Proposal P242 - Foods for Special Medical Purposes
18 December 2002
DRAFT ASSESSMENT REPORT
DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: (See “Invitation for Public Submissions” for details) |
Full Report [ pdf 437 kb ]
Executive Summary and Statement of Reasons
This Draft Assessment Report reviews the issues involved in the regulation of foods for special medical purposes (FSMP), makes recommendations on a regulatory approach to FSMP and proposes the inclusion of draft Standard 2.9.5 – Foods for Special Medical Purposes (Attachment 1) in Part 2.9 of theFood Standards Code.
Background
FSMP are principally formulated food products, used under the supervision of medical or other health professionals, for the dietary management of individuals (including children) with either ongoing chronic medical or disability conditions or during acute phases of illness, injury or disease states. They include ‘complete nutrition’ formulas either consumed orally or through an enteral route (e.g. naso-gastric tube), as well as specialised dietary supplement formulas or foods, and formulas for very low energy diets (VLED) used for weight loss.
There is minimal local manufacture of FSMP as it is estimated that 99% of products are imported, mainly from the European Union (including UK) and the United States of America. On a world scale, the Australian and New Zealand markets are comparatively small.
Regulatory Problem
The regulation of FSMP in Australia and New Zealand is unclear. The Code does not explicitly recognise FSMP and therefore unlike other foods, FSMP are not given any permissions for composition or specific labelling requirements. Because of this, the regulation of FSMP continues to be uncertain for:
- importers and local manufacturers of FSMP in complying with the Code;
- health professionals and consumers in being assured of appropriate and consistent information on the safe and effective use of FSMP; and
- government in enforcing the Code.
By nature, FSMP are products specifically formulated for use under medical or other health professional supervision, for the dietary management of individuals with particular medical conditions. These vulnerable individuals rely either fully or partially on FSMP to meet their specific nutritional requirements that cannot be satisfied by a normal diet. It is therefore essential that FSMP are both safe and effective in meeting the needs of the target population.
Objectives
The specific objectives of Proposal P242 are to:
- protect public health and safety, particularly by ensuring the safe and appropriate use of FSMP;
- develop harmonised food regulations applying to FSMP in Australia and New Zealand; and
- provide health professionals and consumers with sufficient information to make choices about the safe and effective use of FSMP.
Issues
The development of regulations for FSMP requires consideration of a number of existing regulatory principles inherent to the Code as well as issues raised through stakeholder consultation. This report discusses and makes recommendations on the:
- defining features and purpose of FSMP;
- distribution and access to FSMP including a restriction on the advertising of FSMP to the general public;
- prescribed compositional requirements, consistent where possible with international regulations;
- specific labelling requirements to allow for:
- flexibility and consistency with international regulations where possible; and
- the safe and effective use of FSMP including a mandatory advisory statement indicating use under medical supervision; and
- applicability of generic standards to FSMP including food additive permissions, novel foods and microbiological limits.
Options
Two options for the regulation of FSMP have been identified at Draft Assessment:
- Option 1 - maintain status quo i.e. no specific regulation of FSMP in the Code; and
- Option 2 - r egulation by a discrete standard in the Code w ith exemptions from generic standards as appropriate.
Consultation
In October 2001, FSANZ released for public consultation an Initial Assessment for Proposal P242. In response, 26 submissions from various stakeholders were received. A summary of submitter comments is at Attachment 5. The comments and information provided in submissions has assisted with the preparation of this Draft Assessment.
Transitional Issues
In accordance with the transitional requirements for a proposal, which has reached Full (Draft) Assessment prior to the commencement of the FSANZ Act, the Full (Draft) Assessment has been reviewed. No relevant policy guidelines have been notified by the Ministerial Council, and no additional submissions were received in response to the notice given under section 14A of the FSANZ Act.
Conclusion and Recommendation
By maintaining the status quo as per Option 1, there would be minimal impact on consumers except where imported FSMP may be delayed at national borders, and a continuing negative impact on industry and government caused by the regulatory uncertainty of FSMP.
When compared to Option 1, Option 2 provides greater benefits for all affected parties. Option 2 provides continued access to and greater assurance of safe, quality products but also ensures provision of consistent information in labelling to allow for the safe and effective use of FSMP in the Australia/New Zealand context. I t allows for the harmonisation of the regulations for FSMP between Australia and New Zealand, and where appropriate international regulations, providing regulatory certainty for industry and government enforcement agencies and not unduly restricting trade.
Bearing in mind that further information from industry will be gathered on the expected cost of compliance, Option 2 – regulation by a discrete standard in the Code – is at this stage considered the more superior option in meeting the regulatory objectives.
Therefore, it is recommended that the proposed amendments (Attachment 1), incorporating a draft standard for FSMP, be adopted into the Code for the following reasons.
- the inclusion of a standard for FSMP in the Code provides clear, harmonised regulations for FSMP in Australia and New Zealand;
- the explicit recognition of FSMP in the Code provides regulatory certainty for industry in complying with the Code and for government enforcement agencies;
- the regulation of FSMP provides assurance for consumers of protection of public health and safety, particularly for the target group being a vulnerable population;
- the inclusion of FSMP as ‘special purpose foods’ not only allows for regulatory consideration of the primary objective of safety but also efficacy;
- the inclusion of specific regulations for the composition and labelling of FSMP assures regulatory control which is commensurate with the assessed level of risk in Australia and New Zealand; and
- there is consistency with international regulations, wherever possible, to prevent potential barriers to trade that could jeopardise the supply of FSMP products to Australia/New Zealand.
Full Report [ pdf 437 kb ]