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International Conference  

INTERNATIONAL TRADE LAW IN THE REGION OF THE CAUCASUS AND

CENTRAL ASIA:BETWEEN REGIONAL INTEGRATION

AND GLOBALIZATION

Baku, 30-31 May 2013

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Sanitary and Technical Regulation

NCTM O’ConnorIrina Kireeva

Brussels, Belgium

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Major difficulties of some WTO Members in complying with the SPS and TBT Agreements

Objective of the legal research and assessmentThe 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.

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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.

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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.

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

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General observation on Legal Aspects of Food Safety framework in Russia,

Kazakhstan and AzerbaijanBetter 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.

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Scope of the TBT and SPS Agreements

The TBT Agreement covers:

technical regulations; voluntary standards; and conformity assessment procedures.

Except when these are SPS measures as defined by the SPS Agreement.

The SPS Agreement covers all measures whose purpose is to protect:human or animal health from so called food-borne risks; human health from animal or plant diseases; and plants and animals from pests or diseases.

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The use of international standardsfor 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.

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Examples of TBT and SPS measures

TBT measures typically deal with: labelling of composition or quality of food, drink and drugs; quality requirements for fresh food; volume, shape and appearance of packaging; testing vehicles and accessories; regulations for ships and ship equipment; safety regulations for toys and others.

SPS measures typically deal with: additives in food or drink; contaminants in food or drink; certification: food safety, animal or plant health; processing methods with implications for food safety; other sanitary requirements for imports; labelling requirements directly related to food safety and others.

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 non-compliance 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):StandardsCodes of practicePolicy documents

Food Strategy?/ food policy?/ action plan?

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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.

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

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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 SystemIntegrated SystemSingle Agency System

InspectionAnalysis

Administration

Codex

Food Law and standards

Elements of a National Food Safety System – why coordination?

Information, Education,

Communication and

Training

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Multiple Agency SystemDifferent 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);

Memorandums of Understanding, specifying the roles and responsibilities;

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 SystemNational 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.

Typically, the organization of an integrated food safety system would have several levels of operation:

Policy, legislation, Risk analysisCoordination, Food Control, Monit. Auditing

Inspection/enforcementEducation/training

Integrated System

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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.).

Integrated System

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Single Agency SystemA 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.

Major challenges and reasons for non-compliance 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.

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