S.L. 117.36 Art. 10Conformity checks. Selection of the control sample.

(1) The Inspectorate Unit shall perform conformity checks which are to be carried out selectively, based on a risk analysis, and with appropriate frequency, so as to ensure appropriate compliance with the marketing standards and other provisions of these regulations.

(2) Where the conformity checks conducted in terms of sub-regulation (1) reveal significant irregularities, the Malta Food Agency shall order the increase in the frequency of checks in relation to traders, products, origins, or other parameters.

(3) Traders shall provide the competent authority and the Inspectorate Unit with all such information as they consider necessary for organising and carrying out conformity checks.

(4) The competent authority shall in advance publish the criteria for assessing the risk of non-conformity of lots, on the basis of a risk analysis for each risk category. The competent authority shall in advance publish these criteria through a notice in the Gazette.

(5) The sample of the minimum rate of on-the-spot checks shall be drawn partly on the basis of a risk analysis and partly at random. The competent authority shall establish the risk factors. To assure relevant and efficient risk analysis, the effectiveness of the risk analysis shall be assessed and updated on an annual basis taking into account the relevance of each risk factor, comparing the results of randomly and risk-based selected samples and the specific situation in the particular risk category.

(6) The minimum control rate in respect of the marketing standards’ obligations shall be established in accordance with the provisions of this regulation. In this regard the control rate shall be fixed at a minimum of 10% of traders present in the traders database and subject to marketing standards.

(7) The sampling of on-the-spot checks for marketing standards shall take into account the participation of such traders in relevant certifications systems. It should, however, be demonstrated when taking that participation into account, that the traders participating in such schemes represent a lesser risk than traders not participating in those schemes.

(8) (a) Control samples for on-the-spot checks under this regulation shall be selected by the competent authority on the basis of a risk analysis, as per data available in the traders database.

(b) To provide the element of representativeness, the competent authority shall select randomly 20% of the minimum number of traders to be subject to on-the-spot checks: Of 100% 20% Random • 20% Random 80% Risk • 20% largest amount of revenue • 20% largest variety of fruit and vegetables subject to specific marketing standards • 40 % previous cases on non-compliance The effectiveness of the risk analysis shall be assessed and updated on an annual basis:

(a) by establishing the relevance of each risk factor

(b) by comparing the results of the risk based and randomly selected sample

(c) by taking into account the specific situation. The competent authority shall keep records of the reasons for the selection of each farmer for an on-the-spot check. The inspector carrying out the on-the-spot check shall be informed accordingly prior to the commencement of the on-the-spot check.