Source: https://www.legislation.gov.au/Details/F2009L01257
Timestamp: 2019-12-11 20:47:02
Document Index: 451763498

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Details: F2009L01257
- F2009L01257
No. 1 of 2009 Standards/Other as made
This instrument amends the Poisons Standard 2008 to provide for decisions made by the National Drugs and Poisons Schedule Committe.
Registered 08 Apr 2009
POISONS STANDARD AMENDMENT NO.1 OF 2009
The National Drugs and Poisons Schedule Committee, acting in accordance with its power under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act), amends the Poisons Standard 2008 in the manner set out in Schedule 1.
The amendments to the Poisons Standard 2008 as set out in Schedule 1 commence on 1 May 2009.
Dated this 6th day of April 2009
Schedule 1-Amendments to the Poisons Standard 2008
Effective Date – 1 May 2009
ISBN 1-74186-837-8
Publication approval number: P3-4955
The amendments listed in this document were finalised at the October 2008 and February 2009 meetings of the National Drugs and Poisons Schedule Committee (NDPSC) except where separately specified. The basis of these amendments can be found in the ‘Record of the Reasons’, which can be accessed from the NDPSC website:
www.tga.gov.au/ndpsc
Part 2, Labels and Containers – amendment 1
Part 4 – The Schedules 2
Schedule 2 – New Entry 2
Schedule 2 – Amendment 2
Schedule 4 – Amendments 3
Schedule 6 – Amendments 3
Schedule 7 – New Entry 6
PART 5 – appendices 6
Appendix C – Amendment 6
Appendix E, Part 2 – Amendment 6
Appendix F, Part 3 – New Entry 7
Appendix F, Part 3 – Amendment 7
Appendix H – Amendment 7
Appendix I – Amendment 7
Editorial Amendments and Errata 10
Part 1, Interpretation – Amendment 10
Appendix A – Amendment 10
Appendix B, Part 3 – Amendments 10
The National Drugs and Poisons Schedule Committee directs that the amendments below be applied to the Standard for the Uniform Scheduling of Drugs and Poisons No. 23 and recommends that these amendments be adopted by the States and Territories with effect from 1 May 2009 unless otherwise stated. The amendments arise from decisions made by the Committee at its October 2008 meeting and confirmed at the February 2009 meeting except where separately specified.
Part 2, Labels and Containers – amendment
(The following amendment to paragraph 16 includes an editorial change identified at the February 2009 NDPSC Meeting under item 21.3)
Paragraph 16 – Amend entry to read:
(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
(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.
ATROPINE – Amend entry to read:
KETOTIFEN – Delete entry.
(The following amendment to the ethylhexanediol entry includes an editorial change identified at the February 2009 NDPSC Meeting under item 21.3)
ETHYLHEXANEDIOL – Amend entry to read:
KETOTIFEN – Amend entry to read:
PYRITHIONE ZINC – Amend entry to read:
PYRITHIONE ZINC in paints containing 0.5 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint except in paints containing 0.1 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint.
BASIC ORANGE 31 – Amend entry to read:
† BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) except:
(a) in preparations for skin colouration and dyeing of eyelashes or eyebrows; or
(b) in hair dye preparations containing 1 per cent or less of Basic Orange 31 when the immediate container and primary pack are labelled with the following statements:
BENOMYL – Delete entry.
DIDECYLDIMETHYLAMMONIUM CHLORIDE – Amend entry to read:
DIDECYLDIMETHYLAMMONIUM SALTS except in preparations containing 1 per cent or less of didecyldimethylammonium salts labelled with the statement:
(The following amendment to the formaldehyde entry includes editorial changes identified at the February 2009 NDPSC Meeting under item 21.3)
FORMALDEHYDE – Amend entry to read:
† FORMALDEHYDE (excluding its derivatives) in preparations containing 0.05 per cent or more of free formaldehyde except:
(d) in nail hardener cosmetic preparations containing 0.2 per cent or less of free formaldehyde when labelled with the statement:
PROTECT CUTICLES WITH GREASE OR OIL;
(f) in other preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:
LEAD COMPOUNDS – Amend entry to read:
† LEAD COMPOUNDS except:
CAUTION - Harmful if swallowed. Do not use on surfaces which contact food or drink.
METHYL METHACRYLATE – Amend entry to read:
† METHYL METHACRYLATE (excluding its derivatives) except:
(a) for cosmetic use; or
(b) in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer.
(The following amendment to the paraformaldehyde entry includes editorial changes identified at the February 2009 NDPSC Meeting under item 21.3)
PARAFORMALDEHYDE – Amend entry to read:
† PARAFORMALDEHYDE (excluding its derivatives) in preparations containing 0.05 per cent or more of free formaldehyde except:
PYRITHIONE ZINC except:
(a) when included in Schedule 2 or 5;
(b) for human use in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(c) in semi-solid hair preparations for animal use;
(d) in shampoos for animal use containing 2 per cent or less of pyrithione zinc when labelled with the statement “Keep out of eyes” and “If in eyes rinse well with water”;
(e) when immobilised in solid preparations containing 0.5 per cent or less of pyrithione zinc; or
(f) in paints, jointing materials or sealants containing 0.1 per cent or less of pyrithione zinc calculated on the non-volatile content.
(The following benomyl entry includes editorial changes identified at the February 2009 NDPSC Meeting under item 21.3)
BENOMYL except in paints containing 0.5 per cent or less of benomyl.
LEAD COMPOUNDS in paints, tinters, inks or ink additives except in preparations containing 0.1 per cent or less of lead calculated on the non-volatile content of the paint, tinter, ink or ink additive.
Appendix E, Part 2 – Amendment
POISON STANDARD STATEMENTS
Didecyldimethylammonium salts A,G3
STATEMENTS DIRECTIONS
Benomyl 46
Appendix F, Part 3 – Amendment
Paint – Amend entry to read:
(a) First Schedule paints. 83
(b) Second Schedule paints. 84
Appendix I – Amendment
(The following amendment to Appendix I includes an editorial change as identified at the February 2009 NDPSC Meeting under item 21.3)
Amend Appendix I to read:
This Appendix provides regulations for adoption by the States and Territories.
1. A person must not manufacture, sell, supply or use a First Schedule Paint for application to:
(1) a roof or any surface to be used for the collection or storage of potable water; or
(2) furniture; or
(3) any fence, wall, post, gate or building (interior or exterior) other than a building which is used exclusively for industrial purposes or mining or any oil terminal; or
(4) any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.
2. A person must not manufacture, sell, supply or use a Third Schedule paint.
3. A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2003 entitled Safety of toys Part 3: Migration of certain elements.
4. A person must not manufacture, sell, supply, or use a paint containing a pesticide except a fungicide, algicide, bactericide or antifouling agent.
The proportion of a substance for the purposes of this Schedule is calculated as a percentage of the element present in the non-volatile content of the paint.
ANTIMONY or antimony compounds
other than antimony titanate pigments more than 5 per cent
BARIUM salts except barium sulfate or
barium metaborate more than 5 per cent
CADMIUM or cadmium compounds more than 0.1 per cent
CHROMIUM as chromates of ammonia,
barium, potassium, sodium, strontium or zinc more than 5 per cent
SELENIUM or selenium compounds more than 0.1 per cent
DICHLOROMETHANE (methylene chloride) more than 5 per cent by wt
and their acetates more than 10 per cent by vol
TOLUENE more than 50 per cent by vol
XYLENE more than 50 per cent by vol
LEAD or lead compounds more than 0.1 per cent
Part 1, Interpretation – Amendment
“Australian Code for the Transport of Dangerous Goods by Road and Rail” – Amend entry to read:
Appendix A – Amendment
CHEMISTRY SETS – Amend entry to read:
(a) toy, when complying with the requirements of Australian Standard AS 8124.4-2003 Safety of toys - Part 4: Experimental sets for chemistry and related activities; or
(b) for educational use, containing Schedule 5 or 6 poisons in containers of 3 mL or less of each liquid preparation or 5 g or less of each solid preparation in a discrete unit.
Appendix B, Part 3 – Amendments
NICABAZIN – Amend entry to read:
NICARBAZIN Jun 1969 d 2.3
SOMATOTROPHIN, EQUINE – Delete entry.