The New EU Chemicals Legislation – REACH
On 29 October 2003 , the European Commission adopted a proposal for a new EU regulatory framework for chemicals, COM (2003) 644. Under the proposed new system called REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. The aims of the proposed new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production.
The proposal has been drafted in close consultation with all interested parties, including an Internet consultation. This has allowed the Commission to propose a streamlined and REACHt-effective system. The proposal is now being considered by the European Parliament and the Council of the EU for adoption under the so-called co-decision procedure.
The first reading in the European Parliament took place on 17 November 2005 (Provisional amendments (2005) 0434 and (2005) 0435). Following its political agreement on 13 December 2005 , the Council adopted its Common Position on 27 June 2006 (7524/06 and 7525/06). The Commission Communication stating the Commission opinion on the Common Position was adopted on 12 July 2006 (COM (2006) 375).
On 13 December 2006 the Parliament adopted in second reading the compromise package it agreed with the Council on 30 November. The Council adopted the final REACH text at the Environment Council on 18 December. REACH will enter into force on 1 June 2007 . The final text of the Regulation will be available shortly.
• Our REACH Registration Service:
We begin our REACH registration service in 2007.
Our advantages in the REACH Registration Service:
We have an expert team. They will work all along the procedure of the REACH registration, till our client obtains the REACH.
Our headquarters in France : Our Doctors of Pharmaceutics and senior experts will be in charge of the documents' examination, submission and tracing. They will also contact and discuss with the European officers directly.
Our Chengdu office: Our professional team is responsible to contact with Chinese factories and to compile the application files.
Laboratory center: we have established a laboratory in Sichuan University . Our experts of pharmaceutical analysis are in charge of the impurities experiments for REACH registration.
Audit team: we have a professional QA team; they make Third Party GMP Audit to the API manufacturers.
The quality of application files is ensured by our wealth of experience and our independent laboratory center; so the period of application is effectively shortened.
The procedure of our REACH registration service:
1) Establish the intension of cooperation with the API manufacturer; confirm the relationship of client-agent.
2) Provide an outline for compiling the application file to the client.
3) Introduce knowledge of REACH registration and information about GMP from ICH to the client.
4) The client offers original documents in Chinese and samples that will be used in experiments according to the outline for compiling the application file.
5) Examine whether the original document is good, guide the client to supply materials till the final Chinese version is accomplished.
6) Compile the English version of the application file.
7) According to the REACH' requirements and the speciality of our client, we will design a plan of experiments and then complete the experimentation.
8) Examine the final application file's quality with European experts and write a report of the application file's evaluation.
9) Formally submit the application.
10) Keep contact with EDQM, advance the process of registration.
11) Respond to EDQM's questions.
12) Acquirement of REACH.
The mode of our REACH registration service:
We are willing to establish a close relationship between the client and us, to offer special consulting service according the actual situation and our client's special requirements. At the same time, thanks to our advanced project management, every project has its own manager, who is in charge of the client relationship and the internal coordination, so as to serve clients rapidly and effectively.
1) Agent for REACH registration: the client totally entrust the REACH registration to us, he just needs to give us the original Chinese documents. We will accomplish the application file, take experiments, and examine documents, contact people, etc., till we get the REACH finally. This mode is propitious to control the progress of project, and to ensure that the client can get the REACH in the shortest period.
2) Consulting service of REACH registration: according to the client's request, we can provide consulting service by stages; provide the outline for compiling the application file and staff training; take experiments or guide the client to take experiments; compile the application file; provide the expert's report; submit the application and keep in contact with the committee of examination, etc.
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