Application for Approval of a New Ingredient or Product in a Dietary Supplement: Safety Dossier Review

Who can submit an application?

• Food importers or their representatives.
• Food manufacturers or their representatives.
• Anyone interested in marketing a dietary supplement that contains a plant, fungus, algae, or an ingredient that does not appear in the database lists (Hebrew).

Required application materials

• Product identification and ingredients.
• Statutory status in the manufacturing country (if the product is imported) and in other countries.
• Product purpose, including all its ingredients.
• Proof of existing use as a food product.
• Proof of other use, including medical use
• Potential side effects of the product and its ingredients.
• Recommended or anticipated product daily intake.
• Product or ingredients’ potential contaminants and supervision methods.
• Applicant details.

How to submit the application?

• Registered importers must open an application through the National Food Services portal.
• Unregistered manufacturers or importers must submit an application in the open zone of the Food Services portal.
• Registered importers can submit an application for approval of an ingredient as part of an import application through the Food Services Portal (even when adding missing application materials).

The service is free of charge

Further application processing

1. Upon receiving an application, the Dietary Supplements Committee convenes for discussion.
2. The committee will issue a recommendation (for either approval or rejection of the new product or ingredient registration) to the Food Services manager for approval.
3. Upon receiving the manager’s approval, a notification will be sent to the applicant, and the Dietary Supplements Committee’s resolution list will be updated.
4. If any document is found to be missing upon review, the application will be returned to the importer or manufacturer with an explanation on the missing documents.
5. A final response will be given upon finishing the registration process (without a defined schedule) through the email address provided in the online form.