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
PrefaceINTRODUCTION
History
The REACH Regulation -
A Short Overview on the Table of Contents
Purpose and Scope of REACH
Other Regulations and Directives that are Important in the Context of REACH
ROLES UNDER REACH
Manufacturer within the EU
Non-EU Manufacturer, Importer and Only Representative
Downstream User
Trader within EU versus Non-EU Trader and Distributer
Examples and Exercises
WHAT SORT OF SUBSTANCES HAVE TO BE CONSIDERED UNDER REACH
Substance, Mixture and Article under REACH
Different Compositions
Different Types of Use
Phase-In Substances
No-Longer Polymers
Non-Phase-In Substances
Substances that Already Have Been Notified
Overview on Official EC Numbers and not Official List Numbers
Exemptions from REACH
Check-List for Business Managers
Examples and Exercises
OBLIGATION TO SUBMIT A REGISTRATION DOSSIER
Who has to Register? Who may Register?
Pre-registration and Late Pre-registration
When Does a Substance have to be Registered?
Special Rules for Non-EU Manufacturers
Consequences for Globally Acting Enterprises/What to Take into Account within a Decision-Making Process?
Examples and Exercises
TYPES OF REGISTRATION
Standard Registration, Full Registration or Registration as a Substance
Registration as an On-site Isolated Intermediate
Registration a Transported Isolated Intermediate
Formerly Notified Substances
PPORD
Examples and Exercises
DATA REQUIREMENTS AND DOSSIER PREPARATION
Data Requirements
Dossier Preparation
Some Useful Tips for Entering Data and Information in Certain Chapters in IUCLID5.4
Data Requirements, Type of Registration and Costs/Fees
Examples and Exercises
CLAIMING A REGISTRATION NUMBER FOR ALREADY NOTIFIED SUBSTANCES
Formerly Notified Substances are Regarded as Registered Under REACH
How to Claim the Registration Number Under REACH for a Formerly Notified Substance
When to Update a Registration Dossier of a Formerly Notified Substance and How to Do it
Examples and Exercises
PROCESS FOR REGISTRATION OF NON-PHASE-IN SUBSTANCES
Inquiry Dossier
Preparation of the Registration Dossier
Difficulties and Problems that can Arise in the Context of the Registration of Non-Phase-In Substances
Examples and Exercises
PROCESS FOR REGISTRATION OF PHASE-IN SUBSTANCES
Preparing for Pre-registration and Late Pre-registration
Communication within Pre-SIEF
Formation of SIEF
Cooperation within the SIEF
Data Sharing
Data Sharing Disputes
Opt-Out
Registration Dossier of the Lead Company and Registration Dossiers of the Members of Joint Submission
Overview on Important Steps within the Process of Registration of Phase-In Substances
Examples and Exercises
WHAT HAPPENS AFTER SUBMISSION OF YOUR REGISTRATION DOSSIER TO ECHA
Initial Verification
Overall Completeness Check
Receiving the Reference Number
End of Pipeline Activities
Dossier and Substance Evaluation
Further Obligations of the Registrant and Downstream Users
Examples and Exercises
UPDATE OF THE REGISTRATION DOSSIER
When to Update Your Registration Dossier
Requested Updates
Spontaneous Updates
Update of Dossiers of Formerly Notified Substances
Update of Dossiers or PPORD Notifications
Costs Concerning Updates
Examples and Exercises
SUBSTANCES OF VERY HIGH CONCERN AND AUTHORIZATION PROCESS
Uses that are Exempted from Authorization
Substances of Very High Concern (SVHC)
Substance Identification and Identification Procedure
Inclusion of a Substance in the Candidate List of Substances of Very High Concern (SVHC)
Prioritization and Inclusion of Certain SVHCs in Annex XIV
Information in Annex XIV
Restrictions and Information in Annex XVII
Application for Authorization
Data Requirements and Documents Needed for an Application for Authorization
Submission of the Application of Authorization, Deadlines and Fees
Subsequent Applicants and Their Obligations
Process after Submission of the Application for Authorization
Examples and Exercises
ACHIEVING REACH COMPLIANCE WITHIN YOUR COMPANY -
HOW TO IMPLEMENT PROCESSES TO ENSURE LEGAL COMPLIANCE
List of Used Raw Materials
List of Substances that are Manufactured in Your Company
Documentation Concerning Manufacturing Process of OIIs and TIIs and Documentation of the Correct Use of TIIs by Customers
Substance Volume Tracking
Examples and Exercises
COMMUNICATION IN THE SUPPLY CHAIN
Communication Obligations According to the REACH Regulation
Communication to be Done by Suppliers
Communication to be Done by Non-EU Manufacturers
Communication to be Done by Non-EU Distributors or Non-EU Traders
Communication to be Done by a Downstream User or a Downstream Supplier
Communication to be Done by an Only Representative
Examples and Exercises
APPENDIX
Answers and Solutions Concerning the Sections Examples and Exercises within this Book
Index
