4/9/2013
New Revision of EU Restriction of Hazardous Substances (RoHS) Directive and Related Technical File Requirements
Vinay Goyal ASQ Clinic II, April 9, 2013
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Handouts Double sided handout – has self evaluation Quiz For you to keep
1 page survey Will you be interested in other PEC topics in the future? Please return to me (optional to fill out) If you need a copy of this presentation, please provide your contact information, and I will email to you.
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Handouts I use lots of slides so I have very limited time to cover this presentation You may not have enough time to ask questions but email me at
[email protected] or call me at 714.876.3927
Please hold on to your questions, if you have any questions, please refer to the slide number at the bottom right side I will send a copy of this presentation to those who have registered on‐line and/or provided their email address. 3
Take Back What are Product Environmental Compliance (PEC) Requirements What is RoHS How to determine if you product is within the scope of RoHS New Technical Files requirements For the sake of time ‐ Not covered: RoHS related exemptions, testing, materials declaration, and things that apply on a case by case basis and may require further discussion and interpretation. 4
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What are Product Environmental Compliance Requirements
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Definition of Safety Lately We hear a lot about CSR Corporate Social Responsibility
Green Initiative Sustainability ISO 14001 ECO certification …. 6
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Definition of Safety Product Environment Compliance Requirements are one of the key elements of CSR, Green Initiative… The definition of Safety is expanding From: Human safety e.g. electrical shock, EMC, direct exposure through inhalation and skin, accidents, cuts, etc.
To: Environment around us e.g. air, water, landfills etc. Indirect effect That is like slow poisoning 7
Product Environmental Requirements How products effect the environment around us? Hardware: Landfills – affects Land Incinerations – Air, Land, Water Leach – going in the underground waterbeds
Chemicals polluting air, land and water Illegal release in the local municipal sewer system Accidental release Unintentional release 8
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Product Environmental Requirements What can we do to minimize the impact
Reduce the use of hazardous substances Reuse the products/chemicals Recover and reuse for the same and other purposes instead of creating new Recycle ‐ in environmentally safe manner Disposal – Last option
Landfill, Sewer system, Air
Move from Cradle to Grave to Cradle to Cradle
That is how the laws are developed
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Product Environmental Requirements Evolving Trend
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Evolving Trend Worldwide Constant growth of Environmental Regulations Not limited to Developed Countries But also Emerging Markets e.g. China India Brazil
Remember 1/3 of world’s population lives in China and India Their requirements cannot be ignored any more 11
New Regulations
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Kaiser Permanente 10 pages long questionnaire
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Often questions are related to
PVC Phthalates Halogenated Flame Retardants Persistent, Bio‐accumulative Toxins (PBT) Carcinogens and Reproductive Toxins Volatile and Semi‐Volatile Compounds (VoC) Renewable Materials Hazardous Waste Toxicity Testing 16
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Often questions are related to Recycled contents (in our products) Packaging End of Life Management Take back Design for environment Green House Gas Minimization Energy Efficiency
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Kaiser Permanente While the health care industry’s primary goal is to prevent and cure illness, at Kaiser Permanente we are also looking at the negative impacts on human and environmental health through our direct and indirect emissions and activities.
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Courtesy C2P
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F Gas
Mercury
Conflict Minerals
Global Warming and Ozone Depletion
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Product Environmental Requirements Wastewater Inquiries
Other Inquiries e.g. Sound , Conflict Minerals
Mercury Registration Elimination Program
Recycling
and If youBattery are a global company, Product Environmental WEEE Product requirements apply to your products are Global in nature Environmental
REACH, CA Green Chemistry
Packaging
RoHS
Energy Using Products
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Product Environmental Requirements Sound Pressure (HW) Battery (HW) Restriction of Hazardous Substances (RoHS) (HW) Waste Electrical Electronic Equipment (WEEE) (HW) Mercury Laws (IMERC – Elimination and Reduction) (HW & CH) Ozone Depleting (F Gas) and Global Warming Substances (CH) ======================================= Packaging (HW & CH) Other Environmental Requirements (HW & CH) REACH and CLP (CH & HW) Wastewater Analysis (CH & HW) Environmental Hazard Assessment (CH) Seismic Regulations (HW) Conflict Minerals (HW)
HW – Hardware, CH - Chemistry 22
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Evolving Trend in PE Requirements Not applicable – Medical devices used to be exempt
Optional disclosure Must disclose – Yes, No or Not Applicable If “NO” and “Not Applicable” – state the reason Exemptions – based on sound justification Ban – cannot use – period. (Hg Thermometer) Yes – certify and provide objective evidence
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Expectations from Customers Shifting from reactive to more proactive Customers are requesting more and more product environmental compliance disclosures at the Request for Proposal (RFP)/Request for Information stage “To the best of my knowledge” – is not acceptable in many responses Only thing that is still acceptable in some regulations – “not intentionally added or specified” Otherwise – when you say compliant – show the proof/objective evidence/ due diligence
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HP’s GSE GSE – General Specification for Environment That used to be less than 50 pages long 7 years ago Now has over 109 pages And constantly growing
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Laws
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Disclosure
Present or not present No de‐minimus
Present
Above a certain percentage, parts per million etc By weight By homogenous material level
Lowering disclosure threshold level Moving from 1% to 0.1% Moving from 0.1% to 0.01%
Adding more and more substances on the disclosure list 26
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Laws
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Restriction
Unless exempt
Based on application Good compelling reason e.g.
Socio economic reason Lack of safety and reliability data
Can not use above a certain threshold level
Exemptions are granted If applied proactively
18 months prior to becoming a law 12 months prior to becoming a law Etc. and not after it becomes the law
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Laws
3. Ban There is a safer alternate available Can be for all application, certain applications or above a threshold limit Most Product Environmental Compliance requirements are regulatory (legal) in nature
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Challenges External
Lack of consistency Law vary from
City to city State to state Province to province Country to Country
Reporting format
Local language Reporting format
Hard to keep a track
Constantly growing worldwide 29
Challenges Internal
Constant changes Executives Associates
On‐going training
If you don’t use it, you loose it
Keeping ourselves abreast with the changes
What the changes? How do they apply? Who is going to incorporate? Who is going to assure for maintaining and assuring the compliance status?
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RoHS 2 (Recast) Update for IT Equipment – RoHS Cat 3 Directive 2011/65/EU Effective January 3, 2013 ‐ Replaces Directive 2002/95/EC
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RoHS Directive
10 Years ago, RoHS has revolutionized the entire Electrical and Electronic Industry 32
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Disclaimer
Please be aware that the statements contained in this presentation do not represent legal advice and are presented without any guarantee as to accuracy. This material represents the presenter’s interpretation of directives. Before acting on any of this information, you have to verify the accuracy of the author’s interpretation with your “own legal counsel”. 33
RoHS Is an abbreviation for Restriction of certain Hazardous Substances Your product is within the scope if followings conditions apply to your product 1. 2. 3.
Definition of Electrical and Electronic Equipment In one of the Annex I categories If it contains one of the restricted substances
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At homogenous material level
If you are an importer or manufacturer in the EU member countries or considered an responsible party
Or indirectly your product is placed on the EU market 34
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RoHS
1. Definition of Electrical and Electronic Equipment
Your product operating voltage is below1000 VAC or 1500 VDC Cables rated below 250V
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RoHS
2. In one of the Annex I categories
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RoHS ANNEX I CE Marking means RoHS Compliance RoHS Compliance that Product is also 2002/95/EC (No 2011/65/EU RoHS compliant Marking Required)
RoHS Categories 2011/65/EU –1. Large household appliances. –2. Small household appliances. –3. IT and telecommunications equipment. –4. Consumer equipment. –5. Lighting equipment. –6. Electrical and electronic tools. –7. Toys, leisure and sports equipment. –8. Medical devices. –8. IVD –9. Monitoring and control instruments –9. Industrial monitoring and control instruments. –10. Automatic dispensers. –11. Other EEE not covered by any of the categories above.
July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 Not in Scope Not in Scope Not in Scope Not in Scope July 1, 2006 Not Defined
July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 1, 2006 July 22, 2014 July 22, 2016 July 22, 2014 July 22, 2017 July 1, 2006 July 22, 2019
January 3, 2013 January 3, 2013 January 3, 2013 January 3, 2013 January 3, 2013 January 3, 2013 January 3, 2013 July 22, 2014 July 22, 2016 July 22, 2014 July 22, 2017 January 3, 2013 2019
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RoHS
3. If it contains one of the restricted substances At homogenous material level ANNEX II Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials Lead (0.1 % or 1000 ppm) Mercury (0.1 % or 1000 ppm) Cadmium (0.01 % 100 ppm) Hexavalent chromium (0.1 % or 1000 ppm) Polybrominated biphenyls (PBB) (0.1 % or 1000 ppm) Polybrominated diphenyl ethers (PBDE) (0.1 % or 1000 ppm)
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RoHS Homogenous Material Level
‘homogeneous material’ means
one material of uniform composition throughout or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as: unscrewing, cutting, crushing, grinding and abrasive processes 39
RoHS
4. If you are an importer or manufacturer in the EU member countries or considered an responsible party Or indirectly your product is placed on the EU market
Manufacturers who are selling to a customers doing business in the EU member or applicable countries/markets
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European Union EFTA – European Free Trade Association EEA – European Economic Area The Council of Europe EU customs Union Schengen Area European Union Eurozone 41
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What is European Union
1. Austria (became member in 1995) 2. Belgium (Founder Member in 1957) 3. Bulgaria (2007) 4. Czech Republic (2004) 5. Cyprus (2004) 6. Denmark (1973) 7. Estonia (2004) 8. Finland (1995) 9. France (FM 1957) 10. Germany (FM 1957) 11. Greece (1981) 12. Hungary (2004) 13. Ireland (1973) 14. Italy, (FM 1957) 15. Latvia (2004) 16. Lithuania (2004) 17. Luxembourg (FM 1957) 18. Malta (2004) 19. The Netherlands (FM 1957) 20. Poland (2004)
21. Portugal (1986) 22. Romania (2007) 23. Slovakia (2004) 24. Slovenia (2004) 25. Spain (1986) 26. Sweden (1995) 27. United Kingdom (Great Britain) (1973) ...as well as three members of the
European Free Trade Association (EFTA): 28. Iceland 29. Norway 30. Liechtenstein Although Switzerland is member of the EFTA, it does not take part in the EEA.
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What is European Union
NOTE:
Turkey is neither member of the EU, nor is considered a part of the EEA. However, Turkey has fully implemented many of the European CE marking directives. This means that for many products they also require CE Marking
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RoHS If you are doing business in one of the following EU member countries Other countries are coming up with their own RoHS requirements e.g.
China, India, California and many US states, Japan, Australia, Korea Etc.
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RoHS Misconception RoHS applies to Electrical and Electronic Equipment ONLY Reality is: RoHS applies to Electrical and Electronic Equipment and anything that is essential and integral part of the system e.g.
Electrical parts and Electronic parts Cables/ harness, wires Sheet metal, plastic parts Screws, nuts, bolts, Paints, varnish, Ink Labels
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RoHS RoHS applies to everything EXCEPT Batteries Covered under EU Battery Directive 2006/66/EC: Batteries Imported or Manufactured as a Part, Product or Accessory
Packaging Packaging and Packaging Waste Directive 94/62/EC, 2004/12/EC, 2005/20/EC
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RoHS Consumables and Accessories
Broader definition is If it contains electrical component or dependent on electrical current to operate properly Should be reviewed on a case by case basis
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Marking Requirements
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RoHS RoHS 2 also known as RoHS recast 2011/65/EC is a CE marking directive RoHS recast 2011/65/EU calls out for decision 768/2008 Module A Later a guidance document EN 50581 was released by CENELEC members Requires Declaration of Conformity CE Marking Technical File
WE WILL COVER TECHNICAL FILES REQUIREMENTS Later
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RoHS Part Exemptions There are 2 categories of exemptions General exemptions Annex III – 39 exemptions Good for 4 years from the date of implementation unless it has expiration date and not renewed. Typically exemption are good for 4 years but Some exemptions have earlier expiry dates Example: Exemption 7(c) III ‐ Expires on 1 January 2013 and after that date may be used in spare parts for EEE placed on the market before 1 January 2013
Exemptions specific to Medical devices Annex IV – 20 exemptions Good for 7 years
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RoHS Application and Removal of Exemptions The process and requirements to apply or request an exemption is covered in ANNEX V ‐ Applications for granting, renewing and revoking exemptions as referred to in Article 5 An application for renewal of an exemption shall be made no later than 18 months before the exemption expires In the event that the application for renewal of an exemption is rejected or that an exemption is revoked, the exemption shall expire at the earliest 12 months, and at the latest 18 months, after the date of the decision.
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RoHS Surveillance and fines Article 18 requires Member States to carry out market surveillance in accordance with Articles 15 to 29 of Regulation (EC) No 765/2008 Article 23 covers Penalties and required member states to ensure their implementation. The penalties provided for must be effective, proportionate and dissuasive.
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Technical Files Understanding CE Mark Conformance Standard EN 50581 54
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A few Questions
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How many of you are familiar with ‐ CE marking requirements 56
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How many of you know what is a ‐ Technical File 57
The Reason I asked these Questions
If you products are are CE compliant Carrying CE marking
You may be currently dealing with Technical File due to one or more following CE marking directive as applicable:
Medical Device Directive IVD Directive Low voltage Directive Electromagnetic Compatibility Machinery Drive Toy Etc. 58
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New RoHS, Also, Known as RoHS 2, RoHS Recast … is a CE Marking Directive
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Before we get into Technical File – we have to understand “What Does CE Marking mean?”
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The Reason is EU has terms that refer to the legislative act Directives, Regulations and Proclamation
Some directives are called CE marking directives If they partially and fully apply to your product, product must be compliant as applicable before you or manufacturer can place the CE marking If applicable, CE marking is like a passport to place product on the market If you are not compliant, you cannot place it on the EU market 61
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A few more things about CE Marking
Applies to completed products and not parts It is illegal To misuse the marking for marketing purposes or If applied incorrectly
Except Turkey is taking a different approach for (not completed system but parts)
Motors Switches Lamps and Pumps 62
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CE Marking Requirements in the EU CE Marking Directive
Non ‐ CE Marking Directive
Product must meet partially of fully with all applicable CE Marking Directives – Before you can place the product on the EU market and apply the CE marking Product is compliant to all applicable CE markings directives Effective Jan 3, 2013 – all RoHS Cat 3 products (IT) should be compliant
CE Marking is like a Passport to place your product on the EU market Product is within the scope of RoHS 2 (CE marking directive)
Effective Jul 22, 2014 – all Medical and Monitoring and Control Product must be RoHS 63 compliant
Effective Jul 22, 2016 – all IVD Products must be RoHS compliant
After Jul 22, 2017 – Industrial Monitoring and Control Products (not registered as medical or IVD) must be RoHS compliant
If not compliant – cannot sell in the EU market 63
Also Unless a product is within the scope of RoHS A CE marking does not mean it is RoHS compliant
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Relationship Between RoHS 2 (2011/65/EU), 768/2008/EC and EN 50581 Related to Technical Files
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RoHS 2 Directive 2011/65/EU Lists all requirements including Technical File requirement
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Decision 768/2008/EC on a common framework for the marketing of products Repeals Council Decision 93/465/EEC
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Key things about Technical File
1. Declaration of Conformity 2. Internal Production Control
General Description of the product Controls related to RoHS Design and Change Control Supply Chain Management
Procurement, Receiving, Stocking, Manufacturing Processes, Testing, Shipping, After sales and Services etc.)
Risk Management Product found non‐compliant
Recall, correction, Cooperate with Authorities
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EC Declaration of Conformity 1. No … (unique identification of the product):
2. Name and address of the manufacturer or his authorized representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer): 4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate): 5. The object of the declaration described above is in conformity with the relevant Community harmonization legislation: . . . . . . . . . . . . . . . . . . 6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared: 7. Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued the certificate: … 8. Additional information: Signed for and on behalf of: ………………………………… (place and date of issue): (name, function) (signature): 72
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Internal Production Control Design Parts selection, verification and validation Documents reflecting RoHS compliance Specification/Source Control Drawings Notes on the drawing Purchase order
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Internal Production Control Supply Chain Management
Supplier contract/Agreement/ Terms and Conditions Receiving/Receiving Inspection Stocking and Handling Manufacturing Process Controls Review compliance, match against Technical Files and apply marking
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Decision 768/2008/EC Annex II Module A Retention period 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request
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EN50581 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
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EN 50581 EN 50581 “Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances” “This European Standard specifies the technical documentation that the manufacturer needs to compile in order to declare compliance with the applicable substance restrictions.”
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Annex A of 50581 Technical Documentation (“Technical File”) Including (amongst others) information on materials, parts, and/or sub‐assemblies: • Supplier declarations and/or contractual agreements • Material declarations • Analytical test results
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4.3.2 Determine the RoHS information needed All parts essential integral part of the Electrical and Electronic Equipment
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4.3.3 Collect the part information All parts that are essential and integral part of the Electrical and Electronic Equipment (EEE) Supplier declaration and/or Material Declaration and/or Analytical Test Results
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4.3.4 Evaluate Quality and Trustworthiness If you do not trust supplier declaration or material declaration Audit supplier and witness its RoHS compliance controls Request for test report Do your own testing Lab XrF analyzers
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Questions
[email protected] 714‐876‐3927
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