
CHAPTER I
Article 1 
This Regulation lays down rules on food enzymes used in foods, including such enzymes used as processing aids, with a view to ensuring the effective functioning of the ... market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.
For those purposes, this Regulation provides for:

((a)) the authorisation of food enzymes in accordance with this Regulation and Regulation (EC) No 1331/2008;
((b)) conditions of use of food enzymes in foods;
((c)) rules on the labelling of food enzymes sold as such.
Article 2 

1. This Regulation shall apply to food enzymes as defined in Article 3.
2. This Regulation shall not apply to food enzymes when and insofar as they are used in the production of:
(a) food additives falling within the scope of Regulation (EC) No 1333/2008 [on food additives];
(b) processing aids.
3. This Regulation shall apply without prejudice to any specific ... rules concerning the use of food enzymes:
(a) in specific foods;
(b) for purposes other than those covered by this Regulation.
4. This Regulation shall not apply to microbial cultures that are traditionally used in the production of food and which may incidentally produce enzymes, but which are not specifically used to produce them.
Article 3 

1. For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002, Regulation (EC) No 1829/2003 and Regulation (EC) No 1333/2008 [on food additives] shall apply.
2. The following definitions shall also apply:
(a) ‘food enzyme’ means a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms:
((i)) containing one or more enzymes capable of catalyzing a specific biochemical reaction; and
((ii)) added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods;
(b) ‘food enzyme preparation’ means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.
(c) “Authority” means—
(i) as regards  England and Wales, the Food Standards Agency;
(ii) as regards Scotland, Food Standards Scotland;
CHAPTER II
Article 4 
Only authorised food enzymes ... 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) (but see Article 24 with respect to the date of application of this Article).
Article 5 
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 
A food enzyme may be 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.
Article 7 

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 authorised.
2. The authorisation of a food enzyme ... 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  authorisation status of a food enzyme shall be 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].
Article 8 

1. A food enzyme falling within the scope of Regulation (EC) No 1829/2003 may be 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 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.
Article 8A 
The Authority must include the details described in Article 7(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.
Article 9 
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CHAPTER III
Article 10 

1. Food enzymes and food enzyme preparations not intended for sale to the final consumer, whether sold singly or mixed with each other and/or other food ingredients, as defined in Article 6(4) of Directive 2000/13/EC, may only be marketed with the labelling provided for in Article 11 of this Regulation, which must be easily visible, clearly legible and indelible. The information provided for in Article 11 shall be in  English, or in English and Welsh.
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Article 11 

1. Where food enzymes and food enzyme preparations not intended for sale to the final consumer are sold singly or mixed with each other and/or other food ingredients, their packaging or containers shall bear the following information:
(a) the name laid down under this Regulation in respect of each food enzyme or a sales description which includes the name of each food enzyme or in the absence of such a name, the accepted name laid down in the nomenclature of the International Union of Biochemistry and Molecular Biology (IUBMB);
(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its intended food use;
(c) if necessary, the special conditions of storage and/or use;
(d) a mark identifying the batch or lot;
(e) instructions for use, if the omission thereof would preclude appropriate use of the food enzyme;
(f) the name or business name and address of the manufacturer, packager or seller;
(g) an indication of the maximum quantity of each component or group of components subject to quantitative limitation in food and/or appropriate information in clear and easily understandable terms enabling the purchaser to comply with this Regulation or other relevant   assimilated   law; where the same limit on quantity applies to a group of components used singly or in combination, the combined percentage may be given as a single figure; the limit on quantity shall be expressed either numerically or by the quantum satis principle;
(h) the net quantity;
(i) the activity of the food enzyme(s);
(j) the date of minimum durability or use-by-date;
(k) where relevant, information on a food enzyme or other substances as referred to in this Article and listed in Annex IIIa to Directive 2000/13/EC.
2. Where food enzymes and/or food enzyme preparations are sold mixed with each other and/or with other food ingredients, their packaging or containers shall bear a list of all ingredients in descending order of their percentage by weight of the total.
3. The packaging or containers of food enzyme preparations shall bear a list of all components in descending order of their percentage by weight of the total.
4. By way of derogation from paragraphs 1, 2 and 3, the information required in paragraph 1 points (e) to (g) and in paragraphs 2 and 3 may appear merely on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication ‘not for retail sale’ appears on an easily visible part of the packaging or container of the product in question.
5. By way of derogation from paragraphs 1, 2 and 3, where food enzymes and food enzyme preparations are supplied in tankers all of the information may appear merely on the accompanying documents relating to the consignment which are to be supplied with the delivery.
Article 12 

1. Without prejudice to Directive 2000/13/EC, Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs and Regulation (EC) No 1829/2003, food enzymes and food enzyme preparations sold singly or mixed with each other and/or other food ingredients intended for sale to the final consumer may be marketed only if their packaging contains the following information:
(a) the name laid down under this Regulation in respect of each food enzyme or a sales description which includes the name of each food enzyme or in the absence of such a name, the accepted name laid down in the nomenclature of the IUBMB;
(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its intended food use.
2. For the information provided for in paragraph 1 of this Article, Article 13(2) of Directive 2000/13/EC shall apply accordingly.
Article 13 
Articles 10 to 12 shall be without prejudice to more detailed or more extensive laws, regulations or administrative provisions regarding weights and measures or applying to the presentation, classification, packaging and labelling of dangerous substances and preparations or applying to the transport of such substances and preparations.
CHAPTER IV
Article 14 

1. A producer or user of a food enzyme shall inform the  Authority  immediately of any new scientific or technical information which might affect the assessment of the safety of the food enzyme.
2. For a food enzyme already authorised under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the  Authority, a producer or user shall, before marketing the food enzyme, submit to the  Authority  the necessary data to allow an evaluation of the food enzyme with regard to the modified production method or characteristics to be undertaken by the Authority.
3. A producer or user of a food enzyme shall, at the request of the  Authority, inform it of the actual use of the food enzyme. ...
Article 15 
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Article 15A 

(1.) Any power to make regulations under this Regulation—
(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
(2.) Any power to make regulations under this Regulation includes power—
(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
(3.) Any statutory instrument or Scottish statutory instrument  containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
(a) in the case of England, of either House of Parliament;
(b) in the case of Wales, of  Senedd Cymru;
(c) in the case of Scotland, of the Scottish Parliament;
(4.) In this Regulation, any power—
(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
Article 16 
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CHAPTER V
Article 17 

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.
2. Interested parties may submit applications for the initial authorisation of a food enzyme ....The deadline for submitting such applications is to be prescribed by the appropriate authority.
3. The  Authority  shall establish a Register of all food enzymes to be considered for initial authorisation in respect of which an application complying with the validity criteria to be laid down in accordance with Article 9(1) of Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] has been submitted in accordance with paragraph 2 of this Article (referred to in this Regulation as the ‘Register’). The Register shall be made available to the public.The  appropriate authority  shall submit the applications to the Authority for its opinion.
4. In accordance with the procedure laid down in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], the appropriate authority must determine the authorisation status of all of the applications for initial authorisation entered in the Register once the Authority has issued an opinion on each food enzyme included in the Register.However, by way of derogation from that procedure:
(a) Article 5(1) of Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] shall not apply to the Authority's adoption of its opinion;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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.
5. If necessary, any appropriate transitional measures for the purposes of this Article which are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it,  are to be prescribed by the appropriate authority.
Article 18 

1. Notwithstanding Articles 7 and 17 of this Regulation, ... the following food enzymes 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:
(a) E 1103 Invertase and E 1105 Lysozyme, in accordance with any conditions of use set out in authorisations under Regulation (EC) No 1333/2008;
(b) Urease, beta-glucanase and lysozyme for use in wine in accordance with Regulation (EC) No 1493/1999 and the implementing rules for that Regulation.
2. Food enzymes, food enzyme preparations and food containing food enzymes placed on the market or labelled before 20 January 2010 which do not comply with the provisions of Articles 10 to 12 may be marketed until their date of minimum durability or use-by-date.
Article 19 
In Directive 83/417/EEC, in Annex I, Section III(d), the indents shall be replaced by the following:
'
— rennet meeting the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes;
— other milk-coagulating enzymes meeting the requirements of Regulation (EC) No 1332/2008.'
Article 20 
In Regulation (EC) No 1493/1999, the following paragraph shall be added to Article 43:
'
3. Enzymes and enzymatic preparations used in the authorised oenological practices and processes listed in Annex IV shall meet the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes.'
Article 21 
Directive 2000/13/EC is hereby amended as follows:

1.. Article 6(4) shall be amended as follows:

((a)) point (a) shall be replaced by the following:
'
((a)) “Ingredient” shall mean any substance, including additives and enzymes, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form.';
((b)) in point (c)(ii), the introductory word ‘additives’ shall be replaced by ‘additives and enzymes’;
((c)) in point (c)(iii), the words ‘additives or flavouring’ shall be replaced by ‘additives or enzymes or flavourings’;
2.. the following indent shall be added to Article 6(6):
'
— enzymes other than as referred to in paragraph 4(c)(ii) shall be designated by the name of one of the categories of ingredients listed in Annex II, followed by their specific name,'.
Article 22 
In Directive 2001/112/EC, in Annex I, Section II(2), the fourth, fifth and sixth indents shall be replaced by the following:
'
— Pectolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes;
— Proteolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008;
— Amylolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008.'
Article 23 
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Article 24 
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Article 4 shall apply from 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 in accordance with Article 17. Until that date, national provisions in force concerning the placing on the market and use of food enzymes and food produced with food enzymes shall continue to apply ....
Articles 10 to 13 shall apply from 20 January 2010.
...