CHAPTER IIF1AUTHORISATION OF FOOD ENZYMES
Article 4F2Requirement for authorisation
Article 5Prohibition 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 6General conditions for F6authorisation of food enzymes
A food enzyme may be F7authorised 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.
Article 7The content of F8an 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 F9authorised.
2.
(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.
Article 8Food enzyme falling within the scope of Regulation (EC) No 1829/2003 F14or, 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 F15authorised 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 F16that 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.
F173.
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.
F18Article 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.
F19Article 9Interpretation decisions
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