Group standards are a new type of approval for hazardous substances of a similar nature, type or similar circumstance of use, under Part 6A of the Hazardous Substances and New Organisms (HSNO) Act 1996.
Each Group Standard contains a condition requiring notification to ERMA New Zealand of any new hazardous chemical present in products approved under that standard.
Notification to the Authority
Inventory of Chemicals
If a substance imported into, or manufactured in, New Zealand after 30 June 2006, contains a hazardous chemical that is not listed on the Inventory of Chemicals, then the importer or manufacturer of the substance must at the time they first import or manufacture the substance, notify the Authority in writing of-
- the name of the substance; and
- the HSNO approval number and/or title of the Group Standard under which the substance has a deemed approval; and
- the name and CAS number of the chemical not listed on the Inventory of Chemicals that is present in the substance; and
- the concentration of that chemical in the substance; and
- the hazardous properties of the chemical, including the provision of the relevant hazard data used to assign the substance to the Group Standard; and
- the proposed use of the substance.
The New Zealand Inventory of Chemicals (NZIoC) will be used by importers and manufacturers to determine if a product they are assigning to a Group Standard contains a new chemical.
Consultation on the operational policies and procedures for the New Zealand Inventory of Chemicals was undertaken in late 2006. The following links are to the finalized policy and procedures which have been developed after consideration of the submissions received. [word - 189kb] [pdf - 128kb]
The summary of submissions from this consultation is also available. [word - 173kb] [pdf - 126kb]
How do I Notify
Notification of a new chemical component will be required when the substance containing the new chemical is first imported or manufactured in New Zealand.
To notify a new chemical component, an Application Form for Notification of New Chemical Components Approved under Group Standards must be submitted. [pdf - 43kb] [word - 134kb]
The completed form should be emailed to :
or posted to:
Inventory
ERMA New Zealand
PO Box 131
Wellington 6140
New Zealand
Information specified under the conditions of the Group Standard is required. This is set out on the form.
Information on the hazardous properties of the "new chemical" can be supplied in the form of a safety data sheet (SDS).
Notifications will be acknowledged within 15 working days of receipt.
What needs to be notified?
Any hazardous component (chemical) of a new formulated product, using a Group Standard approval, that is not on the Inventory will need to be notified. A new formulated product is one that is imported into, or manufactured in, New Zealand after 30 June 2006.
The definition of chemical with respect to the inventory is the definition given in the group standards.
"chemical" means any element or compound in its natural state or obtained by any production process, including any impurities and any additive necessary to preserve the stability of the chemical, but excluding any solvent which may be separated without affecting the stability of the chemical or change its composition.
By this definition impurities and by-products will not be included on the Inventory
Manufactured articles that contain a hazardous substance (other than an explosive substance) are not considered hazardous substances under the HSNO Act and are therefore not required to be notified. Refer to the ERMA Information Sheet on Manufactured Articles. http://www.ermanz.govt.nz/resources/publications/pdfs/ER-IS-11-1.pdf
Cut-off levels for notification will be based on the respective hazard cut-off concentrations. The simple rule will be that if a component contributes to the hazard of a product, then if the component is not on the Inventory, it is required to be notified. Regulations require much of this information on the safety data sheet (SDS) at the same concentration as the hazard cut-offs for class 6 classifications.
Comparison of Classification, Labeling and SDS cut-offs for class 6 substances
| Hazard Category | Classification Cut-off (%) | Label Identification Cut-off (%) c | Safety Data Sheet Cut-off (%) c |
|---|---|---|---|
| 6.5A | 0.1 | 0.1 a | 0.1 |
| 6.5B | 0.1 | 0.1 a | 0.1 |
| 6.6A | 0.1 | 0.1 | 0.1 |
| 6.6B | 1 | 1 | 1 |
| 6.7A | 0.1 | 0.1 | 0.1 |
| 6.7B | 0.1 | 1 | 0.1 |
| 6.8A | 0.1 | 0.3 | 0.1 |
| 6.8B | 0.1 | 3 | 0.1 |
| 6.8C | 0.1 | 0.3 | 0.1 |
| 6.9A b | 1.0 | 10 | 1 |
| 6.9B b | 1.0 | 10 | 1 |
Notes:
- The label warning for sensitizers between 0.1% and 1.0% (0.2% for gaseous respiratory sensitizers) may differ from the label warning for sensitizers ≥ 1.0% (0.2%). In special case, identification may be required below the 0.1% level if a lower value has been used for classification.
- Applies to both single exposure and repeat exposure target organ systemic toxicants.
- The use of these concentration cut-offs can be subject to variation depending on the outcome of a substance specific risk assessment.
Exceptions to what needs to be notified include:
- Concentration/s of component/s less than the mixture cut off values unless there are hazardous property reasons to notify the component/s. For example, the substance CAS 2634-33-5, 1,2-Benzisothiazol-3(2H)-one (BIT), which is a sensitiser at concentrations as low as 0.05% compared to the standard cut off of 0.1%.
- New fragrance materials for inclusion under a Food Additives and Fragrance Materials Group Standard
- Components of cosmetic products covered under the Cosmetics Group Standard
- chemicals held under exempt laboratory status
While notification of new chemicals which fall under these exceptions is not a requirement, any chemicals that are notified to the Agency will be added to the Inventory.
Notification of single component (pure substances) products is not permitted for most Group Standards under clause 4 (Scope of Group Standard).
Flow Chart: How do I know if I am required to notify?
(Flow Chart: How do I know if I am required to notify? Link to larger version)
Flowchart Notes:
- Not all Chemicals listed on the Inventory have approvals under the HSNO Act to be imported or manufactured in their own right. A small number (6-8000) have been assessed for their hazards and risks and have approval by virtue of having been transferred individually in the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004, or the Hazardous Substances (Chemicals) Transfer Notice 2006. A number of other chemicals transferred under Group Standards approvals are also approved under HSNO. These chemicals can use either the individual approval number or a Group Standard approval if they fit the scope of the Group Standard. The remainder can only be imported as components of approved products.
- Before a chemical which does not have an approval can be used as a single component product it will need to have Part V approval. Part V approval routes include:
- full release
- rapid/low hazard
- rapid/similar
- rapid/reduced Hazard.
- While there is no legal obligation to notify non hazardous chemicals, any such chemical notified will be added to the inventory.
Notification of Non Hazardous Chemicals
Non hazardous chemicals will be included on the Inventory where notified.
While it is not mandatory to notify non hazardous chemicals, you are encouraged to do so if you wish. The notification process will be the same as for hazardous chemicals and evidence the chemical is non hazardous will be required.
Chemical Components with No CAS Number
For confidentiality reasons it is possible a chemical may not have a CAS number.
When notifying a chemical with no CAS number, a proper chemical name will need to be provide. Where this information is required to be kept confidential, good grounds, as described in the Notification Form under confidentiality, will be required.
These chemicals will be verified as not currently having a CAS number before they are added to the confidential or non confidential section of the Inventory as unique chemicals.
Third Party Notification
Where third party notification is required, a reference number will be supplied to the notifier to pass on to the third party. Where the third party has all the relevant information they can notify on behalf of a New Zealand supplier.
Confidential Section of the Inventory
It should be noted the Inventory consists of a list of chemicals with no linkage to commercial or proprietary products containing these chemicals and components.
ERMA New Zealand acknowledges in some circumstance, notifiers may wish to keep some information confidential for commercial sensitivity.
There can be a conflict between a notifier's need for confidentiality and the objective of providing for full and informed public participation in the operation of HSNO Act. However, to the extent that it is legally able to do so, ERMA New Zealand will treat as confidential, for as long a period as is specified by the notifier, all information provided by that notifier classified as commercially confidential.
ERMA New Zealand will, however, rely on the person providing allegedly confidential information, to identify it as such and to justify this position. 'Confidential information' for these purposes is primarily information which may be withheld under the Official Information Act, in particular, section 9(2)(b) which provides a good reason for withholding information where it is necessary to:
"protect information where making available of the information -
- would disclose a trade secret; or
- would be likely unreasonably to prejudice the commercial position of the person who supplied or who is the subject of the information..."
These are potentially robust tests to satisfy, especially given there will be no identification of products containing the notified chemicals on the Inventory. The Agency will not be prepared (or able) to accept mere assertions, for example, as to commercial prejudice, and will require an exact explanation of how prejudice might occur, and why that is unreasonable.
In addition to the Official Information Act, information may be protected by virtue of the interaction of HSNO with other Acts. For example, in applications for an innovative agricultural compound under Part 6 of the ACVM Act 1997, or for an innovative medicine under the Medicines Act 1981, the relevant confidentiality provisions of those Acts will apply to ERMA New Zealand as provided for in section 55 of the HSNO Act.
If you believe that information you may notify should be kept confidential, you will be required to justify the grounds for this belief.
Where the notifier requests the CAS number and name of the new chemical being notified be kept confidential and has provided justification, the chemical will be added to the confidential section of the Inventory.
New CMRs
The 'Scope' of each Group Standard contains a condition restricting components which are carcinogens, mutagens and reproductive toxicants (CMRs).
Under a Group Standard approval, a new CMR can only be added to the Inventory if:
- the new CMR is used to completely replace an existing CMR in the substance,
- the new CMR has a lower hazard classification than the existing CMR.
Further information
- New Zealand Inventory of Chemicals (NZIoC)
- For further information contact ERMA New Zealand - Tel: 04 9162426 or email: info@ermanz.govt.nz.