Title: Document Number:
637347
Document Level:
II
Process Owner:
Engineering
Intermec REACH
Compliance Requirements
Revision:
C
Page:
1 of 18
APPROVED BY:
Mark Steffens
Andrew Chew
David Downey
Stu Adams
Kathy Vorhies
Sr. Director, Engineering
Sr. Director, Engineering
Sr Dir & GM, Data Capture Operation
Dir, Engineering
Dir, Engineering
REFERENCED FORMS, DOCUMENTS, AND RECORDS:
1. REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL, of 18 December 2006, concerning the Registration, Evaluation,
Authorization and Restriction of Chemicals (REACH)
2. Guidance on Registration, see http://echa.europa.eu/home_en.asp
3. Guidance for Articles, see http://echa.europa.eu/home_en.asp
4. ECHA – Data Submission Manual – Part 20 - How to Prepare and Submit a Substance in
Articles Notification using IUCLID
637299 Intermec Declarable Substances Compliance Requirements
SUPPORTING DOCUMENTS
Company Proprietary
___________________________________________________________________________
TABLE OF CONTENTS
Document Number: 637347 Rev C Page 2 of 18
Document Number: 637347 Rev C Page 3 of 18
This specification defines Intermec’s compliance requirements related to the European
REACH regulation.
All Intermec products and accompanying materials including packaging unless specifically excluded or qualified
European Union
Markets that have adopted the European REACH regulation
All substances governed by REACH, regardless of the tonnage of individual substances Intermec puts on the market
A prod uct’s REACH compliance is determined by the –
1. Product’s substance compliance
2. Manufacturer’s compliance with procedural requirements
The substance compliance requirements for the REACH substance classifications are embedded in the Declarable Substance List of BOMcheck.net.
See https://bomcheck.net/, on the Home page, click on “one list of restricted and declarable substances
”.
REACH classifies substances according to three types of regulatory control:
Use allowed, with notification of customers and regulator
Manufacture and use allowed by special authorization only
Presence allowed in imported articles
Use restricted or prohibited
SVHC Candidates for
Authorization
Authorized substances
Restricted substances
Annex XV
Annex XIV
Annex XVII
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REACH defines the compliance requirements for each of its regulated and restricted substances by stating –
1. The regulatory status of the substance (SVHC Candidate for Authorization, authorized substance, restricted substance)
2. A threshold value above which certain rules apply according to the regulatory status of the substance
3. One or more product applications to which the threshold applies
The threshold, and the regulation or restriction of a substance DO NOT apply if the
Intermec product’s properties, use or purpose do not fall inside the stated application(s)
If a supplier reports a substance as being present above the threshold although the product’s properties, use or purpose do not fall inside the application(s) listed for that substance and its threshold, Intermec should take the following action for an Intermec
Regulatory Compliance Declaration (RCD):
1. In PECMS, a ctivate an “Override” in the manufacturer’s RCD
2. Enter text in the override to the effect that the application(s) defined for that substance do not apply to the Intermec product.
Examples: a.
“This product is not a children’s toy” b. “The nickel-plated surface(s) of this product do not come into prolonged contact with human skin”
3. Do not report this substance in the Intermec RCD as being above the threshold
If a substance is compliant per 637299, no further action regarding its REACH substance compliance status is required UNLESS that substance is subject to registration requirements. See section in this document titled Registration of
Substances .
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If a substance is not compliant per Intermec document # 637299, and REACH is the prevailing regulation per Intermec document # 637299, action is required as follows:
Substance is noncompliant at level -
Substance Regulatory
Status is -
Restricted (Annex XVII) or authorized only (Annex XIV) 1
Action
Replace material(s) and/or component(s) immediately
Salable product
Salable Product
Component,
Material
SVHC Candidate for
Authorization (Annex XVII)
Restricted (Annex XVII) or authorized only (Annex XIV)
SVHC Candidate (Annex XVII)
Notify customers per section in this document titled
Notification of Customers
Calculate total metric tonnage of the SVHC put on the market per year – o If tonnage of the offending SVHC > 1 ton/year (t/a), notify ECHA per section in this document titled Notification of the ECHA o Target the non-compliant component(s) or material(s) for replacement
Target the non-compliant component(s) or material(s) for replacement
Target the non-compliant component(s) or material(s) for replacement
Restricted (Annex XVII) or authorized only (Annex XIV)
Replace material(s) immediately
Packaging:
Main material
Packaging:
Finished, labeled, marked
SVHC Candidate for
Authorization (Annex XVII)
Notify customers per section in this document titled
Notification of Customers
Calculate total metric tonnage of the SVHC put on the market per year – o If tonnage of SVHC > 1 ton/year (t/a), notify
ECHA per section in this document titled
Notification of the ECHA
Target the non-compliant component(s) or material(s) for replacement
Packaging:
Labels and printed marks
Documentation:
User instructions, certificates etc.
Restricted (Annex XVII) or authorized only (Annex XIV)
SVHC Candidate (Annex XVII)
Restricted (Annex XVII) or authorized only (Annex XIV)
SVHC Candidate (Annex XVII)
Target the non-compliant material(s) for replacement
Target the non-compliant material(s) for replacement
Treat like packaging
1 Annex XIV substances cannot be produced or used inside the EU without authorization. Imported article are allowed to contain such substances because REACH has no jurisdiction over production and use outside the EU. Annex XIV substances are included here because of efforts in the EU to restrict Annex XIV substances automatically upon inclusion in Annex XIV.
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Procedural compliance requirements that depend on the regulatory status, the compliance status of a substance and the REACH role of Intermec:
1. Notification of users
2. Notification of the ECHA
Procedural compliance requirements that depend on the use classification of a substance and the REACH role of Intermec:
1. Registration of substances
2
If the compliance status action in the above table indicates that notification of customers is required, Intermec must provide, at a minimum, the following information to the customers of the affected product or packaging:
1. Name of the non-compliant substance
2. Instructions for the safe use of the product
3
Important:
If the ECHA must be notified, this notification must be filed no later than 6 months after the substance has been added to the Candidate List.
If the compliance status action in the above table indicates that notification of the
European Chemicals Agency (ECHA) is indicated, the following actions are required:
1. If exposure to humans or the environment during use or disposal can be excluded under normal or reasonably foreseeable conditions – a. Provide appropriate instructions for the users of the Intermec product b. Do not notify the ECHA
2. If exposure cannot reasonably be excluded
– a. Notify the ECHA and supply the following information (this is an overview only) - i. The identity and contact details of the producer or importer ii. The registration number(s) of the substance(s) in question, if available; iii. The identity of the substance(s) (Name, and CAS number if available) iv. The hazard classification of the substance(s) v. A brief description of the use(s) of the substance(s) in the article and of the uses of the article(s); vi. The tonnage range of the substance(s), such as 1-10 metric, 10-
100 metric tons and so on
2
Doc 1, Article 33
3
Doc 1, Article 7
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Important:
1. Before attempting to file a Notification, see Doc 4 for details on the ECHA notification requirements
2. For background on the regulatory requirements, see Doc1, Article 7.
4
Subject to Intermec’s REACH role in the EU market, Intermec is principally responsible for the registration of substances in Intermec products, under the following conditions:
1. Substances that are carried in, or on, Intermec products (articles) which
REACH classifies as “special containers”
2. Substances that are intentionally released from Intermec products
As downstream user, Intermec is not responsible for the registration of such substances, but can only place those substances on the EU market that are either –
1. Imported into, or produced in, the EU in quantities below 1 metric ton annually,
OR
2. Have been registered by the importer or manufacturer
As importer or manufacturer, Intermec is responsible for the registration of a substance carried in a special container (for example, the substances in the ink on a printer ribbon) under these conditions
–
1. Intermec imports more than 1 metric ton of the substance into the EU annually, or
2. Intermec manufactures more than 1 metric ton of the substance in the EU annually
For the REACH definitions of Downstream User, Importer, and Manufacturer, see
Appendix A – Selected REACH Definitions .
For details on the REACH provisions for the registration of substances, see Appendix D – Substances in Special Containers .
4
Registration of a substance with the ECHA involves expensive, complex and time consuming work to prepare a socalled “dossier”. Manufacturers and importers of articles do not have to register substances contained in their articles, except under the certain narrowly defined conditions.
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As downstream user, Intermec is not responsible for the registration of substances intended to be released from an Intermec article, but can place on the market only those substances on the EU market that are either –
1. Imported into, or produced in, the EU in quantities below 1 metric ton annually,
OR
2. Have been registered for that use by the importer or manufacturer
As importer or manufacturer, Intermec is responsible for the registration of substances, intended to be released from an Intermec article, under these conditions –
1. Intermec imports more than 1 metric ton of the substance into the EU annually, or
2. Intermec manufactures more than 1 metric ton of the substance in the EU annually, AND
3. The substance has not already been registered for that use
For the REACH definitions of Downstream User, Importer, and Manufacturer, see Appendix A
– Selected REACH Definitions
.
For details on the REACH provisions for substances intended to be released, see
Appendix D – Substances Intended to be Released
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For the complete list of REACH definitions, see REGULATION (EC) No 1907/2006 ,
Chapter 2, Definitions and General Provision, Article 3.
An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
Intermec is considered a downstream user of a substance if the following conditions are met:
1. Intermec purchases the substance from a non-EU supplier and imports the substance into the EU, AND
2. The non-
EU supplier has appointed an “Only Representative” in the EU 5
, OR
3. Intermec purchases the substance in the EU from a supplier located in the EU
6
Intermec is considered an importer of a substance if the following conditions are met:
1. Intermec purchases the substance from a non-EU supplier and imports the substance into the EU, AND
2. The non-EU supplier has NOT appointed an “Only Representative” in the EU 7
Intermec is considered an EU manufacturer of a substance if the following conditions are met:
1. Intermec manufactures the substance in the EU
8
A mixture or solution composed of two or more substances.
Supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.
[Note: Import to an Intermecowned warehouse does not qualify as “placing on the market"]
5
ECHA – Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is not needed
6
ECHA - Guidance on registration, MAY 2012, pdf page 20, Role and registration obligations of different actors in case of import
7
Guidance on registration, MAY 2012, pdf page 20, Only representative of a ‘non-EU manufacturer’
8
Guidance on registration, MAY 2012, pdf page 17, Examples of when registration is needed
Document Number: 637347 Rev C Page 10 of 18
A mixture or solution composed of two or more substances
Any natural or legal person who makes or assembles an article within the Community.
Any condition for, or prohibition of, the manufacture, use or placing on the market.
An industrial or professional user, or a distributor, being supplied with an article but does not include consumers.
Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Under REACH, Intermec currently participates in the EU market as -
1. Importer of articles, mixtures and substances
2. Downstream user of articles, mixtures and substances
The concentration of a substance in an article is calculated by the weight over weight method: (weight of the substance
/weight of the referenced object
)
In its guidance, REACH allows the complex article (= salable end user product) to be used as the referenced object.
Six EU Member States have objected to this interpretation of the definition of article.
They have requested that the ECHA change its guidance to show that the individual component is the referenced object. It is expected that this disagreement will be resolved in court.
Intermec prefers the interpretation of the individual component as the referenced object.
This Appendix defines certain Intermec obligations under REACH, for printer ribbons, and for all products that are REACH regulatory analogs to printer ribbons.
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Registration requirements for the substances in the inks used on all printer ribbons Intermec sells in the EU
Registration requirements for the substances used by Intermec products that function in regulatory analogy of a printer ribbon (a special container carrying substances)
Note:
The following aspects of printer ribbons are not discussed here because they are well understood –
1. The printer ribbon as an article
2. Substance compliance requirements for printer ribbons and inks, including the use of MSDS
Under REACH, an article that releases one or more substances as its main function, is classified as a special container carrying one or more substances.
9
Applying the general definition, a printer ribbon is an article (special container) carrying one or more substances (the ink)
10
.
For this Appendix, “ribbon” means a completely assembled printer ribbon with the ink applied.
See Appendix A – Selected REACH Definitions.
As downstream user of a substance (in the ink) intended to be released, Intermec is subject to the following REACH requirements:
1. Intermec is not responsible for registering such a substance
11
2. Intermec can place on the market only those substances on the EU market that are either – a. Imported into, or produced in, the EU in quantities below 1 metric ton annually, OR b. Have been registered by the importer or manufacturer for that use
12
9
ECHA – Guidance on requirements for substances in articles, 01 APR 2012, pdf page 21, section 3.1 Intended release of substances from articles
10
ECHA - Guidance on requirements for substances in articles, 01 APR 2011, pdf page 45, Appendix 1.
11
ECHA – Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is not needed
Document Number: 637347 Rev C Page 12 of 18
13
As an importer of substances (the ink on the ribbon) into the EU, Intermec is subject to the following REACH requirements:
1. Intermec must register a substance present in the ink, IF
2. Intermec imports more than 1 metric ton per year of that substance into the EU
Note: There is no provision for the case that a substance has already been registered by another company. That is, each importer must register a substance if the conditions for registration are given, regardless of other existing registrations of the same substance.
14
15
As an EU manufacturer of substances (the ink on the ribbon), Intermec is subject to the following REACH requirements:
1. Intermec must register a substance present in the ink, IF
2. Intermec manufactures more than 1 metric ton per year of that substance in the
EU
Note: There is no provision for the case that a substance has already been registered by another EU manufacturer. That is, each EU manufacturer must register a substance if the conditions for registration are given, regardless of other existing registrations of the same substance.
16
Eliminate from further action all ribbons for which Intermec is not responsible for the registration, then deal with the remaining ribbons individually:
1. Elimination 1 – Ribbons purchased from non-EU suppliers with appointed
Only Representative, and from EU Suppliers a. Identify all ribbons Intermec purchases from non-EU suppliers who have
- i. A ppointed an “Only Representative”, AND ii. Registered the substances in the ink for that use b. Identify all ribbons Intermec purchases from EU suppliers who have - i. Registered the substances in the ink for that use
12
ECHA – Guidance for Downstream Users, JAN 2008, pdf page 14, Executive Summary, Section 1.1.1, When do downstream users have to comply with REACH?
13
14
Doc 1, Article 6
ECHA – Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is needed
15
Doc 1, Article 6
16
ECHA – Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is needed
Document Number: 637347 Rev C Page 13 of 18
2. Elimination 2 – Ribbons using inks that contain only substances Intermec
ships into the EU at a level below 1 metric ton per year a. Collect Full Material Declarations for ribbons and their inks remaining after Elimination 1 and 2 b. Calculate annual tonnage for each substance in the inks c. Sum up total annual tonnage per substance across all ribbons in this category d. Identify all ribbons with each and all ink substances shipped below 1 metric ton per year
3. Consolidate the list of ribbons meeting the elimination requirements 1 and 2, above
4. Decide on action for all ribbons that have not been eliminated from registration requirements
Registration requires a detailed chemical and environmental dossier of each substance, with significant time, personnel and financial implications.
To avoid having to register substances in inks, Intermec has the following options:
1. Switch ribbon purchases to non-EU suppliers who have appointed an Only
Representative in the EU and who have registered the substances in the ink
2. Induce non-EU ribbon suppliers to appoint an Only Representative in the EU and register the substances in the ink
3. Purchase ribbons from EU manufacturers who have registered the substances in the ink
4. Use ribbons with all substances in the ink shipping below 1 metric ton annually
5. Stop manufacturing inks in the EU
This Appendix defines certain Intermec obligations under REACH, for substances that are intended to be released from Intermec articles.
Registration requirements of substances – including substances in mixtures - intended to be released
Note:
The following aspects of articles containing substances intended to be released are not discussed here because they are well understood
–
1. Articles
2. Substance compliance requirements for substances, including the use of
MSDS
Document Number: 637347 Rev C Page 14 of 18
Under REACH, a substance that is released by an article as an accessory function of that article, is classified as a substance intended to be released.
17
See Appendix A
– Selected REACH Definitions.
18
As downstream user of a substance intended to be released, Intermec is subject to the following REACH requirements:
1. Intermec is not responsible for registering such a substance
2. Intermec can place on the market only those substances on the EU market that are either
– a. Imported into, or produced in, the EU in quantities below 1 metric ton annually, OR b. Have been registered by the importer or manufacturer for that use
19
20
As an importer of a substance into the EU, Intermec is subject to the following REACH requirements:
1. Intermec must register a substance intended to be released, IF
2. Intermec imports more than 1 metric ton per year of that substance into the EU,
AND
3. That substance has not already been registered for that use
21
22
As a manufacturer of a substance in the EU, Intermec is subject to the following
REACH requirements:
1. Intermec must register a substance intended to be released, IF
2. Intermec manufactures more than 1 metric ton per year of that substance in the
EU, AND
17
Guidance on requirements for substances in articles, 01 APR 2011, pdf page 21, section 3.1 Intended release of substances from articles
18
19
ECHA – Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is not needed
ECHA – Guidance for Downstream Users, JAN 2008, pdf page 14, Executive Summary, Section 1.1.1, When do downstream users have to comply with REACH?
20
21
Doc 1, Article 7
Doc 1, Article 7(6)
22
Doc 1, Article 7
Document Number: 637347 Rev C Page 15 of 18
3. That substance has not already been registered for that use
23
Eliminate from further action all substances for which Intermec is not responsible for the registration, then deal with the remaining substances individually:
1. Elimination 1 – Substances purchased from non-EU suppliers with appointed
Only Representative, and from EU Suppliers a. Identify all substances Intermec purchases from non-EU suppliers who have - i. A ppointed an “Only Representative”, AND ii. Registered the substances for that use b. Identify all substances Intermec purchases from EU suppliers who have - i. Registered the substances for that use
2. Elimination 2 – Substances Intermec ships into the EU at a level
below 1 metric ton per year - a. Collect Full Material Declarations for the articles containing such substances remaining after Elimination 1 b. Calculate annual tonnage for each substance c. Sum up total annual tonnage per substance across all substances in this category d. Identify all substances shipped below 1 metric ton per year
3. Consolidate the list of substances meeting the elimination requirements 1 and
2, above
4. Decide on action for all substances that have not been eliminated from registration requirements
Registration requires a detailed chemical and environmental dossier of each substance, with significant time, personnel and financial implications.
To avoid having to register substances in inks, Intermec has the following options:
1. Switch substance purchases to non-EU suppliers who have appointed an Only
Representative in the EU and have registered the substances
2. Purchase substances from EU manufacturers who have registered the substances
3. Induce non-EU substance suppliers to appoint an Only Representative in the
EU and to register the substances
4. Use substances shipping below 1 metric ton annually
23
Doc 1, Article 7(6)
Document Number: 637347 Rev C Page 16 of 18
5. Stop manufacturing such substances in the EU
CAS
CAS number
ECHA
Only
Representative
REACH
Registration
SVHC
Chemical Abstract Service a service of the American Chemical Society
CAS registry number, the number under which the American Chemical
Society has registered a chemical (or substance)
European Chemical Agency – Administrator of REACH
EU REACH representative for non-EU companies, carrying the responsibilities of an EU-based entity
Registration, Evaluation, Authorization and Restriction of Chemicals
Means registration of a substance or monomer with the ECHA
Registration can be pre-registration or full registration
Substances of Very High Concern
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Revision
A
Purpose Of Change
Initial Release
B
C
Section Registration of Substances completely re-written, to include:
Substances released from articles as the main function of the article
Substances released from articles as an accessory function of the article
Added:
Definitions of downstream user, importer and manufacturer to Appendix A
Appendix D
– Substances in Special
Containers
Appendix E – Substances Intended to be
Released
Revised:
In section 3.1.1 REACH-Regulated
Substances –
Clarify the regulatory control of
Authorized Substances
In section 3.1 Substance Compliance
Requirements –
Delete reference to 636925 Intermec
Supplier Material Composition
Declaration
Add reference to the Declarable
Substance List of BOMcheck.net
Added:
To section titled Notification of the
European Chemicals Agency
Requirements for submitting a
Notification to the ECHA
Document Date Author
11 OCT 2012 Stefan Truemper
08 NOV 2012 Stefan Truemper
16 DEC 2013 Stefan Truemper
Document Number: 637347 Rev C Page 18 of 18