ALICOM 99/8  |
| ALICOM 99/8 |
Conference on International Food Trade
|
Harmonisation of Food Regulations and Food Quality/Safety Measures Based on Codex Standards, Guidelines and Recommendations |
by |
Ian Lindenmayer, Australia New Zealand Food Authority |
II. Implications of International Standards for Domestic Standards
III. Objectives of Food Standards
VI. Establishment of the national food standards setting agency
for Australia
1. Globally consumers are increasingly demanding that governments take legislative action to ensure that only safe and accurately labeled food is sold and that the risk of food borne health hazards is minimised. Governments and industry seek to trade in safe food to avoid the adverse effects on both consumers and economies when the safety of products is in doubt. In response to these pressures, governments have moved to develop increasingly sophisticated food laws. And yet, it is the development of these food control measures by jurisdictions, independently and often inconsistently, that leads to barriers to trade - barriers which are sometimes legitimate and represent a necessary response to specific local needs, but in other cases unjustified on scientific grounds.
2. There are self-evident benefits to the global community in the principle of uniform and robust food standards - both for the protection of consumers and for facilitation of global trade.
3. For this reason, both the WTO Agreements on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and Technical Barriers to Trade (TBT Agreement) encourage the international harmonisation of food standards. In pursuing international harmonisation, the SPS Agreement uses the Codex Alimentarius standards, guidelines and recommendations as the preferred measures for adoption by the international community. The rules and disciplines of the WTO Agreements are designed to minimise the potentially negative effect on trade of those health and non-health requirements that cannot objectively be justified. They also preserve Members' rights to develop, maintain and enforce measures necessary for the protection of human, animal or plant life or health and for achieving other legitimate public policy objectives provided for under those Agreements. At the same time, these WTO Agreements (and in particular the TBT Agreement) have set a real challenge for Codex.
4. The establishment of the Joint FAO/WHO Codex Alimentarius Commission and development of the Codex Alimentarius have guided and promoted the elaboration and establishment of definitions and requirements for foods to assist in international harmonisation.
5. The WTO dispute settlement system has shown in recent times that the rules and disciplines of the WTO Agreements impose on Members obligations that are capable of effective enforcement. Members must now ensure that their food control measures are: the least trade restrictive available; are not being applied in a manner which constitutes an arbitrary or unjustifiable discrimination between countries where the same conditions prevail; or be disguised restrictions on international trade.
6. The role of Codex standards, guidelines and recommendation has been elevated to a position of some significance through express and implicit recognition in the WTO Agreements. The significance of Codex norms as a reference point or yardstick, in potential WTO trade disputes, has generated a variety of reactions amongst WTO and Codex member countries. It is within this context that I will discuss the importance of Codex standards, guidelines and recommendations as the basis for harmonisation of food regulations and food quality and safety measures, in assisting WTO Members to meet their obligations.
7. While the Codex standards, guidelines and recommendations are recognised in the WTO Agreements, the Agreements have not accorded Codex standards, guidelines and recommendations the force of law. That is, there is no legal obligation on Members to adopt them into domestic law. The Agreements do, however, impose a legal obligation on WTO Members to explain and justify (if requested and where that measure is having a significant effect on trade of other Members) a domestic measure that is more trade restrictive than the relevant Codex standard, guideline or recommendation. Consequently, Members must take these international norms into account when developing domestic food law.
8. In practice, this also means WTO members need to have clear justification, based on public health and safety grounds and sound scientific evidence, to set standards or any other measures that are more stringent than Codex standards. The Codex requirements that standards decisions are based on sound scientific analysis and risk assessment practices are important responses to the WTO challenges.
9. ANZFA strives to apply these principles in developing food standards for Australia and New Zealand.
10. Harmonisation of standards - standards of any sort, including food - must begin with agreement as to the objectives of the standards. In the case of the Codex Alimentarius standards, the stated objectives are to protect consumers' health and ensure fair practices in the trade of food.
11. In Australia, the legislation creating the Australia New Zealand Food Authority as the national food standards agency explicitly mentions these consumer protection objectives together with the need to promote trade and commerce and harmonise with international standards. More recently, under the Treaty between Australia and New Zealand to establish a joint food standard setting system, these objectives guide ANZFA in its operation as a binational food standards agency.
12. Thus there is compatibility between the Codex objectives for food standards and those in place or being developed in Australia and New Zealand.
13. Consideration of the need for and nature of a regulatory measure in Australia follows a process that ensures the promulgation of the least trade restrictive and most effective measure available to protect consumers. In Australia, this process is known as regulatory impact analysis and results in the production of regulatory impact statements. These regulatory impact statements are required for all legislative instruments, including regulations, and for all national standards.
14. Regulatory impact analysis, as used by ANZFA, is a six-step process:
Step 1 _ Identify the problem
Step 2 _ Assess the risk
Risk is assessed scientifically based on the following steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.
Step 3 _ Specify the desired objective(s)
At this stage, the objective of the regulatory initiative is specified in terms of correcting the problem. Care is taken not to preempt the justification for a particular regulatory outcome.
Step 4 _ Identify alternative effective regulatory options
1) Self-regulation is considered where:
2) Quasi- regulation is considered where:
3) Mandatory standards are considered where:
Step 5 _ Assess the impacts of the options
The benefits and costs of each available option are analysed, including any restrictions on competition, both for different groups within the community, and for the community as a whole. Where possible, quantitative measures - such as financial and economic benefits - are identified and compared.
The groups likely to be significantly affected by the regulatory action are separately identified (i.e. consumers, industry and government, disaggregated as necessary) and the advantages and disadvantages of each regulatory option are considered for each affected group.
Step 6 _ Decide on an appropriate regulatory measure
The final choice of an appropriate regulatory measure rests heavily on confirming that the measure will correct the problem effectively in the least trade restrictive manner, with the regulatory imposts on industry being proportionate to the magnitude of the risks.
Such rigor in the Codex arena would assist in the development of appropriate international standards that will withstand scrutiny through the WTO systems. Particular attention needs to be given to those standards developed prior to the completion of the 1994 GATT negotiations.
15. Risk assessment procedures related to chemicals, such as additives, contaminants, agricultural and veterinary chemicals or nutrients, have become an important part of developing both international and national food standards. Exposure assessments, including dietary exposure assessments, are now recognised as a critical step in these risk assessment procedures.
16. In order to ensure that the standards developed by ANZFA for Australia and New Zealand are based on sound science, ANZFA rigorously adheres to internationally recognised risk assessment procedures.
17. Dietary exposure assessments may be used to assess the potential risk to health associated with proposed changes to the food supply and to identify risk minimisation options that can be used to develop appropriate risk management strategies. Strategies may include the development of food standards to restrict permissions for chemicals in food, labeling requirements or appropriate education campaigns.
18. Dietary modeling may also be used within a broader framework of risk assessment and management in food regulation, such as:
19. The Joint Expert FAO/WHO Consultation on Risk Analysis agreed in 1995 on a number of definitions for food safety risk analysis and on a model for risk assessment that consisted of four components: (1) hazard identification, (2) hazard characterisation, (3) exposure assessment, and (4) risk characterisation (see Figure 1). 
Figure 1: Four stages of risk analysis
20. The recognition by the Consultation that exposure assessments are a critical step in risk assessment procedures and the recommendation that this step be strengthened has had important implications for both Codex and national regulatory agencies. Codex committees are increasingly including exposure assessments in their risk assessment procedures, and ANZFA has developed risk analysis practices consistent with Codex procedures.
21. ANZFA has developed a sophisticated computer program, DIAMOND (dietary modeling of nutritional data) which is based on world-best practice, to ensure it has the capacity to fulfil its WTO obligations of basing dietary exposure and risk assessment procedures on sound scientific principles.
22. Dietary modeling requires two sets of data to estimate dietary exposure to food chemicals: food consumption data and concentration levels of the food chemical in the various foods (food chemical data).
23. To underpin this work, ANZFA commissions biannual surveys of certain residues and contaminants in the food supply in Australia, and utilises the dietary information collected through the national nutrition surveys in Australia and New Zealand. The DIAMOND program makes best use of the food consumption data by using individual dietary records rather than population statistics. Potential 'at risk' groups can be identified by selecting specific population subgroups defined by age, sex or other demographic characteristic, or by food consumption patterns, for example, high consumers of a particular food or group of foods.
24. This rigorous work is now providing a strong foundation for development of our food standards. An emphasis on these sound scientific processes within the Codex system would assist in ensuring outcomes to address public health and safety and would reduce or remove the tendency to address non-safety issues.
25. The regulatory reforms that led to the establishment of the National Food Authority in 1991 (which later became the Australia New Zealand Food Authority) were driven by:
26. At that time, the aims of the new food regulatory system were to:
27. These principles shaped the existing food regulatory system and have continued to guide the current food regulatory reforms being undertaken in Australia.
28. There are a number of major current reforms in food regulation in Australia and New Zealand that contribute to the pursuit of local and international harmonisation and improved regulatory efficiency.
29. In 1995 the governments of Australia and New Zealand signed a Treaty establishing a system for the development of joint food standards. It came into force in July 1996. This was a significant step for both countries and follows from the collaborative work undertaken under the aegis of the Australia New Zealand Closer Economic Relations Trade Agreement signed in 1983. There are three areas of food standards excluded from the operation of the joint system - the specification of maximum residue limits for agricultural and veterinary chemicals in foods, the specification of food hygiene practices and export requirements relating to third country trade.
30. The operation of the joint standards setting system is currently under review (as required by the Treaty). There has been agreement, at least by officials at this stage, that collaboration on MRLs and hygiene standards should continue to avoid the entrenchment of incompatible arrangements and to identify areas for closer cooperation.
31. ANZFA now works to ensure that its risk assessment practices and consultation mechanisms take into account the dietary patterns and stakeholder views of both Australia and New Zealand.
32. Both the Australian and New Zealand governments are committed to the principles and obligations enshrined in the WTO Agreements and support harmonisation of food standards with the Codex Alimentarius wherever appropriate.
33. Australian food standards are brought together in the Food Standards Code. A major review of the complete body of standards was begun in 1995. The Review of the Food Standards Code is the vehicle being used to develop a single set of food product standards to apply to Australia and New Zealand. Following completion of the review in December this year and final decisions by the governing Ministerial Council, new standards will be promulgated as a joint Australia New Zealand Food Standards Code.
34. ANZFA, in reviewing the Food Standards Code, must have regard to its section 10 objectives set out in the ANZFA Act 1991. Section 10 gives primacy to protection of the protection of public health and safety and consumer protection issues. It is fully consistent with the Codex Alimentarius objectives and with the rights of WTO Members to set measures to achieve those objectives.
35. ANZFA must also have regard to the policies which set out its domestic and international operating framework and within which it is reviewing its food standards. These objectives and other statutory requirements, the principles for good regulatory practices espoused by the Council of Australian Governments and the international obligations of Australia, all act to shape the development of food standards by ANZFA.
36. Together they act to ensure that Australian and New Zealand food standards and other regulatory measures are:
37. Wherever possible, and consistent with its policy objectives for the review of the Food Standards Code and the development of the Australia New Zealand Food Standards Code, ANZFA develop standards which will:
38. In the review process, ANZFA also considers, wherever appropriate, the use of codes of practice as an alternatives to regulation.
39. In summary, the outcome being pursued is a single set of food laws that are efficient, effective, internally consistent and workable, applying to both countries, based to the extent possible on Codex standards, guidelines and recommendations.
40. ANZFA is also in the process of developing nationally uniform food safety standards which encourage the use by industry of Hazard Analysis Critical Control Point (HACCP) based food safety programs. This risk-based approach to managing food safety is based on the food hygiene work of Codex reflected in the Codex Alimentarius General Principles of Food Hygiene.
41. The FAO training manual on Food Quality and Safety Systems recognises that the mandatory requirement to use HACCP and any subsequent trade barriers or other constraints to trade, particularly for developing countries, need to be considered and identified. In Australia, governments and most industry groups accept that HACCP-based systems are the most appropriate method for agrifood businesses to identify, monitor and control food safety hazards.
42. Current legislation in Australia is unnecessarily prescriptive and focuses on identifying failures after they occur. Emphasis is on a highly prescriptive, inspections-based and curative approach rather than the preventative approach to food safety provided by HACCP.
43. At the request of the Australia New Zealand Food Standards Council, ANZFA has developed a set of draft food safety standards that are preventive in nature, by focussing on outcomes to be achieved in the production of safe food. These provide industry with the flexibility to determine best practice approaches for achieving safe food outcomes. That is, industry will be able to choose and develop their own preventative measures provided those measures achieve the necessary food safety outcomes. At the same time, ANZFA is assisting industry, especially small business, with the implementation of these arrangements through industry sectoral guidelines and model food safety programs.
44. In developing these arrangements, ANZFA's work is consistent with the four Statements of Principle relating to the role of food safety risk assessment1.
2. Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner. 3. There should be a functional separation of risk assessment and risk management, while recognising that some interactions are essential for a pragmatic approach. 4. Risk assessments should use available quantitative information to the greatest extent possible and risk characterisations should be presented in a readily understandable and useful form. |
45. ANZFA recognises its responsibility to work with other countries in the region to share experience and jointly develop an understanding of food regulatory issues. In recognition of the importance of the food-medicine interface in all countries, this work has been undertaken in association with the Therapeutic Goods Administration.
46. Under these arrangements ANZFA has liaised on the food regulatory needs of APEC countries, undertaken development of draft food law for Vietnam, commenced work on a regional directory of food trade contacts and organised two APEC workshops on regulation of the food-medicine interface. Other work is planned for 1999-2000, including an APEC project that will provide training in risk analysis.
47. In undertaking collaborative work in the APEC region, ANZFA aims to:
48. It is important that we use this opportunity to refresh our memories as to why the work of the Codex Alimentarius Commission is so important in furthering the objectives of the WTO Agreements. The ultimate objective of the WTO Agreements is increased social and economic benefits for all Members, whether from developed, developing or the least developed countries, through participation in a stable, equitable and open multilateral trading system.
49. These Agreements impose an obligation on all Members to participate, to the extent possible within their resources, in the development and review of Codex standards, recommendations and guidelines. This ensures that these reference points for international trade are relevant, up to date, based on sound scientific principles and consistent with good regulatory practice.
50. The aim of Codex standards is to protect consumers' health and ensure fair practices in the food trade. It is important that Codex remains faithful to its objectives in a manner that is cognisant of the aims and objectives of the WTO Agreements.
51. To this end, Codex standards are developed according to the four Statements of Principle concerning the role of science in the Codex decision making process 2. The extent to which other factors are taken into account may have a significant impact on whether Codex standards are designed in the least trade restrictive manner possible.
1. The food standards, guidelines and other recommendations of Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply. 2. When elaborating and deciding upon food standards, Codex Alimentarius will have regard, when appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade. 3. In this regard it is noted that food labeling plays an important role in furthering both of these objectives. 4. When the situation arises that members of Codex agree on the necessary level of protection of public health but hold differing views about other considerations, members may abstain from acceptance of the relevant standard without necessarily preventing the decision by Codex. |
52. Membership of WTO effectively commits WTO Member Countries to embrace these principles also in their domestic standards.
53. It is important that the standards, guidelines and recommendations developed by Codex are ones, which are able to be adopted by its Members. Wherever possible, good regulatory practices should ensure that the resulting Codex approach reflects efficient, effective and appropriate regulation. Such an approach facilitates harmonisation and international trade and compliance with WTO objectives.
54. It is very appropriate, and pertinent, for Codex to provide the guide posts to assist Member countries in developing food standards to protect consumers' health and ensure fair practices in the food trade, in a manner that provides flexibility in the regulatory approaches chosen to achieve those outcomes.
55. In participating in Codex, Australia will continue to work to ensure that international standards development is undertaken in accordance with recognised risk assessment and risk management techniques. Wherever possible, decisions should be based on sound evidentiary science. And yet it is important that WTO obligations not lead to an unjustified lessening of food standards. Codex must pursue its own objectives of consumer protection, wherever there is a reasonable need. Consumer safety should not be jeopardised in the pursuit of trade objectives.
56. The WTO Agreements have exposed Members' regulatory approaches to international scrutiny and rigour while providing all of us with the opportunities to benefit from trade liberalisation.
57. The WTO Agreements have emphasised the importance of WTO Members harmonising their food regulations with international standards, guidelines and recommendations. In doing so, they have elevated Codex standards as international reference points, or yardsticks, in settling trade disputes involving SPS or TBT measures.
58. WTO Members have an obligation to ensure that their food regulatory measures are developed in accordance with the principles and disciplines of the WTO Agreements.
59. Similarly, ANZFA, in developing food standards for two countries, must deliver against the international obligations of the two countries, including compliance with WTO objectives. ANZFA is well placed to do this. Regionally, it has started to make a contribution to standards and conformance and is participating in the collaborative activities that are undertaken under the umbrella of APEC and AFTA-CER.
60. The application of the principles of the WTO Agreements to the development of food regulations is a specialised area where ANZFA has given priority to developing its expertise. Engaging in this work with other countries on a bilateral or regional basis can result in stronger relationships based on understanding and greater alignment with the Codex Alimentarius.
61. ANZFA's work in this area leads it to the following conclusions:
62. It is important that Members recommit themselves to working together to ensure that the best possible regulatory outcome is achieved at the international level, in order to facilitate commitment to greater harmonisation of food standards. It is also important that these standards are up to date and consistent with the internationally accepted norms.
63. Finally, trade liberalisation, as promoted through the rights and obligations contained in the WTO Agreements, benefits us all - governments through the economic benefits which flow to their people from increased trade, industry through new markets and competition, consumers through access to a safe and varied food supply. And yet, in striving for international harmonisation, adequate and sufficient attention needs to be given to consumer protection. International standards must be effective and efficient.
64. That the CAC:
1 Decision of the 22nd Session of the Codex Alimentarius Commission, 1997.
2 Decision of the 21st Session of the Codex Alimentarius Commission, 1995.