Definitions

The following definitions shall apply:

‘micro-organisms’ means bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites;

‘microbiological criterion’ means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch;

‘food safety criterion’ means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market;

‘process hygiene criterion’ a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law;

‘batch’ means a group or set of identifiable products obtained from a given process under practically identical circumstances and produced in a given place within one defined production period;

‘shelf-life’ means either the period corresponding to the period preceding the ‘use by’ or the minimum durability date, as defined respectively in Articles 9 and 10 of Directive 2000/13/EC;

‘ready-to-eat food’ means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern;

‘food intended for infants’ means food specifically intended for infants, as defined in Commission Directive 91/321/EEC ( 14 ) ;

‘food intended for special medical purposes’ means dietary food for special medical purposes, as defined in Commission Directive 1999/21/EC ( 15 ) ;

‘sample’ means a set composed of one or several units or a portion of matter selected by different means in a population or in an important quantity of matter, which is intended to provide information on a given characteristic of the studied population or matter and to provide a basis for a decision concerning the population or matter in question or concerning the process which has produced it;

‘representative sample’ means a sample in which the characteristics of the batch from which it is drawn are maintained. This is in particular the case of a simple random sample where each of the items or increments of the batch has been given the same probability of entering the sample;

‘compliance with microbiological criteria’ means obtaining satisfactory or acceptable results set in Annex I when testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective action, in accordance with food law and the instructions given by the competent authority.

COMMISSION REGULATION (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs ANNEX I Microbiological criteria for foodstuffs ANNEX II