anx_ANNEX__cpt_5__cpt_10__point_18__point_e__text_2

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four · European Union

‘1. Tricalcium phosphate must be produced by a process that ensures: (a) that all Category 3 bone-material is finely crushed and degreased in counter-flow with hot water (bone chips less than 14 mm); (b) continuous cooking with steam at 145 °C during 30 minutes at 4 bars; (c) separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation; and (d) granulation of the tricalcium phosphate after drying in a fluid bed with air at 200 °C; or by an equivalent production process approved by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).’;

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Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.