Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation

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Legislation au F2012L01341 Not in force Legislative Instrument

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Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation

 

 

 

 

1 Name

 

This instrument is the Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation.

 

2 Variation to Standards in the Australia New Zealand Food Standards Code

 

The Schedule varies the Standards in the Australia New Zealand Food Standards Code.

 

3 Commencement

 

This variation commences on the date of gazettal of Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation.

 

SCHEDULE

 

[1] Standard 1.1.1 is varied by

 

[1.1] inserting in clause 2 the following definitions in alphabetical order

 

food for special medical purposes has the meaning given by Standard 2.9.5.

 

small package means a package with a surface area of less than 100 cm2.

 

transportation outer means a container or wrapper which –

 

(a) encases packaged or unpackaged foods for the purpose of transportation and distribution; and

(b) is removed before the food is used or offered for retail sale, or is not taken away by the purchaser of the food.

 

[1.2] omitting paragraph (e) from the definition of warning statement in clause 2, substituting

 

(e) sub clauses 3(3) and 3(4) of Standard 2.9.4; and

(f) subclause 10(4) of Standard 2.9.5.

 

[1.3] inserting in alphabetical order in the Table to clause 8 –

 

MJ

Megajoule

 

[2] Standard 1.1A.6 is varied by omitting subclause 2(3), substituting

 

(3) This Standard ceases to have effect in relation to:

 

(a) food for special medical purposes on the date of gazettal of Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation; and

(b) other special purposes food, including food formulated and represented as being for the dietary management of obesity or overweight, two years from the commencement of any alternative applicable provisions elsewhere in this Code.

[3] Standard 1.2.1 is varied by omitting from clause 1 the definitions of small package and transportation outer

 

[4] Standard 1.3.1 is varied by

 

[4.1] omitting from Schedule 1, the heading to Item 13, substituting

 

13 SPECIAL PURPOSE FOODS

[4.2] inserting in Schedule 1 after Item 13.4.2

 

13.5 Food for special medical purposes*

 

200 201 202 203

Sorbic acid and sodium, potassium and calcium sorbates

1500

mg/kg

 

 

 

210 211 212 213

Benzoic acid and sodium, potassium and calcium benzoates

1500

mg/kg

 

 

 

338

Phosphoric acid

GMP

 

 

Permitted for use as an acidity regulator

 

524

Sodium hydroxide

GMP

 

 

Permitted for use as an acidity regulator

 

525

Potassium hydroxide

GMP

 

 

Permitted for use as an acidity regulator

 

950

Acesulphame potassium

450

mg/kg

 

 

 

954

Saccharin

200

mg/kg

 

 

 

962

 

Aspartame-acesulphame salt

450

mg/kg

 

 

13.5.1 Liquid food for special medical purposes*

 

123

Amaranth

30

mg/kg

 

 

 

160b

 

Annatto extracts

10

mg/kg

 

 

13.5.2 Food for special medical purposes other than liquids*

 

123

Amaranth

300

mg/kg

 

 

 

160b

Annatto extracts

25

mg/kg

 

 

 

[5] Standard 1.3.4 is varied by adding at the end of the Schedule –

 

Specification selenium-enriched yeast

 

Selenium-enriched yeasts are produced by culture in the presence of sodium selenite as a source of selenium. These yeasts contain selenium according to the following criteria –

 

Total selenium content

No more than 2.5 mg/kg of the dried form as marketed

 

 

Levels of organic selenium species (% total extracted selenium):

 

    Selenomethionine

No less than 60% and no more than 85%

 Other organic selenium compounds (including selenocysteine)

No more than 10%

Levels of inorganic selenium (% total extracted selenium)

No more than 1%

 


Amendment History

 

The Amendment History provides information about each amendment to the Instrument. The information includes commencement or cessation information for relevant amendments.

 

These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.

 

About this compilation

 

This is a compilation of Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation as in force on 21 February 2013 (up to Amendment No. 139). It includes any commenced amendment affecting the compilation to that date.

 

Prepared by Food Standards Australia New Zealand on 21 February 2013.

 

Uncommenced amendments or provisions ceasing to have effect

 

To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Standard as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislative Instruments including or omitting those amendments and provided in the Amendment History once the date is passed.

 

 

The following abbreviations may be used in the table below:

 

ad = added or inserted am = amended

exp = expired or ceased to have effect rep = repealed

rs = repealed and substituted

 

Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation was published in the Food Standards Gazette No. FSC 74 on 28 June 2012 as part of Amendment 132 (F2012L01341 – 27 June 2012) and has been amended as follows:

 

Clause affected

A’ment No.

FRLI registration

Gazette

Commencement

(Cessation)

How affected

Description of amendment

3

139

F2013L00250

21 Feb 2013

FSC81

21 Feb 2013

 

21 Feb 2013

am

Commencement date brought forward from 28 June 2014 to 21 February 2013.

Item 2 of Sch

139

F2013L00250

21 Feb 2013

FSC81

21 Feb 2013

 

21 Feb 2013

rs

Consequential amendments to Standard 1.1A.6.

 

 

Overview

The Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation was enacted in 2012 as part of Amendment 132 (F2012L01341 – 27 June 2012) under section 92 of the Food Standards Australia New Zealand Act 1991. This variation was introduced to address the need for consequential amendments to the Australia New Zealand Food Standards Code, particularly in relation to the regulation of food for special medical purposes. This was necessary to ensure that the standards were aligned with the changes proposed in Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation, which also came into effect on 21 February 2013. The objective of this legislative instrument was to update and refine the definitions, standards, and regulations concerning special purpose foods, particularly those intended for special medical purposes, ensuring they are accurately reflected in the Australia New Zealand Food Standards Code.

Scope and Application

The Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation applies to the Standards in the Australia New Zealand Food Standards Code, impacting the definitions and requirements related to food for special medical purposes. This legislative instrument specifically targets food businesses and entities involved in the production, packaging, and distribution of foods designated for special medical purposes, ensuring these products meet the required safety and quality standards. The geographic reach of this Act is national, operating under the Commonwealth jurisdiction as outlined in the Food Standards Australia New Zealand Act 1991. This Act does not explicitly state exclusions or exemptions but extends its application through subordinate instruments that provide further details on the implementation and compliance requirements. The variation also includes consequential amendments that clarify definitions and modify standards to align with the new regulatory framework, ensuring comprehensive oversight of food for special medical purposes across Australia.

Key Provisions

The Food Standards (Proposal P242 – Food for Special Medical Purposes – Consequential) Variation (F2012L01341) introduces consequential amendments to the Australia New Zealand Food Standards Code in response to changes in food standards for products intended for special medical purposes. Specifically, it modifies Standard 1.1.1 by adding definitions for "food for special medical purposes" and "small package," and by altering the definition of "warning statement" (Section 1.1.1). It also modifies Standard 1.1A.6 by specifying that this standard ceases to apply to food for special medical purposes on the date of gazettal of the Food Standards (Proposal 1023 – Tutin, Tocopherols & Food for Special Medical Purposes Standards Amendments) Variation, and to other special purpose foods two years after the commencement of any alternative applicable provisions (Section 2). Additionally, it removes the definitions of "small package" and "transportation outer" from Standard 1.2.1 and modifies Standard 1.3.1 by updating the list of permitted additives for special purpose foods, including food for special medical purposes (Sections 3 and 4). The Act imposes several obligations on parties or entities it governs. Firstly, it requires compliance with the amended definitions and standards for food products intended for special medical purposes, ensuring that these products meet the specified criteria. Secondly, it mandates that any food products intended for special medical purposes adhere to the permitted additives and concentration limits as outlined in the amended standards (Section 5). These obligations are crucial for ensuring the safety and quality of food products intended for special medical purposes. The Act does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of its provisions. However, any non-compliance with the Australia New Zealand Food Standards Code generally attracts penalties under the Food Standards Australia New Zealand Act 1991. These penalties can include fines and, in severe cases, criminal charges. The exact penalties depend on the nature and severity of the breach, with potential maximum penalties for serious offences reaching up to significant fines and imprisonment. Compliance is essential to avoid these potential legal repercussions.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.