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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
24 June 2014
Globalization of trade in foods
• Advantages:
– Consumer choices of products
– Foreign exchange
• Impediment:
– Tariff and non-tariff barriers to trade
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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
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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.
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REGIONAL AND INTERNATIONAL
TRADE
SPS AGREEMENT
This 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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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
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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.
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WTO: SBS AND TBT AGREEMENTS
(WHO/FSF/FOS/97.8.REV 1 (1998)
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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?
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HOW?
International standards
HARMONIZATION
and/or
Scientific risk assessment
consistently applied / not more trade restrictive
than necessary
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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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INTERNATIONAL ORGANIZATIONS
• Codex Alimentarius Commission (CAC) - Food
• International Office of epizootics (OIE) animals
• International Plant Protection Convention
(IPPC) - Plants
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REGIONAL AND INTERNATIONAL
TRADE
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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
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SPS MEASURES
SISTERS
NOT BASED ON 3
• Available scientific evidence
• Relevant processes and production
methods
• Relevant inspection, sampling and testing
protocols
• ETC
• Economic factors
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CODEX: STRUCTURE OF RISK
ANALYSIS
Scientific advice /
Information/
analysis
Risk Assessment
Risk Management
Regulation and
control/
Enforcement
Risk Communication
Risk assessment
policy
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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-forcodex/en/loading
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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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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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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)
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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.pdf
http://www.who.int/foodsafety/publications/chem/regional_diets/en/
• Map - Countries by Cluster – 2006 png, 151kb
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JECFA assessment
CASSAVA toxicants
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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
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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
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South Africa - additives
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List of permissible sweeteners referred to in Regulation 4 of the
regulations 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
regulations 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 thereof the
foodstuffs may contain (R115/1986)
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.
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•
•
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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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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)
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DISPUTE SETTLEMENTS
• Mad cow disease
• Animal growth promoter - 3x naturalhormones & 3 synthetic hormones
• EU ban on GMOs not based on science,
consumer perceptions
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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
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Control, inspection an approval procedures
CHALLENGES
• Harmonizing
– Guidelines for pesticides and veterinary
drugs risk assessment and management.
• Capacity
• Toxicologist?
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WTO.
http://www.wto.org
wilnajvr@telkomsa.net