Australia New Zealand Food Authority Variations to the Food Standards Code (Amendment No. 40) 1. Preamble The variations set forth in the Schedule below are variations to the Food Standards Code (hereinafter called ``the code'') which was published by the National Health and Medical Research Council in the Commonwealth of Australia Gazette, No. P 27, on 27 August 1987, and which has been varied from time to time. The Schedule contains variations adopted by the Australia New Zealand Food Standards Council in July 1998. These variations are published pursuant to section 32 of the Australia New Zealand Food Authority Act 1991. 2. Citation These variations may be collectively known as Amendment No. 40 to the code. 3. Commencement These variations commence on the date of publication of this New Zealand Gazette with the exception of Item 4] which will commence 9 months after the date of publication of this New Zealand Gazette. Item 1.1 will commence on the date of publication of this New Zealand Gazette and cease to have effect 18 months from that date. 4. Explanatory Note In relation to Item 1.1, the implementation of the folate/neural tube defect health claims pilot is contingent on a further recommendation to the Australia New Zealand Food Standards Council containing details of those foods and food products approved for participation in the pilot and listing in the Register. The proposed implementation date for the approved Register listings is 18 November 1998. Schedule 1 Standard A1 is varied by 1.1 inserting after subclause (19)(d) ``(e) (i) The table to this subclause sets out permitted health claims that may be made in respect of food listed in the table which meets the qualifying and disqualifying criteria specified; and which also meets the eligibility criteria set out subclause (ii). (ii) A food meets the eligibility criteria of this subclause if it is a primary food as defined in Standard A9, or else if it contains, in each serving as specified in the nutrition information panel, not more than (A) 14 g fat; (B) 5 g saturated fat; (C) 500 mg sodium; (D) 10 g in total of added sugars and honey. (iii) The label on or attached to a package of food in respect of which a health claim set out in the table has been made must include a nutrition information panel in accordance with clause (13), provided that in relation to the claim for ``Folate and Neural Tube Defects'' the entry in the nutrition information panel should be based on a recommended dietary intake (RDI) of 400 g folate rather than the 200 g specified in Standard A9. (iv) Where the health claim appears on the label on or attached to a package of food it must be accompanied by a statement that it is important to maintain a varied diet. (v) Where the ability of a food to meet the qualifying criteria set out in the table depends on particular storage, handling or cooking requirements, the label on or attached to a package containing the food for which a health claim is made must include a statement of those requirements. Table to Subclause (19) (e) Permitted Health Claims Food Criteria Permitted Claim Amounts specified are per each serving as specified in the nutrition information panel FOLATE AND NEURAL TUBE DEFECTS (Approved foods/products are listed in the Folate/Neural Tube Defects Health Claims Pilot Register) Qualifying Criteria At least 40 g folate. Disqualifying Criteria None A claim which states (a) that increased maternal folate consumption in the month before and 3 months following conception may reduce the risk of foetal neural tube defects; and (b) the recommendation that women consume at least 400 g folate per day in the month before and 3 months following conception. Editorial Note: Subclause (e) implements a pilot trial of a management system for health claims. The outcomes of the pilot will be used to assist in the evaluation of a proposal to allow wider use of health claims in food labels and advertisements. The subclause ceases to have effect 18 months from the date on which commencement of the pilot is gazetted. The register referred to in the table to subclause (19) (e) is held at and by the Australia New Zealand Food Authority. 1.2 inserting in columns 1 and 2 respectively of Part 1 of the Schedule in the appropriate alphabetical position ``Oxidised polyethylene 914''; and 1.3 inserting in columns 1 and 2 respectively of Part 2 of the Schedule in the appropriate numerical position ``Oxidised polyethylene 914''. 2 Standard A11 is varied by 2.1inserting in columns 1 and 2 respectively of the Schedule in the appropriate numerical position ``Oxidised polyethylene Addendum 6''; and 2.2 omitting ``NHMRC (88)'' from column 2 of the Schedule, in relation to the entry in column 1 for ``Sodium polyacrylate'', and substituting ``NHMRC (105)''; and 2.3 inserting after Addendum 5 ``Addendum 6 Specification for Oxidised Polyethylene Oxidised polyethylene (CAS 68441-17-8) is the polymer produced by the mild air oxidation of polyethylene. Average molecular weight min 1200 (osmometric) Viscosity at 125 c min 200 cP Oxygen content max 9.1% Acid value: max 70 mgKOH/g (ASTM D 1386)* Drop point : min 95 c (ASTM D 566)* Density (20c) 0.93 1.05 g/cm3 (ASTM D 1298, D 1505)* Extractable constituents (See note 1): in water max. 1.5% in 10% ethanol max. 2.3% in 3% acetic acid max. 1.8% in n-pentane max. 26.0% CAS is the Chemical Abstracts Service (CAS) Registry Number * ASTM refers to standard test methods prepared by the American Society for Testing and Materials. Note 1: Extraction of Oxidised Polyethylene 25.0 g of finely ground oxidised polyethylene powder (particle size 3001000 mm) are extracted for 5 hours in the Soxhlet apparatus with 350 ml of solvent. The solvent is then distilled off and the distillation residue is dried in a vacuum oven at 8090c. After weighing the obtained residue, the components soluble in the solvent are calculated in % weight (based on the initial weight used).''. 3 Standard A13 is varied by omitting paragraph (3)(b) and substituting ``(b) the object or thing is composed of materials that will not contaminate or migrate into the food.''. 4 The Food Standards Code is varied by inserting ``Standard A18 Food Produced Using Gene Technology Purpose This Standard regulates the sale of foods and food ingredients, other than additives and processing aids, which are produced using gene technology. The Standard prohibits the sale of these foods unless they are included in the table to clause 2 and comply with any special conditions in that table. The Authority will assess the safety for human consumption of each food or class of food prior to its inclusion in the table. The safety assessment will be done in accordance with the Authority's approved safety assessment criteria. Additives and processing aids which are produced using gene technology are not regulated in this Standard. Other Standards in this code regulating additives and processing aids require pre-market approval for these substances. Table of Provisions 1. Definitions 2. General prohibition on the sale of food produced using gene technology 3. Labelling Definitions 1. In this Standard a `food produced using gene technology' is a food which has been derived from an organism which has been modified by gene technology, but does not include any substance regulated as a food additive or a processing aid. `gene technology' refers to recombinant DNA techniques that alter the heritable genetic material of living cells or organisms. General prohibition on the sale of food produced using gene technology 2. A food produced using gene technology must not be sold or used as an ingredient or component of another food unless it is listed in column 1 of the table to this clause and complies with the conditions, if any, specified in column 2. Table to clause 2 Column 1 Column 2 Food produced using gene technology Special conditions Labelling 3. (1) A food that is, or contains as an ingredient or component, a food produced using gene technology that (a) contains new or altered genetic material; and (b) is not substantially equivalent in any characteristic or property of the food; must indicate on the label the origin and nature of the characteristic or property modified. Editorial note: Not substantially equivalent in any characteristic or property of the food includes (a) where the modification results in one or more significant compositional or nutritional parameters having values outside of the normal range of values for the existing equivalent food or food ingredient; or (b) where the level of anti-nutritional factors or natural toxicants are considered significantly different in comparison to the existing equivalent food or food ingredient; or (c) where the food contains a new factor known to cause an allergic response in particular sections of the population; or (d) where the intended use of the food or food ingredient is different to the existing equivalent food or food ingredient. ''. 5 Standard N1 is varied by 5.1 omitting ``paragraphs'' from subclause (7) (a) and substituting ``subclauses''; 5.2 omitting ``and (ba)'' from subclause (7) (a); 5.3 omitting ``beeswax, carnauba wax and shellac'' from subclause (7) (a) and substituting ``the mixture''; and 5.4 omitting subclause (7) (ba) and substituting ``(ba) Mixtures used for the coating of citrus fruit may, in addition to those substances specified in subclause (b), contain (i) not more than 30 g/kg of propylene glycol; and (ii) not more than 250 mg/kg of oxidised polyethylene.''.