Toxikos provides a full range of science based advocacy services to assist national and international companies obtain timely and cost effective approvals for their products under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), the Australian Pesticides and Veterinary Medicines Authority (APVMA), and the Therapeutic Goods Administration (TGA) of Australia and the Hazardous Substances and New Organisms (HSNO) legislation of New Zealand.

We have experience with the registration requirements of most classes of chemicals including agricultural, industrial, cosmetic, consumer chemicals, biocides, and therapeutic goods.

Toxikos provide a range of services to assist businesses in meeting their regulatory compliance needs. Our services include:

New Product Development

Toxikos assists clients early in chemical product development to identify regulatory, safety and other issues likely to arise during the commercialisation process. Toxikos assists product developers understand key costs and timelines. We are able to develop and implement tailored strategies which include appropriate scientific, economic, regulatory, and public interest components.

Toxikos staff have played critical roles in the successful launch of numerous chemical products in Australia and New Zealand.

Data Review and Test Management

Toxikos’s scientific know how and experience with testing guidelines allows us to conduct in depth data reviews to identify data gaps and recommend options for correction so product registration and safety is appropriately supported. Toxikos staff are committed to recommending and designing studies which answer critical questions about product safety but minimise the need for experimental animals. Our expertise gives clients the opportunity to anticipate data requests from regulators and avoid missing critical target dates. Toxikos can also design, oversee or monitor experimental studies to ensure they are ‘fit for purpose’. Toxikos works with qualified laboratories and alternatives to animal testing (such as quantitative structure activity relationships) to assist clients make cost effective choices.

Registration Coordination and Guidance   

Toxikos works closely with clients to ensure that NICNAS, TGA, APVMA, FSANZ or NZ EPA requirements are met efficiently. We can arrange and participate in meetings with regulatory officials, negotiate on behalf of clients with regulatory evaluators of product submissions, track the progress of regulatory reviews and decisions, offer strategic and policy advice, and coordinate/conduct lobbying efforts needed to obtain timely regulatory approval of new chemicals and products.

NICNAS (National Industrial Chemical Notification and Assessment Scheme) Services

The scheme was introduced in the early 1990’s with the aim of protecting the public, workers and environment from potential harmful effects of industrial chemicals. NICNAS is responsible for assessing, reviewing and registering new and existing industrial chemicals. A new chemical is defined as one which is not listed on the Australian Inventory of Chemical Substances (AICS). Without a certificate or permit it is illegal to manufacture or import a new chemical into Australia, substantial penalties may be imposed on businesses who offend.

Toxikos provides comprehensive NICNAS support, and compliance services.

NZ EPA (New Zealand’s Environmental Protection Authority formally ERMA) Services

The HSNO (The New Zealand Hazardous Substances and New Organisms) legislation is administered by the NZ EPA and became operational in 2001. Unlike NICNAS the HSNO scheme is a ‘product’ assessment scheme and applies to all new hazardous substances (i.e. industrial and agricultural chemicals). Anyone importing or manufacturing a new product is required to ensure their product meet the HSNO legislation. Toxikos 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.

Toxikos provide comprehensive HSNO product support, classification, and compliance services.

Other chemical registration services

• Advice on strategies for notification in other parts of the world such as the Asia Pacific region.
• Prepare scientific arguments using resources such as structure activity relationships, where data is not available.
• Conduct pesticide operator risk assessment using exposure modelling.

For further information on chemical registration services please contact consulting@pacific-environment.com