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General statement on the use of international standards and assessments

(April 2016)
 
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) requires FSANZ to have regard, among other matters, to the objective of achieving consistency between domestic and international food standards when it is considering the development of the Australia New Zealand Food Standards Code. However, FSANZ’s legislation does not permit us to adopt international standards directly.
 
FSANZ is an active participant in the development of international standards, especially through its participation in the Codex Alimentarius Commission and the APEC Food Safety Cooperation Forum.
 
FSANZ considers the existence and relevance of international standards, including New Zealand standards, in all of its standards development work. In particular, FSANZ reviews the relevance of international standards when applied to foods as they are consumed in Australia and New Zealand. Our consideration of international standards is discussed transparently in all FSANZ assessment and approval reports.
 
FSANZ must comply with the procedures that are set out in the FSANZ Act when it is developing the Australia New Zealand Food Standards Code and cannot adopt foreign standards by reference.
 
FSANZ will routinely consider and adopt relevant foreign scientific assessments that meet accepted scientific standards.
 
Industry can apply international standards directly when self-assessment or self-substantiation is permitted, if the conditions of self-assessment or self-substantiation are satisfied or to determine the safety of food when no domestic standard has been developed.

Is there credible evidence that the approach to regulation taken in Australia is leading world best practice, both in terms of effectiveness and cost/efficiency?

The system of food regulation in Australia is compatible with international best practice. However, our food regulatory system has some significant differences, which arise because we operate in a federal system in which legislative and enforcement powers are vested in the states and territories.

Do relevant standards or assessments exist internationally?

There are relevant international standards in many areas of FSANZ activity. In particular, the work of Codex Alimentarius is contributed to by FSANZ and informs our work. In particular areas, such as the safety of food additives, FSANZ contributes to and relies on the work of transnational bodies such as the World Health Organization’s Joint Expert Committee on Food Additives (JECFA).
 
Relevance of a standard should not be confused with applicability. A standard is, generally, an expression of risk appetite. The appetite for risk that is reflected in an international standard may be inappropriate in all local conditions. The purpose of international standards is, generally, to indicate the international scientific community’s consensus opinion about the matters that can reasonably be included in domestic food law, having regard to the provisions of international trade law. International standards do not impose mandatory restrictions and are developed with the understanding that local factors might make an international standard less relevant. International trade law recognises the right of local regulators to adopt local standards when scientific evidence supports variation from an internationally accepted control measure.
 
FSANZ does adopt some international standards with minimal independent assessment. It does so when the relevant safety data is available for review and the risk is minimal. Examples include our regular updating of references to materials such as national pharmacopeia, the FEMA and European Union (EU) flavouring lists, and chemical specifications in secondary sources.

Are the standards or assessments available from credible, trusted sources?

FSANZ has a high regard for standards developed through international organisations such as the United Nations and World Health Organization.
It also has a high regard for the work done by regulators such as those of the EU and North America, which have transparent and well-established risk analysis systems.  On a case-by-case basis, FSANZ will have regard to assessments provided by other national regulators whose work is relevant to current FSANZ activity. A complication of acceptance of standards developed by trusted sources is that although the source and its procedures might be trusted, it is not always possible to access the data that the source relied on. In some jurisdictions, the data will be retained by applicants and only made available to the risk assessor on a confidential basis. This reduces the level of confidence that can be had in the trusted source.

Can the Australian Health portfolio regulator establish a formal and robust framework for cooperation with the source of the assessments or standards?

 
FSANZ has well-established formal and robust working relationships with international standards-setting bodies and the major foreign food regulators, eg EU, USA and Canada. Those relationships provide a position of advantage for working with those agencies and assessing the relevance and quality of their output. The arrangements can be given greater effect on a case-by-case basis. FSANZ is currently working with Canada to assess the viability of sharing the workload in some risk analysis work.

Is the regulatory framework (e.g. governing legislation, regulations and policies) of the potential international source of the assessment or standards compatible with the Australian Health portfolio regulator’s legislative and policy obligations?

The FSANZ Act is prescriptive about the manner in which a food regulatory measure can be developed or varied. That prescription, and legislative requirements of the Australian Parliament, limit the capacity of FSANZ to simply adopt foreign regulation into Australian law. FSANZ is required to consult on any new measure or a variation of an existing measure and must have regard to matters that are set out in the legislation. It would be inconsistent with its statutory obligations for FSANZ to accept international assessments or standards without conducting its own assessment of the best available scientific evidence and consulting in the manner required by law.
In each case, it is essential that FSANZ be aware of the legislative framework that supports an international standard. As an example, the EU has approved as permitted health claims a range of statements that would not be allowed as health claims in Australia because our law does not have the same scope. We define claims differently.

Is the adoption of the international assessments and standards likely to impact positively or negatively on the international reputation of the Australian Health portfolio regulator or more broadly on areas such as Australia’s trade performance?

Many areas of food regulatory policy are contestable. As a consequence, there is some likelihood that broad adoption of international standards would be subject to the criticism that there has not been adequate consideration of the suitability of the standard for Australian conditions.

Will the adoption of the international standards or risk assessments actually reduce regulatory burden, red tape and costs?

A benefit of the Australia New Zealand Food Standards Code is that it provides a single source of regulatory standards. In this respect, it is relatively unique. It is likely that a practice of drawing standards from multiple sources; requiring business to access diverse sources of legislation, would impose rather than reduce costs, especially in areas of activity in which many participants are small businesses.

Will adoption of the international standards and assessments impact adversely on stakeholder confidence in the regulatory system?

The current legislation has been developed with the primary objective of ensuring confidence. Accordingly, it is likely that any arrangement that is inconsistent with the systems of assessment that are mandated in the FSANZ Act would compromise that confidence.

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