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THE PHARMA REVIEW (MAY - JUNE 2012)

REACH Regulation: Need of the Hour

Pradnya Palekar Shanbhag, Sneha V. Jog, Sujata A. Bagal, Manasi M. Chogale

Abstract: REACH stands for Regulation, Evaluation, Authorization and Restriction on chemicals. The basic principle of Regulation is that the industry is responsible for ensuring that the substances contained in cosmeceuticals do not adversely affect human health or environment. The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki.
 
Introduction
REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances. Both raw materials and finished cosmetics products are impacted by REACH. Most of cosmeceutical products belong to chemical preparations (mixtures) under REACH regulation and each chemical substance or ingredient shall be (pre) registered with the European Chemical Agency (ECHA) if the annual tonnage of the substance exceeds 1 tonne.
Its main requirements for chemicals are as follows:
Registration or pre-registration.
Evaluation of substances and of registration dossiers.
Authorization of specific uses for substances of very high concern.
Restriction of other substances of concern.
Communication within the supply chain and to the public.2
 

 

 

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