
Article 1 
By the way of derogation from Article 2 and Article 4(1) of Directive 91/321/EEC, the placing on the market of infant formulae based on hydrolysates of cows’ milk, as set out in the Annex to this Regulation, is authorised for a two-year period from the date of adoption of this Regulation.
Article 2 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 27 October 2006.
For the Commission
Markos KYPRIANOU
Member of the Commisison
ANNEX
(1) 
Protein content = nitrogen content × 6,25


Minimum Maximum
0,44 g/100 kJ 0,7 g/100 kJ
(1,86 g/100 kcal) (3 g/100 kcal)

(2) 
Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:


((a)) 63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and
((b)) 37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %.

(3) 
Two-stage hydrolysis process using a trypsin preparation with a heat treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.

(4) 
Essential and semi-essential amino acids in breast milk as set out in Annex V to Directive 91/321/EEC.
