By Stephen Parker,

On 2 July 2001, new legislation for the regulation of chemical and biological products in New Zealand came into full effect. This legislation will effect everyone involved in the manufacture, importation, sale, and use of chemical and biological products in New Zealand.

Previously, chemical and biological products were regulated under a range of legislation. Each piece of legislation was directed towards the regulation of a particular product type or aspect of its use, e.g. the Pesticides Act 1979, the Animal Remedies Act 1967, the Toxic Substances Act 1979, the Explosives Act 1957, and the Dangerous Goods Act 1974, etc. This legislation has now been repealed.

Purpose of the legislation
The new Hazardous Substances and New Organisms ("HSNO") legislation seeks to regulate all chemical and biological products that present a risk to human or environmental health.

All manufacturers and importers will now need to consider whether or not their products require approval under the HSNO legislation. A product will require approval if it is a substance with one or more hazardous properties that exceeds a prescribed threshold.

If approval is required, then manufacturers and importers should ensure such an approval exists prior to that product entering New Zealand. In the absence of an approval, manufacturers and importers should ensure that their products are captured by the transitional provisions of the new legislation. The transitional provisions are intended to allow for the continued manufacture and importation of products that were legally used in New Zealand before commencement of the new legislation.

Particular features
Penalties under the new legislation should be noted. Persons committing an offence under the HSNO Act can be imprisoned for up to three months or fined up to NZ$500,000. Penalties are higher for continuing offences.

A number of features of the new legislation should be noted:

(i) The definition of substance in the new legislation is broad. It includes mixtures of chemical and biological compounds such as household detergents, industrial reagents, agricultural compounds, ingredients for medicines, etc.

(ii) In the absence of a pre-existing approval, the new legislation places the onus on the manufacturer or importer of a product to have sufficient information concerning the hazardous properties of their products. It is this information that a determination is based on as to whether or not a product is hazardous and therefore requires approval under the new legislation.

(iii) The new legislation provides approval for products, not proprietors. Once a product is approved, any manufacturer or importer may rely on that approval. The exception to this general rule is where the product is also an innovative agricultural compound or medicine.

(iv) Applicants for approval of products under the new legislation should also be aware of its information disclosure provisions. Although applicants may identify information submitted in support of an application as being confidential, situations may arise where this information can still be released to the public.

Manufacturers and importers who wish to obtain more information concerning the new regulatory regime in New Zealand can visit the following site or contact the Marketing Approval Team at Baldwin Shelston Waters.

This is a general summary only and should not be taken as a substitute for specific advice.

For more information concerning the HSNO legislation: http://www.hsno.govt.nz

To contact the BSW Marketing Approval Team: email@bsw.com

Web site: Baldwin Shelston Waters

August 2001