Volume 2 of the CSL series (Consolidated Substances Legislation) presents the consolidated version of the REACH regulation (EC) No 1907/2006 (June 2012) with an introduction and future prospects regarding the area of Chemicals legislation.
Table of Contents
TITLE I GENERAL ISSUES
Chapter 1 Aim, scope and application
Chapter 2 Definitions and general provision
TITLE II REGISTRATION OF SUBSTANCES
Chapter 1 General obligation to register and information requirements
Chapter 2 Substances regarded as being registered
Chapter 3 Obligation to register and information requirements for certain types of isolated intermediates
Chapter 4 Common provisions for all registrations
Chapter 5 Transitional provisions applicable to phase-in substances and notified substances
TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
Chapter 1 Objectives and general rules
Chapter 2 Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
Chapter 3 Rules for phase-in-substances
TITLE IV INFORMATION IN THE SUPPLY CHAIN
TITLE V DOWNSTREAM USERS
TITLE VI EVALUATION
Chapter 1 Dossier evaluation
Chapter 2 Substance evaluation
Chapter 3 Evaluation of intermediates
Chapter 4 Common provisions
TITLE VII AUTHORISATION
Chapter 1 Authorisation requirement
Chapter 2 Granting of authorisations
Chapter 3 Authorisations in the supply chain
TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES AND M3 MIXTURES
Chapter 1 General issues
Chapter 2 Restrictions process
TITLE IX FEES AND CHARGES
TITLE X AGENCY
TITLE XII INFORMATION
TITLE XIII COMPETENT AUTHORITIES
TITLE XIV ENFORCEMENT
TITLE XV TRANSITIONAL AND FINAL PROVISIONS
Objectives and Research Scope
This consolidated regulation establishes a comprehensive legal framework for the registration, evaluation, authorisation, and restriction of chemicals within the European Union. Its primary objective is to ensure a high level of protection for human health and the environment while promoting the free circulation of substances on the internal market and encouraging the development of alternative hazard assessment methods.
- Establishing mandatory registration procedures for substances manufactured in or imported into the EU.
- Implementing evaluation, authorisation, and restriction mechanisms for chemicals of concern.
- Defining the roles and administrative responsibilities of the European Chemicals Agency (ECHA).
- Clarifying the obligations of manufacturers, importers, and downstream users regarding risk management.
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Introduction
In June 2007 the REACH regulation entered into force. Symbolized by its acronym it created the legal base for the most important mechanisms in chemicals legislation, registration, evaluation, authorisation and restriction of chemicals. Until mid 2012 these mechanisms led to the following results:
Registration
The obligation to register substances has been newly implemented with REACH. Therefore, nearly all substances which are produced in or imported into the European Union have to be registered at the European Chemicals Agency (ECHA), however “step-by-step”. Substances which are not registered are not marketable in Europe. In addition, for example, German law provides for the possibility to prosecute with a maximum penalty of two years prison, persons who are found responsible for production and distribution of substances unregistered contrary to duty. However, the legal consequences of breaches of the REACH regulation differ widely in different Member States.
Registration means the transmission of data about the effects of a certain substance on man and environment. Extent and details of the needed data are defined in the Annexes of the REACH regulation and depend on the production/import volume of a substance.
Summary of Chapters
TITLE I GENERAL ISSUES: Defines the scope and fundamental objectives of the REACH regulation, including application and general definitions.
TITLE II REGISTRATION OF SUBSTANCES: Sets out the mandatory requirements for manufacturers and importers to register substances based on their production volumes and specific thresholds.
TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING: Establishes rules to minimize animal testing through joint data submission and information exchange among registrants.
TITLE IV INFORMATION IN THE SUPPLY CHAIN: Details the requirements for communicating information, particularly through safety data sheets, throughout the supply chain.
TITLE V DOWNSTREAM USERS: Specifies the obligations for downstream users to conduct chemical safety assessments for uses not covered by suppliers.
TITLE VI EVALUATION: Outlines the processes for dossier and substance evaluation to ensure compliance and identify potential risks.
TITLE VII AUTHORISATION: Describes the strict procedure for authorising the use of substances of very high concern.
TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES AND M3 MIXTURES: Provides the process for imposing bans or specific conditions on dangerous substances.
TITLE IX FEES AND CHARGES: Explains the fee structure for registration and other agency services.
TITLE X AGENCY: Details the composition, powers, and governance structure of the European Chemicals Agency.
Keywords
REACH, Chemicals, Regulation, Registration, Evaluation, Authorisation, Restriction, ECHA, Chemical Safety Report, Substances, Mixtures, Downstream Users, Risk Management, Human Health, Environment
Frequently Asked Questions
What is the primary purpose of the REACH regulation?
The primary purpose is to ensure a high level of protection for human health and the environment, while enhancing the competitiveness of the EU chemical industry and promoting alternative methods for assessing substance hazards.
Which entities are primarily responsible for the obligations under REACH?
The responsibility lies primarily with manufacturers, importers, and downstream users who produce, import, or use chemical substances within the European Union.
What is the role of the European Chemicals Agency (ECHA) under this regulation?
ECHA acts as the central administrative and scientific entity, managing the technical, scientific, and administrative aspects of the regulation, including the registration and evaluation databases.
What is "Registration" in the context of this work?
Registration is the process by which manufacturers and importers provide the European Chemicals Agency with data on the substances they produce or import, demonstrating how the risks associated with these substances are managed.
What is the "Authorisation" procedure for?
Authorisation is designed to ensure that risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable, safer alternatives when economically and technically viable.
What does the "No data, no market" principle mean?
It means that substances manufactured in or imported into the European Union must be registered according to REACH requirements; without such registration, they are not permitted to be marketed.
How does the regulation address the protection of animal welfare?
The regulation emphasizes the need to avoid unnecessary testing on vertebrate animals by promoting data sharing, joint submission, and the use of alternative methodologies such as in vitro tests and (Q)SAR modeling.
What information must be included in a Safety Data Sheet?
A Safety Data Sheet must include information on the substance's identification, hazards, composition, first-aid measures, firefighting, accidental release, handling, storage, exposure controls, and physical/chemical properties.
- Quote paper
- Stefanie Merenyi (Author), 2012, REACH: Regulation (EC) No 1907/2006, Munich, GRIN Verlag, https://www.hausarbeiten.de/document/203248
