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.
Global Scenario On Sustainable and Resilient Coconut Industry by Dr. Jelfina...
RoHS Technical File Creation Webinar Slides
1. 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
RoHS II
Technical File Creation
Assent Compliance
Krystal Noseworthy-Baker
phone: 613.882.1429
krystal.baker@assentcompliance.com
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 ]
2. 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 ]
3. 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 ]
4. 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• Previous RoHS Directive (2002/95/EC) repealed: January 3, 2013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 ]
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 ]
6. 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 ]
7. 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 ]
8. 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 ]
9. 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
6. 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 ]
10. 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 ]
11. 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 ]
12. 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
• 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 released
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 ]
13. 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 ]
14. 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 ]
15. 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 ]
16. 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 ]
17. 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 ]
18. 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 ]
19. 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 extract
Power 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 ]
20. 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 ]
21. 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 ]
22. 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 ]
23. 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 ]
24. 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 ]