Schedule 9 contains substances that should be available only for medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State/Territory Health Authorities. Although appearing as a Schedule in this Standard the method by which it is implemented in the States/Territories may vary.
Substances in products which have been considered for scheduling but have been exempted from this standard may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
Appendix C contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties. It is recommended that provisions of this appendix be put into effect through inclusion of the substances in appropriate State and Territory legislation.
READING THE SCHEDULES
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are now scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are being revised and replaced by individual entries as time permits although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry these have been emphasised by printing the word “except” in bold type.
Where the schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation such as pesticide registration may apply.
Where a schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption (‘reverse scheduling’), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.
Where a poison has been included in more than one Schedule the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.
It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Interpretation PART 1 [paragraph 1(2)]).
It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria. Classification of a substance as a derivative of a Scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, toxicologically) to a Scheduled poison or is readily converted (either physically or chemically) to a Scheduled poison. However, a substance is only considered a derivative of a Scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry. Additionally, some entries specifically exclude derivatives. Once a substance is determined to be a derivative of a Scheduled poison, the same scheduling requirements as the Scheduled poison, including limits on access, supply and availability, will apply.
Finally, when using the Standard to determine the scheduling status of a poison it may be necessary to search each relevant Schedule as well as Appendices A, B and C. In this process if the poison is not found under its “approved name” it may be shown under a group term such as:
Group Example
the parent acid of salts “oxalic acid” to find sodium oxalate
the radical of a salt “chromates” to find potassium chromate
the element “arsenic” to find arsenic trioxide
a chemical group with similar “hydrocarbons, liquid” to find kerosene
toxicological or pharmacological
activity
a pharmacological group “anabolic steroidal agents” to find
“androsterone”
INTERPRETATION
- (1) In this Standard, unless the contrary intention appears —
“Animal feed premix” means a concentrated preparation, containing one or more poisons, for mixing with food ingredients to produce a bulk feed for a group of animals (including fish or birds), but does not include a preparation for mixing with an individual animal’s food.
“Appropriate authority” means:
(a) in the Australian Capital Territory, ACT Health;
(b) in New South Wales, the Director-General of New South Wales Health;
(c) in the Northern Territory, the Chief Health Officer of the Department of Health & Families;
(d) in Queensland, the Chief Executive of Queensland Health;
(e) in South Australia, the Chief Executive of the Department of Health;
(f) in Tasmania, the Secretary of the Department of Health and Human Services;
(g) in Victoria, the Secretary to the Department of Human Services;
(h) in Western Australia, the Chief Executive Officer of the Department of Health.
“Approved name” means:
(a) in relation to a poison that is for therapeutic use -
(i) the Australian Approved Name for the poison, not including synonyms, as listed in the publication entitled “Therapeutic Goods Administration Approved Terminology for Medicines”, July 1999, or its successor, published by the Therapeutic Goods Administration, Canberra; or, if the poison is not listed in that publication,
(ii) the international non-proprietary name recommended for the poison by the World Health Organisation; or, if no such name is recommended,
(iii) the English name, not including synonyms, by which the poison is described in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian Pharmaceutical Formulary and Handbook or the British Pharmacopoeia (Veterinary); or, if the poison is not described in any of those publications,
(iv) the approved name given to the poison by the Medicines Commission of Great Britain; or, if no such name is given,
(v) the accepted scientific name or the name descriptive of the true nature and origin of the poison;
(b) in relation to a poison that is not for therapeutic use
(i) the English name recommended by the Standards Association of Australia as the common name for the poison; or, if no such name is recommended,
(ii) the English name given to the poison by the International Organisation for Standardisation; or, if no such name is given,
(iii) the English name given to the poison by the British Standards Institution; or, if no such name is given,
(iv) the Australian Approved Name for the poison, not including synonyms, as listed in the publication entitled “Therapeutic Goods Administration Approved Terminology for Drugs”, January 1993 (ISBN 0 644 28628 8), or its successor, published by the Australian Government Publishing Service; or, if the poison is not listed in that publication,
(v) the English name, not including synonyms, by which the poison is described in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian Pharmaceutical Formulary and Handbook or the British Pharmacopoeia (Veterinary); or, if the poison is not described in any of those publications,
(vi) the approved name given to the poison by the Medicines Commission of Great Britain; or, if no such name is given,
(vii) the international non-proprietary name recommended for the poison by the World Health Organisation; or, if no such name is recommended,
(viii) the accepted scientific name or the name descriptive of the true nature and origin of the poison.
“Australian Code for the Transport of Dangerous Goods by Road and Rail” means the seventh edition of the document of that name.
“Blood” means whole blood extracted from human donors.
“Blood components” means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and plasma), except for products derived through fractionation of plasma.
“Child-resistant closure” means:
(a) a closure that complies with the requirements for a child-resistant closure in the Australian Standard AS1928-2007 entitled Child—resistant packaging—Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);
(b) a closure approved by any order made under section 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(c) in the case of a can fitted with a press-on lid, a lid of the design known as “double tight” or “triple tight”.
“Child-resistant packaging” means packaging that:
(a) complies with the requirements of the Australian Standard AS1928-2007 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);
(b) is reclosable and complies with the requirements of at least one of the following standards:
(i) the International Organization for Standardization Standard ISO 8317:2003 entitled Child-resistant packaging - Requirements and testing procedures for reclosable packages;
(ii) the British Standards Institution Standard BS EN ISO 8317:2004 entitled Child-resistant packaging - Requirements and testing procedures for reclosable packages;
(iii) the Canadian Standards Association Standard CSA Z76.1-06 entitled Reclosable Child-Resistant Packages;
(iv) the United States Code of Federal Regulations, Title 16, Section 1700.15, entitled Poison prevention packaging standards and Section 1700.20, entitled Testing procedure for special packaging;
(c) is approved as child-resistant by any order made under section 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(d) is in the form of blister or strip packaging in which a unit of use is individually protected until the time of release and that complies with Section 3 (Requirements for non-reclosable packages) of Australian Standard AS1928-2001 entitled Child-resistant packages.
“Compounded” in relation to a substance means combined with one or more other therapeutically active substances in such a way that it cannot be separated from them by simple dissolution or other simple physical means.
“Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.
“Dermal use” means application to the skin primarily for localised effect.
“Designated solvent” means the following:
acetone
dimethylformamide
N-(N-dodecyl)-2-pyrrolidone
hydrocarbons, liquid
methanol when included in Schedule 5
methyl ethyl ketone
methyl isoamyl ketone
methyl isobutyl ketone
N-methyl-2-pyrrolidone
N-(N-octyl)-2- pyrrolidone
phenyl methyl ketone
styrene
tetrachloroethylene
1,1,1-trichloroethane
“Distributor” means a person who imports, sells or otherwise supplies a poison.
“Divided preparation” means a preparation manufactured and packed as discrete pre-measured dosage units prior to sale or supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.
“Dosage unit” means an individual dose of a poison for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.
“Drug” means a poison intended for human or animal therapeutic use.
“Essential oils” means products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation. For scheduling purposes it also means:
(a) oils of equivalent composition derived through synthetic means; or
(b) prepared mixtures of oils of equivalent composition comprising a mixture of synthetic and natural components.
“External” in relation to the use of a poison means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.
“First Schedule Paint” means a paint containing the specified proportion of any substance in the First Schedule to Appendix I of this Standard.
“Graphic material” means the material which is to be deposited on another material by a graphic instrument during writing, drawing or marking and includes cores of pencils, school pastels or crayons, blackboard chalks, finger or showcard colours, poster paints and watercolour blocks.
“Height” in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or a descender.
“Hemp seed oil” means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.
“Immediate container” includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.
“Immediate wrapper” means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.
“Internal use” means administration:
(a) orally, except for topical effect in the mouth; or
(b) for absorption and the production of a systemic effect,
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin.
“Label” means a statement in writing on a container of a poison.
“Main label” means, where there are two or more labels on a container or a label is divided into two or more portions:
(a) that label or portion of the label on which the name of the product is most prominently shown and which is primarily designed to attract attention; or
(b) where the name of the product is equally prominent on two or more labels or portions of a label, each of those labels or portions of the label on which the name of the product is equally prominent.
“Manufacturer” means a person who manufactures, produces, or packs a poison.
“Measure pack” means a sealed container which contains a measured quantity of poison for use on one occasion as a pesticide or domestic product and one or more of which is enclosed in a primary pack.
“Name and address” means the name and address, in Australia, of the manufacturer or distributor of a poison but does not include a post office, cable, telegraphic or code address. Where such manufacturer or distributor is a company incorporated in accordance with the appropriate law of any State or Territory of the Commonwealth of Australia or a firm registered under the Business Names Act of any State or Territory, the inclusion in the label of the registered name of the corporation or firm or its branch or its division and the city or town in which a registered office is situated shall be deemed to comply with the requirements.
“Non-access packaging” is packaging that complies with the requirements of Australian Standard AS4710-2001 entitled Packages for chemicals not intended for access or contact with their contents by humans, in relation to products that are not intended for human therapeutic use.
“Non-volatile content” in relation to a paint or tinter means that portion of a paint or tinter determined to be the non-volatile content by Method 301.1 of Australian Standard AS 1580-301.1-2005 entitled Paints and related materials – Methods of test – Non-volatile content by mass.
“Paint”, without limiting the ordinary meaning, includes any substance used or intended to be used for application as a colouring or protective coating to any surface but does not include graphic material.
“Pesticide” means any substance or mixture of substances used or intended to be used:
(a) for preventing, destroying, repelling, attracting, inhibiting or controlling any insects, rodents, birds, nematodes, bacteria, fungi, weeds or other forms of plant or animal life or viruses, which are pests; or
(b) as a plant regulator, promoter, defoliant or desiccant for food storage, household, industrial, commercial, agricultural and non-agricultural application, but does not include veterinary drugs, stock medicines, stock feeds, stock feed additives, drugs for human use, food additives or fertilisers.
“Poison” means any substance or preparation included in a Schedule to this Standard.
“Primary pack” means the pack in which a poison and its immediate container or immediate wrapper or measure pack are presented for sale or supply.
“Required Advisory Statements for Medicine Labels” means the document of that name, as published by the Therapeutic Goods Administration in September 2008.
“Restricted flow insert” means a restriction fitted, or moulded, in the neck of a container which:
(a) cannot readily be removed from the container by manual force; and
(b) limits the delivery of the contents to drops each of which is not more than 200 microlitres.
“Second Schedule Paint” means a paint containing the specified proportion of any substance in the Second Schedule to Appendix I of this Standard.
“Selected container” means:
(a) an injection vial having a nominal capacity of ten millilitres or less;
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of ten millilitres or less.
“Solid” is considered to include “powder” for the purposes of scheduling.
“Therapeutic use” means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human beings or animals;
(b) influencing, inhibiting or modifying a physiological process in human beings or animals; or
(c) testing the susceptibility of human beings or animals to a disease or ailment.
“Third Schedule Paint” means a paint containing the specified proportion of any substance in the Third Schedule to Appendix I of this Standard.
“Tinter” means any pigment or admixture of pigment with other substances, in powder, semi-solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.
“Topical use” means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
“Toy” means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of fourteen years.
“Transdermal use” means application to the skin primarily for systemic effect.
“Writing” includes the visible representation or reproduction of words or figures in any form, and “to write” and “written” have corresponding meanings.
(2) Unless the contrary intention appears a reference to a substance in a schedule or an appendix to this Standard includes:
(a) that substance prepared from natural sources or artificially; and
(b) where the substance is a plant (other than a plant included in Schedule 8 or 9), that plant or any part of that plant when packed or prepared for therapeutic use; and
(c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative; and
(d) every alkaloid of the substance and every salt of such an alkaloid; and
(e) every stereoisomer of the substance and every salt of such a stereoisomer; and
(f) every recombinant form of the substance; and
(g) a preparation or admixture containing any proportion of the substance,
but does not include:
(h) a preparation or product included in Appendix A, or a substance and the reason for its entry in Appendix B; or
(i) a substance included in Appendix G at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of that substance; or
(j) any other substance included in Schedules 1 to 6, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8; or
(k) any substance present as an impurity in a pesticide, at a concentration at or below the maximum content for that substance, specified for the pesticide in the Standards for Active Constituents, as published by the Australian Pesticides and Veterinary Medicines Authority.
(3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a schedule or an appendix to this Standard in respect of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and
(b) the expression “one per cent” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 millilitres of the preparation; or
(ii) in the case of a solid, semi-solid or pressurised spray aerosol preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning; and
(c) in the case of codeine such concentration, strength or quantity is calculated as anhydrous codeine.
(4) A reference to a boiling or distillation temperature in the schedules means that temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of mercury).
LABELS AND CONTAINERS
LABELS
- A person must not sell or supply a poison unless it is labelled in accordance with paragraphs 3 to 19 of this Standard.
General requirements
- Any word, expression or statement required by this Standard to be written on a label or container must be written:
(1) on the outside face of the label or container; and
(2) in the English language; and
(3) in durable characters; and
(4) in a colour or colours to provide a distinct contrast to the background colour; and
(5) in letters at least 1.5 millimetres in height.
- Sub-paragraph 3(5) does not apply to a word, expression or statement on a container which has a capacity of 20 millilitres or less, or on the label of such a container if:
(1) an appropriate authority approves the use of smaller letters; and
(2) the letters are at least 1 millimetre in height.
- The label must be printed on, or securely attached to:
(1) the outside of the immediate container; and
(2) if the immediate container is enclosed in a primary pack, the outside of that primary pack.
Immediate wrapper
- (1) A poison enclosed in an immediate wrapper must be contained in a primary pack labelled in accordance with paragraph 7 of this Standard; and
(2) the immediate wrapper must be conspicuously labelled with:
(a) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for that poison; and
(b) the approved name of the poison; and
(c) a statement of the quantity or strength of the poison in accordance with paragraph 8.
Primary packs and immediate containers
- (1) The primary pack and immediate container of a poison must be labelled as follows:
(a) with the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the following table:
Schedule Purpose Signal words required
2 for any purpose PHARMACY MEDICINE
3 for any purpose PHARMACIST ONLY MEDICINE
4 for human use PRESCRIPTION ONLY MEDICINE
4 for animal use PRESCRIPTION ANIMAL REMEDY
5 for any purpose CAUTION
6 for any purpose POISON
7 for any purpose DANGEROUS POISON
8 for any purpose CONTROLLED DRUG
(i) on the first line or lines of the main label; and
(iii) in letters at least half the height of the largest letter or numeral on the label but need not be larger than:
(A) 6 millimetres on labels for packages having a nominal capacity of 2 litres or less; or
(B) 15 millimetres on labels for packages having a nominal capacity of more than 2 litres; and
(iv) if the poison:
(A) is a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail or a statement of the principal hazard of the poison, written on that line; or
(B) is not a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on that line;
(b) if the poison is a Schedule 8 poison, with the cautionary statement –
POSSESSION WITHOUT AUTHORITY ILLEGAL
(i) on a separate line or lines immediately below the signal words required by sub-paragraph 7(1)(a); and
(iii) in letters at least four tenths the height of the letters used for the signal words; and
(iv) with no other statement written on the same line;
(c) with the cautionary statement –
KEEP OUT OF REACH OF CHILDREN
(i) on a separate line or lines:
(A) immediately below the signal word or words required by sub-paragraph 7(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by sub-paragraph 7(1)(b), on the line immediately below that statement; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(d) if the poison is a dry chlorinating compound containing more than 10 per cent of available chlorine, except for preparations certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5.1 (oxidising substances) as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FIRE AND EXPLOSION HAZARD
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(e) if the poison is an alkaline salt in a dishwashing machine product, with the cautionary statement –
BURNS SKIN AND THROAT
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and
(iii) in letters at least four tenths the height of the letters used for the signal word; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line of the main label;
(f) if the poison is an aqueous solution of paraquat, with the cautionary statements –
CAN KILL IF SWALLOWED
DO NOT PUT IN DRINK BOTTLES
KEEP LOCKED UP
(i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and
(iii) in letters at least four tenths the height of the letters used for the signal words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same lines of the main label;
(g) if safety directions are required on the label by sub-paragraph 7(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); or
(B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(h) if the poison meets the criteria for a ‘flammable liquid’ in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FLAMMABLE
written on the main label in bold-face sanserif capital letters of uniform thickness, unless already present in accordance with the requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail Rail;
(i) if the poison is for the treatment of animals, with the cautionary statement –
written on the main label in bold-face sanserif capital letters of uniform thickness;
(j) if the poison is a Schedule 5 poison intended for any purpose other than internal or pesticidal use, with the cautionary statement –
DO NOT SWALLOW
written in sanserif capital letters on the main label or as part of the directions for use;
(k) with the approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with paragraph 8:
(i) if the poison is for human therapeutic use, written in accordance with orders made under section 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or
(ii) if the poison is not for human therapeutic use, written in bold-face sanserif capital letters on the main label, unless:
(A) a list of approved names is required; and
(B) it is impractical to include the list on the main label; and
(C) an appropriate authority has authorised its inclusion on another part of the label; or
(iii) if the poison is a Schedule 5 poison referred to in column 1 of the following table the appropriate name opposite thereto in column 2 may be used as the approved name:
TABLE
Alkaline salts Alkaline salts
Amines for use as curing Aliphatic amines or
agents for epoxy resins aromatic amines
(unless separately specified
in the Schedules)
Epoxy resins, liquid Liquid epoxy resins
Hydrocarbons, liquid Liquid hydrocarbons
Quaternary ammonium Quaternary ammonium
compounds compound(s)
(iv) if a poison contains a mixture of designated solvents in excess of 25 per cent of the total volume of the poison but the proportion of one or more individual designated solvents in the mixture is equal to or less than 25 per cent, the approved names of those solvents may be expressed as follows:
(A) where the designated solvent is a liquid hydrocarbon as “liquid hydrocarbons”; or
(B) where the designated solvent is a ketone as “ketones”; or
(C) in any other case as “solvents” or “other solvents”;
(l) if the poison is an organophosphorus compound or carbamate for pesticidal use or for the treatment of animals, with the following expression written immediately below the approved name or the list of declared contents –
AN ANTICHOLINESTERASE COMPOUND
(i) the requirements of sub-paragraph 7(1)(l) do not apply to:
(A) dazomet, mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or
(B) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or
(C) an organophosphorus compound or carbamate contained in a
pressurised spray pack for household use;
(m) if the poison is prepared, packed or sold for a specific purpose, with clear and adequate directions for use unless:
(i) the poison is included in Schedule 4 or Schedule 8; or
(ii) it is impractical to include such directions on the label and:
(A) the primary pack and the immediate container are labelled with the statement “DIRECTIONS FOR USE: See package insert”; and
(B) an appropriate authority has authorised the directions for use to be written on a package insert instead of the label; and
(C) the insert is enclosed in the primary pack;
(n) if use of the poison may be harmful to the user, with appropriate safety directions (see Appendix F), grouped together as a distinct section of the label and prefaced by the words –
SAFETY DIRECTIONS
written in bold-face capital letters;
(o) if any warning statement or statements are required for the poison (see Appendix F), with that warning statement or those statements grouped together:
(i) if safety directions are included on the label, immediately after the words “SAFETY DIRECTIONS”; or
(ii) if there are no safety directions, immediately preceding the directions for use;
(p) if the poison is not for human internal use and is not a Schedule 3, Schedule 4 or Schedule 8 poison, with appropriate first aid instructions (see Appendix E):
(i) grouped together and prefaced by the words –
FIRST AID
written in bold-face capital letters; or
(ii) if a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:
(A) written on each immediate container as specified in sub‑paragraph 7(1)(p)(i); and
(B) replaced on the primary pack with the statement –
FIRST AID: See inner packs;
(q) with the name and address of the manufacturer or distributor.
(2) For the purposes of sub-paragraph 7(1)(a)(iii) the term “largest letter or numeral” does not include:
(a) a single letter or numeral which is larger than other lettering on the label; or
(b) an affix forming part of the trade name; or
(c) in the case of a poison for therapeutic use, numerals used to distinguish the strength of a preparation from the strengths of other preparations of the same poison.
Statements of quantity, proportion or strength
- The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:
(1) if the poison is for human therapeutic use, in the manner prescribed by orders made under section 10(3) of the Commonwealth Therapeutic Goods Act, 1989;
(2) if the poison is for a purpose or purposes other than human therapeutic use and:
(a) if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;
(b) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(c) if the poison is a liquid in a solid or semi-solid preparation, as the mass or volume of the poison per stated mass of the preparation;
(d) if the poison is a solid or semi-solid in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(e) if the poison is a solid or semi-solid in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(f) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(g) if the poison is a gas in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(h) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;
(3) if the poison is a solution of a mineral acid, the proportion of the acid may be expressed as the mass of the acid per stated mass of the preparation;
(4) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:
contains not more than 10 per cent (name of the metal); or
contains not more than 30 per cent (name of the metal); or
contains more than 30 per cent of (name of the metal);
(5) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5 per cent of the product;
(6) if the poison is a lead-based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non-volatile content of the paint;
(7) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.
(8) For the purposes of sub-paragraph 8(7) “derivative” includes alkaloid.
Exemptions
Selected containers and measure packs
- The requirements of paragraph 7 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which paragraphs 10 or 11 apply) when:
(2) labelled with:
(a) the signal word or words, relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the table to sub-paragraph 7(1)(a); and
(b) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(c) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(d) if the poison is for the treatment of animals, with the cautionary statement –
written in sanserif capital letters.
Ampoules, pre-filled syringes and injection vials
- The requirements of paragraph 7 do not apply to a selected container, or an ampoule (other than an ampoule to which paragraph 11 applies) when:
(2) labelled with:
(a) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(b) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(c) if the poison is for the treatment of animals, with the cautionary statement –
written in sanserif capital letters.
- The requirements of paragraph 7 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:
(2) the strip is labelled in accordance with paragraph 10; and
(3) the ampoule is labelled with:
(a) the approved name of the poison or the trade name of the product; and
(b) the quantity, proportion or strength of the poison in accordance with paragraph 8.
Transport containers and wrappings
- The labelling requirements of this Standard do not apply to a transparent cover, or to any wrapper, hamper, packing case, crate or other cover used solely for the purposes of transport or delivery.
Dispensary, industrial, laboratory and manufacturing poisons
- The labelling requirements of this Standard do not apply to a poison that:
(1) is packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes; and
(2) is labelled in accordance with the National Occupational Health and Safety Commission’s National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012 (1994)].
Dispensed medicines
- Unless otherwise specified by regulation, the labelling requirements of this Standard do not apply to a poison for therapeutic use that:
(1) is supplied by a medical, dental or veterinary practitioner in the ordinary course of their professional practice; or
(2) is supplied on and in accordance with a prescription written by a medical, dental or veterinary practitioner or any other person authorised to prescribe drugs and poisons; or
(3) is prepared and supplied by a pharmacist for an individual patient.
Gas cylinders
- The requirements of sub-paragraphs 7(1)(a)(iv), 7(1)(c)(iv), and 7(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.
Paints
- The requirements of paragraph 7 do not apply to:
(1) paint (other than a paint for therapeutic or cosmetic use) which:
(a) contains only Schedule 5 poisons; or
(b) is a First Schedule or Second Schedule paint that is labelled with:
(i) the word “WARNING”, written in bold-face sanserif capital letters, the height of which is not less than 5 mm, on the first line of the main label with no other words written on that line; and
(ii) the expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sanserif capital letters, the height of which is not less than 2.5 mm, on a separate line immediately below the word “WARNING”; and
(iii) the appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and
(iv) the name and proportion of the First Schedule or Second Schedule poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the paint; or
(2) a tinter which contains:
(a) only Schedule 5 poisons; or
(b) a poison included in the First Schedule or Second Schedule to Appendix I, provided that it is labelled with the name and proportion of that poison, and where the poison is a metal or metal salt, the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the tinter.
Camphor and naphthalene
- The labelling requirements of sub-paragraph 3(4) and paragraph 7 do not apply to a device that contains camphor or naphthalene in block, ball, disc or pellet form if the device:
(1) complies with paragraph 28; and
(2) is sold or supplied in a primary pack labelled in accordance with paragraphs 3 and 7.
Prohibitions
- A label used in connection with any poison must not include:
(1) any reference to this Standard, or any comment on, reference to, or explanation of any expression required by this Standard that directly or by implication contradicts, qualifies or modifies such expression; or
(2) any expression or device suggesting or implying that the poison is safe, harmless, non-toxic, non-poisonous, or is recommended or approved by the Government or any government authority unless required by legislation; or
(3) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or
(4) any trade name or description that:
(a) represents any single constituent of a compound preparation; or
(b) misrepresents the composition or any property or quality of the poison; or
(c) gives any false or misleading indication of origin or place of manufacture of the poison.
- A label must not be attached to the immediate container or primary pack used in connection with any poison in such a manner as to obscure:
(1) any expression required by this Standard to be written or embossed on the container or pack; or
(2) any of the ribs or embossed or printed words required by paragraph 21, 22 or 23 as appropriate.
CONTAINERS
- A person must not sell or supply a poison unless the immediate container complies with the requirements of paragraphs 21 to 28 of this Standard.
Containers for poisons other than Schedule 5 poisons
- If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of 2 litres or less, the container must comply with Australian Standard AS 2216-1997, entitled Packaging for poisonous substances.
21a. Notwithstanding subparagraph 21, a poison which is in Schedule 6 and is an essential oil may be packed in an amber glass container which does not comply with the tactile identification requirements of Australian Standard AS 2216-1997, entitled Packaging for poisonous substances, if:
(1) the other safety factors are not diminished; and
(2) the container has a restricted flow insert and a child-resistant closure.
- If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of more than 2 litres, the container must:
(1) comply with sub-section 1.4 (General Requirements) of Australian Standard
AS 2216 – 1997 entitled Packaging for poisonous substances; and
(2) have the word “POISON”:
(a) in sanserif capital letters the height of which is at least one thirty second part of the length, height or width of the container, whichever is the greatest:
(i) embossed; or
(ii) indelibly written in a colour in distinct contrast to the background colour;
(b) on the side or shoulder of the container.
Containers for Schedule 5 poisons
- (1) The container in which any Schedule 5 poison is sold or supplied must:
(a) comply with the container requirements of paragraph 21 or paragraph 22; or
(b) be readily distinguishable from a container in which food, wine or other beverage is sold; and
(i) comply with sub-section 1.4 (General Requirements) of Australian Standard AS 2216 – 1997 entitled Packaging for poisonous substances, excluding paragraph 1.4.3;
(ii) be securely closed and, except when containing a preparation for use on one occasion only, be capable of being re-closed to prevent spillage of its contents; and
(iii) have the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD CONTAINER” embossed or indelibly written thereon, or printed on a permanent adhesive label designed to adhere to a substrate without lifting and which cannot be removed without damaging either the label or the substrate.
(2) Notwithstanding sub-paragraph 23(1), the following Schedule 5 poisons namely:
(a) methylated spirit(s);
(b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;
(c) petrol;
(d) toluene; or
(e) xylene,
must not be sold or supplied in a bottle or jar having a nominal capacity of 2 litres or less, unless the immediate container complies with the container requirements specified in paragraph 21.
Approved containers
- Notwithstanding sub-paragraphs 21, 22 and 23 a poison may be packed in a container that does not comply with the tactile identification requirements of Australian Standard
AS 2216-1997 entitled Packaging for poisonous substances or the requirements of paragraphs 22(2) or 23(1)(iii) if:
(1) the other safety factors are not diminished;
(2) the container is for a specific purpose; and
(3) an appropriate authority has approved the use of the container for that purpose.
Child-resistant closures
- (1) If a poison listed in column 1 of the following table is sold or supplied in a container having a nominal capacity specified for that poison in column 2 it must be closed with a child-resistant closure.
TABLE
Alkaline salts included All sizes
in Schedule 5, when packed and labelled
as dishwashing machine tablets.
Alkaline salts included in Schedule 5, 5 litres / kilograms or less
when packed and labelled as
dishwashing machine liquids,
solids or gels.
Alkaline salts included in Schedule 5, 2.5 litres or less
when packed and labelled as a food
additive.
Anise oil when included in Schedule 5. 200 millilitres or less
Basil oil when included in Schedule 5. 200 millilitres or less
Bay oil when included in Schedule 6. 200 millilitres or less
Cajuput oil when included in Schedule 6. 200 millilitres or less
Cassia oil when included in Schedule 5. 200 millilitres or less
Cineole when included in Schedule 6. 2 litres or less
Cinnamon bark oil when included 200 millilitres or less
in Schedule 5.
Cinnamon leaf oil when included 200 millilitres or less
Clove oil when included in Schedule 6. 200 millilitres or less
Essential oils when included in 200 millilitres or less