Novel Foods

Novel Foods

Novel foods are food or food ingredients that were not used for human consumption to a significant degree in the European Union (EU) before 15th May 1997.

• EU Novel Food Regulation

  As of January 1st 2018, the placing of novel foods on the EU market must be in accordance with Regulation (EU) 2015/2283.

  The novel food Regulation does not apply to: 

  • genetically-modified food falling within the scope of Regulation (EC) No 1829/2003;
  • food enzymes falling within the scope of Regulation (EC) No 1332/2008; 
  • food used solely as additives falling within the scope of Regulation (EC) No 1333/2008; 
  • food flavourings for use in foodstuffs falling with the scope of Regulation (EC) No 1334/2008; 
  • extraction solvents used in the production of foodstuffs falling within the scope of Directive 2009/32/EC.

• Procedure for Determination of Novel Food Status

  If a food business is unsure whether or not a food or food ingredient which they intend to place on the EU market falls within the scope of the novel food Regulation, they can avail of Article 4 on the “procedure for determination of novel food status”.

  In order to determine the novel food status of a particular food or food ingredient, the food business shall consult the Member State (‘recipient Member State’) where they first intend to market the novel food. The consultation request has to be developed in accordance with Commission Implementing Regulation (EU) 2018/456. The recipient Member State shall decide on the novel food status within four months of the consultation request being deemed valid. Where justifiable, this timescale may be extended by the recipient Member State for a maximum of four extra months. The recipient Member State may consult other Member States and the Commission on the novel food status. 

  Once the decision is made and the food business is informed, the Commission will make the novel food status publicly available on the European Commission website.

  In Ireland, the FSAI is the competent authority responsible for the implementation of Commission Implementing Regulation (EU) 2018/456 (novelfood@fsai.ie).

• Novel Food Catalogue

  The novel food catalogue is an informal record of discussions at EU level about the novel food status of numerous foods and food ingredients.

• Novel Food Authorisation Procedure

  The procedure for authorising a novel food or food ingredient is set out in Articles 10, 11 and 12 of the novel food Regulation. A food business that wishes to market a novel food or food ingredient for the first time in the Community must submit directly to the European Commission an application using the e-submission system. Training and support on the e-submission system is available on the European Commission's dedicated webpage. The application dossier is developed in accordance with Commission Implementing Regulation (EU) 2017/2469. 

  The Commission has prepared a user guide to give assistance to food businesses on the use of the e-submission system for novel foods applications.

  The European Food Safety Authority (EFSA) has developed guidance documents that outline the scientific information and data needed for the safety assessment of novel foods:

  • Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1, 2021)
  • Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283.
  • Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283

• Traditional Foods from Third Countries

  Traditional foods from third (non-EU) countries are foods or ingredients derived from primary production (defined in Regulation (EC) No 178/2002) with a 25-year history of consumption by a significant number of people as part of a normal diet.

  Traditional foods from third countries may avail of a simpler notification option set out in Article 14 of the novel food Regulation. A food business that wishes to market a traditional food from a third country for the first time in the Community must submit directly to the European Commission a notification using the e-submission system. Training and support on the e-submission system is available on the European Commission’s dedicated webpage.The notification dossier is developed in accordance with Commission Implementing Regulation (EU) 2017/2468.

  The Commission has prepared a user guide to give assistance to food businesses on the use of the e-submission system for traditional food from third countries notifications.

  EFSA has developed a guidance document to support food businesses in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries: 

  • Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1, 2021)

• The Union list of novel foods

  Once a food or ingredient is authorised as a novel food, or a traditional food from a third country is successfully notified, the Union list of novel foods, established by Commission Implementing Regulation (EU) 2018/1023, is updated. The Union list contains all novel foods and traditional foods from third countries that have been authorised to date in the EU and includes the name, conditions of use, labelling and other requirements as well as specifications.

• Novel Food Applications under Regulation (EC) 258/97

  Regulation (EC) No 258/97 has been replaced by Regulation (EU) 2015/2283 with safety assessments now being carried out by the European Food Safety Authority (EFSA) rather than individual Member States. 

  In Ireland, FSAI is the competent authority for novel foods and was the national body that assessed a number of novel food applications under Regulation (EC) No 258/97 that can be found at the link below.

  View safety assessments of novel food applications carried out by FSAI.

• Substantial Equivalence Opinions

  Regulation (EC) No 258/97 provided a simplified procedure for food businesses to bring certain novel foods and ingredients to the EU market. The food or ingredient in question had to be “substantially equivalent” to an existing food or ingredient in terms of composition, nutritional value, metabolism, intended use and level of undesirable substances based on the opinion of a Member State. 

  In Ireland, FSAI is the competent authority for novel foods and has issued a number of substantial equivalence opinions under Regulation (EC) No 258/97 that can be found at the link below.

  View substantial equivalence opinions carried out by FSAI.