New Year, 125 New Functional Ingredients in the EU / by Sebastian MELCHOR

The long-awaited Union list of novel foods has become law in the EU following publication in the Official Journal of Commission Implementing Regulation (EU) 2017/2470 on December 20. For the first time, any food business operator can use novel botanical extracts, vitamins, minerals, microalgae, proteins, etc. when following the conditions and specifications laid down in the Regulation.

Until now, only those companies to which the Commission decision authorizing the novel food was addressed, as well as those obtaining authorization through the substantial equivalence procedure could use the novel ingredients. Other companies needed to obtain the novel ingredients from those officially authorized suppliers.

Detailed conditions under which the novel food may be used, especially food categories and maximum levels, as well as additional specific labelling and other requirements are laid down for each of the ingredients, which include top-selling ingredients like chia seeds, noni juice, synthetic hydroxytyrosol, clostridium butyricum, bovine lactoferrin, low fat cocoa extract, etc.

From now on, once a novel food is authorized, it will be added to this positive list and there will be no need to apply for substantial equivalence to use it.

To protect the investment of the applicants, however, there is a period of 5 year of data protection, which means that the newly developed information used to get approval cannot be used by other applicants. This may provide a monopoly on the marketing of the food or food ingredient for 5 years, unless the applicant agrees to share the data or if another applicant obtains their own information to get approval.

Detailed rules on administrative and scientific requirements published

At the same time, two other Commission Regulations lay down the administrative and scientific requirements for authorization of novel food applications and traditional foods from third countries, which are subject to a fast-track procedure.

The legislative package can be found here:

Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods