REACH24H Consulting Group

杭州华测瑞欧科技有限公司 www.keyllico.com Value in Compliance

EU REACH

Overview

EU REACH is a European Community Regulation on chemicals and their safe use. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.

The EU REACH regulation set out an approach for the control of manufacture, import and use of chemicals in the EU, and entered into force on 1 Jun 2007. EU REACH introduced an obligation to send a registration, to the European Chemicals Agency (ECHA) for chemical substances on their own or in mixtures, which are manufactured in or imported into the EU in quantities of at or above 1 t/a by any company in the EU. The obligation applies in certain cases also to substances in articles. Failure to register will mean for a company that it is no longer allowed to manufacture the substance in or import it into the EU.

A full copy of REACH Regulation (EC) No 1907/2006 can be found here.

The core contents under EU REACH can summarized as follows:

? Four Obligations:

Registration, Evaluation, Notification/Authorisation, and Restriction

? Three Chemical Objects:

Substances (phase-in substance and non-phase-in substance), Mixture, Article

? Four Major Roles:

EU Manufacturers, EU Importers, the Only Representatives, Downstream Users

? Two Administrative Tools:

REACH-IT for information communication, IUCLID for creating dossier

Applicable Scope

Registration shall apply to any of the following conditions under EU REACH:

? Substance as such, Manufacture / Importation > 1 t/a;

? Substance in a mixture, Manufacture / Importation > 1 t/a;

? Substance intended to release in an article, Manufacture / Importation above a concentration of 0.1% (w/w) & > 1 t/a ;

Note: The release of a substance from an article is deliberately planned and has a specific function in the use of the article. This is frequently not the main but an accessory function of the object, such as air freshener.

Registration Bodies

? Manufacturers and importers of substances, mixtures, article in EU;

? Non-EU companies can export to the European Union through two different routes under REACH: either via an importer who has registered the substance, or by appointing an Only Representative (OR).

Registration Types

EU REACH covers different types of registrations: standard registration (Article 10) and intermediate registration (Article 17 and 18).

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Other Obligations under EU REACH

If a given substance constitutes a risk to human health or the environment, ECHA and the Member States will evaluate the information submitted by companies, and even include the substance in the Authorisation List or Restriction List. Manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation. Restrictions may limit or ban the manufacture, placing on the market or use of a substance.

How to Comply with EU REACH?

??Set up branch offices in the EU:

Non-EU manufacturers shall comply with the time consuming and complicated process under REACH regulation with high costs.

??Entrust local importers to comply with EU REACH:

Non-EU manufacturers have to consider the situation that communication of information needed by the importers would require the disclosure of confidential business information.

??Appoint an Only Representative (OR):

Non-EU manufacturers can prevent their valuable substance information from being disclosed to the public and their importers in EU while appointing an OR.

Our Services

? Late Pre-registration Service

? Registration Service

? Only Representative (OR) Service

? OR Exchange Service

? Third Party Technical Support Service

? SIEF Management

? Exposure Scenario (ES) Development

? Chemical Safety Assessment Service

? Chemical Safety Report (CSR) Preparation

? Extended Safety Data Sheet (eSDS) Preparation

? Compliance Check of QualiFIed Suppliers

? REACH Supply Chain Compliance System-NEWRSCC

? SVHC Notification Service

? Authorisation Application

? REACH Training Service

? HSA Inspection Assistance

? Consortium Supporting Service

Our Strength

Company Capabilities

? Proven to be the largest consulting firm of EU REACH in China

? Acquisition of the first pre-registration number in China

? Acquisition of the first registration number in China

? First Conducting Lead Registration Project Team in China

Technical Strength

? Experienced Expert Teams Over 130 professionals with extensive academic and practical experience in the field of chemistry, toxicology and eco-toxicology

? Excellent Project Management, Extensive Experience ·

? Strict CBI Protection Mechanism

? Close Collaboration with Certified Test Facilities

? Good Communication with ECHA, the Member States

Achievements ·

? The sole strategic partner with PetroChina - Fortune Global 500 in compliance of EU REACH

? The designated strategic partner with several associations in compliance of EU REACH

? Strict Quality Control System: 100% Passing Rate for all Types of Registration

? 5000+ EU REACH Registration

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