Guidelines for the Management of Chemical Substances in ... · The Role of the “Guidelines for...

Guidelines for the Management of Chemical Substances in Products

September 27, 2005

Revision 1

Japan Green Procurement Survey Standardization Initiative (JGPSSI)

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Table of Contents 1. Background.......................................................................................................................................................3 2. Definition of Terms...........................................................................................................................................4 3. The Role of the “Guidelines for the Management of Chemical Substances in Products” ................................8 3.1. Purpose ........................................................................................................................................................10 3.2. Applicability to Management System Standards .........................................................................................10 3.3. Applicable Industries ...................................................................................................................................10 3.4. Anticipated Users .........................................................................................................................................10 3.5. Units and Targets of Management ............................................................................................................... 11 3.6. Use of the Guidelines................................................................................................................................... 11 4. Fundamental Approach to the Management of Chemical Substances in Products .........................................12 4.1. Principles .....................................................................................................................................................12 4.2. Structure of the Supply Chain......................................................................................................................13 4.3. Characteristics of the Manufacturing Processes that Convert Substances/Preparations into Articles

(Original Components) ....................................................................................................................................14 4.4. The Four Types of “Manufacturing Processes” ...........................................................................................14 4.5. Classifications of the “Manufacturer Name” and Identification of the “Manufacturing Processes” ...........17 4.6. Importance of Management Focusing on the “Unit Process” ......................................................................18 4.7. “Frameworks” Focusing on “Manufacturing Processes” and “Unit Processes” ..........................................19 5. The “Action Item List & Check Sheet” ..........................................................................................................21 6. Evaluation Criteria..........................................................................................................................................22 7. Self-Declaration of Conformance ...................................................................................................................24 8. Principles for Use............................................................................................................................................24 8.1. Disclousure of Validated Records ................................................................................................................24 8.2 Validating Self-Declaration of Conformance................................................................................................25 8.3. Use of These Guidelines ..............................................................................................................................25 8.4. Protecting Proprietary Information ..............................................................................................................25 8.5 An Approach to Incorporation into Existing Systems (ISO 9001, ISO 14001) ............................................25 Attachment 1: Information Sheet on the Inclusion of Certain Chemical Substances .........................................26 Attachment 2: JIG Annex A and Annex B……………………………………………………………………...27 Attachment 3: Comparisons between the Action Item List & Check Sheet, ISO 9001, and ISO 14001 .......28-29 (Annex 1) Action Item List & Check Sheet.....................................................................................Separate Sheet (Annex 2) Self-Declaration of Conformance (Example), Self-Declaration of Conformance (Data Example),

Explanation of Self-Declaration of Conformance (Data Example) ..............................................Separate Sheet

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List of Abbreviations

EIA Electronic Industries Alliance EICTA European Information and Communications Technology Industry Association JCIA Japan Chemical Industry Association JGPSSI Japan Green Procurement Survey Standardization Initiative REACH Registration, Evaluation and Authorization of Chemicals (currently under discussion) RoHS Directive Directive 2002/95/EC of the European Parliament and of the Council on the Restriction

of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment TSCA Toxic Substances Control Act of 1976

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1. Background

With regard to environmental and human health issues that result from the content of chemical substances in products, there are those caused by exposure to hazardous chemical substances given off by products (for example, Sick House Syndrome), and those soil and ground water pollution issues caused by hazardous chemical substances that leach out of discarded products. Against this backcloth, we have entered an age where it has become necessary to control certain hazardous chemical substances contained in electrical products and machinery. Evidence of this is offered by the Directives of the European Parliament and the European Council regarding the “Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment” (EU Directive, 2002/95/EC: hereinafter abbreviated “RoHS”). These directives cover products used in the European Union. To respond to the needs of the times, all firms within a supply chain must implement systems for the appropriate and effective management of chemical substances contained in their products. Work by related groups has produced tools by which to share information on both the applicable chemical substances and on the amount of these substances contained within products. Centering on major information technology equipment manufacturers within Japan, the Japan Green Procurement Survey Standardization Initiative (JGPSSI) was established with the aim of developing a common procurement system. At the same time, JGPSSI cooperated with the Electronic Industries Alliance (EIA) and the European Information and Communications Technology Industry Association (EICTA) to establish common guidelines for investigations from a global perspective, and in May 2005, under the approvals of JGPSSI and EIA, the Joint Industry Guide (JIG) for Material Composition Declaration for Electronic Products was issued. It is in such an environment that, in cooperation with the Ministry of Economy, Trade and Industry (METI), the “Survey Report for the Certification of the Control of Information Regarding Chemical Substances Included in Products” was published in March 2004 by the Committee for Researching Certification Systems for Controlling Information Regarding Chemical Substances included in Products (which included the participation of electrical and electronic equipment manufacturers, the chemical industry, etc.). The report included a draft proposal on “Guidelines for the Management of Chemical Substances in Products.” The essence of the draft was that it is imperative that there be standardization of the systems for controlling chemical substances within the products of each company in order to insure information reliability. This standardization was to be obtained through the cooperation of all firms in the supply chain, from raw materials suppliers through to the final product manufacturers. After receiving this draft, in order to further specify action items, the JGPSSI analyzed specific cases to add standards by which to evaluate conformance, arriving at the “Guidelines for the Management of Chemical Substances in Products” published by the JGPSSI.

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2. Definition of Terms Terms used in these guidelines are defined as follows:

(1) Substance (a single chemical substance)

A “substance” is a chemical element or compound that either exists in nature or is obtained via a manufacturing process. A “substance” includes impurities introduced in manufacturing processes, and additives required for stability maintenance. However, solvents that can be broken down without affecting the stability of the single chemical substance and without changing the composition thereof, are excluded from this definition. (Reference: JIS Z 7250)

Examples: Lead oxides, nickel chlorides, benzenes, etc.

(2) Preparation (a mixture) A “preparation” is a mixture comprising two or more individual chemical substances (including solvents). (Reference: JIS Z 7250)

Examples: Paints, inks, solders prior to use, adhesives, alloys, etc. * Note that in use, preparations become “articles” at the point wherein reactions, such

as curing, have occurred.

(3) Articles (fabricated products) (3-1) TSCA Definition

The United States’ Toxic Substances Control Act (TSCA) refers to an “article” also as “product” or “goods,” and defines an “article” as an item that: 1) Is formed into a specific shape or design during manufacture, 2) Has end use functions dependent in whole or in part upon its shape or design during end

use, 3) Has either no change of chemical composition during its end use, or only those changes of

composition which have no commercial purpose separate from that of the article, with the added provision in the United States Occupational Safety and Health Agency Hazard Communication Standard and the Code of Federal Regulations (CFR) Toxic Chemical Release Reporting (40 CFR Part 372) that the item “does not release a toxic chemical under normal conditions of processing or use,” where

4) Fluids or particles are not considered articles regardless of their shape or design. Examples: Keyboards, main units of computers, and other fabricated objects. The application of the terminology is broader than that of “Original Components.”

(3-2) REACH Definition (not yet approved*) The European Union’s chemical policy known as REACH (Registration, Evaluation and Authorization of Chemicals) has the following definition: “An article is an object made from a chemical substance or mixture that is given a specific shape, appearance, or design in manufacturing that determines the ultimate function in use more than does the chemical composition thereof. (Reference: Draft Directive for REACH)

* As of August 2005, this definition has not been approved, and so should be used for reference purposes only.

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(4) Original Components

A component that has been produced through a manufacturing process such as molding, drying, heating, coating, etc., wherein the amounts of chemical substances included are fixed.

Example: A single key in a keyboard for a personal computer, a capacitor, solder after use, etc.

Note: Original components are subsets of articles. They have been produced through passing through a manufacturing process that fixes the amounts of chemical substances included.

(5) JIG

Guidelines regarding the disclosure of information related to chemical substances in products, created jointly by the JGPSSI, EIA and EICTA and issued after approvals of the JGPSSI and EIA. Its English official name is the “Joint Industry Guide (JIG) for Material Composition Declaration for Electronic Products” and the issuer is the EIA. There is a Japanese version of this guide issued by the JGPSSI. The guide is abbreviated as the JIG.

(6) JIG Annex A and Annex B

These are the lists of groups of common chemical substances to be investigated, as stipulated by the JIG. There are 15 and 9 groups of substances listed in Annex A and Annex B, respectively. Groups of substances in Annex A and Annex B were selected based on the following criteria:

Annex A: Chemical substances whose use is prohibited, restricted or required to be reported, subject to domestic or overseas regulations

Annex B: a) Substances that are of significant environmental, health, or saefty interest b) Substances that would trigger hazardous waste management requirements c) Substances that could have a negative impact on end-of-life management

(7) JGP Files

This refers to the JGP file format, established by the JGPSSI, for electronic files used in standardized green procurement survey responses. The JGP files establish the types of response data, the sequence of response data, and the data delimiters (tab characters). The following freeware templates are provided by the JGPSSI: the “Survey Response Tool” in Excel format for creating the JGP files; and the “Data Checking Tool” by which to check the contents of the JGP files. In accordance with the introduction of the JIG, the JGPSSI will propose a JGPSSI recommended format that meets the JIG standards and improve the existing JGP files.

(8) “Content Flag ” Information

An investigation item stipulated in the JGPSSI recommended format that meets the JIG standards. In this recommended format, the investigator is asked to answer in Yes or No whether the relevant group(s) of chemical substances are intentionally added (“intentionally added” refers to the case where the substance is added to the product in order to add a certain performance to the product) or are present in excess of the threshold level.

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(9) MSDS This refers to data sheets regarding the safety of chemical substances and is an abbreviation of the Material Safety Data Sheet. In Europe, it is called the Safety Data Sheet (SDS). It is a document created and provided for companies who handle chemical substances, so that the environment and human health may be protected, work safety may be maintained, and necessary measures may be addressed. In Japan, submisssion of the MSDS is required by the Industrial Safety and Health Law, the Law Concerning Reporting, Etc., of Releases to the Environment of Specific Chemical Substances and Promoting Improvements in their Management (the so-called “PRTR Law”), and the Poisonous and Deleterious Substances Control Law. The form is stipulated in ISO11014-1 (corresponding JIS: JIS Z 7250) and the guidelines for the preparation of the MSDS is published by the Japan Chemical Industry Association (JCIA).

(10) Information Sheet on the Content of Certain Chemical Substances A format that supplements the MSDS. It is used to provide information regarding the amount of certain hazardous substances contained in products, such as some traces of cadmium. It is used in cojunction with the MSDS and is recommended by the JCIA. Please see the JCIA website and the Information Sheet on the Content of Certain Chemical Substances (Annex 1). It is also referred to as the MSDS Plus.

http://www.nikkakyo.org/library/dioxin_lib_doc.php3?issueid=32

(11) Contain “Content” refers to the content of a chemical substance, as a constituent of a component, material, or product. The “content” includes cases wherein a chemical substance that is contained naturally (an impurity) is included, or wherein a substance that is left over from a common industrial refining process (an impurity, a residual solvent, a non-reacted monomer, or other residual substance) is included.

(12) Threshold

This is a boundary value that evaluates the figures. When managing chemical substances in products, is is used to determine whether the relevant chemical substance is present or absent in the product. <Remarks> Generally in green procurement surveys, it is used as the lower limit of the amount of

included chemical substances when it is required to answer the survey. However, in carrying out green procurement surveys, the JGPSSI defines that a threshold is a concentration level that requires notification based on the green procurement survey requirement items stipulated by the JGPSSI. When the amont of chemical substances or materials contained in a homogeneous material of a product or a component exceeds (or equalizes with) this value, notification is required.

JIG Definition Threshold level: Concentration level which defines the limit (equal to or) above which the

presence of a substance or material in a product or subpart must be declared based on the requirements of this guide.

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(13) Supply Chain The “supply chain” generally refers to the linked series of operations linking the provider to the consumer, from development through procurement, manufacturing, distribution, and sale. In this document, this extends to the manufacturing of the final product, where the supply chain relates to materials manufacturers, chemical product manufacturers, article manufacturers, parts manufacturers, set manufactures, and so forth.

(14) Products A “product” refers to that which is shipped by a company. This includes not just the final product, but also materials and semi-completed goods requiring further processing or conversion prior to being sent to the greater market.

(15) Manufacturing Process Although for products produced by the supply chain, manufacturing processes can be categorized broadly into 1) Substance/preparation manufacturing, 2) Original component manufacturing, 3) Parts manufacturing, and 4) Equipment manufacturing, typically firms perform more than one type of manufacturing mentioned above. The “manufacturing process” refers to the processes that perform these types of manufacturing. These are also referred to as “processes.”

(16) Unit Process Each of the manufacturing processes described in (15), above, requires the three actions of “purchasing,” “manufacturing,” and “sales.” These three processes are known as the “unit process” for control.

(17) Management Framework

The “management framework” refers to the action items that are controlled in the unit processes for substances, preparations, and articles. These are also referred to as “management schemes.”

(18) High-Risk Materials

The word “high-risk materials” does not have a clear definition. Generally speaking, however, it is used in the following meaning: “A raw material or component with a concern of exceeding the threshold in a certain frequency (see 2. Definition of Terms (12)), resulting from unevenness in the amount or concentration of included chemical substances which require management.” Reporting of high-risk materials are required mainly in the following cases: chemical substances which require management that are contained in raw materials and components are highly likely to become mixed, difficult to remove, or easily accumulable when recycling and reusing the products.

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3. The Role of the “Guidelines for the Management of Chemical Substances in Products” - It is important to standardize several requirements that are required for the various companies in

the supply chain to cooperate with each other and for the appropriate management of the chemical substances contained in the products to be performed efficiently. These requirements are outlined in Table 1. Of these, “Selection of types of substances subject to management” and “Making of survey reply format for sending information” have been prepared thanks to the efforts of the JGPSSI and the JCIA. These guidelines are the requirements for improving the reliability of the information disclosed, and summarize the “specific action items and requirement items regarding the management of chemical substances in products.”

Table 1: Requirements for the Efficient Management of Chemical Substances in Products by Firms

in the Supply Chain, Specific Approaches Thereto, Etc. Requirement Purpose Specific Approach, Etc.

Selection of types of substances subject to management

- To standardize the focus of surveys

- To avoid excessive surveys

- Standardized by JIG Annex A and Annex B

- To rectify imprecision in surveys

- Standardized by JGPSSI after introduction of JIG (JGP files)

Making of survey reply format for sending information

- To supplement the information included in the MSDS

- JCIA “Datasheet for Certain Chemical Substances in Products”

Determination of the subject of these guidelines: specific action items regarding the management of chemical substances in products

- To improve reliability of information disclosed through survey reply format described above

- To standardize key points in the structure of management systems

- These guidelines are being drawn up by the JGPSSI with the aim of providing a reference when individual companies structure control systems for the chemical substances in products

- There are already a variety of approaches taken to management of chemical substances in the chemical industry, including the “responsible care” movement. These guidelines compile information that will serve as a reference when structuring management systems in order to make it possible to address the management of chemical substances included in products in firms outside of the chemical industry as well.

- It is necessary to create a system in the overall supply chain by which to control chemical substances in products and by which to transmit appropriate information such as the amounts of contained chemical substances. This figure shows how these guidelines standardize the requirements so that there will not be inconsistencies in management from company to company in structuring and running systems for the appropriate management of the chemical substances contained in the products of each individual company.

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Figure 1: Overview Regarding the Use of Tshese Guidelines

S ch em e to ca lc u la te da ta o f h aza rd o u s su b stan c es in p u rch as ed p ro d u c tsa n d in fo rm d ata o f hazard o u s s ub s tan ce s in its p ro d u c ts to its cu sto m e rs

S upplie r B 1

S upplie r B 2

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T o enh ance th e cre d ib ility o f da ta o fhaza rd ous su bstance s in p ro du cts ,the o rg an iza tion(s) shou ld e s ta b lish ,im p le m e n t and m a in ta in them an agem en t sys tem o f h azardoussubstances.

Id en tificat ion o f organ ization stru ctu re ,ro les , resp o nsib ilities a nd a utho rit ies

M a na gem en t rev iew

P lan n in g o f o pe ra tio na l p ro cesses

S election o f sig n ifica nt issuesto be a dd re ssed

M a nag em en t r ev iew A n a lysing a nd h a nd lin g no ncon form ities

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< ex> D ata o f cer ta in hazardous substances in p rod ucts are traceab le

< ex> O pera tion p ro ced ures to p reven t the m ixing o f cer ta in haza rdo us substances a re defined

< ex> D a ta o f certa in hazardous substances and its ev idence ex ist fo r a ll purchased p roducts

< ex> R ule m en tions that p roh ib ition and restric tio n o f the use o f cer ta in hazardous substances m ust be no ted on specifica tions

D esign an d D evelop m en t P u rcha sing P rodu ctio n P rodu ct re lease

M a te ria l D e c la ra tio n As su ran ce S ys te m

It w ill be exp ec ted to red uce th e load s fo r b o th m an ufacturers and su pp lie rsby ho ld ing the m anag em ent sys tem of hazardous sub stances in com m on

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3.1. Purpose The purpose of these guidelines is to define the requirements for firms in the electric and electronics industry supply chain in order to accurately control the chemical substances contained in their own products, and to provide standardized requirements for accurate and efficient management of contained chemical substances. The goal is to have firms in the supply chain establish management of the contained chemical substances in order to increase the reliability of the information on the chemical substances contained in raw materials and components, making it possible to comply with legal regulations such as the RoHS Directive. However, even if the management of chemical substances in products is implemented in accordance with these guidelines, these guidelines do not verify the compliance of individual products with regulations such as the RoHS Directive, regardless of whether the products are sold by companies that have introduced these guidelines.

3.2. Applicability to Management System Standards

Because the supply chain may include interactions with foreign companies, the ISO Guide 72, “Guidelines for the Justification and Development of Management System Standards,” was used as a reference when compiling the action items shown in these guidelines. Specifically, the action items were researched while referencing standard requirements for management systems.

3.3. Applicable Industries

These guidelines apply to all industries in the supply chains of the electrical and electronic industries, from materials manufacturers through to set manufacturers.

3.4. Anticipated Users

The users anticipated for these guidelines are as follows: (1) Parties Responsible For Structuring the Systems for Managing Chemical Substances in the

Products of Their Firms These guidelines are anticipated to be a reference when the systems for managing chemical substances in products are constructed in individual firms. When, during the stage wherein the systems are constructed, the parties with the primary responsibilities for constructing the systems engage in the work after referencing these guidelines, then later, after the systems have been constructed, these guidelines can be used as training tools within the company, making it possible to insure a shared knowledge of the critical points of the system for managing chemical substances in products. Moreover, these guidelines may also be used when the firm’s compliance department performs internal audits regarding whether or not the system for managing the chemical substances in products is functioning.

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(2) Individuals Auditing the Systems for Managing Chemical Substances in Products on the Supplier Side

These guidelines are anticipated to be used as a reference by external organizations including purchasers, in order to confirm whether a system for managing chemical substances has been constructed on the supply side.

3.5. Units and Targets of Management

The units and targets for management in these guidelines are as described below:

(1) Units for Performing Management In these guidelines, the unit for managing chemical substances in products is envisioned as the “organization,” rather than the “product.” From the standpoint of information reliability, there are those who would point out that the “product” unit is superior to the “organization” unit, but it cannot be denied that management by the “product” unit may be costly in terms of the labor, efficiency, and costs for the companies. Moreover, from the perspective of corporate social responsibility (CSR), it is becoming increasingly important to exhibit compliance as an “organization” regarding the management of chemical substances in products, and thus in these guidelines it is recommended that the unit of management be the “organization” unit.s

* Here the “organization” indicates companies, corporations, business departments, and individual contractors, and combinations of the same.

Example: ○○ Factory, ○○ Inc.; ×× Division., ×× Inc.; ∆∆ Product Dept., ∆∆ Group

(2) Substances Subject to Management The substances subject to management are not specifically stipulated in these guidelines, and they rather vary depending on the green procurement standards of each firm. However, in consideration of efficiency in management and surveys, it is recommended that the management cover the survey substances listed in the JIG Annex A and Annex B.

3.6. Use of the Guidelines

These guidelines may be used by following the flow described below: (1) Structure the Management System

The first task to be performed by each firm in the supply chain is to provide/structure a system for controlling the chemical substances included in the products of the firm. Although the optimal form of the control system will vary depending on the type of industry, industrial conditions, and details of the operations within the firm, these guidelines will serve as a reference when structuring management systems.

(2) Declare Structure of the Management System

There are the following two methods by which to indicate to external organizations, such as purchasers, that a system for managing chemical substances in products has been structured based on these guidelines.

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1) Self-declaration of conformance 2) Be audited and obtain certification from an external organization (either a second party (an

external organization with a direct interest) or a third party (an external organization without a direct interest))

Of these, there are many issues requiring research, such as globalization, when it comes to obtaining certification from a third party in particular, where it is anticipated that substantial time will elapse before globalization. Thus the JGPSSI favors the use of self-declaration of conformance to allow firms to begin participation as quickly as possible. The method of self-declaration of conformance uses the definition in the international standard for self-declaration of conformance (ISO/IEC17050-1, 2), and a portion thereof is quoted below: - When an individual or organization (supplier) that has the responsibility for fulfilling

requirements makes a declaration that the product (or service), process, management system, individual, or organization complies with specific requirements.

- The specific requirements include standard documentation such as standards, guides, technical specifications, laws, regulations, etc. This type of declaration of conformance can reference the results of evaluations by a first party (internal organization), a second party (interested external organization), or a third party (not interested external organization), or by more than one of the above. However, the reference cannot be interpreted as reducing the liability of the supplier in any way.

Note that these guidelines provide only information to serve as a reference in structuring the system for managing chemical substances in products. The self-declaration of conformance for structuring the system based on these guidelines does not form a guarantee for commercial transactions between the two parties of the supplier and the purchaser.

4. Fundamental Approach to the Management of Chemical Substances in Products In order to use these guidelines, it is necessary to understand the management of chemical substances in products. The management of chemical substances in products will be explained by going through the process for a specific example.

4.1. Principles

The management of chemical substances in products can be described as 1) the acquisition of content information for purchased materials (IN information), 2) the manufacture of products using those materials in a manufacturing process, and 3) the provision of content information for the products sold (OUT information). The management of these three processes 1), 2) and 3) must be performed throughout the entire supply chain.

1) Content Information for Products Purchased (IN): Obtain content information (IN information) for each substance/preparation and each article, and confirm the reliability of the content information.

2) Manufacturing Using a Manufacturing Process: Increase the reliability in the daily quality management activities, such as preventing the content of incorrect components and preventing contamination by substances/preparations or

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articles that contain prohibited substances. 3) Content Information for Products Sold (OUT):

Improve reliability by providing content information (OUT information) for each substance/preparation or article.

4.2. Structure of the Supply Chain

Figure 2 shows the overall flow in the supply chain from the upstream companies (the materials manufacturers) to the downstream company (a set manufacturer) for the specific example provided by personal computers.

Figure 2: Supply Chain Flow

1) The further upstream the company, the more likely the products sold are substances or preparations, and the further downstream the company, the more likely the products sold are articles.

2) The further upstream the company, the more likely the products purchased are substances or preparations, and the further downstream the company, the more likely the products purchased are articles.

3) Between 1) and 2) are manufacturing processes that convert substances/preparations into articles. These are the original component manufacturing processes.

<Discussion> As discussed in 1) through 3), the management in the upstream companies requires

management of substances and preparations, where management in the downstream company requires management of articles in addition to management of substances and preparations. Note that the amounts of chemical substances contained are fixed in the manufacturing processes that convert substances/preparations into articles.

plus 情報の流れ

Product

Amounts included in components do not change

Fixed included amounts

Raw materials (Chemical substances)

Articles

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Manufacturing/ Processing

JGP files etc. MSDS MSDS Plus etc.

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4.3. Characteristics of the Manufacturing Processes that Convert Substances/Preparations into Articles (Original Components) As explained in Section 4.2, there are manufacturing processes in the supply chain that convert substances and preparations into articles, and these manufacturing processes serve as a boundary between different management methods. The characteristics of the manufacturing processes that convert substances/preparations into articles are described below:

1) Because the articles are made out of substances and preparations, the amounts of contained chemical substances are fixed in these manufacturing processes. Consequently, these manufacturing processes are key points in the management of amounts of chemical substances in products.

2) These manufacturing processes are found even among the processes at the set manufacturers, such as soldering operations (because solder is a preparation).

3) In these manufacturing processes, the substances/preparations are purchased as raw materials, and so it is important to receive from the vendor correct inclusion information for any substances subject to management. Specific examples on how to obtain content information include the MSDS, Information Sheet on the Content of Certain Chemical Substances, JGP files (including “Content Flag” information), specifications, and the like.

4) The content amounts do not vary in the articles after manufacturing using these manufacturing processes. Consequently, there is an obligation to disclose to subsequent processes accurate inclusion data. (The JGPSSI system works by trusting responses and receiving accurate information.) As specific examples of disclosures of content information there are JGP files (including “Content Flag” information) and so forth. It is desirable to acquire this content information in order to assure greater accuracy of content information through obtaining both the Information Sheet on the Content of Certain Chemical Substances and the “Content Flag” information of the JGP files.

4.4. The Four Types of “Manufacturing Processes”

The manufacturing companies involved in the supply chain come from a broad variety of industries, and each has its own manufacturing processes. As explained above, the pivotal point in managing the chemical substances in products is the manufacturing processes that purchase substances and preparations and convert them into articles. From this perspective, the unit of management should be the “manufacturing process.” For each of the “manufacturing process” units, there are the following four “manufacturing processes,” depending on the characteristics of the management. A specific example will be used in the explanation in order to facilitate understanding.

* In the sections below, “substance” will be abbreviated as “S,” “preparation” will be abbreviated as “P,” and “article” will be abbreviated as “A.” The numbers following “S,” “P,” or “A” indicate the type of product.

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1) Substance/Preparation Manufacturing Process (hereinafter “S/P Manufacturing Process”) Example (1) Product Purchased Manufacturing Process Product Sold

S1 S0 Refining

* The production of a metal powder from ore through processes such as extraction and refining. This also applies to the production of any single substance from petroleum as a raw material, etc.

Example (2) Product Purchased Manufacturing Process Product Sold S1 S0 P1 S2 Reaction S3 Mixing * Substances S1, S2, and S3 are purchased and a chemical product (P1) with a higher

added value is produced. P1 is a preparation, such as ink or an adhesive.

2) Original Component Manufacturing Process

Example (1) Product Purchased Manufacturing Process Product Sold S1 A1 P1 Hot Molding P2 * S1, P1, and P2 are purchased, and a product that is an original component (an article, A1)

is produced through hot molding and curing. This applies to plastic cases, ceramic capacitors, etc.

Example (2) Product Purchased a Manufacturing Process Product Sold S1 A00 S2 Molding/Sintering P1 Coating/Drying Product Purchased b A1 Article Assembly A2 * The Product (A00) is produced through purchasing S1, S2, and P1, and subjecting them

to processes such as molding, sintering, coating, and drying, and then assembling purchased A1 and A2. This often applies to button capacitors and semiconductors, coated wires, coated metal plating, and components structured from so-called compound materials.

Note: The purchased products “a” are often referred to as “main raw materials,” and the purchased products “b,” such as a terminal, are often referred to as “secondary materials.” (This is different from 3), below.)

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3) Parts Manufacturing Process Product Purchased a Manufacturing Process Product Sold A01 A000 A02 A03 Article Assembly Product Purchased b Surface Painting, Soldering P1 * Articles (such as components) A01, A02, and A03 are purchased and assembled.

Adhesive, display ink, etc. (P1) are purchased when assembling. Note: The purchased products “a” are often referred to as “main raw materials,” and the

purchased products “b,” such as the display ink, are often referred to as “secondary materials.” (This is different from Example (2) in 2), above.)

4) Finished Goods Manufacturing Process

Product Purchased a Manufacturing Process Product Sold A001 A0000 A002 A003 Equipment Assembly Product Purchased b Surface Painting, Soldering P1 * Fundamentally the same as 3), above. A001, A002, and A003 are parts manufactured in

3), above, and the products purchased “b” are secondary materials such as solder.

Note: It has been explained that there are four manufacturing processes [1) S/P Manufacturing Process, 2) Original Component Manufacturing Process, 3) Parts Manufacturing Process, and 4) Finished Goods Manufacturing Process], however, do not make judgments based only on your in-house ordinary manufacturing processes. (Example: If a set manufacturer has a process in which substances/preparations are converted into articles, not only the “Finished Goods Manufacturing Process” but also the “Original Component Manufacturing Process” shall be covered for management. See 4.4 2) for details.)

<Supplementary> “Products” include both “substances/preparations” and “articles.” JGPSSI’s

survey is based on the unit of “product,” however, it comprises two groups, one being “substances/preparations,” wherein the contained amounts change during the manufacturing processes, and “articles,” wherein the contained amounts do not change. For an “article,” because there are cases wherein the chemical substances cannot be specified, caution is required when handling these two different groups as a single group.

17

4.5. Classifications of the “Manufacturer Name” and Identification of the “Manufacturing Processes”

(1) The respective manufacturing processes of the manufacturing companies in the supply chain shown in Section 4.2 were categorized into four different “manufacturing processes”: 1) the S/P Manufacturing Process, 2) the Original Component Manufacturing Process, 3) the Parts Manufacturing Process, and 4) the Finished Goods Manufacturing Process.

(2) Each manufacturer has at least one of the four different manufacturing processes. (Companies such as trading companies that do not have their own manufacturing processes are categorized by the products they sell.)）

(3) The relationships described above are summarized in Table 2. However, there are times when, at the discretion of the company, the frameworks can be viewed as encompassing all companies in an industrial group, or may be looked at in terms of an outsourcing vendor or a factory as the unit of analysis, or may be looked at with the Manufacturing Department as the unit of analysis. Moreover, the ○, ● and ◙ characters in the figure below indicate specific examples, and are provided as a reference with the understanding that there may be differences depending on the product of the firm.

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Table 2: The Manufacturing Process Unit Manufacturer Name Class

ification

Manufacturing Process Examples of the Processes

Materials/chemical product manufacturers

○ S/P manufacturing process Refining, chemical substance manufacturing, chemical substance mixing

Original component manufacturers

○ ◙

S/P manufacturing process Original component manufacturing process◊

Chemical substance manufacturing, chemical substance mixing Molding, sintering, coating, drying, soldering, electroplating

Parts manufacturers ○ ◙ ●

S/P manufacturing process Original component manufacturing process◊ Parts manufacturing process

Chemical substance mixing Molding, painting, soldering Article/component assembly

Set manufacturers ○ ◙ ● ●

S/P manufacturing process Original component manufacturing process◊ Parts manufacturing process Finished goods manufacturing process

Chemical substance mixing Molding, painting, soldering Article/component assembly Equipment assembly

○: Requires substance/preparation management ●: Requires article management ◙: Requires both substance/preparation management (on the purchasing side) and article

management (on the sales side) ◊: Critical process for determining the contained amounts

<Discussion> If it is possible to check the manufacturing processes possessed by the firm, all of

the manufacturing processes that are owned by the firm are subject to management of the chemical substances in products.

4.6. Importance of Management Focusing on the “Unit Process”

The manufacturing processes described in Section 4.4 are those having to do with “purchasing,” “manufacturing,” and “sales” processes, and these are positioned as the unit processes for management.

(1) Because the management methods are different for substances/preparations and articles, there are a total of six processes that are termed “unit processes”: The “purchasing,” “manufacturing,” and “sales” for substances/preparations, and “purchasing,” “manufacturing,” and “sales” for articles.

(2) For specific management of chemical substances included in products, it is rational to select management methods based on these six “unit processes” for each of the four “manufacturing processes.”

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(3) For the six “unit processes” for each of the four “manufacturing processes,” described above, actually check, referencing Figure 3 in page 21, the applicability of the unit processes to the manufacturing processes subject to management within the firm. It is also necessary to control each of the individual chemical substances in firms that have multiple “manufacturing processes” and “unit processes.”

4.7. “Frameworks” Focusing on “Manufacturing Processes” and “Unit Processes”

Section 4.6 explained that it is rational to establish management methods based on the six “unit processes” for each of the four “manufacturing processes.” The items that must be controlled for the management of the included chemical substances, performed for each of the six unit processes, are known as the “frameworks.” Moreover, those items that are the same for all six frameworks (policies, objectives, etc.) comprise the “common management framework.”

I [Substance/Preparation Purchasing] II [Substance/Preparation Manufacturing] III [Substance/Preparation Sales] IV [Article Purchasing] V [Article Manufacturing] VI [Article Sales] VII [Common Management Framework]

The items in the parentheses, above, are “unit processes.” (1) Considering the above, checks should be performed as to which of the “frameworks” that should

be managed actually apply to the company. The method of checking is that the “frameworks” in the company are the “I” through “VII” beneath the intersections of the four “manufacturing processes” and the six “unit processes” in Figure 3, page 21. In organizations wherein there are multiple “manufacturing processes” and “unit processes,” it will be necessary to manage multiple “frameworks.” For example, if in the organization the “manufacturing process” is “article manufacturing” and the “unit processes” are “purchasing and manufacturing of substances/preparations,” and “purchase of articles,” then the “frameworks” will be “I,” “II,” “VI,” and “VII.” (It is necessary to control multiple “frameworks” when there are multiple “manufacturing processes,” just as it is in the “unit process” example above.) Note that these guidelines also cover companies without manufacturing processes, such as sales companies, importers, and distributors, incorporated with organizations that purchase or sell substances, preparations or articles. Also, for organizations without manufacturing processes that perform designing process only, the management of designing is covered by these guidelines, when such designing involves the six unit processes described above.

<Discussion> If management methods are established combining the six unit processes of I

[Substance/Preparation Purchasing] through VI [Article Sales], with V [Common Management Framework], then the method of managing chemical substances in products will be defined clearly for the entire supply chain. With regard to sales companies and importers who do not have manufacturing processes, it is desirable that manufacturers of relevant products communicate these guidelines to

20

them and instruct them so that they may be able to carry out activities in accordance with these guidelines. Also, sales companies and importers are required to know the management status of the manufacturers who sell products through collecting information from them regarding compliance with these guidelines, etc.

Substances/Preparations Articles Purchasing Manufacturing Sales Purchasing Manufacturing Sales Unit Processes

S/P Manufacturing Process

Materials/Chemical Products Purchasing

Materials/Chemical Products

Manufacturing

Materials/Chemical Products Sales

Original Component

Manufacturing Process

Materials/Chemical Products Purchasing

Original Component Manufacturing

(Conversion of substances/preparations into articles) Original Component

Sales

Parts Manufacturing Process

Original Component Purchasing

Parts Assembly

Parts Sales

Finished Goods Manufacturing

Process

Man

ufac

turin

g Pr

oces

ses

Parts Purchasing

Parts Assembly

Products Sales

Frameworks I II III IV V VI ◊Key Points in

Management 1) Obtain the MSDS

2) Exchange of specifications

1) Process management

2) Prevention of contamination/

mixing 3) Understanding of

change in composition

1) Obtain the MSDS2) Exchange of specifications 3) Provision of

information that there is “no inclusion”

1) Obtain JGPSSI data and

other data 2) Confirm

receipt

1) By-lot management 2) Prevention of inclusion of

incorrect components

1) Provision of JGPSSI data and

other inclusion

data

Common Management Framework: VII

Figure 3: Manufacturing Processes, Unit Processes, and Frameworks

<Supplementary> Based on Figure 3, how to determine frameworks of a company is explained

below, using a specific example: The company has a manufacturing process in which electronic parts are soldered to printed circuit boards after purchasing printed circuit boards, electronic parts such as capacitors, and solders. Solders: Because electronic parts are soldered to printed circuit boards, there is a

process of “Materials/Chemical Products Purchasing” of the “Original Component Manufacturing Process” (framework I. “Framework” omitted hereafter), and “Original Component Manufacturing” of the “Original Component Manufacturing Process” (II) is also applied.

Electronic parts and printed circuit boards: “Original Component Purchasing,” “Parts Assembly,” and “Products Sales (includes cases where the parts are handed over to the next process)” of the “Parts Manufacturing Process” (IV, V, VI respectively) are applied.

In the example above, frameworks I, II, IV, V, VI, and the Common Management Framework VII must be covered in the management. Also, in addition to “soldering,” when display inks and adhesives are incorporated into the equipment (articles) after

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hardening them in the manufacturing processes, it is important to correctly acknowledge that these are the “Original Component Manufacturing Process” (conversion process into articles).

5. The “Action Item List & Check Sheet”

The “Action Item List” summaraizes what is actually to be performed in the seven frameworks (I through VII) explained in Section 4.7. Also, based on the Action Item List, the “Check Sheet” evaluates whether the systems for managing chemical substances in products are properly constructed and operated within companies that implement these guidelines. The “Action Item List & Check Sheet” (Annex 1) incorporates the “Action Item List” and the “Check Sheet.” In the “Action Item List,” the action items picked up from among the action frameworks I through VII have been organized and described using PDCA in order to make the action items easily understood. Note that “PDCA” refers to the act of ongoing improvement through performing a cycle of planning (P: establishing policies and plans), doing (D: implementing the plans and performing the operations), checking (C: evaluating and improving performance) and taking action (A: Performing a management review). In order to satisfy the “Action Details” in the “Action Item List,” creating “systems (rules)” and actually “implementing (operating)” them are both required.

Each item in the “Action Item List” is explained below:

“Action Items”: These list the items that are required for managing the chemical substances in products and comprise the five major items of “1. Establishing guidelines for the management of chemical substances in products” through “5. Management Review,” where these five major items are divided into 18 minor items.

“Action Details”: The Action Details describe, for each Action Item, specifically what the Action Item is to accomplish. Although it is important to have shared terminology throughout the entire supply chain, there may be cases where the words used do not communicate in a specific industry. In such cases, “Action Details” should be performed according to the line of business of the relevant company based on an understanding of the intent of the “Additional Explanations” or “Required Level,” and on an understanding of the degree to which the Action Item is to be performed. However, note that “Action Details” that do not apply to the firm need not be fulfilled. For example, if there is no design functionality (department) in the firm, then the “Action Details” in “3-1-1: Design/Development” of the “Action Item List” is deemed not applicable.

“Required Level”: To further clarify the meaning of the “Action Details,” the “Required Level” describe the degree to which the “Action Items” must be performed in a more specific manner, demanding for important common requirements throughout the entire supply chain. There may be cases where some requirements do not apply to your company, or some requirements that are important to your company are not included or are inadequate. In such cases, on reading

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“Additional Explanations” or examples specified in the relevant “Required Level” column, change the expressions (terms, words, etc.) into similar expressions used in your company in order that you may be able to carefully determine such descriptions are applicable to your company and ensure that management is not lacking.

6. Evaluation Criteria

(1) Determination of Frameworks Applicable to Your Unit Processes Based on the Required Level in the Action Item List, select from management frameworks I through VII that are applicable to your company’s unit processes. If none of the frameworks are applicable, clarify the reasons.

(2) Evaluation for Each Action Item

Regarding whether the systems for managing chemical substances in products are properly constructed and operated, evalution is carried out for each Action Item and Action Details according to the following four levels based on the Required Level.

Conforming:

When there are both appropriate systems (rules) for fulfilling the Required Level and activities (implementation) based on the systems (rules), then it is deemed “Conforming.” The results of systems (rules) and activities (implementation) must be verfied objectively either through documentation or records.

Requires Improvement:

When there are appropriate systems (rules) for fulfilling the Required Level but the activities (implementation) are insufficient or partially performed, or when activities (implementation) for fulfilling the Required Level are performed but the systems (rules) are insufficient or partially stipulated, then it is deemed “Requires Improvement.” The results of systems (rules) and activities (implementation) must be verfied objectively either through documentation or records.

Non-Conforming:

It is deemed “Non-Conforming” when one of the following applies: 1) There are systems (rules) for fulfilling the Required Level (including cases where

they are partially inappropriate) but activities (implementation) based on the rules are not performed.

2) Activities (implementation) based on Action Details are performed (including cases where they are partially inappropriate) but there are no systems (rules).

3) There are systems (rules) and activities (implementation) are performed but both of them are partially insufficient.

Not Applicable:

When the Required Level does not apply to management within the company, then it is deemed

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“Not Applicable.” For example, if there is no design department in the firm, then “3-1-1: Design/Development” in the “Action items” in the “Action Item List” is deemed not applicable.

Table 3: List of Evaluation Criteria

Systems for Fulfilling the Action Details (Rules)

Activities for Fulfilling the Action Details (Implementation)

Conforming ○ ○ ○ ∆ Requires

Improvement ∆ ○ ○ × × ○ ∆ ∆ ∆ × × ∆

Non-Conforming

× × ○: Required Level is satisfied ∆: Some actions are performed but partially insufficient ×: Required Level is not satisfied

(1) Total Evaluation

When the criteria below is satisfied based on the evaluation of Action Items and Action Details, it is deemed as “passed.” Passed:

It is deemed as “Passed” when all relevant items in “Action Items” and “Action Details” are “Conforming,” or when the number of “Requires Improvement” is equal to or less than one third of the relevant “Action Items.” However, remediation plans must be prepared for “Requires Improvement” items.

<Reference> Check Sheet Scoring

“Check Sheet” scoring is conducted in the following manner. However, the scored results shall not be used as an evaluation standard. This scoring method has been established so that it may be used for confirming a company’s or supplier’s progress in establishing systems for managing chemical substances in products. Based on the Required Level of the “Action Item List,” the scores are as follows: “Conforming” = 3 pts., “Requires Improvement” = 2 pts., “Non-Conforming” = 0 pts. The points are added to calculate the total score. When the Action Items or Action Details are not applicable to the company’s management, the relevant column shall be left blank. Because there are 31 items in total, when all Required Levels are “Conforming,” the full marks shall be 93 points. Since the full marks change when there are “Not Applicable” columns, the full marks are converted into 100 points using the following method.

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Actual score × 100 = Converted into full marks of 100 points Number of relevant columns × 3

<Example> When 28 items are applicable among the 31 Required Level items and the score is 70 points:

70 70 ×100 = ×100 = 84 points

28×3 84 7. Self-Declaration of Conformance

The Self-Declaration of Conformance is a declaration that the system for managing chemical substances in products is in conformance with these guidelines. Conformance is validated when the result of the total evaluation is deemed “Passed” based on the “Check Sheet” as stipulated in the previous Section 6. When making the Self-Declaration of Conformance, rules 1) through 6) should be followed:

1) One must assume personal responsibility for the contents of the Self-Declaration of Conformance.

2) The Self-Declaration of Conformance must only be made after a first party or second party has validated conformance to these guidelines. The evaluated records (Action Item List & Check Sheet, etc.) must be stored. The period of storage may be decided at the discretion of the company.

3) Details of self-declaration must be included in the Self-Declaration of Conformance. The Self-Declaration of Conformance shall be able to indicate who (either the first party or the second party) carried out the validation. See “Self-Declaration of Conformance (Example), Self-Declaration of Conformance (Data Example), Explanation of Self-Declaration of Conformance (Data Example)” (Annex 2) for a template, filled-out sample and an explanation regarding the filled-out sample of the Self-Declaration of Conformance.

4) The Self-Declaration of Conformance must be presented when there is a request from either within or without the firm.

5) The details in the Self-Declaration of Conformance must reflect ongoing operations, and the conformance to these guidelines must be validated periodically.

6) The results scored in the Check Sheet must be disclosed on the Self-Declaration of Conformance.

8. Principles for Use This section explains the fundamental rules for using these guidelines.

8.1. Disclousure of Validated Records

Self-declarion of conformance is carried out under the company’s responsibility based on validations by a first or second party. Purchasers may request to suppliers for the disclosure of validation records related to self-declaration of conformance. In such cases, it is desirable that validation records be disclosed after mutual consultation.

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8.2 Validating Self-Declaration of Conformance These guidelines stipulate that a self-declaration of conformance may be issued based on validations by a first or second party. The companies who have made self-declarations of conformance have also made a promise to society that they will perform the Action Items in the spirit of true self-regulations. In order to realize these objectives, it is important that the companies understand these guidelines correctly and implement them properly. Generally speaking, however, it may be difficult for companies with little experience in this field to issue a self-declaration of conformance based on validations by a first party. Therefore, for the time being, it is considered necessary that the JGPSSI member companies take the lead in requesting their suppliers to construct and establish systems in accordance with these guidelines and checking and validating the appropriateness regarding the self-declaration of conformance processes of suppliers.

8.3. Use of These Guidelines

1) These guidelines can be used freely even by companies that are not JGPSSI members. 2) Companies that perform internal management based on these guidelines, and that seek

supplier management based on these guidelines, promise to understand the details of these guidelines and to respect the intent thereof.

<Supplementary> The self-declaration of conformance ties into improvements in the precision of use of raw materials and components by large set manufacturers that have transactions with many suppliers. It may be used in confirming whether or not the processes for managing the chemical substances in products are performed correctly within the supplier firms.

8.4. Protecting Proprietary Information

Companies that use these guidelines promise not to provide or divulge externally any confidential information obtained through transactions between companies, such as validation records, etc. However, this does not include information that is not confidential, such as the number of suppliers who were requested to control chemical substances in products.

8.5 An Approach to Incorporation into Existing Systems (ISO 9001, ISO 14001)

The management of chemical substances in products may either be built into existing systems within the firms, such as ISO 9001 (TS 16949) or ISO 14001, or may be setup as a new system, at the discretion of the company; however, it is recommended that they be built into existing systems. When this is done, caution is required to make sure that none of the Action Items in these guidelines is overlooked. See Attachment 3 for comparisons between the Action Item List & Check Sheet, ISO 9001, and ISO 14001.

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Attachment 1: Information Sheet on the content of Certain Chemical Substances Source: Japan Chemical Industry Association

Information Sheet on the Content of Certain Chemical Substances

Company Name: ______ Company, Ltd. Address: _____ Building, 1-20-51 ______, ______-ku, Tokyo Responsible Department: _____ Section, ______ Department, ______ Division Telephone No.: _____-____-____ Fax No.: ____-____-____ [Management Number] __-____ Created/Revised On: ____/___/___ and ___/___/___ [Name of Product] [How to Use This Sheet]

In our company we strive to control the substances in our products and to collect information. This information had been written in the Material Safety Data Sheets (MSDS) and provided to the customers, in conformance with Japanese Law. However, given the establishment of foreign laws, etc., we have come to receive requests on more detailed inclusion information regarding certain chemical substances. This sheet is in response to these requests, and was made as a supplement to the MSDS.

[Investigation Regarding the Inclusion of Certain Chemical Substances in Products]

Investigations were performed focusing on important substances regulated under foreign law. Substance Name Presence Concentration Included (%)1) Comments1)

Cadmium and cadmium compounds Present/Absent Hexavalent chromium compounds Present/Absent

Lead and lead compounds Present/Absent Mercury and mercury compounds Present/Absent

TBTs/TPTs Present/Absent TBTO Present/Absent

Paraffin chloride (short chain) Present/Absent PBBs Present/Absent

PBDEs Present/Absent PCBs Present/Absent

Naphthalene polychloride (with three or more chlorines)

Present/Absent

Asbestos Present/Absent Specific azo compounds2 Present/Absent

Substances that damage the ozone layer

Present/Absent

Radioactive substances Present/Absent 1) Concentrations of deliberately added substances are recorded. If it has been confirmed that the inclusion is not deliberate,

this is indicated in the comments. 2) By German law, the use of azo pigments that produce more than 30ppm of amin, which is suspected of causing cancer, is

regulated. Those substances for which the manufacturer has performed tests and can guarantee their safety may be excluded. Applicable applications are, for example, textiles that come into contact with the skin. Consult the manufacturer for details. See the ETAD Japan website.

[Other] See the Material Safety Data Sheets (MSDS) for the amount of inclusion of substances that require control under the

following Japanese Laws. * Law Concerning Reporting, Etc., of Releases to the Environment of Specific Chemical Substances and Promoting

Improvements in their Management * Industrial Safety and Health Law (for substances requiring notification) * Poisonous and Deleterious Substances Control Law (for poisonous and deleterious substances) There is no intentional addition to this produce of any substances for which manufacturing or importation is prohibited

under the following Japanese Laws: * Law Concerning the Examination and Regulation of Manufacture, Etc., of Chemical Substances (for the Type-1 certain

chemical substances) * Industrial Safety and Health Law (substances for which manufacturing is prohibited) * Poisonous and Deleterious Substances Control Law (certain poisonous substances) Created: Quality Assurance Department Manager: _______, ______ Division, ________ Company, Ltd. Stamp by Responsible Party

27

Attachment 2: JIG Annex A and Annex B JIG Annex A: Level A Materials and Substances (JIG 101) Classification No.(JGPSSI)

Material/Substance Category Threshold level

C01 Asbestos Intentionally added C02 Certain Azocolourants and Azodyes

Intentionally added (see Directive 76/769/EEC for applicability)

A05 Cadmium /Cadmium Compounds 75 ppm or Intentionally added A07 Hexavalent Chromium/Hexavalent

Chromium Compounds 1000 ppm or Intentionally added

A09 Lead/Lead Compounds 1000 ppm or Intentionally added 300 ppm (PVC cables only)

A10 Mercury/Mercury Compounds 1000 ppm or Intentionally added C04 Ozone Depleting Substances (CFCs,

HCFCs, HBFCs, carbon tetrachloride, etc.)

Class I: Intentionally added Class II . HCFCs: 1000 ppm

B02 Polybrominated Biphenyls (PBBs) 1000 ppm or Intentionally added B03 Polybrominated Diphenylethers

(PBDEs) 1000 ppm or Intentionally added

B05 Polychlorinated Biphenyls (PCBs) Intentionally added B06 Polychlorinated Naphthalenes (more

than 3 chlorine atoms) Intentionally added

C06 Radioactive Substances Intentionally added B09 Certain Shortchain Chlorinated

Paraffins (See Annex F) Intentionally added

A18 Tributyl Tin (TBT) and Triphenyl Tin (TPT)

Intentionally added

A17 Tributyl Tin Oxide (TBTO) Intentionally added JIG Annex B: Level B Materials and Substances (JIG 101) Classification No.(JGPSSI)

Material/Substance Category Threshold level

A01 Antimony/Antimony Compounds 1000ppm A02 Arsenic/Arsenic Compounds 1000ppm A03 Beryllium/Beryllium Compounds 1000ppm A04 Bismuth/ Bismuth Compounds

1000ppm

B08 Brominated Flame Retardants (other than PBBs or PBDEs)

1000ppm

A11 Nickel (external applications only) 1000ppm C05 Certain Phthalates (see Annex F)

1000ppm

A13 Selenium/Selenium Compounds

1000ppm

B07 Polyvinyl Chloride (PVC) (Disclosure is limited to ″is present“/“is not present“ in amounts that exceed threshold)

1000ppm

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Attachment 3: Comparisons between the Action Item List & Check Sheet, ISO 9001, and ISO 14001

Action Item List & Check Sheet ISO9001/2000 ISO14001/2004

Guidelines for the Management of Chemical Substances in Products

4. Quality Management System 4. Environmental Management System Requirements

1. Guidelines 5.1 Management Commitment 5.3 Quality Policy 8.5.1 Continual Improvement

4.2 Environmental Policy

2. Planning 2-1 Definition of Needs and Requirements

& Analysis of Key Issues 2-1-1 Definition of Legal, Customer &

Other Requirements 2-1-2 Definition of Application Parameters

5.2 Customer Focus 7.2.1 Determination of Requirements

Related to the Product 7.2.2 Review of Requirements Related to

the Product

4.3.1 Environmental Aspects 4.3.2 Legal and Other Requirements

2-2 Establishment of Targets and Planning of Operational Processes

5.4.1 Quality Objectives 5.4.2 Quality Management System Planning8.5.1 Continual Improvement

4.3.3 Objectives, Targets and Programs

2-3 Definition of Organizational Systems, Roles, & Responsibilities

5.1 Management Commitment 5.5.1 Responsibility and Authority 5.5.2 Management Representative 6.1 Provision of Resources 6.3 Infrastructure

4.4.1 (Programs) Resources, Roles, Responsibility and Authority

3. Implementation & Management 3-1 Operational Management 3-1-1 Design/Development

7.1 Planning of Product Realization 7.2.1 Determination of Requirements

Related to the Product 7.2.2 Review of Requirements Related to

the Product 7.2.3 Customer Communication 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs

4.4.6 Operational Control

3-1-1 Design/Development (continued)

7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation

3-1-2 Obtain and Confirm Information Regarding Substances in Products

7.4.1 Purchasing Process 7.4.3 Verification of Purchased Products

3-1-3 Purchasing Management 7.4.1 Purchasing Process 7.4.2 Purchasing Information

3-1-4 Manufacturing Processes 3-1-4-1 Confirmation on Receipt 3-1-4-2 Process Management

7.4.3 Verification of Purchased Products 7.5.1 Control of Production and Service

Provision 7.5.2 Validation of Processes for Production

and Service Provision 7.5.5 Preservation of Product

3-1-5 Revision Management 7.3.7 Control of Design and Development Changes

4.4.6 Operational Control (continued)

3-1-6 Shipping Confirmations 7.6 Control of Monitoring and Measuring Devices

8.1 (Measurement, Analysis and Improvement) General

8.2.3 Monitoring and Measurement of Processes

8.2.4 Monitoring and Measurement of Product

8.4 Analysis of Data

4.5.1 Monitoring and Measurement 4.5.2 Evaluation of Compliance

3-1-7 Handling Non-Conformances 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5.2 Corrective Action 8.5.3 Preventive Action

4.5.3 Nonconformity, Corrective Action and Preventive Action 4.4.7 Emergency Preparedness and Response

3-2 Human Resources Management (education/training)

6.2.1 (Human Resources) General 6.2.2 Competence, Awareness and Training

4.4.2 Competence, Training and Awareness

3-3 Documentation and Documentation Management

4.2.1 (Documentation Requirements) General

4.2.3 Control of Documents 4.2.4 Control of Quality Records

4.4.4 Documentation 4.4.5 Control of Documents 4.5.4 Control of Records

3-4 Communication (Sharing & Provision of Information)

5.5.3 Internal Communication 7.2.3 Customer Communication

4.4.3 Communication

29

4 Performance Evaluation and Improvement (Checking and Improving the State of Implementation)

8.2.2 Internal Audit 4.5.5 Internal Audit

5 Management Review (Correction by Management)

5.1 Management Commitment 5.6.1 (Management Review) General 5.6.2 Management Review Input 5.6.3 Management Review Output 8.5.1 Continual Improvement

4.6 Management Review

(Annex 1) Action Item List & Check Sheet Version 1. September 27. 2005(Circle (○) Applicable) (Refer to Entry Methods)

Evidence (Facts, Document Names, Etc.)I II III IV V VI VII

(Enter Action Details and Areas of Insufficiency)

1. Guidelines Establish guidelines, etc. regarding"approaches" taken to the management ofchemical substances in products and ensurethese are maintained.

- For thorough internal management of chemical substances inproducts, it is very important that approaches are represented bymanagers who are able to allocate management resources. Forthe management of chemical substances in products, it isimportant that guidelines establishing approaches are developed(no specific formats are designated regarding guidelines,declarations, philosophies or slogans, etc).

1. "Guidelines" (Note 1) incorporated with "approaches" (Note2) to the management of chemical substances with an approvalby the "business management" (Note 3) should be conveyed torelated parties.2. Guidelines should be checked periodically and updated.With regard to Notes "1" "2" and "3" above, depending onmanagement structures, the following terms may be inserted inplace of those within inverted commas:(Note 1)1) Environmental guidelines2) Quality guidelines3) Business guidelines(Note 2)1) Complete compliance with RoHS regulations2) Observing legal regulations and customer requirements3) Constructing a system for the management of chemicalsubstances(Note 3)1) Person responsible for the business2) Manager in charge of the business location3) Factory manager

●

2. Planning2-1 Definition of Needs and Requirements & Analysis of Key Issues

Product documentation on legal regulations,customer and other requirements should beclarified and conveyed to the necessarycorporate units.

- For chemical substances in products, it is important thatdecision content (Note 1) regarding internal compliance (in-house standards) is in accordance with relevent legal regulations,customer and other requirements, etc. It is also necessary thatsuch requirements are suitably conveyed to stakeholders withinthe company.(Note 1)It is important that the goals set in in-house standards (regardingthe elimination of certain substances or timeframes set forreductions in their usage) are in compliance with legalregulations. When changes occur in legal regulations, customerand other requirements vis-a-vis products, it is important that in-house standards are modified in a timely fashion to reflect thesechanges.

1. Legal regulations, customer and "other requirements" (Note 1)related to the management of chemical substances in productsshould be observed and defined. Materials related to suchinformation should be maintained and managed so as to bealways up-to-date.2. With regard to "information on the management of chemicalsubstances in products" (Note 2), it should available at all times.It should also be appropriately conveyed to the necessarycorporate units.With regard to Notes "1" and "2" above, depending onmanagement structures, the following terms may be inserted inplace of those within inverted commas:(Note 1)1) Goals developed by the company itself2) Industry goals accepted by the company(Note 2)1) Company standards and policies related to the management ofchemical substances in products

●

Clearly define items subject to themanagement of chemicals substances inproducts such as "products," "processes" and"substances."

- It is necessary to specifically define what should be controlled.For example, if outsourcing is used, the commissioned partyshould also be covered in the scope of management, such ascases where processes that exert an impact on the managementof chemical substances in products are outsourced.

1. Clearly define the products (electronic and electricalproducts), processes and substances subject to the managementof chemicals substances.(Example)1) They are clearly defined within the corporate managementstandards.

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Goals (activity goals) and plans should beestablished and maintained to realize themanagement of chemical substances inproducts.

- In order to achieve conformance with the company's targetsregarding chemical substances in products, it is necessary thatactivity goals within the company are clearly established.- In line with changes in legal regulations regarding chemicalsubstances in products, changes in customer requirements, etc.,and the progress of company activities, it is necessary that goalsand plans are reviewed in a timely manner.

1. Goals and plans should be developed to realize themanagement of chemical substances in products.2. Progress regarding goals and plans should be clarified. Basedon progress, etc. (Note 1), goals and plans should be modified.(Note 1)It is sometimes necessary to modify plans as a result of externalcauses including changes in related legal regulations andcustomer requirements, etc.

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(Circle (○) Applicable)

Action Items Action Details Additional ExplanationsRequired Level

(Following Content Executedin an Appropriate Manner)

Management FrameworkEvaluation Score

2-1-1 Definition of Legal,Customer & OtherRequirements

2-1-2Definition of ApplicationParameters

2-2Establishment of Targets andPlanning of OperationalProcesses

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(Enter Action Details and Areas of Insufficiency)Action Items Action Details Additional Explanations

Required Level(Following Content Executed

in an Appropriate Manner)


Systems for promoting the management ofchemical substances in products (roles,responsible parties and organizations) shouldbe clearly defined.

- Including the collection of information, it is necessary that thesystem under which chemical substances in products aremanaged is clearly defined in terms of its execution.

1. Regulations (Note 1), organizational charts, etc. should becreated regarding the management of chemical substances inproducts.2. Roles and responsibilities should be clarified.(Note 1)The naming of regulations is not the objective. The content ofthe management should be clearly stated.

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3. Implementation & Management 3-1 Operational Management - If processes that impact the management of chemical

substances in products such as design and manufacturing, etc.are outsourced, and these processes are brought within theparameters of management, then it is necessary that thecommissioned party execute the following activities.

What must be achieved by productdesign/development processes (design andverification) in order to conform to corporatestandards should be clearly defined andexecuted.

1. During the design and development processes of products (orproduct parts) whose constructional elements aresubstances/preparations, the company has to monitor thecomposition of any chemical substances used in such processesand any substance changes that occur. Also, it has to be verifiedthat the products are in accordance with corporate standards.And also there are rules to be followed in the event of designnon-conformity.(Example)1) There is an operating system in place that confirms (1)compositions of chemical substances that might be added orremoved, and (2) conformance of specific chemical substanceswithin the final products being sold that they are in accordancewith corporate standards. Furthermore, design results aredocumented as specification sheets and diagrams, etc.

● ●

2. For design and development processes of products (or productparts) whose constructional elements are articles, anyrequirements should be included on diagrams, etc. It also has tobe verified that the products are in accordance with corporatestandards.(Example)1) On designs, development specification documents anddiagrams, procedures for the handling of substances inaccordance with company management standards are includedas requirements. With regard to chemical substances inproducts, these are verified as being in accordance withcorporate standards. Also, there is an operating structure thatuses these verifed results as a precondition for mass production.

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Obtain information about chemical substancesincluded in the raw materials and componentsof subject products.

1. A method for acquiring information regarding the chemicalcontent of purchased products should be established andinformation is collected based on this method.(Examples)1) Information on the content of substances and preparations isobtained from specifications, MSDS, Information Sheet on theContent of Certain Chemical Substances, questionnaires andother materials.2) Information on the content of articles is obtained fromspecifications, JGP files, questionnaires and other materials.

● ●

3-1-1Design/Development

- On this Action Item, it is necessary to verify whether thereexists a system for checking that the content of chemicalsubstances subject to management are in accordance withcorporate standards. Furthermore, it is also necessary to verifythat at the design stage, such conformance has been confirmed.With regard to the parameters of chemical substances that aresubject to management, these extend to include all materialsrelated to a particular product (this includes those componentsand raw materials from which a product is constructed.).

2-3Definition of OrganizationalSystems, Roles, &Responsibilities

3-1-2Obtain and ConfirmInformation RegardingSubstances in Products

- With regard to the management of information concerning thechemical substances in products, one assumed pre-condition ofmanagement is that information received from suppliers isaccurate. To ensure this, a system that allows for theconfirmation of data accuracy is necessary.- For raw materials and components from suppliers etc., it isnecessary to confirm the content accuracy of any informationprovided regarding chemical substances in products. Thisinformation may be included in the MSDS, Information Sheetson the Content of Certain Chemical Substances, JGP files (acommon format developed by the JGPSSI) or other forms ofdata. Moreover, in order to promote enhanced chemicalsubstance management, if a problem occurs, correction requests,etc. should be made to the information provider.

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Confirm that information obtained aboutchemical substances in the raw materials andcomponents of subject products is accurate.

2. Within the information obtained, it must be confirmed that allnecessary content is written in a suitable manner. Queriesregarding uncertainties should be directed to suppliers.(Example)1) If information obtained comes via the MSDS, it is confirmedthat the content provided is in accordance with JIS (JapanIndustrial Standard) Z 7250. The content of the InformationSheet on the Inclusion of Certain Chemical Substances is also beconfirmed.2) If information obtained comes via the JGP files, it isconfirmed that the information (including information regardingthe "Content Flag" ) has been written in a suitable manner.

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Validate information about chemicalsubstances in products and confirmconformance with corporate standards.

3. There are "verification rules" (Note 1) to confirm that thecontent information obtained is in accordance with the"requirements of the company" (Note 2).With regard to Notes "1" and "2" above, depending onmanagement structures, the following terms may be inserted inplace of those within inverted commas:(Note 1)1)　Corporate standards2) Requirements to suppliers

(Note 2)1) Systems for verifying during development processes2) Systems for verifying at time of certification3) Systems for verifying at time of (product) receipt

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Require appropriate management of chemicalsubstances in products of suppliers whoprovide raw materials and components thatconstitute company products.

1. Requirements should be stipulated regarding managementsystems, handling of restricted materials, and provision of data,etc with regard to chemical substances in products. Suppliersshould be informed of these requirements and they should beused to instruct suppliers.(Examples)1) The company makes accurate information requests viaspecification sheets, documentation in accordance with the greenprocurement survey standards and JGP files, etc.2) The company requests suppliers that they implement therelevant necessary items from the Guidelines for the Control ofChemical Substances in Products and the Action Items.3) When supplier raw materials and components include high-risk materials, special requests are made regarding theirmanagement.

● ●

Evaluate and select suppliers based on theirability to supply products to the company thatconform to company standards.

2. Suppliers should be evaluated and selected in accordance withthe standards (Note 1).(Note 1)It is necessary that the following case scenarios be considered:1) Evaluations of suppliers when business relationships are beingcommenced for the first time.2) Evaluations of suppliers when business relationships areongoing.

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Confirm supplier management conditions anddemand improvements when necessary.

3. When considered necessary, suppliers should be requested toconfirm their implementation of any content requested by thecompany. They should also be urged to make improvements asrequired.(Examples)1) Supplier management conditions are regularly surveyed.2) Management conditions are monitored via audits and whennecessary improvements are requested. To follow on, the resultsof such improvements are confirmed.

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3-1-3Purchasing Management

- It is necessary for suppliers to display high standards in termsof their management of chemical substances in products.- It is necessary to confirm that suppliers are able to monitor andmanage the following information: Changes in the raw materialsand components that they purchase; changes in manufacturingprocesses, and; changes in their own supplier networks.- When suppliers use recycled materials in their own materials,in order to ensure that such materials are in accordance withcorporate standards (any corporate self-declarations regardingchemical substances in products).- If as a result of audits, etc, it is found that a supplier hasproblems in terms of their ability to manage chemical substancesin products, improvements that address these problems shouldbe requested. Furthermore, it is necessary that the results of anyimprovements be confirmed.

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3-1-4ManufacturingProcesses

3-1-4-1Confirmation onReceipt

What must be achieved by "Confirmation onReceipt" in order to carry out the managementof chemical substances in products should beclearly defined and executed.

- It is necessary that the company confirm that products suppliedby suppliers are in accordance with company requirements.- If the company conducts analysis (or asks that such analysis beundertaken by an external party), it is necessary to confirm thefollowing points:1) Subject of analysis (what materials and what items)2) Method/frequency of analysis3) Analysis standards (preparation of test materials,measurement criteria, measurement machinery)4) Analysis procedures flowchart5) Calibration/maintenance and analysis records of measurementmachineryPlease note that it is necessary for the objectives of any analysisto be clarified (content determination/simple evaluation ofsubstance presence).

1. Implement a system for receipt confirmation. This should bein accordance with the prevailing conditions at the company(namely, the types of products handled, the types of rawmaterials, and the size of the operation, etc.)(Examples)1) Confirm all materials received, the names of any componentsreceived and any brand names.2) Confirm the content information received from suppliers.3) Confirm data analysis received from suppliers.4) Confirm data through in-house analysis as needed (this alsoincludes the outsourcing of analysis).

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3-1-4-2ProcessManagement

In the case of changes in the nature ofchemical substances or changes in theconcentrations of chemical substances as aresult of chemical reactions in themanufacturing process, steps should be takento manage such changes after they occur.

- In manufacturing processes related to chemical materials andbasic components, it is sometimes the case that chemicalsubstance properties and content levels change. It is necessaryfor management to be able to monitor such changes and reflectthis understanding in control systems. Furthermore, when usingchemical substances that are subject to control, it is necessary toconfirm that policies regarding incorrect usage and mixingprevention are sufficiency enforced.- If manufacturing processes that have an impact on themanagement of chemical substances are outsourced to externalentities, with any such commissioned processes there is anecessity to confirm that management of chemical substances isconducted correctly. (Please refer to Section 4.4 of the"Guidelines for the Management of Chemical Substances inProducts.")

1. If during processes conducted by the company there arechanges in the nature of chemical substances due to oxidation orchemical reactions, etc, or if due to evaporation, etc. during themanufacture of recycled materials there are changes in theconcentrations of restricted substances, a suitable managementsystem for handling such occurrences must be implemented.(Examples)1) Any compositional change process that occurs due tooxidation and chemical reactions created when trivalent chrometransforms into hexavalent chrome is monitored and suitalblyresponded.2) With regard to changes in concentrations of lead in soldertanks, the method of management is clearly indicated in workstandards manuals and it is actually implemented.

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If during manufacturing processes controlledsubstances are used, measures should be putin place to prevent incorrect usage or mixing.

2. When controlled chemical substances are being used, stepsshould be implemented to prevent the substance mixing andcontamination.(Examples)1) During manufacture, a process layout that prevents the mixingof such chemical substances is followed. (article productionprocesses)2) Materials, components and products that contain suchsubstances are seprately managed to prevent mixing.3) Work standards are developed and implemented to preventcontamination. (substance/preparation production processes)

● ●

In the case that production functions areoutsourced, the necessary processmanagement should be requested ofmanufacturing vendors. Check vendormanagement conditions periodically.

3. If manufacturing is outsourced, make requests, giveinstructions and conduct audits of the outsourcing entities’management procedures whenever necessary.(Examples)1) The company’s own in-house management methods aretransferred to the commissioned entity and managementprocedures at the entity is implemented as though the entity werea part of the company.2) Requests are made to the commissioned entity. Managementconditions are periodically confirmed at the entity andinstructions are offered as necessary.

● ●

Rules of revision management related to themanagement of chemical substances inproducts should be established and followedin-house appropriately.

- Based on changes in management regulations andmethodologies, there may be resulting changes in the content ofchemical substances in products. To deal with this, it isnecessary that a suitable level of change management beemployed.

1. Rules regarding the operation of revision management shouldbe stipulated. These rules define procedures to process changesin the management of chemical substances in products as theyoccur. Provisions related to communications with relevant in-house parties are included.(Example)1) The specific content of revision management actually operateswithin quality control systems. Subjects of revision managementregarding chemical substances in products is clearly defined.

● ● ● ● ● ●3-1-5Revision Management

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Decide on the manner in whichcommunications outside the company areconducted.

2. Procedures for contacting related external parties (customers,suppliers, etc), should be defined.(Examples)1) It is established that the person responsible for quality controlmakes decisions about whether or not to report to customers.(Such decisions also take into consideration report timing.)2) It is established that, in the event that it becomes necessary tocontact suppliers, the purchasing department is informed of thisnecessity and also the method of contact.

● ● ● ● ● ●

With regard to the management of chemicalsubstances in products, establish a systemwhich allows for the monitoring andconfirmation of the fact that reliableoperational management is being conductedand ensure that this system is being practiced.

1. There should be a structure that allows for monitoring andconfirming correct upstream management at the shippingprocesses.(Examples)1) Management conditions vis-à-vis the content of certainprocesses can be confimred from identification tags.2) Through the management system, it is possible to grasp thecontrol data within certain processes.3) A system is in place to ensure accurate informationcommunication regarding non-conformities from upstreamprocesses to shipping processes.

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With regard to shipping decisions, clearlydefine that a checklist exists regarding themanagement of chemical substances inproducts.

2. The confirmation items and standards regarding conformingand non-conforming judgments should be clearly stated.(Examples)1) It can be confirmed that there is no information regardingproblems occurring in upstream processes.2) It can be confirmed that, if there is a problem, the suitableresponse is implemented in a suitable manner.

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1. There should be rules regarding the management of non-conforming products (standards and flow charts are alsoacceptable). Furthermore, the following points are clarified.1) Definition of non-conforming products and identification oflots in which such products were produced. Furthermore, thereare rules regarding the treatment of such products and lots.2) Communication routes (both in-house routes and routes tocustomers, etc).3) Surveys for finding the cause of non-conformities and policiesfor dealing with them.4) Parameters of management records to be kept.

● ● ● ● ● ●

2. When non-conforming products occur, reports should bemade to the person responsible for the promotion of chemicalsubstances management (the person in charge of chemicalsubstances management). The "manager responsible for thebusiness" (Note 1) should also be reported to. Furthermore,when such products may have an external impact, reports shouldbe made to customers and suppliers, etc.With regard to Note "1" above, depending on managementstructures, the following terms may be inserted in place of thosewithin inverted commas.1) Person responsible for the business2) Manager in charge of the business location3) Factory manager

● ● ● ● ● ●

Training and education required for themanagement of chemical substances inproducts should be defined, and there shouldbe systematic education and training for theemployees involved in management functions.

- For the effective operation of the management of chemicalsubstances in products, employees must have the necessaryskills (knowledge, experience and ability to use theirknowledge).

1. The necessary education and training should be planned andimplemented for the management of chemical substances inproducts, and implementation records should be kept.

● ● ● ● ● ●3-2Human Resources Management (education/training)

Make sure that a sysem exists for thehandling of non-conformances when suchevents occur.

3-1-6Shipping Confirmations

- With regard to the management of chemical substances inproducts, it is important to have accurate shipping decision-making systems that prevent the shipping of products that do notconform to corporate standards. Furthermore, with regard toupstream process problem information, it is important that at theshipping level there be a system in place that allows for theaccurate capture of such information.

3-1-7Handling Non-Conformances

- It is necessary that preparations be made to prevent both theaccidental shipping of non-conforming products and anyreoccurrence of such non-conformities. It is also important thatsteps are taken to prevent the occurrence of products that do notconform to corporate standards.

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Create, maintain and control systematicdocuments regarding the management ofchemical substances in products within thecompany.

1. Documents that both outline the company’s systems for themanagement of chemical substances in products and therelationships (charts, etc.) among documentation related to thesesystems should be developed. When necessary, the content ofsuch documentation should be reviewed and maintained.

● ● ● ● ● ●

Document rules and regulations regarding themanagement of chemical substances inproducts, and ensure that documentation ismaintained and managed. Furthermore,make sure that records are created and storedin an appropriate manner.

2. Establish standards such as specifications, regulations, andalso develop procedural manuals. When necessary, make itpossible to access the most up-to-date version of thesedocuments. Records (survey data and audit data, etc) should beappropriately managed and kept.

● ● ● ● ● ●

Necessary information about the managementof chemical substances in products should beconveyed and shared within the company.

1. What constitutes necessary information for successful in-house management of chemical substances in products should bedefined. A system should be developed so that such informationwill be appropriately conveyed and shared within the company.

● ● ● ● ● ●

A system should be put in place so thatinformation regarding the management ofchemical substances in products is conveyedto parties outside the company in anappropriate manner. The company shouldalso be able to quickly respond to queriesfrom parties outside the company.

2. Rules need to be clarified vis-à-vis how external queries forinformation regarding the management of chemical products arehandled and how information is released. Appropriate responseshould be made to the queries.(Examples)1) With regard to using the MSDS for the purpose of givinginformation, the content is written appropriately in accordancewith JIS (Japan Industrial Standard) Z 7250. Furthermore, withregard to the requirements for the management of chemicalsubstances in products, irrespective of whether there arerequests, the requirements are supplemented with specificationsheets and Information Sheet on the Inclusion of CertainChemical Substances, etc.2) With regard to using the JGP files (including informationregarding the "Content Flag") for the purpose of givinginformation, based on the operations manual, informationregarding the company's products is disclosed in a suitablemanner.3) In the case that disclosure of information is mandatory, thatinformation is disclosed in a suitable manner.

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There should be internal audits, etc. regardingthe management of chemical substances inproducts, and, as part of this, relatedoperations should be confirmed andimprovements executed.

1. There should be an implementation procedure for theconducting of "internal audits" (Note 1), and these audits shouldbe conducted once a year or more, with the records produced.2. "Employees involved in internal audits" (Note 2) should havereceived education and training related to the management ofchemical substances in products.3. With regard to the results of internal audits and any problemitems that are identified, requests for improvements to respondto such issues should be made. Furthermore, the results of suchimprovements should be confirmed.With regard to Notes "1" and "2" above, depending onmanagement structures, the following terms may be inserted inplace of those within inverted commas:(Note 1)1) Objective confirmation of facts(Note 2)1) A person receiving an order from a business manager

●- A system that can regularly, effectively and objectively confirmmanagement of chemical substances in products is necessary.- With regard to those persons who carry out confirmationactivities via internal audits, etc. (members of internal auditteams), they should possess sufficient knowledge regarding themanagement of chemical substances in products. They shouldalso know how this subject relates to legal regulations, customerrequirements and technical trends. It is also necessary that theyundergo audit skills training, etc.- When a problem is discovered, it is important that its truecauses be pursued. It is also necessary that operationalprocedures and methods be reviewed to deal with suchproblems.- Reports on confirmation results derived from internal audits,etc., and response outcomes for discovered problems must besent to the business management, etc., because this is theelement of the corporate structure where the final responsibilityfor the management of chemical substances in products lies.

4. Performance Evaluation andImprovement (Checking andImproving the State ofImplementation)

3-4Communication (Sharing &Provision of Information)

- To promote accurate understanding and implementation ofthose internal rules and regulations that the company has decidedupon vis-à-vis its management of chemical substances inproducts, it is necessary that such rules and regulations aredocumented and managed. Furthermore, implementation resultsshould also be recorded and stored whenever necessary.- It is necessary to clarify the overall nature of the managementof chemical substances in products.- When using existing systems such as ISO14001 and ISO9001for management purposes, it is necessary to clarify theirpositioning and linkages.

- So that information regarding the management of chemicalsubstances in products may be used by necessary organizationsas required, it is important to develop systems that promote thedistribution and sharing of information.- For legal, customer and other requirements related to chemicalsubstances in products, it is necessary that the content of suchrequirements be conveyed to the relevant parties within thecompany.- Relevant parties within the company must share all necessaryinformation in order to ensure that adequate informationregarding chemical substances in company products is availablewhen using it for calculations.- For the overall supply chain, in order to increase the reliabilityof content information, one of the most basic and importantfactors is that the reliability of information on chemicalsubstances in company products is assured. It is also necessarythat correct information regarding chemical substances incompany products be released to external parties.

3-3Documentation andDocumentation Management

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Confirmed results should be reported tobusiness managers, etc.

4. The results of internal audits and any improvements madeshould be reported to the manager of the business (Note).With regard to the Note above, depending on managementstructures, the following terms may be inserted in place of thosewithin inverted commas:(Examples)1) Person responsible for the business2) Manager in charge of the business location3) Factory manager

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The situation regarding the execution of themanagement of chemical substances inproducts should be confirmed. Based on theresults of such confirmations, improvementsshould be implemented whenever necessary.

As the people who are finally responsible for issues related to themanagement of chemical substances in products, the businessmanagement must monitor the related situations. Furthermore,they must implement reviews to improve the situations.

1. Based on the results of internal audits and external audits, etc.,or if there are any problems such as that there is an informationregarding non-conformities, countermeasures should be reflectedin the goals that are set for the next period and improvementsshould be implemented by business management (Examples).(Examples)1) Person responsible for the business2) Manager in charge of the business location3) Factory manager

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Failed

Total Evaluation No Improvement Required Requires Improvement Presence of Non-Conformitiespts.

Explanation of Columns Data Entry Steps

Data Entry Steps

（C） Copyright by the Japan Green Procurement Survey Standardization Initiatives

Step 4: Based on the evaluation results for each Required Level specified in Step 2, the followingmethod of evaluation should be employed when entering scores in the "Score" column (See Note).However, if it is not applicable, do not enter data. (Note: If the Required Level evaluation is"Conforming," enter 3 points. If "Requires Improvement," enter 2 points. If "Non-Conforming," enter"0" points. For "Not Applicable" results, nothing should be entered and the column should remainblank.)Step 5: In the "Overall Total" column, the combined total of all the numbers in the "Score" columnshould be entered. However, if Microsoft Excel is used, this result should be automatically calculated.Please note that if all items are evaluated, then the highest possible score would be 96 points due to thefact that there are 32 items and the top possible score for each is 3 points. In order to convert any scoreobtained into a percentage, the score obtained should be divided by a factor of 96 and then multiplied by100%. Before this result is entered, decimal numbers should be rounded to the nearest whole number.

“Action Items”:These list the items that are required for managing the chemical substances in products and comprise the five major items of “1. Establishing guidelines for the management of chemical substances in products” through “5.Management Review,” where these five major items are divided into 18 minor items.

Using the specified method, please enter applicable information in the cells encapsulated by the boldborders.

“Action Details”:The Action Details describe, for each Action Item, specifically what the Action Item is to accomplish. Although it is important to have shared terminology throughout the entire supply chain, there may be cases where thewords used do not communicate in a specific industry. In such cases, “Action Details” should be performed according to the line of business of the relevant company based on an understanding of the intent of the“Additional Explanations” or “Required Level,” and on an understanding of the degree to which the Action Item is to be performed. However, note that “Action Details” that do not apply to the firm need not be fulfilled.For example, if there is no design functionality (department) in the firm, then the “Action Details” in “3-1-1: Design/Development” of the “Action Item List” is deemed not applicable.

Step 1: For the seven columns within the "Management Framework" (numbered I to VII), place a circlein all those columns judged to fall within the company's management parameters. If none of thecolumns within the framework is felt to be applicable, do not enter data (see Note). (Note: If there issomething not applicable, please follow the instructions outlined in Step 3.)

Step 2: With regard to each of the "Required Level" elements marked with a circle in accordance withStep 1, make an evaluation based on the prescribed judging criteria (see Note). After doing so, whereapplicable mark the results using circles within the "Evaluation" column. The choices are "Conforming,""Requires Improvement," "Non-Conforming" and "Not Applicable." (Note: Please refer to Section 6 ofthe "Guidelines for the Management of Chemical Substances in Products.")

“Required Level”:To further clarify the meaning of the “Action Details,” the “Required Level” describe the degree to which the “Action Items” must be performed in a more specific manner, demanding for important common requirementsthroughout the entire supply chain. There may be cases where some requirements do not apply to your company, or some requirements that are important to your company are not included or are inadequate. In such cases,on reading “Additional Explanations” or examples specified in the relevant “Required Level” column, change the expressions (terms, words, etc.) into similar expressions used in your company in order that you may be ableto carefully determine such descriptions are applicable to your company and ensure that management is not lacking.

Step 3: The "Evidence" column is where evidence is entered. In addition to facts that have beenobjectively confirmed, the names of documents can be entered into this column. If something is felt tobe not applicable, the reasons behind this decision should be given in as much detail as possible.(Note: When objectively confirming evidence through the use of document copy attachments, inaddition to creating the document reference number, it is necessary to enter the same number in the"Evidence" column.)

"Management Framework":This offers action items for the management in unit processes of substances, preparations and articles. (Please refer to Sections 4.5 and 4.6 of the "Guidelines for the Management of Chemical Substances in Products").This column is used to display at what level each "Required Level" is being managed within the Management Framework. When checking conformance, the "Management Framework" column should be used.

"Additional Explanations":"Additional Explanations" are designed to support "Action Items" and "Action Details." In this column, specific implementation examples and reasons are offered.

5. Management Review(Correction By Management)

Passed

Step 6: Make an evaluation using the prescribed judging criteria (see Note), and mark a circle in theapplicable "Total Evaluation" column. (Note: Please refer to Section 6 of the "Guidelines for theManagement of Chemical Substances in Products").

Comments:

適　要

不　非

適　要

不　非

適　要

不　非

適　要

不　非

Conforming

RequiresImprovement

Non-Conforming

Not Applicable

Conforming

RequiresImprovement

Non-Conforming

Not Applicable

ScorePoints whenfull marksare 100

(Reference)OverallTotal

7 / 7 Page

(Annex 2) Self-Declaration of Conformance (Example) Version 1. September 27. 2005

1. Number:

2. Subject of declaration:

3. Issuing authority: Company name:Address:

Company name:Address:

Document name: Guidelines for the Management of Chemical Substances in Products

Version no.: 1

Date of issue: XX (month), 2005

Issuing authority Japan Green Procurement Survey Standardization Initiative (JGPSSI）

5. Additional information:

Score: Other:

6. Place and date of issue:

Place: Date of issue: XX (day), XX (month), XX (year)

Date of renewal: XX (day), XX (month), XX (year)

7. Representative, department:

Company name: Person's name: Department:

If you have any queries regarding this declaration, please contact the person listed below: Company name: Person's name: Department: Telephone: E-mail:

1

4. The subject of the declaration above comply with requirements specified in the documentation below:

Self-Declaration of Conformance Regarding Systems forControlling Chemical Substances in Products

This document declares that our company has systems in place for controlling chemical substances in its productsand that such systems are functioning effectively.

(Annex 2) Self-Declaration of Conformance (Data Example) Revision 1. September 27, 2005

1. Number: PEMS-2005-01

2. Subject of declaration: The management system for XXXX product used for XXXX purpose. The management system for XXXX product used for XXXX purpose.

3. Issuing authority: Company name: The Corporate Headquarters of XXXX Co., Ltd.Address: 1-2-3, XXXX Ward, Tokyo

Company name: The XXXX Factory of XXXX Co., Ltd. Address: 12-3, XXXX Machi, XXXX Gun, Shizuoka Prefecture

Document name: Guidelines for the Management of Chemical Substances in Products

Version no.: 1

Date of issue: XX (month), 2005

Issuing authority: Japan Green Procurement Survey Standardization Initiative (JGPSSI）

5. Additional information:

Score: 94 points (Full marks: 100 points) Other: Based on the results of an internal audit (conducted on

XX month, XXXX year), compliance was confirmed.

6. Place and date of issue:

Place: 12-34-56 XXXX, XXXX City, Chiba PrefectureDate of issue: XX (day), XX (month), 2005 (year)

]Date of renewal: XX (day), XX (month), 2006

7. Representative, department

Company name: XXXX Co., Ltd. Person's name: XXXX Department: XXXX Management Department, Corporate Headquarters

If you have any queries regarding this declaration, please contact the person listed below: Company name: XXXX Co., Ltd. Person's name: XXXX Department: XXXX Promotion Office, XXXX Management Department, Corporate HeadquartersTelephone: 03-XXXX-XXXXE-mail: [email protected]

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4. The subject of the declaration above comply with requirements specified in the documentation below:

Self-Declaration of Conformance Regarding Systems forControlling Chemical Substances in Products

This document declares that our company has systems in place for controlling chemical substances in its productsand that such systems are functioning effectively.

Note 2

Enter signature here

Note 1

Note 3

Note 4

Note 5

Note 6

Note 7

Note 8

Note 9

(Annex 2) Explanation of Self-Declaration of Conformance (Data Example)

indicates mandatory details. indicates voluntary details.

Identification number may include letters in addition to numerical figures.

Write in the details of the management system covered by the declaration of conformance.If text is numerous, the information may be written on another attached document.

(Example 2-1) The management system for XXXX product used for XXXX purpose.

(Example 2-2)

(Example 2-3)

A. If a specific organization within the company is making a declaration of conformance:

(Example 3-1) The XXXX Factory of XXXX Co., Ltd. 12-3, XXXX Machi, XXXX Gun, Shizuoka Prefecture

(Example 3-2) The XXXX Business Division of XXXX Co., Ltd.12-3, XXXX Machi, XXXX Gun, Shizuoka Prefecture

(Example 3-3) The XXXX Business Division of XXXX Factory of XXXX Co., Ltd. 12-3, XXXX Machi, XXXX Gun, Shizuoka Prefecture

(Example 3-4) The XXXX Factory of XXXX Co., Ltd. 12-3, XXXX Machi, XXXX Gun, Shizuoka Prefecture

The XXXX Factory of XXXX Co., Ltd. 12-3, XXXX City, Yamanashi Prefecture

Tohoku XXXX Co., Ltd.12-3, XXXX Machi, XXXX Gun, Akita Prefecture

Shonai XXXX Co., Ltd.12-3, XXXX City, Yamagata Prefecture

Taiwan XXXX Co., Ltd.1234-56 XXXX, Taipei City

(Example 3-5) XXXX Co., Ltd.1-2-3, XXXX Ward, Tokyo

XXXX Industries Co., Ltd.123-4, XXXX City, Chiba Prefecture

C. When a company (as a whole) is making a declaration of conformance:

(Example 3-6) XXXX Co., Ltd.1-2-3, XXXX Ward, Tokyo

3

B. If the declaration of conformance involves a number of organizations within a company, group companies or outsourcing entities that are working on the company's behalf, etc.

If this is the case, it is also possible to include outsourcing entities that are working on the company's behalf who have no capital relationship with the company.

The party making the conformance declaration should allocate an identification number that can be used forreference when there are queries from within or outside the company.

Write in here the organization making the declaration of conformance. For example, this information might besimilar to the following examples. If text is numerous, the information may be written on another attacheddocument.

The management system for development, manufacture and sale of XXXX product used forXXXX purpose.

The management system for development, manufacture and sale of electronic components.

Note XNote X

Note 1

Note 2

Note 3

Write in information as indicated in the example.

After confirming the result figures from the (Attachment 1) "Action Item List & Check Sheet,"write these in based on a calculation where 100 points is the maximum score possible.

The date of issue represents the date on which the declaration of conformance was first made.

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For the purpose of supporting the declaration of conformance, evaluations of a second party may be included asevidence.

For place of issue, the address given in Item 7 should be listed. Even if it is same as Item 3, it should be writtenagain.

If you want to show that the conformance is ongoing based on the results of periodic internal audits, etc., renewaldates may also be listed.

Depending of the size of the company and its management structure, it is possible to select from the president,director-in-charge, officer-in-charge, or person-in-charge of the department.Both the company representative and the person actually responsible (the point of contact for queries) may be listed.

It is acceptable that an attached document be made to list in detail the content of the self-declaration ofconformance.If in addition to conformance with these guidelines, if conformance with other requirements are being made, pleaseinclude this information in the attached document.At the same time, however, it is not necessary that the attached document be disclosed along with the Self-Declaration of Conformance.

List the name of the individual, their department and their signature.

Furthermore, point-of-contact telephone and email address information may also be listed.

Note 4

Note 6

Note 7

Note 8

Note 5

Note 9

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