Traceability and risk assessment of FCM FEST.A CROPAK 2014 29. – 31. May 2014. Hotel Jezero, NP Plitvička Jezera Croatian Food Agency Andrea Gross-Bošković, director
OUTLINE • Food safety framework • Traceability • Risk assessment - methodology - example – scientific opinion • Conclusions
GLOBALISATION AND FOOD SAFETY SISTEMS • Food safety policy should be based on the comprehensive principlescovers all stages of production chain; • Because of the longer shelf live, better quality, transportation and other characteristics of food, the most of the food are packed in certain packagingfood contact materials (FCM) • Globalization requires that different countries provide similar systems of food safety • The responsibility for food safety is on the manufacturer • Importance of HACCP • Modern food safety policy, which includes FCM, is based on the concept ofrisk analysis
FOOD SAFETY AND RISK ANALYSIS FOOD SAFETY - scientific discipline describing and linking production, processing, storage and handling of food in ways that will affect the prevention of foodborne illness. Includes materials, which are in contact with the food, and which can also adversely affect the health of consumers. Today's knowledge about the diseases that stem from unsafe food have led to the development of complex and highly complicated scientific disciplines - risk analysis - which integrates experts from different fields (medicine, veterinary science, microbiology, chemistry, mathematics, computer science ...) politics science • RISK ASSESSMENT • Hazard identification • Hazard characterisationi • Expoasure assessment • Risk Characterisation • RISK MANAGEMENT • Preliminary activities • Assessment of options • Implementation of possibilities • Monitoring and control RISK COMMUNICATION Interactive exchange of information and opinions CODEX ALIMENTARIUS FRAMEWORK FOR RISK ANALYSIS
HAH IN NATIONAL FOOD SAFETY SYSTEM COMPETENT AUTHORITY INSPECTIONS ACADEMIC SOCIETY INSTITUTES LABORATORIES Food Law FOOD PRODUCERS INDUSTRY Ordinance on the establishment of national Network of institutions in the area of food safety Ordinance on the issuing of scientific opinion and scientific and technical support CROATIAN FOOD AGENCY HAH SCIENTIFIS OPINIONS based on RISK ASSESSMENT SCIENTIFIC PROJECTS SCIENTIFIC STUDIES
TRACEABILITY - significance • Tracking the products throughout the entire food production chain as well as during the sales and consumption • Getting the information in cases of incidents related to a particular product • Helps when targeted withdrawal from the marketand informing thepublic • It is crucial to identify the source of contamination of food products in order to take certain measures for its removal from the market BUT ! • Traceability by it self does not guaranty the safety
LEGAL FRAMEWORK OF TRACEABILITY • In 2002., the European Parliament passed a law on the introduction of traceability in the food industry, which was published in the Official Journal of the European Communities, Regulation (EC) No. 178/2002 • It requires that all food manufacturers within the European Union and those outside who exported to the EU, have the obligation to introduced some form of monitoring of their productsby the 01January 2005. • In order to facilitated the implementation of traceability based on European Food Act (Regulation 178/2002),The European Commission has developed a guide for the application of certain articles of the Regulation 178/2002 - Guide has no formal legal status • Based on the Act - Guidelines for the implementation of Article 20 (Traceability) • Standard EN ISO 22005:2007 - a voluntary application; procedures and basic principles for traceability of food / feed
GLOBAL TRACEABILITY SYSTEMS • RASFF - rapid alert system, the basic tool for the exchange of information between the competent institutions in cases where there is a risk to human health created food for which were initiated certain measures, such as withdrawal from the market or prohibit imports of risky identified products. • Legal framework of RASFF Regulative EC/178/2002 chapter IV, part 1 i 2 • RASFF network members are EU Member States and EEA competent institution • "third countries", which are not EU members also receive a RASFF notification of the European Commission, but only under the following conditions: - If it is known that the subject of the notification exported to a third country - If the subject information originating from a third country
TRACEABILITY AS A FUNCTION OF RISK ASSESSMENT AND RISK MANAGEMENT • The interaction between the bodies of RM and the body which assess the risk is necessary: - in case they need to be functionally separate - to ensure the acceptability of the conductivity of planned control measures GOAL • rapid exchange of information between the participants in the system, • preventing the distribution and withdrawal from the market that pose a risk to the health of consumers
RISK ASSESSMENT 3.
HAZARD AND RISK Elements of risk for certain scenario • What makes hazard? • What is the probability of hazard occurring? • What are the consequences?
HAZARD AND RISK Possibilities?
RISK ASSESSMENT METHODOLOGY Exposure assessment Possible way of introduction of hazards via food or via any other way Hazard characterization The nature of adverse effect; Dose – response relationship Risk characterization Connecting of previous steps Hazard identification (Which hazards can cause adverse heath effects?) Conclusion/OPINION Question
CURRENT HAH OUTPUTS RELATED TO FCM 2006. – Scientific opinion on 2-isopropylthioxanton (ITX) in food http://www.hah.hr/upisnik_z_m.php?id=1 2012. - Scientific opinion concerning the migration of epoxidised soybean oil (ESBO) from lids of jars containing green olive tapenade http://www.hah.hr/upisnik_z_m.php?id=23 2012. - Scientific opinion on the novel technology of production of mineral water bottles with additional layer of material on the inner contact side with a view to prolonging shelf life of packaged goods http://www.hah.hr/upisnik_z_m.php?id=25 2013. – Scientific opinion regarding exposure of phalates from food – in preparation
SCIENTIFIC OPINION - example 4.
SCIENTIFIC OPINION BACKGROUND • Ministry of Agriculture (RASFF NCP) received alert notification through Weekly notification system "2012.0011” regardingmigraration of epoxidised soybean oil (ESBO) from lids of jars containing green olive tapenade from Croatia • Based on this, Ministry requested delivery of scientific opinion with regard to the nature of the hazard and the fact that the Ordinance on safety of materials and articles intended to come into direct contact with food (Regulations 2009, 2011) was not took over the EU Commission Regulation no. 10/2011 (EC 2011) on plastic materials and articles intended to come into contact with food.
HAZARD IDENTIFICATION • ESBO is used as a plasticiser and stabiliser for plastics such as poly(vinyl chloride) PVC. • It is used in particular in sealing gaskets of metal lids for glass jars, where it can be present at up to 40% of the weight of the gasket. There is thus a potential for migration into the food both during processing and storage. • ESBO is also used as a stabiliser in plasticised PVC cling films for wrapping foods. • When we talk about the specific migration is a very important relationship between the contact area and volume of content (food) in order to express the results (mg/dm2 or mg /kg of food or food appropriate model solution) was as credible. • Because of safer health care consumers, testing are conducted in conditions much stricter than those in actual service. • Table 1 (EFSA, 2006) specifies the percentage of the exceedance of the maximum permitted value of the specific migration of ESBO for a particular type of food.
HAZARD IDENTIFICATION • Based on average concentration levels of ESBO in foods packaged in glass jars with PVC lined lids, the potential high dietary exposure of adults was estimated to be 0.25 mg/kg body weight (bw) /day. • Metal lids of jars containing the seal , which provides hermetic closure , which is usually made of PVC plastisol . • Lids containing about 1 g of sealants , of which 250-350 mg is in direct contact with food ( Fankhauser - Noti and Grob 2006a ) . • Because PVC contains 35-45 % softened , about 100 mg softened exposed to the workings of the food . • Small amounts of free oil (usually on the surface of the food ) are sufficient to extract soften the sealant which can be completely extracted during prolonged storage. However , in food products in aqueous medium ( jams , food in a solution of vinegar ), or if it is a solid food whose content does not come into contact with a lid ( mustard ) migration is negligible . • Migration softened in fatty foods from 100 to 1000 mg/kg , which significantly exceeds the legally allowable total migration (OML) of 60 mg / kg or 10 mg/dm2 and usually exceeds the specific migration limit (SML) arising out of or limit values allowable daily intake (TDI) (Fankhauser - Noti et al . 2005 ; Fankhauser - Noti et al . 2006b)
HAZARD IDENTIFICATION • A tolerable daily intake (TDI) for ESBO has been established by the European Food Safety Authority (EFSA) • The TDI established for ESBO is 1 mg/kg body weight (EFSA, 2004, 2006). • The European Union (EU) and Croatian (RH) legislation has set a specific migration limit (SML) for ESBO of 60 mg per kg food for general foods and 30 mg per kg infant foods (EC 2002, 2005, 2007a, 2007b; Pravilnik 2009). • The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) evaluated the results of the surveys available on the migration of epoxidised soybean oil (ESBO) into foodstuffs such as sauces, condiments and products in oil packaged in glass jar with metal lids lined with polyvinyl chloride (PVC) containing ESBO (EFSA, 2006).
HAZARD CHARACTERISATION • Toxicity of ESBO • low acute oral toxicity , LD501 of at least > 5 g / kg body weight of rat causes slight skin and eye irritation in rabbits ( OECD , 2006) • Genotoxicity , teratogenicity, mutagenicity of ESBO • no indication of genotoxicity and ESBO - based on bacterial tests ( EPA / OTS , 1987 Heath and Reilly , 1982) , in- vitro tests on mammals ( EPA / OTS , 2000 ) orembryotoxicity and teratogenicity in vitro using the kit ( battery ) tests ( Han et al . , 2000 ; Fantoni and Simoneau 2003) • showed negative findings in a series of in vitro mutagenicity tests and in vitro tests for chromosomal aberration . It was concluded that it is not expected to be genotoxic ESBO ( OECD , 2006 ; Bibra 1988) . • at the highest dose of ESBO there was signs of toxicity, but no indication of the possible occurrence of tumors in rats . • in a limited study in rats fed with ESBO doses up to 5 % , there was no indicator - carcinogenic effects of ESBO ( Larsen et al . , 1960 ; OECD , 2006) . • Evaluation of dose - effect ( LOEL , NOEL , ADI and TDD ) to take orally ESBO - observed changes in body weight and liver weight
CONCLUSION OF THE OPINION • Specific migration of ESBO in foods is not an unknown factbecause of sufficient data from the literatureconducted scientific research. • Contamination of product jars containing green olive tapenade with ESBO poses a health risk in terms of exceeding the permissible values of TDI(tolerable daily intake) established by the European Food Safety Authority (EFSA, the European Food Safety Agency) for ESBO which is 1 mg / kg body weight (EFSA, 2004, 2006). • Given that and applicable regulations, the conclusion is that the concerned product poses a health risk to consumers
RECOMENDATIONS • Producers who pack oily foods in glass jars with metal lids containingseal made of PVC ( Twist off caps and closures ) should take into account what kind of food will be packed in that kind of packaging to avoid possible harmful effects on the health of the consumer, and ultimately withdrawal from the market • There are different types of plasticizers on the market used as sealant made of PVC ( plastisol ) for twist off lids and closures. These softeners have different migratory potential and affinity for a particular type of food (acid , fatty , neutral ). • With the proper selection of packaging food producer can significantly reduce the possibility of exceeding the maximum permissible level of specific migration into food or food in model solutions • To comply with the legislation would be preferable to obtain all certificates from manufacturers of packaging that are in compliance with all currently applicable regulations and establish a system of traceability of packaging and packaging materials related tofinal product • Traceability shall be ensured at all stages in order to facilitate control, the withdrawal of defective products informing consumers and assigning responsibilities and also on the availability of information to the competent authorities on request
CONCLUSIONS • When the packages, i.e. materials in contact with food, in any way adversely affect the food, the food itself is unsafe and vice versa • The responsibility of food producersis in the selection of safe and convenient packages and materials from which it is made • Suitability of pre-packaged for individual product depends on the composition, technology, consistency and preservation of food products, and technological design and the materials from which it is made packages are closely related with the safety of the final product • European legislation covers these issues in part of legislation that sets out the terms of food safety as "materials and objects which are in direct contact with food“ • The purpose of traceability is the establishment of an adequate system of identifying ways of labeling or relevant documentation or information .
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