
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.
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 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 ± 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'
