5 Statement of Compliance with Rigorous Control Print

In steps 2 through 4 you have compiled an inventory of your intermediates, reviewed and listed your company’s management systems and technical measures (including the corresponding documentation), and with reference to a set of key parameters, have assessed whether the systems in place for your manufacture and handling of intermediates match what might reasonably be required for RIGOROUS CONTROL under the circumstances of your company’s operation.  The most likely outcome of the assessment is that it will appear probable that some further management systems or technical measures, or documentation will be required to ensure that your systems provide for working under STRICTLY CONTROLLED CONDITIONS, and you will need to determine the time and cost requirements to do this.

For downstream users, you should be able to get help from your suppliers and to obtain help and advice to put appropriate systems in place if this is seen to be necessary.  As indicated earlier, the concept of closed systems may not work in practice for relatively small scale operations involved in batch processing, but it should be possible to devise a workable system which will provide the necessary worker protection, at an affordable cost.

For larger installations, involving more complicated operations, with more hazardous substances, it may be necessary to review and upgrade the plant layout and/or design of equipment, and/or amend actual process directions and instructions.  In all cases, it is recommended that changes, upgrades and modifications would be properly documented.  If on the basis of the above assessment, you are satisfied:

  • either, that the necessary management systems and technical controls are in place to provide for STRICTLY CONTROLLED CONDITIONS, or
  • that you will be able to do this within a reasonable space of time

You can proceed to prepare a formal statement setting out in writing, in the form of a risk assessment or otherwise, how your operation can be managed under  STRICTLY CONTROLLED CONDITIONS, as a justification for working with intermediates under the reduced burden of registration provided by Articles 17 and 18.

For the actual format or framework of the risk assessment or declaration it is recommended that you would use one of the models being developed by CEFIC or EFCG or the various national or European trade associations, and, as always, take expert advice as needed.


If you are not in a position to complete the declaration at this stage, you may want, following the preliminary assessment you have completed, to review what is needed, work out a programme of putting the various defined elements into place and then carry out the assessment again when this is completed.

If, having completed the assessment, you are not in a position to complete the declaration, and have determined that the cost of implementing suitable new procedures is not feasible for the particular operation, or product, even after taking expert advice from the sources indicated, you will need to discontinue that particular operation, and/or discontinue the use of that particular intermediate.

Last Updated ( Friday, 07 August 2009 )
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