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Pharma intermediates Overview on Light Registration procedure after last deadline

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ANTONIO CONTO
Chemsafe, Colleretto Giacosa (TO), Italy

The “so called” intermediate substances are defined in Regulation EC 1907/2006 in three main categories as for Art. 17 and 18 of the legal text.

  • Non isolated intermediate: during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis take place (vessels, ancillary equipment, pipelines, etc). Tanks of other vessels used for storage are excluded. They are not subjected to registration as for Reach Title II.
  • on site isolated: manufactured and used in the same site not responding to the definition of non isolate
  • transported isolated: transported between or supplied to other site

The intermediate substances, mainly, but not only, used in the synthesis of pharmaceutical API (Active Principle Ingredient) can be registered with a “light registration” procedure if they meet the following two conditions:

  1. They are soon transformed in another substance during a synthetic process
  2. They are handled under Strict Controlled Condition (SCC) of Use 

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