RoHS Technical File Creation Webinar Slides
 

RoHS Technical File Creation Webinar Slides

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Assent Compliance www.assentcompliance.com provides free informational webinars for the latest in REACH, RoHS, Conflict Mineral and other restricted substances. ...

Assent Compliance www.assentcompliance.com provides free informational webinars for the latest in REACH, RoHS, Conflict Mineral and other restricted substances.

Assent Compliance with offices in Canada, US and EU provides consulting services and compliance software to businesses that must comply with local, national or global environmental regulations. Visit Assent Compliance for more information.

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RoHS Technical File Creation Webinar Slides RoHS Technical File Creation Webinar Slides Presentation Transcript

  • AS SENTCOM PLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 RoHS II Technical File Creation Assent Compliance Krystal Noseworthy-Baker phone: 613.882.1429 krystal.baker@assentcompliance.comC u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Introduction to Assent Compliance Assent Compliance • Consulting • Global Requirements • Compliance Strategies • Regulatory Interpretations and Impacts • IT • Cloud Computing • Application Design • Operations • Program Implementation • Data Management C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Agenda • Requirements • RoHS recast (RoHS II) • DoCs • Technical File • Due Diligence and Testing • Technical File Sample • Enforcement • Demonstration • Q&A C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements RoHS II Overview • DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) • Published in the Official Journal of the European Union: July 2011 • In Effect: July 21, 2011 • Into Member State law: January 2, 2013 • Previous RoHS Directive (2002/95/EC) repealed: January 3, 2013 C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements RoHS II – New products in scope Category 11 TODAY Medical Devices: In Vitro Diagnostic Devices: (other) Equipment: 23 May 2012 22 July 2014 22 July 2016 22 July 2019 Consumer Monitoring and Professional Monitoring Control Instruments: and Control Instruments: 22 July 2014 22 July 2017 C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements RoHS II and the CE Mark • CE Marking Directive • DoC, Technical File, CE Mark »» Declaration of Conformity: • Decision No 768/2008/EC • Format in the RoHS recast, Annex VI »» Technical file: • Module A of Decision No 768/2008/EC »» CE Mark: • Directive 93/68/EEC of 22 July 1993 • Subject to Article 30 of Regulation (EC) No 765/2008. • Applicable to: »» Finished products in scope of RoHS recast »» Placed on the market after January 2, 2013 • For those products already under scope of RoHS • For the new products under scope, the previous slide provides the dates C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements RoHS II Responsibilities Manufacturer Importer EU Declaration of Conformity EU Declaration of Conformity from manufacturer on record Technical File Ensure manufacturer has completed the technical file CE Marking Ensure CE Mark is affixed to the product Product marking Ensure manufacturer has completed required product marking (brand name, serial number, contact information) C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements Declaration of Conformity General Requirements: 1. No… (unique identification of the EEE): 2. Name and address of the manufacturer or his authorised representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer): 4. Object of the declaration (identification of EEE allowing traceability. It may include a photo- graph, where appropriate): 5. The object of the declaration described above is in conformity with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.80446. Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which conformity is declared:7. Additional information: Signature: • Signed for and on behalf of: • (place and date of issue): • (name, function) (signature): NOTE: Declaration must be translated into the language or languages required by the Member State of the market on which the product is placed or made available AND safety in- structions must be in a language that can be easily understood in every country in the EU in which the product is sold.C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements Technical File • Based on Module A of DECISION No 768/2008/EC • Has to contain at least the following elements: • a general description of the product, • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. • descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, • a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised • standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, • results of design calculations made, examinations carried out, etc., and • test reports. • The documentation shall make it possible to assess the product’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk • EN 50581 – Standard for EU Technical Files – In voting stage C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements Technical File – EN 50581 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances • Combination of: • RoHS Recast (Directive 2011/65/EU) • Module A of Decision 768/2008 • IEC 62476 – Guidance for evaluation of products with respect to substance-use restric- tions in electrical and electronic products [Existed Previous to RoHS Recast] C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044• Status: • At voting stage • Original schedule »» Official announcement in 6 months from ratification vote »» In effect in 12 months • Accelerated schedule [Proposed] »» Announcement in 3 months from ratification vote »» In effect in 6 months• Essentially the items covered under Module A of Decision 768/2008 (previous slide) are covered in this standard• More in-depth coverage once the standard is officially releasedC u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements Technical File – EN 50581 Beyond EN 50581, it should not be expected that there will be significantly more detail from the EU Commission. Official statement by the EU Commission regarding RoHS recast: …as a general rule and in the interests of legal certainty, it is inappropriate for the Commission to make interpretative statements on legislative texts, which should be comprehensible in themselves. …note that it is in any event for the Court of Justice alone to provide authoritative interpretations as to the meaning of Union law. C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Requirements Technical File – EN 50581 FOUR MAJOR TASKS: • Determine the information needed • Collect the information • Evaluate the information for: • quality and trustworthiness • whether to include the documentation in the technical file • Ensure that the technical documentation remains valid C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing What is their role in RoHS II Compliance – specifically the Technical File? Determination of Necessary Information • Assess what types of documents are required based on substance presence risk and supplier risk • Technical judgement allowed Collection of Information • Types of allowed documentation »» Supplier declarations »» Material Declarations »» Analytical test results C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing What is their role in RoHS II Compliance – specifically the Technical File? Evaluation of Data • Mandatory for Manufacturers • Requirements include: • Establish procedures for evaluating collected information / documentation • Evaluate whether each part, component, or material meets the materials restriction re- quirements of RoHS Recast • Evaluate whether the document is of sufficient quality to include in the technical documentation »» Criteria met = Included »» Criteria not met = further corrective actions or analysis Ensuring Validity of Data • Requirements: • periodic review of the documents contained in the technical documentation to ensure that they are still valid; • technical documentation must reflect any changes to materials, parts or sub-assemblies C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing What is their role in RoHS II Compliance – specifically the Technical File? STANDARD PRACTICE: • Annual Updates – with the Annual Audit! • Significant Product Changes = Update File • Completeness in the Technical File: • Consumables • Out of Scope Parts • Not part of the RoHS Compliance THEREFORE not required to be included »» Recommended that the out of scope and consumable parts are footnoted Technical Files – In Practice… C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing – EN 62321 What is their role in RoHS II Compliance – specifically the Technical File? Electrotechnical products – Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers) • EU Standard for RoHS testing • Not Mandatory…HOWEVER: »» Most effective method of risk management »» Usually less costly than alternative (further/increased) supplier data gathering and/or corrective action methods »» Testing to an established standard allows you to quote it in the file = lends credibility • If you have done it right, others don’t have to! • Recommended to have at least scan testing to EN 62321:2009 in technical file »» XRF C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing – EN 62321 Declaration and Test Report Sample Review Test Report No. : CE/2010/22946 Date : 2010/02/24 Page : 4 of 5 BOURNS TRIMPOT ELECTRONICAS, LIMITADA DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS *CE/2010/22946* MATERIAL DECLARATION SHEET AL OESTE HEREDIA, COSTA RICA. Test Report No. : CE/2010/22946 Date : 2010/02/24 Page : 2 of 5 BOURNS TRIMPOT ELECTRONICAS, LIMITADA *CE/2010/22946* DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS PBB/PBDE analytical FLOW CHART AL OESTE HEREDIA, COSTA RICA. No. Construction Element Material Group Report Note 1) Name of the person who made measurement: Roman Wong Test results by chemical method (Unit: mg/kg) 2) Name of the person in charge of measurement: Shinjyh Chen Test Item (s): Method Result MDL (Refer to) No.1 1 Element Ink + Ceramic B First testing process Cadmium (Cd) (1) n.d. 2 Sample Lead (Pb) (2) 2520 2 Confirmation process Bourns Trimpot Electronicas, Limitada Optional screen process Mercury (Hg) (3) n.d. 2 Hexavalent Chromium Cr(VI) by (4) n.d. 2 2 Back plate 263 Copper alloy A Del Cruce a San Antonio de Belen Sample pretreatment alkaline extraction Sum of PBBs n.d. - Test Report No. 150 Mts Al Oeste : 2010/02/24 Autopista Cañas - : CE/2010/22946 Date Monobromobiphenyl of 5 Page : 1 Dibromobiphenyl n.d. n.d. 3 5 5 Back plate 220 Copper alloy A Screen analysis BOURNS TRIMPOT ELECTRONICAS, LIMITADA Tribromobiphenyl *CE/2010/22946* Heredia, Costa Rica n.d. 5 DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150Tetrabromobiphenyl MTS n.d. 5 Pentabromobiphenyl n.d. 5 AL OESTE HEREDIA, COSTA RICA. Hexabromobiphenyl n.d. 4 5 Wire Copper Alloy A Sample extraction/ Heptabromobiphenyl n.d. 5 Soxhlet method Octabromobiphenyl n.d. 5 Nonabromobiphenyl The following sample(s) was/were submitted and identified by/on behalf of the client as : n.d. No. : CE/2010/22946 Date : 2010/02/24 5 5 5 Mold compound Page : 3 of 5 Various Test Report A Decabromobiphenyl n.d. (5) BOURNS TRIMPOT ELECTRONICAS, LIMITADA *CE/2010/22946* Concentrate/Dilute Sum of PBDEs n.d. - DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS Sample Description Extracted solution : Monobromodiphenyl ether BOURNS MODELS PWR263, PWR163, PWR220T, PWR221T AL OESTE HEREDIA,n.d. COSTA RICA. 5 Test Report No. : CE/2010/22946 Date : 2010/02/24 Style/Item No. Page : 5 of 5 : Dibromodiphenyl ether THICKFILM POWER RESISTORS/ELEMENT ether n.d. 5 Tribromodiphenyl n.d. Note A: RoHS compliance. 5 Sample Receiving Date BOURNS TRIMPOT ELECTRONICAS, LIMITADA : 2010/02/11 Filter *CE/2010/22946* Tetrabromodiphenyl ether n.d. 5 DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS Testing Period : 2010/02/11 TO 2010/02/24 Pentabromodiphenyl ether n.d. Note B: ROHS Compliant By Exemption 5 (lead 1) These samples were dissolved totally by pre-conditioning method according to below flow chart. 5 in glass of AL OESTE HEREDIA, COSTA RICA. Hexabromodiphenyl ether (Cr 6+ test method excluded) n.d. 5 Heptabromodiphenyl ether 2) Name of the person who electronic components) n.d. made measurement: Climbgreat Yang 5 Analysis by GC/MS ============================================================================================ person in charge of measurement: Troy Chang Octabromodiphenyl ether 3) Name of the n.d. 5 Nonabromodiphenyl ether n.d. 5 Decabromodiphenyl ether Cutting / Preparation n.d. 5 Test Requested : Issue ReportIn accordance with the RoHS Directive 2002/95/EC, and its amendment Requirement: Review points directives. TEST PART DESCRIPTION: NO.1 : MIXED ALL PARTS Sample Measurement Hg Cr6 + Test Method : Note: 1. mg/kg = ppm; 0.1wt% = 1000ppm With reference to IEC 62321: 2008 Pb、Cd Contain Pb Hg Cr+6 PBB and PBDE< 0.1 % (1000 ppm) by 2. n.d. = Not Detected Procedures for the Determination of Levels of=Regulated Substances in 3. MDL Method Detection Limit Acid digestion by suitable acid weight. digestion with Microwave Add appropriate amount of Electrotechnical Products. • Directive Stated 4. "-" = Not Regulated depended on different sample 5. The sample(s) was/were analyzed on behalf of the applicant astable) sample in one testing. /HCl/HF 0.01 material (as below mixing Contain Cd < HNO3 % (100 ppm) by weight digestion reagent (1) Determination of Cadmium by ICP-AES. The above result(s) was/were only given as the informality value. (2) Determination of Lead by ICP-AES.the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permission of the Company. Unless otherwise stated Filtration (3) Determination of Mercury byReport is issued by the Company under its General Conditions of Service printed overleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention This Test ICP-AES. 除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 Heat to appropriate • Standard Stated is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings (4) Determination of Hexavalent Chromium and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction at the time of its intervention only by UV/Vis Spectrometry. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permissionfrom exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and of the Company. temperature to extractPower Resistor RoHS Test This Test Report is issued by the Company under its General Conditions of Service printed overleaf or available on request and(5) Determination of PBB and PBDE by GC/MS. 除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 offenders may be prosecuted to the fullest extent of the law. accessible at http://www.sgs.com/terms_and_conditions.htm. Attention Ltd. SGS Taiwan Residue ** End of Report ** is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings Solution 台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and Member of the SGS Group (SGS SA) Cool, filter digestate offenders may be prosecuted to the fullest extent of the law. Test Result(s) : Please refer to next page(s). • Dates through filter Report SGS Taiwan Ltd. 台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com 1) Alkali Fusion Member of the SGS Group (SGS SA) 2) HCl to dissolve Add diphenyl-carbazide for ICP-AES color development Sample Material Steel, copper, aluminum, solder Glass Digestion Acid Aqua regia, HNO3 , HCl, HF, H 2O2 HNO3 /HF • Signature measure the absorbance at 540 nm by UV-VIS MODEL: PWR263S Gold, platinum, palladium, ceramic Silver Aqua regia HNO3 • This lab is fairly well known Plastic H2 SO4 , H2O2 , HNO 3, HCl Others Any acid to total digestion Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permission of the Company. 除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 This Test Report is issued by the Company under its General Conditions of Service printed overleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction • Product Identification is very clear Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permission of the Company. from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and 除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 offenders may be prosecuted to the fullest extent of the law. This Test Report is issued by the Company under its General Conditions of Service printed overleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention SGS Taiwan Ltd. is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permissionthe time Company. at of the of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction 台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com 除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and This Test Report is issued by the Company under its General Conditions of of the SGS Group (SGSoverleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention Member Service printed SA) offenders may be prosecuted to the fullest extent of the law. is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findingsLtd. SGS Taiwan at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction 台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Member of the SGS Group (SGS SA) SGS Taiwan Ltd. 台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com Member of the SGS Group (SGS SA) C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing – EN 62321 Declaration and Test Report Sample Review 456 Seastrom St. Twin Falls, ID 83301 October 13, 2011 Certificate of Compliance European Union Directive 2002/95/EC Restriction of Hazardous Substances Any Seastrom part number, produced by Seastrom Manufacturing Co., Inc. that meets the following conditions is classified as compliant in accordance with European Union Directive 2002/95/EC (RoHS).  Material: 456 Seastrom St. Twin Falls, ID 83301 Any of the materials listed below without a process/finish. October 13, 2011 Non-Metals:  Delrin (Acetal) Non-Compliance Certificate of  Mica  Polyethylene  Epoxy Glass  Mylar  PVC (Polyvinyl Chloride) (Fiberglass)  Neoprene European Union Directive 2002/95/EC  Santoprene  FluorocarbonHazardous Substances Restriction of (Viton)  Nitrile (Buna-N)  Silicone  Fluorosilicone  Nylatron  Teflon The following materials and processes used at Seastrom Manufacturing Co., Inc. have  Kapton  Nylon been classified as Non-Compliant in accordance with the European Union Directive  Vulcanized Fibre  KEL-F (PCTFE) 2002/95/EC (RoHS). This Directive, however, does not Phenolic affect the use of parts in Metals: applications outside of the Directive’s specified countries. Review points  Brass  Phosphorus Bronze  Stainless Steel Non-Compliant Process/Finish  Copper  Cold Rolled Steel  Steel  Beryllium Copper  Spring Steel  Titanium Process/Finish: Denoted @ end of part # as: • Directive Stated Chemical Film Finish The following base materials contain > 0.1% lead, but are exempt under note 6 of the Directive’s Annex: -CF Hexavalent Chromium Finish -CHR  12L14 Steel (0.35% -C1,weight max) of -C2  C - 360 Brass Rod (3.7% of weight max) • Note that this is in accordance with the “original” RoHS and not the recast however Cadmium Chrome -CHR  Process/Finish: 60/40 Tin Lead Finish -TL1, -TL2 Any Seastrom part number-Z2 Zinc Plate, Type II (Yellow) you will also note that most of the important elements are included produced with a process/finish listed below is compliant under the Chromatic Anodize, Directive, unless the base material is Aluminum. (Contact Seastrom for Aluminum part status) Type I -A1 Standard Electroless Nickel Plating (can be RoHS compliant if specified by customer on Compliant Process/Finish: Denoted @ end of order) part # as: Less Finish -LF • Regulatory wording may be slightly different but the declaration speaks to it! Non-Compliant Materials: Sulfuric Anodize, Type II -A2 2011 Aluminum Rod (primarily used in shoulder washers, spacers, and washers with Black Oxide a specified part. to see if Aluminum 2011 is used for • Highlights non-compliant and compliant parts/processes/finishes thin side walls.) For Aluminum parts, please contact Seastrom at info@seastrom-mfg.com -A3 Hard Anodize, Type III -BO Passivate -P Sincerely, Phosphate Electrolytic Nickel Plate • Includes part # denotations -PH -N Silver Plate -S Maegan Melton Quality Engineer Tin Plate Tin Dip Brad Mohr • Exemptions (as applicable) Process Engineer -T1 -T2 Zinc Plate, Type I (Blue) -Z1 • Dated Seastrom Manufacturing Co., Inc. is Certified ISO 9001:2000 and AS9100:2004 Zinc Plate, Type III (Clear) -Z3 Designated Electroless Nickel Plate (RoHS Compliance must be requested by customer) Sincerely, • Signature and Function Maegan Melton Brad Mohr Quality Engineer • Letterhead Process Engineer • Contact for further information C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing – EN 62321 Declaration and Test Report Sample Review 1630 McCarthy Boulevard Milpitas, CA 95035-7417 RoHS DIRECTIVE 2011/65/EU MATERIAL DECLARATION CERTIFICATE Linear Technology Corporation certifies the deliverable products, when ordered as lead-free meet the RoHS DIRECTIVE Review points 2011/65/EU. • Restriction of the use of certain hazardous substances in electrical and electronic equipment (Recast) does not pertain to • Directive Stated Linear Technology Corporation. • Linear Technology Corporation also complies with: People’s Republic of China RoHS Directive EIS SJ/T11364-2006 • RoHS recast RoHS Definitions: • Concentration limit of 0.1% by mass (1000 PPM) in homogeneous material for Lead (Pb), Mercury (Hg), Hexavalent Chromium (Cr), Polybrominated Biphenyl (PBB), Polybrominated Diphenyl Ether (PBDE), »» Does not include the specific regulatory wording Decabromodiphenyl Ether (Deca-BDE), Toluene, Trichlorobenzene, and Hexabromocyclododecane (HBCDD), Bis (2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutylphthalate (DBP) (as indicated in the earlier slide) • Concentration limit of 0.01% by mass (100 PPM) of homogeneous material for Cadmium (Cd) • Concentration limit of 0.005% by mass (50 PPM) for Perfluorooctane Sulfonates (PFOS) RoHS Exemption: • Confusing wording • Products in the TO-220, DDPAK, SOT223 and TO247 packages are currently assembled with a Soft Solder Die Attach material containing Lead (Pb). Article 4, Annex 7a (>85% Lead, Pb, in high melting point solders) exempts this material at this time. • Certifies that it meets the directive HOWEVER The Chinese RoHS EFUP Logo 2 applies when these packages are shipped to the People’s Republic of China. • The micro modules products contain lead in the glass frit. Article 4, Annex 7(c)-1, (electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound. »» Restriction of the use of certain hazardous substances in The Chinese RoHS EFUP Logo 2 applies when these packages are shipped to the People’s Republic of China. Substances of Concern: electrical and electronic equipment (Recast) does not pertain to • Antimony Trioxide, Sb2O3 (CAS# 1309-64-4) and Bromine, Br (CAS# 10097-32-2) are used as a flame retardant in mold compound in several products. Linear Technology Corporation is evaluating and qualifying new mold compounds that contain Linear Technology Corporation. no Sb2O3, or Br. Once qualified these products will be considered Halogen-Free. • Polyvinyl Chloride (PVC) – in shipping tubes, CAS #9002-86-2. The tubes are reused 2 times then recycled. • Linear Technology Corporation products do not contain or have termination finishes of Pure Lead or Pure Zinc. • Exemptions (as applicable) Linear Technology Corporation’s Device Material Declaration concentrations are estimated and are derived from engineering calculations. Linear Technology Corporation has a lifetime warranty on all our products, with Linear Technology Corporation standard liability • Dated limited to the replacement of confirmed defective products. Linear Technology Corporation’s ongoing Environmental Program will help ensure we are in compliance with our customer’s environmental needs. • Signature and Function _____________________________________________________ Paul Chantalat • Letterhead Vice President, Quality and Reliability LINEAR TECHNOLOGY CORPORATION ACCEPTS NO DUTY TO NOTIFY USERS OF THIS DECLARATION OF UPDATES OR CHANGES TO THIS DECLARATION. • Contact for further information LTC Revision 7 February 3, 2012 CONTACT INFORMATION: Name: Bobbi Bennett Title: QA Specification Review Manager and Product Environmental Specialist Email: bdbennett@linear.com • The final statement does not provide confidence in the long-term compliance Linear Technology Corporation, 1630 McCarthy Blvd, Milpitas, CA 95035-7417, 408-432-1900 C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Due Diligence and Testing – EN 62321 Declaration and Test Report Sample Review Review points • Directive Stated • Note that this is in accordance with the “original” RoHS • Exemption is simply stated as exception with no detail • Dated • No Signature or Function • Letterhead • Contact for further information C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Enforcement • Declaration of Conformity • Easy diagnosis of compliance • Technical File • Member State Enforcement Agency’s – first line of defense • RoHS material restrictions are MUCH easier and less destructive to test for than REACH • Be AWARE • Fines – member state by member state • Stuck at Customs • Rejected at Customs C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
  • AS SENTCOM PLIANCE info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 Questions? Please submit your questions in writing using the Q&A tool along the top menu tool bar. Any questions not addressed during the Q&A portion of this webinar will be addressed in private correspondence after the webinar. C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]