This guide outlines all the documents and certificates that Swiss Formula provides to EU-based customers so they can complete the notification of their products with the competent authorities in their country.
Final Label & Product Samples
Mock-up / final label
Trade name + indication “Food Supplement”
Product composition with content per daily serving
Warnings, contraindications, allergens
Net quantity / weight / volume
Batch number and expiration / manufacturing date
Production and distribution statement:
Manufactured in the European Union for the account of [Customer]
and distributed exclusively by [Customer with full details].
Product and packaging samples
Provided for inspection, photography, or submission to the competent authority.
Product Information File (PIF)
Detailed product composition and daily intake
Product form description (capsule, tablet, powder, liquid, etc.)
Specifications of raw materials and finished product
Production and quality control protocols (GMP, HACCP)
Quality & Origin Certificates
Certificate of Origin
Confirms that all ingredients originate from the EU.
Certificates of Analysis (CoA)
For each raw material and finished product
Includes microbiological analysis, purity, active substance content, heavy metals, other contaminants
Monographs / Phytochemical Documentation (if herbal extracts are used)
References from official sources (EMA, ESCOP, USP, Pharmacopoeias)
Declaration of Compliance with EU Legislation
Confirms that the product complies with EU food supplement regulations
For novel or non-standard ingredients, includes Novel Food / EFSA compliance, maximum use levels
GMO / Contaminant Declaration
Confirms that ingredients are non-GMO and within safety limits for contaminants
Free Sale Certificate (if required)
Confirms the product is legally sold in the EU.
Notification Documents
Completed notification form or product information template, providing all data required for submission to the national competent authority.
Instructions for proper use and product indication according to the requirements of the destination country.
Practical Notes
Documents may need to be translated into the official language of the country where the notification is submitted.
Swiss Formula provides all authentic certificates and technical files, but the notification submission is the responsibility of the customer.
Samples and documentation ensure that the competent authority can verify the product and issue a notification number.