Notice Type
Authorities/Other Agencies of State
Notice Title

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.
N o t i c e
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 23ºC and an initial boiling point of greater
than 35ºC, HSNO 3.1B classification;
- a flammable liquid with a flashpoint of greater than 23ºC and less than or equal to 60ºC, HSNO 3.1C classification;
- a flammable liquid with a flashpoint of greater than 60ºC and less than or equal to 93ºC, 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, HNSO 6.6A or 6.6B classifications;
- carcinogenicity, HSNO 6.7A or 6.7B classifications;
- reproductive toxicity, HSNO 6.8A, 6.8B or 6.8C classifications;
- target organ toxicity, HSNO 6.9A or 6.9B classifications;
- metallic corrosivity, HSNO 8.1A classification;
- skin corrosivity, HSNO 8.2A, 8.2B or 8.2C classifications;
- eye corrosivity, HSNO 8.3A classification;
- ecotoxicity, HSNO class 9.
(2) This Group Standard does not apply to a substance that is an excipient ingredient.
5. Conditions of Group Standard-The conditions in Schedules 1 and 2 are imposed on the substances and, unless otherwise specified, apply to any person who imports, manufactures, possesses, or disposes of the substance.
6. Availability-The full Group Standard, 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 11th day of November 2010.
HELEN ATKINS, for and on behalf of the Environmental Risk Management Authority.