Along with the physico-chemical, toxicological and eco-toxicological data, it is necessary to record all of the findings from the tests. An assessment then has to be completed, that may include a toxicokinetic study, and the results interpreted to identify any hazardous effects.

After the data assessment has been completed all of the information has to be entered into a Safety Data Sheet (SDS) which consists of 16 separate sections. Each of these sections contains specific information or instructions for safe use of the chemical such as the full chemical name, CAS-No, fire fighting, handling and transportation considerations. Along with the general information are the proposed Risk and Safety phrases that will enable people handling the chemicals to have a good understanding of its hazards.

If a substance is newly manufactured or imported into the EU then all the information has to be entered into a dossier for submission to a Competent Authority (CA). Along with the paperwork it is often necessary to discuss with the CA any findings from the assessments and whether it is anticipated that further testing may be required.

The amount of information required for the dossier will depend upon the anticipated level of manufacture of the product, from Level VIIC with an annual quantity of > 10 kg, through Level VIIA (often referred to as the Base Set level) to Level 2 with annual quantities > 1000 tonnes.

Finally, the newly registered substance is entered onto the European List of Notified (New) Chemical Substances (ELINCS).

Documentation

C3-B is an informal collaboration between AstraZeneca UK Limited (Brixham Environmental Laboratory), Chilworth Technology Limited, Centre de Recherches Biologiques (CERB) and Chemsafe S.a.S. No legal relationship exists between the aforementioned entities and none of them has the authority to contract on behalf of any other of the entities.