Specific rules for testing and sampling
Article 5
1. The analytical methods and the sampling plans and methods in Annex I shall be applied as reference methods. 2. Samples shall be taken from processing areas and equipment used in food production, when such sampling is necessary for ensuring that the criteria are met. In that sampling the ISO standard 18593 shall be used as a reference method. Food business operators manufacturing ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health, shall sample the processing areas and equipment for Listeria monocytogenes as part of their sampling scheme. Food business operators manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose an Enterobacter sakazakii risk shall monitor the processing areas and equipment for Enterobacteriaceae as part of their sampling scheme. 3. The number of sample units of the sampling plans set out in Annex I may be reduced if the food business operator can demonstrate by historical documentation that he has effective HACCP-based procedures. 4. If the aim of the testing is to specifically assess the acceptability of a certain batch of foodstuffs or a process, the sampling plans set out in Annex I shall be respected as a minimum. 5. Food business operators may use other sampling and testing procedures, if they can demonstrate to the satisfaction of the competent authority that these procedures provide at least equivalent guarantees. Those procedures may include use of alternative sampling sites and use of trend analyses. Testing against alternative micro-organisms and related microbiological limits as well as testing of analytes other than microbiological ones shall be allowed only for process hygiene criteria. The use of alternative analytical methods is acceptable when the methods are validated against the reference method in Annex I and if a proprietary method, certified by a third party in accordance with the protocol set out in EN/ISO standard 16140 or other internationally accepted similar protocols, is used. If the food business operator wishes to use analytical methods other than those validated and certified as described in paragraph 3 the methods shall be validated according to internationally accepted protocols and their use authorised by the competent authority.