Under Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, novel foods may be placed on the market within the Union as such, or used in or on foods, only if they are authorised and included in the Union list established by the Commission Implementing Regulation 2017/2470. The Union list has recently been first updated by Implementing Regulations No 2018/460, 2018/461, 2018/462, 2018/469 of 20 March 2018.

The authorisation of a novel food and updating of the Union list consists of adding a novel food to the Union list or removing a novel food from the Union list, or adding, removing or changing the specifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a novel food in the Union list (see Article 9(2) of Regulation 2015/2283).

The authorisation procedure is completed by the Commission adopting an implementing act (Articles 10 to 12 or, for traditional foods with a history of safe food use in a third country, Articles 14 to 18 of Regulation 2015/2283).

The Union list of novel foods was updated for the first time last month.

The following novel foods were authorised:

  1. an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) pursuant to Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 (can be used in food supplements intended for post-menopausal women, with the labelling containing a statement indicating that it should not be consumed by individuals with known celery allergy);
  2. Ecklonia cava phlorotannins pursuant to Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 (can be used as antioxidant, with the labelling containing a statement indicating that it should not be consumed by certain groups, e.g. persons with thyroid disease).

The following novel foods had their use extended:

  1. taxifolin-rich extract pursuant to Commission Implementing Regulation (EU) 2018/461 of 20 March 2018 (can be used as antioxidant while the use extension applies to both food categories and persons);
  2. L-ergothioneine pursuant to Commission Implementing Regulation (EU) 2018/462 of 20 March 2018 (can be used as antioxidant while the use extension applies to both food categories and persons).

Importantly, the new Implementing Regulations do not mean that the Union list as per Regulation 2017/2470 has been automatically consolidated. Accordingly, a full picture of what novel foods have been authorised and listed can be obtained through verification of the annex to Regulation 2017/2470 and of any subsequent Implementing Regulations (this is possible also via Commission website).

Commission website may also be used to monitor novel food authorisation applications currently in process.

 

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Check what we refer to:

  • Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 – link;
  • 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 – link;
  • Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 authorising the placing on the market of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 – link;
  • Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 authorising the placing on the market of Ecklonia cava phlorotannins as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 – link;
  • Commission Implementing Regulation (EU) 2018/461 of 20 March 2018 authorising an extension of use of taxifolin-rich extract as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 – link;
  • Commission Implementing Regulation (EU) 2018/462 of 20 March 2018 authorising an extension of use of L-ergothioneine as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 – link.