REACH Testing

What Is REACH?

REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals – is the EU regulation requiring registration, evaluation and authorisation of all chemicals placed on the EU market, together with safety monitoring. It entered into force on 1 June 2007 and is administered by the European Chemicals Agency.

The regulation raised the quality requirements and entry thresholds for products from all countries and regions entering the EU market, with far-reaching effects on export trade in chemical-related industries.

Background

The EU is the world’s leading region for chemical imports and exports. In 2006, EU chemical imports and exports accounted for 55.3% and 46.0% of the global total respectively. Since 1967 the European Community had adopted a series of regulations that were inefficient and overlapping. The EU therefore consolidated more than 40 chemical regulations into an 849-page regulation, supported by thousands of pages of technical guidance. It was adopted on 18 December 2006, entered into force on 1 June 2007 and became applicable on 1 June 2008.

REACH aims to protect human health and the environment, maintain and enhance the competitiveness of the EU chemical industry, increase transparency and consumer awareness, promote alternatives to animal testing and remain consistent with the EU’s international obligations under the WTO.

Content

Registration

Registration is the main obligation under the regulation. The registrant must be a legal entity established in the EU. After successfully submitting a registration dossier for a substance to the European Chemicals Agency (ECHA), the company receives an 18-digit registration number. Companies that fail to register by the relevant deadline may not continue to place the products concerned on the EU market.

Depending on whether a substance is on the EU’s existing chemicals inventory, registrations are divided into phase-in substance registrations and new substance registrations.

Evaluation

Evaluation is carried out by the Agency and comprises dossier evaluation and substance evaluation. According to EU estimates, about 27,000 chemical companies and about 30,000 substances are affected by REACH.

Authorisation

For substances included in Annex XIV of REACH, the regulation establishes an authorisation system for their use and placing on the market, carried out in two steps.

Restriction 

Provides a procedure for controlling, conditionally restricting or banning the placing on the market or use of hazardous substances by manufacturers and importers – for example the ban on asbestos and restrictions on certain azo dyes.

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