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TM Developing harmonized food safety regulations and standards based on science to promote regional and international trade Wilna Jansen van Rijssen PhD, ILSI-SA, Dr Boishoko Ntshabele, Director: Food Safety and Quality Assurance, Department of Agriculture, Forestry and Fisheries, SA 24 June 2014

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Developing harmonized food safety regulations and standards based on science to promote regional and international trade. Wilna Jansen van Rijssen PhD, ILSI-SA, Dr Boishoko Ntshabele , Director: Food Safety and Quality Assurance, Department of Agriculture, Forestry and Fisheries, SA - PowerPoint PPT Presentation

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Page 1: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

TM

Developing harmonized food safety regulations and

standards based on science to promote regional and

international tradeWilna Jansen van Rijssen PhD, ILSI-SA,

Dr Boishoko Ntshabele, Director: Food Safety and Quality Assurance, Department of Agriculture, Forestry and Fisheries, SA

24 June 2014

Page 2: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

TM

Globalization of trade in foods

• Advantages: – Consumer choices of products– Foreign exchange

• Impediment:– Tariff and non-tariff barriers to trade

Page 3: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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International organizations

• Codex Alimentarius Commission (FAO/WHO) - 1962 – Protect health of consumers – Ensure fair practices in trade

• World Trade Organization (WTO) Agreements (1995)– SPS (Sanitary and Phyto-Sanitary) - measures– TBT (Technical Barrier to Trade) - measures

Page 4: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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GOALS OF THE AGREEMENT

• Recognise the sovereign right of members to provide the level of health they deem appropriate

• Ensure that SPS measures do not represent unnecessary , arbitrary, scientifically unjustifiable, or disguised restriction on international trade.

Page 5: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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REGIONAL AND INTERNATIONAL TRADE

SPS AGREEMENTThis Agreement applies to all sanitary and

phytosanitary measures which may, directly or indirectly, affect international trade. Such measures

shall be developed and applied in accordance with the provisions of this Agreement.

http://www.wto.org/english/res_e/publications_e/wtocan_e.pdf

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Page 6: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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SPS MEASURES

• Protect animal and plant life or health within the territory of the Member

• Protect human and animal health from risks arising from additives, contaminant, toxins, disease-causing organisms in foods, beverages or feedstuffs

• Diseases carried by animals, plants or products thereof

• Spread of pest

Page 7: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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SPS vs TBT

• SPS – a narrowly defined range of health protection but strict requirements on these measures. Always based on scientific principles

• TBT – range of technical requirements – to avoid consumer deception, standards, quality, some safety and health.

Page 8: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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WTO: SBS AND TBT AGREEMENTS (WHO/FSF/FOS/97.8.REV 1 (1998)

Page 9: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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SCIENTIFIC JUSTIFICATION

• An appropriate level of protection (ALOP) or acceptable level of risk?

• How does members show that measures are based on science?

Page 10: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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HOW?

International standards HARMONIZATION

and/or

Scientific risk assessmentconsistently applied / not more trade restrictive

than necessary

Page 11: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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REGIONAL AND INTERNATIONAL TRADE

To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their

sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this

Agreement

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Page 12: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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INTERNATIONAL ORGANIZATIONS

• Codex Alimentarius Commission (CAC) - Food

• International Office of epizootics (OIE) - animals

• International Plant Protection Convention (IPPC) - Plants

Page 13: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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REGIONAL AND INTERNATIONAL TRADE

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Page 14: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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CASE STUDY Steviol glycoside

• Stevia rebaudiana Bertoni leaves• Sweetener• Stevioside and Rebaudioside A (Nine named

steviol glycosides)• ADI of 0-4 Mg/kg in 2004• European Commission authorized the use in

2011

http://whqlibdoc.who.int/publications/2009/9789241660600_eng.pdf

Page 15: Wilna Jansen van  Rijssen  PhD, ILSI-SA,
Page 16: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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SPS MEASURES NOT BASED ON 3 SISTERS

• Available scientific evidence• Relevant processes and production

methods• Relevant inspection, sampling and

testing protocols• ETC• Economic factors

Page 17: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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Risk Assessment Risk Management

Risk Communication

Scientific advice /

Information/ analysis

Regulation and control/

Enforcement

Dialogue with

all stakeholders

CODEX: STRUCTURE OF RISK ANALYSIS

Risk assessment policy

Page 18: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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COMPONENTS OF RISK ANALYSIS AS DEFINED BY CODEX

Risk assessment: A scientifically based process consisting of the following steps:

i) hazard identification; ii) hazard characterization; iii) exposure assessment and iv) risk characterization.

http://www.codexalimentarius.org/scientific-basis-for-codex/en/loading

• RI

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Page 19: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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COMPONENTS OF RISK ANALYSIS AS DEFINED BY CODEX

Risk management: The process, distinct from risk assessment, of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

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Page 20: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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COMPONENTS OF RISK ANALYSIS AS DEFINED BY CODEX

Risk communication: An interactive process of exchange of information and opinion on risk among risk assessors, risk managers and other interested parties.(individuals, groups and institutions).

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Page 21: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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FOOD SAFETY REGULATION: PROACTIVE LEGISLATION / REACTIVE LEGISLATION• RISK ASSESSMENT : toxicity assessment

Registration/permit for new molecules (additives /pesticides/toxicants/vet drugs)

• Hazard assessment/characterization: Toxicological assessment of chemical ADI / ARfD (acute reference dose)/PMTDI (provisional maximum tolerate daily intake)

Page 22: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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FOOD SAFETY REGULATION:

EXPOSURE ASSESSMENT: Residue limits (MRLs) /tolerance levels , statutory determined/GAPs/exposure Dietary intake data

• GEMS/food intake (Global Environmental Monitoring System- Food Contamination Monitoring and Assessment Programme

http://www.who.int/foodsafety/chem/acute_data/en/ http://www.who.int/foodsafety/chem/cluster_diets_2012.pdfhttp://www.who.int/foodsafety/publications/chem/regional_diets/en/

• Map - Countries by Cluster – 2006 png, 151kb

Page 23: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

JECFA

Page 24: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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JECFA assessmentCASSAVA toxicants

Further research is needed to more accurately quantify how nutritional

factors ultimately contribute to the human diseases observed in

populations whose diets consist mainly of improperly processed cassava,

which involves high cyanide exposure. There is a need for more

extensive occurrence data for cyanogenic glycosides. These include data

showing the ratio of cyanogenic glycosides to cyanohydrins to HCN in

raw and processed versions of a range of foods containing cyanogenic

glycosides. More occurrence data for foods other than cassava are

needed, as are occurrence data for all foods from a broader range of

countries around the world.

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More consumption data for cassava and cassava products from a broader

range of countries would enable more detailed estimates of dietary exposure to be

conducted or refined. More acute and chronic dietary exposure assessments from a

broader range of countries, particularly African countries, would enable a better

estimation of the global risk of dietary exposure to cyanogenic glycosides.

Codex practice nonglycoside cassava.pdf CAC/RCP 73-2013

JECFA 2012

Page 25: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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PROVISIONAL MEASURES

INSUFFICIENT scientific evidence to permit a final decision.

• Emergency response• Provisional measures adopted on the

basis of available pertinent info• Seek for additional information• Reasonable time period

Page 26: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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PRECAUTIONARY PRINCIPLE

• Precaution vs precautionary principle (approach)

• Cartagena Protocol on Biosafety• Risk management - decision making• “uncertainty” in risk assessment• No zero risk

Page 27: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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South Africa - additives• List of permissible sweeteners referred to in Regulation 4 of the re

gulations relating to the use of sweeteners in foodstuffs

• Regulations relating to the use of sweeteners in foodstuffs (R733/201)

• Also see Codex General Standards for Food Additives • List of permissible sweeteners referred to in Regulation 4 of the re

gulations relating to the use of sweeteners in foodstuffs

• Regulations relating to baking powder and chemical leavening substances (R2486/1990)

• Regulations – Preservatives and antioxidants: Amendment (R60/2009)

• Regulations relating to mayonnaise and other salad dressings (R92/1986)

• Regulations relating to food colourants (R1055/1996) • Regulations – Jam, conserve, marmalade and jelly (R2627/1986) • Regulations governing emulsifiers, stabilisers

and thickeners and the amounts thereof that foodstuffs may contain (R2527/1987)

• Regulations - Preservatives and antioxidants (R965/1977) • Regulations governing acids, bases and salts and the amounts the

reof the foodstuffs may contain (R115/1986)

Page 28: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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REGIONAL AND INTERNATIONAL TRADE

• Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection.

• Zoning (Kruger National Park – TB in lions)• Compartmentalization (a farm quarantined) • Zero tolerance• Single source (a single exporting a novel product)

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Page 29: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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EQUIVALENCE

• More than one measure may be effective • The importer must be granted

reasonable access to inspect, test etc• Ex – FMD treatment of milk (EU), New

Zealand accept products only from FMD free countries.

• Pest and disease free regions – fruit (oranges)

Page 30: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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DISPUTE SETTLEMENTS

• Mad cow disease• Animal growth promoter - 3x

natural- hormones & 3 synthetic hormones

• EU ban on GMOs not based on science, consumer perceptions

Page 31: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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WTO: RIGHTS AND OBLIGATIONS• Transparency- Information exchange

– One enquiry point– Publication of regulations– Notification procedures

• International harmonization (Codex standards)– Food additives/ veterinary drugs/pesticide residues

• Risk-based approach– HACCP (Hazard Analysis and Critical Control Point), process control– Risk assessment

• Control, inspection an approval procedures

Page 32: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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CHALLENGES

• Harmonizing– Guidelines for pesticides and veterinary

drugs risk assessment and management.

• Capacity• Toxicologist?

Page 33: Wilna Jansen van  Rijssen  PhD, ILSI-SA,

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WTO. http://www.wto.org

[email protected]