EN    EN EN 
SANCO/2009/6358 (POOL/E3/ 2009/6358/6358-EN.doc)EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION DIRECTIVE 
of 
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) EN 2   EN Draft 
COMMISSION DIRECTIVE 
of 
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 COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission, 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 Eu ropean Parliament and of th e Council of 30 June 1994 on 
sweeteners for use in foodstuffs
2 lays down a list of sweetener s that may be used in the 
Community 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 e xpressed its opinion of 27 September 20073. 
After considering all the data on stabilit y, degradation products and toxicology, EFSA 
concluded that neotame is not of safety conc ern with respect to th e proposed uses as a 
sweetener and flavour enhancer and establis hed an Acceptable Daily Intake (ADI) of 
0-2 mg/kg bw/day. EFSA also noted that c onservative estimates of neotame dietary 
exposure both in adults and ch ildren suggest that it is ve ry unlikely that  the ADI would 
be exceeded at the proposed use levels. 
(3) Neotame is a highly intense sweetener w ith a sweetness potency ranging from 7000 to 
13000 times that of sucrose. It may be used  as a replacement fo r sucrose or other 
sweeteners in broad range of products. Neot ame can be used alone or with other 
sweeteners. In addition, neotame can modify  the flavour of foods and beverages. 
                                                 
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 Additiv es, 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, 1-43. EN 3   EN (4) It is necessary to amend the Annex of Dir ective 94/35/EC to permit the use of neotame 
in the same food applications as the ot her currently permitted intense sweeteners. 
Neotame should be assigned a new E number, namely E 961. 
(5) The measures provided for in this Directiv e 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 […] at the latest. They shall forthwith communicate to the Commission th e text of those provisions and a 
correlation table between those pr ovisions and th is Directive. 
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 determin e 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.  
Article 3 
This Directive shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU 
 Member of the Commission EN 4   EN ANNEX   
In the Annex to Directive 94/35/ the following entry E961 is inserted after the entry E 959
  
EC 
No Name Foodstuffs Maximum 
usable dose 
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 dessert s, 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-re duced 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-re duced 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 E961 Neotame 
Cornets and wafers, for ice crea m, with no added sugar 60 mg/kg EN 5   EN EC 
No Name Foodstuffs Maximum 
usable dose 
Essoblaten 35 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 fiber 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 pastil les 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 mixt ure 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/Ta ble beer (original wort 
content less than 6%) except for ‘Obergäriges 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 vege table preparations 32 mg/kg EN 6   EN EC 
No Name Foodstuffs Maximum 
usable dose 
Sweet-sour preserves of fru it 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 speci al nutritional uses 55 mg/kg 
Foods intended for use in energy-restricted diets for 
weight reduction as referre d to in Directive 1996/8/EC 26 mg/kg 
Dietary foods for special medi cal 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 non chewable form 185 mg/kg 
Table top sweeteners GMP