REACH Compliance E-Book

Susanne Kamptmann

• Herausgeber: Wiley-VCH
• Kategorie: Wissenschaft und neue Technologien
• Sprache: Englisch

Seitenzahl: 459

Veröffentlichungsjahr: 2013

Beschreibung

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.

Leseprobe

Table of Contents

Related Titles

Title page

Copyright page

Foreword

Preface

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

Chapter 2

Chapter 3

Chapter 4

Chapter 5

Chapter 6

Chapter 7

Chapter 8

Chapter 9

Chapter 10

Chapter 11

Chapter 12

Chapter 13

Chapter 14

Index

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The Author

Dr. Susanne Kamptmann

Am Weiheracker 5

79585 Steinen

Germany

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Foreword

Considering the political and economic challenges the European Union is presently facing, one might wonder, how it came to pass, but REACH is one of the largest legislative projects of the union ever.

Obviously, the driving force behind this has been the widespread deep concern about chemical substances in the environment, in food, in articles of daily use, in cosmetics, in detergents, in toys and at the workplace. In the past, the European continent has indeed experienced the destructive consequences of frivolous or even grossly negligent if not criminal exposure to chemicals. The author of these lines experienced in his childhood whitecaps in horribly looking and smelling rivers as everyday occurrences. Furthermore, serious environmental and health disasters have happened. Since those days, much has changed for the better. The quality of the environment has improved to a degree that some of the once most-polluted rivers are now used as bathing waters. This happened as a result of a combination of a number of causes: societal pressure, that led to new laws and governmental institutions, technological improvements, the achieved prosperity, changing mentality and priorities, a relocation of manufacturing to other parts of the world and the deindustrialization of entire regions of Europe.

It is a great challenge for the lawmaker to find the right balance between further improving the protection of health and the environment on the one hand and stifling economic growth by creating bureaucratic monsters on the other. From my point of view, the legislator has not always succeeded.

Today's legislation and in particular REACH are not just a couple of clear-cut commands and interdictions to be obeyed. As I am writing these lines, the consolidated version of REACH, which was last updated in September 2012, comprises 516 pages including the annexes. At the same time, even some single paragraphs of Article 3 on definitions, which one should think is the simpler part of the legislation, have become subject to lengthy opposed legal opinions or even to lawsuits. Moreover, the legislation deals with an extremely complicated and diverse subject matter: substances, mixtures and articles. Already, the universe of chemical substances that ranges from inorganic compounds, which already in themselves form a large kingdom, to the empire of organic compounds, to gases, to the many metals, which are used by mankind. A large variety of human activities are in the scope of the legislation, ranging from domestic everyday activities and pastimes, to artisanal small trade, to commerce, to large-scale industrial manufacturing. What makes it even trickier is that very often there is sometimes not just one solution, which is compliant, but there might be a specific solution that is the best in a particular situation.

Moreover, to make it even more difficult, REACH forces the different commercial actors to interact or even to collaborate with each other either within the supply chain or horizontally between competitors. This fact introduces confidentiality issues, supplementary economic considerations and potential problems related to antitrust legislation. And all of a sudden, the personnel responsible for the compliance with REACH are confronted with complicated legal aspects or with “exotic” topics like social-economic analysis. At the same time, complex scientific and technical problems need to be resolved in the field of toxicological and ecotoxicological testing and risk assessment.

There is hardly anybody within the concerned industries who has not heard about REACH. Even outside Europe, where REACH triggered numerous regulatory initiatives around the world, REACH has become almost a generic word for chemical legislation. Sometimes, I am asked the question when will REACH eventually be over. The clear answer is: no end is scheduled. REACH is designed to evolve on and on.

It is recommended that beginners to this field receive a well-structured introduction. Before one can get involved with the above-mentioned complicated, high-level problems, a novice needs a sound understanding of the basic craft. Without having understood the detail, it is difficult to competently deal with the subject. Therefore, I recommend starting your career as a regulatory expert here, with the next page.

Jan Backmann

Head Chemical Legislation

F.Hoffmann-La Roche Ltd

Basel, October 2013

Preface

Globally acting enterprises have to face the fact that it is not enough just to offer products of good quality, but they sell directly or indirectly a large number of additional services, for example, packaging, transportation, clearance and sometimes also taking back (parts of the) product and treatment as waste.

In almost every state of the world there are laws, directives and regulations concerning different aspects that all have to be considered to be in legal compliance when dealing with chemical substances. As customers expect their suppliers to take care of all necessary actions to achieve legal compliance it is a necessary capital investment when having the aim to ensure that business will go on in the future.

For every chemical company, especially in the case of globally acting enterprises, this is a great challenge. Ensuring legal compliance is a time-consuming and also costly process. There is a need for well-trained personnel in the Regulatory Affairs Department that know what to do to achieve legal compliance and how to do it in time, but the decision-makers (Chief Executive Officers, Business Managers, Project Managers among others) have to be aware of the most important aspects of certain regulations to be in the position to make good business decisions. They have to estimate the costs for the achievement of legal compliance and take them into account when they offer the product and they have to be aware of the risks that accompany with the decisions they make.

A lot of detailed information has to be considered to make the right decisions. In industry, economic aspects are as important as legal compliance and the idea to prevent humans and environment from any harm.

As the REACH regulation and its effects on different parts of globally acting enterprises is of high complexity, it is important that decision makers understand the basics of REACH to develop more than one option how to achieve REACH compliance in their company. In a decision-making process different options can be evaluated to find advantages and disadvantages of each option.

It is the aim of this book to show the fundamental aspects of REACH in only a few pages to decision makers that may read the book either from the beginning to the end or via several chapters as they never will have the time and patience to study all the boring legal documents, but are interested in minimizing the risks of making the wrong decisions concerning REACH matters.

At the end of every chapter there are given some examples and also exercises that help to think through and understand in more depth certain aspects. It may be that there is, as in real life, more than only one solution to achieve the desired REACH compliance.

Hopefully, the case studies will encourage the readers to look for more than one option to solve the problems that arise in their own companies and afterwards to evaluate the perfect solution for their special case.

I am sure it will be rewarded at a later stage with saving time and costs for your company and you will additionally have the good feeling that you made your job at least a little bit better than you would have done without turning over the leaves of this book.

However, please be aware that the content of this book is based on my best knowledge, but as regulations and laws are living documents they can be amended or the meaning could be changed. Therefore, whenever in doubt, please check the latest version of the mentioned documents provided by the authorities or ask a competent lawyer. I am not in the position to undertake responsibility for any of your business decisions.

Dr. Susanne Kamptmann

Steinen

October 2013

1

Introduction

REACH or REACh is the widespread and well-known abbreviation for a Euro­­pean regulation that is entitled “Regulation (EC) No 1907/2006 of the European Parliament and of the Council” [1]. This regulation entered into force on 18 December 2006.

The single letters of the word REACH go back on the subtitle of this regulation [1] that tells us something about the content of this piece of legislation – Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) [1].

1.1 History

The concept to notify substances is not completely new. Before REACH entered into force European manufacturers or importers of new substances were obliged to notify these substances with the national authorities when they intended to produce or import a new substance in amounts of 10 kg/year or more. This was demanded by the predecessor(s) of REACH [1], whereas in Directive 67/548/EEC [2] also classification, packaging and labeling of dangerous substances was regulated. Directive 67/548/EEC [2] was repealed by the Regulation (EC) No 1272/2008. The former notified new substances are called NONS (notified new substances).

Already well-known substances that had been marketed before 1981 and therefore were listed in the EINECS [3] were not considered at all.

In the past there had been national laws and rules concerning the handling of chemical compounds. EU enterprises doing business with other companies in different countries had to struggle with a jungle of not clearly arranged rules in their daily business. It was hardly possible to follow up all amendments of the different laws being in force in different countries.

Therefore, it was an aim to harmonize the laws in the member states of the European Union. As a starting point the European Commission in Brussels made directives. Every directive had to be converted into national law(s) by all member states.

Very often this resulted in smaller or greater discrepancies between certain member states, because the directive was transformed in a slightly different way into national laws. In some cases it was necessary to amend existing national laws, because European right has a higher priority than already existing laws in a member state.

The situation is completely different with REACH as it is a European regulation. Therefore, REACH is directly valid in the whole European Economic Area (EEA), consisting of the member states of the European Union plus Norway, Iceland and Liechtenstein (see ) without any necessity to transform it into national law.