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Commission Directive 2009/163/EU
of 22 December 2009
amending Directive 94/35/EC of the European Parliament and of the Council on sweeteners for use in foodstuffs with regard to neotame
（Text with EEA relevance）
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation （EC） No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [1], and in particular Article 31 thereof,
After consulting the European Food Safety Authority （EFSA）,
Whereas:
（1） Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs [2] lays down a list of sweeteners that may be used in the union and the conditions for their use.
（2） The European Food Safety Authority （EFSA） evaluated the safety of neotame as a sweetener and flavour enhancer and expressed its opinion of 27 September 2007 [3]. After considering all the data on stability, degradation products and toxicology, EFSA concluded that neotame is not of safety concern with respect to the proposed uses as a sweetener and flavour enhancer and established an acceptable daily intake （ADI） of 0–2 mg/kg bw/day. EFSA also noted that conservative estimates of neotame dietary exposure both in adults and children suggest that it is very unlikely that the ADI would be exceeded at the proposed use levels.
（3） Neotame is a highly intense sweetener with a sweetness potency ranging from 7000 to 13000 times that of sucrose. It may be used as a replacement for sucrose or other sweeteners in a broad range of products. Neotame can be used alone or with other sweeteners. In addition, neotame can modify the flavour of foods and beverages.
（4） It is necessary to amend the Annex of Directive 94/35/EC to permit the use of neotame in the same food applications as the other currently permitted intense sweeteners. Neotame should be assigned a new E number, namely E 961. In order to facilitate the marketing and use of this new sweetener, it is provided that products which comply with the provisions of this Directive may be marketed from the date of its entry into force.
（5） In accordance with point 34 of the Interinstitutional agreement on better law-making [4], Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public.
（6） The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The Annex to Directive 94/35/EC is amended in accordance with the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 12 October 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
3. Products which comply with the provisions of this Directive may be marketed from the date of entry into force of this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 22 December 2009.
For the Commission
The President
José Manuel Barroso
[1] OJ L 354, 31.12.2008, p. 16.
[2] OJ L 237, 10.9.1994, p. 3.
[3] Scientific Opinion of the Panel on Food Additives, "Flavourings, processing aids and materials in contact with food on a request from European Commission on neotame as a sweetener and flavour enhancer". The EFSA Journal （2007） 581, pp. 1-43.
[4] OJ C 321, 31.12.2003, p. 1.
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ANNEX
In the Annex to Directive 94/35/EC the following entry E 961 is inserted after the entry E 959:
EC No | Name | Foodstuffs | Maximum usable dose |
"E 961 | Neotame | Non-alcoholic drinks | |
Water-based flavoured drinks, energy-reduced or with no added sugar | 20 mg/l |
Milk- and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar | 20 mg/l |
Desserts and similar products | |
Water-based flavoured desserts, energy-reduced or with no added sugar | 32 mg/kg |
Milk- and milk derivative-based preparations, energy-reduced or with no added sugar | 32 mg/kg |
Fruit- and vegetable-based desserts, energy-reduced or with no added sugar | 32 mg/kg |
Egg-based desserts, energy-reduced or with no added sugar | 32 mg/kg |
Cereal-based desserts, energy-reduced or with no added sugar | 32 mg/kg |
Fat-based desserts, energy-reduced or with no added sugar | 32 mg/kg |
Snacks: certain flavours of ready-to-eat, pre-packed, dry, savoury starch products and coated nuts | 18 mg/kg |
Confectionery | |
Confectionery with no added sugar | 32 mg/kg |
Cocoa or dried fruit-based confectionery, energy-reduced or with no added sugar | 65 mg/kg |
Starch-based confectionery, energy-reduced or with no added sugar | 65 mg/kg |
Cornets and wafers, for ice cream, with no added sugar | 60 mg/kg |
Essoblaten | 60 mg/kg |
Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no added sugar | 32 mg/kg |
Breakfast cereals with a fibre content of more than 15 %, and containing at least 20 % bran, energy-reduced or with no added sugar | 32 mg/kg |
Breath-freshening micro-sweets, with no added sugar | 200 mg/kg |
Strongly flavoured throat pastilles with no added sugar | 65 mg/kg |
Chewing gum with no added sugar | 250 mg/kg |
Energy-reduced tablet form confectionery | 15 mg/kg |
Cider and perry | 20 mg/l |
Drinks consisting of a mixture of a non-alcoholic drink and beer, cider, perry, spirits or wine | 20 mg/l |
Spirit drinks containing less than 15 % alcohol by volume | 20 mg/l |
Alcohol-free beer or with an alcohol content not exceeding 1,2 % vol. | 20 mg/l |
Bière de table/Tafelbier/Table beer （original wort content less than 6 %） except for "Oberg?riges Einfachbier" | 20 mg/l |
Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH | 20 mg/l |
Brown beers of the "oud bruin" type | 20 mg/l |
Energy-reduced beer | 1 mg/l |
Edible ices, energy-reduced or with no added sugar | 26 mg/kg |
Canned or bottled fruit, energy-reduced or with no added sugar | 32 mg/kg |
Energy-reduced jams, jellies and marmalades | 32 mg/kg |
Energy-reduced fruit and vegetable preparations | 32 mg/kg |
Sweet-sour preserves of fruit and vegetables | 10 mg/kg |
Feinkostsalat | 12 mg/kg |
Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs | 10 mg/kg |
Energy-reduced soups | 5 mg/l |
Sauces | 12 mg/kg |
Mustard | 12 mg/kg |
Fine bakery products for special nutritional uses | 55 mg/kg |
Foods intended for use in energy-restricted diets for weight reduction as referred to in Directive 1996/8/EC | 26 mg/kg |
Dietary foods for special medical purposes as defined in Directive 1999/21/EC | 32 mg/kg |
Food supplements as defined in Directive 2002/46/EC supplied in a liquid form | 20 mg/kg |
Food supplements as defined in Directive 2002/46/EC supplied in a solid form | 60 mg/kg |
Food supplements as defined in Directive 2002/46/EC based on vitamins and/or mineral elements and supplied in a syrup-type or chewable form | 185 mg/kg |
Table top sweeteners | quantum satis" |
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