Novel Food Dossier • Policy Report

Novel Food Dossier • Policy Report

Posizioni e obiettivi sui quali Sustainable Economy Europe concorda:

  1. To simplify the steps of pre-market authorisation, making the process more appealing and competitive also for SME;
  2. To protect consumer health;
  3. To improve labels transparency.

 

SUMMARY

Novel Food is defined as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force.

 ‘Novel Food’ can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU.

Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill, oil rich in phospholipids from Euphausia superba), agricultural products from third countries (chia seeds, non-fruit juice), or food derived from new production processes (UV-treated milk, bread, mushrooms and yeast).

RESULTS

As of 1 January 2018, the new Regulation (EU) 2015/2283 on NOVEL FOOD is applicable. It replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017.

 

IMPROVEMENTS

1) Generic authorisations of Novel Foods: Easier authorisation process. This means that any food business operator can place an authorised Novel Food on the European Union market if the authorised conditions of use, labelling requirements, and specifications are respected. The centralized procedure is now managed by the European Commission using an online application submission system and the evaluation will be carried out by the European Food Safety Authority (EFSA).

2) Establishment of a Union list of authorised Novel Foods: the list contains all authorised novel foods. Novel Foods which will be authorised in the future will be added to the list through Commission Implementing Regulations. Once a novel food is added, then it is automatically authorised and it can be placed in the European Union market.

3) Promotion of innovation: by granting an individual authorisation for five years based on protected data. Data protection provisions are included in the new Regulation. That means that an applicant may be granted an individual authorisation for placing on the market of a novel food. This is based on newly developed scientific evidence and proprietary data and is limited in time to 5 years.

 

MAIN AMENDMENTS

General conditions for inclusion of novel foods in the Union list:

  1. The Commission shall only authorise and include a novel food in the Union list if it complies with the following conditions;
  2. The food does not, on the basis of the scientific evidence available, pose a safety risk to human health;
  3. The food’s intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value;

 

These amendments have been presented in the Draft Opinion before the vote in the Plenary Session.

Amendment 32: this Amendment requests the harmonization of national laws concerning the safety assessment and authorization of novel food, to protect agri-food business operators and small and medium enterprises.

Text proposed by the CommissionAmendment
(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, as well as benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the free movement of such food, thereby creating unfair conditions of competition.(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, as well as benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the free movement of such food, thereby creating unfair conditions of competition, as well as among agri-food business operators and SMEs.

 

Amendment 140: with this Amendment the Commission requests that any novel food coming from a third Country be consumed continuously and inserted in the daily diet for at least 25 years prior to a notification.

Text proposed by the CommissionAmendment
(c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country, prior to a notification referred to in Article 13;(c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use and significant consumption for at least 25 years in the normal daily diet of a large part of the population or geographical region of a third country, prior to a notification referred to in Article 13;