Division 1 The production process for gelatine must ensure that:X1F1

all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined BSE risk in accordance with F2... legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days. This treatment is followed either by:

• an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a heat treatment step of 138 °C minimum during at least four seconds, or

• an acid treatment (pH < 3,5) during 10 hours minimum with a heat treatment step of 138 °C minimum during at least four seconds, or

• a heat-and-pressure process for at least 20 minutes with saturated steam of 133 °C at more than 3 bars, or

• any approved equivalent process;

other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or more times in succession, followed by purification by means of filtration and heat treatment.