LegalizeRegulation (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 (Text with EEA relevance)
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
(Text with EEA relevance)
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and purpose
This Regulation lays down rules for the placing of novel foods on the market within the Union.
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
This Regulation applies to the placing of novel foods on the market within the Union.
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
For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 apply.
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
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.
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.
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.
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).
CHAPTER II
REQUIREMENTS FOR PLACING NOVEL FOODS ON THE MARKET WITHIN THE UNION
Article 6
Union list of authorised novel foods
The Commission shall establish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 7, 8 and 9 (‘the Union list’).
Only novel foods authorised and included in the Union list may be placed on the market within the Union as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein.
Article 7
General conditions for inclusion of novel foods in the Union list
The Commission shall only authorise and include a novel food in the Union list if it complies with the following conditions:
(a) the food does not, on the basis of the scientific evidence available, pose a safety risk to human health;
(b) 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;
(c) where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Article 8
Initial establishment of the Union list
By 1 January 2018 the Commission shall, by means of an implementing act, establish the Union list by including in it the novel foods authorised or notified under Article 4, 5 or 7 of Regulation (EC) No 258/97, including any existing authorisation conditions.
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 30(2).
Article 9
Content and updating of the Union list
The Commission shall authorise a novel food and update the Union list in accordance with the rules laid down in:
(a) Articles 10, 11 and 12 and, where applicable, Article 27; or
(b) Articles 14 to 19.
The authorisation of a novel food and updating of the Union list provided for in paragraph 1 shall consist of one of the following:
(a) adding a novel food to the Union list;
(b) removing a novel food from the Union list;
(c) 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.
The entry for a novel food in the Union list provided for in paragraph 2 shall include the specification of the novel food and, where appropriate:
(a) the conditions under which the novel food may be used, including in particular any requirements necessary to avoid possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption;
(b) additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;
(c) post-market monitoring requirements in accordance with Article 24.
CHAPTER III
AUTHORISATION PROCEDURES FOR A NOVEL FOOD
SECTION I
General rules
Article 10
Procedure for authorising the placing on the market within the Union of a novel food and updating the Union list
The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission's initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States without delay. The Commission shall make a summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.
The application for an authorisation shall include:
(a) the name and address of the applicant;
(b) the name and description of the novel food;
(c) the description of the production process(es);
(d) the detailed composition of the novel food;
(e) scientific evidence demonstrating that the novel food does not pose a safety risk to human health;
(f) where appropriate, the analysis method(s);
(g) a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.
Where the Commission requests an opinion from the European Food Safety Authority (the ‘Authority’), the Authority shall make public the application in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health.
When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation shall be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials.
The procedure for authorising the placing on the market within the Union of a novel food and updating the Union list as provided for in Article 9 shall end with the adoption of an implementing act in accordance with Article 12.
By way of derogation from paragraph 5, the Commission may terminate the procedure at any stage, and decide not to proceed with an update, where it considers that such an update is not justified.
In such cases, where applicable, the Commission shall take account of the views of Member States, the Authority's opinion and any other legitimate factors relevant to the update under consideration.
The Commission shall inform the applicant and all Member States directly of the reasons for not considering the update to be justified. The Commission shall make the list of such applications publicly available.
The applicant may withdraw its application at any time, thereby terminating the procedure.
Article 11
Opinion of the Authority
Where the Commission requests an opinion from the Authority, it shall forward the valid application to the Authority without delay, and not later than one month after having verified its validity. The Authority shall adopt its opinion within nine months from the date of receipt of a valid application.
In assessing the safety of novel foods, the Authority shall, where appropriate, consider whether:
(a) the novel food concerned is as safe as food from a comparable food category already placed on the market within the Union;
(b) the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union;
(c) a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
The Authority shall forward its opinion to the Commission, to the Member States and, where applicable, to the applicant.
In duly justified cases, where the Authority requests additional information from the applicant, the nine-month period provided for in paragraph 1 may be extended.
After consulting the applicant, the Authority shall specify a period within which that additional information is to be provided and shall inform the Commission thereof.
Where the Commission does not object to the extension within eight working days of being informed by the Authority, the nine-month period provided for in paragraph 1 shall be automatically extended by that additional period. The Commission shall inform the Member States of that extension.
Where the additional information referred to in paragraph 4 is not provided to the Authority within the additional period referred to in that paragraph, the Authority shall draw up its opinion on the basis of the available information.
Where an applicant submits additional information on its own initiative, it shall send that information to the Authority.
In such cases, the Authority shall give its opinion within the nine-month period provided for in paragraph 1.
The Authority shall make the additional information provided in accordance with paragraphs 4 and 6 available to the Commission and to the Member States.
Article 12
Authorisation of a novel food and updates of the Union list
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