Our Regulatory Measures

Objectives

Continue to work with our government partners to develop food standards through the bi-national regulatory arrangements.

  • Use best regulatory practice in the delivery of food regulatory outcomes.
  • Anticipate and work proactively to address new food regulatory challenges.

Performance

Number of Applications and Proposals finalised within statutory timeframes and consistent with Ministerial policy guidelines.

  • Timeliness of our management of food emergencies and public health issues arising from food.
  • Ability to maintain the integrity and currency of the agency’s scientific evidence base and to augment this evidence base with consumer research and regulatory analysis.

Highlights

  • 18 Applications and 7 Proposals gazetted (published).
  • Amendments to the  Food Standards Code included mandatory fortification of food with iodine, new levels for cadmium in peanuts and hydrocyanic acid in ready-to-eat cassava chips, and approval for food derived from three genetically modified commodities.
  • Collaborated with the Office of Best Practice Regulation to identify more effectively the underlying problem behind each Application and Proposal.
  • Reviewed the use of food colours in Australian and New Zealand foods in relation to children’s behaviour and reported safe levels.
  • Provided the Ministerial Council with an assessment of the effectiveness of health advisory labelling on alcohol products.
  • Coordinated the response of Australian food regulators to a food incident involving dairy-based products adulterated with melamine.
  • Completed a chemical and microbiological risk assessment for eggs, and received submitter support for a proposed approach for assessing raw (unpasteurised) milk products, such as cheese.

Overview

FSANZ develops regulatory measures in the form of food standards, which appear in the Australia New Zealand Food Standards Code. This Code has existed in its present form since December 2000. The food standards contain requirements for the content, labelling and handling of food for sale in Australia and New Zealand – requirements that apply to imported foods as well as to domestically produced products.

Food standards normally address market failure or a potential market failure.  A market failure could be the emergence of new knowledge about the adverse effects of a contaminant or chemical residue on human health or consumer not being provided with the information required to make wise buying decisions. Potential market failure could include the addition of substances to foods for which there is no history of safe use. Or the introduction of new food production technologies.

FSANZ has to ensure that the regulatory burden on the food industry is no greater than that considered necessary for effective public health and safety and is commensurate with the risk.  This is minimum effective regulation.

The ultimate minimum regulation, of course, is no regulation. However, food is unlike other traded commodities. People have to consume food to exist – they cannot opt out. Government therefore has assumed a responsibility, through the provisions of the Code, for ensuring that food products do not compromise public health and safety.

This leaves FSANZ with the task of determining what is meant by ‘minimum’ and what is meant by ‘effective'. Both are tied to the underlying problem being addressed by a new or amended food standard.  

For example, we received an Application to require pregnancy advisory statements on alcohol products.  Was the underlying problem one of lack of information in the marketplace about the adverse effects of alcohol or the potential effects of alcohol on the foetus?  We decided that ‘minimum’ and ‘effective’ should be applied to the latter. Thus, we are focusing on the likely effectiveness of a labelling measure to reduce foetal alcohol syndrome, rather than on increasing the level of awareness of foetal alcohol syndrome in the community as an end in itself.

During the year, we paid greater attention to identifying the problems being addressed by Applications and Proposals in an attempt to target our outcomes more accurately.  

We collaborated with the Office of Best Practice Regulation on a number of major projects – e.g. food safety standards for the primary industries – to ensure that we could justify the costs to the community of our regulatory measures. These costs are borne by industry and government enforcement agencies. We have to demonstrate that benefits outweigh the costs.

FSANZ has always had regard to cost-benefit and cost-effectiveness analyses through the production of regulatory impact statements. We extended that work in 2008-09 by integrating regulatory impact analysis more thoroughly into our decision making, earlier in the process, as a means of achieving relevant outcomes.

While the above considerations impose a discipline on our regulatory decision making, and contribute valuable information to the evidence base, the quality of our food standards depends largely on the robustness of FSANZ’s regulatory science. Science provides the cornerstone of standards development in FSANZ

Our risk assessors use an internationally recommended process (Codex) to evaluate the safety of foods. They determine whether a food poses a threat to human health, the likelihood of a consumer being adversely affected and the severity of any food-borne illness.   A risk assessment could examine the consequences of a lack of information being provided to consumers – especially vulnerable groups – about a food product. It could also assess the potential benefits of a mandatory fortification measure.

Risk managers develop regulatory options based on the scientific risk assessments, within the context of minimum effective regulation and relevant policy guidelines. This requires a thorough understanding of the problem being addressed, the scientific evidence of risk and the current relevant regulatory environment, in Australia,  New Zealand and overseas.

The resulting food standards are the minimum measures necessary to maintain public safety – measures that need to be reviewed from time to time.

A case in point is the existing prohibition in the Food Standards Code of the sale of food products made from milk that has not been heat treated (i.e. unpasteurised milk).  FSANZ is in the process of examining whether it is possible to produce safe ‘raw milk’ products (e.g. cheese) without the mandatory requirement that the milk should have been heat treated.   In other words, we are looking at whether it is feasible to pull back from the current prohibition and case-by-case approval process.

Applications and Proposals gazetted 1 July 2008-30 June 2009

We gazetted 18 variations to food standards arising from Applications (17 in 2007-08) and 7 variations to standards arising from Proposals (7 in 2007-08).  Please consult Appendix 1 for more detail.

 

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