equipment,clothing, sports items like roller blades andexercise bicycles

• These items are covered by the General ProductSafety Directive (2001/95/EC)

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CE Mark – Self-Certification

Example—Packaging Machine

--Assess for directives covering product

EMC Directive -- (Use of European standards, probably thegeneric standards for emissions and immunity unless thereis a product specific standard)

Low Voltage Equipment Directive – (EN 60204-1: 2006 –electrical safety for machinery)

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CE Mark –Self-Certification

Machine Directive – European standards are not required but there are EU standards for packaging machines acompany could use

Meet requirements in Annex I such as controls,characteristics of guards, emergency on-off switch,maintenance and instruction manual (languagerequirement)

Technical file

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Technical File Contents

Normally includes:

---Declaration of Conformity

---Type Exam certificate for Notified Body if required---Contact for manufacturer or European rep

---List of directives and harmonized standards applied

---Detailed product description and operating instructions

---Detailed test reports---Drawings, diagrams, etc. to show conformance

---Internal measures used to ensure conformity

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CE Mark – Self-Certification

--Lab test to show you met the EN standards forEMC and LV Directives (can be with anindependent lab)

--No lab test required for the Machine Directiveunless the machine appears in Annex IV

--Affix the CE mark

--Fill out the declaration of conformity

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The CE Mark

Affix the “CE”

--as described in EU directive 93/68/EEC

--must be at least 5 mm high--visible on the outside of the equipment

--can also be placed on packaging

--must be on packaging if impractical on product (ie

product is too small)

“CE Mark” = ticket to trade

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Declaration of Conformity-Example

Manufacturer: Jones Packaging Corp. Date325 Grassy Knoll

Garden City, New York

Telephone No. (516) 555-3475

Product: Deluxe Packaging Machine

Model No. 3.5L

Serial Number 35000-256

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Declaration of Conformity -- Example

The undersigned hereby declares, on behalf of Jones PackagingCompany of Garden City, New York, that the above referencedproduct, to which this declaration relates, is in conformity withthe provisions of:

Council Directive 98/37/EC on Machine Safety

Council Directive 2004/108/EC on Electromagnetic

Compatibility (EMC)

Council Directive 2006/95/EC on Low Voltage Equipment

Standards: EN 60204-1:2006 (electrical safety), EN 61000-6-2:2005 (immunity), EN 61000-6-4:2007 (emissions)

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Declaration of Conformity - Example

The technical file required by this directive is maintained atthe corporate headquarters of Jones Packaging Corp., 325Grassy Knoll, Garden City, New York

______________

Joseph P. Glass Vice President-Design Engineering

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Routes to CE Mark Conformance

Companies can usually self-certify for CE mark requirements for the Machine, EMC and Low Voltage

Directives, although a company would still need a lab test

(can be an independent lab) to verify that EU standards for

the EMC and Low Voltage Directives were met.

*(A machine listed in Annex IV of the Machine Directive will

need to get a type examination from a lab connected to aEuropean notified body)

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Routes to CE Mark Conformance

Directives that require or almost always require notified body approval include:

--Pressure Equipment (97/23/EC)

--Simple Pressure Vessels (88/404/EC)

--Equipment for Use in Potentially Explosive Atmospheres(94/9/EC)

--Medical Device Directive (93/42/EC)—Class II and III

products--Personal Protective Equipment (89/686/EEC)—Products

with complex design

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New CE Mark Revisions

New CE Mark Revisions include:

EMC – 2004/108/EC – July 2009

Machine – 2006/42/EC – December 2009

Medical Device – 2007/47/EC – March 2010

Toy Directive – Due by the end of this year

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CE Mark Standards Dispute

• French lawnmower case

• US companies got CE mark approval from notified bodiesin other countries. The Government of France had a

different interpretation of the standard for safety of lawnmowers, EN 836.

• US Government (MAC, FCS-Paris, US Mission) providedassistance to the US company and the US trade associationinvolved in this dispute. The case is currently beingdecided by the European Commission

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Steps to CE Marking



RoHS Directive - Overview

• An Article 95 (Single Market) Directive

• Seeks to reduce the environmental impact

of electrical and electronic equipment(EEE) at end of life

• Products which do not comply cannot beplaced on the EU market

• Complementary to the WEEE Directive

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RoHS Directive - Requirements

• From July 1, 2006, new electrical andelectronic equipment put on the market shouldnot contain….

--Lead--Mercury

--Hexavalent Chromium

--Cadmium--Polybrominated Biphenyls (PBB)

--Polybrominated Diphenyl Ethers (PBDE)

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• Large Household Appliances

• Small Household Appliances• IT/Telecommunications

• Consumer Equipment

• Lighting Equipment –

includes electric light bulbs

and household luminaires

• Electrical and Electronic

Tools

• Toys, Leisure & Sport

• Medical Devices

• Monitoring and Control

Instruments• Automatic Dispensers

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RoHS Directive – Scope

All equipment dependent on electrical currents orelectromagnetic fields in 10 indicative categories:



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RoHS -- Scope

• In most cases the answer is straightforward. (i.e.

Cookers, mobile phones, DVD players and so on)

• But significant areas of doubt, particularly

in the specialized or industrial sectors

(such as gas analyzers, telecom test equipment and

actuators used as a valve in a utility plant)• Decisions at the EU level are essential

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RoHS– Max Concentration Values

• Agreed levels (published August 19, 2005):

--0.1% for lead, hexavalent chromium, mercury

--0.1% for PBBs and PBDEs

--.01% for cadmium

“By weight in homogeneous materials..shall be tolerated.”

(uniform composition throughout)

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RoHS – Exclusions

• Medical Devices, Monitoring & ControlInstruments

• Large-scale stationary industrial tools

• “Spare parts” that are used for the repair or reuse

of electrical and electronic equipment put on the

market before 1 July 2006, (plus capacity extensions and/or upgrades)

• Exemptions listed in Annex (plus additions)

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ROHS Directives – Complianceand Enforcement

Key Principles

• Self-certification by manufacturers

• Backed up by standards on agreed tests(IEC and ASTM are working on standards forproducts and for materials, due out by 2009)

• Standardized Reporting Formats(Material Declaration Forms)

• RoHS mark is voluntary

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Self-declaration by manufacturers

• Manufacturers should gather materialsdeclaration forms from their component andmaterial suppliers

• Manufacturers should audit their RoHSprocedures and also audit their suppliers RoHScompliance methods

• Manufacturers should consider RoHScompliance tests to finalize compliance

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RoHS Enforcement

• Each Member State is responsible for their ownenforcement of RoHS

• Products placed on the market are presumed to comply with the RoHS Directive

• Enforcement body can challenge manufacturers“declaration” of RoHS compliance

• If so, producers will need to demonstrate they have taken“reasonable steps” to comply

• So far, we have not heard of any major enforcementactions taken in the EU, but that could change

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Revision of RoHS• Whether or not to include Category 8 & 9

(Medical Devices and Monitoring andControl Equipment) within the scope of RoHS

• New banned substances (such as beryllium, arsenic, and TBBPA)

• Exemption process• Definitions and scope

• Should exemptions be lifted

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• New Proposed RoHS Revision due in late2008

• USEU website for WEEE/RoHS:

• www.buyusa.gov/europeanunion/weee.html

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WASTE OF ELECTRICAL ANDELECTRONIC EQUIPMENT (WEEE)

EN 50419 – Companies affix

WEEE insignia totheir product

--Effective

August 2005



Waste of Electrical and ElectronicEquipment (WEEE)

• All Electrical and Electronic Equipment placedon the EU market after August 13, 2005 mustprovide these markings:

• A Unique identification of the producer• Date marking of manufacturer/placing the

product on the market (after August 13, 2005)

• Some companies put website( www.blackbox.com) under the WEEE insigniato give information

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Key Principle of WEEE Directive– Producer Pays

Member State infrastructure for WEEE Directive

-Registration Agencies in each Member State

-Collection Centers-Treatment Centers

-Companies are required to keep records on how much EEE they place on the market and reportthis to a Member State agency

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• Parties putting the product on the nationalmarket are responsible for WEEE financialobligations”

- Sales subsidiaries- Manufacturing plants

- Distributors

• Technically US exporters should not be affected by WEEE registration requirements butsometimes they are.

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How will U.S. exporters be affected?



Join Compliance Scheme or TakeIndividual Responsibility

• Most companies will join a compliance scheme• Companies might have to give a bank guarantee

on a yearly basis (to cover expenses in case the

firm goes out of business)• Compliance schemes base rates on tonnage and

percentage of market

• Compliance scheme will take care of collecting,transport, treatment, and record keeping (WEEEData Sheets).

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Join Compliance Scheme or TakeIndividual Responsibility

• Compliance scheme will meet WEEE goals onrecovery, reuse and recycling

• Producer must include instructions on how product should be treated and recycled(instructions identify components and materials

with dangerous substances)

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Some Pan-European Schemes

• Rene– http://www.rene-europe.com/en/index.htm

• European Advanced Recycling Network (EARN)– http://www.earn-electronics.com

• Landbell (located in Germany)– www.landbell.de

• European Recycling Platform (ERP)

– http://www.erp-recycling.org• WEEE Forum

– www.weee-forum.org

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Pan-European Schemes

• These organizations operate in multipleEU countries and have partnerships withrecycling companies.

• They can handle, administrativefunctions, collection, transport,treatment, and record-keeping.

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Commerce Website Tracking WEEE Implementation

• http://www.buyusa.gov/europeanunion/weee_rohs_countries.html

- Tracks WEEE implementation in each Member State

- Gives names, phone numbers, and contact points forall Registration Centers

- Provides names of recyclers, some of which offer Pan-European services

- General WEEE & RoHS documents

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Costs of WEEE/RoHS to Firms

Mostly WEEE• Product labelling

• Administrative: registration and record-keeping

• Cost of joining a compliance scheme or

setting up a take-back system• Information for consumers

• Information for recyclers

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Energy Using Products (EuP) Directive

What is the EuP Directive?

• It’s a framework directive covering any product that usesenergy (electric, gas, renewable, fossil), but seems to be

primarily for electrical products at this point

• That framework directive will be applied to individualproducts through “implementing measures.”

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Key Definitions -- EuP

• Eco-design – the integration of environmentalaspects into product design with the aim of improving the environmental performance of theEuP throughout its whole life cycle.

• Life Cycle – the consecutive and interlinkedstages of an EuP from raw material use to finaldisposal

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Key Definitions -- EuP

• Life cycle stages

--raw material selection and use

--manufacturing

--packaging, transport and distribution

--installation and maintenance

--use

--end-of-life, from end of first use to disposal

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EuP Directive -- Approach

• To identify the significant environmentalaspects of a product through its life cycle(resource procurement, manufacturing, in

use, end of life) and then improving onthem in the design stage

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EuP Directive -- Approach

• These environmental aspects to be improvedinclude:

--predicted consumption of materials, of energy and water

--anticipated emissions to air, water and soil

--anticipated pollution through noise, vibration, radiation

and electromagnetic fields

--expected generation of waste--possibilities of reuse, recycling and recovery of materials

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Implementing Measures

• The “implementing measures” to the EuPDirective will probably stress energy efficiency targets but might also include other factors suchas noise emissions, water emissions, generationof waste

• Standards (being developed by both CEN andCENELEC) will be the key for products coveredunder “implementing measures”

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Preparatory Studies

• Preparatory studies lead to “implementingmeasures.” These studies provide information

that the Commission and Consultation Forumneed in order to decide if a product should beconsidered for an implementing measure underEuP.

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First Set of Preparatory Studies

• Boilers• Water Heaters

• Person Computers and Monitors (x)

• Imaging Equipment

• Televisions (x)

• Domestic Refrigeration

• Washing Machines and Dishwashers

• Simple set-top boxes• Office Lighting (x)

• Public Street Lighting (x)

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First Set of Preparatory Studies

• Battery Chargers and External Power Supplies (x)• Residential Air Conditioners

• Commercial Refrigeration and Freezers

• Motors, Pumps, Fans and Circulators

• Standby losses (x)

• (x) – Study Finished

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Second Set of Preparatory Studies

• Five more studies are underway:

--solid fuel boilers

--laundry driers--vacuum cleaners

--domestic lighting

--complex set top boxes

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Naming of ImplementingMeasures

• The Commission, with recommendations from theConsultation Forum and the EC’s Regulatory Committee,should start naming “implementing measures” later this

year and into 2009.• Emphasis on standards at the design phase

• Self-certification likely, but we still need to follow up onthis

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• Commission’s EuP website:

• http://ec.europa.eu/energy/demand/legislation/

eco_design_en.htm

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REACH: the issue

• Registration: safety data to central chemicalsagency

• Evaluation:

• Authorization of substances of very highconcern

• For more information on REACH, contact Don Wright at 202-482-5844

• www.buyusa.gov/europeanunion/reach.html

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Contact Information

Bob StraetzOffice of EU Affairs

US Department of Commerce

Tel: 202-482-4496

[email protected]

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CE Marking and European Environmental Directives Presentation.pdf

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