Kamptmann | REACH Compliance - The Great Challenge for Globally Acting Enterprises | Buch | sack.de

Kamptmann REACH Compliance - The Great Challenge for Globally Acting Enterprises

1. Auflage 2013, 304 Seiten, Gebunden, Format (B × H): 172 mm x 251 mm, Gewicht: 806 g
ISBN: 978-3-527-33316-5
Verlag: Wiley VCH Verlag GmbH

Kamptmann REACH Compliance - The Great Challenge for Globally Acting Enterprises

REACH is the abbreviation for the European Regulation (EC) No 1907/2006.
This regulation encompasses the Registration, Evaluation, Authorisation and Restriction of Chemicals that are manufactured in the EU or imported into the EU. This book not only provides an overview on the registration process, but also raises questions in regard of resulting business risks and offers solutions for companies established within EU and also for non-EU companies that have to deal with European customers or suppliers.
In this text for practitioners, the author pulls together the key knowledge needed to achieve REACH compliance, distilling thousands of pages of the legal framework and additional Guidance documents. Her experience from the past five years is incorporated and covers the situation of globally acting enterprises by considering the requirements for EU and non-EU sites.
Starting with the basics of the REACH framework, the entire registration process is described. There are also tables and lists that may support companies in preparing their dossiers ready for submission to the European Chemicals Agency (ECHA) with a particular emphasis on small and medium-sized enterprises. Along the way, the key milestones are described and sample documents that may be used for real cases are presented. The final part of the book addresses strategies to ensure that a company is REACH-compliant, including recommendations for in-house processes as well as communication with suppliers and downstream users.
Examples and exercises at the end of each chapter may be used to deal with example cases in greater detail. Hints and solutions are presented in a separate chapter at the end of the book.
As a result, not only REACH managers to be, but also Business Managers, Project Managers, CEOs, people working in Customer Service, in Sourcing Departments or within Marketing & Sales Departments in the pharmaceuticals and chemicals industries will learn how to operate their companies in full compliance with REACH requirements.

Weitere Infos & Material

Foreword XIII

Preface XV

1 Introduction 1

1.1 History 1

1.2 The REACH Regulation - A Short Overview on the Table of Contents 3

1.3 Purpose and Scope of REACH 4

1.4 Other Regulations and Directives that are Important in the Context of REACH 7

1.4.1 Fees and Charges Payable to the European Chemicals Agency 8

1.4.2 Competition Law 9

1.4.3 GHS and CLP 10

1.4.4 Other Regulations Containing the Wording REACH 11

References 11

2 Roles under REACH 15

2.1 Manufacturer within the EU 15

2.2 Non-EU Manufacturer, Importer and Only Representative 16

2.3 Downstream User 20

2.4 Trader within EU versus Non-EU Trader and Distributor 23

2.5 Examples and Exercises 25

References 26

3 What Sort of Substances have to be Considered under REACH 27

3.1 Substance, Mixture and Article under REACH 27

3.2 Different Compositions 28

3.2.1 Mono-constituent Substance 28

3.2.2 Multi-constituent Substance 28

3.2.3 Substances of Unknown or Variable Composition, Complex Reaction Products or Biological Materials 29

3.3 Different Types of Use 29

3.3.1 Substance with End Use 29

3.3.2 Intermediate 30

3.4 Phase-In Substances 31

3.5 No-Longer Polymers 32

3.6 Non-Phase-In Substances 32

3.7 Substances that Already Have Been Notified 33

3.8 Overview on Official EC Numbers and not Official List Numbers 33

3.9 Exemptions from REACH 34

3.9.1 Non-isolated Intermediates 35

3.9.2 Substances Manufactured or Imported in Amounts below 1 t/a 35

3.9.3 Substances Mentioned in Annex IV 35

3.9.4 Substances Listed in Annex V 36

3.9.5 Substances in the Interest of Defense 36

3.9.6 Waste and Recovered Substances 37

3.9.7 Polymers 37

3.9.8 Re-imported Substances 39

3.9.9 Further Exemptions: Use in Medicinal Products or for Food and Feedingstuffs 39

3.9.10 Product and Process Orientated Research and Development 40

3.9.11 Substances Regarded as Being Registered 40

3.9.12 How to Cope with Situations in Which Parts of the Manufactured Amount are Falling under REACH and Another Part is Exempted 42

3.10 Check-List for Business Managers 43

3.11 Examples and Exercises 44

References 47

4 Obligation to Submit a Registration Dossier 49

4.1 Who has to Register? Who may Register? 49

4.2 Pre-registration and Late Pre-registration 53

4.3 When Does a Substance have to be Registered? 55

4.4 Special Rules for Non-EU Manufacturers 56

4.5 Consequences for Globally Acting Enterprises/What to Take into Account within a Decision-Making Process? 59

4.6 Examples and Exercises 59

References 60

5 Types of Registration 61

5.1 Standard Registration, Full Registration or Registration as a Substance 70

5.2 Registration as an On-site Isolated Intermediate 70

5.3 Registration as a Transported Isolated Intermediate 71

5.4 Formerly Notified Substances 80

5.5 PPORD 80

5.6 Examples and Exercises 80

References 81

6 Data Requirements and Dossier Preparation 83

6.1 Data Requirements 83

6.2 Dossier Preparation 84

6.2.1 PPORD 89

6.2.2 Inquiry Dossier 90

6.2.3 On-site Isolated Intermediate 91

6.2.4 Transported Isolated Intermediate 93

6.2.5 Standard Registration (Full Registration) 95

6.3 Some Useful Tips for Entering Data and Information in Certain Chapters in IUCLID5.4 98

6.3.1 IUCLID Section 1.2 98

6.3.2 IUCLID Section 1.3 99

6.3.3 IUCLID Section 1.4 100

6.3.4 IUCLID Section 1.7 101

6.3.5 IUCLID Section 2.3 101

6.3.6 IUCLID Section 3.1 102

6.3.7 IUCLID Chapter 11 102

6.3.8 IUCLID Chapter 13 103

6.4 Data Requirements, Type of Registration and Costs/Fees 103

6.5 Examples and Exercises 105

References 105

7 Claiming a Registration Number for Already Notified Substances 107

7.1 Formerly Notified Substances are Regarded as Registered under REACH 107

7.2 How to Claim the Registration Number Under REACH for a Formerly Notified Substance 108

7.3 When to Update a Registration Dossi

Kamptmann, Susanne
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.

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