ce marking and european environmental directives presentation.pdf
TRANSCRIPT
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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CE Mark – New Approach
• 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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CE Mark – New Approach
• 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
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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
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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?
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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
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