New Semicarbazine in Fish products: The importance of collecting … · 2016. 12. 13. ·...

Semicarbazine in Fish products:

The importance of collecting true

data and their traceability

Dr Popi Kanari

Director

State General Laboratory,

Ministry of Health

Cyprus EFSA AF MEETING, PARMA, ITALY

8-9 DECEMBER 2016

EFSA AF MEETING, PARMA, ITALY 8-9 DECEMBER 2016

Semicarbazine (SEM) • What is SEM and where does it come from ?

• SEM belongs to the hydrazine family of chemicals some members of which are known to possess carcinogenic potential

• Information on the potential hazard of SEM itself is incomplete and the possibility that it is genotoxic cannot be ruled out

• SEM from Nitrofurans usage

• SEM has been employed as an excellent marker metabolite for the illicit use of the Nitrofuran – Nitrofurazone, in food producing animals


Nitrofurans Nitrofurans:

• They are synthetic broad spectrum antimicrobial reagents

• Their use in food producing animals is not permitted since 1993 -1995 in the EU

• They have however been reported to be used mostly in poultry and aquaculture production in third countries

• Such reports led to large numbers of these products being tested by MS prior to acceptance of the goods at the port of entry , in food producing animals

• Are rapidly metabolized as residues in foods of animal origin and therefore they are found in animal tissues as protein-bound metabolites

• Sampling of food for Nitrofuran testing in foods of animal origin is undertaken in the context of the National Residue Monitoring plans Directive 96/23/EC in accordance with Decision 2002/657/EC

According to the above legislation it is required to

report Only the protein Bound metabolites of Nitrofurans to prove their illicit use in food producing animals


Nitrofurans Parent cpd Metabolites

Nitrofurazone semicarbazide (SEM)

Furazolidone met 3-amino-2-oxazolidinone (AOZ)

Furaltadone 3-amino-5-methylmorpholino-2- oxazolidinone (AMOZ)

Nitrofurantoin 1-aminohydantoin (AHD)

Nifursol 3,5-dinitrosalicylic acid hydrazide (DNSH)


SEM from different origins other than Nitrofurans

• SEM was detected also in foods of non animal origin and this triggered research and was found that its presence in food may be from sources other than use of Nitrofurazone

• from azodicarbonamide (ADC) ( not authorized for use in EU as from 2005 )used as blowing agent for plastic gaskets for metal lids on glass bottles and jars .Processed food packaged in bottles and jars where these gaskets are used ,include baby food !

ADC also used as a flour improver (not authorized in the EU but permitted in some third countries ) ,

From treatment of carrageenan gum (an additive from sea weeds )with hypochlorite for bleaching and


Unbound SEM from different sources other than Nitrofurans

• The breakdown of ADC (from flour improver or from blowing agent in plastics ) gives rise to the presence of SEM in a number processed food consumed such as breaded fish and chicken consumed by children

• So this SEM in the bread will be in the unbound part

• Also in the case of treatment of carrageenan gum with hypochlorite ,residual chlorine may persist give rise to SEM also in the unbound part


EFSA opinion on Nitrofurans Nitrofurans:

- The EC requested EFSA to provide a scientific opinion on the risks of human health related to the presence of nitrofurans and their metabolites in food and whether the Reference Point of Action (RPA, 1.0 ug/kg) for the marker metabolites is adequate to protect public health.

EFSA (CONTAM)Panel (provided in 2015 (EFSA Journal 13(6) a Scientific Opinion on nitrofurans and their metabolites in food Data on occurrence of Nitrofuran metabolites were taken from the residue monitoring plans of the MS from 2002-2013 And also from RASFF Database where 808 notifications events were reported ,of which 416 were crustaceans and 150 poultry and meat products


Limitations • EFSA concluded that the occurrence data and from

RASFF were too limited to perform a reliable human dietary exposure assessment

• The exposure assessment estimation was based on the scenario in which a single nitrofuran marker metabolite is present at the RPA of 1 microgm/kg in foods of animal origin (even worst case scenarios were applied).

• Milk and dairy products were excluded


Findings in the EFSA opinion • . • Nitrofurazone and its marker metabolite SEM are

genotoxic in vitro .The in vivo tests showed negative results with Nitrofurazone but no conclusion can be drawn for SEM

• Acute toxicity studies in Lab animals showed that for Nitrofurazone and some others ,the lung is an important target for toxicity leading to respiratory failure and death signs of neurotoxicity were also found .

• There is limited evidence that SEM is carcinogenic in mice but not in rats .SEM increased the incidence of malignant lung tumours in female mice. Also ,effects on bone development were observed .


Not conclusive studies on SEM • Because most of the nitrofurans and their metabolite are

genotoxic, and /or carcinogenic derivation of Health Based Guidance Values were not possible .Therefore margin of exposure (MOE ) were used.

• SEM carcinogenicity study cannot be evaluated – The need of a new study for the SEM action mechanism and more information for genotoxic/carcinogenic effects

• For Nitrofurazone no conclusion could be drawn on its possible carcinogenicity and for SEM the available information was not suitable to derive Ref.Point for carcinogenicity effects


SEM from different origins other than Nitrofurans

• SEM is monitored in foods of animal origin to test for illegal use of Nitrofurazone at RPA level (or MRPL Decision 2002/657/EC, 1.0 ug/kg ) in the bound form at import control –Decision 2005/34/EC

• Laboratories wash samples to get rid of unbound SEM and consequently Report bound SEM

However People do not DO washing steps and consume usually the bound and unbound SEM

Problems persist with e.g. breaded products in fish or chicken


Impelemntation of EU legislation

CCa Decision level ;varies from country to country as it depends on the method used RPA Reference point of Action 1 microgramme /kg (MRPL) In Cyprus: for SEM ,CCa is 0,127 microgramme /kg From a Cyprus pilot study SEM was determined in a number of food samples breaded and non breaded and results are shown below . 4 samples were non compliant but no action could be taken as they results are below RPA . IF total SEM (bound and unbound )was reported then there would be 3 samples where action would be taken Other Samples tested were meat, milk, eggs and fish.


SEM in imported fish 2015-2016 (CCa=0,127 μg/kg-RPA 1μg/kg)

Kind of fish Origin Concentration (μg/kg)-bound and

unbound

Concentration after wash (μg/kg)-

bound

Pangasius fillet frozen

Vietnam

3,21 0,968


Vietnam 1,17 0,547


Vietnam 0,391 0,144

Pangasius breaded fillet frozen

Vietnam 1,76 0,271

Cod breaded fillet frozen

Atlantic Ocean 0,135 0,0842


SEM in imported fish 2015-2016

Number of samples Kind of fish Non compliant

12 Pangasius fillet frozen 3

4 Breaded Cod fillet 2

3 Frozen Shrimps 0

1 Common sole fillet 0

3 Cod Fish Fillet 0

1 Salmon 0


What should be the true data reported for SEM?

• Laboratories wash samples to get rid of unbound SEM and consequently Report bound SEM

• People however do not DO washing steps and consume usually the bound and unbound SEM

• It is important to know the source of SEM , if not in the bound form , but it is also good to know the total , as this the quantity that is consumed .

• Consumers and especially children eat breaded fish or chicken for example Bound and unbound ! • Is this agreeable to Risk assessors and/or Risk managers ?


Since more data are needed for conclusive opinions ,true data and the origin of the parameters is essential

especially for SEM

If you are going to have breaded Turkey or salmon for Christmas have

this in mind Thank you for your

attention

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