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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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11. Glossary of terms and abbreviations

This guideline is currently under review.

Note: Where relevant, references to particular definitions are provided in brackets (…)

ACCC means the Australian Competition and Consumer Commission.

Active ingredient (in relation to a sunscreen) means an active substance included in a sunscreen to protect the skin from ultraviolet (UV) radiation. It is an ingredient in a therapeutic good's formulation that is responsible for its physiological or pharmacological action (see regulation 2 of the Regulations).

Antimicrobial preservative means an ingredient added to a product to inhibit the growth of micro-organisms in the product. (TGO 69).

ARGOM means the Australian Regulatory Guidelines for OTC Medicines.

ARTG means the Australian Register of Therapeutic Goods.

AS/NZS 2604:2012 - The Australian and New Zealand Standard for Sunscreen Products (2012 edition)

Australian Approved Name (AAN) - The approved name applied to a therapeutic substance, as outlined in the TGA Approved Terminology for Medicines, which includes: Approved Biological Substance Names (ABNs); Approved Chemical Substance Names; Approved Herbal Names (AHNs); and Approved Herbal Substances (AHSs).

Batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution (TGO 69).

Batch number prefix means the prefix which precedes the batch number and clearly indicates that the number is the batch number. Examples of acceptable batch number prefixes include 'Batch Number', 'BATCH NUMBER', 'Batch No.', 'BATCH NO.', 'Batch', 'BATCH', 'B', '(B)', 'B/N', 'Lot Number', 'LOT NUMBER', 'Lot No.', 'LOT NO.', 'Lot' or 'LOT'; or words or symbols to this effect.

Broad spectrum product means a sunscreen product which has been shown, using the in vitro test method defined in AS/NZS 2604:2012 to provide protection from the sun's terrestrial UVA and UVB rays. (AS/NZS 2604:2012)

Category description means the designation of the level of protection given by a grouping of label sun protection factors (AS/NZS 2604:2012).

Container means an article (for example, bottle, jar, tube, sachet) that immediately covers the goods, and includes an ampoule, blister pack, bottle, sachet, dial dispenser pack, strip pack, syringe, tube, vial, wrapper or other similar article, but does not include an article intended for ingestion (TGO 69).

Cosmetic (For the full definition, see subsection 2.2.)

Cosmetic sunscreen product means a product containing a sunscreening ingredient that is regulated as a cosmetic by the Industrial Chemicals (Notification and Assessment) Act 1989 and by the Cosmetics Standard and is not a therapeutic good (see subsection 2.2).

Excipient ingredient (in relation to a sunscreen) means an ingredient of a sunscreen other than an active ingredient. Excipient ingredients may have multiple uses such as fragrance, preservative and/or solvent.

Excipient mix is a Proprietary Ingredient formulation comprised of a mixture of excipient ingredients that may be used in a therapeutic good. Examples include emulsifiers and anti-oxidants. Excluded sunscreen means a sunscreen product that is not regulated under the Therapeutic Goods Act 1989 (see the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011).

Exempt sunscreen means a sunscreen product that is regulated under the Act but is not required to be registered or listed in the ARTG (see Item 4(g) of Schedule 5 of the Regulations).

Expiry date means the date (month and year) after which the goods should not be used, being a date not more than five years after the date of manufacture (TGO 69).

Expiry date prefix means the prefix which precedes the expiry date, and clearly indicates that the following information is the expiry date. Examples of acceptable prefixes include 'Expiry Date', 'EXPIRY DATE', 'Expiry', 'EXPIRY', 'Expires', 'EXPIRES', 'Exp. Date', 'EXP. DATE', 'Use before', 'USE BEFORE', 'Use By', 'USE BY', 'Exp', or 'EXP' but terms such as 'Best by' or words to this effect are not acceptable (TGO 69).

Fragrance (or perfume) is a substance whose primary purpose is to alter the smell of a therapeutic good.

Ingredients of human or animal origin are those derived directly from a human or animal source. They are also listed in the Regulations.

INCI means International Nomenclature Cosmetic Ingredient.

INN means International Non-proprietary Name.

Label means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods (TGO 69).

Label Sun Protection Factor (SPF) means the SPF indicated on the label.

Letter height means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated (TGO 69).

Listing or registration number means the combination of numbers, symbols and letters assigned to the goods by the TGA under section 27 of the Act (TGO 69).

Medicine means a therapeutic good that is represented to achieve, or is likely to achieve, its principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal (see subsection 3(1) of the Act).

Minimum Erythemal Dose (MED) means the lowest dose of ultraviolet radiation that produces the first perceivable unambiguous erythema with defined borders appearing over most of the field of UV exposure 16-24 hours after UV exposure (AS/NZS 2604:2012).

New substance is an ingredient (chemical, herbal or biological) that is currently not used in a medicine for supply in Australia, or is proposed for a new route of administration to the previous use of the ingredient. This ingredient may or may not have an Australian Approved Name.

NICNAS means the National Industrial Chemicals Notification and Assessment Scheme.

Primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers (see subsection 3(1) of the Act).

Primary sunscreen product means a product which is represented as being primarily to protect the skin from ultraviolet radiation (AS/NZS 2604:2012).

Principal or main label means (a) where there are two or more labels or two or more portions of a single label - that label or portion of the label where the product name is more or most conspicuously shown; or (b) where the product name is equally conspicuous on two or more labels or portions of a label - each such label or portion (TGO 69).

RASML means Required Advisory Statements for Medicine Labels

Secondary sunscreen product means a product that is represented as having a primary purpose other than sun protection whilst providing some protection of the skin from ultraviolet radiation (AS/NZS 2604:2012).

Sun Protection Factor (SPF) means the arithmetic mean of all valid individual SPF values obtained from all subjects in the test (AS/NZS 2604:2012). See also, Minimum Erythemal Dose (MED).

SUSMP means the Standard for the Uniform Scheduling of Medicines and Poisons (previously called the Standard for the Uniform Scheduling of Drugs and Poisons [SUSDP]).

TGO 69 - see the Labelling Order.

The Act means the Therapeutic Goods Act 1989.

The Labelling Order means Therapeutic Goods Order (TGO) No. 69 - General requirements for labels for medicines (or any subsequent order amending or replacing TGO 69).

The Regulations means the Therapeutic Goods Regulations 1990.

Therapeutic good includes a good that is represented in any way to be, or that is, whether because of the way in which the good is presented or for any other reason, likely to be taken to be for therapeutic use or for use as an ingredient or component in the manufacture of therapeutic goods (subsection 3(1) of the Act).

Therapeutic sunscreen product means a primary or secondary sunscreen product that meets the definition of a therapeutic good rather than the definition of a cosmetic (see subsection 2.1).

Therapeutic use means use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals, or influencing, inhibiting or modifying a physiological process in persons or animals (subsection 3(1) of the Act).

Topical - for sunscreen use means applied to a certain area of the skin for a localised effect.

TSEs means the transmissible spongiform encephalopathies.

Ultraviolet radiation (UV) means the terrestrial solar ultraviolet radiation in the range 290-400 nm. Ultraviolet radiation A (UVA) is the terrestrial solar ultraviolet radiation in the range 320-400 nm and ultraviolet radiation B (UVB) is the terrestrial solar ultraviolet radiation in the range 290-320 nm.

UV filter, for the purposes of these Guidelines, means a substance that is exclusively or mainly intended to protect the skin against certain UV radiation by absorption, reflection or scattering of UV radiation.

Water resistant product means a sunscreen product which has been shown after designated periods of water immersion, using in vivo Sun Protection Factor test methods to provide protection against certain of the sun's UV rays (AS/NZS 2604:2012).

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