Pacific Environment can provide full range of science-based legislative/regulatory services to assist national and international companies obtain timely and cost effective approvals for their products with the following agencies:
- National Industrial Chemicals Notification and Assessment Scheme (NICNAS),
- Australian Pesticides and Veterinary Medicines Authority (APVMA),
- Therapeutic Goods Administration (TGA)
- New Zealand Environmental Protection Agency (NZ EPA)
We have experience with the registration requirements of most classes of chemicals including agricultural, industrial, cosmetic, consumer chemicals, biocides, and therapeutic goods.
National Industrial Chemical Notification & Assessment Scheme (NICNAS)
The National Industrial Chemical Notification and Assessment Scheme(NICNAS) is Australia’s regulatory authority for Industrial Chemicals. It is part of the Australian Government Department of Health and aids in the protection of the Australian people and the environment by finding out the risks to occupational health and safety, to public health and to the environment that could be associated with the importation, manufacture or use of industrial chemicals and by maintaining a national standard for cosmetic products.
NICNAS is administered under the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act). It maintains the Australian Inventory of Chemical Substances (AICS) which is the national database to which notified chemicals are registered. A new industrial chemical is defined as a chemical which is:
- not listed on the AICS,
- listed on the AICS however its condition of use and its import and/or manufacture is proposed to be different or;
- considered a new synthetic polymer as defined in the NICNAS Handbook for Notifiers.
These chemicals are introduced to Australia by either import or manufacture and have to be notified to NICNAS for assessment (under either a certificate or permit category) and subsequent registration on AICS.
Existing chemicals are defined as chemicals which are listed on the AICS and are not defined as a new chemical. They are assessed as either non- priority or priority existing chemicals.
Without a certificate or permit or notification, as required, it is illegal to manufacture or import a new or existing chemical into Australia, substantial penalties may be imposed on businesses who offend.
Pacific Environment provides comprehensive NICNAS support, and compliance services.
The Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. It is part of the Australian Government Department of Health and Ageing responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. The TGA administers ”The Therapeutic Goods ACT 1989” – the same Act under which it was established. It maintains the Australian Register of Therapeutic Goods (ARTG) and plays an instrumental role in the Australian Government’s implementation of the National Medicines Policy.
Any product for which therapeutic claims are made must be listed, registered or included in the ARTG before it can be supplied in Australia. These include medicines, medical devices and other therapeutic goods. The TGA bases its assessment on the evidence of risk compared with the benefit of the therapeutic products.
Companies and individuals looking to supply products to the Australian market place must submit their applications to the TGA for assessment.
Pacific Environment has expertise in the area of therapeutic goods registration and can assist you with. TGA submissions and offer advice in relation to regulatory requirements.
The Australian Pesticides & Vetinary Medicines Authority (APVMA)
The Australian pesticides and Veterinary Medicines Authority (APVMA) is the Australian government statutory authority that regulates pesticides, veterinary medicines, and household chemicals such as insect sprays, personal insect repellents, products for treating plant diseases in home garden plants, and medicines for companion animals such as dogs, cats and horses. Its role is to independently evaluate the safety and performance of pesticides and veterinary medicines intended for sale, ensuring that the health and safety of people, animals and crops, the environment and trade are protected.
Companies and individuals looking to supply such products into the Australian marketplace must submit their applications to the APVMA for assessment.
Pacific Environment’s experts have experience working with companies in the area of agricultural and veterinary product registration. We understand and work with the APVMA’s co-operative statutory scheme for the evaluation, registration and control of agricultural and veterinary chemical products up to the point of retail sale. Contact us today to register your agricultural and veterinary products and deal with various registration issues that may arise.
The New Zealand Environmental Protection Authority
The New Zealand Environmental Protection Authority (NZ-EPA) is New Zealand’s regulatory authority responsible for regulatory functions concerning New Zealand’s environmental management. One of its main functions under the Resource Management Act is to regulate hazardous substances, new organisms, ozone depleting chemicals, hazardous waste exports and imports.
Specific to hazardous substances, NZ-EPA regulates the introduction and use of all hazardous substances (e.g. industrial and agricultural chemicals) and new organisms under the Hazardous Substances and New Organisms (HSNO) Act 1996. NZEPA deals with over 100,00 different types of hazardous substances, hanging from explosives, pesticides, inustrial chimeicals, petrol and gas, to household cleaners and other consumer goods. The HSNO system approves substances, not products.
Importers and/ or manufacturers of hazardous substances into New Zealand must therefore be approved under one of the applicable approvals and included in the New Zealand Inventory of Chemical Substances (NZIoCS).
Pacific Environment staff have contributed as reviewers of the draft HSNO regulations and have played a critical role in the development of trial applications to NZ-EPA. Pacific Environment provide comprehensive HSNO product support, classification, and compliance services.
Data Review and Test Management
Pacific Environment staff have extensive experience conducting product safety assessments to support product registrations in Australia and internationally. Our staff have knowledge and understanding of testing guidelines allowing them to conduct in-depth data reviews, identifying data gaps and providing recommendations to address these. In addition our staff can design, coordinate, oversee or monitor experimental studies to ensure they are ‘fit for purpose’.
We are committed to recommending and designing studies which answer critical questions about product safety but minimise the need to use experimental animals. Our staff maintain knowledge of the capabilities of qualified laboratories and alternatives to animal testing (such as quantitative structure activity relationships) to assist clients make cost time and effective choices.
Contact us today to determine how we can help you address your product safety requirements.