DIRECTIVES  
COMMISSION DIRECTIVE 2010/37/EU  
of 17 June 2010  
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 (EC) No 1333/2008 of the 
European Parliament and of the Council of 16 December 
2008 on food additives (  1 ) and in particular Article 30(5) 
thereof,  
After consulting the European Food Safety Authority (EFSA),  
Whereas:  
(1) Commission Directive 2008/60/EC (  2 ) 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 2007 (  4 ). On the basis of the 
proposed uses, it has been considered appropriate to 
permit the use of this food additive. 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 into account the specifications and 
analytical techniques for additives as set out in the Codex 
Alimentarius 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 indi ­
vidual heavy metals of interest, where appropriate.  
(4) Directive 2008/60/EC should therefore be amended 
accordingly.  
(5) 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  
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 March 2011 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.  
Article 3  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union .EN L 152/12 Official Journal of the European Union 18.6.2010  
( 1 ) OJ L 354, 31.12.2008, p. 16.  
( 2 ) OJ L 158, 18.6.2008, p. 17.  
( 3 ) OJ L 237, 10.9.1994, p. 3.  
( 4 ) Scientific opinion of the Panel on Food Additives, Flavourings, 
Processing Aids and Materials in Contact with Food on a request 
from the European Commission on neotame as a sweetener and 
flavour enhancer.  The EFSA Journal  (2007) 581, 1-43.Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 17 June 2010.  
For the Commission  
The President  
José Manuel BARROSO  
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 of 
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 No  165450-17-9  
Chemical name  N-[N-(3,3-dimethylbutyl)-L- α-aspartyl]-L-phenylalanine 1-methyl 
ester  
Chemical formula  C  20 H 30 N 2 O 5 
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 ± 5 mg)  
pH 5,0 – 7,0 (0,5 % aqueous solution)  
Melting range  81 °C to 84 °C  
N-[(3,3-dimethylbutyl)-L- α-aspartyl]- 
L-phenylalanine  Not more than 1,5 %  
Lead  Not more than 1 mg/kg’EN 18.6.2010 Official Journal of the European Union L 152/13