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LEGISLATIONS FOR MYCOTOXIN CONTROL

S. O. FAPOHUNDA PhDSchool of Basic and Applied Sciences

Babcock University, Ilishan remoNigeria

sfoodfeedf@yahoo.comoystak@yahoo.co.uk

234-8033709492

presentedat the 2nd International Symposium on Mycotoxins in Nuts, Dried fruits and Cereals

September 8-12, 2015 RMRDC, Abuja

Introduction

Mycotoxins are secondary bioactive metabolites of fungal origin produced under certain temperature and humidity conditions. Produced on virtually all crops—maize, beans, soybeans, groundnut, melon, sesame; and express in animal products like milk, eggs and meat. Pre harvest, harvest and postharvest.

Mycotoxins can be categorized based on structure and effect. On the basis of their chemical structure they can be grouped as =Aflatoxins(Aspergillus), Ochratoxin-OTA(Aspergillus westerdjikiae), Patulin(Aspergillus and Penicillium) and DON, ZEA , Fumonisin(Fusarium ) However, based on their effect, they can be carcinogenic(Afl,OTA,Fumonisin,)neurotoxic(Fumonisin)nephrotoxic(OTA),dermatotoxic(Trichothecenes eg DON), Immunosuppressive(Afl,OTA, DON ) and embryotoxic, teratogenic(Afl,ZEA)

Implicated fungi-mostlyAspergillus, Fusarium and Penicillium

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More than 500 mycotoxins exist. Only a few are regulated

Some unregulated mycotoxins Alternariol

Altertoxin

Malformin C (MAL-C)

Malformin A (MAL-A)

Afl M2

Beauvericin (BEAU)

Enniatin B1 (ENN-B1)

Regulated mycotoxins Afl B1, B2, G1, G2, M1, DON,

OTA, ZEA, Fum B1, 2, Patulin for EU(see Appendix 1) and USA(Hengst and Mastovska 2015) ‘T-2 and HT-2 toxins, sterigmatocystin ‘(FAO 2014)

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Legislation is a directive placed by a government or governing body on either an industry, a section of community or on people of a country which must be complied with in order to remain within the legal boundaries of that particular country, community or industry

It is the ‘software’ that drives food safety regulations

Once in place, a legislation becomes a law, that must be enforced.

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It is almost always internally generated within a country or sometime a combination of countries having parliament e.g EU.

A regulation is specific requirement that can take on various forms, such as industry specific regulation or regulations that are much broader in scope. Regulations represent specific directive(s)/requirement(s) within a legislation packaged to achieve protection…..

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Mycotoxin regulations are legislated to address consumer protection through product safety.

Put in place to address specific problems

May be internally or externally generated in respect to a particular industry

Legislation on mycotoxins is essential to protect public health (risk assessment)

and to avoid trade barriers and unfair competition

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Categories of Legislation

National(USA),

Regional(e g European Commission; ASEAN, Mercosur, Australia/NZ),

Global-FAO/WHO(Codex Alimentarius Commission, through the Codex Committee on Food Additives and Contaminants (CCFAC) Each is expected to have Procedural Manual revealing detailed description of methods of sampling and analysis

Distribution

About 100 countries have regulations.

For most of Africa, Specific Mycotoxin Regulations (SMR) perhaps ,do not exist only Adopted MycotoxinRegulations(AMR) do e.g Nigeria adopts EU 2 and 4ug/kg for B1 and total afl. USA has the specific regulation of 20ug/kg afl. for food. Morocco has the most detailed regulations in Africa

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Justification

Reliable/Conclusive report on hazard

a. Health concerns can be substantiated with sufficient, reliable toxicological data/observed toxicity are available (JECFA).

1. Provisional Tolerable Weekly Intake (PTWI) or a Provisional Tolerable Daily Intake (PTDI) can be set for each mycotoxin

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).

2.No-Observed-Adverse-Effect-Level (NOAEL) can be set(accompanied by an uncertainty factor). Where it is not possible to arrive at a value, then the toxicity will be As Low As Reasonably Achievable (ALARA)

b. Need to avoid international trade disputes

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Procedure

Must pass through the required legislative process(democracy). A bill must pass four stages and receive three readings before it can be passed into law

• 1st Reading

2nd Reading and Referral Public Hearing

3rd Reading and passage

Two ingredients are necessary—Technical and Political

The analyst and policy maker are important but the latter has the responsibility

Analysis(experts, other stakeholders) and Authorization(National assembly)- Legislation/ formulation

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Fig. 1 . Technical Contributors to Mycotoxicology

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The legislation has to be EFFECTIVE i. e valid, efficient and implementable and ACCEPTABLE i.earrived at through majority building, politically feasible

Feedback is an essential ingredient

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History

The first regulations for mycotoxins were set in the late 1960s or around 1970 when they were established for the aflatoxinsin USA(FAO 2004).

Factors that determine legislations

1.Method of sampling. For total aflatoxins in peanuts and corn, US requires three 22 kg laboratory samples. In the EU, one 30 kg laboratory sample is required (USDA2002; EU 2002).

2.Available analytical methods. More than 40 methods of analyses are available(Gilbert and Anklam, 2002).Acceptability depends on reliability , sensitivity andaffordabibility. (QuEChERS)

e.g Association of Official Analytical Chemists (AOAC International) and the European Standardization Committee (CEN), the European equivalent of ISO.

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3. Availability of toxicological data; must be conclusive not observational. Risk assessment(significant to public health?) focuses on 2 factors- HAZARD- same in all humanity e.g liver cancer(aflatoxin B1) , oesophageal cancer(fumonisin), and EXPOSURE-different with respect to social economic status. Must take care of other risk factors.

Metabolism in humans and animals ; toxicokinetics and toxicodynamics (TK-TD)

4. Availability of data on the occurrence of mycotoxins in various commodities=Bill and Melinda Gates Foundation/AbtAssociates Country assessment on Nigeria, Tanzania; (DALYand VSL )

5.Legislation in countries with which trade contacts exist. Respect for laws in importing countries .

6.Available solutions(including alternative uses ).

7.Sufficient food supply; legislations should not result in food shortages/hike in food prices 14

Expected Content of a mycotoxin Legislation

1.Background to the legislation

2.Commodities of target- origin, state(dried, raw, processed, compounded), variety, intended use.

3.Maximum permissible levels/limits for each mycotoxinin microgram /kilogram or milligram per kilogram e.gCommission Regulation (EC) No 1881/2006(appendix 1)

4.Guidelines for sampling and analytical procedure, e.g.Commission Regulation (EC) No 401/2006

5.Signature of authority with date. It is the final stage of authorization (Presidential system)

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6.Provision for subsequent amendment Ref= http://eur-lex.europa.eu/legal-

content/EN/TXT/?qid=1440584231642&uri=CELEX:32014R0519 http://eur-lex.europa.eu/legal-

content/EN/TXT/?qid=1440584231642&uri=CELEX:32015R0949(see Appendix 2)

Must be published in acceptable journal (hard or online) for ALL stakeholders.

=The Legislation/Directive shall enter into force on the day of its publication e g Official Journal of the European Union or as otherwise stated.(appendix 2)

The document is deposited in the Justice Ministry

OBJECTIVES OF LEGISLATIONS To achieve 3 Ps Promotion-Helping consumers make informed choices for healthy and

safe food Prevention-Maintaining strong rules for the food and feed industry Protection-Identifying and addressing food safety risks

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General Characteristics

of a mycotoxin legislation

1 It must embrace and emphasize Surveillance,compliance, Nonconformance Tracking , instant risk communication and Recall on food safety infractions where and when necessary.

2 Protocols must be friendly to prevailing economic reality.

3 Implementable legislation must focus on conducive ‘fa:fs’ (food abundance: food safety ) relationship. Excessive or unclear regulations can place a burden on business and local consumption.

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IMPLEMENTATION/ENFORCEMENT

By the Executive and backed by Judiciary.

1. Corporate= (only products of legislation)

Nigeria= Standards Organization of Nigeria (SON)Custodian, implementer member of (ISO, ARSO)

NAFDAC, implementer

NAQS, implementer

Consumer Protection Council (CPC)implementer

Kenya - Min Health

Zimbabwe------Min Agriculture

Singapore Agri- food and Veterinary Authority

The Netherlands-Commodity Boards for Animal feedstuffs

2. Individuals/NGOs- whistleblowing, when mycotoxin- related food fraud or criminal threats to the consumer are ignored.

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Consequences of Non conformance/Exceedance of action levels

=ALERTS (RASFF)

= DESTRUCTION

RECALLS,

REJECTS

= BANS

= LEGAL ACTION

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Country Product Action Reason Date

Ireland(FSAI) Wheat pasta Recall High OTA 10.10.2014

France chezLeclerc Son de Ble Recall High mycotoxins 06 09 2014

Ireland Liquorice root Recall High OTA 22.5.2015

Hong Kong shelled pistachios Customers alerts High aflatoxins 12.08.2014

South Africa. Dried Dog food Recall High mycotoxins 17.07.2014

France Corn Cakes Recall High mycotoxins 27/01/2015

Norway raw peanuts without

shells

Recall aflatoxins 14 04. 2014

Spain Apple Alert High patulin 11.06. 2013

Table 1. Non-conformance actions

Nigeria =high aflatoxin levels in melon , ogbono , and durum beans , 81 of 102 EU trade alerts issued on Nigerian crop exports- 2007-2012 (EU, 2012).

In 2015, beans, sesame seeds, melon seeds, dried fish and meat, peanut chips and palm oil from Nigeria have been banned by the EU till June 2016 Reasons—aflatoxins and pesticides at unacceptable levels

There can be legal redress e.g India and Nestle August 2015 -National Consumer Disputes Redressal Commission(NCDRC) Unfair trade practice. Reason= Lead at high levels.

‘Kroger …. sued for selling dangerous dog food ...’www.wcpo.com/.../kroger-has-also-been-sued-for-selling-

dangerous-dog...Feb 25, 2015 - A local company also has some experience being sued after the ... In a case very similar to the Beneful lawsuit, Kroger Co. settled out of court in 2010 after ... Specifically, Kroger measured dangerously high levels of aflatoxin,

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RECOMMENDATIONS

= Policy on Food Safety, separate Policy on Mycotoxins

=More involvement in government activities on food safety e. g National Food Safety Committee

FAO approves $495 000 to support implementation of the National Food Safety Policy Abuja, Nov. 26, 2014 (NAN) The Food and Agriculture Organisation (FAO) on Tuesday in Abuja said it has earmarked 495,000 dollars to support the implementation of Nigeria's food safety policy.

=Regulations/ phytosanitory certificate issuance(by trained and validated inspectors) should emphasize “present(as is)status at point of exit (pre export) and point of entry respectively.

=Packaging materials/labels to include mycotoxin levels

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Fig. 2 CHART OF LEGISLATION ON MYCOTOXINS

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AVAILABLE

INTERVENTIONS

FOOD AVAILABILITY/ABUNDANCE

(DATA)PROBLEM IDENTIFICATION

Pre, post harvest, human, animal health,

International trade

Surveillance studies(Researchers eg Univ. Res

Institutes )

Risk assessment-Feedback-

Farmers/Exporters

- Regulatory agencies

LEGISLATION

-NON-CONFORMANCE TRACKING

-NON-CONFORMANCE ACTION

alerts,bans, recalls, legal actionDISPUTES

JUDICIARY

-Awareness (extension services,)

Individuals(whistleblowing)CONFORMANCE

IMPLEMENTATION

REGULATORY AGENCIES

Some useful websiteswww.ngmycotoxin.org

www.sfoodfeedf.org

www.knowmycotoxins.com

www.mycotoxins.org

www.iarc.fr

www.fda.gov

www.codexalimentarius.net

www.mycored.eu

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References European Commission. (2002). Commission Directive 2002/27/EC of 13 March

2002amending Directive 98/53/EC laying down the sampling methods and the methods of analysisfor the official control of the levels for certaincontaminants in foodstuffs. Official Journal ofthe European Communities L75: 44-45.

EU (2012),COMMISSION REGULATION (EU) No 1058/2012 of 12 November 2012 amending Regulation (EC) No 1881/2006 as regards maximum levels

FAO (2004).Worldwide regulations for mycotoxins in food and feed in 2003... http://www.fao.org/docrep/007/y5499e/y5499e00.htm accessed 28 Aug 2015

FDA.(2002). Investigative Operations Manual. Food and Drug Administration, WashingtonDC, USA (available at www.fda.gov/ora/inspect_ref/iom/Contents/ch4_TOC.html

FSAI. (2015). Legislation on Chemical Contaminants January 2015 Contaminants legislation Guidelines 84pp. Food Safety Authority of Ireland

Hengst D and Mastovska K (2015).PersonalCommunicationhttps://www.agilent.com/cs/library/posters/.../HengstNACRW13-pg1.pd

http://www.iol.co.za/news/south-africa/western-cape/toxic-dog-food-products-recalled accessed 17 Aug 2015

http://www.inspection.gc.ca/food/action-plan/framework/eng/1385063041685/1385063100087 accessed 20 Aug 2015

http://www.haccpeuropa.com/food-recalls/ accessed 27 Aug 2015 https://www.food.gov.uk/enforcement/regulation accessed 26 Aug 2015 http.www.googlesearch.

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THANK YOU