Natural Complex Substances
Even if the 2018 – deadline has been passed, Natural Complex Substances (NCS) of which the most are covered by the 1-10 and the 10-100 t/a tonnage band, are still of great interest.
The most common NCS are:
- Essential oils
- Concretes and absolutes
- Oleoresins and Resinoids
- CO2 extracts
- Infusions and alcoholic extracts
Being botanical products, there are natural variations in the chemical compositions of NCS obtained from one unique genus and species. This is a consequence of:
- the region of growth
- the annual variations in climte within the region
- the part of the plant as source material
The methodologies for processing will also affect variations in chemical composition, e.g. drying, cutting, expression, extraction, distillation, fractionation, concentration, precipitation. Registration dossiers can still be submitted until further notice if the substance had been pre-registered until 31 May 2018. If no pre-registration no. exists, an inquiry needs to be submitted (Inquiry). In both cases special attention should be given to the chemical composition or the identification of the substance.
The exact designation of your substance composition also influences your obligation for Classification and Labelling according to Regulation (EC) No 1272/2008 (CLP). Depending on composition there are also different strategies for cost-optimized registrations (e.g. if your substance consists of well-characterized main components). For instance, sharing of data may avoid unnecessary and cost intensive animal experiments.
You want to submit a request dossier or a registration dossier, but you are not sure if your substance has been correctly identified?