
CHAPTER I
Article 1 

1. This Regulation lays down rules for novel foods placed on the market within Great Britain.
2. The purpose of this Regulation is to ensure a high level of protection of human health and consumers' interests.
Article 2 

1. This Regulation applies to the placing of novel foods on the market within  Great Britain.
2. This Regulation does not apply to:
(a) genetically modified foods falling within the scope of Regulation (EC) No 1829/2003;
(aa) within England, food produced from precision bred plants within the meaning of section 1, as read with section 2(1), and section 30(2), of the Genetic Technology (Precision Breeding) Act 2023;
(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 

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 EU or the United Kingdom before 15 May 1997, irrespective of the dates of accession of member States, 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  EU or the United Kingdom  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  EU or the United Kingdom  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  EU or the United Kingdom  before 15 May 1997; or
— non-traditional propagating practices which have not been used for food production within the  EU or the United Kingdom  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  EU or the United Kingdom  before 15 May 1997 and the food from those animals has a history of safe food use within the  EU or the United Kingdom;
((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  EU or the United Kingdom  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  EU or the United Kingdom  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  EU or the United Kingdom  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 third country or the interested party;
(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.
(g)  “third country” means any country or territory other than the British Islands;
(h) “prescribe” means prescribe by regulations;
(i) “appropriate authority” means—
(i) in relation to England, the Secretary of State;
(ii) in relation to Wales, the Welsh Ministers;
(iii) in relation to Scotland, the Scottish Ministers;
(j) “Food Safety Authority” means—
(i) as regards England and Wales, the Food Standards Agency;
(ii) as regards Scotland, Food Standards Scotland;
(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 3A 

1. For the purposes of this Regulation, determining the authorisation status of a novel food is to consist of the appropriate authority determining whether or not to:
(a) authorise the placing on the market, or the use in or on food, of a novel food;
(b) modify the authorisation of a novel food, including modifying any conditions of use, post-market monitoring requirements, restrictions, specific labelling requirements or specifications associated with the authorisation of the novel food concerned;
(c) revoke or suspend the authorisation of a novel food.
2. For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—
(a) existing stocks of the novel food concerned, and any products derived from it or containing it, may be placed on the market or used;
(b) the novel food concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;
(c) the labelling of the novel food concerned, and any products derived from it or containing it, may continue to be applied.
(3.) The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation.
Article 3B 

1. The Food Safety Authority must establish and maintain a list (the “domestic list”) of novel foods, the placing on the market or use of which has been authorised in accordance with this Regulation, including the details described in Article 9(3).
2. The domestic list must be made available to the public.
Article 4 

1. Food business operators must verify whether or not the food which they intend to place on the market within Great Britain  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 Great Britain  falls within the scope of this Regulation, food business operators must consult the Food Safety Authority. Food business operators must provide the necessary information to the Food Safety Authority to enable it to determine whether or not a food falls within the scope of this Regulation.
Article 5 
The appropriate authority may prescribe that a particular food is a novel food within the meaning of this Regulation.
CHAPTER II
Article 6 
Only novel foods authorised by the appropriate authority in accordance with this Regulation may be placed on the market within Great Britain as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified in the authorisations concerned.
Article 7 
The  appropriate authority must  only authorise  a novel food  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 
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Article 9 

1. The  appropriate authority mustdetermine the authorisation status of a novel food  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.
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3. The authorisation of a novel food  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
SECTION I
Article 10 

1. The procedure for  determining the authorisation status   of a novel food ... provided for in Article 9 must start either on the initiative of the appropriate authority or following an application to the appropriate authority by an applicant. The appropriate authority must make the summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.
2. The application for an authorisation must 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;
(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;
(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.
3. Upon request by the appropriate authority, the Food Safety Authority must give its opinion as to whether the  proposed determination of authorisation status  is liable to have an effect on human health.
4. When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation must 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.
5. The procedure for authorising the placing on the market within Great Britain  of a novel food ... as provided for in Article 9 ends when the appropriate authority determines the authorisation status  of that novel food in accordance with Article 12.
6. By way of derogation from paragraph 5, the appropriate authority may terminate the procedure at any stage, and decide not to proceed with  a determination of the authorisation status of the novel food concerned  where the appropriate authority considers that  a determination  is not justified.
7. The applicant may withdraw its application at any time, thereby terminating the procedure.
Article 11 

1. Where the appropriate authority requests an opinion from the Food Safety Authority, it must forward the valid application to the Food Safety Authority without delay, and not later than one month after having verified its validity. The Food Safety Authority must adopt its opinion within nine months from the date of receipt of a valid application.
2. In assessing the safety of novel foods, the Food Safety Authority must, 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 Great Britain;
(b) the composition of the novel food and the conditions of its use do not pose a safety risk to human health in Great Britain;
(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.
3. The Food Safety Authority must forward its opinion to the appropriate authority and, where applicable, to the applicant.
4. In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the nine month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided.
5. Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.
6. Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the nine month period provided for in paragraph 1.
7. The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.
Article 12 

1. Within seven months from the date of publication of the Food Safety Authority's opinion, the appropriate authority must determine the authorisation status   of a novel food, taking into account the following—
(a) the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;
(b) any relevant provision of assimilated direct legislation, including the precautionary principle as referred to in Article 7 of Regulation (EC) No. 178/2002;
(c) the Food Safety Authority's opinion;
(d) any other legitimate factors relevant to the application under consideration.
2. Where the appropriate authority has not requested an opinion from the Food Safety Authority in accordance with Article 10(3), the seven month period provided for in paragraph 1 of this Article starts from the date on which the valid application is received by the appropriate authority in accordance with Article 10(1).
(2A.) Where the appropriate authority determines the authorisation status of a novel food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.
Article 13 
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SECTION II
Article 14 
Instead of following the procedure referred to in Article 10, an applicant, who intends to place on the market within  Great Britain  a traditional food from a third country, may opt to submit a notification of that intention to the  appropriate authority.
The notification shall include the following information:

((a)) the name and address of the applicant;
((b)) the name and description of the traditional food;
((c)) the detailed composition of the traditional food;
((d)) the country or countries of origin of the traditional food;
((e)) documented data demonstrating the history of safe food use in a third country;
((f)) 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.
Article 15 

1. The appropriate authority must forward the valid notification provided for in Article 14 without delay, and not later than one month after having verified its validity, to the Food Safety Authority.
2. Within four months from the date on which a valid notification under Article 14 is received by the appropriate authority, the Food Safety Authority may issue to the appropriate authority duly reasoned safety objections to the placing on the market within Great Britain  of the traditional food concerned.
3. The appropriate authority must inform the applicant of any duly reasoned safety objection as soon as it is issued.
4. Where no duly reasoned safety objections have been issued in accordance with paragraph 2 within the time limit laid down in that paragraph, the appropriate authority must authorise the placing on the market within  Great Britain  of the traditional food concerned ... without delay. The  authorisation  must specify that it concerns a traditional food from a third country. Where applicable, certain conditions for use, specific labelling requirements, or post market monitoring requirements may be specified.
5. Where duly reasoned safety objections have been issued in accordance with paragraph 2, the appropriate authority must not authorise the placing on the market within  Great Britain  of the traditional food concerned .... In that case, the applicant may submit an application to the appropriate authority in accordance with Article 16.
Article 16 
Where the appropriate authority does not authorise the placing on the market within Great Britain  of a traditional food from a third country, the applicant may submit an application including, in addition to the information already provided in accordance with Article 14, documented data relating to the duly reasoned safety objections issued in accordance with Article 15(2). The appropriate authority must, without delay, forward the valid application to the Food Safety Authority.
Article 17 

1. The Food Safety Authority must adopt its opinion within six months from the date of receipt of a valid application.
2. In assessing the safety of a traditional food from a third country, the Food Safety Authority must consider the following matters—
(a) whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant in accordance with Articles 14 and 16;
(b) whether the composition of the food and the conditions of its use do not pose a safety risk to human health in Great Britain;
(c) where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
3. The Food Safety Authority must forward its opinion to the appropriate authority and the applicant.
4. In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the six month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided and the six month period provided for in paragraph 1 is extended by that additional period.
5. Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.
6. Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the six month period provided for in paragraph 1.
7. The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.
Article 18 

1. Within three months of the date of publication of the Food Safety Authority's opinion, the appropriate authority must authorise the placing on the market within Great Britain  of the traditional food from a third country ..., taking into account the following—
(a) the conditions provided for in points (a) and (b) of Article 7 and, where applicable, point (c) of that Article;
(b) any relevant provision of law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No. 178/2002;
(c) the Food Safety Authority's opinion;
(d) any other legitimate factors relevant to the application under consideration.
2. By way of derogation from paragraph 1, the appropriate authority may, having taken account of the Food Safety Authority's opinion and any other legitimate factors relevant to the  authorisation  under consideration, terminate the procedure at any stage and decide not to  authorise the placing on the market of the traditional food where it considers that authorisation  is not justified. The appropriate authority must inform the applicant of the reasons for  its decision.
3. The applicant may withdraw its application referred to in Article 16 at any time, thereby terminating the procedure.
(4.) Where the appropriate authority determines the authorisation status of a traditional food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.
Article 19 
Articles 3A and 3B and 9 to 12 apply to modifying any specifications, conditions of use, specific labelling requirements or post-market monitoring requirements associated with the authorisation of a traditional food from a third country or to suspending or revoking an authorisation of a traditional food from a third country.
Article 20 
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CHAPTER IV
Article 21 

1. Where the appropriate authority requests from an applicant additional information on matters concerning risk management, the appropriate authority must determine, together with the applicant, the period within which that information is to be provided. In such cases, the period provided for in Article 12(1) or (2) or in Article 18(1) may be extended accordingly.
2. Where the additional information referred to in paragraph 1 is not received within the additional period referred to in that paragraph, the appropriate authority must act on the basis of the available information.
Article 22 
In exceptional circumstances, the appropriate authority may extend the time periods provided for in Articles 11(1), 12(1) or (2), 17(1) and 18(1) on its own initiative or, where applicable, at the Food Safety Authority's request, where the nature of the matter in question justifies an appropriate extension.
Article 23 

1. Applicants may request confidential treatment of certain information submitted under this Regulation where disclosure of such information may harm their competitive position.
2. For the purposes of paragraph 1, applicants must indicate which parts of the information provided they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality. Verifiable justification must be given in such cases.
3. After being informed of the appropriate authority's position on the request, applicants may withdraw their application within three weeks, during which the confidentiality of the information provided must be observed.
4. After expiry of the period referred to in paragraph 3, if an applicant has not withdrawn the application and in case of disagreement the appropriate authority must decide which parts of the information are to remain confidential and notify the applicant accordingly. However, the following information is not confidential—
(a) the name and address of the applicant;
(b) the name and description of the novel food;
(c) the proposed conditions of use of the novel food;
(d) a summary of the studies submitted by the applicant;
(e) the results of the studies carried out to demonstrate the safety of the food;
(f) where appropriate, the analysis method;
(g) any prohibition or restriction imposed in respect of the food by a third country.
5. The appropriate authority and the Food Safety Authority must take necessary measures to ensure appropriate confidentiality of the information as referred to in paragraph 4 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.
6. Where an applicant withdraws, or has withdrawn, its application, the appropriate authority and the Food Safety Authority must not disclose confidential information, including the information whose confidentiality is the subject of disagreement between the appropriate authority and the applicant.
7. The application of paragraphs 1 to 6 does not restrict the exchange of information concerning the application between the appropriate authority and the Food Safety Authority.
8. The appropriate authority may prescribe rules for the implementation of paragraphs 1 to 6.
Article 24 
The  appropriate authority  may, for food safety reasons and taking into account the opinion of the Authority, impose post-market monitoring requirements. Such requirements may include, on a case-by-case basis, the identification of the relevant food business operators.
Article 25 
Any food business operator which has placed a novel food on the market must immediately inform the Food Safety Authority of any information of which it has become aware concerning—

((a)) any new scientific or technical information which might influence the evaluation of the safety of use of the novel food;
((b)) any prohibition or restriction imposed by a third country in which the novel food is placed on the market.
CHAPTER V
Article 26 

1. On request by the applicant, and where supported by appropriate and verifiable information included in the application provided for in Article 10(1), newly developed scientific evidence or scientific data supporting the application shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the novel food without the agreement of the initial applicant.
2. The data protection shall be granted by the  appropriate authority  under Article 27(1) where the following conditions are met:
(a) the newly developed scientific evidence or scientific data was designated as proprietary by the initial applicant at the time the first application was made;
(b) the initial applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made; and
(c) the novel food could not have been assessed by the Authority and authorised without the submission of the proprietary scientific evidence or scientific data by the initial applicant.However, the initial applicant may agree with a subsequent applicant that such scientific evidence and scientific data may be used.
3. Paragraphs 1 and 2 shall not apply to notifications and applications concerning the placing on the market within  Great Britain  of traditional foods from third countries.
Article 27 

1. Where a novel food is authorised ... pursuant to Articles 10 to 12 based on proprietary scientific evidence or scientific data that are granted data protection as provided for in Article 26(1), the  authorisation of that novel food  must indicate, in addition to the information referred to in Article 9(3)—
(a) the date of  authorisation;
(b) the fact that that inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26;
(c) the name and address of the applicant;
(d) the fact that during the period of data protection the novel food is authorised for placing on the market within Great Britain  only by the applicant specified in point (c) of this paragraph, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 or with the agreement of the initial applicant;
(e) the end date of the data protection provided for in Article 26.
2. Scientific evidence or scientific data protected in accordance with Article 26 or for which the protection period under that Article has expired is not to be granted renewed protection.
Article 28 

1. The  appropriate authority must, on request by the applicant, stay an authorisation procedure for a novel food started following an application, where the applicant has submitted:
(a) a request for data protection in accordance with Article 26; and
(b) an application for the authorisation of a health claim on the same novel food in accordance with Article 15 or 18 of Regulation (EC) No 1924/2006, in conjunction with a request for data protection in accordance with Article 21 of that Regulation.The stay of the authorisation procedure shall be without prejudice to the assessment of the food by the  Food Safety Authority  in accordance with Article 11.
2. The  appropriate authority must  inform the applicant about the date of effect of the stay.
3. While the authorisation procedure is stayed, time shall cease to run for the purposes of the time-limit laid down in Article 12(1).
4. The authorisation procedure shall resume when  the opinion has been received  on the health claim pursuant to Regulation (EC) No 1924/2006.The  appropriate authority must  inform the applicant about the date of resumption of the authorisation procedure. From the date of resumption, time shall begin to run afresh from the beginning for the purposes of the time-limit laid down in Article 12(1) of this Regulation.
5. In the cases referred to in paragraph 1 of this Article, where data protection has been granted in accordance with Article 21 of Regulation (EC) No 1924/2006, the period of data protection granted in accordance with Article 26 of this Regulation shall not exceed the period of data protection granted in accordance with Article 21 of Regulation (EC) No 1924/2006.
6. The applicant may withdraw at any time the request for staying the authorisation procedure submitted in accordance with paragraph 1. In that case, the authorisation procedure shall resume and paragraph 5 shall not apply.
CHAPTER VI
Article 29 
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Article 30 
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Article 31 
For the purposes of achieving the objectives of this Regulation, the appropriate authority may prescribe changes to the definition of engineered nanomaterials referred to in point (f) of Article 3(2) to reflect technical and scientific progress or definitions agreed at international level.
Article 32 
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Article 32A 

(1. Any power to make regulations under this Regulation—
 (a)  so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
 (b)) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.
2. For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).
3. Any power to make regulations under this Regulation includes power—
 (a)) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and
 (b)) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
4. 
                      Any statutory instrument or Scottish statutory instrument  containing regulations made under this Regulation is subject to annulment in pursuance of a resolution—
 (a)) in the case of England, of either House of Parliament;
 (b)) in the case of Wales, of Senedd Cymru;
 (c)) in the case of Scotland, of the Scottish Parliament.
5. In this Regulation, any power—
 (a)) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
 (b)) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
 (c)) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.
CHAPTER VII
Article 33 
Regulation (EU) No 1169/2011 is amended as follows:

((1)) In Article 2(1) the following point is added:
'
(h) the definition of “engineered nanomaterials” as established by point (f) of Article 3(2) of Regulation (EU) 2015/2283 of the European Parliament and of the Council.
'.
((2)) Point (t) of Article 2(2) is deleted.
References to the deleted point (t) of Article 2(2) of Regulation (EU) No 1169/2011 shall be construed as references to point (f) of Article 3(2) of this Regulation.
((3)) In Article 18, paragraph 5 is deleted.
Article 34 
Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 are hereby repealed from 1 January 2018. References to Regulation (EC) No 258/97 shall be construed as references to this Regulation.
Article 35 

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2. A novel food, which is the subject of an application for authorisation submitted in accordance with Article 10, and which is received by the appropriate authority on or before 31 December 2023, may remain on the market in Great Britain until the application concludes, if—
(a) it did not fall within scope of Regulation (EC) No 258/97 before that Regulation was repealed;
(b) it was lawfully placed on the market in the European Union or the United Kingdom before 1 January 2018; and
(c) it was the subject of an application for authorisation or notification of a traditional food from a third country received by the European Commission on or before 1 January 2019.
(2A.) For the purpose of paragraph 2, an application concludes when—
(a) the appropriate authority informs the applicant, in accordance with Article 6(5) of Commission Implementing Regulation (EU) 2017/2469, that the application is not considered valid;
(b) the appropriate authority terminates the procedure in accordance with Article 10(6);
(c) the applicant withdraws the application; or
(d) there is a determination of the authorisation status of the novel food concerned.
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Article 36 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2018, except for the following provisions:

((a)) Article 4(4), Articles 8, 13 and 20, Article 23(8), Article 30 and Article 35(3) shall apply from 31 December 2015;
((b)) Article 4(2) and (3) shall apply from the date of application of the implementing acts referred to in Article 4(4);
((c)) Article 5 shall apply from 31 December 2015. However, implementing acts adopted under Article 5 shall not apply before 1 January 2018;
((d)) Articles 31 and 32 shall apply from 31 December 2015. However, delegated acts adopted under those Articles shall not apply before 1 January 2018.
...Done at Strasbourg, 25 November 2015.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
N. SCHMIT