NICNAS Matters June/July 2014
Registration and annual reporting requirements 2014–15
All introducers (importers and/or manufacturers) of relevant industrial chemicals are required to be registered with NICNAS, under the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act).
The new (2014–15) registration year runs from 1 September 2014 to 31 August 2015.
NICNAS will mail registration renewal kits (including an invoice and application form) to all introducers in mid-July, and registrations must be renewed by 31 August 2014.
If you have not received your renewal pack by 31 July 2014, please contact NICNAS:
Freecall: 1800 638 528; email: email@example.com.
There are four levels of registration.
Your registration level is based on the total value of the relevant industrial chemicals you introduce each year. Your registration might not be current if you are not registered at the correct level.
Your registration renewal invoice and application form for 2014–15 will be based on your registration level as at 1 July 2014.
Under sections 21AA and 40N of the Act, a person introducing a new industrial chemical using certain permits, certificates or exemptions in a registration year must provide a report to the Director, NICNAS, stating the name and quantity of the chemical that was introduced.
Introducers must submit this annual report to NICNAS where there is a requirement to do so, even if the quantity being reported is 0 kg.
The 2013–14 reports for new chemicals introduced during the previous registration period (1 September 2013 to 31 August 2014) must be submitted to NICNAS by 30 September 2014.
For further information, please refer to the Annual reporting pages on the NICNAS website or call NICNAS on Freecall: 1800 638 528.
Handbook for notifiers
The NICNAS Handbook for notifiers remains one of our most commonly visited, viewed and referenced website publications. It is a 'live' web-based resource that summarises statutory requirements, provides contextual information, and can be readily updated in response to user feedback and regulatory change.
NICNAS does not encourage notifiers to print copies of the entire Handbook because it is a guidance document, designed to be accessed online to provide the most up-to-date information.
In response to stakeholder requests for a printable version, NICNAS now provides a daily PDF version of the 'digital' Handbook that can be downloaded either as a (dated) hard-copy or as a digital document onto a tablet or computer, for convenient offline access.
Printing a hard-copy version of the entire Handbook for use over an extended period is not recommended, as changes are occasionally made to the publication as procedures and requirements for notification evolve.
If you wish to conduct a search of the Handbook, the global search function on the NICNAS website can be filtered to only show results from the Handbook (check 'Handbook' in the right-hand options box after doing the initial search, as at left).
You can still print each section of the Handbook, as required,
by clicking on the 'Print Page' icon.
Compliance requirements: low concentration cosmetic new chemicals
New industrial chemicals may be introduced to Australia without being notified to NICNAS provided they meet criteria outlined in section 21 of the Act.
Full details and requirements are available in the notice in May 2014 Chemical Gazette.
Reminder: revised Sunscreen Standard
It is an offence to import into, or manufacture in, Australia a cosmetic that is subject to—but does not meet—the requirements set out in the Cosmetics Standard 2007.
From 1 August 2013, a revised Sunscreen Standard was given legal effect by inclusion in the Cosmetics Standard 2007, with a five-year transition period before full compliance is required. The revised Australian/New Zealand Sunscreen Standard (AS/NZS 2604:2012 Sunscreen products—Evaluation and classification) (known as the 2012 Sunscreen Standard) applies to two categories of cosmetic sunscreen products (face/nail and skin care) regulated under the Cosmetics Standard 2007.
Manufacturers and importers of cosmetic products have four years left (to 31 July 2018) to fully comply with the updated requirements.
Rotterdam Convention changes
Australia is a signatory to the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the Convention).
The sixth meeting (late April–10 May 2013) of the Conference of the Parties (COP 6) to the Convention agreed to list certain industrial chemicals in Annex III of the Convention. The Annex includes chemicals that are subject to the Prior Informed Consent (PIC) procedure under the Convention.
The Convention requires parties to:
- advise whether they will permit chemicals in Annex III to be imported and, if so, under what conditions, and
- observe other parties' advice on importing such chemicals, including any applicable prohibitions or conditions.
Import and export controls on industrial chemicals subject to the PIC procedure are enforced under the Industrial Chemicals (Notification and Assessment) Act 1989, and the chemicals are detailed in regulation 11(C)(1) of Industrial Chemicals (Notification and Assessment) Regulations 1990 (the ICNA Regulations).
For more information, see June 2014 Chemical Gazette.
For details of PIC fees and charges, see: Table 4—Summary of other fees on NICNAS's Fees and charges web-page.
Fees and charges
NICNAS fees and charges for 2014–15 (effective from 1 July 2014) are now available. The fees and charges accord with those forecast in the 2012–16 Cost Recovery Impact Statement (CRIS).
For further information please contact NICNAS on Freecall: 1800 638 528, phone: 02 8577 8800 or email: firstname.lastname@example.org
The staged implementation of the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework continues. We have recently reached the second anniversary of the IMAP launch.
IMAP focuses on a subset of chemicals on AICS that meet characteristics for priority assessment confirmed through stakeholder consultation.
In addition to producing information about the hazards and risks associated with the use of these industrial chemicals, the framework identifies chemicals which could require further risk mitigation to ensure safe use.
The latest tranche of assessments—Tranche Nine—was released on Friday 4 July 2014.
Assessments scheduled for 2014–15
In 2014-15, NICNAS will assess (for human health or environmental risks) more of the chemicals nominated in the Stage One Chemicals list, including (but not limited to):
- compounds of mercury and boron
- perfluorinated chemicals
- petroleum stream chemicals
- nonylphenol ethoxylates, and
- a subset of hair-dyes restricted overseas.
In order to gain further efficiencies while implementing IMAP Stage One, NICNAS has identified some additional chemicals for assessment. These extra chemicals can be rapidly assessed for either (or both) human health and environmental risks because they can be added to a group of chemicals already being assessed in IMAP Stage One.
As a result, some extra chemicals related to the remaining 'priority' existing chemicals (PECs) might also be assessed during 2014–15. An updated Stage One Chemicals list—including additional chemicals identified to date for assessment—is now available.
NICNAS welcomes information provided by introducers and users of Stage One chemicals and a template is available for providing information on use, exposure, hazard or any other relevant information. Comment on draft assessments, published in tranches, is also welcomed.
Note: While assessments for some of these chemicals have already been completed—for either human health and/or environment (the two types of assessments are conducted separately)—data provided will assist with assessments yet to be commenced for human health or environmental impacts.
Training and outreach sessions for notifiers, industry, customs brokers
NICNAS promotes compliance with our legislation by working with notifiers, industry representatives and other stakeholders. We provide advice and guidance to ensure that people understand their regulatory obligations, and collaborate to find the most practical way for them to meet those obligations.
Staff from NICNAS's New Chemicals programme will be conducting workshops for notifiers in Sydney and Melbourne in August 2014. See July 2014 Chemical Gazette for details.
Staff from both the Department of Health (who conduct human health risk assessments for NICNAS) and the Department of the Environment (who assess environmental risks for NICNAS) will be presenting at the workshops—and will be available to answer any questions. Topics will be presented in two half-day sessions:
- Morning (9:30 am to 12:30 pm): overview of new chemical notification categories and NICNAS's approach to risk assessment.
- Afternoon (1:30 pm to 4:30 pm): detailed look at new chemical submissions process, including common issues, use of analogues and environmental assessments.
Sydney—5 August 2014—Rydges Sydney Central, 28 Albion Street, Surry Hills NSW 2010
Melbourne—12 August 2014—Best Western Airport Motel and Convention Centre, 33 Ardlie Street, Attwood VIC 3049
Please note: attendance is free, but numbers are limited.
Industry awareness sessions
These sessions are designed to raise industry awareness of their obligations in relation to NICNAS, and are intended for new registrants who may be unfamiliar with NICNAS, or those wanting to learn more about the scheme.
The sessions run for approximately 1.5 to 2 hours—and attendance is free. Topics covered are available on our Training and outreach page.
Please note that there is a limited number of places available, so you need to register your interest (see bottom of this item for further details).
Sunshine Coast, QLD—27 October, 2014—Expression of Interest (EOI) by 17 October 2014
Brisbane—28 October, 2014—EOI by 17 October 2014
Gold Coast, QLD—29 October, 2014—EOI by 17 October 2014
Wollongong, NSW—4 December, 2014—EOI by 21 November 2014
Sydney—4 June, 2015—EOI by 22 May 2015
Ballarat, VIC—4 March, 2015—EOI by 21 February 2015
Melbourne—5 March, 2015—EOI by 21 February 2015
Customs broker seminars
NICNAS also conducts seminars for customs brokers and forwarders; they are run in parallel with conferences and meetings of the Customs Brokers and Forwarders Council of Australia (CBFCA)
Adelaide—26 July, 2014—CBFCA Conference
Brisbane—30 October, 2014—CBFCA AGM
Melbourne—5 March, 2015—EOI by 21 February 2015
Sydney— 4 June, 2015—EOI by 22 May 2015
All sessions run for 1.5 to 2 hours and attendance is free.
For more details, please see our Training and outreach page.
Registering your interest
If you wish to attend any session. please provide your name; industry/company; training session; number of attendees and preferred city, and email: email@example.com.
If you have any further queries about industry training, please phone: 02 8577 8800, or Freecall: 1800 638 528 or email: firstname.lastname@example.org
NICNAS and ECHA experts collaborate on topics of mutual interest
The European Chemicals Agency (ECHA) implements the European Union's (EU) chemicals legislation for the protection of human health and the environment.
ECHA was founded in 2007 and is based in Helsinki, Finland. ECHA is a leading regulatory authority with over 500 staff from 27 European countries.
NICNAS and ECHA signed a Memorandum of Understanding (MoU) in 2011 to enhance technical cooperation in the area of chemical risk assessment. By working collaboratively with our international counterparts, NICNAS avoids unnecessary duplication of assessment effort and optimises the use of resources.
The MoU operates in accordance with the respective mandates of each agency and includes scientific collaboration and information exchange, sharing information and experiences on risk assessment and risk management tools and exchange of operational experiences. The MoU is implemented through a rolling bilateral work plan, which is updated annually.
Two technical teleconferences were held in May 2014 on topics of mutual interest: use of predictive toxicology for risk assessment, and determination of chemical 'sameness' for complex substances.
The teleconferences resulted in a deeper understanding of the respective approaches used by both agencies, and provided an opportunity for staff to identify areas for further collaboration.
Regular exchanges between technical staff occur as required. Further topic-specific teleconferences currently planned for 2014–15 are on communication activities and industrial nanomaterials.
NICNAS involvement in harmonising regulatory approaches and methodologies for assessing industrial chemicals
OECD Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology
At the February 2014 meeting, several matters of interest to NICNAS were discussed, including:
- a harmonised approach to characterisation of unknown or variable composition, complex reaction products and biological materials (UVCBs) for hazard assessment, for regulatory purposes
- a project to develop a knowledge base (wiki) of adverse outcome pathways to support an integrated approach to testing and assessment, ensuring that uncertainties relating to gaps in scientific evidence are appropriately characterised (to support targeted research)
- terms of reference for a comparative analysis of risk reduction approaches for per- and poly-fluorinated chemicals (PFCs) across the OECD, focused on longer chain substances. Work is to be undertaken in cooperation with United Nations Environment Programme (UNEP).
Further to the last item, NICNAS participated in a teleconference about populating the PFC portal with information on short chain PFCs, which reached agreement that a balanced view of benefits and adverse effects of short chain PFCs should be presented.
OECD New Chemicals Clearing House
Government agencies (NICNAS, the US EPA, Environment Canada and Health Canada) have agreed to participate in a polyester project, with a modus operandi for the work-sharing arrangements on the OECD website and the governments involved accepting a template for assessment reports. Dossiers for new candidate nominations were sought by the end of December 2013. NICNAS has received five nominations from three companies—plus several requests for extension. There are 37 new candidate substances altogether.
The Clearing House is also planning an analogues workshop to be held by teleconference over one day, with industry and regulatory agencies in Australia, the US, Canada and Japan.
Alternative testing methods
To ensure continuous improvement in enhancing NICNAS scientific staff skills and expertise, ongoing activities undertaken include a review of OECD guidance on assessing both categories and alternatives to animal testing methods, to identify new information.
Test guidelines on skin and eye corrosion/irritation, skin sensitisation, genotoxicity and carcinogenicity have been added to NICNAS's internal database, allowing assessors easy access to the latest information.
For more information on these topics, see: OECD Environment, Health and Safety News (June 2014).
Calendar of events
26 July—NICNAS Customs broker seminar at Customs Brokers and Forwarders Council of Australia (CBFCA) Conference, Adelaide SA
05 August—NICNAS Notifiers' Workshop, Rydges Sydney Central, 28 Albion Street, Surry Hills NSW
09–12 August—APEC Chemical Dialogue and Regulators Forum, Beijing CHINA
12 August—NICNAS Notifiers' Workshop, Best Western Airport Motel and Convention Centre, 33 Ardlie Street, Attwood VIC
16–24 August—National Science Week—events across Australia
19 August — NICNAS Industry Government Consultative Committee (IGCC)—49th meeting, Sydney NSW
23–24 August—Sydney International Spa and Beauty Expo, Sydney NSW
31 August—Final date for lodging 2014–15 NICNAS registration renewals
11–12 September—European Food Safety Authority's 21st Scientific Colloquium, Edinburgh SCOTLAND
17–19 September—Expert meeting on categorisation of nanomaterials, Washington USA
18–19 September—Surface Coating Association of Australia—64th Annual Conference 'Innovate to Survive', Melbourne VIC
30 September—Final date for lodging 2013–14 annual reports for introduced new chemicals
30 Sept–03 Oct—Sixth Cooperative Chemicals Assessment Meeting (CoCAM-6), Paris FRANCE
08–10 October—Australasian College of Toxicology and Risk Assessment (ACTRA) symposium: Advances to alternative methods for toxicology in chemical health risk assessment, Sydney NSW
22 October—Accord Australasia Cosmetic and personal care conference, Sydney NSW
27 October—NICNAS Industry training session, Sunshine Coast QLD
28 October—NICNAS Industry training session, Brisbane QLD
29 October—NICNAS Industry training session, Gold Coast QLD
29–31 October—Ecoforum conference, Gold Coast QLD
30 October—NICNAS Customs broker seminar at CBFCA AGM, Brisbane QLD
29 Nov–3 Dec—Australian Institute of Occupational Hygienists inc (AIOH) conference, Melbourne VIC
04 December—NICNAS Industry training session, Wollongong NSW
04 March—NICNAS Industry training session, Ballarat VIC
05 March—NICNAS Industry training session & NICNAS Customs broker seminar, Melbourne VIC
04 June—NICNAS Industry training session & NICNAS Customs broker seminar, Sydney NSW
Australian Government 2014–15 Health Portfolio Budget Statements (noting that NICNAS has been relocated to Outcome 7)
Draft Guidelines for applying for certain information to be exempt from publication by NICNAS and establishing a case for confidential listing of chemicals on the Australian Inventory of Chemical Substances (AICS)—comments on this document are due by c.o.b. 29 July 2014—see item in July 2014 Chemical Gazette for details.
Around the regulators
Research report: Regulator engagement with small business
Over 1000 regulators across all three levels of government in Australia 'engage' with small business in carrying out various functions from licensing and accreditation to monitoring and enforcing compliance with regulations. The way regulations are implemented and 'delivered' by regulators is often as important an influence on small business compliance costs as the content of the regulations themselves.
Australian Pesticides and Veterinary Medicines Authority (APVMA)
Australian Competition and Consumer Commission (ACCC)
In response to the recommendations in NICNAS's report on its IMAP assessment of Azo dyes, the ACCC conducted tests, announced a recall of retail goods, and issued statements on the matter (see 'Chemicals in the spotlight', below, for the background to these).
Survey on chemicals of security concern
The Attorney-General's Department invited businesses to participate in a survey about toxic chemicals of security concern The invitation (and links to the survey) were published on the NICNAS website until the survey closed (on 20 June). It invited businesses which import, distribute, transport, manufacture, handle or use the chemicals, to play a role in keeping Australia safe by responding.
Further information about government policy towards chemicals of security concern can be found on the Chemical security page of the Attorney-General's Department. If you have any queries about the online survey, please email: email@example.com
Australian Customs and Border Protection Service
New website now available
Chemicals in the spotlight: Azo dyes
Most textile dyes belong to the general class of dyes called 'azo dyes'.
Of these, only certain (generally older) azo dyes—which are based on a limited number of hazardous aromatic amines, including benzidine—are of concern.
In June 2013, NICNAS reported findings from its human health assessment of eleven benzidine-based azo dyes, conducted using the IMAP framework.
In April 2014, NICNAS published another IMAP report: the assessment of an additional 64 benzidine-congenor-based azo dyes.
All chemicals in the group of chemicals assessed in 2014 are non-metalised and metalised 3,3'-disubstituted benzidine-congener-based (3,3'-DCB) dyes, which have the characteristic diazotised 3,3'-benzidine-congener structure. NICNAS published a report in February 2014 which identified these benzidine congeners as potent carcinogens.
While the metabolic pathway for the dyes based on benzidine congeners is not certain, data from a representative metalised dye, C.I. Direct Blue 218 (CAS No. 28407-37-6) indicated that metal chelation (the way that ions and molecules bind metal ions) does not completely eliminate carcinogenic effects. It is the potential carcinogenic effects following exposure to azo dye chemicals, that are the focus—and most critical concern—in NICNAS risk assessments.
Azo dyeing chemicals all have similar uses in Australia: as textile dyes (in mills), as wood stains and polishes and as colour in detergents and crepe paper. Around the world, the use of azo dyes based on particular aromatic amines is being phased out, and replaced with safer types of dye.
However these chemicals are known to be used domestically (including in ink-jet dyes) and commercially (including to colour textiles, leather, paper, plastic and rubber, in liquid crystal displays, in electro-optical devices, in colour photography, and as tint for cinematographic film).
NICNAS's assessment of some azo dyes identified the potential carcinogenic effects following exposure. Based on these findings, NICNAS made a number of recommendations to regulatory agencies to protect human health, in June 2013 and again in April 2014.
In response to the NICNAS recommendation, the Australian Competition and Consumer Commission (ACCC) surveyed textiles and clothing, to determine if goods supplied in Australia were manufactured using the dyes of concern and, if so, what level of exposure consumers may have to the these potentially hazardous dyes. The survey included a range of potentially hazardous aromatic amines including benzidine (which was the focus of the 2013 NICNAS assessment) and these were found in five of 199 samples tested. The results of this survey led to ACCC seeking a number of recalls.
In response to the NICNAS recommendation, home dyeing products containing the benzidine-based dyes are now (since 1 June 2014) prohibited for domestic use by being listed under the Poisons Standard in Schedule 7, based on their carcinogenic potential.
Occupational health and safety
Adequate control measures are needed to minimise dermal (skin) contact and inhalation exposure to these dyes, otherwise workers may experience long-term health effects. Based on the available data, the hazard classification in the Hazardous Substances Information System (HSIS) was considered appropriate for three out of the eleven chemicals assessed. NICNAS recommended that this should be applied to all 11 chemicals assessed.
Refer to Safe Work Australia's Managing risks of hazardous chemicals in the workplace—Code of practice for general guidance on managing risks from hazardous chemicals. Safe Work Australia's Guidance on the interpretation of workplace exposure standards for airborne contaminants provides advice concerning exposure to carcinogens.
Advice for consumers
Consumers should use products containing these chemicals according to label instructions.
Consumers should store, handle and use these chemicals in ways that eliminate or minimise risk.
Consumers should minimise their exposure to these dyes on their skin or by inhalation, or use safer alternatives.
NICNAS has assessed various azo dyes under its New Chemicals programme.
NICNAS's long-serving Head of the Business Management and Communications programme, Mr Nick Miller, has recently left the organisation.
Nick joined NICNAS 15 years ago, and held several roles over the years. He was particularly well known to members of groups such as the Industry Government Consultative Committee (IGCC)—for which he held the secretariat role through its entire 48 meetings—and the Community Engagement Forum (CEF)—of which he was chairperson.
Nick has joined the staff of the Asbestos Safety and Eradication Agency.
NICNAS's internal programmes now number just five, following consolidation of the work of the Business Management and Communications and Regulatory Strategy teams. The combined group—known as the Corporate and Regulatory Strategy programme—is headed by Dr Roshini Jayewardene.
© Commonwealth of Australia 2014
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the National Industrial Chemicals Notification Scheme. Requests and inquiries concerning reproduction and rights should be addressed to: Head, Corporate and Regulatory Strategy Programme, National Industrial Chemicals Notification and Assessment Scheme, GPO Box 58, Sydney NSW 2001 AUSTRALIABack to top