REACH Compliance - The Great Challenge for Globally Acting Enterprises (eBook)

Susanne Kamptmann studied Chemistry at the University of Karlsruhe (Technische Hochschule) and obtained her PhD in the field of Organic Chemistry. Afterwards she worked on several research projects at university and then as a Postdoc in industry (Roche and DSM). In the company where she is currently employed, she started as a Group Leader Development. In 2008 she changed jobs internally and became a REACH Manager. Since then she has been responsible for all REACH dealings in the company. The company group now comprises of several European sites, a Swiss site and also sites in Asia.

Preface

INTRODUCTION
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 Materia