Regulation (EU) 2015/2283 of the European Parliament and of the CouncilShow full title

CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 Subject matter and purpose

1. This Regulation lays down rules for the placing of novel foods on the market within the Union.

2. The purpose of this Regulation is to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumers' interests.

Article 2 Scope

1. This Regulation applies to the placing of novel foods on the market within the Union.

2. This Regulation does not apply to:

(a) genetically modified foods falling within the scope of Regulation (EC) No 1829/2003;

(b) foods when and in so far as they are used as:

(i)

food enzymes falling within the scope of Regulation (EC) No 1332/2008;

(ii)

food additives falling within the scope of Regulation (EC) No 1333/2008;

(iii)

food flavourings falling within the scope of Regulation (EC) No 1334/2008;

(iv)

extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive 2009/32/EC.

Article 3 Definitions

1. For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 apply.

2. The following definitions also apply:

(a) ‘novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the following categories:

(i)

food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;

(ii)

food consisting of, isolated from or produced from microorganisms, fungi or algae;

(iii)

food consisting of, isolated from or produced from material of mineral origin;

(iv)

food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:

• traditional propagating practices which have been used for food production within the Union before 15 May 1997; or

• non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;

(v)

food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;

(vi)

food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;

(vii)

food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;

(viii)

food consisting of engineered nanomaterials as defined in point (f) of this paragraph;

(ix)

vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where:

• a production process not used for food production within the Union before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; or

• they contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;

(x)

food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC;

(b) ‘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 significant number of people in at least one third country, prior to a notification referred to in Article 14;

(c) ‘traditional food from a third country’ means novel food as defined in point (a) of this paragraph, other than novel food as referred to in points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof which is derived from primary production as defined in point 17 of Article 3 of Regulation (EC) No 178/2002 with a history of safe food use in a third country;

(d) ‘the applicant’ means the Member State, the third country or the interested party, which may represent several interested parties and has submitted to the Commission an application in accordance with Article 10 or 16 or a notification in accordance with Article 14;

(e) ‘valid’ in respect to an application or a notification means an application or a notification which falls within the scope of this Regulation and contains the information required for risk assessment and authorisation procedure;

(f) ‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

(i)

those related to the large specific surface area of the materials considered; and/or

(ii)

specific physico-chemical properties that are different from those of the non-nanoform of the same material.

Article 4 Procedure for determination of novel food status

1. Food business operators shall verify whether or not the food which they intend to place on the market within the Union falls within the scope of this Regulation.

2. Where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation, food business operators shall consult the Member State where they first intend to place the novel food. Food business operators shall provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of this Regulation.

3. In order to determine whether or not a food falls within the scope of this Regulation, Member States may consult the other Member States and the Commission.

4. The Commission shall, by means of implementing acts, specify the procedural steps of the consultation process provided for in paragraphs 2 and 3 of this Article, including deadlines and the means to make the status publicly available. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).

Article 5 Implementing power concerning the definition of novel food

The Commission may decide, on its own initiative or upon a request by a Member State, by means of implementing acts, whether or not a particular food falls within the definition of novel food, as laid down in point (a) of Article 3(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).