32015R2283

WHAT IS THE AIM OF THE REGULATION?

• It lays down rules for the placing of novel foods¹ on the market in the European Union (EU). These are designed to provide a high level of protection for human health and consumers’ interest.

KEY POINTS

• Food business must determine whether the product they wish to place on the market is covered by the legislation. If they are unsure:
  • they may consult the national authorities of the market concerned by providing all the necessary information;
  • those national authorities may consult colleagues in other EU countries and the European Commission.
• The Commission must establish a positive list of authorised novel foods by 1 January 2018 and update it regularly.
• An authorised product must not:
  • pose a risk to human health, on the basis of scientific evidence;
  • mislead consumers, especially when it is intended to replace another food and there is a significant change in nutritional value;
  • be nutritionally disadvantageous when replacing another food under normal consumption.
• The authorisation procedure for the placing of a novel food on the market can be triggered either by an applicant (EU country, a non-EU country or an interested party) or by the Commission.
• The application must include details, such as the name and description of the novel food, its detailed composition, production processes and scientific evidence, confirming that it does not pose any danger to human health.
• The Commission may ask the European Food Safety Authority to give its opinion on the safety of the novel food.
• The Commission presents its final opinion on whether to authorise a novel food to the Standing Committee on Plants, Animals, Food and Feed. Its endorsement is necessary before the new product can be added to the positive list.
• Specific rules apply to traditional foods from non-EU countries which their food business operators or importers wish to sell in the EU.
• The legislation does not apply to:
  • genetically modified foods covered by Regulation (EC) No 1829/2003;
  • foods used as enzymes, additives and flavourings covered by Regulations (EC) No 1332/2008, (EC) No 1333/2008, (EC) No 1334/2008;
  • extraction solvents within the scope of Directive 2009/32/EC.

FROM WHEN DOES THE REGULATION APPLY?

It applies from 1 January 2018.

BACKGROUND

For more information, see:

• Novel food (European Commission)

KEY TERMS

1. Novel food: food not used for human consumption to a significant degree in the EU before 15 May 1997. This covers a wide range of products, such as food with a new or intentionally modified molecular structure, food using a new food production process (bread treated with UV-light to increase vitamin D content) or produced from microorganisms, fungi or algae (e.g. the use of the micro-algae Schizochytrium sp in foods such as cereal bars, cooking fats, etc. as an alternative source of Docosahexaenoic acid).

MAIN DOCUMENT

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 (OJ L 327, 11.12.2015, pp. 1-22)

Successive amendments to Regulation (EU) No 2015/2283 have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

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 (OJ L 351, 30.12.2017, pp. 55-63)

See consolidated version.

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 (OJ L 351, 30.12.2017, pp. 64-71)

See consolidated version.

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 (OJ L 351, 30.12.2017, pp. 72-201)

See consolidated version.