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EU REACH Regulation

REACH is the regulation for Registration, Evaluation, Authorization (and Restriction) of Chemicals.

The regulation places greater responsibility on the industry to manage the risks chemicals may pose to health and the environment.

The main aims of REACH are to:

  • Improve the protection of human health and the environment from the risks that can be posed by chemicals
  • Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU
  • Promote alternative methods for the assessment of hazards of substances
  • Ensure the free circulation of substances on the internal market of the European Union

Who does it apply to?

REACH applies to substances manufactured in, or imported into the EU in annual quantities of 1 ton or more.

What is required of me?

REACH gives requirements for substances themselves, in preparations, or intended to be released from an article. These substances may be required to be registered, notified, authorized, subject to classification and labeling, subject to restrictions, or a combination of the above. It can be difficult and complex to determine where the substances you deal with fall under REACH.

Registration

Most of the substances that fall under REACH are subject to registration. Registration of these substances includes submitting a vast technical dossier with information on the substance and its uses to the European Chemicals Agency (ECHA). Click here for further information on articles under REACH.

REACH Process for Non Phase-In Substances

Non Phase-In substances can be broadly defined as the "new" substances which have not been manufactured, placed on the market or used in the EU before 1 June 2008.

They include all substances that do not meet the definition of phase-in substance as given in the Regulation.

Non phase-in substances that are manufactured or imported in quantities of 1 tonne or more per year, will have to be registered by the company before the start of its activities involving these substances.

  • Inquiry

The inquiry process is essentially a three-step process whereby:

  • The potential registrant must inquire with ECHA prior to registration if the same substance has already been registered;
  • ECHA facilitates contact between the previous registrant(s) and the potential registrant(s) and/or other Potential Registrants, if any;
  • Data sharing is organized between previous registrant(s) and/or Potential Registrants including for new tests to be potentially conducted

One of the main differences with the rules for phase-in substances is the early involvement of ECHA and its role in determining substance equivalence before facilitating contacts between registrants.

  • SIEF Participation (if required)

Substance Information Exchange Forum (SIEF) will be formed for different companies who have the same substances and the same uses. This includes a joint submission of data, allowing groups to work together to find the required information on the substances and will lessen the amount of testing on vertebrate animals.

  • Registration

The actual registration dates for substances will vary from 2010-2018 depending on the quantity and risks of the substance.

First the large volume substances and the substances known to be of ‘very high concern’ will need to be registered by 2010. Lower volume substances will follow later. By 2018 all substances will have been registered.

Phase In Substances

Many manufacturers and importers are currently circulating substances which are required to comply with REACH. These substances are referred to as "Phase In" substances, or "existing substances." REACH provides a transition regime for these substances to comply with the regulation.

Not sure if you need to comply? Contact us