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Regulatory affairs for your formulation, label and target market

Labelling & Regulatory Compliance

Labelling & Regulatory Compliance

You may need a formulation review, complete labelling text or a review of your label. An existing product may also be intended for sale in additional countries.

The work brings composition, labelling and advertising claims into alignment with the requirements of the target markets. You receive specific corrections and the documentation needed for the agreed next step.

I Stock 1439713713
I Stock 1439713713

Formulation & Composition

The review starts with the product category and intended use. Formulation, specifications and available analytical results are considered together. National requirements and classification issues, such as the distinction from medicinal products or the application of novel food legislation, are taken into account.

  • Assess ingredients, nutrient compounds, additives and use levels against the requirements of the product category

  • Check manufacturers’ documentation for completeness and consistency with the intended product

  • Coordinate additional analyses, safety assessments or specialist food law reviews with expert partners

I Stock 2249697400
I Stock 2249697400

Preparing & Reviewing Labelling

Whether you need complete labelling text or a review of an existing label design, the work covers the EU Food Information to Consumers Regulation and the additional requirements for the specific product. The formulation, wording and final label artwork are aligned.

  • Prepare or review the name of the food, ingredients list, allergens, quantitative ingredient declarations and required origin information

  • Address nutrition or nutrient declarations, portion information and product-specific mandatory statements, warnings and instructions for use

  • Check labels for completeness, legibility and consistency; include product information used in online sales

Claims & Product Communication

An intended claim may impose requirements on composition and the amount consumed. Potential claims are therefore considered during product planning and checked against the actual formulation.

  • Assess nutrition and health claims against their conditions of use, required quantities and accompanying information

  • Include product names, visual claims, packaging, website content and advertising copy in the review

  • Address botanicals and specific classification issues case by case with specialist legal expertise

I Stock 1199371830
I Stock 1199371830

Regulatory Compliance & External Expert Reports

To assess whether a product may lawfully be placed on the market, its formulation, specifications, analytical results and labelling are compiled into traceable product documentation. Any identified non-conformities are addressed with you and the manufacturer.

Where a formal food law compliance report is required, I commission a suitable external expert or institute. I prepare the documentation, coordinate additional testing and manage follow-up questions. The product version, target markets and outstanding issues are documented.

Target Markets & Food Supplement Notifications

The review is based on the countries in which the product is to be marketed. For projects within and beyond the EU, country-specific requirements and the necessary specialist partners are considered at an early stage.

  • Adapt product and labelling versions to the requirements of the intended countries of sale

  • Identify food supplement notification requirements and prepare the necessary documentation

  • Submit or commission notifications within the agreed mandate and coordinate follow-up questions

What You Can Expect

Depending on the assignment, you receive an annotated review report, prepared labelling text, coordinated product documentation or completed notification documents. The review status and any further action required are clearly recorded. A food supplement notification does not replace the assessment of whether the product complies with the requirements for placing it on the market.

Would you like a formulation, label or market requirement reviewed?

Tell me about your product, the intended countries of sale and the question you need answered. We will agree the scope of the review and the documentation required with you.

Following your enquiry, we will clarify the scope you require. You will receive a tailored proposal.