Where the regulation applies
The regulation concerns specified specialised foods, including dietary foods for therapeutic and preventive use. Classification depends on the target population, formulation and intended purpose, not merely the product name.
What the regulation covers
Checks address microbiological safety, contaminants and suitability of the composition for the target population. Claimed nutritional properties, use restrictions and label recommendations require supporting evidence.
Examples of products and facilities
- sports nutrition foods
- foods for pregnant women
- foods for breastfeeding women
- dietary foods for therapeutic use
- dietary foods for preventive use
These examples are indicative. Applicability depends on intended use, specifications and the regulation’s exclusions.
Documentation we help prepare
PLANCK reviews the formulation, evidence of intended use, labelling and state-registration materials and helps identify the assessment route and prepare the required documentation.
What to prepare
- Technical description and intended use
- The key parameters listed above
- Models, manufacturer and applicant details
- Existing conformity evidence
What you receive
A requirements matrix for your product: scope, assessment route, necessary evidence and next actions.
Sources & regulatory basis
Regulatory basis checked:
Timing & cost
Quoted after reviewing models, manufacturers, testing scope, site visits and translation needs. The proposal separates the stages and their deliverables.