Miscellaneous regulatory regimes enforce submission of notification dossiers before new chemicals can be placed on the market, similar to REACH registration obligation. But, whereas classification & labeling criteria are moving towards global harmonization through GHS, the information requirements of the ten existing schemes vary considerably in terms of the data to be supplied and the risk assessment. Doing business on global markets remains challenging and delay or disruption of market access is a potential, but realistic risk.
Therefore, careful planning of new chemicals notifications is of key importance. To support companies, Royal Haskoning offers a range of services ranging from strategic planning of test programs and registration strategies to complete dossier preparation and submission. We will guide you or undertake the process for you, wherever your business takes you.
Our services include, but are not limited to:
- Regulatory consultancy & compliance checks.
- Dossier preparation, submission and support services.
- Strategic planning of test programs and registration strategies.
- Liaison with regulatory authorities and scientific bodies.
- Project management / study monitoring.
- Data (gap) analysis and interpretations.
- Support in selection test laboratories.
- Data compensation appraisals.
- Preparation of independent expert position papers and data waivers.