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REACH Compliance: The Great Challenge for Globally Acting Enterprises

REACH Compliance: The Great Challenge for Globally Acting Enterprises

Susanne Kamptmann

ISBN: 978-3-527-66431-3

Oct 2013

304 pages

$106.99

Description

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.

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 Dossier of a Formerly Notified Substance and How to Do It 109

7.4 Examples and Exercises 109

References 110

8 Process for Registration of Non-Phase-In Substances 111

8.1 Inquiry Dossier 112

8.2 Preparation of the Registration Dossier 113

8.2.1 Registration as Member of Joint Submission 115

8.2.2 Registration within a Joint Submission in Cooperation with Other Potential Registrant(s) 115

8.2.3 Single Submission 116

8.3 Difficulties and Problems that can Arise in the Context of the Registration of Non-Phase-In Substances 117

8.4 Examples and Exercises 118

References 119

9 Process for Registration of Phase-In Substances 121

9.1 Preparing for Pre-registration and Late Pre-registration 121

9.2 Communication within Pre-SIEF 124

9.2.1 Data Holders 125

9.2.2 Third Party Representatives 126

9.2.3 Potential Registrants 126

9.2.4 Duties and Rights of the Different SIEF Participants 126

9.3 Formation of SIEF 127

9.3.1 Substance Sameness and Substance Identification Profile (SIP) 130

9.3.2 Lead Registrant Agreement 131

9.3.3 Lead Registrant Notification 134

9.4 Cooperation within the SIEF 134

9.4.1 Obligations of SIEF Participants 135

9.5 Data Sharing 135

9.5.1 Consortium Agreement 137

9.5.2 Cooperation Agreement 137

9.5.3 SIEF Agreement 137

9.5.4 Letter of Access 137

9.6 Data Sharing Disputes 140

9.7 Opt-Out 142

9.8 Registration Dossier of the Lead Company and Registration Dossiers of the Members of Joint Submission 144

9.9 Overview on Important Steps within the Process for Registration of Phase-In Substances 145

9.10 Examples and Exercises 145

References 146

10 What Happens after Submission of Your Registration Dossier to ECHA? 147

10.1 Initial Verification 147

10.2 Overall Completeness Check 149

10.3 Receiving the Reference Number 150

10.4 End of Pipeline Activities 150

10.5 Dossier and Substance Evaluation 152

10.5.1 Examination of Testing Proposals 152

10.5.2 Compliance Check of Registration 153

10.5.3 Substance Evaluation 154

10.5.4 On-site Isolated Intermediates are not the Object of Evaluation 155

10.6 Further Obligations of the Registrant and Downstream Users 155

10.6.1 Safety Data Sheets and extended Safety Data Sheets 155

10.6.2 Documentation of Correspondence with Customers Purchasing Transported Isolated Intermediates 157

10.6.3 Substance Volume Tracking 157

10.6.4 Obligation to Update Information 158

10.6.5 Obligations of Downstream Users 158

10.7 Examples and Exercises 159

References 160

11 Update of the Registration Dossier 163

11.1 When to Update Your Registration Dossier 163

11.2 Requested Updates 164

11.2.1 Update Requested Because of Missing Information 164

11.2.2 Updates Requested as a Result of Dossier Evaluation 165

11.3 Spontaneous Updates 166

11.3.1 Update Because of Change in Status or Identity of the Registrant 167

11.3.2 Update Because of Change in the Composition of the Substance 168

11.3.3 Update Because of Change of Tonnage Band 169

11.3.4 Update Because of New Identified Uses 169

11.3.5 Update Because of New Knowledge of the Risks of the Substance 170

11.3.6 Update Because of Any Change in Classification and Labeling 170

11.3.7 Update Because of an Amendment in the Chemical Safety Report 171

11.3.8 Update Because of the Need to Perform Further Tests 171

11.3.9 Update Because of a Change in the Access Granted to Information in the Registration 171

11.4 Update of Dossiers of Formerly Notifi ed Substances 172

11.4.1 Update Because of Tonnage Band Increase for Former Notified Substances 172

11.4.2 Other Updates for Former Notified Substances 173

11.4.3 Confidentiality Claims that were Previously Done in the Notification 173

11.5 Update of Dossiers for PPORD Notifications 174

11.6 Costs Concerning Updates 175

11.7 Examples and Exercises 176

References 178

12 Substances of Very High Concern and Authorization Process 181

12.1 Uses that are Exempted from Authorization 181

12.2 Substances of Very High Concern (SVHC) 182

12.3 Substance Identification and Identification Procedure 184

12.3.1 Identification Procedure 185

12.3.2 Content of an Annex XV Dossier 185

12.4 Inclusion of a Substance in the Candidate List of Substances of Very High Concern (SVHC) 187

12.5 Prioritization and Inclusion of Certain SVHCs in Annex XIV 188

12.6 Information in Annex XIV 188

12.7 Restrictions and Information in Annex XVII 189

12.8 Application for Authorization 190

12.8.1 Main Elements of an Application for Authorization 191

12.9 Data Requirements and Documents Needed for an Application for Authorization 196

12.9.1 Substance Identity and Composition Concerning IUCLID Sections 1.1 and 1.2 197

12.9.2 Identifiers to be Entered in IUCLID Section 1.3 198

12.9.3 Identification of the “Uses Applied for” Concerning IUCLID Section 3.5 198

12.9.4 Assessment Reports Concerning IUCLID Chapter 13 199

12.9.5 Information to be Provided in the Dossier Header 199

12.10 Submission of the Application of Authorization, Deadlines and Fees 200

12.11 Subsequent Applicants and Their Obligations 201

12.12 Process after Submission of the Application for Authorization 201

12.13 Examples and Exercises 203

References 204

13 Achieving REACH Compliance within Your Company – How to Implement Processes to Ensure Legal Compliance 207

13.1 List of Used Raw Materials 207

13.1.1 Define Your Role under REACH 208

13.1.2 Define the Registration Deadline Based on Properties 211

13.1.3 Identify Uses of a Certain Substance within Your Company 211

13.1.4 List of Raw Materials when Our Company is a Downstream User 214

13.1.5 Process after Receiving a SDS or an eSDS from Your Supplier 216

13.2 List of Substances that are Manufactured in Your Company 217

13.2.1 Identification of Registration Obligations 218

13.2.2 Define the Registration Deadline for Substances Manufactured within Your Company Based on Their Properties and Consider Consequences if a Substance is Included in the SVHC Candidate List 218

13.2.3 Uses at the Company’s Own Site and Identified Uses of the Customers 221

13.3 Documentation Concerning Manufacturing Process of OIIs and TIIs and Documentation of the Correct Use of TIIs by Customers 224

13.3.1 In-house Documentation 224

13.3.2 Confirmation from Downstream Users Concerning Art. 18(4) and Further Exemptions 224

13.4 Substance Volume Tracking 225

13.4.1 Substance Volume Tracking for EU Manufacturer 225

13.4.2 Substance Volume Tracking for a Non-EU Manufacturer 225

13.5 Examples and Exercises 228

References 228

14 Communication in the Supply Chain 229

14.1 Communication Obligations According to the REACH Regulation 229

14.2 Communication to be Done by Suppliers 231

14.2.1 Communication from Supplier to EU Customers 231

14.2.2 Communication from Supplier to Non-EU Customers 232

14.2.3 Information for Workers 233

14.2.4 Communication with Upstream Supplier 234

14.2.5 Communication with Authorities 234

14.2.6 Further Communication Obligations for Suppliers in the Context of Authorisation 235

14.3 Communication to be Done by Non-EU Manufacturers 235

14.3.1 Communication from Non-EU Manufacturer to his Only Representative 236

14.3.2 Communication from Non-EU Manufacturer to EU Customer 236

14.3.3 Communication from Non-EU Manufacturer to Non-EU Customers 236

14.3.4 Communication from Non-EU Manufacturers to Their Suppliers 241

14.4 Communication to be Done by Non-EU Distributors or Non-EU Traders 243

14.4.1 Communication with EU Customers 244

14.4.2 Communication with Non-EU Manufacturers 245

14.4.3 Communication with Only Representative Acting on behalf of a Non-EU Manufacturer (Supplier) 246

14.5 Communication to be Done by a Downstream User or a Downstream Supplier 247

14.5.1 Communication with Suppliers 247

14.5.2 Communication with Only Representative of Non-EU Manufacturer 248

14.5.3 Communication with Customers (Downstream Users) 248

14.5.4 Communication from Downstream User with Workers 249

14.5.5 Communication from Downstream User to Authorities 249

14.6 Communication to be Done by an Only Representative 249

14.6.1 Communication with Non-EU Manufacturer 250

14.6.2 Communication with ECHA and National Authorities 250

14.6.3 Communication with Customers of the Non-EU Manufacturer 250

14.7 Examples and Exercises 253

References 254

Appendix – Answers and Solutions Concerning the Sections Examples and Exercises within this Book 255

Index 281