Regulatory Review and Quality Evaluation

Get Your Food Supplement Ingredients and Label Quality-Checked and Compliant

One quality and regulatory team audits your manufacturer’s contract, reviews every ingredient’s technical documents, validates your composition and label, and prepares your notification dossier, so your food supplement is ready for the market and for control

Get Your Food Supplement Ingredients Quality-Checked and Compliant

Regulation (EC) No. 178/2002 establishes a safety principle: a food business operator must not place on the market foodstuffs that are hazardous to health. It is therefore important to ensure that the food complies with the various existing safety and quality regulations.

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FAQ

What does a food supplement regulatory review and quality evaluation cover?

It covers eight checkpoints between formulation and market: quality clauses in your manufacturing contract, EU and UK standards, ingredient technical and quality review, country-specific composition analysis, labeling review, technical file constitution, notification dossier preparation and quality control at manufacture.

Why insert quality clauses into my manufacturing subcontract?

Quality clauses make your specifications part of the contract with your manufacturer, so ingredient sourcing, formulation and manufacturing conditions are contractually enforceable rather than only agreed informally.

What technical documents do you review for each ingredient?

We review the technical data sheet, safety data sheet and certificate of analysis provided by your ingredient supplier for every raw material in your formula.

What quality criteria are evaluated for each ingredient?

We assess the quality criteria defined for each ingredient, including microbiology, heavy metals, pesticides, solvent residues, GMOs, BSE, allergens, PAHs, dioxins, mycotoxins, irradiation etc …,against the specifications and applicable standards.

How do you check that my composition complies with each target country?

We review the regulatory status of every active ingredient and additive in your formula, along with their authorized maximum doses, against the rules of each country where you plan to sell.

What does the labeling regulatory analysis include?

We check the mandatory information required under the Food Information to Consumers (FIC) Regulation and Directive 2002/46/EC, review any voluntary claims such as health claims, and validate the final label before it is printed.

What is the technical file of a food supplement and why do I need it?

The technical file gathers the essential information that characterizes your food supplement, including composition, specifications and supporting documentation. It must be ready to present in the event of an inspection or control by the authorities.

Do you submit the notification dossier to the authorities?

Yes. We prepare the notification dossier and manage exchanges with the competent authority on your behalf so your food supplement can be marketed.

What happens during quality control at manufacture?

At the end of each production run, we check that the finished product complies with the specifications defined for your food supplement before it is released to the market.

How is this different from your Regulatory Audit & Notification service?

Regulatory Review and Quality Evaluation focuses on ingredient quality, manufacturer contract clauses and the technical file, alongside labeling and notification. For notification-focused support, see our Regulatory Compliance Audit and Notification service; for broader regulatory and scientific guidance, see our Health & Nutrition Consulting services.

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