REACH Compliance The Great Challenge for Globally Acting Enterprises 1st Edition by Susanne Kamptmann 3527664297 9783527664290

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Product details:

ISBN 10: 3527664297 

ISBN 13: 9783527664290

Author: Susanne Kamptmann

The only book to not only discuss the technicalities of the European REACH chemicals registration process, but also to directly address the resulting business risks and business solutions. In this text for practitioners, the author pulls together the key knowledge needed to successfully run a business under REACH, distilling thousands of pages of official documentation, and incorporating experiences from different-sized enterprises in a global context. Starting with the basics of the REACH framework, she explains the entire process on how to register with the European ECHA office with a particular emphasis on small and medium-sized businesses. Along the way, she describes key milestones and presents sample documents from real case studies. The final part of the book addresses strategies to ensure a reach-compliant operation, including recommendations for in-house processes as well as communicating with suppliers and downstream users. As a result, managers in the pharmaceuticals and chemicals industries will learn how to operate their companies in full compliance with REACH standards.

Table of contents:

1: Introduction

1.1 History

1.2 The REACH Regulation – A Short Overview on the Table of Contents

1.3 Purpose and Scope of REACH

1.4 Other Regulations and Directives that are Important in the Context of REACH

2: Roles under REACH

2.1 Manufacturer within the EU

2.2 Non-EU Manufacturer, Importer and Only Representative

2.3 Downstream User

2.4 Trader within EU versus Non-EU Trader and Distributor

3: What Sort of Substances have to be Considered under REACH

3.1 Substance, Mixture and Article under REACH

3.2 Different Compositions

3.3 Different Types of Use

3.4 Phase-In Substances

3.5 No-Longer Polymers

3.6 Non-Phase-In Substances

3.7 Substances that Already Have Been Notified

3.8 Overview on Official EC Numbers and not Official List Numbers

3.9 Exemptions from REACH

3.10 Check-List for Business Managers

4: Obligation to Submit a Registration Dossier

4.1 Who has to Register? Who may Register?

4.2 Pre-registration and Late Pre-registration

4.3 When Does a Substance have to be Registered?

4.4 Special Rules for Non-EU Manufacturers

4.5 Consequences for Globally Acting Enterprises/What to Take into Account within a Decision-Making Process?

5: Types of Registration

5.1 Standard Registration, Full Registration or Registration as a Substance

5.2 Registration as an On-site Isolated Intermediate

5.3 Registration as a Transported Isolated Intermediate

5.4 Formerly Notified Substances

5.5 PPORD

6: Data Requirements and Dossier Preparation

6.1 Data Requirements

6.2 Dossier Preparation

6.3 Some Useful Tips for Entering Data and Information in Certain Chapters in IUCLID5.4

6.4 Data Requirements, Type of Registration and Costs/Fees

7: Claiming a Registration Number for Already Notified Substances

7.1 Formerly Notified Substances are Regarded as Registered under REACH

7.2 How to Claim the Registration Number Under REACH for a Formerly Notified Substance

7.3 When to Update a Registration Dossier of a Formerly Notified Substance and How to Do It

8: Process for Registration of Non-Phase-In Substances

8.1 Inquiry Dossier

8.2 Preparation of the Registration Dossier

8.3 Difficulties and Problems that can Arise in the Context of the Registration of Non-Phase-In Substances

9: Process for Registration of Phase-In Substances

9.1 Preparing for Pre-registration and Late Pre-registration

9.2 Communication within Pre-SIEF

9.3 Formation of SIEF

9.4 Cooperation within the SIEF

9.5 Data Sharing

9.6 Data Sharing Disputes

9.7 Opt-Out

9.8 Registration Dossier of the Lead Company and Registration Dossiers of the Members of Joint Submission

9.9 Overview on Important Steps within the Process for Registration of Phase-In Substances

10: What Happens after Submission of Your Registration Dossier to ECHA?

10.1 Initial Verification

10.2 Overall Completeness Check

10.3 Receiving the Reference Number

10.4 End of Pipeline Activities

10.5 Dossier and Substance Evaluation

10.6 Further Obligations of the Registrant and Downstream Users

11: Update of the Registration Dossier

11.1 When to Update Your Registration Dossier

11.2 Requested Updates

11.3 Spontaneous Updates

11.4 Update of Dossiers of Formerly Notified Substances

11.5 Update of Dossiers for PPORD Notifications

11.6 Costs Concerning Updates

12: Substances of Very High Concern and Authorization Process

12.1 Uses that are Exempted from Authorization

12.2 Substances of Very High Concern (SVHC)

12.3 Substance Identification and Identification Procedure

12.4 Inclusion of a Substance in the Candidate List of Substances of Very High Concern (SVHC)

12.5 Prioritization and Inclusion of Certain SVHCs in Annex XIV

12.6 Information in Annex XIV

12.7 Restrictions and Information in Annex XVII

12.8 Application for Authorization

12.9 Data Requirements and Documents Needed for an Application for Authorization

12.10 Submission of the Application of Authorization, Deadlines and Fees

12.11 Subsequent Applicants and their Obligations

12.12 Process after Submission of the Application for Authorization

13: Achieving REACH Compliance within Your Company – How to Implement Processes to Ensure Legal Compliance

13.1 List of Used Raw Materials

13.2 List of Substances that are Manufactured in Your Company

13.3 Documentation Concerning Manufacturing Process of OIIs and TIIs and Documentation of the Correct Use of TIIs by Customers

13.4 Substance Volume Tracking

14: Communication in the Supply Chain

14.1 Communication Obligations According to the REACH Regulation

14.2 Communication to be Done by Suppliers

14.3 Communication to be Done by Non-EU Manufacturers

14.4 Communication to be Done by Non-EU Distributors or Non-EU Traders

14.5 Communication to be Done by a Downstream User or a Downstream Supplier

14.6 Communication to be Done by an Only Representative

Appendix – Answers and Solutions Concerning the Sections Examples and Exercises within this Book

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