Division 3.3Ingredient determinations

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## Part 2—Substances or mixtures declared to be veterinary chemical products #### 2 Substances or mixtures declared to be veterinary chemical products The following table sets out the classes of substances or mixtures of substances that are declared to be veterinary chemical products: | Item | Class of substance or mixture of substances | | ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 1 | Allergenic substances supplied or used for administration to an animal by any means, or for consumption by an animal, except excluded nutritional or digestive products | | 2 | Medicated blocks or licks | | 3 | Enzymes supplied or used for administration to an animal by any means, or for consumption by an animal, except an enzyme that is an excluded nutritional or digestive product or that is a product covered by item 6 of the table in clause 3 of this Schedule | | 7 | Teat sealants | | 8 | Parts of a vertebrate animal, material produced from a vertebrate animal or matter the production of which involves the use of a vertebrate animal, if represented supplied or used for a purpose mentioned in subsection 5(2) of the Code | ## Part 3—Substances or mixtures declared not to be veterinary chemical products ### Division 3.1—Substances or mixtures declared not to be veterinary chemical products—general #### 3 Substances or mixtures declared not to be veterinary chemical products The following table sets out the classes of substances or mixtures of substances that are declared not to be veterinary chemical products: | Item | Class of substance or mixture of substances | | ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 1 | Animal feed products that incorporate an excluded nutritional or digestive product, if:(a) the container for the animal feed product is labelled in accordance with the instructions on the label for the container for the excluded nutritional or digestive product; and(b) the excluded nutritional or digestive product is incorporated at a rate of use in accordance with the label for the container for the excluded nutritional or digestive product; and(c) the claims made for the animal feed product do not exceed the claims made for the incorporated nutritional or digestive product. | | 2 | Medicated stockfoods and medicated premixes, if:(a) any veterinary chemical product that is incorporated in the medicated stockfood or medicated premix:(i) is a registered chemical product; and(ii) is incorporated at a rate of use in accordance with the approved label for containers for that registered chemical product; and(b) the container for the medicated stockfood or medicated premix is labelled in accordance with the instructions on the approved label for that registered chemical product | | 3 | Excluded nutritional or digestive products | | 4 | Colour intensifiers for aviary birds | | 5 | Any bitterant product for application to a building, piece of equipment or other object, that:(a) is solely for reducing or preventing animals that are not food producing species from biting or chewing the building, piece of equipment or other object; and(b) contains no antiseptic, antimicrobial, antibiotic or other active constituent other than a bitterant | | 6 | Any product applied topically to the teeth, hair, fur or intact skin of an animal to cosmetically alter the animal’s appearance or odour, that:(a) contains no antiseptic, antimicrobial, or antibiotic active constituent, and(b) is solely for cosmetic purposes; and(c) is not claimed to have any benefits other than cosmetic benefits; and(d) is not supplied or used for any therapeutic benefit other than to cosmetically alter the animal’s appearance or odour | | 7 | Any product for topical application to an animal to provide a physical barrier, that:(a) is chemically inert; and(b) does not act by biochemical means; and(c) is not a teat sealant; and(d) contains no antiseptic, antimicrobial, antibiotic or other active constituent; and(e) is not claimed to have any effect other than as a physical barrier | | 8 | Any autograft, allograft or xenograft product supplied to veterinary surgeons for surgical procedures, except blood, blood products, stem cells or stem cell products | | 9 | Any product for use as an extender for sperm, ova or semen, if:(a) the product contains no ingredients other than antibiotics, albumins, electrolytes, amino acids, EDTA, buffers or stabilising agents; and(b) any antibiotic in the product is not at a concentration greater than 0.1 mg/mL or 0.1mg/g | | 10 | Any product for topical application to an animal to act as a lubricant, that:(a) is chemically inert; and(b) does not act by biochemical means; and(c) is not a teat sealant; and(d) contains no antiseptic, antimicrobial, antibiotic or other active constituent; and(e) is not claimed to have any effect other than as a lubricant | | 11 | Semen, ova or embryos if represented, supplied or used for the purpose of reproduction | | 12 | Whole vertebrate animals if represented, supplied or used for a purpose mentioned in subsection 5(2) of the Code | ### Division 3.2—Excluded nutritional or digestive products #### 4 Excluded nutritional or digestive products (1) A substance or mixture of substances is an excluded nutritional or digestive product if: (a) the substance or mixture is intended for consumption by an animal; and (b) the following requirements are met in relation to the substance or mixture: (i) the ingredient requirements under clause 5; (ii) the claims requirements under clause 6; (iii) the labelling requirements under clause 7; (iv) the manufacturing requirements under clause 8. (2) Subparagraph (1)(b)(iv) does not apply if the substance or mixture is a block or lick that only contains one or more of the following: (a) vitamins; (b) minerals; (c) amino acids; (d) binders. (3) Despite subclause (1), none of the following is an excluded nutritional or digestive product: (a) a substance or mixture of substances included in a class of substances or mixtures of substances set out in the table in clause 2 (substances or mixtures declared to be veterinary chemical products); (b) an intraruminal bolus; (c) a substance or mixture of substances intended for direct application by a person to an animal’s digestive tract. #### 5 Ingredient requirements for excluded nutritional or digestive products (1) The ingredient requirements under this clause are met in relation to a substance or a mixture of substances if, at the time it is supplied: (a) each ingredient used in the substance or mixture is covered by subclause (2) or (3); and (b) each ingredient used in the substance or mixture meets the quality specification requirements under subclause (5); and (c) the substance or mixture does not contain any ingredient referred to in subclause (7). Ingredients that may be in substance or mixture (2) An ingredient is covered by this subclause if the ingredient is a substance of plant or animal origin that is edible by an animal, including: (a) an edible grain and a processing by‑product of an edible grain; and (b) whey powder and any other milk by‑product. (3) An ingredient used in a substance or a mixture of substances for a particular purpose is covered by this subclause if: (a) the use of the ingredient in the substance or mixture for that purpose is (subject to subclause (4)) authorised in a particular country by, or in accordance with, a standard, rule, code, specification or method referred to in an item in the following table; and (b) if the ingredient’s use for that purpose is authorised by, or in accordance with, more than one such standard, rule, code, specification or method—the ingredient’s use for that purpose is in accordance with the most stringent standard, rule, code, specification or method that is applicable. ```html <table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Ingredients authorised for use by certain standards, rules, codes, specifications or methods</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Standards, rules, codes, specifications and methods</td></tr></thead><tbody><tr><td style="width:10.08%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:89.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">The following ingredients authorised by the Food Standards Code, as existing at the time of the supply:(a) permitted flavouring substances;(b) generally permitted processing aids;(c) food additives (including colourings) specified in Schedule 16 to the Food Standards Code</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">3</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">A determination under section 8B of the Agricultural Compounds and Veterinary Medicines Act 1997 of New Zealand (substances generally recognised as safe for use as or in an agricultural compound), as existing on 5 March 2015</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">4</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Annex I (list of additives) of the European Union Register of Feed Additives established in accordance with Article 17 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, as existing at the time of the supply</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">5</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Parts 573, 582 and 584 of Title 21 of the Code of Federal Regulations of the United States of America, as existing at the time of the supply</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">6</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Chapter 6 (Feed Terms and Ingredient Definitions) of the Official Publication of the Association of American Feed Control Officials, as existing at the time of the supply</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">7</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Handbook of Pharmaceutical Excipients published by the Royal Pharmaceutical Society, as existing at the time of the supply</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">8</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">An ingredient determination (see Division 3.3), as existing at the time of the supply</td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">9</td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Part 1 of Schedules IV and V to the Feeds Regulations 1983 of Canada, as existing at the time of the supply</td></tr></tbody></table> ``` (4) For paragraph (3)(a): (a) the use of an ingredient is only authorised by, or in accordance with, the Annex referred to in item 4 of the table if: (i) the ingredient is not referred to as a category 5 substance in the Annex; and (ii) the Annex specifies an expiry date for authorisations for the ingredient; and (b) the use of an ingredient is only authorised by, or in accordance with, the Chapter referred to in item 6 of the table if the ingredient is not specified as a tentative listing in that Chapter; and (c) the use of an ingredient is only authorised by, or in accordance with, the Handbook referred to in item 7 of the table if the substance or mixture in which the ingredient is used is for canine or equine consumption. Quality specification requirements (5) An ingredient used in a substance or a mixture of substances for a particular purpose meets the quality specification requirements under this subclause if the use of the ingredient for that purpose is, at the time it is supplied, in accordance with any quality specification under: (a) a standard (however described) about animal feed, as existing at that time, provided for by or under a law of the Commonwealth; or (b) if no such standard exists at that time—a law of this jurisdiction; or (c) if neither paragraph (a) nor (b) applies—a standard about animal feed published by Standards Australia, as existing at that time. (6) If there is no quality specification of a kind mentioned in subclause (5) that applies in relation to the use of an ingredient for a particular purpose in a substance or a mixture of substances at the time it is supplied, then the ingredient is taken to meet the quality specification requirements under that subclause in relation to its use for that purpose. Ingredients that cannot be in substance or mixture (7) For paragraph (1)(c), the substance or mixture must not contain any of the following: (a) a hormone; (b) if the substance or mixture is intended for consumption by ruminants—any of the following: (i) any part of a vertebrate animal; (ii) material produced from a vertebrate animal; (iii) matter the production of which involves the use of a vertebrate animal; other than tallow, gelatine, an oil, whey power or any other milk by‑product; (c) an antibiotic substance listed in Schedule 2, 3, 4, 7, 8 or 9 of the current Poisons Standard; (d) an antibiotic substance listed in Schedule 6 of the current Poisons Standard, unless the antibiotic substance is used in the substance or mixture as a preservative; (e) an ingredient determined by the APVMA, by legislative instrument, for the purposes of this paragraph. #### 6 Claims requirements for excluded nutritional or digestive products The claims requirements under this clause are met in relation to a substance or a mixture of substances if: (a) a label for a container of the substance or mixture, and any accompanying information, does not, at the time the substance or mixture is supplied, expressly or impliedly claim or represent that it: (i) alleviates or prevents a disease or condition in an animal; or (ii) modifies the physiology of an animal; or (iii) cures a disease or condition in an animal; or (b) if such a claim or representation is made—the substance or mixture is supplied by, or in accordance with the instructions of, a veterinary surgeon, being a supply that would be permitted under a law of this jurisdiction if the substance or mixture were a chemical product; or (c) if a claim or representation covered by subparagraph (a)(i) or (ii) is made—the claim or representation is substantiated, having regard to either or both of the following: (i) scientific studies that are published in a reputable, refereed scientific journal, or that are of a standard publishable in such a journal; (ii) information showing that the claim or representation would, if EU Commission Directive 2008/38/EC (as in force at the time of the supply) applied in relation to the substance or mixture, be established under that Directive. #### 7 Labelling requirements for excluded nutritional or digestive products (1) The labelling requirements under this clause are met in relation to a substance or a mixture of substances if the following information is included on a label for a container of the substance or mixture, or accompanies the substance or mixture, at the time it is supplied: (a) the name of the substance or mixture; (b) instructions for use of the substance or mixture for each species for which it is intended to be used, including: (i) application or dosage rates for each species; and (ii) the length of the period during which it may be used for each species; (c) instructions for the safe handling of the product; (d) a crude or a key nutrient analysis relating to the claims made about the product; (e) a list of the ingredients in the substance or mixture, ordered by decreasing mass of: (i) the ingredients; or (ii) if the ingredients are grouped as mentioned in subclause (3)—the grouped ingredients; (f) the name of, and an address and telephone number for, the party primarily responsible for marketing the product; (g) a batch number; (h) an expiry date (or equivalent); (i) if the claims requirements under clause 6 are met in relation to the substance or mixture only because of paragraph 6(b)—a statement that the substance or mixture is for veterinary supply only; (j) if the claims requirements under clause 6 are met in relation to the substance or mixture only because of subparagraph 6(c)(ii)—any information required to be included on a label by a standard, rule, code, specification or method set out in EU Commission Directive 2008/38/EC (as in force at the time of the supply) in relation to a claim established under that Directive; (k) if the current Poisons Standard requires signal words in relation to the supply of the substance or mixture: (i) the appropriate signal words; and (ii) first aid instructions for the substance or mixture; and (iii) poisons information centre contact details. (2) Paragraph (1)(b), (c), (d), (e) or (h) is taken to be satisfied in relation to a substance or a mixture of substances if: (a) the information mentioned in that paragraph is made available for downloading from a website; and (b) the label or information that accompanies the substance or mixture includes, at the time the substance or mixture is supplied: (i) the URL of the website; or (ii) another method by which a person may download that information from the website. (3) For paragraph (1)(e), the ingredients may be grouped in accordance with any of the following standards, rules, codes, specifications or methods as existing at the time of the supply: (a) the Collective Terms outlined in Chapter 6 (Feed Terms and Ingredient Definitions) of the Official Publication of the Association of American Feed Control Officials; (b) the Group names outlined in Types 7, 8 and 11 of Section 2 “CODEX Classification of Foods and Animal Feeds” in CODEX Alimentarius Commission, CODEX Alimentarius, Volume 2, Pesticides Residues in Food; (c) sections 1.2.4—3, 1.2.4—4, 1.2.4—6, 1.2.4—7 and 1.2.4—8 of the Food Standards Code; (d) any applicable Australian industry code of practice. #### 8 Manufacturing requirements for excluded nutritional or digestive products The manufacturing requirements under this clause are met in relation to a substance or a mixture of substances if the substance or mixture is manufactured in accordance with any of the following standards, rules, codes, specifications or methods as existing at the time of manufacture: (a) both the manufacturing principles and the Australian GMP Code; (b) any applicable Australian industry code of practice; (c) the quality assurance requirements for animal feed products applicable to substances or mixtures of that kind in: (i) a member state of the European Union; or (ii) the United States of America. ### Division 3.3—Ingredient determinations #### 9 Ingredient determinations (1) The APVMA may, by legislative instrument, determine that one or more ingredients, or classes of ingredients, are authorised to be used in one or more classes of substances or mixtures of substances. > Note 1: An ingredient may be used in a substance or a mixture of substances if the use of the ingredient in the substance or mixture is authorised by the ingredient determination (see item 8 of the table in subclause 5(3)). > Note 2: A determination under this subclause is referred to in this Schedule as an ingredient determination (see clause 1). > Note 3: For variation and revocation, see subsection 33(3) of the Acts Interpretation Act 1901. (2) Without limiting subclause (1), an ingredient determination may do either or both of the following: (a) authorise an ingredient’s use only for one or more specified purposes in a class of substances or mixtures of substances; (b) authorise an ingredient’s use in a class of substances or mixtures of substances for a particular purpose only if one or more requirements specified in the ingredient determination are met. (3) The power under subclause (1) may be exercised on the APVMA’s own initiative or on application under clause 10. APVMA to be satisfied of certain matters (4) Before making or varying an ingredient determination, the APVMA must be satisfied that the use of a substance or a mixture of substances in a class covered by the ingredient determination as made or varied: (a) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and (b) would not be likely to have an effect that is harmful to human beings; and (c) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and (d) would not unduly prejudice trade or commerce between Australia and places outside Australia. (5) The APVMA must revoke or vary an ingredient determination if the APVMA is no longer satisfied as to any of the matters mentioned in subclause (4) in relation to the ingredient determination. (6) For the purposes of being satisfied as to the matters mentioned in paragraphs (4)(a), (b) and (c), the APVMA: (a) must have regard to the following: (i) the toxicity of substances or mixtures in the class and their residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (ii) the relevant poison classification of substances or mixtures in the class under the law in force in this jurisdiction; (iii) how substances or mixtures in the class are formulated; (iv) the composition and form of the ingredients of substances or mixtures in the class; and (b) may have regard to such other matters as it thinks relevant. (7) For the purposes of being satisfied as to the matter mentioned in paragraph (4)(d): (a) if it can reasonably be expected that a substance or mixture in a class covered by an ingredient determination will be used in relation to an animal, a product of which might be provided to a place outside Australia—the APVMA must have full regard to the matter mentioned in that paragraph; and (b) otherwise—the APVMA is to have regard to the matter mentioned in that paragraph to the extent that the APVMA thinks is relevant. Publishing ingredient determinations (8) The APVMA must publish an ingredient determination, as existing from time to time, on its website. #### 10 Applying for ingredient determinations (1) A person may apply to the APVMA to make or vary an ingredient determination to authorise the use of one or more ingredients in one or more classes of substances or mixtures of substances specified in the application. (2) The application must specify the following for each ingredient covered by the application: (a) one or more purposes for which the ingredient determination would authorise the use of the ingredient in the classes of substances or mixtures of substances specified in the application; (b) any requirements (including quality specifications) that would need to be met for the use of the ingredient for those purposes in the classes of substances or mixtures of substances specified in the application to be authorised by the ingredient determination. (3) The APVMA must make or vary an ingredient determination in accordance with the application if the APVMA is satisfied: (a) that the application meets the application requirements (other than the requirement set out in paragraph 8A(b) of the Code); and (b) of the matters mentioned in subclause 9(4), in accordance with subclauses 9(6) and (7). (4) If the APVMA is not satisfied as mentioned in subclause (3), the APVMA must refuse the application. (5) The APVMA must give written notice to the applicant, within 14 days of making or varying the ingredient determination, stating that it has been made or varied in accordance with the application. (6) The following provisions of the Code apply in relation to an application under subclause (1) in relation to an ingredient as if the application were an application made under the Code in relation to an active constituent for a proposed or existing chemical product: (a) section 157 (samples to be given for analysis); (b) section 159 (requiring information to determine application). > Note 1: A number of provisions in the Code apply automatically in relation to applications made under it (including applications made under these Regulations). See, for example, sections 8B to 8D, and sections 8G, 8S, 156A, 164 and 165, of the Code. > Note 2: Clause 11 applies certain other provisions in relation to applications made under this clause. #### 11 Information that may be used for ingredient determinations Overseas trials and experiments, and consultation (1) The following provisions apply in relation to the making, variation or revocation of an ingredient determination in relation to an ingredient as if the ingredient were an active constituent for a proposed or existing chemical product: (a) subsections 160(2) and (3) of the Code (overseas trials and experiments); (b) section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (consultation). Limits on use of information (2) The APVMA must not use information given to it in connection with an application under the Code: (a) to assess an application made under clause 10 in relation to an ingredient; or (b) to make any other decision in relation to the making, variation or revocation of an ingredient determination in relation to an ingredient; unless the information was given to it in connection with the application mentioned in paragraph (a) or the decision mentioned in paragraph (b). (3) A person or body consulted under section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as that section applies under subclause (1), must not, for the purposes of providing information or advice in relation to the making, variation or revocation of an ingredient determination, use information that the APVMA must not, under subclause (2), use in relation to the ingredient determination. (4) The following provisions of the Code apply in relation to subclauses (2) and (3) in the same way as they apply in relation to subsections 34G(1) and (3) of the Code: (a) subsections 34G(1B) and (2); (b) sections 34H to 34M. (5) For subclause (4), the condition in subsection 34J(4) of the Code is taken to be replaced by the condition that: (a) the information relates to the making, variation or revocation of an ingredient determination in relation to an ingredient; and (b) the information shows that a matter mentioned in subclause 9(4) of this Schedule may not be satisfied in relation to the ingredient. (6) For subclause (4), if the APVMA relies on information given in connection with an application under clause 10 to make or vary an ingredient determination in accordance with the application, a limitation period is taken to apply to the information under section 34M of the Code that ends 3 years after the information is given. (7) To avoid doubt, this clause applies in relation to the making, variation or revocation of an ingredient determination whether on the APVMA’s own initiative or on application under clause 10. Schedule 3B—Listed chemical products Note: See regulation 8AR. ## Part 1—Preliminary #### 1 Particulars of listed chemical products Each chemical product, or class of chemical product, listed in this Schedule is described in a separate item in the table in Part 2 as follows: (a) column 2 describes the product; (b) column 3 describes the product use. #### 2 Active constituents in listed chemical products (1) A substance mentioned in column 2 of an item in the table in Part 2 as an active constituent of a chemical product or class of chemical product, means the substance with that name that complies with the particulars specified for that substance in an item in a Subdivision of Part 3 of this Schedule. (2) Each substance dealt with in a Subdivision of Part 3 is described in a separate item as follows: (a) the first row gives the common name of the substance; (b) the second row lists any synonyms for the substance; (c) the third row gives the Australian approved name, if any, for the substance; (d) the fourth row gives the chemical name or names of the substance; (e) the fifth row gives the chemical abstract service number for the substance; (f) the sixth row identifies the relevant monograph or compendial standard, if any, with which the substance is required to comply.