Regulation (EC) No 1332/2008 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER II U.K. [F1 AUTHORISATION OF FOOD ENZYMES]

Article 4 U.K. [F2 Requirement for authorisation]

Only [F3 authorised] food enzymes F4 ... may be placed on the market as such and used in foods, in accordance with the specifications and conditions of use provided for in Article 7(2) [F5 (but see Article 24 with respect to the date of application of this Article)].

Textual Amendments

F2 Art. 4 heading substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(4)(a) (with reg. 23)

F3 Word in Art. 4 inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(4)(b)(i) (with reg. 23)

F4 Words in Art. 4 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(4)(b)(ii) (with reg. 23)

F5 Words in Art. 4 inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(4)(b)(iii) (with reg. 23)

Article 5 U.K. Prohibition of non-compliant food enzymes and/or non-compliant food

No person shall place on the market a food enzyme or any food in which such a food enzyme has been used if the use of the food enzyme does not comply with this Regulation and its implementing measures.

Article 6 U.K. General conditions for [F6 authorisation of food enzymes]

A food enzyme may be [F7 authorised] only if it meets the following conditions and, where relevant, other legitimate factors:

(a)

it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed;

(b)

there is a reasonable technological need, and

(c)

its use does not mislead the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness and quality of the ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product.

Textual Amendments

F6 Words in Art. 6 heading substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(5)(a) (with reg. 23)

F7 Word in Art. 6 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(5)(b) (with reg. 23)

Article 7 U.K. The content of [F8 an authorisation of a food enzyme]

1. A food enzyme which complies with the conditions set out in Article 6 may, in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], be [F9 authorised].

2. The [F10 authorisation] of a food enzyme F11 ... shall specify:

(a) the name of the food enzyme;

(b) the specifications of the food enzyme, including its origin, purity criteria and any other necessary information;

(c) the foods to which the food enzyme may be added;

(d) the conditions under which the food enzyme may be used; where appropriate, no maximum level shall be fixed for a food enzyme. In that case, the food enzyme shall be used in accordance with the quantum satis principle;

(e) if appropriate, whether there are any restrictions on the sale of the food enzyme directly to the final consumer;

(f) where necessary, specific requirements in respect of the labelling of food in which the food enzymes have been used in order to ensure that the final consumer is informed of the physical condition of the food or the specific treatment it has undergone.

3. The [F12 authorisation status of a food enzyme] shall be [F13 determined] in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].

Textual Amendments

F8 Words in Art. 7 heading substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(6)(a) (with reg. 23)

F9 Word in Art. 7(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(6)(b) (with reg. 23)

F10 Word in Art. 7(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(6)(c)(i) (with reg. 23)

F11 Words in Art. 7(2) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(6)(c)(ii) (with reg. 23)

F12 Words in Art. 7(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(6)(d)(i) (with reg. 23)

F13 Word in Art. 7(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(6)(d)(ii) (with reg. 23)

Article 8 U.K. Food enzyme falling within the scope of Regulation (EC) No 1829/2003 [F14 or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023]

1. A food enzyme falling within the scope of Regulation (EC) No 1829/2003 may be [F15 authorised] in accordance with this Regulation only when it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.

2. When a food enzyme [F16 that is already authorised] is produced from a different source falling within the scope of Regulation (EC) No 1829/2003, it will not require a new authorisation under this Regulation, as long as the new source is covered by an authorisation in accordance with Regulation (EC) No 1829/2003 and the food enzyme complies with the specifications established under this Regulation.

[F17 3. In relation to England, a food enzyme falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act.

4. In relation to England, when a food enzyme that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food enzyme complies with the specifications established under this Regulation.]

Textual Amendments

F14 Words in Art. 8 heading inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 4(2)

F15 Word in Art. 8(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(7)(a) (with reg. 23)

F16 Words in Art. 8(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(7)(b) (with reg. 23)

F17 Art. 8(3)(4) inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 4(3)

[F18 Article 8A U.K. Details 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.]

Textual Amendments

F18 Art. 8A inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(8) (with reg. 23)

F19 Article 9 U.K. Interpretation decisions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19 Art. 9 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 67; 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F1 Ch. 2 heading substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 7(3) (with reg. 23)