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Laws and regulations
In this section you can find an update of national and EU regulatory guidelines about probiotics/prebiotics and health related claims on food.
QPS concept
Law on promulgation: 01/04/2010
Summary report of EFSA Scientific Colloquim held in Brussels, Belgium, the 13 and 14 December 2004 about “Microorganisms in food and feed: qualified presumption of safety – QPS”. This report summarizes the position of EFSA, and of the main scientists of the field, on procedures to be followed for the safety assessment of microorganisms used in food and feed production, in order to harmonise the strict regulation on feed additives with the lack of rules for microorganisms used in food.
(1.64 MB)
AFFSA approach to prebiotics and probiotics
Law on promulgation: 01/04/2010
Publication of the report on the "Effects of prebiotics and probiotics on microflora and immunity in adults" from AFFSA (French Agency for Food Safety)
(969.94 KB)
Italian guidelines for prebiotics and probiotics
Guidelines for the Evaluation of Probiotics in Food
Law on promulgation: 01/04/2010
Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food (2002)
(525.73 KB)
EFSA Assessment of bacteria for antibiotics (2005)
Law on promulgation: 01/04/2010
Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed
(178.51 KB)
EFSA Update of the criteria used in the assessment of bacterial resistance to antibiotics
Law on promulgation: 01/04/2010
Prepared by the Panel on Additives and Products or Substances used in Animal Feed
(144 KB)
Sicurezza alimentare e salute dell’infanzia
Physiological and functional properties of probiotics
Health claims EU Regulation
PASSCLAIM 2005
Law on promulgation: 01/04/2010
PROCESS FOR THE ASSESSMENT OF SCIENTIFIC SUPPORT FOR CLAIMS ON FOODS
Consensus on Criteria
(780.12 KB)
Passclaim 2008
Law on promulgation: 01/04/2010
Health Claims in Europe: New Legislation and PASSCLAIM for Substantiation
(533.72 KB)
FAO Technical Meeting Report on Prebiotics
Law on promulgation: 01/04/2010
The purpose was to discuss the prebiotic concept and its application to human health. An aim was to determine if prebiotics is an area of food research which would benefit from an Expert Consultation drawn from independently recognised leading experts convened under the auspices of the FAO.
(199.22 KB)
Rapporti ISTISAN 08/36 - Analisi integratori
Law on promulgation: 01/04/2010
Metodi microbiologici tradizionali e metodi molecolari per l’analisi degli integratori alimentari a base di o con probiotici per uso umano
(533.38 KB)
LINEE DI INDIRIZZO SUGLI STUDI CONDOTTI PER VALUTARE LA SICUREZZA E LE PROPRIETA' DEI PRODOTTI ALIMENTARI
Law on promulgation: 01/04/2010
In campo alimentare è possibile effettuare sperimentazioni in vitro, in vivo
(95.61 KB)
LINEE GUIDA PER GLI STUDI CLINICI CHE PREVEDONO L’ARRUOLAMENTO DI BAMBINI NEI PRIMI 3 ANNI DI VITA
Law on promulgation: 01/04/2010
Modifiche del regime alimentare o introduzione di nuove formule nell’alimentazione del lattante devono essere valutate con studi clinici che soddisfino standard clinici riconosciuti internazionalmente.
(52.83 KB)