Lee continues her investigation into the processes within the National Industrial Chemicals Notification and Assesment Scheme with the Director of NICNAS, Dr Brian Richards. She asks about their procedure for assessment of individual chemicals for use in cosmetics and also for an update on how many cosmetic ingredients have had applications to NICNAS to accept overseas non-animal tested substances validated in other jurisdictions.
Senator RHIANNON: ...Staying with NICNAS but moving on to cosmetics. Under the reforms to NICNAS that I understand have been rolled out, will NICNAS continue to assess class 3 individual chemicals for use in cosmetics?
Dr Richards: The government announced, in the context of the most recent federal budget, that reforms to NICNAS would proceed and outlined a broad framework in which a more risk-based and proportionate regulatory regime would be established. NICNAS was then given the task of consulting with the wide range of stakeholders who have interests in chemical regulation on the way in which that broad framework would be operationalised. NICNAS did, last year, release the first of a series of four consultation papers proposing a possible way forward for the purposes of consultation and we received a large number of submissions in response. We propose to release the second consultation paper next week, taking note of all the views that were expressed by the wide range of stakeholders, and further refining the proposed implementation approach. The government announcement in the context of the budget did indicate that in developing a risk based regulatory stance, the risk posed by a chemical is a function of the intrinsic hazards of the chemical-the toxicity of the chemical, which is a property of the actual chemical substance itself-and the exposure of an organism whether it is human, animal or environmental. In looking at risk, it is a function of hazard versus exposure. It has been expressed in the first consultation paper and broadly outlined in the government decision as being a matrix, which, by developing a hazard versus exposure matrix, you can categorise chemicals into one of three class. It is proposed that class 3 chemicals, which are higher hazard and higher exposure, would continue to be assessed by NICNAS, whereas, conversely, those chemicals that are very low hazard or non-hazardous and are very low exposure would be exempt under the new arrangements. So, yes, it is proposed that the so-called class 3 chemicals, the third class of the higher hazard and higher exposure chemicals, which are therefore higher risk, will continue to be-
Senator RHIANNON: Thank you for explaining that. For cosmetics, it is often the ingredients that are coming into the country. Do I take it from that that sometimes cosmetic ingredients may be class 3, but sometimes they are not; therefore, they are assessed in different ways?
Dr Richards: That is right. This regime relates to new industrial chemicals. So new industrial chemicals are defined as those chemicals that are not already listed on the Australian Inventory of Chemical Substances. They are not necessarily chemicals that have never been used in Australia before, but they are chemicals that are not listed. Under current arrangements, a large number of chemicals are exempt from the current scheme and so each year there are close to 10,000 new chemicals-that is, chemicals not listed on the Inventory of Chemical Substances-that are introduced. But each year probably two-thirds of the 10,000 are the same as the year before and the year before that.
Senator RHIANNON: I am interested in the non-animal tested cosmetics. Is it possible for you to say that they are class 3, or would it just be very variable?
Dr Richards: It would depend on where they fell within the matrix in terms of the-
Senator RHIANNON: Right. So I need to have a more specific question, I think.
Dr Richards: At the moment, we are developing a proposal to take to government on how these reforms would be implemented. It is my expectation that the vast majority of chemicals that are used in cosmetics would be either exempt from assessment or reported to NICNAS without assessment. It would only be those chemicals that are very high hazard and a high exposure that might fall into class 3. That is a different question from 'What are the data requirements to conduct an assessment?'
Senator RHIANNON: Is it possible under this system that you could expect the new process to facilitate or encourage non-animal tested validations?
Dr Richards: Yes.
Senator RHIANNON: Can you provide an update on how many cosmetic ingredients have had
manufacturers or importers applications to NICNAS to accept overseas non-animal tested substances validated in other jurisdictions?
Dr Richards: I would have to take that on notice. We did an analysis for the 2013-14 year. I am not sure that we have repeated that. It was quite a labour intensive analysis. I am not sure whether we have completed an analysis to allow an updated figure, but I could take on notice whether we have done that analysis.
Senator RHIANNON: I will just add three points, if you could take them on notice. And then I am finished, Chair. In the context of this question, could you provide the categories those ingredients belong to?
Dr Richards: Senator, could you explain. The new system with class 1, class 2, class 3 does not yet exist.
Senator RHIANNON: I see. So that is redundant. How many of those applications were for new ingredients not previously approved in Australia?
Dr Richards: As I said, NICNAS generally only looks at the new chemical ingredients-that is, chemicals not listed on the AICS. So any chemical that is submitted to NICNAS for an assessment is by definition a new chemical.
Senator RHIANNON: Thank you.