Intermec REACH Compliance Requirements

Transcription

1 Document Level: II Process Owner: Engineering Title: Intermec REACH Compliance Requirements Document Number: 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 3. Guidance for Articles, see 4. ECHA Data Submission Manual Part 20 - How to Prepare and Submit a Substance in Articles Notification using IUCLID Intermec Declarable Substances Compliance Requirements SUPPORTING DOCUMENTS Company Proprietary

2 TABLE OF CONTENTS 1 PURPOSE SCOPE INTERMEC PRODUCTS MARKETS TONNAGE PUT ON THE MARKET COMPLIANCE REQUIREMENTS SUBSTANCE COMPLIANCE REQUIREMENTS REACH-Regulated Substances Product Application Substance Compliance Status Action: Compliant Substance Substance Compliance Status Action: Non-Compliant Substance PROCEDURAL COMPLIANCE REQUIREMENTS Notification of Customers Notification of the European Chemicals Agency Registration of Substances Substances Carried in Special Containers (Such as Ink in Printer Ribbons)... 8 Substances Intended to be Released APPENDIX A SELECTED REACH DEFINITIONS ARTICLE EU DOWNSTREAM USER OF SUBSTANCE EU IMPORTER OF A SUBSTANCE EU MANUFACTURER OF A SUBSTANCE MIXTURE PLACING ON THE MARKET PREPARATION PRODUCER RESTRICTION RECIPIENT SUBSTANCE APPENDIX B INTERMEC S ROLE IN THE EU MARKET APPENDIX C REFERENCE WEIGHT OF ARTICLES APPENDIX D SUBSTANCES IN SPECIAL CONTAINERS PURPOSE SCOPE REQUIREMENTS Definitions Printer Ribbons Downstream User, Importer and Manufacturer Intermec s Registration Obligations as EU Downstream User Intermec s Registration Obligations as EU Importer Intermec s Registration Obligations as EU Manufacturer Intermec Action First Step Intermec Action Substances in Inks Intermec Must Register APPENDIX E SUBSTANCES INTENDED TO BE RELEASED Document Number: Rev C Page 2 of 18

3 8.1 PURPOSE SCOPE REQUIREMENTS Definitions Substances Intended to be Released Downstream User, Importer and Manufacturer Intermec s Registration Obligations as EU Downstream User Intermec s Registration Obligations as EU Importer Intermec s Registration Obligations as EU Manufacturer Intermec Action First Step Intermec Action Substances Intermec Must Register GLOSSARY REVISION HISTORY Document Number: Rev C Page 3 of 18

4 1 Purpose This specification defines Intermec s compliance requirements related to the European REACH regulation. 2 Scope 2.1 Intermec Products 2.2 Markets All Intermec products and accompanying materials including packaging unless specifically excluded or qualified European Union Markets that have adopted the European REACH regulation 2.3 Tonnage Put on the Market All substances governed by REACH, regardless of the tonnage of individual substances Intermec puts on the market 3 Compliance Requirements A product s REACH compliance is determined by the 1. Product s substance compliance 2. Manufacturer s compliance with procedural requirements 3.1 Substance Compliance Requirements The substance compliance requirements for the REACH substance classifications are embedded in the Declarable Substance List of BOMcheck.net. See on the Home page, click on one list of restricted and declarable substances REACH-Regulated Substances REACH classifies substances according to three types of regulatory control: Regulatory Control Classification Name List Use allowed, with notification of SVHC Candidates for customers and regulator Authorization Annex XV Manufacture and use allowed by special authorization only Presence allowed in imported Authorized substances Annex XIV articles Use restricted or prohibited Restricted substances Annex XVII Document Number: Rev C Page 4 of 18

5 3.1.2 Product Application 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, activate 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 Substance Compliance Status Action: Compliant Substance If a substance is compliant per , 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. Document Number: Rev C Page 5 of 18

6 3.1.4 Substance Compliance Status Action: Non-Compliant Substance If a substance is not compliant per Intermec document # , and REACH is the prevailing regulation per Intermec document # , action is required as follows: Substance is noncompliant at level - Status is - Substance Regulatory Action Restricted (Annex XVII) or authorized only (Annex XIV) 1 Replace material(s) and/or component(s) immediately Salable product Notify customers per section in this document titled Salable Product Component, Material Packaging: Main material Packaging: Finished, labeled, marked Packaging: Labels and printed marks Documentation: User instructions, certificates etc. SVHC Candidate for Authorization (Annex XVII) Restricted (Annex XVII) or authorized only (Annex XIV) SVHC Candidate (Annex XVII) Restricted (Annex XVII) or authorized only (Annex XIV) SVHC Candidate for Authorization (Annex XVII) Restricted (Annex XVII) or authorized only (Annex XIV) SVHC Candidate (Annex XVII) 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 Replace material(s) immediately Restricted (Annex XVII) or authorized only (Annex XIV) Treat like packaging 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 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 Target the non-compliant material(s) for replacement Target the non-compliant material(s) for replacement 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. Document Number: Rev C Page 6 of 18

7 3.2 Procedural Compliance Requirements 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 Notification of Customers 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 Notification of the European Chemicals Agency 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, metric tons and so on 2 Doc 1, Article 33 3 Doc 1, Article 7 Document Number: Rev C Page 7 of 18

8 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 Registration of Substances 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 Substances Carried in Special Containers (Such as Ink in Printer Ribbons) 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 so-called dossier. Manufacturers and importers of articles do not have to register substances contained in their articles, except under the certain narrowly defined conditions. Document Number: Rev C Page 8 of 18

9 Substances Intended to be Released 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 Document Number: Rev C Page 9 of 18

10 4 Appendix A Selected REACH Definitions 4.1 Article 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. 4.2 EU Downstream User of Substance 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 EU Importer of a Substance 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 EU Manufacturer of a Substance Intermec is considered an EU manufacturer of a substance if the following conditions are met: 4.5 Mixture 1. Intermec manufactures the substance in the EU 8 A mixture or solution composed of two or more substances. 4.6 Placing on the market 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 Intermec-owned 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: Rev C Page 10 of 18

11 4.7 Preparation A mixture or solution composed of two or more substances 4.8 Producer Any natural or legal person who makes or assembles an article within the Community. 4.9 Restriction Any condition for, or prohibition of, the manufacture, use or placing on the market Recipient An industrial or professional user, or a distributor, being supplied with an article but does not include consumers Substance 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. 5 Appendix B Intermec s role in the EU Market 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 6 Appendix C Reference Weight of Articles 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. 7 Appendix D Substances in Special Containers 7.1 Purpose This Appendix defines certain Intermec obligations under REACH, for printer ribbons, and for all products that are REACH regulatory analogs to printer ribbons. Document Number: Rev C Page 11 of 18

12 7.2 Scope 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 7.3 Requirements Definitions 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 Printer Ribbons 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 Downstream User, Importer and Manufacturer See Appendix A Selected REACH Definitions Intermec s Registration Obligations as EU Downstream User 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 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 ECHA Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is not needed Document Number: Rev C Page 12 of 18

13 7.3.3 Intermec s Registration Obligations as EU Importer 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 Intermec s Registration Obligations as EU Manufacturer 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 Intermec Action First Step 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. Appointed 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 Doc 1, Article 6 14 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: Rev C Page 13 of 18

14 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 Intermec Action Substances in Inks Intermec Must Register 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 8 Appendix E Substances Intended to be Released 8.1 Purpose 8.2 Scope 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: Rev C Page 14 of 18

15 8.3 Requirements Definitions Substances Intended to be Released 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 Downstream User, Importer and Manufacturer See Appendix A Selected REACH Definitions Intermec s Registration Obligations as EU Downstream User 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 Intermec s Registration Obligations as EU Importer 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 Intermec s Registration Obligations as EU Manufacturer 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 ECHA Guidance on registration, MAY 2012, pdf page 17, Examples on when registration is not needed 19 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 Doc 1, Article 7 21 Doc 1, Article 7(6) 22 Doc 1, Article 7 Document Number: Rev C Page 15 of 18

16 3. That substance has not already been registered for that use Intermec Action First Step 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. Appointed 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 Intermec Action Substances Intermec Must Register 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: Rev C Page 16 of 18

17 5. Stop manufacturing such substances in the EU Glossary 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 Document Number: Rev C Page 17 of 18

18 Revision History Revision Purpose Of Change Document Date Author A B C Initial Release 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 REACH-Regulated Substances Clarify the regulatory control of Authorized Substances In section 3.1 Substance Compliance Requirements Delete reference to 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 11 OCT 2012 Stefan Truemper 08 NOV 2012 Stefan Truemper 16 DEC 2013 Stefan Truemper Document Number: Rev C Page 18 of 18