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FSAI and Supplements
Dr. Wayne Anderson
Chief Specialist Food Science
F.S.A.I.
Food Safety Authority of IrelandFood Safety Authority of Ireland Mission Statement Mission Statement
““To protect consumers’ healthTo protect consumers’ health
by ensuring that food consumed, distributed, by ensuring that food consumed, distributed,
marketed or produced in the State meetsmarketed or produced in the State meets
the highest standards of food safety and the highest standards of food safety and hygiene.”hygiene.”
Food Safety Authority of IrelandFood Safety Authority of Ireland Putting responsibility on industry to produce Safe
Food
Independent, Science Based Consumer Protection Body
Developing a “Seamless” inspection service from “Farm gate to Fork”
Food standards based on risk analysis and sound science
Definition of “food” as stated in the Food Safety Authority of Ireland Act, 1998
“food” includes –
a) Any substance used, available to be used or intended to be used, for food or drink by human persons, and
b) Any substance which enters into or is used in the production, composition or preparation of these substances
and references to food include, as the context may require, reference to a particular food or class of food
Dioxins
Fish Oil Capsules
C1
The following figure shows the formula of 2,3,7,8-Tetrachlorodibenzo-p-dioxin, the most toxic compound of PCDD’s/PCDFs.
meta ortho
3
para
2
4 1
65meta ortho
ortho meta
2’ 3’
1’ 4’
5’6’
metaortho
para
The following figure shows the general structure of a biphenyl:
C1 C1
C1
Sources of Dioxin
• Environment
• Pollution
• Food– Animal– Plant
• Oils
Contamination Pathway
Dioxins and PCB’s
• Carcinogenic
• TWI 14 pg/kg b.w./week
• EC three prong strategy– Environment– Food– Feed
European Food Legislation and testing
Fish Liver Oils Legislation
COUNCIL REGULATION (EC) No 2375/2001 of November 2001
Amending Commission Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs
ProductProduct Max levels Max levels (PCDD+PCDF) (!) (PCDD+PCDF) (!) (pg WHO-PCDD/F-(pg WHO-PCDD/F-TEQ/g fat or TEQ/g fat or product)product)
Performance Performance criteria for criteria for samplingsampling
Performance Performance criteria for the criteria for the methods of methods of analysisanalysis
Fish oil intended for human consumption
2 pg WHO-PCDD/F-TEQ/g fat (²)
Directive 2001/…/EC (*)
Directive 201/…/EC (*)
The legislation comes into effect 1st July 2002
Dioxins Dioxins (PCDD’s)(PCDD’s) WHO Toxic WHO Toxic Equivalent Equivalent FactorFactor²²
2,3,7,8-Tetra-CDD 1.0
1,2,3,7,8-Penta-CDD
1.0
1,2,3,4,7,8-Hexa-CDD
0.1
1,2,3,6,7,8-Hexa-CDD
0.1
1,2,3,7,8,9-Hexa-CDD
0.1
1,2,3,4,6,7,8-Hepta-CDD
0.01
OCDD 0.0001
Furans Furans (PCDF’s)(PCDF’s)
WHO Toxic WHO Toxic Equivalent Factor²Equivalent Factor²
2,3,7,8-Tetra-CDF
0.1
1,2,3,7,8-Penta-CDF
0.05
2,3,4,7,8-Penta-CDF
0.5
1,2,3,4,7,8-Hexa-CDF
0.1
1,2,3,6,7,8-Hexa-CDF
0.1
1,2,3,7,8,9-Hexa-CDF
0.1
2,3,4,6,7,8-Hexa-CDF
0.1
1,2,3,4,6,7,8-Hepta-CDF
0.01
1,2,3,4,6,7,9-Hepta-CDF
0.01
OCDF 0.0001
Dioxin-Like PCB’sDioxin-Like PCB’s WHO Toxic Equivalent WHO Toxic Equivalent FactorFactor³³
NON-ORTHO PCB’s
Congener 77 0.0001
Congener 81 0.0001
Congener 126 0.1
MONO-ORTHO PCB’s
Congener 105 0.0001
Congener 114 0.0005
Congener 118 0.0001
Congener 123 0.0001
Congener 156 0.0005
Congener 157 0.0005
Congener 167 0.00001
Congener 189 0.0001
FSAI FINDINGSBrand Product Description Concentration (WHO-TEQ ng/kg)
PCDD’s PCDF’s
Dioxin-like PCB’s
A Fish liver oil 0.25 10.75
B Fish liver oil 7.80 30.2
C Fish body oil 0.44 0.16
D Fish liver oil 3.10 14.9
E Fish liver oil 0.58 1.42
F Fish body oil 0.65 4.25
G Fish liver oil 2.9 16.1
H Fish liver oil 11.00 19.0
I Fish liver oil 5.40 17.6
J Fish liver oil 3.80 14.2
K Fish liver oil 5.10 25.9
L Fish liver oil 2.70 13.3
M Fish liver oil 0.22 6.18
N Fish liver oil 5.70 16.3
O Fish liver oil 3.90 11.1
Messages
• 1st July 2002 –– fish oil >2ng/kg dioxin = illegal
• Must source ‘clean oil’– Low levels of dioxins (<2 ng/kg)
– Low levels of PCB’s
– Low Levels of PAH’s
• Must have certs of analysis for oil• Must test periodically to ensure certs are valid
FSAI ACT
Section 12
You are responsible for the safety of the products
you put on the Irish market
You are Required to Have
• A recall system
• A traceability system
• Records of tests