COMPLYING WITH EU-REACH : WHAT INDUSTRIES SHOULD KNOW AND DO

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a new European Union (EU) regulation on chemicals and their safe use. Registration of chemical substances under REACH commenced on 1 December 2008. Pre-registration was a requirement in order to continue manufacturing and marketing of chemical substances in the European market. The European Chemicals Agency (ECHA) reported that a total of 2,212,129 chemical substances had been pre-registered in their database during the pre-registration period from 1 June to 1 December 2008. Only substances manufactured or imported for the first time of at least one tonne/year are allowed for registration after 1 December 2008.

In order to facilitate the registration ECHA has extended the dateline for registration as follows: 

30 November 2010 - Applies on carcinogens, mutagens and repro toxic (CMRs) substances imported into EU in quantities of one tonne per year or more;

31 May 2013 - all substances manufactured or imported in quantities of 100 tonnes per year or more

31 May 2018 - all substances manufactured or imported in quantities of one tonne per year or more.

Those who missed the pre-registration dateline may still register chemical substances subject to inquiries by ECHA.

REACH covers exports of:

• chemical substances (e.g. base chemicals, specialty chemicals)

• or mixtures (preparations) of chemical substances(e.g. cleaning products, formulated process chemical products(e.g. paints or motor oils)

• or substances or preparations in container (e.g. printer cartridges)

• articles which contain substances which are intentionally released during their use ( e.g. fragrance in a scented candle)

• or contain substances which are on the List of ‘Substances of Very High Concern' (SVHC) What is REACH?

• exemptions from registration include chemicals in food, medicine and natural substances provided that they are not dangerous and have not been chemically modified.

WHO SHOULD REGISTER?

The registration of chemical substances is the responsibility of EU importer or legal entity (or Only Representative) based in the EU. The Malaysian manufacturers/exporters do not and cannot register. However under the registration procedure, they are required to provide data and information for the EU importers and Only Representative.

WHAT CAN MALAYSIAN MANUFACTURERS/EXPORTERS DO?

• Identify and create an inventory of all substances or substances in preparations/articles that is exported or distributed in EU;

• Check if the substances or uses are exempted from one or all aspects of REACH; and

• Prepare data and information for EU importers or Only Representative.

WHAT INFORMATION IS REQUIRED FOR A REGISTRATION?

• Different information on technical dossier, chemical safety report and chemical safety assessment are required based on the level of hazards, use conditions and exposure in different volume bands.

• Technical Dossier:

  • Identity of manufacturer/importer

  • Identity of substance

  • Information on manufacture and use

  • Classification and labelling

  • Guidance on safe use

  • Substance properties

  • test proposal (if relevant)

  • Exposure information

• Chemical Safety Report (CSR):

• Hazards and PBT(Persistent, Bio accumulative and Toxic vPvB (very persistent and very bio accumulative assessment

• Chemical Safety Assessment (CSA):

  • Hazards and PBT(Persistent, Bio accumulative and Toxic vPvB (very persistent and very bio accumulative assessment

  • Exposure assessment

  • Risk characterisation

  • Exposure scenarios

WHERE CAN INDUSTRIES TURN FOR FURTHER INFORMATION?

• visit website of the European Chemicals Agency (ECHA) for information on the Regulation and study the guidance on relevant REACH obligation (http://ec.europa.eu/echa/)

• Malaysian helpdesk has been set-up at Chemical Industries Council Malaysia (CICM).