Call for submissions on proposed changes to cosmetics regulations

ERMA New Zealand is calling for submissions on a proposal to amend the Cosmetic Products Group Standard.

The Cosmetic Products Group Standard regulates cosmetics, including toiletries, sunscreens, oral hygiene and other personal care products that contain hazardous substances. It is based on the European Union’s Cosmetics Directive and is reviewed annually to take into account changes made to the EU Directive as well as consideration of any issues we are aware of in comparable jurisdictions such as the US, Canada and Australia and issues raised by interested parties in New Zealand.

ERMA New Zealand has proposed several amendments in order to improve clarity of the group standard requirements. Industry has also proposed changes covering transition period provisions, sun protection factor testing requirements and permanent identification requirements for 6.1D liquid substances (the second-lowest category for acute toxicity).

The amendments proposed in light of changes to the EU Directive include proposals for additional warnings to be printed on the labels of certain hair dyes, modification of warning statements for fluorine-containing toothpastes, and transfer of some hair dyes from the schedule of Components Cosmetic Products May Contain Provisionally with Restrictions to the schedule of Components Cosmetic Products May Contain with Restrictions.

ERMA New Zealand is now seeking public consultation on the amendments. Full details of the proposed amendments can be viewed here. Submissions close on 31 May, 2009. 

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Hearing dates for methyl bromide reassessment announced

ERMA New Zealand will hold a series of hearings next month as part of its reassessment of fumigant methyl bromide.

Hearings are an opportunity for the decision-making committee of the Authority to gain further information from submitters and the applicant on an application. Anyone can attend a hearing, but only those who have requested to be heard may participate.

Dates and locations of the hearings are: 

             Wellington, 17 May 2010
             Nelson, 18 May 2010
             Picton, 19 May 2010 
             Tauranga, 20 May 2010
             Auckland, 21 May 2010

A full schedule of venues and times will be posted on our website shortly.

Further information on the reassessment can be viewed here.

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Strict controls placed on AgResearch approval

The Environmental Risk Management Authority has placed strict controls on an approval for Crown research institute AgResearch to genetically modify bacterial and mammalian cells, mice, goats, sheep and cattle.

After hearing all the evidence, the decision-making committee of the Authority granted approval to AgResearch to develop GM goats, sheep and cattle to produce therapeutic proteins in milk. The approval is to be conducted in full containment at Ruakura.

The Authority considered the main benefit of this research to be an increase in scientific knowledge and the capacity for innovation in New Zealand.
The approval is subject to stringent conditions, which include:
• Imposing stringent containment measures, such as two-metre high, double fencing of outdoor containment facilities;
• Preventing animal products from entering the food chain;
• Restricting the research to AgResearch’s Ruakura facility; and
• Limiting the range of modifications and types of organisms, and excluding some organisms.

A full list of the controls is detailed in Appendix 2 of the decision.

The full decision can be read here.

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Chief Executive-Initiated Reassessment list revised

ERMA New Zealand has revised the list of substances on the Chief Executive-Initiated Reassessment (CEIR) programme.

The list was first drawn up following public consultation in 2006 and has been revised twice since then. More than a dozen substances on the original list have been reassessed or have reassessments well under way.

A reassessment involves taking a second look at the risks, costs and benefits of a substance already approved under HSNO. The risk-based approach takes into account the potential for exposure to the substance (using ‘surrogate’ indicators of exposure such as application rates and estimated quantities used in New Zealand) as well as the substance’s inherent hazardous properties.

The CEIR programme is part of ongoing work covering a wide range of hazardous substances that includes reassessment of industrial chemicals, agricultural chemicals and other pesticides.

The list is intended to be a living list and other substances may be added from time to time, should new information on their safety or use come to light.

Public submissions on the revised list were called for in September 2009. The list can be viewed here.

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Proposal to change child-resistant packaging rules

ERMA New Zealand is seeking submissions on a proposal to amend the child-resistant packaging requirements for products covered by its group standards.

The application, from industry association ACCORD Australasia, relates to child-resistant packaging requirements and alternative compliance provisions for certain substances covered under a number of group standards ranging from cleaning, dental and embalming products to surface coatings, fertilisers and fuel additives.

There is also a recommendation to permanently allow products to be packaged in accordance with Australian, EU and US requirements as an alternative to the New Zealand group standards.

The current provisions expire on 31 December 2010.

Submissions close on Friday, 14 May, 2010.

The full application and associated documentation can be viewed here.
 

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Inventory of chemicals updated

The New Zealand Inventory of Chemicals (NZIoC) has been updated.

The inventory is a list of all the chemicals in products covered under ERMA New Zealand’s group standards.

Changes to the inventory this year include adding 43 new chemicals to the list and changing the status of two chemicals to allow them to be used as a single component chemical under an appropriate group standard. Previously they were allowed as components only.  No chemicals have been taken off the inventory in this update.

The April 2010 updates can be found here. A complete list of the NZIoC can be found here.

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New Organisms (NO) 

1 March 2010 to 31 March 2010

The applications in The Bulletin are for reference only. Our public notification process includes alerts in four main daily newspapers with the full information and submission forms available on our website.

To ensure that you are advised directly about applications open for public submission contact us to be added to our interested party list. You will need to nominate the types of applications that you are interested in. 

NO notified applications received and open for submissions

ERMA200281 by SCION, to import and release the parasitoid Cotesia urabae (Hymenoptera: Braconidae) as a biological control agent for gum leaf skeletoniser, Uraba lugens (Lepidoptera: Noctuidae)

Submission period: 15 April 2010 - 27 May 2010

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NO decisions on applications - delegated authority to the Chief Executive

The Chief Executive of the Environmental Risk Management Authority, acting under delegated power from the Authority, reached a decision on the following applications:

ERMA200332 by AgResearch Limited, to genetically modify Escherichia coli to understand the evolutionary processes involved in coping and repairing genetic material, and adapting to living, with or without oxygen

Formally received: 15 March 2010

Application decision: Approved with controls

Decision notified: 18 March  2010

ERMA200256 by AgResearch Limited, to genetically modify cells and embryos for research applications related to mammalian development using recombinant lentiviral vectors

Formally received: 18 March 2010

Application decision: Approved with controls

Decision notified: 30 March 2010

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NO decisions on applications - delegated authority to IBSCs

The following applications were decided by institutions acting under delegated powers from the Authority:

ERMA200389, GMO10/MU001 by Massey University, to develop genetically modified eukaryotic expression systems to produce protein for biochemical and structural analysis in order to investigate the effect of filamin gene-encoding mutations on filamin function

Application decision: Approved with controls

Decision notified: 19 March 2010

ERMA200409, GMO10/MU002 by Massey University, to develop transgenic Drosophila melanogaster in order to study the molecular pathways involved in development and neurological function

Application decision: Approved with controls

Decision notified: 25 March 2010

ERMA200407, GMO10/UA001 by the University of Auckland, to develop genetically modified Candida albicans to investigate genes essential for morphological switching

Application decision: Approved with controls

Decision notified: 25 March 2010 

ERMA200408, GMO10/UO001 by the University of Otago, to import the Lactobacillus gasseri strain B72 mutated in the oxalate decarboxylase (oxc) gene, to be used in mouse experiments to determine the metabolic impact of these gut bacteria on oxalate concentrations in urine

Application decision: Approved with controls

Decision notified: 25 March 2010

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NO amendments to approvals

The following amendments, made under section 67A of the HSNO Act for minor or technical errors amendments, was decided by the Authority:

GMF98009 by AgResearch Limited, to amend the controls in GMF98009 in Part I and Part II of the decisions

Amendment notified: 16 March 2010

GMD02028 by AgResearch Limited, to amend controls on GMD02028

Amendment notified: 16 March 2010

The following amendment, made under section 67A of the HSNO Act for minor or technical errors amendments, was decided by the Chief Executive:

GMD04093 by ERMA New Zealand, to amend GMD04093 (GMO04/HRA090), to correct an error in control 2

Amendment notified: 16 March 2010
 

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NO amendments to approvals - delegated authority

The following amendments made under section 67A of the HSNO Act for minor or technical errors.  The amendments were decided by institutions acting under delegated powers from the Authority.

GMD05103 (GMO05/LU002) by Lincoln University, to add approved laboratory facilities at Lincoln University

Amendment notified: 8 March 2010

GMD05102 (GMO05/LU004) by Lincoln University, to add approved laboratory facilities at Lincoln University

Amendment notified: 25 March 2010

GMD05099 (GMO05/LU005) by Lincoln University, to add approved laboratory facilities at Lincoln University

Amendment notified: 25 March 2010

GMD04106 (GMO04/MU016 s67A) by Massey University, amendment made to include homologous components from other secretion systems

Amendment notified: 18 March 2010 
 

Hazardous Substances (HS) 

1 March 2010 to 31 March 2010

The applications in The Bulletin are for reference only. Our public notification process includes alerts in four main daily newspapers with the full information and submission forms available on our website.

To ensure that you are advised directly about applications open for public submission contact us to be added to our interested party list. You will need to nominate the types of applications that you are interested in.

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HS notified applications received and open for submissions

ERMA200348 by Syngenta Crop Protection Limited, to import or manufacture Instrata containing chlorothalonil, propiconazole and fludioxonil for use as a fungicide mixture on amenity turf for the control of foliar diseases

Submission period: 29 March 2010 - 12 May 2010

ERMA200367 by Pfizer New Zealand Limited, to import PNZL-TC1310 as an oral veterinary medicine for use in dogs

Submission period: 29 March 2010 - 12 May 2010

ERMA200143 by Accord Australasia, to vary certain provisions relating to child resistant packaging and specific packaging requirements of certain substances as a condition of the Group Standards

Submission period: 30 March 2010 - 13 May 2010

ERMA200328 by Sumitomo Chemical Company Limited, New Zealand Branch, to import or manufacture SUNNY Plant Growth Regulator, containing uniconazole-p, as a management tool for growers to achieve improved size and shape of avocados

Submission period: 30 March 2010 - 13 May 2010

ERMA200343 by Norbrook NZ Ltd, to import or manufacture NOR004 as a topical anthelmintic intended for use in cattle

Submission period: 30 March 2010 - 13 May 2010

ERMA200321 by Syngenta Crop Protection Limited, to import and manufacture AMISTAR OPTI as a fungicide for the control of Early and Late Blight in potatoes

Submission period: 31 March 2010 - 14 May 2010

ERMA200344 by Copper Care Wood Preservatives Inc, to import or manufacture CU-BOR Wood Preservative as a paste product containing copper and borate compounds for use as a wood preservative

Submission period: 31 March 2010 - 14 May 2010

ERMA200347 by Syngenta Crop Protection Limited, to import Primo Maxx containing trinexapac-ethyl for use as a plant growth regulator on amenity turf for the the inhibition of grass growth

Submission period: 1 April 2010 - 17 May 2010

ERMA200351 by Bayer New Zealand Limited, to import Falcon as an agricultural fungicide for the control of foliar diseases of wheat and barley

Submission period: 1 April 2010 - 17 May 2010

ERMA200323 by Trical Inc, to import or manufacture TRI-FORM 60 containing 1,3-dichloropropene and chloropicrin as a soil fumigant.

Submission period: 6 April 2010 - 18 May 2010

HSR09022 by Syndel Laboratories Ltd, to import OPT, containing a salmon gonadotrophin releasing hormone analogue, as a reproductive hormone analogue preparation intended for injection into fish

Submission period: 6 April 2010 - 18 May 2010 

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HS non-notified applications received

ERMA200382 by Chubb New Zealand, to import Fenwal Explosive Switch Kit as an explosive device, used to actuate auxiliary systems such as fire alarms, process controls, fire dampers and other related equipment

Formally received: 22 March 2010

ERMA200313 by Connovation Limited, to manufacture into containment Paste Bait and Block Bait containing Diphacinone as a vertebrate toxic agent to undertake rodent cage trials

Formally received: 25 March 2010 

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HS decisions on applications

Decisions were made by the Authority of ERMA New Zealand on the following applications:

ERMA200086 by New Zealand Crop Care Limited, to import or manufacture Vienna to use for the control of annual grasses and broadleaf weeds in carrots, forest nurseries, certain fruit crops, transplanted lettuce, maize, onions and peas

Application decision: Approved with controls

Decision notified: 5 March 2010

ERMA200094 by Nufarm New Zealand Limited,  a modified reassessment of the approval for emulsifiable concentrate containing 50g/litre esfenvalerate to add a flammability classification

Application decision: Approved with controls

Decision notified: 5 March 2010

ERMA200108 by New Zealand Crop Care Limited, to import Glacier for the control of various fungal diseases in a range of crops

Application decision: Approved with controls

Decision notified: 12 March 2010

ERMA200290 by Bayer New Zealand Limited, to determine whether or not there are grounds to reassess Oberon

Application decision: Grounds exist for reassessment

Decision notified: 18 March 2010

ERMA200338 by Heathgate Resources PTY Ltd, to tranship Uranium Ore Concentrate through the Port of Auckland, en-route to Tahiti destined for the USA

Application decision: Approved with controls

Decision notified: 16 March 2010

ERMA200199 by Nufarm New Zealand Limited, to import azoxystrobin technical for use in the manufacture of fungicide products in New Zealand

Application decision: Approved with controls

Decision notified: 18 March 2010

ERMA200173 by Virbac New Zealand Limited, to import for sale and distribution Effipro Spot On, a veterinary medicine containing Fipronil, for topical use on cats and dogs

Application decision: Approved with controls

Decision notified: 22 March 2010

ERMA200066 by Renovo Technologies Ltd, for a modified reassessment for use of chlorpropham

Application decision: Approved with controls

Decision notified: 24 March 2010

ERMA200294 by Bayer New Zealand Limited, to determine whether there are grounds to reassess the approval to import or manufacture Mesurol Pro as a molluscicide to control slugs and snails on the basis of additional information

Application decision: Grounds exist for reassessment

Decision notified: 24 March 2010

ERMA200375 by Energy Resources of Australia (ERA) Ltd, to tranship Uranium Oxide U308 through the Port of Auckland en route to USA/Canada via Papeete

Formally received: 15 March 2010

Application decision: Approved with controls

Decision notified: 30 March 2010 

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HS decisions on applications - delegated authority to the Chief Executive

The Chief Executive of the Environmental Risk Management Authority, acting under delegated power from the Authority, reached a decision on the following applications:

ERMA200352 by Troy Laboratories NZ Pty Ltd, to import TL0110 (active ingredient Meloxicam) as a veterinary medicine for the treatment of horses

Application decision: Approved with controls

Decision notified: 9 March 2010

ERMA200308 by Jurox New Zealand Limited, to import RD0248 for use as an anthelmintic in ruminants

Application decision: Approved with controls

Decision notified: 11 March 2010

ERMA200345 by Jurox New Zealand Limited, to import Jurox Formulation RD0134 as an anthelmintic for use in horses

Application decision: Approved with controls

Decision notified: 11 March 2010  

ERMA200366 by HaS Expertise Limited, to manufacture into containment J57.41 as a timber treatment preservative for use in trials

Formally received: 1 March 2010

Application decision: Approved with controls

Decision notified: 12 March 2010

ERMA200392 by Arysta LifeScience North America Corporation, to manufacture (into containment) Ripper 500 (methyl iodide and chloropicrin) for field trials, to evaluate lower application rates using Virtually Impermeable Film

Formally received: 22 March 2010

Application decision: Approved with controls

Decision notified: 24 March 2010

ERMA200374 by Troy Laboratories NZ Pty Ltd, to import TL0210 (active ingredient Meloxicam) as a veterinary medicine for the treatment of dogs and cats

Formally received: 5 March 2010

Application decision: Approved with controls

Decision notified: 25 March 2010

ERMA200330 by Bayer New Zealand Limited, to import Baytril 25 Flavour Antibacterial Oral Suspension as a veterinary medicine for use in dogs and cats

Application decision: Approved with controls

Decision notified: 29 March 2010

ERMA200341 by Jurox New Zealand Limited, to import Mineralised RD0190 as an anthelmintic for use in ruminants

Formally received: 11 March 2010

Application decision: Approved with controls

Decision notified: 30 March 2010

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Test Certifiers

The Chief Executive of the Environmental Risk Management Authority, acting under delegated power from the Authority, reached a decision on the following applications:

TST100018, to approve Paul Cambie as a test certifier

Application decision: Approved with limitations

Decision notified: 4 March 2010

TST100019, to approve Christine Young as a test certifier

Application decision: Approved with limitations

Decision notified: 11 March 2010

TST100020, to approve Karl Emson as a test certifier

Application decision: Approved with limitations

Decision notified: 24 March 2010

TST100021, to approve Ricky Holmes as a test certifier

Application decision: Approved with limitations

Decision notified: 30 March 2010

TST100022, to approve Christopher Munday as a test certifier

Application decision: Approved with limitations

Decision notified: 30 March 2010

Recent Publications 

The following ERMA publications are now available. For more information on their availability, please contact publicationinfo@ermanz.govt.nz

Te Putara - Issue 18 March 2010

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