Material Declarations For Any Environmental Regulation

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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

Product Material
Declarations for Any
Environmental Regulation
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 ]

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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 ]

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Agenda


• What are material declarations?
• Why are material declarations being requested?
• How do I develop a strategy to meet the requirements?
• Declaration Procurement from your Supply Chain
• Assent Services
• 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 ]

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 What are material declarations?
REACH
Any producers or importers of articles placed on the market1 in the EU must declare the presence
of any Substances of Very High Concern (SVHCs) in an article in a concentration exceeding 0.1%
w/w.
1. Test Reports are not a required component of the declaration
• Upstream suppliers can provide their declarations for components of your product
• Due diligence a requirement

• Engineering Assessment

• Testing as a last resort and as a quality control measure

Article 33 – Source of compliance requirement:
Duty to communicate information on substances in articles:

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 ]

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1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified
in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall pro-
vide the recipient of the article with sufficient information, available to the supplier, to allow safe
use of the article including, as a minimum, the name of that substance.

2. On request by a consumer any supplier of an article containing a substance meeting the criteria in
Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight
by weight (w/w) shall provide the consumer with sufficient information, available to the supplier,
to allow safe use of the article including, as a minimum, the name of that substance.

The relevant information shall be provided, free of charge, within 45 days of receipt of the request.
What does this mean?
• Once a substance has been added to the SVHC List, you must declare its presence and the ap-
propriate safe handling instructions to your downstream users if the concentration is above 0.1%
of your products weight.

• This is to be done upon immediately for professional customers and within 45 days from request
for consumers.

1
Article 3.12 of the REACH Regulation specifies:
Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third
party. Import shall be deemed to be placing on the market;


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REACH – Example
AMERICAN ZETTLER, INC.
75 COLUMBIA • ALISO VIEJO, CA 92656 • 949-831-5000 • FAX 949-831-8642

To: Supplier Reach Team

From: Ed Edsinga

Date: 10/27/2008 Release date
2/12/2010 Revised Not updated to the most recent SVHC list but the format
6/29/2010 Revised
2/14/2011 Revised
6/25/2011 Revised and necessary elements are otherwise present

Subject: Reach Directive

Supplier Communication of SVHC _ EU Regulation EC 1907/2006_AMERICAN ZETTLER
INCORPORATED

Reach Directive declaration: Valid for all American Zettler Inc. companies:
American Zettler, Zettler Magnetics, Zettler Controls, and AZ Displays.

American Zettler products supplied to customers do not contain any of the reported
substances listed in the SVHC_EU Regulation EC 1907/2006 “list of substances” from
October 28, 2008, added substances f rom January 13, 2010, June 18, 2010 &
December 15, 2010. (Candidate List of Substances of very High Concern – total 53
substances).

Zettler procures articles (not chemicals) which are not intended to release any
substance under normal and reasonable foreseeable conditions of use.

Signed:

Ed Edsinga
Engineering Manager

www.azettler.com


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Substances of Very High Concern in Product X

CAS Number # of Parts Substance
117-81-7 156 Bis (2-ethyl(hexyl)phthalate) (DEHP)
84-74-2 3 Diisobutyl phthalate (DIBP)
115-96-8 6 Tris(2-chloroethyl)phosphate (TCEP)

• Safe Use Instructions
• Bis (2-ethyl(hexyl)phthalate) (DEHP)
»» DEHP is a known reproductive toxin2 and should have safe use instructions con-
sistent with a classification as a known reproductive toxin. The recommended safe
use instructions are:
• Avoid prolonged contact. If necessary, wear gloves
• Pregnant or nursing women should avoid contact
• Keep out of reach of children

»» These safe use instructions are only recommendations and are not explicitly
necessary to include in the SVHC declaration of Product X. The minimum require-
ment under the REACH regulation is the SVHC substance name and product.

2
Support document for identification of Bis (2-ethyl(hexyl)phthalate) (DEHP) as a substance of very high concern.
European Chemical Agency. Oct 2008


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• Diisobutyl phthalate (DIBP)
»» DIBP is a known reproductive toxin3 and should have safe use instructions
consistent with a classification as a known reproductive toxin. It is recommended
that products containing DIBP above 0.1% should be used with the same safe use
instructions as DEHP containing products.
• Tris(2-chloroethyl)phosphate (TCEP)
»» TCEP is a known reproductive toxin and a known carcinogen4 and should have
safe use instructions consistent with a classification as a known reproductive toxin
and carcinogen. It is recommended that products containing DIBP above 0.1%
should be used with the same safe use instructions as DEHP containing products.

3
Agreement of the Member State Committee on identification of Diisobutyl phthalate (DIBP) as a substance
of very high concern.
European Chemical Agency. Nov 2009

4
Member State Committee support document for identification of Tris(2-chloroethyl)phosphate as a substance
of very high concern.
European Chemical Agency. Nov 2009


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RoHS
The RoHS regulation is actually quite a bit more specific than REACH in terms of the declaratory
requirements. The original RoHS declaration (seen on the next slide) is not especially complex
however RoHS II, the RoHS recast, is part of the CE Marking Directive which means there are 2
major components making it significantly more intensive:
1. EU Declaration of Conformity
a. General Requirements:
i. No… (unique identification of the EEE)
ii. Name and address of the manufacturer or his authorised representative:
iii. This declaration of conformity is issued under the sole responsibility of the manufac-
turer (or installer)
iv. Object of the declaration (identification of EEE allowing traceability. It may include
a photograph, where appropriate):
v. 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)
vi. Where applicable, references to the relevant harmonised standards used or references
to the technical specifications in relation to which conformity is declared


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vii. Additional information:
viii. 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

2.Technical File
a. Technical Documentation according to Module A of Decision 768/2008
i. Description of product and function
ii. List of harmonized standards used
iii. Results of design calculations and examinations used
iv. Test reports
B. Fundamentals
i. 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


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Standards
• EN62321:2009 – Standard for RoHS Testing
• IEC 62476 – Guidance for evaluation of products with respect to substance-use restrictions in
electrical and electronic products
• New standard for the technical file (EN 50581 is still in development) is not expected to
differ greatly from this International Electrotechnical Commission guidance.


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RoHS – Example

3 June 2011

Declaration of RoHS Compliance

Wurth Electronics Midcom Inc. declares that our products are in compliance with Directive 2002/95/EC of
the European Parliament and of the Council of 27 January 2003 on the Restriction of the use of certain
Hazardous Substances in electrical and electronic equipment, including all applicable amendments. The
hazardous substances are:

Mercury (Hg _1000ppm), lead (Pb _1000ppm), cadmium (Cd _100ppm), hexavalent chromium
(Cr6 _1000ppm), polybrominated biphenyls (PBB _1000ppm), polybrominated diphenyl ether
(PBDE _1000ppm), decabromodiphenyl ether (DecaBDE _1000ppm), octabromodiphenyl ether
(OctaBDE _1000ppm), pentabromodiphenyl ether (PentaBDE_1000ppm).

These substances are not intentionally added but may be present as impurities and do not exceed the
maximum allowed value. However, some products may contain lead (Pb) as deemed permissible under the
RoHS exemptions, namely:
CE Mark Technical File Information.
• Lead in high melting temperature type solders (i.e. lead-based alloys containing 85% by weight or
more lead).
• Lead in solders for servers, storage and storage array systems, network infrastructure equipment
for switching, signaling, transmission as well as network management for telecommunications.
• Lead in electronic ceramic parts (e.g. piezoelectronic devices).

Product specification sheets that show the status of lead-free/RoHS compliance are available on our
website at www.we-online.com/midcom.

Wurth Electronics Midcom Inc. bases its knowledge of the substance content of its products on information
provided by third parties such as suppliers and test laboratories.

Wurth Electronics Midcom Inc. makes no warranties, expressed or implied, and assumes no liability in
connection with the use of this information.

Frank Stupnik
Environment Compliance Engineer


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Conflict Minerals
Summary:
• Disclosure on use of specific conflict minerals
• 3TGs
»» Tantalum (Coltan Ore)
»» Tin (Cassiterite Ore)
»» Tungsten (Wolframite)
»» Gold
»» Others determined by the Secretary of State to be financing conflict in DRC

• Origin: Democratic Republic of Congo and adjoining countries
»» If originated in DRC Countries OR cannot conclude that conflict minerals DID
NOT originate in the DRC countries

• Reasonable Country of Origin Inquiry
• Defined as what a “Reasonable person would consider a prudent country of origin inquiry”.
»» If you can determine that your conflict minerals do NOT come from DRC or
adjoining countries then you disclose this determination to the SEC along with
the reasonable country of origin inquiry used to make this determination in the
annual report.


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• Conflict Minerals Report – Due Diligence is of utmost importance
• If a product uses conflict minerals from the DRC/adjoining countries or the company
DOES NOT KNOW, a Conflict Mineral Report must be provided.

• A description of the measures it had taken to exercise due diligence on the source and chain
of custody of its conflict minerals,

• The efforts to determine the mine or location of origin with the greatest possible specific-
ity – required to exercise due diligence in making these determinations in the Conflict
Minerals Report.

EICC and GeSI – the Electronic Industry Citizenship Coalition and the Global
e-Sustainability Initiative have developed a reporting template to enable a common
means of collecting sourcing information.


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Conflict Minerals – Example


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Custom Requirements
Extended Producer Responsibilities (EPRs) can be more easily identified as Custom Requirements.
These usually include regulations like REACH and RoHS but have additional requirements which
can include:
a. Radioactive substances
b. Asbestos, Refractory Fibers (some covered by REACH) and Ceramics
c. JIG
d. Proposition 65
e. Some may even ask for a full material declaration as their requirement or have you en-
roll in a program like
i. Sony Green
ii. Agilent Technologies’ General Specification for the Environment
GSE Example
• You can see in the GSE a very extensive list of substances


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Full Material Declarations
Essentially this is a request for the disclosure of all materials and their composition. This is primarily
seen in the electronics industry and is typically requested in IPC1752A format.

See Example on following page


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MANAGEMENT REGULATIONS FOR THE ENVIRONMENT-RELATED SUBSTANCES TO BE
CONTROLLED WHICH ARE INCLUDED IN PARTS AND MATERIALS – SS-00259 for General
Use, Eleventh Edition (Copyright 2012 Sony Corporation)

Table 4.1: List of “Environment-related Substances to be Controlled (‘Controlled Substances’)”
Trisubstituted organotin compounds (including tributyltin Bis (2-ethylhexyl)phthalate, Dibutyl phthalate, Benzyl butyl
Cadmium and cadmium compounds
(TBT) compounds and triphenyltin (TPT) compounds) phthalate, Diisobutyl phthalate
Di-isononyl phthalate, Di-isodecyl phthalate, Di-n-octyl
Lead and lead compounds Dibutyltin (DBT) compounds
phthalate, Di-n-hexyl phthalate,
“1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters,
Mercury and mercury compounds Dioctyltin (DOT) compounds
C7-rich”,
“1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear
Hexavalent chromium compounds Asbestos
alkyl esters”,
Polychlorinated biphenyls (PCB),
Polychlorinated naphthalenes (PCN), Specific azo compounds Bis(2-methoxyethyl) phthalate
Polychlorinated terphenyls (PCT)

Short-chain chlorinated paraffins (SCCP) Formaldehyde Hydrofluorocarbon (HFC), Perfluorocarbon (PFC)

Polyvinyl chloride (PVC) and PVC blends Specific benzotriazole Ozone depleting substances (ODS)

Tris(2-chloroethyl) phosphate (TCEP) Dimethyl fumarate (DMF) Perfluorooctane sulfonates (PFOS)

Other chlorinated organic compounds Beryllium oxide Boric acid, specific sodium borates

Polybrominated biphenyls (PBB) Beryllium copper 4-(1,1,3,3-tetramethylbutyl) phenol

Polybrominated diphenylethers (PBDE)(including
Cobalt dichloride Bis(2-methoxyethyl) ether
decabromodiphenyl ether [DecaBDE])

Hexabromocyclododecane (HBCDD) Diarsenic trioxide, Diarsenic pentaoxide N,N-dimethylacetamide (DMAC)

Other brominated organic compounds


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Material Composition Declaration


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Electronic Reporting on the rise
TSCA:
The US Environmental Protection Agency (EPA) has issued a draft proposed rule under the Toxic
Substances Control Act (TSCA) that will ask manufacturers of chemicals and allied products to
electronically report certain information including:

• TSCA section 4 – study plans and other documents relating to test rules and enforceable
consent agreements (ECAs)
• TSCA section 5 – notices of commencement or import (NOCs) correspondence and other data
• TSCA section 8a – preliminary assessment information manufacturer’s report form
• TSCA section 8d – health and safety studies full study reports and related documents

Under the proposed rule, organisations would submit this data to the US EPA through the agency’s
Central Data Exchange (CDX). They would use a new web-based reporting tool, the Chemical
Information Submission System (CISS), that will be made available when the proposed rule be-
comes final.
The CISS will allow information to be converted into PDF format for review before it is submitted
to the US EPA. CISS will also permit reports and other data to be submitted as PDF attachments
or in other electronic formats such as extensible markup language (XML).


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 Why are material declarations
being requested?
1. Either a legal requirement (EU importers, SEC Issuers)
a. As seen by the REACH, RoHS and Conflict Minerals regulatory requirements

2. Contractual requirement of their downstream users (who are likely EU Importers or SEC issuers)

3. Customer requirements usually come from larger companies that are trying to cover all their bases
a. Worldwide regulations
i. China REACH
ii. US, California
• Proposition 65
• TSCA
iii. Japan – Japanese Existing and New Chemical Substances Inventory(ENCS), The
Chemical Substances Control Law
iv. Taiwan ECN


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b. Worldwide proposed regulations and proposed regulatory amendments
i. REACH Registry of Intentions
ii. REACH Candidate List Proposals
iii. Turkey Chemicals Management Regulation

c. NGO-created “Dangerous Substances Lists”
i. SIN-list


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 How do I develop a strategy to meet
all of these requirements?
1. Determine which requirements actually apply to your company and your products.
2. Assess the current regulatory program
a. Does your company currently have any processes in place where compliance data is
collected or tested for?
ii. Standards
iii. Regulations
iv. ISO
b. Do you have existing data?
i. RoHS
• Regulation has been “in circulation” for a significant period of time, data may
already exist via technical data sheets
c. Can you add questions/data requests to the existing processes?
d. Do you have the resources to collect the extra data and take the new next steps of compliance?
i. Communication
ii. Notification


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iii. Product Marking
iv. Product Documentation
3. Prioritize
a. Products headed to those regulatory markets
b. Products being placed on the market after the applicable regulatory deadline

4. Develop a Data Collection plan
a. Who?
b. How?
c. Data Storage?
d. Process for non-responsive suppliers
i. Follow-up from another department?
ii. Engineering Assessment for parts

5. Develop a Due Diligence plan
a. Supplier Declaration Verification
b. Testing?

6. Develop a Declaration Template


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 Declaration Procurement from
your Supply Chain
1. Education of suppliers is vital to success
i. Vendor education on the regulations
ii. Vendor education on the compliance process

Kingfisher plc, Europe’s leading home improvement retailer with over 900 stores in 8 countries in
Europe and Asia.
Provide an “e-learning programme” as they have found that even now, their vendors lack under-
standing, are not prepared and do not have a compliance program in place

2. Clear standards of acceptability
i. Appropriate regulatory reference
ii. Appropriate date
iii. Company Letterhead
iv. Appropriate individual within company


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3. “Rolling up” supplier info
i. Manual
ii. Electronic
• Determine to what level
a. Product
b. Component

4. How to deal with non-responsive suppliers
i. Increase pressure
• This information is required to continue buying
ii. Bring in other departments
• Longer/Better relationship with the supplier
iii. Engineering Assessment


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 Declaration Procurement from
YOUR Supply Chain
Examples


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USA: P.O. BOX 115 - Oskaloosa, IA 52577-0115 (U.S.A.) / Tel: 641/673-5000 * Fax 641/673-5100
UK: 10 Kelvin Drive- Knowlhill – Milton Keynes – Buckinghamshire MK5 8NH – UK / Tel: +44 (0) 1908 327700 Fax: +44 (0) 1908 327706

Date: June 2011,

From: Joe Caligiuri, Product Compliance Specialist

To: To whom it may concern

RE: Interpower Corporations’ Status on REACH

Interpower Group of Companies strives to keep our customers informed with the most up-to-date
information of changes to safety standards or European directives such as the new REACH directive.

REACH is a new European Community Regulation on chemicals and their safe use. It deals with the
Registrations, Evaluation, Authorization and Restriction of Chemical substances (Regulation (EC) No
1907/2006 of the European Parliament and of the Council). The new law became effective June 1, 2007.

The aim of REACH is to improve the protection of human health and the environment through the better
and earlier identification of the intrinsic properties of chemical substances. This directive is similar to EPA
(Environmental Protection Agency) regulations in the United States in that the manufacturers of
chemicals are required to register what they manufacture, how much they manufacture or import, and any
ill affects the chemical could cause to humans or the environment.

Based on our research, Interpower products are not affected by this regulation. Interpower does not
manufacture chemical substances or mixtures of chemical substances in containers. Our products do not
contain substances which are intentionally released during their use.

To our knowledge, our EU approved products do not contain any of the substances which are on the
“substance of very high concern”
http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp?sortby=Date_inclusi
on&order=descending and in accordance with Annex XIV of EC 1907/2006. If any Substance of Very
High Concern is identified in our products for use in the EU, Interpower Corporation will take all necessary
actions to make the required notification to our customers.

If you would like to research this directive further, please visit the website: www.echa.europa.eu for more
information. If you have questions pertaining to any of our products, please email your request to Interpower Customer REACH Letter-1
jcaligiuri@interpower.com.
• Company Header
• Appropriate individual
Joe Caligiuri
Product Compliance Specialist
• Includes some information on REACH
Interpower Corporation
www.interpower.com • Gives the actual link to the Candidate List
• Date is not current


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Subject: European Union Regulation (EC) 1907/2006. Updated December 19, 2011. Registration,
Evaluation, Authorization and Restriction of Chemicals. (REACH)

The subject directive undertakes the identification and definition of chemicals of concern, and
preparation of said chemicals, that are contained in products for use in the European Union. It
details registration obligations of manufactures and suppliers to assure compliance.
The shape, surface and design of our products (articles) are paramount to the chemical composition.
LYN-TRON products are deemed articles, as defined in the REACH Directive.
Articles are exempt from REACH unless they release a SVHC (Substance of Very High Concern) as
identified in the regulation.

Lyn-Tron, Inc. does not manufacture or distribute any products that contain these substances.
No chemicals or substances are intentionally released from Lyn-Tron’s products.

Lyn-tron, Inc. products are Halogen free.

For these reasons, Lyn-Tron products are considered articles that are not affected by the
REACH Directive. They do not require registration. -- Paragraph 32 and Chapter 2 (3.3)

Sincerely,

Michael E. Quinn
Exec Vice President

Lyn-Tron Reach Statement
• Company Header
• Date is current
• Inaccurate understanding of REACH
responsibilities


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Momentive SVHC – RTV167 2012-01-16
• Company Header
• Includes appropriate regulatory reference
• Date is current


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PDE cae reach cofc
• Company Header
• Regulatory reference is weak
• Date is current


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Customer Information Request
Customer Information Request: CR-001079

On behalf of Semtech Corporation, I am pleased to provide you with this final report that
closes your request for information. Your request consisted of providing compliance
statement of our products as listed to REACH Directive, EU Regulation EC1907/2006
including recent addition of SVHC candidate list of substances published by ECHA
(European Chemical Agency) in October 2011.

Herewith Semtech Corporation is pleased to declare that the devices supplied to you, P/Ns
SR2.8.TCT and RClamp0504F.TCT, do not intentionally use, contain/exceed 0.1% weight by
weight or add any of the substances contained within REACH Directive as specified in the
table below.

Semtech Corporation is pleased that we are able to accommodate your needs and look
forward to a continued and successful business relationship.

If you have any questions, do not hesitate to give me a call.

Sincerely,

Roya Reader
SEMTECH CR-001079 CAE REACH
Semtech Corporation
Quality Customer Service Specialist
SVHC Declaration
200 Flynn Road
Camarillo, CA 93012 • Company Header
Rreader@semtech.com
Office: (805) 389-2742
Fax: (805) 498-3804 • Appropriate individual
• Gives the table of SVHCs as of date noted
• Date is not current

Semtech Corporation • 200 Flynn Road • Camarillo • Ca • 93012 • Phone (805) 498-2111


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 How can Assent Help?
Consulting Services
• Manage the compliance to ROHS, REACH, CLP and other Environmental standards
• Ensure compliance with regulatory agencies and compliance regulations
• Review and evaluate environmental requirements and changes as published by regulating bodies
• Support sourcing and selection of electronic and mechanical components
• Serve as subject matter expert on regulatory matters
• Specification and drawing review for compliance
• Obsolescence management and part substitution
• Work with suppliers on corrective actions


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Assent Technical Report – RoHS – WEEE
• Company requirements summary – WEEE and RoHS


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RoHS
Overall Compliance Process
[Products placed on market before January 2nd, 2013]

Step 1: Determine Parts in Scope

Project Manager to determine Parts in
Scope using Scope Determination Process

Step 2: Conduct Supplier Survey on
parts in Scope

Project Manager to administer a Supplier Survey on
parts in scope using Supplier Survey Process

NO
Has Supplier
completed Project Manager to initiate
Survey after 90 Escalation Process
days?

YES
Step 3: due diligence

Project Manager to apply Due Diligence according to
Due Diligence Plan

Step 4: Declaration Roll-up

Project Manager to create template for RoHS Certificate of Conformity and
make available for Clients based on Supplier Survey and Due Diligence results
using Certificate Process.

Single certificate of conformity created which lists
the exemptions as applicable.

end process


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Flammability Compliance Certification


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 How can Assent Help?
Software Services
• Automatically gather environmental compliance data from your supply chain (Declarations,
COC’s, DOC’s, etc.)

• Platform for suppliers to enter environmental compliance information

• Generate custom reports based on gathered compliance data:
• Allows for a top level view of compliance progress or a drill down to product or part level
compliance
• Instantly isolate problem areas based on products, parts or materials.

• Generate compliance documents for Enforcement agencies and downstream users.
• Acts as a platform for internal teams to manage environmental data and make internal declara-
tions based on obtained information:
• Engineering Override

• Automatic communication tool to inform suppliers of changes to environmental regulations
• Free model for large cap companies looking to implement a software platform with their
supply chain


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 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.


Material Declarations For Any Environmental Regulation

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