Latest Info

Food Product Formula Compliance Check in the EU

Latest Info
Food Product Formula Compliance Check in the EU

The Food industry is investing greatly in product development to develop new food products. Before selling a new food product within the EU market, compliance with the current regulatory EU requirements, which includes the food product formula compliance check, is required.

Classification and categorization of new food products

The first step in the food product formula compliance check is product classification / categorization. One needs to first consider the different food categories and align these with the intended use of the food product. Secondly is the importance of product designation, meaning is the product going to be a final product intended for use by consumers or will this be designated as a raw material (i.e., food ingredient) used to make a final food product? Thereafter, one would need to check if there are any specific regulatory requirements to comply with for a specific type of food product. For instance, in the case of milk, butter, mayonnaise, etc. there are technological processes and/or ingredients allowed to be used to produce such products.

Types and amounts of ingredients

Once the above aspects have been covered, a regulatory expert needs to check the type and the level of food additives intended to be used, which are required to be EU authorized in accordance with Regulation (EC) No 1333/2008 and other related EU regulations. One would not only need to check for the type and
the level of the food additive, but also for its function and use in a dedicated food category. Furthermore, all the other food ingredients, which are intended to be used in the product formula e.g., flavourings, extracts, novel foods, colourants (not consider as an additive) etc., would also need to be compliant with the corresponding relevant EU regulations.

Analyse the claim of the new product

Another essential element to be checked is the claim associated with a given food product. Very often this step is forgotten and is only addressed at a very last stage of the process, i.e., during the label creation.

However, to avoid any problems at later stages, the product claims need to be carefully analysed far befor when the label is prepared.
The food product formula compliance check is a complex exercise, which confirms not only compliance, but also looks at the possibility of use and the claims that can be used ensuring that the introduction of a new final food product into the EU market is fully compliant.

Our Food Regulatory Services


  •  EU Regulatory compliance checks for new food ingredients or food ingredients with new intended uses.
  •  Customized regulatory strategies to introduce food ingredients to the EU marketplace.
  •  Food ingredients compliance check in accordance with the intended use.
  •  Food product formula compliance check.
  •  Food product claims check.
  •  Preparation of food product labelling for all EU countries.
  •  Design the regulatory approach and perform data gap analysis for a new authorization or use extension.
  •  Preparation and facilitation of food additive petitions to the EC/ EFSA with full involvement of food regulators, food chemists, and human toxicologists.
  •  Post-submission support and response to EC/ EFSA questions.
  •  Protocol design and study monitoring for toxicological studies.
  •  Exposure modelling.

knoell as your go-to partner for registration - worldwide

Founded in 1996, knoell is a leading provider of global regulatory services for food and food contact materials. Our strength is to be where it matters: with sites in Europe, Asia and North America and an extensive network of co-operation partners, we combine global know-how with local experience and intercultural competence.

Our experienced Food & Food Contact Materials Team can help you with all aspects of food product formula compliance checks.

Please contact the knoell FFCM team  read more on the regulatory requirements of food contact materials here.

Angelique Downey
Angelique Downey
Head of Division, Food & Food Contact Materials