PART 2
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.
- Subparagraph 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
written:
(i) on the first line or lines of the main label; and
(ii) in bold-face sans serif capital letters of uniform thickness; 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
written:
(i) on a separate line or lines immediately below the signal words required by subparagraph 7(1)(a); and
(ii) in bold-face sans serif capital letters of uniform thickness; 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
written:
(i) on a separate line or lines:
(A) immediately below the signal word or words required by subparagraph 7(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by subparagraph 7(1)(b), on the line immediately below that statement; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or 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 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), with the cautionary statement –
FIRE AND EXPLOSION HAZARD
written:
(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
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal word or 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 line;
(e) if the poison is an alkaline salt in a dishwashing machine product, with the cautionary statement –
BURNS SKIN AND THROAT
written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; 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
written:
(i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; 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 subparagraph 7(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
written:
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 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
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or 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 line;
(h) if the poison meets the criteria for a ‘flammable liquid’ in the Australian Code for the Transport of Dangerous Goods by Road or Rail, as in force at the commencement of this Standard and as amended from time to time, 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 or Rail;
(i) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written on the main label in bold-face sans serif 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 sans serif 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 subsection 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or
(ii) if the poison is not for human therapeutic use, written in bold-face sans serif 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
Column 1 Column 2
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 subparagraph 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 subparagraph 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 subparagraph 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 subsection 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 a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(b) 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;
(c) 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;
(d) 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;
(e) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(f) 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;
(g) 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 subparagraph 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 paragraph 10 or 11 apply) when:
(1) packed in a primary pack labelled in accordance with paragraph 7; and
(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 subparagraph 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 –
FOR ANIMAL TREATMENT ONLY
written in sans serif 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:
(1) packed in a primary pack labelled in accordance with paragraph 7; and
(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 –
FOR ANIMAL TREATMENT ONLY
written in sans serif 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:
(1) packed in a primary pack labelled in accordance with paragraph 7; and
(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)] or its successors.
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 subparagraphs 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, Second Schedule or Third 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
(vi) the name and proportion of the First Schedule, Second Schedule or Third 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.
(2) a tinter which contains:
(a) only Schedule 5 poisons; or
(b) a poison included in the First Schedule, Second Schedule or Third Schedule to Appendix I, provided that it is labelled with:
(i) 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 as “calculated on the non-volatile content” or “in the dried film”; and
(ii) if it contains more than 0.1 per cent of lead in the non-volatile content of the tinter, with:
(A) 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
(B) 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
(C) the warnings specified for tinters in Appendix F (see paint), written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”.
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, Packaging for Poisonous Substances (ISBN 0 7337 1176 6) as published by Standards Australia.
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 the Australian Standard 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; and
(2) have the word “POISON”:
(a) in sans serif 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 subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 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 subparagraph 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 the Australian Standard 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) IIf 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.