This guide outlines all documents and certificates that our company provides to customers located outside the European Union so they can complete regulatory submission, import, or marketing authorization in their respective countries.
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, registration, import clearance, or local regulatory submission.
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 and the final product are manufactured in 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 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 ingredients are non-GMO and within safety limits for contaminants
Free Sale Certificate / Export Certificate
Confirms the product is legally manufactured and sold in the EU
Usually required for customs clearance or local regulatory approval
Regulatory Submission Documents
Product information template / dossier including:
Label mock-up
Composition, batch size, recommended intake
Safety and quality certifications
Instructions for use and compliance notes according to the destination country’s requirements
Any additional documentation requested by local regulatory authorities (customs, ministry of health, or food safety agency)
Practical Notes
Some countries may require official translation of all documents into the local language.
The company provides all certificates, technical files, and product samples, but the regulatory submission / registration / import clearance is the responsibility of the customer.
Free Sale / Export Certificates are usually mandatory for customs clearance or local registration.
Depending on the country, additional local approvals, testing, or labeling requirements may apply.
This package ensures that the customer outside the EU has all technical documentation needed for import, registration, or regulatory notification, facilitating legal market entry.