(EC) REACH – Non-Phase-In Substances -- MEDICA - World Forum for Medicine


GiDoS s.p.r.l

(EC) REACH – 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.

Process for Non-Phase-In Substances


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.


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

It is vital to your company to appoint an Only Representative for this process (for both EU and non-EU manufacturers).

Contact us for more information (kasia@gidos) or visit our website: www.gidos.net

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