Irina Kireeva

Report
Baku, 30-31 May 2013
1
2
Major difficulties of some WTO Members in complying
with the SPS and TBT Agreements
 Objective of the legal research and assessment
The objective of the legal research and
assessment was to review the sanitary and
technical regulatory frameworks of the Russian
Federation, Kazakhstan and Azerbaijan (focusing
on norms and requirements related to food and
product safety) and indicate major shortcomings
and difficulties in complying with the WTO
Agreements as well as to provide
recommendations in relation to harmonisation
with international norms and standards.
3
Harmonization of standards, regulations
and laws with international requirements
are vital arguments for further accession of
Azerbaijan and Kazakhstan to the WTO.
Although Russia has recently joined the
WTO, issues of SPS and TBT compliance are
also of the importance for increasing
competitiveness and quality of traded
goods.
4
How to ensure food safety and consumer
protection in accordance with the national
legislation? What is harmonisation?
Harmonisation of national legislation
in line with international standards is
a process by which a state transplants
identical regulatory principles or
adopts the same laws, regulations or
standards as those internationally
agreed.
5
What is Food Safety?
Assurance that food will not cause
harm to the consumer when it is
prepared and /or
eaten according to its intended use
General observation on Legal Aspects of Food
Safety framework in Russia, Kazakhstan and
Azerbaijan
 Better understanding of the deference between the
SPS and TBT measures (particularly in light of the
adoption of new Technical Regulations for various
food products for the Customs Union trade
facilitation – relevant for Russia and Kazakhstan);
 Major deficiencies of the Technical Regulations
with sanitary provisions;
 General problems with all the Sanitary and
Epidemiological Rules and Norms;
 Choice of the Institutional Framework for Food
Safety – Integrated Approach versus Single Agency
System.
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Better understanding of the difference between SPS
and TBT measures will help countries with compliance
to these WTO Agreements.
Relationship of the SPS Agreement with the
TBT Agreement
 Health-related trade restrictions are addressed by both
the Sanitary and Phytosanitary Agreement and the
Agreement on Technical Barriers to Trade. Although the
two agreements are similar in a number of ways, their
substantive provisions are different.
 The SPS Agreement and the TBT Agreement exclude
each other from their scope.
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The main differences
of the SPS and TBT measures reside in:
 the scope of application;
 the use of international standards;
 the reasons for application and
maintenance of the measures.
9
Scope of the TBT and SPS Agreements
The TBT Agreement
covers:
 technical regulations;
The SPS Agreement covers all measures
whose purpose is to protect:
 voluntary standards; and
human or animal health from so called
food-borne risks;
 conformity assessment
procedures.
human health from animal or plant
diseases; and
plants and animals from pests or
diseases.
Except when these are SPS measures as
defined by the SPS Agreement.
10
The use of international standards
for TBT and SPS Measures:
 Under the SPS Agreement, WTO Members are
compelled to use international standards unless
they can show a specific scientific justification
based on an assessment of the possible risk.
 WTO Members may set TBT measures that
deviate from international standards for other
reasons, including technological difficulties or
geographical issues.
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The reasons for application and
maintenance of SPS and TBT measures:
 SPS measures may only be applied to “the extent
necessary to protect human, animal or plant life or
health, based on scientific principles and not
maintained without sufficient scientific evidence”.
 TBT measures may be applied and maintained for
other reasons, including national security or to prevent
deceptive practices.
12
Examples of TBT and SPS measures
TBT measures typically deal with:
SPS measures typically deal with:
 labelling of composition or quality of
food, drink and drugs;
 additives in food or drink;
 quality requirements for fresh food;
 contaminants in food or drink;
 volume, shape and appearance of
packaging;
 certification: food safety, animal or
plant health;
 testing vehicles and accessories;
 processing methods with
implications for food safety;
 regulations for ships and ship
equipment;
 safety regulations for toys and others.
 other sanitary requirements for
imports;
 labelling requirements directly
related to food safety and others.
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SPS and TBT measures are often used as
non-tariff barriers to trade
WTO Member's right to employ protective
measures in the veterinary, plant
health/quarantine and human health areas,
coincides with their obligation to comply with
provisions of the SPS Agreement.
In practice, national protective measures known
as sanitary and phytosanitary border controls,
which include all official actions, decision or
supporting laws, regulations or other documents,
lead to restriction of trade.
SPS restrictions are justified on condition that the
objective is a legitimate purpose recognised by the
SPS Agreement, such as protection of human life
and health, plant and animal life and health.
Often SPS or TBT measures or their
administration and application are not based on
science or not transparent (although per se
appropriate) and that leads to a problem of noncompliance with the WTO obligations.
Major shortcomings in relation to SPS and TBT
sectors in the reviewed countries:
 Comparison of the GOST system with the
International Standards approach reveals that
procedures, methodologies and criteria applied
are inconsistent, vague and not transparent.
 Incompatible laboratory facilities, equipment and
tests are often used and become impediments for
trade.
 Limited in technical, human and financial
resources countries do not have the ability to
implement fully and enforce all SPS measures and
regulations.
Major shortcomings in relation to SPS and TBT
sectors in the reviewed countries:
 Countries find it difficult to provide the necessary
scientific and technical justification for their
sanitary and phytosanitary measures and to
conduct risk analysis – which is the process of
evaluating biological or other scientific and
economic evidence to determine whether a hazard
should be regulated.
 The nature of GOST standards and mandatory
regulations requirements is highly prescriptive
and the focus of control is on the “end-of-pipe”
and not in the process of production or “entire
chain”.
Major shortcomings in relation to SPS and TBT
sectors in the reviewed countries:
 Further the responsibility for food safety is within
the public sector causing the private stakeholders
to be subject to controls (in this way the financial
burden is not well balanced and efficiency is low).
 Enforcement of the existing provisions, effective
controls and inspection services for any SPS or
TBT measures including checks at the borders.
Elements of a food regulatory framework
Legal framework (example of Kazakhstan)
 Primary legislation – Law on Safety of Food
Products;
 Secondary legislation – Technical Regulations and
Sanitary Requirements and Norms;
 Non-binding instruments (not part of the legal
assessment):
 Standards
 Codes of practice
 Policy documents
 Food Strategy?/ food policy?/ action plan?
Major issues in relation to the Law of the Republic
of Kazakhstan on Safety of the Food Products:
• The purpose and aim of the Kazakh Law on
Safety of the Food Products is not explained.
• Definition of “food” does not include notion of
food “reasonably expected to be ingested by
humans”.
• Control of process of production and HACCP.
• It is crucial to have a clear understanding of
what is “unsafe food” and how to prevent
unsafe food being placed on the market for
the consumers.
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Major issues in relation to the Law of the Republic
of Kazakhstan on Safety of the Food Products:
• Feed should be within the scope of food safety and
traceability in order to ensure integrated “farm
to fork” approach.
• The concept of the food business operator
should include elements of responsibility for safe
food products production, processing and
distribution.
• There is a need for definitions of primary
production and all stages of production,
processing and distribution, including import.
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Why integrated “Farm to Fork” approach is important for food safety?
The aim is: to produce safe food ... For this reason feed
should be included
Major issues in relation to the Law of the Republic
of Kazakhstan on Safety of the Food Products:
• Official control as an important element of legal
framework should be implemented effectively.
• Inspections shall be carried out regularly and
where non-compliance is suspected.
• Clear procedures of Rapid Alert and product
recall and utilization should be established by
the primary legislation.
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Major deficiencies of the Technical Regulations
with sanitary provisions:
 No information or references to the Good
Agricultural Practices or experience gained in
implementing systems based on HACCP.
 Risk Analyses appear to be out of the scope of
Technical Regulations, so it is not clear how the Law
on Food Safety is operating or implemented by the
TR. There are no provisions on the identification of
hazards and their assessment, selection of control
measures and establishment of technical criteria.
 Most of the TR say nothing about the conduct of the
necessary documentation, record keeping.
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General problems with all the Sanitary and
Epidemiological Rules and Norms:
 None of the SanPiNs apply the rules of the Hazard Analysis
and Critical Control Points (HACCP) to the primary
production, as well as monitoring of CCP (this is one of the
requirements of the Codex Alimentarius too).
 No reference to Guidelines for good manufacturing practices
is made.
 International obligations, in particular, the Sanitary and
Phytosanitary Agreement of the WTO, as well as international
standards of food safety of the Codex Alimentarius, defining
the pathogens (microbiology) and other pollutants, as well as
the use of veterinary medicinal products, plant protection
products and biocides are not taken into account.
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General problems with all the Sanitary and
Epidemiological Rules and Norms:
 Nothing is said about the registration of food business
operators or possibility of traceability (although
provided by the Law on Food Safety).
 Unspecified responsibility for food safety for the food
business sector, which is based on HACCP, including the
application of good hygienic practices.
 Registration, approval, and storing records for the
control purposes are missing.
 No information is provided for preventing the emergence
and spread of infectious diseases that can pass to
humans through food.
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Choice of the Institutional Framework for
Food Safety – Integrated Approach versus
Single Agency System
Three major systems:
Multiple Agency System
o Integrated System
o Single Agency System
o
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Elements of a National
Food Safety System – why coordination?
Administration
Food Law and
standards
Information,
Education,
Communication
and Training
Analysis
Inspection
Multiple Agency System
 Different Ministries / agencies carry out food
control activities in accordance with:
 their legal mandates (recognized by their
organic legislation);
 their decentralized structure (at central,
regional and local levels);
 mechanisms for coordination (if any);
o Memorandums of Understanding, specifying
the roles and responsibilities;
o Delegation of functions.
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Identified shortcomings




Lack of overall coordination at the national level;
Gaps/Overlaps at central and decentralised level;
Differences in levels of expertise;
Conflict between public health objectives and the
facilitation of trade and industry development;
 Limited capacity for appropriate scientific inputs
in decision-making processes.
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Integrated System
National food authority should be responsible for:
• coordinating and ensuring the integrated food
chain approach;
• implement some of the functions related to
food safety and coordinate implementation of
other functions;
• monitor implementation of the food safety
legal framework.
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Integrated System
Typically, the organization of an integrated food safety
system would have several levels of operation:
Policy, legislation, Risk analysis
Coordination, Food Control, Monit. Auditing
Inspection/enforcement
Education/training
Integrated System
 Provides coherence in the national food policy and
control system;
 Politically more acceptable as it does not disturb the day
to day inspection and enforcement role of other agencies;
 Promotes uniform application of control measures across
the whole food chain through the country;
 Separates risk assessment and risk management
functions;
 Better equipped to deal with international dimensions
(Codex, SPS/TBT Agreements etc.).
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Single Agency System
A Single Agency assumes the overall responsibility for food
safety, may include also plant health and animal health
considerations, normative and implementation functions.
It ensures:
 Uniform application of protection measures;
 Ability to act quickly to protect consumers;
 Improved cost efficiency;
 Harmonization of food standards;
 Joint mechanisms for inspections/surveillance;
 Independent decision making and financial autonomy.
Usually, governed by a Management Board with a
chairperson and Directors.
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Single Agency System
 Provides a coordinating mechanism for uniform
implementation of food control activities;
 Adopts a strategic view across the whole food chain;
 Utilizes an open and transparent decision making
process;
 However, there ate issues to consider:
 Need for strong political will;
 Financial costs;
 Disruption of control during the early stages of its
operation.
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Major challenges and reasons for noncompliance for Azerbaijan, Russia and
Kazakhstan:
 the lack of infrastructure (e.g. sufficient number of
accredited laboratories or other testing facilities);
 absence of balanced and appropriate legal framework,
regulatory framework based not on risk assessment
but on mandatory compliance with the set up
requirements (often not justified or scientifically
sound);
 a weak and insufficient institutional framework (e.g.
multiple regulations and various agencies and bodies,
without proper coordination and duplication of work);
 scarcity of qualified human resources.
Thank you for your attention!
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