Intermediates for the APIs can be classified again under 2 main categories under REACH:

* Non-isolated intermediates
* Isolated intermediates
* On-site (non transported) isolated intermediates
* Transported isolated intermediates

A non-isolated intermediate is an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.

On-site isolated intermediate means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of another substance from that intermediate take place on the same site, operated by one or more legal entities.

A transported isolated intermediate is an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites.

Under REACH regulations, non-isolated intermediates are exempted from review process as non-isolated intermediates remain in the reaction process and are not isolated.

Most of Indian pharmaceutical companies exporting intermediates for APIs would fall under the perview of the "Isolated intermediates" category for which the companies will need to undergo review procedure under REACH regulations. the pharmaceutica intermediates

Relief under Strictly controlled conditions:

For both on-site and transported isolated intermediates, there is possibility to provide a reduced set of information for their registration under the following conditions:

* For on-site isolated intermediates, the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole life cycle.
* For transported isolated intermediates, the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of another substance from that intermediate takes place on other sites under strictly controlled conditions