11 NOVEMBER 2010

NEW ZEALAND GAZETTE, No. 150

(d) adding Chemical Abstract Service (CAS) numbers to the substances listed in Schedule 4;

(e) extending the deadline for components provisionally allowed with Restrictions in Schedule 5 Table 3 to 30 September 2011;

(f) modifying entry 450 in Schedule 4 (Verbena oil, Lippia citriodora Kunth., CAS No. 8024-12-2) to exclude Verbena absolute obtained from Lippia citriodora Kunth;

(g) adding diethylene glycol (DEG, CAS # 111-46-6) to Schedule 4 as entry 1370;

(h) adding phytonadione [INCI], phytomenadione [INN] (CAS # 84-80-0/ 81818-54-4) to Schedule 4 as entry 1371;

(i) modifying entries 8 (p-Phenylenediamines) and 9 (Methylphenylenediamines), and adding entries 8a and 9a in Schedule 5 Table 1;

(j) additional warnings to be printed on the labels of certain hair dyes in Schedule 5 Tables 1 and 3;

(j) specifying that additional warnings are to be printed on the labels of certain hair dyes in Schedule 5 Tables 1 and 3;

(k) the modification of warning statements for fluorine-containing compounds in Schedule 5 Table 1;

(l) modifying entry 130 (Terpene terpenoids sinpine) in Schedule 5 Table 1 to remove the word “sinpine”;

(m) adding allyl phenethyl ether (CAS No. 14289-65-7) to Schedule 5 Table 1 as entry 151a;

(n) adding toluene, CAS No. 108-88-3 to Schedule 5 Table 1 as entry 185;

(o) adding diethylene glycol (DEG) CAS No. 111-46-6 to Schedule 5 Table 1 as entry 186;

(p) adding diethylene glycol monobutyl ether (DEGBE) CAS No. 112-34-5 to Schedule 5 Table 1 as entry 187 and ethylene glycol monobutyl ether (EGBE) CAS No. 111-76-2 as entry 188;

(q) deleting entries 7, 9, 14, 24, 26, 28, 29, 47 and 58 from Schedule 5 Table 3 and adding them to Table 1;

(r) adding Verbena absolute (Lippia citriodora Kunth.), CAS No. 8024-12-2 to Schedule 5 Table 1 as entry 206;

(s) adding ethyl lauroyl arginate HCl to Schedule 5 Table 1 as entry 207;

(t) adding ethyl lauroyl arginate HCl to Schedule 7 as entry 58; and

(u) adding clause 4(5) in the “Scope” section clarifying the exclusion of substances intended to be ingested, inhaled, injected or implanted into the human body.

5. Availability

The full original Group Standard and amended Group Standard as well as Schedules and any information incorporated by reference may be:

(a) inspected free of charge during normal business hours at the ERMA New Zealand office; or

(b) purchased from ERMA New Zealand; or

(c) viewed at www.ermanz.govt.nz

ERMA New Zealand Contact Details

BP House, 20 Customhouse Quay, Wellington 6011, or PO Box 131, Wellington 6140. Telephone: (04) 916 2426, Facsimile: (04) 914 0433. Email: info@ermanz.govt.nz

Dated at Wellington this 4th day of October 2010.

HELEN ATKINS, for and on behalf of the Environmental Risk Management Authority.

Pharmaceutical Active Ingredients Group Standard 2010

Pursuant to section 96B(1) of the Hazardous Substances and New Organisms Act 1996 (“the Act”), the Environmental Risk Management Authority (ERMA New Zealand) gives notice that a Group Standard is issued.

Notice

1. Title—(1) This notice is the Pharmaceutical Active Ingredients Group Standard 2010 Notice.

(2) The Hazardous Substances and New Organisms (HSNO) Approval Number for the Group Standard is HSR100425.

2. Purpose—The purpose of the Pharmaceutical Active Ingredients Group Standard 2010 is to provide an efficient and effective way of monitoring the risks of pharmaceutical active ingredients. These substances are intended for use in the manufacture of approved human pharmaceutical products at licensed manufacturing sites, for the New Zealand or overseas market.

3. Commencement—The Pharmaceutical Active Ingredients Group Standard 2010 comes into force 28 days after the date of its notification in the New Zealand Gazette.

4. Scope of Group Standard—(1) The Pharmaceutical Active Ingredients Group Standard 2010 applies to a substance that:

(a) is destined solely for use as a pharmaceutical active ingredient in a pharmaceutical product, whether imported or manufactured, and where that pharmaceutical active ingredient meets the minimum degrees of hazard as set out in the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001; and

(b) is a pharmaceutical active ingredient of a medicine that has been assessed and approved for use in New Zealand by the Ministry of Health, in Europe by the European Medicines Agency, in Australia by the Therapeutic Goods Administration, in Japan by the Pharmaceutical and Food Safety Bureau (PFSB) or the United States by the Food and Drug Administration (US FDA); and

(c) has one or more of the following (but only the following) hazards:

• A flammable liquid with a flashpoint of less than 23°C and an initial boiling point of greater than 35°C, HSNO 3.1B classification;
• A flammable liquid with a flashpoint of greater than 23°C and less than or equal to 60°C, HSNO 3.1C classification;
• A flammable liquid with a flashpoint of greater than 60°C and less than or equal to 93°C, HSNO 3.1D classification;
• A flammable solid with low hazard, HSNO 4.1.1B classification;
• An oxidising solid or liquid with low hazard, HSNO 5.1.1C classification;
• Acute toxicity, HSNO 6.1A, 6.1B, 6.1C, 6.1D, 6.1E classifications;
• Skin irritancy, HSNO 6.3A or 6.3B classification;
• Eye irritancy, HSNO 6.4A classification;
• Respiratory sensitisation, HSNO 6.5A classification;
• Contact sensitisation, HSNO 6.5B classification;
• Mutagenicity, HSNO 6.6A or 6.6B classifications;