For products containing ingredients outside Annexes I & II and originating from EU countries
Swiss Formula undertakes the production, labeling, and distribution of food supplements under the customer’s brand, as well as their notification to EOF through the electronic platform.
This process applies to products containing ingredients outside Annexes I & II, such as herbal extracts, amino acids, bioactive compounds, etc., which increases the requirements for documentation and certificates.
Formula Selection & Product Design
Formula selection: from the existing list or creation of an exclusive formula for the customer.
Collaboration with the customer to define all ingredients and the daily dosage.
Ingredient legality check: ensure their use as a food supplement is acceptable by EOF.
Product form selection: capsules, tablets, powder, or liquid.
Packaging selection: Blister, biodegradable, or glass bottles with color options; safety cap with heat-shrink film.
Role of Swiss Formula:
Provide technical guidance and ensure compliance with safety limits for “non-Annex I & II” ingredients.
Label Design & Approval
Full label design: logo, trade name, mandatory statements.
Mandatory information: trade name + “Food Supplement”, composition / dosage, warnings, net content, EOF notification number, expiration / manufacturing date.
Production and distribution statement:
Manufactured in the European Union for the account of [Your Company Name]
and distributed exclusively in Greece by [Your Company Name with full details].
Trade name check: must not refer to a medicine / treatment or mislead the consumer.
Role of Swiss Formula:
Deliver the final label and packaging samples to the customer for approval before submission to EOF.
Preparation of Notification Documents
Standard documents:
EOF notification application
Product information form
Label / packaging sample
Proof of fee payment
Additional documents / certificates for non-Annex I & II ingredients:
Certificate of Origin: confirms the ingredients come from the EU.
Certificates of Analysis (CoA): for each raw material, including microbiological analysis, purity, content, heavy metals, etc.
Monographs / phytochemical documentation for herbal extracts, according to official sources (e.g., EMA, ESCOP, USP, Pharmacopoeias).
Safety assessment / toxicity studies, if required for innovative ingredients.
Declaration of compliance with EU legislation (e.g., Novel Food, EFSA, permissible usage limits).
Free Sale Certificate (where required): confirms that the product is legally sold in the EU.
GMO / contaminant declaration: confirms ingredients are non-GMO and within safety limits.
Submission via MyEOF
Upload all documents to the electronic platform.
Check for completeness and accuracy.
Receive the notification / protocol number, which will be printed on the label.
Production & Distribution
Manufacture according to specifications.
Final quality control for each batch.
Keep two samples per batch for two years for potential EOF inspection.
Packaging and labeling with the approved label.
Delivery to the customer and distribution to consumers or through the customer’s network.
Key Points
Special attention to safety documentation for “non-standard” ingredients.
Label and health claims approval before marketing.
Maintain records of all documents, samples, and reports for potential EOF inspection.