Infant Formula and Follow-up Formula Directive No.335/2020.

This Directive is applicable on all import, export, and wholesale trade of infant formula, special formula, and follow-up formula. The objectives of this Directive are to: 1) protect infants and young children from health risks emerging out of unsafe or poor quality this products; 2) take regulatory measures in safeguarding breast feeding; and 3) control the packaging, labeling information and advertisement of regulated products under this directive. “Infant formula” means breast milk substitute formulated industrially in accordance with applicable standards to satisfy the normal nutritional requirements of infants up to six months of age and adapted to their physiological characteristics.
Any product regulated under this directive and to be marketed in Ethiopia shall be registered by the Authority after satisfying requirements provided under Article 7 to Article 10. Art. 7 (Administrative documents for registration), Art. 8 (Technical documents), Art. 9 (Packaging and labelling requirements for finished product) and Article 10 (Quality analysis result). Any person who wants to import, export, wholesale or distribution a food supplement under this directive shall apply for a certificate of competence; Part 3 establishes minimum requirements in relation to location, building materials and work force. Part 4 regulates product import, export and wholesale.