EN    EN EN 
SANCO/2009/10825  
EN    EN  EUROPEAN COMMISSION 
Brussels,   
C (2010)    final 
 
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 2008/60/EC laying down  specific purity criteria on sweeteners 
(Text with EEA relevance) 
  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 2008/60/EC laying down  specific purity criteria on sweeteners  
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation 1333/2008 of the Eur opean Parliament and of the Council of 16 
December 2008 on food additives and in particular article 30(5) thereof
1, 
After consulting the European F ood Safety Authority (EFSA),  
Whereas: (1) Commission Directive 2008/60/EC
2 of 27 August 2008 laying down specific purity 
criteria on sweeteners sets out the purity criteria for the sweeteners for use in foodstuffs listed in European Parliament and Council Directive 94/35/EC of 30 June 
1994 on sweeteners for use in Foodstuffs
3. 
(2) The European Food Safety Authority (EFSA) assessed the information on the safety in 
use of neotame as a sweetener and flavour enhancer  and expressed its opinion of 27 
September 20074. On the basis of the proposed uses, it has been considered 
appropriate to permit the use of this food a dditive. It is therefore necessary to adopt 
specifications for this food additive which is allocated E 961 as E number. 
(3) It is necessary to take in to account the specifications and analytical techniques for 
additives as set out in the Codex Alimenta rius drafted by the Joint Expert Committee 
on Food Additives (JECFA). In particular, the specific purity criteria need to be 
adapted to reflect the limits for individual he avy metals of interest , where appropriate. 
(4) Directive 2008/60/EC should therefore be amended accordingly. 
(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,  
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 OJ L 253, 20.9.2008, p. 1. 
3 OJ L 61, 18.3.1995, p. 1. 
4 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 HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 2008/60/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 31 Ma rch 2011 at the latest. They shall 
forthwith communicate to the Commissi on the text of those provisions. 
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the o ccasion of their official publication. Member 
States shall determine how such  reference is to be made. 
2. Member States shall communicate to the Co mmission 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 
 The President  José Manuel BARROSO  
EN 4   EN ANNEX  
In Annex I to Directive 2008/60/EC the following entry E 961 is inserted  after the entry E 959 
E  961 Neotame 
Synonyms  N-[N-(3,3-dimethylbutyl)-L- α-aspartyl]-L-phenylalanine 1-
methyl ester , 
 N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester.  
Definition  Neotame is manufactured by reaction under hydrogen pressure o f 
aspartame with 3,3,-dimethylbutyraldehyde in methanol in 
presence of a palladium/carbon catalyst. It is isolated and purified 
by filtration, where diatomaceous earth may be used. After 
solvent removal via distillation, neotame is washed with water, 
isolated by centrifugation and finally vacuum dried. 
CAS Nr. : 165450-17-9 
 Chemical name N-[N-(3,3-dimethylbutyl)-L- α-aspartyl]-L-phenylalanine 1-
methyl ester  
 Chemical formula C20H30N2O5 
 Molecular weight 378.47  
Description  white to off-white powder 
Assay  Not less than 97.0% on the dried basis 
Identification  
Solubility  4.75% (w/w) at 60°C in water, soluble in ethanol and ethyl acetate
Purity  
Water content  Not more than 5% (Karl Fischer, sample size 25±5mg) 
pH 5.0 – 7.0 (0,5 % aqueous solution)  
Melting range 81°C to  84°C 
N-[(3,3-dimethylbutyl)-L- α-  Not more than 1.5%  
EN 5   EN aspartyl]-L-phenylalanine  
Lead Not more than 1  mg/kg