The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025
In accordance with paragraph 5(1) and (5) of Schedule 5 to the 2023 Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.
PART 1Introductory
Citation, commencement and interpretation1.
(1)
These Regulations may be cited as the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025.
(2)
These Regulations come into force on 1st April 2025.
(3)
In these Regulations—
(a)
(b)
(c)
Extent and application2.
(1)
The following provisions of these Regulations extend to England and Wales—
(a)
this Part and Parts 2 to 8;
(b)
Schedules 2 to 9, 11 and 12.
(2)
The provisions in paragraph (1) apply to England and Wales, save as follows—
(a)
Schedules 2 and 11 apply only in relation to Wales;
(b)
Schedules 3 and 12 apply only in relation to England.
(3)
The following provisions of these Regulations extend to Scotland—
(a)
this Part and Parts 2 to 8;
(b)
Schedules 1 and 4 to 10.
PART 2Amendments relating to feed additives
Amendment of Regulation (EC) No 1831/20033.
(1)
Regulation (EC) No 1831/2003 is amended as follows.
(2)
“(t)
‘Register’ means the Register of Feed Additives referred to in Article 17.”.
(3)
In Article 3(3), omit “Regulation”.
(4)
In Article 4(2), omit “renewed,”.
(5)
In Article 5(1), for “Regulation authorising” substitute “authorisation concerned in respect of”
.
(6)
In Article 9—
(a)
in the heading, after “Authorisation” insert “by the appropriate authority”
;
(b)
in paragraph 1, in the third sentence, for “The authorisation must be prescribed by the appropriate authority and” substitute “Where the appropriate authority determines that the feed additive is to be authorised, the authorisation”
;
(c)
“7.
Where the appropriate authority determines that a feed additive is, or is not, to be authorised:
(a)
in the event of a determination to authorise the feed additive:
(i)
the appropriate authority must specify the date on which the authorisation is to have effect; and
(ii)
the Food Safety Authority must enter the authorisation, including the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number, in the Register;
(b)
the appropriate authority must communicate the determination to the Food Safety Authority.”.
(7)
“Article 12ASupervision: supplementary
1.
This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive.
2.
Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 13.
3.
The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 13.
4.
The Food Safety Authority may extend the period of time described in paragraph 3.
5.
Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 13 based on such information as the Food Safety Authority has which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive.
6.
In this Article, “relevant person” means any person who is—
(a)
the holder of the authorisation concerned;
(b)
a producer or manufacturer of the feed additive concerned; or
(c)
any feed business placing on the market, processing or using the feed additive concerned.”.
(8)
In Article 13—
(a)
in paragraph 1, in the first sentence, for “or following a request from the appropriate authority, the Food Safety Authority must” substitute “, the Food Safety Authority may, or following a request from the appropriate authority, the Food Safety Authority must,”
;
(b)
in paragraphs 2 and 3, in both places, for “in light of” substitute “having regard to”
;
(c)
“3A.
The appropriate authority must, in relation to any determination it makes under this Article:
(a)
specify the date on which the modification, suspension or revocation is to have effect; and
(b)
communicate the determination to the Food Safety Authority.”;
(d)
in paragraph 4—
(i)
in the words before point (a), for “appropriate authority must, without delay” substitute “Food Safety Authority, without delay after being informed by the appropriate authority, must”
;
(ii)
omit point (b);
(e)
“4A.
Where the appropriate authority determines that an authorisation of a feed additive is to be modified, suspended or revoked, the Food Safety Authority must update the Register accordingly.”;
(f)
“6.
For the purposes of this Article, 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 product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the product 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 product concerned, and any products derived from it or containing it, may continue to be applied.
7.
The appropriate authority may prescribe other transitional measures not falling within paragraph 6 in relation to the modification, suspension or revocation of an authorisation.”.
(9)
Omit Article 14.
(10)
In Article 15—
(a)
the existing paragraph is renumbered as paragraph 1;
(b)
in paragraph 1, as so renumbered, omit the second sentence;
(c)
“2.
The appropriate authority may withdraw a provisional authorisation given under paragraph 1.
3.
Where the appropriate authority determines that a provisional authorisation is to be withdrawn, the appropriate authority may specify, in relation to the withdrawal of a provisional authorisation, a period of time, or different periods of time, within which:
(a)
existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the product 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 product concerned, and any products derived from it or containing it, may continue to be applied.
4.
The appropriate authority may prescribe other transitional measures not falling within paragraph 3 in relation to the withdrawal of a provisional authorisation.
5.
Where the appropriate authority determines that a feed additive is, or is not, to be provisionally authorised (including a determination to withdraw a provisional authorisation), the appropriate authority must communicate the determination to the Food Safety Authority and:
(a)
in the event of a determination to provisionally authorise a feed additive:
(i)
the provisional authorisation must, to the extent that it is possible to do so, include information equivalent to that which must be included for an authorisation under Article 9(1);
(ii)
the appropriate authority must specify the date on which the provisional authorisation is to have effect; and
(iii)
the Food Safety Authority must enter the provisional authorisation, including the information mentioned in paragraph (i), in the Register;
(b)
in the event of a determination to withdraw a provisional authorisation:
(i)
the appropriate authority must specify the date on which the withdrawal is to have effect; and
(ii)
the Food Safety Authority must update the Register accordingly.”.
(11)
“2.
The Food Safety Authority must make the Register available to the public.”.
(12)
In Annex IV, in paragraph 1, omit “Regulation”.
Amendment of Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives4.
(1)
(2)
In Article 3(3), in the first subparagraph—
(a)
for “valid for the entire period of” substitute “for”
;
(b)
for “those expired” substitute “any that expire”
.
(3)
In Article 5(4), omit point (c).
(4)
In Annex IV, omit paragraph 5.
Amendment of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives5.
(1)
(2)
In Annex I, in the application form, in the first part, omit “Renewal of a feed additive authorisation (Article 14 of Regulation (EC) No 1831/2003)” and the corresponding checkbox.
(3)
In Annex II—
(a)
in the first paragraph (general aspects)—
(i)
at the end of the second indent, insert “or”
;
(ii)
at the end of the third indent, omit “, or”;
(iii)
omit the fourth indent (“a renewal of the authorisation of a feed additive”);
(b)
in section 5 (post-market monitoring plan), in the fourth paragraph, omit “, preferably during the latter part of the period of authorisation”.
(4)
In Annex III—
(a)
in the text before part 1 (technological additives), in the second paragraph (list of the specific requirements for establishing dossiers for:), omit “(10) Renewal of authorisations”;
(b)
in part 2 (sensory additives), in point 2.2.3.1., in paragraph (2), omit “(following by analogy Regulation (EU) No 872/2012)”;
(c)
omit part 10 (renewal of authorisations).
PART 3Amendments relating to food additives, food enzymes and food flavourings
Amendment of Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings6.
(1)
(2)
In Article 1—
(a)
in paragraph 2—
(i)
for “updating the lists” substitute “determining the authorisation status”
;
(ii)
for “the marketing of which is authorised pursuant to” substitute “for the purposes of”
;
(b)
in paragraph 3, for “included on the domestic list” to “Article 7” substitute “authorised”
.
(3)
In Article 2—
(a)
for the heading, substitute “Definitions”
;
(b)
omit paragraphs 1 and 2;
(c)
“7.
‘Substance’ includes a flavouring substance under evaluation, within the meaning given in Regulation (EC) No 1334/2008.”.
(4)
“Article 2ARequirement for appropriate authority to determine authorisation status
The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation.
Article 2BDetermination of authorisation status
1.
For the purposes of this Regulation, determining the authorisation status of a substance 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 substance;
(b)
modify the authorisation of a substance, including modifying any conditions, restrictions or specifications associated with the authorisation concerned;
(c)
revoke or suspend the authorisation of a substance.
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 substance concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the substance 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 substance 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 under the sectoral food law concerned and this Regulation.
4.
In this Article, “authorisation” includes the permission for a substance to be placed on the market or used in or on food under the sectoral food law concerned, and for this purpose includes food enzymes for which an application for initial authorisation has been entered in the Register under Regulation (EC) No 1332/2008 and flavouring substances under evaluation under Regulation (EC) No 1334/2008; and related terms are to be construed accordingly.
Article 2CDomestic list of substances
1.
The Authority must establish and maintain a list (the “domestic list”) of substances, the placing on the market, or the use in or on food, of which is permitted in accordance with the sectoral food law concerned and this Regulation.
2.
The Authority must make the domestic list available to the public.”.
(5)
In Article 3—
(a)
in paragraph 1, for “updating the domestic list” substitute “determining the authorisation status of a substance”
;
(b)
in paragraph 2, in the second subparagraph—
(i)
for “the updates referred to in Article 2(2)(b) and (c)” substitute “a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c)”
;
(ii)
for “the updates”, in the second place it occurs, substitute “any changes as a result of the determination”
;
(c)
in paragraph 3, for “prescribing the update” substitute “determining the authorisation status of the substance concerned”
;
(d)
in paragraph 4—
(i)
in the first subparagraph, in the first sentence—
(aa)
for “a planned update” substitute “determining the authorisation status of a substance”
;
(bb)
for “an update” substitute “a determination”
;
(ii)
in the second subparagraph, for “considering the update justified” substitute “determining the authorisation status of the substance concerned”
.
(6)
In Article 4(1), in the words before point (a), for “update the domestic list” substitute “determine the authorisation status of a substance”
.
(7)
In Article 7—
(a)
for the heading, substitute “Determination of authorisation status and amendment of sectoral food laws”
;
(b)
in paragraph 1, for “take the decision whether to update the domestic list” substitute “determine the authorisation status of the substance concerned,”
;
(c)
“1A.
Where the appropriate authority makes a determination as to the authorisation status of a substance:
(a)
the appropriate authority must:
(i)
specify the date on which the authorisation, modification, suspension or revocation is to have effect; and
(ii)
communicate the determination to the Authority;
(b)
the Authority must update the domestic list referred to in Article 2C accordingly.”;
(d)
in paragraph 3, for “decision”, in both places, substitute “determination”
;
(e)
in paragraph 4, for “removal of a substance from the domestic list” substitute “revocation of the authorisation of substances generally”
;
(f)
in paragraph 5—
(i)
for “addition of a substance to the domestic list” substitute “authorisation of substances generally”
;
(ii)
for “adding, removing or changing” substitute “modifying”
;
(iii)
for “presence of the substance on the domestic list” substitute “authorisation of substances generally”
.
Amendment of Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes, etc.7.
(1)
(2)
“(a)
the authorisation of food enzymes in accordance with this Regulation and Regulation (EC) No 1331/2008;”.
(3)
Before Article 4, for the heading for Chapter II, substitute “AUTHORISATION OF FOOD ENZYMES”
.
(4)
In Article 4—
(a)
for the heading, substitute “Requirement for authorisation”
;
(b)
in the text—
(i)
after “Only” insert “authorised”
;
(ii)
omit “included in the domestic list”;
(iii)
after “Article 7(2)” insert “(but see Article 24 with respect to the date of application of this Article)”
.
(5)
In Article 6—
(a)
in the heading, for “inclusion of food enzymes in the domestic list” substitute “authorisation of food enzymes”
;
(b)
in the words before point (a), for “included in the domestic list” substitute “authorised”
.
(6)
In Article 7—
(a)
in the heading, for “the domestic list of food enzymes” substitute “an authorisation of a food enzyme”
;
(b)
in paragraph 1, for “included in the domestic list” substitute “authorised”
;
(c)
in paragraph 2, in the words before point (a)—
(i)
for “entry” substitute “authorisation”
;
(ii)
omit “in the domestic list”;
(d)
in paragraph 3—
(i)
for “domestic list” substitute “authorisation status of a food enzyme”
;
(ii)
for “amended” substitute “determined”
.
(7)
In Article 8—
(a)
in paragraph 1, for “included in the domestic list” substitute “authorised”
;
(b)
in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”
.
(8)
“Article 8ADetails to be included in the domestic list
The Authority must include the details described in Article 7(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.”.
(9)
In Article 14(2), for “approved” substitute “authorised”
.
(10)
In Article 17—
(a)
for the heading, substitute “Initial authorisation of food enzymes”
;
(b)
“1.
This Article applies for the purpose of the authorisation (“initial authorisation”) of food enzymes which are to be included in the domestic list of food enzymes published and maintained under Regulation (EC) No 1331/2008 when it is first established by the Authority. The initial authorisation of food enzymes must be made in accordance with this Article.”;
(c)
in paragraph 2—
(i)
for “inclusion” substitute “initial authorisation”
;
(ii)
omit “in the domestic list”;
(d)
in paragraph 3—
(i)
for “inclusion in the domestic list” substitute “initial authorisation”
;
(ii)
for “hereinafter referred to as the Register” substitute “referred to in this Regulation as the ‘Register’”
;
(e)
in paragraph 4—
(i)
in the first subparagraph—
(aa)
for “The domestic list shall be adopted by the appropriate authority in” substitute “In”
;
(bb)
after “food flavourings,” insert “the appropriate authority must determine the authorisation status of all of the applications for initial authorisation entered in the Register”
;
(ii)
in the second subparagraph, omit point (b);
(f)
“4A.
This Article, and the Register, shall cease to have effect at the start of the day after the day on which the appropriate authority has determined the authorisation status of all initial authorisation applications in the Register.”.
(11)
In Article 18(1)—
(a)
in the words before point (a)—
(i)
omit “the domestic list shall, when drawn up, include”;
(ii)
after “enzymes” insert “are, immediately after the end of the day on which the appropriate authority determines the authorisation status of all the applications for initial authorisation in the Register in accordance with Article 17, to be deemed to be authorised for the purposes of this Regulation”
;
(b)
in point (a), for “stating the conditions governing their use as specified in Annex I and Part C of Annex III to Directive 95/2/EC” substitute “in accordance with any conditions of use set out in authorisations under Regulation (EC) No 1333/2008”
.
(12)
In Article 24, in the second subparagraph, for “date of application of the domestic list” substitute “start of the day after the day on which the appropriate authority has determined the authorisation status of all initial authorisation applications in the Register in accordance with Article 17”
.
Amendment of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives8.
(1)
(2)
In Article 1, in the second subparagraph—
(a)
“(a)
the authorisation of food additives;”;
(b)
in point (b)—
(i)
after “enzymes”, in the first place it occurs, insert “, food flavourings or nutrients,”
;
(ii)
omit “in food flavourings as covered by”;
(iii)
omit “of the European Parliament and of the Council of 16 December 2008”.
(3)
In Article 2(3), for “date of adoption of the domestic list of food enzymes in accordance with Article 17” substitute “start of the day after the day on which the appropriate authority has determined the authorisations status of all initial authorisation applications on the Register referred to in Article 17(3)”
.
(4)
“(j)
‘nutrients’ means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes, in accordance with Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods12, the Food Supplements (Scotland) Regulations 200313, the Food Supplements (England) Regulations 200314, the Food Supplements (Wales) Regulations 200315 and Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, etc.16, for the purposes of secondary use;(k)
‘primary use’ means the use of a food additive in food in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation;
(l)
‘secondary use’ means the use of a food additive, including carriers, in food additives, food enzymes, food flavourings or nutrients in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation.”.
(5)
Before Article 4, in the heading for Chapter II, for “DOMESTIC LISTS OF APPROVED” substitute “AUTHORISATION OF”
.
(6)
“Article 4Requirement for authorisation
1.
Only food additives authorised for primary use may be placed on the market as such and used in foods under the conditions of use specified in the authorisation concerned.
2.
Only food additives authorised for secondary use may be used in food additives, food enzymes, food flavourings and in nutrients under the conditions of use specified in the authorisation concerned.
3.
Where a food additive is authorised for primary use, the authorisation must include the categories of food to which the additive may be added.
4.
Where a food additive is authorised for secondary use, the authorisation must include the food additives, food enzymes, food flavourings and nutrients or categories thereof to which the food additive may be added.
5.
Food additives must comply with the specifications referred to in Article 14.”.
(7)
In Article 6—
(a)
for the heading, substitute “General conditions for authorisation of food additives”
;
(b)
in paragraph 1, in the words before point (a), for “included in the domestic lists in Annexes II and III” substitute “authorised”
;
(c)
in paragraph 2, in the words before point (a), for “included in the domestic lists in Annexes II and III” substitute “authorised”
;
(d)
in paragraph 3, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”
.
(8)
In Article 7, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”
.
(9)
In Article 8, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”
.
(10)
In Article 9(1), for “Food additives may be assigned in Annexes II and III” substitute “An authorisation may state that a food additive is assigned”
.
(11)
In Article 10—
(a)
in the heading, for “the domestic lists” substitute “an authorisation”
;
(b)
in paragraph 1, for “included in:” to the end substitute “authorised.”
;
(c)
in paragraph 2—
(i)
in the words before point (a), for “entry for a food additive in the domestic lists in Annexes II and III” substitute “authorisation of a food additive”
;
(ii)
in point (b), after “the foods” insert “, food additives, food enzymes, food flavourings or nutrients or categories thereof”
;
(iii)
“(e)
any specifications concerned, in accordance with Article 14.”;
(d)
omit paragraph 3.
(12)
In Article 11—
(a)
in paragraph 3, in the first sentence, for “Annex II” substitute “the authorisation for primary use concerned,”
;
(b)
in paragraph 4, for “Annex II” substitute “the authorisation for primary use concerned”
.
(13)
In Article 12—
(a)
in the heading and in the text, in each place, for “included in a domestic list” substitute “authorised”
;
(b)
for “entry in the domestic lists or a change in the specifications” substitute “authorisation or a modification to the existing authorisation”
.
(14)
In Article 13—
(a)
in paragraph 1, for “included in the domestic lists in Annexes II and III” substitute “authorised”
;
(b)
in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”
.
(15)
In Article 14—
(a)
for “adopted” substitute “set out in the authorisation concerned”
;
(b)
for “included in the domestic lists in Annexes II and III for the first time” substitute “authorised”
.
(16)
“Article 14AEthylene oxide: restrictions
1.
Ethylene oxide may not be used for sterilising purposes in food additives.
2.
Total residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide (i.e. ethylene oxide + (0.55 x 2-chloroethanol))), irrespective of origin, in authorised food additives, or mixtures of those food additives, must not exceed 0.1 mg/kg.
Article 14BDetails to be included in the domestic list
The Authority must include the details described in Article 10(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.”.
(17)
In Article 15—
(a)
after “Food additives” insert “authorised for primary use”
;
(b)
for “Annex II” substitute “the authorisations concerned”
.
(18)
In Article 16—
(a)
after “Food additives” insert “authorised for primary use”
;
(b)
for “Annex II to this Regulation” substitute “the authorisations concerned”
.
(19)
In Article 17, for “listed in Annex II to this Regulation may be used” substitute “that are authorised for primary use may be used, as provided for in the authorisations concerned,”
.
(20)
In Article 18—
(a)
in paragraph 1(a), for “Annex II” substitute “an authorisation for primary use for the food additive concerned”
;
(b)
in paragraph 1(b), for “or food flavouring”, in each place it occurs, substitute “, food flavouring or nutrient”
;
(c)
in paragraph 3, for “or food enzyme”, in both places, substitute “, food enzyme or nutrient”
;
(d)
“5.
Paragraph 1(a) does not apply to foods listed in Table 1, as regards food additives in general, or in Table 2, as regards food colours, in Annex Ia.”.
(21)
In Article 22(1)(a), for “in”, in the first place it occurs, substitute “under”
.
(22)
In Article 23(1)(a), for “in”, in the first place it occurs, substitute “under”
.
(23)
Omit Article 30.
(24)
Omit Article 31.
(25)
Omit Article 34.
(26)
“ANNEX IaCarry-over principle: Article 18(1)(a) – exceptions”.
(27)
Annex II is omitted, save that in Part A, in Section 2—
(a)
Table 1 (foods in which the presence of an additive may not be permitted by virtue of the carry-over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008); and
(b)
Table 2 (foods in which the presence of a food colour may not be permitted by virtue of the carry-over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008),
respectively, including their headings, become Table 1 and Table 2 following the heading in Annex Ia (as inserted by the previous paragraph of this regulation).
(28)
Omit Annex III.
Amendment of Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc.9.
(1)
(2)
In Article 1, in the second subparagraph—
(a)
“(a)
the authorisation of food flavourings and source materials for use in or on foods;”;
(b)
“(d)
the use of flavouring substances under evaluation in or on foods.”.
(3)
“(m)
‘flavouring substance under evaluation’ means a substance which, immediately before the entry into force of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025, was:
(i)
permitted to be placed on the market and used in or on foods by virtue of Article 4 of Commission Implementing Regulation (EU) No 872/201218; and(ii)
listed in a table (whether the table concerned related to England, Scotland or Wales) in Part A of Annex I to this Regulation and, in the entry for the substance concerned in that table, that substance was indicated by a footnote in column (8) of the table concerned.”.
(4)
In Article 8—
(a)
in the heading, for “approval” substitute “authorisation”
;
(b)
in paragraph 1, for “approval” substitute “authorisation”
.
(5)
Before Article 9, for the heading for Chapter III, substitute “AUTHORISATION OF FOOD FLAVOURINGS AND SOURCE MATERIALS FOR USE IN OR ON FOODS”
.
(6)
In Article 9, in the heading, for “approval” substitute “authorisation”
.
(7)
“Article 9AFlavouring substances under evaluation
1.
A flavouring substance under evaluation may, pursuant to regulation 23 (savings and transitional provision: general) of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025, continue to be placed on the market and used in or on foods, until the appropriate authority determines the authorisation status of that substance.
2.
The authorisation status of a flavouring substance under evaluation is to be determined in accordance with Regulation (EC) No 1331/2008.
3.
A substance ceases to be a flavouring substance under evaluation once the appropriate authority has determined the authorisation status of that substance.
Article 10Flavourings and source materials that may be placed on the market or used in or on foods
Only authorised flavourings and source materials referred to in Article 9 and, pursuant to regulation 23 (savings and transitional provision: general) of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025, flavouring substances under evaluation, may be placed on the market as such and used in or on foods under the conditions of use specified in relation to the substance concerned.”.
(8)
In Article 11—
(a)
for the heading, substitute “Authorisation of flavourings and source materials”
;
(b)
in paragraph 1, for “included in the domestic list” substitute “authorised”
;
(c)
in paragraph 2—
(i)
for “entry for” substitute “authorisation of”
;
(ii)
omit “in the domestic list”;
(iii)
for “approved” substitute “authorised”
;
(d)
omit paragraph 3.
(9)
In Article 12—
(a)
in paragraph 1, for “included in the domestic list in Annex I” substitute “authorised”
;
(b)
in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”
.
(10)
“Article 12ADetails to be included in the domestic list
The Authority must include in the domestic list published and maintained under Regulation (EC) No 1331/2008:
(a)
the details described in Article 11(2); and
(b)
equivalent information for each flavouring substance under evaluation.”.
(11)
In Article 19(2), for “approved” substitute “authorised”
.
(12)
Omit Annex I.
Amendment of Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008, etc.10.
(1)
(2)
In Article 4—
(a)
in point (g), omit “as defined in retained EU law on food additives”;
(b)
in point (i), omit “as defined in retained EU law on flavourings”.
(3)
In Article 6(1)(g)—
(a)
after “use levels in” omit “the”;
(b)
omit “mentioned in the domestic list”.
(4)
In Article 7(2)(f)—
(a)
after “use levels in” omit “the”;
(b)
omit “mentioned in the domestic list”.
(5)
In Article 10(1)(e)—
(a)
after “use levels in” omit “the”;
(b)
omit “according to the domestic list”.
(6)
In Article 12—
(a)
in paragraph 3, in the second subparagraph, for “establishment of the domestic list” substitute “the determination of applications for initial authorisation”
;
(b)
in paragraph 4, for “update the domestic list” substitute “determine the authorisation status”
.
(7)
In the Annex, in each model letter, in each place it occurs, for “in order to update the domestic list on” substitute “for a determination of authorisation status in relation to”
.
PART 4Amendments relating to food contact materials
Amendment of Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, etc.11.
(1)
(2)
“(h)
‘specific measure’ means a measure under Article 5.”.
(3)
In Article 5(1)—
(a)
in point (a), for “a list of” substitute “provision regulating”
;
(b)
in point (b)—
(i)
for “list(s) of”, in the first place it occurs, substitute “provision regulating”
;
(ii)
in the second place it occurs, omit “list(s) of”;
(iii)
omit “and, when necessary, special conditions of use for these substances”;
(c)
omit points (c) and (d);
(d)
in point (e) omit “specific”;
(e)
in point (m)—
(i)
for “provisions requiring the appropriate authority to establish and maintain” substitute “provision relating to the establishment and maintenance of”
;
(ii)
after “Register” insert “or list”
.
(4)
In Article 8—
(a)
“1.
A person seeking an authorisation for a substance in accordance with a specific measure, where that substance has not yet been authorised by the appropriate authority, must submit an application in accordance with Article 9(1) and any relevant provisions in the specific measure concerned.”;
(b)
in paragraph 2—
(i)
for “in the specific measures” substitute “out in the authorisation concerned”
;
(ii)
after “Article 4” insert “and any relevant specific measures”
.
(5)
In Article 11—
(a)
in paragraph 1—
(i)
for “prescribed” substitute “determined”
;
(ii)
for “in light of” substitute “, having regard to”
;
(b)
“1A.
Where the appropriate authority determines that a substance is, or is not to be, authorised, the appropriate authority must:
(a)
in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and
(b)
communicate the determination to the Food Safety Authority.”.
(6)
In Article 12—
(a)
in paragraph 4, for “may prescribe amendments to the authorisation” substitute “determine whether the authorisation is to be modified, suspended or revoked”
;
(b)
“4A.
Where the appropriate authority determines that an authorisation is, or is not, to be modified, suspended or revoked:
(a)
the appropriate authority must:
(i)
specify the date on which the modification, suspension or revocation is to have effect; and
(ii)
communicate the determination to the Food Safety Authority;
(b)
the Food Safety Authority must ensure that the domestic list referred to in Article 12A is updated accordingly.
4B.
For the purposes of this Article, 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 substance, material or article concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the substance, material or article 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 substance, material or article concerned, and any products derived from it or containing it, may continue to be applied.
4C.
The appropriate authority may prescribe other transitional measures not falling within paragraph 4B in relation to the modification, suspension or revocation of an authorisation.”.
(7)
“Article 12ADomestic list of authorised substances
1.
The Food Safety Authority must establish and maintain a list (the “domestic list”) of substances authorised for use in materials and articles, including any restrictions or conditions specified by the appropriate authority under Article 11.
2.
The domestic list must be made available to the public.”.
(8)
In Article 18(1), for “application of the provisions” substitute “the authorisation of the material or article”
.
Amendment of Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food12.
(1)
(2)
“(g)
‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004;
(h)
‘registered substance’ means a substance that was entered in the Register immediately before IP completion day;
(i)
‘Register’ means the “Register of substances for which a valid application for authorisation was submitted under Regulation (EC) No 450/2009” published by the European Commission, dated 14 June 2012, version 1.1, as it had effect in the European Union immediately before IP completion day23.”.
(3)
Before Article 5, for the heading for “Section 1”, substitute “Authorised substances”
.
(4)
In Article 5—
(a)
for the heading, substitute “Requirement for authorisation”
;
(b)
“1.
Only substances that are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) No 1935/2004 may be used in components of active and intelligent materials and articles.”;
(c)
in paragraph 2, in the words before point (a), for “included in the list” substitute “authorised”
.
(5)
In Article 6—
(a)
in the heading, for “inclusion of substances in the list” substitute “authorisation”
;
(b)
in the text, for “included in the list” substitute “authorised”
.
(6)
In Article 7—
(a)
in the heading, for “the list” substitute “an authorisation”
;
(b)
in the words before point (a), for “The list” substitute “An authorisation”
.
(7)
“Article 8ARegistered substances
1.
The Food Safety Authority may ask a person (“the applicant”) who applied for a registered substance to be entered in the Register to provide, within a specified period, such supplementary information or additional data as the Food Safety Authority considers necessary to evaluate that substance for the purpose of delivering its opinion to the appropriate authority prior to the determination of the authorisation status of that substance.
2.
The Food Safety Authority may extend the period of time described in paragraph 1.
3.
Where the Food Safety Authority makes a request under paragraph 1 and the applicant fails to provide the information or data requested within the specified period (including any extension of that period), the substance shall cease to be treated as a registered substance after the end of the day on which the applicant was required to provide the requested information but failed to do so.
4.
Before determining the authorisation status of all registered substances (which, under Article 14, would cause Article 4(e) and 5 to begin to apply), the appropriate authority must:
(a)
have regard to substances (“unregistered substances”) other than registered substances lawfully placed on the market; and
(b)
consider the time that may reasonably be needed by a person to apply for an unregistered substance to be authorised in accordance with Regulation (EC) No 1935/2004 and this Regulation.
Article 8BDetermination of authorisation status: registered substances
1.
For the purposes of Article 8A, determining the authorisation status of a registered substance is to consist of the appropriate authority determining whether the registered substance is:
(a)
to be authorised for placing on the market or for use in contact with food;
(b)
to cease to be permitted to be placed on the market or used in contact with food, and to cease to be a registered substance.
2.
A determination of a type falling within paragraph 1(b) may specify a period of time, or different periods of time, within which:
(a)
existing stocks of the registered substance concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the registered substance 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 registered substance concerned, and any products derived from it or containing it, may continue to be applied.
3.
Where the appropriate authority makes a determination as to the authorisation status of a registered substance, the appropriate authority must:
(a)
in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and
(b)
communicate the determination to the Food Safety Authority.”.
(8)
Before Article 9, in the heading for “Section 2”, for “not to be included in the list” substitute “referred to in Article 5(2)”
.
(9)
In Article 14—
(a)
in the second paragraph, for “of application of the Community list” substitute “that the appropriate authority determines the authorisation status of all registered substances in the Register pursuant to Article 8A and 8B”
;
(b)
in the final paragraph—
(i)
for “of application of the Community list,” substitute “described in the second paragraph of this Article, registered substances and other”
;
(ii)
for “authorised” substitute “permitted to be placed on the market”
;
(iii)
in the second place it occurs, omit “Community”.
Amendment of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food13.
(1)
(2)
“(20)
‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004.”.
(3)
In Article 5—
(a)
for the heading, substitute “Requirement for authorisation”
;
(b)
“1.
Only substances of a type falling within paragraph 2 and which are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) 1935/2004 may be intentionally used in the manufacture of plastic layers in plastic materials and articles.”;
(c)
in paragraph 2, in the words before point (a), for “The list shall contain:” substitute “For the purposes of paragraph 1, the types of substances that may be authorised are:”
;
(d)
omit paragraph 3.
(4)
Omit Article 5A.
(5)
In Article 6—
(a)
in the heading, for “not included in the list” substitute “that are not authorised”
;
(b)
in paragraph 1, for “included in the list” substitute “that are authorised”
;
(c)
in paragraph 3, for “not included in the list are authorised” substitute “, if not otherwise authorised, are nevertheless deemed to be authorised,”
;
(d)
in paragraph 4, for “not included in the list” substitute “, if not otherwise authorised,”
;
(e)
in paragraph 5—
(i)
for “not included in the list” substitute “that were not authorised”
;
(ii)
for “to include or not to include them in the list” substitute “on whether or not they are to be authorised,”
.
(6)
In Article 7—
(a)
in paragraph 1, for “regularly prescribe” substitute “determine whether there are to be”
;
(b)
in paragraph 2—
(i)
in point (a), for “included in the list set out in Annex 1” substitute “authorised”
;
(ii)
in point (b), for “include it in the list” substitute “authorise it”
;
(c)
“3.
Where the appropriate authority determines that there is to be an update to the provisional list, the appropriate authority must:
(a)
specify the date on which the update is to have effect; and
(b)
communicate the determination to the Food Safety Authority.
4.
The Food Safety Authority must publish and maintain the provisional list, and where the Food Safety Authority is informed by the appropriate authority that there is to be an update to the provisional list, the Food Safety Authority must publish the update.”.
(7)
In Article 9—
(a)
in paragraph 1—
(i)
in point (c)—
(aa)
for “the” substitute “any”
;
(bb)
for “column 10 of Table 1 of point 1 of Annex I” substitute “the authorisations for the substances concerned”
;
(ii)
in point (d)—
(aa)
for “the” substitute “any”
;
(bb)
for “in point 4 of Annex I” substitute “the authorisations for the substances concerned”
;
(b)
in paragraph 2, for “in Annex I” substitute “concerned”
.
(8)
In Article 11—
(a)
in paragraph 1, for “Annex I” substitute “the authorisations for the substances concerned”
;
(b)
in paragraph 3(a), for “in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation” substitute “pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008 or this Regulation”
;
(c)
in paragraph 3(b), for “Annex I to this Regulation” substitute “the authorisations for the substances concerned”
.
(9)
In Article 13—
(a)
in paragraph 2—
(i)
in point (a)—
(aa)
after “set out in” insert “, or pursuant to,”
;
(bb)
for “Annex I” substitute “the authorisation for the substance concerned”
;
(ii)
in point (b), for “not listed in the list or” substitute “that are not authorised or not listed”
;
(b)
in paragraph 4, omit “not listed in the list or provisional list”.
(10)
In Article 14—
(a)
in paragraph 2, for “not listed in the list or” substitute “that are not authorised or in”
;
(b)
in paragraph 3, in the words before point (a), omit “not listed in the list or provisional list”;
(c)
in paragraph 5, for “Annex I to this Regulation” substitute “the authorisation for the substance concerned”
.
(11)
In Article 19—
(a)
in the heading, for “not included in the list” substitute “that are not authorised”
;
(b)
in the text, for “covered by an inclusion in Annex I to this Regulation” substitute “authorised substances”
.
(12)
In Article 22, omit paragraph 4.
(13)
Omit Annex I.
(14)
In Annex II—
(a)
in note (2) to Table 1, omit “The note in Annex I, Table 1, FCM No 398 applies:”;
(b)
after the notes to Table 1, in paragraph 2 (which begins with the words “Primary aromatic amines”)—
(i)
for “Table 1 of Annex I” substitute “an authorisation for the substance concerned”
;
(ii)
for “Annex I”, in the second place it occurs, substitute “the authorisation concerned”
.
(15)
In Annex IV, in point (6), for “Annex I and” substitute “the authorisation for the substance concerned and in Annex”
.
(16)
In Annex V—
(a)
in Chapter 2, in point 2.1.8., for “Annex I” substitute “the authorisation for the substance concerned”
;
(b)
in Chapter 4, in point 4.1., in the first sentence—
(i)
omit “in Annex I”;
(ii)
for “column 7” substitute “the authorisation for the substance concerned”
.
PART 5Amendments relating to products containing, consisting of, or produced from, genetically modified organisms
Amendment of Regulation (EC) No 1829/200314.
(1)
Regulation (EC) No 1829/2003 is amended as follows.
(2)
“24.
‘Register’ means the register of genetically modified food and feed referred to in Article 28.”.
(3)
In Article 4(5), omit “renewed,”.
(4)
In Article 7—
(a)
in paragraph 3, for “Any authorisation” to “authority and” substitute “Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation”
;
(b)
in paragraph 4—
(i)
omit the first sentence;
(ii)
in the second sentence, after “entered” insert “, by the Food Safety Authority,”
.
(5)
“Article 9ASupervision: supplementary
1.
This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of detection, of the authorised food concerned.
2.
Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 10.
3.
The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 10.
4.
The Food Safety Authority may extend the period of time described in paragraph 3.
5.
Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 10 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the food concerned or the suitability of the method of detection.
6.
In this Article, “relevant person” means any person who is—
(a)
the authorisation-holder;
(b)
a producer or manufacturer of the food concerned; or
(c)
any food business placing on the market the food concerned.”.
(6)
In Article 10—
(a)
in paragraph 2, for the third sentence substitute “The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.”
;
(b)
“2A.
Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the 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 Register accordingly.”;
(c)
“4.
For the purposes of this Article, 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 product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the product 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 product concerned, and any products derived from it or containing it, may continue to be applied.
5.
The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.”.
(7)
Omit Article 11.
(8)
In Article 16(5), omit “renewed,”.
(9)
In Article 19—
(a)
in paragraph 3, for “Any authorisation” to “authority and” substitute “Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation”
;
(b)
in paragraph 4—
(i)
omit the first sentence;
(ii)
in the second sentence, after “entered” insert “, by the Food Safety Authority,”
.
(10)
“Article 21ASupervision: supplementary
1.
This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of detection, of the authorised feed concerned.
2.
Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 22.
3.
The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 22.
4.
The Food Safety Authority may extend the period of time described in paragraph 3.
5.
Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 22 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the feed concerned or the suitability of the method of detection.
6.
In this Article, “relevant person” means any person who is—
(a)
the authorisation-holder;
(b)
a producer or manufacturer of the feed concerned; or
(c)
any feed business placing on the market, processing or using the feed concerned.”.
(11)
In Article 22—
(a)
in paragraph 2, for the third sentence substitute “The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.”
;
(b)
“2A.
Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the 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 Register accordingly.”;
(c)
“4.
For the purposes of this Article, 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 product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the product 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 product concerned, and any products derived from it or containing it, may continue to be applied.
5.
The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.”.
(12)
Omit Article 23.
(13)
In Article 28—
(a)
in paragraph 1—
(i)
omit “and maintain”; and
(ii)
for “hereinafter” substitute “in this Regulation”
;
(b)
“2.
The Food Safety Authority must maintain the Register and make it available to the public.”.
(14)
In Article 44(1), omit “renewal,”.
Amendment of Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material, etc.15.
(1)
(2)
In Article 2—
(a)
in point (b), omit the “and” at the end;
(b)
omit point (c).
Amendment of Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed, etc.16.
(1)
(2)
In Article 1, in the words before point (a), for “5, 11, 17 and 23” substitute “5 and 17”
.
(3)
In Article 8—
(a)
in the heading, for “5(3), 11(2), 17(3) and 23(2)” substitute “5(3) and 17(3)”
;
(b)
omit paragraph 2.
(4)
In Annex III, in section 4 (certified reference material), in the second paragraph, for “throughout the period of validity of the authorisation” substitute “with respect to the authorisation, and whilst the authorisation continues to have effect”
.
PART 6Amendments relating to novel foods
Amendment of Regulation (EU) 2015/2283 on novel foods, etc.17.
(1)
(2)
In Article 3(2), omit point (k).
(3)
“Article 3ADetermination of authorisation status
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 3BDomestic list of authorised novel foods
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.”.
(4)
“Article 6Requirement for authorisation
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.”.
(5)
In Article 7—
(a)
in the heading, for “inclusion of novel foods in the list” substitute “authorisation of novel foods”
;
(b)
in the words before point (a), for “and include a novel food in the list” substitute “a novel food”
.
(6)
In Article 9—
(a)
for the heading, substitute “Obligations of the appropriate authority in relation to the procedure for determining authorisation status and content of an authorisation”
;
(b)
in paragraph 1, in the words before point (a), for “authorise a novel food and update the list” substitute “determine the authorisation status of a novel food”
;
(c)
omit paragraph 2;
(d)
in paragraph 3, in the words before point (a), for “The entry for a novel food in the list provided for in paragraph 2” substitute “The authorisation of a novel food”
.
(7)
In Article 10—
(a)
for the heading, substitute “Procedure for determining authorisation status”
;
(b)
in paragraph 1, in the first sentence—
(i)
for “authorising the placing on the market within Great Britain” substitute “determining the authorisation status”
;
(ii)
omit “and updating the list”;
(c)
in paragraph 3, for “update” substitute “proposed determination of authorisation status”
;
(d)
in paragraph 5—
(i)
omit “and updating the list”;
(ii)
for “prescribes an update of the list in respect” substitute “determines the authorisation status”
;
(e)
in paragraph 6—
(i)
for “an update of the list” substitute “a determination of the authorisation status of the novel food concerned”
;
(ii)
for “an update”, in the second place it occurs, substitute “a determination”
.
(8)
In Article 12—
(a)
in the heading, omit “and updates of the list”;
(b)
in paragraph 1, in the words before point (a), for “, by prescribing an update of the list, authorise the placing on the market within Great Britain” substitute “determine the authorisation status”
;
(c)
“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.”.
(9)
In Article 15—
(a)
in paragraph 4—
(i)
in the first sentence, omit “by prescribing an update to the list”;
(ii)
in the second sentence, for “entry in the list” substitute “authorisation”
;
(b)
in paragraph 5, omit “or update the list”.
(10)
In Article 18—
(a)
in the heading, omit “and updates of the list”;
(b)
in paragraph 1, in the words before point (a), omit “by prescribing an update of the list”;
(c)
in paragraph 2—
(i)
in the first sentence—
(aa)
for “update”, in the first place it occurs, substitute “authorisation”
;
(bb)
for “proceed with an update of the list where it considers that such an update” substitute “authorise the placing on the market of the traditional food where it considers that authorisation”
;
(ii)
in the second sentence, for “not considering the update to be justified” substitute “its decision”
;
(d)
“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.”.
(11)
“Article 19Application of provisions to authorised traditional foods from third countries
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.”.
(12)
In Article 23, in the heading, for “updates of the list” substitute “authorisation”
.
(13)
In Article 27—
(a)
in the heading, omit “and inclusion in the list”;
(b)
in paragraph 1—
(i)
in the words before point (a)—
(aa)
omit “and included in the list”;
(bb)
for “entry of that novel food in the list” substitute “authorisation of that novel food”
;
(ii)
in point (a), for “inclusion of the novel food in the list” substitute “authorisation”
.
(14)
“(d)
there is a determination of the authorisation status of the novel food concerned.”.
Amendment of Commission Implementing Regulation (EU) 2017/246818.
(1)
(2)
In Annexes I and II, in the template cover letter in each Annex, for “in order to update the list on” substitute “for a determination of authorisation status in relation to”
.
Amendment of Commission Implementing Regulation (EU) 2017/246919.
(1)
(2)
In Annex I, in the template cover letter, for “in order to update the list on” substitute “for a determination of authorisation status in relation to”
.
PART 7Amendments relating to smoke flavourings
Amendment of Regulation (EC) No 2065/200320.
(1)
Regulation (EC) No 2065/2003 is amended as follows.
(2)
In Article 1(2)—
(a)
in point (a), at the end, insert “, and their conditions of use in or on foods”
;
(b)
omit point (b).
(3)
In Article 3, omit paragraph 8.
(4)
In Article 4(2), for “Article 6” substitute “this Regulation”
.
(5)
In Article 6—
(a)
for the heading, substitute “Content of authorisations”
;
(b)
omit paragraph 1;
(c)
in paragraph 2, for “list referred to in paragraph 1 shall give” substitute “authorisation must include”
;
(d)
omit paragraph 3.
(6)
“Article 6ADomestic list of authorised smoke flavouring primary products
1.
The Authority must establish and maintain a list (the “domestic list”) of primary products for use as such in or on foods or for the production of derived smoke flavourings, which have been authorised in accordance with this Regulation, including the details described in Article 6(2).
2.
The Authority must make the domestic list available to the public.”.
(7)
In Article 7(1)—
(a)
for “inclusion” substitute “authorisation”
;
(b)
omit “in the list referred to in Article 6(1)”.
(8)
In Article 9—
(a)
in paragraph 1—
(i)
in the first sentence; for “include a primary product in the list referred to in Article 6(1)” substitute “authorise the primary product”
;
(ii)
in the second sentence, for “inform the” substitute “specify the date on which the authorisation (if it is a decision to authorise) is to have effect, and inform the Authority and the”
;
(b)
omit paragraphs 2 and 3.
(9)
“Article 9ASupervision
1.
This Article applies where the Authority receives, or becomes aware of, any information which might affect the assessment of the safety of an authorised primary product or derived smoke flavouring.
2.
Where the Authority receives, or becomes aware of, information under paragraph 1, the Authority must consider whether it is necessary to issue an opinion under Article 11(2).
3.
The Authority may ask a relevant person to provide, within a specified period, such other information as the Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 11(2).
4.
The Authority may extend the period of time described in paragraph 3.
5.
Where the Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Authority must consider whether it is necessary to issue an opinion under Article 11(2) based on such information as the Authority has which might affect the assessment of the safety of the authorised primary product or derived smoke flavouring concerned.
6.
In this Article, “relevant person” means any person who is—
(a)
the authorisation holder of the authorised primary product or derived smoke flavouring concerned;
(b)
a producer or manufacturer of the authorised primary product or derived smoke flavouring concerned; or
(c)
any food business placing on the market or using the authorised primary product or derived smoke flavouring concerned.”.
(10)
In Article 11—
(a)
“2.
An opinion on whether an authorisation or the requested modification is still in accordance with this Regulation, following the procedure laid down in Article 8, where applicable:
(a)
may be delivered by the Authority of its own initiative to the appropriate authority; or
(b)
must be delivered by the Authority to the appropriate authority:
(i)
following an application under paragraph 1, but only where the modification could affect the safety assessment of the authorised primary product; or
(ii)
following a request to do so from the appropriate authority.”;
(b)
in paragraph 3, for “the entry for that authorisation” substitute “, suspend or revoke the authorisation”
;
(c)
“4.
Where the appropriate authority decides to modify, suspend or revoke an authorisation, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the decision to the Authority, and the Authority must update the domestic list referred to in Article 6A accordingly.
4A.
For the purposes of this Article, 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 product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)
the product 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 product concerned, and any products derived from it or containing it, may continue to be applied.
4B.
The appropriate authority may prescribe other transitional measures not falling within paragraph 4A in relation to the modification, suspension or revocation of an authorisation.”.
(11)
Omit Article 12.
(12)
In Article 13(1)—
(a)
in the words before point (a), omit “specified in the list referred to in Article 6(1)”;
(b)
in point (a), omit “as given in the list referred to in Article 6(1)”;
(c)
in point (b), omit “as set out in the list referred to in Article 6(1)”;
(d)
in point (c), for “set out in the list referred to in Article 6(1)” substitute “for that product”
.
(13)
In Article 18—
(a)
in the heading, after “Amendments” insert “to the Annexes”
;
(b)
omit the “and” at the end of point (a);
(c)
omit point (b).
(14)
Omit Article 20.
PART 8Revocations, consequential amendments, savings and transitional provision
Revocations21.
(1)
Schedules 1, 2 and 3 have effect.
(2)
The instruments listed in Schedules 4 to 8 are revoked.
Consequential amendments22.
Schedules 9 to 12 have effect.
Savings and transitional provision: general23.
(1)
Subject to paragraphs (2) and (3), an authorisation set out in relevant revoked provision continues to have effect following the entry into force of these Regulations—
(a)
as it had effect under regulated products legislation immediately before the entry into force of these Regulations, notwithstanding the revocation of any provision by these Regulations; and
(b)
as if it were an authorisation made under, and subject to, that regulated products legislation as amended by these Regulations.
(2)
This paragraph applies to any authorisation made under the following instruments that is set out in relevant revoked provision—
(a)
Regulation (EC) No 1829/2003;
(b)
Regulation (EC) No 1831/2003, except for any urgent provisional authorisation made under Article 15 of that instrument; or
(c)
Regulation (EC) No 2065/2003.
(3)
For the purposes of paragraph (1), an authorisation to which paragraph (2) applies continues to have effect as if it did not contain a period of validity or an authorisation period end date.
(4)
An authorisation falling within paragraph (1) must be published in accordance with the regulated products legislation applicable to the authorisation concerned, as that regulated products legislation has effect immediately after the coming into force of these Regulations.
(5)
In this regulation—
subject to paragraph (6), an “authorisation”—
(a)
(b)
includes any terms, conditions and specifications on, or pursuant to, which anything, immediately before the entry into force of these Regulations, remained allowed to be used, processed or placed on the market by virtue of the operation of any of the following provisions, as they had effect immediately before the entry into force of these Regulations—
- (i)
Article 11(4) or 23(4) of Regulation (EC) No 1829/2003;
- (ii)
Article 14(4) of Regulation (EC) No 1831/2003; or
- (iii)
Article 12(4) of Regulation (EC) No 2065/2003;
“authorisation period end date” means a date—
(a)
at, on or by which the authorisation or the period of authorisation was expressed as ending; or
(b)
until which the authorisation was expressed as being valid;
“period of validity” means a period during which the authorisation concerned was expressed as being valid;
“regulated products legislation” means an instrument amended by Parts 2 to 7 of these Regulations;
“relevant revoked provision” means—
(a)
the instruments revoked by Schedules 1, 2 and 3;
(b)
the assimilated direct legislation revoked by Schedules 4 to 7;
(c)
Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;
(d)
Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc.; or
(e)
Annex I to Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
(6)
But, for the purpose of this regulation, an authorisation does not include any terms, conditions and specifications on, or pursuant to, which anything was, immediately before the entry into force of these Regulations, permitted to be used, processed or placed on the market pursuant to a saving or transitional provision in an instrument—
(i)
made under Regulation (EC) No 1829/2003;
(ii)
made under Regulation (EC) No 1831/2003;
(iii)
that amended relevant revoked provision; or
(iv)
revoked by Schedule 1, 2 or 3.
Savings in relation to the operation of Article 10 of Regulation (EC) No 1831/200324.
Notwithstanding the amendments or revocations made by regulations 3(4) and (9), 4 and 5, the following provisions continue to have effect as they did immediately before the entry into force of these Regulations insofar as is necessary for the continued operation of Article 10 of Regulation (EC) No 1831/2003 after the entry into force of these Regulations—
(a)
Article 4(2) and 14 of Regulation (EC) No 1831/2003;
(b)
Article 3(3), 5(4)(c) and Annex IV paragraph 5 of Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives;
(c)
Annex I, II and III of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives.
Signed by authority of the Secretary of State for Health and Social Care
SCHEDULE 1Revocations with savings: Scotland statutory instruments
The following Scottish statutory instruments are revoked in full unless specified otherwise—
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
SCHEDULE 2Revocations with savings: Wales statutory instruments
The following statutory instruments are revoked in full unless specified otherwise—
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
SCHEDULE 3Revocations with savings: England statutory instruments
The following statutory instruments are revoked in full unless specified otherwise—
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
SCHEDULE 4Revocations: miscellaneous assimilated direct legislation
Revocation of assimilated direct legislation: miscellaneous instruments
1.
Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council.
2.
Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008, etc.
3.
4.
SCHEDULE 5Revocation of assimilated direct legislation: instruments containing feed additives authorisations
Revocation of assimilated direct legislation containing feed additives authorisations
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
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17.
18.
19.
20.
21.
22.
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24.
25.
26.
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32.
33.
34.
35.
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38.
39.
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41.
42.
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48.
49.
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51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
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398.
399.
400.
401.
402.
403.
404.
405.
406.
407.
408.
409.
410.
411.
SCHEDULE 6Revocation of assimilated direct legislation: instruments containing authorisations of products containing, consisting of, or produced from, genetically modified organisms
Revocation of assimilated direct legislation containing authorisations of products containing, consisting of, or produced from, genetically modified organisms
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
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53.
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55.
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60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.
77.
SCHEDULE 7Revocation of assimilated direct legislation: instruments containing, and relating to, novel foods authorisations
Revocation of assimilated direct legislation containing, and relating to, novel foods authorisations
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
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42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
SCHEDULE 8Revocation of assimilated direct legislation that is redundant by virtue of the revocations in Schedules 5 and 6
PART 1Assimilated direct legislation: redundant feed additives amending instruments
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
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22.
23.
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32.
33.
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35.
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37.
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39.
40.
41.
42.
43.
44.
45.
46.
PART 2Assimilated direct legislation: redundant amending instruments in respect of products containing, consisting of, or produced from, genetically modified organisms
1.
2.
3.
4.
5.
6.
7.
8.
9.
SCHEDULE 9Consequential amendments to assimilated direct legislation
Amendment of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, etc.
1.
(1)
(2)
In Article 1(5)(e)(ii), omit “or Commission implementing Regulation (EU) No 872/2012” to the end.
Amendment of Regulation (EC) No 1907/2006 (REACH), etc.
2.
(1)
(2)
In Article 2(5)(b)(ii) and (6)(d)(ii), in each place, omit “or Commission Implementing Regulation (EU) No 872/2012” to the end.
Amendment of Commission Regulation (EU) No 101/2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases
3.
(1)
(2)
In the Annex, in Part 1, in paragraph 1, for “Regulation (EU) No 231/2012” substitute “accordance with authorisations for food additives under Regulation (EC) No 1333/2008”
.
Amendment of Commission Delegated Regulation (EU) 2019/934 supplementing Regulation (EU) No 1308/2013 as regards wine-growing areas where the alcoholic strength may be increased, etc.
4.
(1)
(2)
In Article 9(1), for “by Commission Regulation (EU) No 231/2012” substitute “in specifications for food additives authorised under Regulation (EC) No 1333/2008”
.
(3)
In Annex I—
(a)
in Part A, in Table 2 (authorised oenological compounds as referred to in Article 3(1)), in rows 4.1 and 4.1a (microcrystalline cellulose), in column 7 (conditions and limits of use), for “laid down in the Annex to Regulation (EU) No 231/2012” substitute “for food additives authorised under Regulation (EC) No 1333/2008”
;
(b)
in Appendix 1 (tartaric acid (L(+)-) and derived products), in paragraph 2, for “Regulation (EU) No 231/2012” substitute “accordance with authorisations for food additives under Regulation (EC) No 1333/2008”
.
SCHEDULE 10Consequential amendments to Scotland statutory instruments or to provision in statutory instruments extending only to Scotland
Amendment of the Bread and Flour Regulations 1998
1.
(1)
(2)
In regulation 2(1), in the definition of “food additive” omit “as last amended by Commission Regulation (EU) 2018/1497”.
Amendment of the Specified Sugar Products (Scotland) Regulations 2003
2.
(1)
(2)
“7.
Specified sugar products may contain—
(a)
a permitted extraction solvent, as defined in regulation 9 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013;
(b)
any food additive authorised under Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives.”.
Amendment of the Materials and Articles in Contact with Food (Scotland) Regulations 2012
3.
(1)
(2)
In regulation 12(3)—
(a)
for “listed in Annex I to” substitute “authorised under”
;
(b)
for “that Annex” substitute “the authorisations concerned”
.
(3)
In regulation 14(1), for “22(4) and (5)” substitute “22(5)”
.
(4)
In Schedule 1, in the first column of the table—
(a)
in each place it occurs, omit “and Annex I” and “and Annex 1”;
(b)
in the row relating to Article 9, omit “as read with Annex I”.
Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013
4.
(1)
(2)
In regulation 2—
(a)
in paragraph (1)—
(i)
in the definition of “Regulation 1333/2008”, omit “, as read with” to the end;
(ii)
in the definition of “Regulation 1334/2008”, omit “, as read with” to the end;
(b)
in paragraph (3)—
(i)
for “an Article of or Annex to” substitute “a provision of”
;
(ii)
for “Article or Annex” substitute “provision”
.
(3)
In regulation 4, omit “Article 4” to “Council and with”.
(4)
In regulation 5, omit “as read with Article 20 (transitional measures) of that Regulation,”.
(5)
In regulation 16(1)—
(a)
in sub-paragraph (b), omit “as read with Article 4 of Commission Implementing Regulation (EU) No 872/2012 and”;
(b)
in sub-paragraph (c), omit “, as read with Article 20 of Regulation 2065/2003”.
(6)
In Schedule 1, in the table, in the second column—
(a)
in the row for Article 4.1—
(i)
for “included in the list in Annex II to” substitute “authorised in accordance with”
;
(ii)
for “that Annex” substitute “in the authorisations concerned”
;
(b)
in the row for Article 4.2—
(i)
for “included in the list in Annex III to” substitute “authorised in accordance with”
;
(ii)
for “that Annex” substitute “the authorisations concerned”
;
(c)
in the rows for Article 15 and for Article 16, for “Annex II to”, in both places, substitute “authorisations in accordance with”
;
(d)
in the row for Article 17, for “listed in Annex II to” substitute “authorised in accordance with”
.
(7)
In Schedule 2, in the table, in the second column, in the row for Article 10, for “included on the Union list” substitute “permitted to be placed on the market or used in or on foods in accordance with Regulation 1334/2008”
.
(8)
In Schedule 3, in the table, in the second column, in the first row for Article 4.2, for “not on the list of authorised smoke flavourings” substitute “that is not authorised in accordance with Regulation 2065/2003”
.
(9)
In Schedule 4, in the table, in the second column, in the row for Article 4, for “appear in the list” to the end substitute “are authorised in accordance with Regulation 1332/2008, and in accordance with any specifications and conditions of use set out in the authorisations concerned, subject to Article 24 of Regulation 1332/2008”
.
Amendment of the Products Containing Meat etc. (Scotland) Regulations 2014
5.
(1)
(2)
In the Schedule, in the definition of “curing salt”, in sub-paragraph (c)—
(a)
after “use in” insert “accordance with”
;
(b)
omit “as last amended by Commission Regulation (EU) 2018/1497”.
Amendment of the Novel Foods (Scotland) Regulations 2017
6.
(1)
(2)
In regulation 4, for “6(2)” substitute “6”
.
(3)
In regulation 5(2)—
(a)
in the modifications to subsections (1), (3) and (6) of section 9, in each place, for “6(2)” substitute “6”
;
(b)
in the modifications to subsection (5) of section 9, for “on the Union list of authorised novel foods as established” substitute “authorised, as required”
.
Amendment of the Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022
7.
(1)
(2)
In regulation 5, omit paragraphs (5) to (14).
SCHEDULE 11Consequential amendments to Wales statutory instruments
Amendment of the Specified Sugar Products (Wales) Regulations 2003
1.
(1)
(2)
In Schedule 1, in the notes following the table—
(a)
“7.
Caiff cynhyrchion siwgr penodedig gynnwys—
(a)
toddydd echdynnu a ganiateir, fel y’i diffinnir yn rheoliad 11 o Reoliadau Ychwanegion, Cyflasynnau, Ensymau a Thoddyddion Echdynnu Bwyd (Cymru) 2013;
(b)
unrhyw ychwanegyn bwyd a awdurdodir o dan Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ar ychwanegion bwyd.”.
(b)
“7.
Specified sugar products may contain—
(a)
a permitted extraction solvent, as defined in regulation 11 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013;
(b)
any food additive authorised under Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives.”.
Amendment of the Plastic Kitchenware (Conditions on Imports from China) (Wales) Regulations 2011
2.
(1)
(2)
In regulation 8(2)—
(a)
in the Welsh language text, in sub-paragraph (ch)(ii) omit “fel y diwygir Atodiad I iddo o bryd i’w gilydd”;
(b)
in the English language text, in sub-paragraph (d)(ii) omit “as Annex I to which is amended from time to time”.
Amendment of the Materials and Articles in Contact with Food (Wales) Regulations 2012
3.
(1)
(2)
In regulation 12(3)—
(a)
in the Welsh language text—
(i)
for “a restrir yn Atodiad I i” substitute “a awdurdodir o dan”
;
(ii)
for “yr Atodiad hwnnw” substitute “yr awdurdodiadau o dan sylw”
;
(b)
in the English language text—
(i)
for “listed in Annex I to” substitute “authorised under”
;
(ii)
for “that Annex” substitute “the authorisations concerned”
.
(3)
In Schedule 1, in the first column of the table—
(a)
in the Welsh language text—
(i)
in the row relating to Article 5, omit “ac Atodiad I”;
(ii)
in the row relating to Article 9, omit “fel y’i darllenir gydag Atodiad I”;
(iii)
in the row relating to Article 11, for “ac Atodiad I, fel y’u” substitute “, fel y’i”
;
(iv)
in the row relating to Article 13, for “ac Atodiad I fel y’i” substitute “, fel y’u”
;
(v)
in the row relating to Article 14, for “ac Atodiad 1, fel y’i” substitute “, fel y’u”
;
(b)
in the English language text—
(i)
in each place it occurs, omit “and Annex I” and “and Annex 1”;
(ii)
in the row relating to Article 9, omit “as read with Annex I”.
Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013
4.
(1)
(2)
In regulation 2—
(a)
in paragraph (1)—
(i)
in the Welsh language text—
(aa)
in the definition of “Rheoliad 1333/2008” (“Regulation 1333/2008”) omit “, fel y’i darllenir gyda’r canlynol” to the end;
(bb)
in the definition of “Rheoliad 1334/2008” (“Regulation 1334/2008”) omit “, fel y’i darllenir gyda” to the end;
(ii)
in the English language text—
(aa)
in the definition of “Regulation 1333/2008” (“Rheoliad 1333/2008”) omit “, as read with” to the end;
(bb)
in the definition of “Regulation 1334/2008” (“Rheoliad 1334/2008”) omit “, as read with” to the end;
(b)
in paragraph (3)—
(i)
in the Welsh language text—
(aa)
for “Erthygl neu Atodiad i” substitute “darpariaeth mewn”
;
(bb)
for “yr Erthygl honno neu’r Atodiad hwnnw” substitute “y ddarpariaeth honno”
;
(ii)
in the English language text—
(aa)
for “an Article of or Annex to” substitute “a provision of”
;
(bb)
for “Article or Annex” substitute “provision”
.
(3)
In regulation 4—
(a)
in the Welsh language text, for “gydag Erthygl” to “Cyngor a chyda” substitute “gyda”
;
(b)
in the English language text, omit “Article 4” to “Council and with”.
(4)
In Schedule 1, in Table 1, in the second column—
(a)
in the row for Article 4.1—
(i)
in the Welsh language text—
(aa)
for “a gynhwysir yn y rhestr yn Atodiad II i Reoliad” substitute “a awdurdodir yn unol â Rheoliad”
;
(bb)
for “a’r Atodiad hwnnw” substitute “ac yn yr awdurdodiadau o dan sylw”
;
(ii)
in the English language text—
(aa)
for “included in the list in Annex II to” substitute “authorised in accordance with”
;
(bb)
for “that Annex” substitute “in the authorisations concerned”
;
(b)
in the row for Article 4.2—
(i)
in the Welsh language text—
(aa)
for “a gynhwysir yn y rhestr yn Atodiad III i Reoliad” substitute “a awdurdodir yn unol â Rheoliad”
;
(bb)
for “yr Atodiad hwnnnw” substitute “yr awdurdodiadau o dan sylw”
;
(ii)
in the English language text—
(aa)
for “included in the list in Annex III to” substitute “authorised in accordance with”
;
(bb)
for “that Annex” substitute “the authorisations concerned”
;
(c)
in the rows for Article 15 and for Article 16—
(i)
in the Welsh language text, for “yn Atodiad II i Reoliad”, in both places, substitute “mewn awdurdodiadau yn unol â Rheoliad”
;
(ii)
in the English language text, for “Annex II to”, in both places, substitute “authorisations in accordance with”
;
(d)
in the row for Article 17—
(i)
in the Welsh language text, for “a restrir yn Atodiad II i Reoliad” substitute “a awdurdodir yn unol â Rheoliad”
;
(ii)
in the English language text, for “listed in Annex II to” substitute “authorised in accordance with”
.
(5)
In Schedule 2, in Table 1, in the second column, in the row for Article 10—
(a)
in the Welsh language text, for “sydd heb eu cynnwys ar y rhestr ddomestig” substitute “na chaniateir eu gosod ar y farchnad na’u defnyddio mewn bwydydd neu ar fwydydd yn unol â Rheoliad 1334/2008”
;
(b)
in the English language text, for “included on the domestic list” substitute “permitted to be placed on the market or used in or on foods in accordance with Regulation 1334/2008”
.
(6)
In Schedule 3, in Table 1, in the second column, in the first row for Article 4.2—
(a)
in the Welsh language text, for “ar y rhestr o gyflasynnau mwg awdurdodedig” substitute “wedi ei awdurdodi yn unol â Rheoliad 2065/2003”
;
(b)
in the English language text, for “not on the list of authorised smoke flavourings” substitute “that is not authorised in accordance with Regulation 2065/2003”
.
(7)
In Schedule 4, in Table 1, in the second column, in the row for Article 4—
(a)
in the Welsh language text, for “yn ymddangos yn y rhestr ddomestig” to the end substitute “wedi eu hawdurdodi yn unol â Rheoliad 1332/2008, ac yn unol ag unrhyw fanylebau ac amodau defnyddio a nodir yn yr awdurdodiadau o dan sylw, yn ddarostyngedig i Erthygl 24 o Reoliad 1332/2008”
;
(b)
in the English language text, for “appear in the domestic list” to the end substitute “are authorised in accordance with Regulation 1332/2008, and in accordance with any specifications and conditions of use set out in the authorisations concerned, subject to Article 24 of Regulation 1332/2008”
.
Amendment of the Products Containing Meat etc. (Wales) Regulations 2014
5.
(1)
(2)
In Schedule 1—
(a)
in the Welsh language text, in the definition of “halen halltu” (“curing salt”), in sub-paragraph (c)—
(i)
after “defnyddio yn” insert “unol â”
;
(ii)
omit “fel y diwygir yr Atodiadau iddo o bryd i’w gilydd”;
(b)
in the English language text, in the definition of “curing salt” (“halen halltu”), in sub-paragraph (c)—
(i)
after “use in” insert “accordance with”
;
(ii)
omit “as the Annexes to which are amended from time to time”.
Amendment of the Novel Foods (Wales) Regulations 2017
6.
(1)
(2)
In regulation 4—
(a)
in the Welsh language text, for “6(2)” substitute “6”
;
(b)
in the English language text, for “6(2)” substitute “6”
.
(3)
In regulation 5(2)—
(a)
in the Welsh language text, for “6(2)” substitute “6”
;
(b)
in the English language text, for “6(2)” substitute “6”
.
(4)
In Schedule 1, in the table, in the row for Article 6(2)—
(a)
in the first column—
(i)
in the Welsh language text, for “6(2)” substitute “6”
;
(ii)
in the English language text, for “6(2)” substitute “6”
;
(b)
in the second column—
(i)
in the Welsh language text—
(aa)
for “ac a gynhwysir yn y rhestr” substitute “yn unol â Rheoliad (EU) 2015/2283”
;
(bb)
after “rhoi ar y farchnad” insert “, yn yr awdurdodiadau o dan sylw”
;
(ii)
in the English language text—
(aa)
for “and included in the list” substitute “in accordance with Regulation (EU) 2015/2283”
;
(bb)
after “monitoring requirements” insert “, in the authorisations concerned”
.
(5)
In Schedule 2—
(a)
in Part 2, in the modifications to subsections (1), (3) and (5) of section 9—
(i)
in the Welsh language text, for “6(2)”, in each place it occurs, substitute “6”
;
(ii)
in the English language text, for “6(2)”, in each place it occurs, substitute “6”
;
(b)
in Part 3, in the table, in the entry for section 32, in the second column—
(i)
in the Welsh language text, for “6(2)” substitute “6”
;
(ii)
in the English language text, for “6(2)” substitute “6”
.
SCHEDULE 12Consequential amendments to England statutory instruments
Amendment of the Materials and Articles in Contact with Food (England) Regulations 2012
1.
(1)
(2)
In regulation 12(3)—
(a)
for “listed in Annex I to” substitute “authorised under”
;
(b)
for “that Annex” substitute “the authorisations concerned”
.
(3)
In regulation 13, in the heading and in the text, for “the Schedule” substitute “Schedule 1”
.
(4)
In regulation 14(1)—
(a)
for “22(4) and (5)” substitute “22(5)”
;
(b)
for “the Schedule” substitute “Schedule 1”
.
(5)
In regulation 15, omit “and Annex 1, Table 3 (notes on verification of compliance), Notes (23) and (27) to”.
(6)
In regulation 20(3)(d), omit “and Annex 1, Table 3 (notes on verification of compliance), Notes (23) and (27) to”.
(7)
The first Schedule (specified provisions of Regulation 10/2011) is renumbered as Schedule 1.
(8)
In Schedule 1 (as so renumbered), in the first column of the table—
(a)
in each place it occurs, omit “and Annex I” and “and Annex 1”;
(b)
in the row relating to Article 9, omit “as read with Annex I”.
Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013
2.
(1)
(2)
In regulation 2—
(a)
in paragraph (1)—
(i)
in the definition of “Regulation 1333/2008”, omit “, as read with” to the end;
(ii)
in the definition of “Regulation 1334/2008”, omit “, as read with” to the end;
(b)
in paragraph (3)—
(i)
for “an Article of or Annex to” substitute “a provision of”
;
(ii)
for “Article or Annex” substitute “provision”
.
(3)
In regulation 4, omit “Article 4” to “Council and with”.
(4)
In regulation 5, omit “as read with Article 20 (transitional measures),”.
(5)
In Schedule 1, in Table 1, in the second column—
(a)
in the row for Article 4.1—
(i)
for “included in the list in Annex II to” substitute “authorised in accordance with”
;
(ii)
for “that Annex” substitute “in the authorisations concerned”
;
(b)
in the row for Article 4.2—
(i)
for “included in the list in Annex III to” substitute “authorised in accordance with”
;
(ii)
for “that Annex” substitute “the authorisations concerned”
;
(c)
in the rows for Article 15 and for Article 16, for “Annex II to”, in both places, substitute “authorisations in accordance with”
;
(d)
in the row for Article 17, for “listed in Annex II to” substitute “authorised in accordance with”
.
(6)
In Schedule 2, in Table 1, in the second column, in the row for Article 10, for “included on the domestic list” substitute “permitted to be placed on the market or used in or on foods in accordance with Regulation 1334/2008”
.
(7)
In Schedule 3, in Table 1, in the second column, in the first row for Article 4.2, for “not on the list of authorised smoke flavourings” substitute “that is not authorised in accordance with Regulation 2065/2003”
.
(8)
In Schedule 4, in Table 1, in the second column, in the row for Article 4, for “appear in the domestic list” to the end substitute “are authorised in accordance with Regulation 1332/2008, and in accordance with any specifications and conditions of use set out in the authorisations concerned, subject to Article 24 of Regulation 1332/2008”
.
Amendment of the Products Containing Meat etc. (England) Regulations 2014
3.
(1)
(2)
In Schedule 1, in the definition of “curing salt”, in sub-paragraph (c)—
(a)
after “use in” insert “accordance with”
;
(b)
omit “as last amended by Commission Regulation (EU) 2018/1497”.
Amendment of the Novel Foods (England) Regulations 2018
4.
(1)
(2)
In Schedule 1, in the table, in the row for Article 6.2—
(a)
in the first column, for “6.2” substitute “6”
;
(b)
in the second column—
(i)
for “and included in the list” substitute “in accordance with Regulation (EU) 2015/2283”
;
(ii)
omit “therein”;
(iii)
after “monitoring requirements” insert “, in the authorisations concerned”
.
These Regulations amend, revoke and replace various provisions in secondary assimilated law within the meaning of section 12(2) of the Retained EU Law (Revocation and Reform) Act 2023 (c. 28).
Part 2 contains amendments to Regulation (EC) No 1831/2003 on additives for use in animal nutrition (EUR 2003/1831). It also contains consequential amendments to Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (EUR 2005/378) and Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (EUR 2008/429).
Part 3 contains amendments to the following assimilated direct legislation relating to food additives, food enzymes and food flavourings:
Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (EUR 2008/1331);
Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes, etc., (EUR 2008/1332);
Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (EUR 2008/1333);
Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc., (EUR 2008/1334);
Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008, etc., (EUR 2011/234).
Part 4 contains amendments to the following assimilated direct legislation relating to food contact materials:
Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, etc., (EUR 2004/1935);
Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food (EUR 2009/450); and
Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (EUR 2011/10).
Part 5 contains amendments to Regulation (EC) No 1829/2003 on genetically modified food and feed (EUR 2003/1829). It also contains consequential amendments to Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material, etc., (EUR 2011/619) and Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed, etc., (EUR 2013/503).
Part 6 contains amendments to Regulation (EU) 2015/2283 on novel foods, etc., (EUR 2015/2283). It also contains consequential amendments to Commission Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 (EUR 2017/2468) and Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 (EUR 2017/2469).
Part 7 contains amendments to Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods (EUR 2003/2065).
Part 8 sets out revocations, consequential amendments, savings and transitional provision, and gives effect to the Schedules.
Schedules 1 to 3, respectively, set out revocations of Scotland, Wales and England statutory instruments, with certain savings in respect of transitional provisions.
Schedules 4 to 8 contain revocations of assimilated direct legislation.
Schedules 9 to 12, respectively, set out consequential amendments to assimilated direct legislation, and to Scotland, Wales and England statutory instruments.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.