2. FSAI and Supplements Dr. Wayne Anderson Chief Specialist Food Science F.S.A.I.

3. Food Safety Authority of Ireland Mission Statement “ To protect consumers’ health by ensuring that food consumed, distributed, marketed or produced in the State meets the highest standards of food safety and hygiene.”

4. Food Safety Authority of Ireland u Putting responsibility on industry to produce Safe Food u Independent, Science Based Consumer Protection Body u Developing a “Seamless” inspection service from “Farm gate to Fork” u Food standards based on risk analysis and sound science

5. 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

6. Dioxins Fish Oil Capsules

7. C1 The following figure shows the formula of 2,3,7,8- Tetrachlorodibenzo-p-dioxin, the most toxic compound of PCDD’s/PCDFs. metaortho 3 para 2 4 1 65 metaortho meta 2’3’ 1’4’ 5’6’ metaortho para The following figure shows the general structure of a biphenyl: C1

8. Sources of Dioxin Environment Pollution Food –Animal –Plant Oils

9. Contamination Pathway

10. Dioxins and PCB’s Carcinogenic TWI 14 pg/kg b.w./week EC three prong strategy –Environment –Food –Feed

11. European Food Legislation and testing

12. 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 Product Max levels (PCDD+PCDF) (!) (pg WHO-PCDD/F- TEQ/g fat or product) Performance criteria for sampling Performance criteria for the methods of analysis 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 1 st July 2002

13. Dioxins (PCDD’s) WHO Toxic Equivalent Factor² 2,3,7,8-Tetra-CDD1.0 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 OCDD0.0001 Furans (PCDF’s) WHO Toxic Equivalent 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 OCDF0.0001

14. Dioxin-Like PCB’s WHO Toxic Equivalent Factor³ NON-ORTHO PCB’s Congener 770.0001 Congener 810.0001 Congener 1260.1 MONO-ORTHO PCB’s Congener 1050.0001 Congener 1140.0005 Congener 1180.0001 Congener 1230.0001 Congener 1560.0005 Congener 1570.0005 Congener 1670.00001 Congener 1890.0001

15. FSAI FINDINGS BrandProduct DescriptionConcentration (WHO-TEQ ng/kg) PCDD’s PCDF’s Dioxin-like PCB’s AFish liver oil0.2510.75 BFish liver oil7.8030.2 CFish body oil0.440.16 DFish liver oil3.1014.9 EFish liver oil0.581.42 FFish body oil0.654.25 GFish liver oil2.916.1 HFish liver oil11.0019.0 IFish liver oil5.4017.6 JFish liver oil3.8014.2 KFish liver oil5.1025.9 LFish liver oil2.7013.3 MFish liver oil0.226.18 NFish liver oil5.7016.3 OFish liver oil3.9011.1

16. Messages 1 st 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

17. FSAI ACT Section 12 You are responsible for the safety of the products you put on the Irish market

18. You are Required to Have A recall system A traceability system Records of tests