S.L. 437.68 Art. 16Detailed arrangements, amendment of the Annex and imports from non-member countries. Minimum Additives - - substances: - - Vitamins, chemically having a - Trace - Enzymes: - - - Substances effects: Products - Proteins organisms bacteria, - amino acids - Amino - Hydroxy 1. Facilities and design and r

The following shall be adopted in accordance with the procedure laid down in Article 16 of Directive 95/69/EEC:

(a) practical arrangements for the approval pursuant to rule 3 and registration pursuant to rule 8 of establishments located in a third country and putting additives, pre-mixtures, products covered by Directive 82/471/EEC as referred to in Chapter 1.1 (a) of the Schedule or feeding stuffs into circulation within Malta or a trading partner, so that safeguards are provided equivalent to those supplied by establishments located in Malta or in the territory of a trading partner. These arrangements shall comprise:

(i) publication of the list established and updated by the Commission, of third countries able to provide safeguards equivalent to those offered by Malta or the territory of a trading partner in respect of their own establishments and able to perform the checks referred to in rule 14,

(ii) publication of the list established and updated by the Commission of establishments which have been found by the third countries on the list referred to in sub-paragraph (i) to fulfil the conditions laid down in these rules,

(iii) the possibility that experts from the Commission, Malta and the territory of trading partners may carry out on-the-spot checks if necessary;

(b) measures for implementing the Schedule;

(c) the amendments to be made to the Schedule. SCHEDULE

CHAPTER 1 conditions which must be fulfilled by establishments and intermediaries referred to in rules 3 and 4 (subject to approval) CHAPTER I.1. (a) Additives and products covered by Directive 82/471/EEC (‘products’) and referred to in rule 3(2)(a) and rule 4(1)

Antibiotics: all additives in the group Coccidiostats and other medicinal all additives in the group Growthpromoters: all additives in the group provitamins and well-defined substances similar effect: all additives in the group elements: all additives in the group all additives in the group Micro-organisms: all additives in the group Carotenoids and xanthophylls: all additives in the group with antioxidant only those with a fixed maximum content covered by Directive 82/471/EEC obtained from micro-belonging to the group of all products in the group (except for sub-yeasts, algae, lower fungi: group 1.2.1) Co-products of the manufacture of by fermentation: all products in the group acids and their salts: all products in the group analogues of amino acids: all products in the group

CHAPTER I.1. (b) Minimum conditions which must be fulfilled by establishments referred to in rule 3(2)(a) and intermediaries referred to in rule 4(1) (‘products’ referred to in Chapter I.1(a)) Facilities and equipment and manufacturing equipment must be located, designed, constructed maintained to suit the manufacture of the ‘products’ concerned. The lay-out, operation of the facilities and equipment must be such as to minimize the and permit effective cleaning and maintenance in order to avoid cross-contamination and any adverse effects generally on the quality products. Facilities and equipment to be used for manufacturing operations essential for the quality of the products must undergo appropriate and checks, in accordance with written procedures pre-established by the for production of the products. Personnel The manufacturer must have sufficient staff possessing t qualifications necessary for the manufacture of the ‘products’ concerned. organizational chart setting out the qualifications (diplomas, experience) and responsibilities of the supervisory staff must be drawn available to the competent authorities of the supervisory staff must be made available to the competent authorities responsible for inspection. must be informed clearly in writing of their duties, responsibilities especially when any change is made, in such a way as to obtain the desired the ‘products’ concerned.