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 7 000 to 13 000 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.EN 23.12.2009 Official Journal of the European Union L 344/37  
( 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.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 BARROSOEN L 344/38 Official Journal of the European Union 23.12.2009ANNEX  
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/lEN 23.12.2009 Official Journal of the European Union L 344/39EC No  Name  Foodstuffs  Maximum usable 
dose  
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 “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 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 ’EN L 344/40 Official Journal of the European Union 23.12.2009