Legal provisions of COM(2006)425 - Food enzymes - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2006)425 - Food enzymes. |
|---|---|
| document | COM(2006)425  |
| date | December 16, 2008 |
Contents
CHAPTER I - SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
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 internal 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) | a Community list of approved food enzymes; |
| (b) | conditions of use of food enzymes in foods; |
| (c) | rules on the labelling of food enzymes sold as such. |
Article 2
Scope
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 Community 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
Definitions
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:
|
| (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. |
CHAPTER II - COMMUNITY LIST OF APPROVED FOOD ENZYMES
Article 4
Community list of food enzymes
Only food enzymes included in the Community list 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).
Article 5
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
General conditions for inclusion of food enzymes in the Community list
A food enzyme may be included in the Community list 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
The content of the Community list of food enzymes
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 included in the Community list.
2. The entry of a food enzyme in the Community list 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 Community list shall be amended 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
Food enzyme falling within the scope of Regulation (EC) No 1829/2003
1. A food enzyme falling within the scope of Regulation (EC) No 1829/2003 may be included in the Community list 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 already included in the Community list 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 9
Interpretation decisions
Where necessary, it may be decided in accordance with the regulatory procedure referred to in Article 15(2) whether or not:
| (a) | a given substance meets the definition of food enzyme in Article 3; |
| (b) | a particular food belongs to a category of food in the Community list of food enzymes. |
CHAPTER III - LABELLING
Article 10
Labelling of food enzymes and food enzyme preparations not intended for sale to the final consumer
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 a language easily understandable to purchasers.
2. Within its own territory, the Member State in which the product is marketed may, in accordance with the Treaty, stipulate that the information provided for in Article 11 shall be given in one or more of the official languages of the Community, to be determined by that Member State. This shall not preclude such information from being indicated in several languages.
Article 11
General labelling requirements for food enzymes and food enzyme preparations not intended for sale to the final consumer
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 Community 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
Labelling of food enzymes and food enzyme preparations intended for sale to the final consumer
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 (17) 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
Other labelling requirements
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 - PROCEDURAL PROVISIONS AND IMPLEMENTATION
Article 14
Information obligation
1. A producer or user of a food enzyme shall inform the Commission 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 approved under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the European Food Safety Authority (hereinafter referred to as the Authority), a producer or user shall, before marketing the food enzyme, submit to the Commission 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 Commission, inform it of the actual use of the food enzyme. Such information shall be made available to Member States by the Commission.
Article 15
Committee
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 16
Community financing of harmonised policies
The legal basis for the financing of measures resulting from this Regulation shall be Article 66(1)(c) of Regulation (EC) No 882/2004.
CHAPTER V - TRANSITIONAL AND FINAL PROVISIONS
Article 17
Establishment of the Community list of food enzymes
1. The Community list of food enzymes shall be drawn up on the basis of applications made pursuant to paragraph 2.
2. Interested parties may submit applications for the inclusion of a food enzyme in the Community list.
The deadline for submitting such applications shall be 24 months after the date of application of the implementing measures 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].
3. The Commission shall establish a Register of all food enzymes to be considered for inclusion in the Community list 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 (hereinafter referred to as the Register). The Register shall be made available to the public.
The Commission shall submit the applications to the Authority for its opinion.
4. The Community list shall be adopted by the Commission 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], 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) | the Commission shall adopt the Community list for the first time after the Authority has delivered its opinion on all the food enzymes listed 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, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
Article 18
Transitional measures
1. Notwithstanding Articles 7 and 17 of this Regulation, the Community list shall, when drawn up, include the following food enzymes:
| (a) | E 1103 Invertase and E 1105 Lysozyme, stating the conditions governing their use as specified in Annex I and Part C of Annex III to Directive 95/2/EC; |
| (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
Amendments to Directive 83/417/EEC
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 (18); |
| — | other milk-coagulating enzymes meeting the requirements of Regulation (EC) No 1332/2008. |
Article 20
Amendment to Regulation (EC) No 1493/1999
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 (19).
Article 21
Amendments to Directive 2000/13/EC
Directive 2000/13/EC is hereby amended as follows:
| 1. | Article 6(4) shall be amended as follows:
|
| 2. | the following indent shall be added to Article 6(6):
|
Article 22
Amendments to Directive 2001/112/EC
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 (20); |
| — | Proteolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008; |
| — | Amylolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008. |
Article 23
Amendment to Regulation (EC) No 258/97
In Regulation (EC) No 258/97, the following point shall be added to Article 2(1):
| ‘(d) | food enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (21). |
Article 24
Entry into force
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 date of application of the Community list. 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 in the Member States.
Articles 10 to 13 shall apply from 20 January 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.