Kamptmann, S: REACH Compliance - Great Challenge

1. Auflage 2013
ISBN: 978-3-527-33316-5
Verlag: Wiley VCH Verlag GmbH

Buch, Englisch, 304 Seiten, Format (B × H): 164 mm x 247 mm, Gewicht: 802 g

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.

Autoren/Hrsg.

Kamptmann, Susanne

Weitere Mitwirkende

Backmann, Jan

Fachgebiete

• Wirtschaftswissenschaften Betriebswirtschaft Management Compliance
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Verfahrenstechnik, Chemieingenieurwesen
• Naturwissenschaften Chemie Chemie Allgemein Toxikologie, Gefahrstoffe, Sicherheit in der Chemie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Chemische Industrie
• Naturwissenschaften Chemie Analytische Chemie Umweltchemie, Lebensmittelchemie
• Rechtswissenschaften Internationales Recht und Europarecht Europarecht Europäisches Verwaltungs-, Umwelt- und Gesundheitsrecht

Inhaltsverzeichnis

PrefaceINTRODUCTIONHistoryThe REACH Regulation - A Short Overview on the Table of ContentsPurpose and Scope of REACHOther Regulations and Directives that are Important in the Context of REACHROLES UNDER REACHManufacturer within the EUNon-EU Manufacturer, Importer and Only RepresentativeDownstream UserTrader within EU versus Non-EU Trader and DistributerExamples and ExercisesWHAT SORT OF SUBSTANCES HAVE TO BE CONSIDERED UNDER REACHSubstance, Mixture and Article under REACHDifferent CompositionsDifferent Types of UsePhase-In SubstancesNo-Longer PolymersNon-Phase-In SubstancesSubstances that Already Have Been NotifiedOverview on Official EC Numbers and not Official List NumbersExemptions from REACHCheck-List for Business ManagersExamples and ExercisesOBLIGATION TO SUBMIT A REGISTRATION DOSSIERWho has to Register? Who may Register?Pre-registration and Late Pre-registrationWhen Does a Substance have to be Registered?Special Rules for Non-EU ManufacturersConsequences for Globally Acting Enterprises/What to Take into Account within a Decision-Making Process?Examples and ExercisesTYPES OF REGISTRATIONStandard Registration, Full Registration or Registration as a SubstanceRegistration as an On-site Isolated IntermediateRegistration a Transported Isolated IntermediateFormerly Notified SubstancesPPORDExamples and ExercisesDATA REQUIREMENTS AND DOSSIER PREPARATIONData RequirementsDossier PreparationSome Useful Tips for Entering Data and Information in Certain Chapters in IUCLID5.4Data Requirements, Type of Registration and Costs/FeesExamples and ExercisesCLAIMING A REGISTRATION NUMBER FOR ALREADY NOTIFIED SUBSTANCESFormerly Notified Substances are Regarded as Registered Under REACHHow to Claim the Registration Number Under REACH for a Formerly Notified SubstanceWhen to Update a Registration Dossier of a Formerly Notified Substance and How to Do itExamples and ExercisesPROCESS FOR REGISTRATION OF NON-PHASE-IN SUBSTANCESInquiry DossierPreparation of the Registration DossierDifficulties and Problems that can Arise in the Context of the Registration of Non-Phase-In SubstancesExamples and ExercisesPROCESS FOR REGISTRATION OF PHASE-IN SUBSTANCESPreparing for Pre-registration and Late Pre-registrationCommunication within Pre-SIEFFormation of SIEFCooperation within the SIEFData SharingData Sharing DisputesOpt-OutRegistration Dossier of the Lead Company and Registration Dossiers of the Members of Joint SubmissionOverview on Important Steps within the Process of Registration of Phase-In SubstancesExamples and ExercisesWHAT HAPPENS AFTER SUBMISSION OF YOUR REGISTRATION DOSSIER TO ECHAInitial VerificationOverall Completeness CheckReceiving the Reference NumberEnd of Pipeline ActivitiesDossier and Substance EvaluationFurther Obligations of the Registrant and Downstream UsersExamples and ExercisesUPDATE OF THE REGISTRATION DOSSIERWhen to Update Your Registration DossierRequested UpdatesSpontaneous UpdatesUpdate of Dossiers of Formerly Notified SubstancesUpdate of Dossiers or PPORD NotificationsCosts Concerning UpdatesExamples and ExercisesSUBSTANCES OF VERY HIGH CONCERN AND AUTHORIZATION PROCESSUses that are Exempted from AuthorizationSubstances of Very High Concern (SVHC)Substance Identification and Identification ProcedureInclusion of a Substance in the Candidate List of Substances of Very High Concern (SVHC)Prioritization and Inclusion of Certain SVHCs in Annex XIVInformation in Annex XIVRestrictions and Information in Annex XVIIApplication for AuthorizationData Requirements and Documents Needed for an Application for AuthorizationSubmission of the Application of Authorization, Deadlines and FeesSubsequent Applicants and Their ObligationsProcess after Submission of the Application for AuthorizationExamples and ExercisesACHIEVING REACH COMPLIANCE WITHIN YOUR COMPANY - HOW TO IMPLEMENT PROCESSES TO ENSURE LEGAL COMPLIANCEList of Used Raw Materia

Über Autor(innen)

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.