- 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;
- 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;
- food intended for infants
means food specifically intended for infants, as defined in Commission Directive 91/321/EEC;
- food intended for special medical purposes
means dietary food for special medical purposes, as defined in Commission Directive 1999/21/EC;
- food safety criterion
means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market;
- independent certification body
means a body which is independent from the organisation that manufactures or distributes the alternative method and which provides a written assurance, in the form of a certificate, testifying that the validated alternative method meets the requirements of EN ISO 16140-2;
- 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;
- production process assurance of the manufacturer
means a production process whose management system guarantees that the validated alternative method remains conform to the characteristics required by EN ISO 16140-2 and ensures that mistakes and defects in the alternative method are prevented;
- 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;
- representative sample
means a sample in which the characteristics of the batch from which it is drawn are maintained.
- reptile meat
means reptile meat as laid down in point (16) of Article 2 of Commission Delegated Regulation (EU) 2019/625.
- 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;
- 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;