Transcript Studija o mikotoksinima

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
1.
FOOD SAFETY
FRAMEWORK
GLOBALISATION AND FOOD SAFETY SISTEMS
• Food safety policy should be based on the comprehensive
principles
covers 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 packaging
food 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 of risk 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 ...)
science
RISK ASSESSMENT
•Hazard identification
•Hazard characterisationi
•Expoasure assessment
•Risk Characterisation
politics
RISK MANAGEMENT
•Preliminary activities
•Assessment of options
•Implementation of possibilities
•Monitoring and control
RISK COMMUNICATION
CODEX ALIMENTARIUS
FRAMEWORK
FOR RISK ANALYSIS
Interactive exchange of information
and opinions
HAH IN NATIONAL FOOD SAFETY SYSTEM
COMPETENT
AUTHORITY
INSPECTIONS
ACADEMIC SOCIETY
INSTITUTES
LABORATORIES
Food Law
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
SCIENTIFIC PROJECTS
SCIENTIFIC STUDIES
FOOD PRODUCERS
INDUSTRY
SCIENTIFIS OPINIONS
based on
RISK ASSESSMENT
2.
TRACEABILITY
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 market and informing the
public
• 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 products
by 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
3.
RISK
ASSESSMENT
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
Question
Hazard identification
(Which hazards can cause
adverse heath effects?)
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
Conclusion/OPINION
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
4.
SCIENTIFIC
OPINION example
SCIENTIFIC OPINION
BACKGROUND
• Ministry of Agriculture (RASFF NCP) received alert notification
through Weekly notification system "2012.0011” regarding
migraration 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
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 ) or embryotoxicity 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 fact
because of sufficient data from the literature conducted 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 containing
seal 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 to final 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 producers is 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 .
Hrvatska agnecija za hranu
I.Gundulića 36 b
31 000 Osijek
Phone: 00385 31 214 900
00385 31 227 500
Free phone: 08000025
[email protected]