Videos - transitioning from NICNAS to AICIS
These presentation videos were originally published by NICNAS during April - June 2020 and have been archived. The presentation slides and scripts are available below. Please contact us if you'd like to see the original videos.
NICNAS to AICIS – overview of changes
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Hello! This video will provide a general overview on the journey to a new regulatory framework for industrial chemicals.
Now it’s been a long and winding road but we’re finally, nearly there. We’re about to close the door on NICNAS (the National IC N and A Scheme) and step into the new world of AICIS (the Australian IC Introduction Scheme). This presentation aims to give you an overview of what that means in practical terms.
On the 1st of July it’ll be a new day, and a new scheme, with the same Mission – to protect human health and the environment. Right now we’ll start with a general outline of how the new scheme is built: what the different functions of the scheme are; what the underlying principles are; and the key similarities and differences between NICNAS and AICIS.
Here are the main functions of AICIS, most of which might sound familiar to anyone who’s dealt with NICNAS. Most of these will be covered in a bit more detail later in this presentation, and each of them will be covered in a lot more detail in their own dedicated presentations.
Starting at the top and going clockwise, our first key function is registration of introducers, so we know who’s introducing industrial chemicals into Australia.
Our second key function here is ‘assessment of applications’, which in the new scheme includes applications where necessary for pre-market risk assessment, and applications for protection of Confidential Business Information from publication.
Our third key function is Evaluations, which is a new piece of terminology for the new scheme, which broadly encompasses post-market risk assessment activities similar to those currently being done under NICNAS.
Next are ‘risk management referrals’ and ‘publication of information’, which are related in that they are the way our risk assessment work is translated into external value. We use our risk assessment conclusions about industrial chemical introductions to make risk management recommendations, which we publish and also refer directly to the relevant risk management bodies responsible for the safe use of industrial chemicals. We also publish more broadly information about industrial chemicals that will help protect human health and the environment.
Coming around to the left side of the wheel we have the function of Inventory management, the Inventory being of course a central and critical feature of the regulatory framework now and in the future, as it defines the regulatory treatment for industrial chemical introductions based on its listings.
And the last 2 major functions are also related: Post-introduction monitoring and Compliance activity. The new scheme features a much fuller range of monitoring and enforcement powers and actions available to the regulator, to accompany a more risk-proportionate approach to regulatory effort.
Now we have a couple of slides outlining the Principles upon which the new scheme is based. The first and foremost of these, which pretty well underscores all the others, is the notion of ‘risk proportionate regulation’. By using risk as the basis for directing our regulatory effort, we can re-balance our regulatory controls so that our pre-market (or pre-introduction) assessment is focused on higher risk introductions, and this is accompanied by greater post-market (post-introduction) monitoring and a framework for comprehensive processes for evaluating chemicals already in use, including the ability to take prompt action should new information about chemical risks become available. In this way we aim to incentivise lower risk chemical introductions.
Here are the rest of our major Principles, all still underscored by the overarching Principle of risk-proportionality:
AICIS will be a risk assessor, not a risk manager. However, the new scheme will include certain ‘last resort’ powers of risk management, only available for use when there is a risk that cannot be managed any other way, by any other agency. In the new scheme the ED can effectively ‘ban’ a chemical, but only as a last resort (and with substantial checks and balances).
As mentioned earlier, the new scheme will have at its disposal the full range of graduated compliance powers (rather than the choice between a severely worded letter and a prosecution), to allow for risk-proportionate compliance action.
One area that features a quite new approach is the publication and protection of information relating to industrial chemical introduction. The new scheme seeks to publish the information of value in protecting human and the environment from chemical risks, while protecting commercial information that is not necessary for that purpose.
We will also be continuing our ongoing quest for greater use of trusted international risk assessments, to reduce regulatory burden. As well as continuing our current practice of using international materials to inform (and reduce the burden of) our own risk assessments, introducers will be able to use international assessments from trusted overseas bodies to allow immediate introduction where the risks are the same as overseas and can be managed in a comparable way.
Finally, a new and developing Principle for AICIS is the restriction of our use – and the ability of introducers to use – data from testing on animals for ingredients used in cosmetic products.
This slide highlights the things about the new scheme that are the same as the current scheme.
We will continue to regulate ‘industrial chemicals’, and the definition of an industrial chemical will still be made by exclusion, that is, an industrial chemical is a chemical that is NOT a therapeutic, a food, an agricultural or veterinary chemical. We will continue to regulate at the point of introduction into Australia, be that by importation or by domestic manufacture, and our role will continue to be assessing risks and making recommendations for management of those risks (notwithstanding the ‘risk manager of last resort’ new powers mentioned earlier).
All of this is in pursuit of the same primary goal, to protect the health and environment of the Australian people.
This diagram demonstrates the unchanging interfaces between the new scheme and the other Commonwealth chemical regulators: therapeutics will go on being regulated by the Therapeutic Goods Administration, foods by Food Standards ANZ, and agricultural and veterinary products by the APVMA.
Now here are the things that are going to change.
OK the first one is the obvious one, but also contains a meaningful message: the current scheme is called NICNAS and focuses on pre-market notification and assessment; the new scheme is called AICIS and focuses more broadly on risk-proportionate regulation of industrial chemical introduction.
Next, we have a title change for the head of the scheme; however it’ll be the same person doing the job.
The chemical Inventory has a title change too, and more changes besides, which we’ll come to later.
The next 4 points are terminology changes that also indicate a change in approach. In particular, and importantly, the new scheme focuses on introductions, not just on chemicals – this is in order to focus on risk, which comprises hazard and exposure, i.e. the introduction and use of the chemical, not just the innate characteristics of the chemical considered in isolation. So instead of ‘existing chemicals’ (being chemical on NICNAS’s Inventory), we’ll have ‘listed introductions’, being introductions in accordance with the terms of a listing on AICIS’s Inventory. The flipside of those will be, instead of ‘new chemicals’, ‘unlisted introductions’.
As I mentioned earlier, there’ll be an entirely new approach to protecting confidential business information, so no more ‘exempt information’, but rather protected CBI.
And the last point here is that we won’t have ‘notifiers’ making ‘notifications’ any more, but rather ‘applicants’ for various items.
Here are some more key changes.
We won’t be issuing permits any more. We will retain a separate authorisation category for commercial (that is, non retail) evaluation.
There’ll be no more Confidential section of the Inventory, but rather listings all on the one Inventory, some of which will have protection CBI (that’s confidential business information).
In the new scheme, a framework for post-introduction ‘evaluations’ will cover activities that are currently constrained by overly prescriptive legislative processes, namely the processes for secondary notification and assessing Priority Existing Chemicals, and will also cover what is currently an administrative program of assessing chemicals on our Inventory, known as IMAP. Certain aspects of secondary notification will also be replaced in the new scheme by information obligations, and pathways to apply for variation of Inventory listings, or of the terms of certificates.
In this last slide describing the overall framework we’re moving into, we come to the chemical Inventory. AICIS’s Inventory will explicitly be an Inventory of industrial chemicals. It may be surprising to note that NICNAS’s Inventory, the AICS, is not an Inventory of exclusively industrial chemicals. Because of this, there’s transitional legislation that stops the non-industrial chemicals from being included on the new Inventory, and NICNAS has engaged in a process to identify non-industrial chemicals on the AICS for this purpose.
Listings on the new Inventory will include links to statements of the conclusions of any risk assessments AICIS has completed.
Finally, the new Inventory has entirely new means of protecting confidential business information.
There’ll be a lot more detail about the Inventory in a separate presentation dedicated to that topic. There’s also a presentation that goes into the ins and outs of ‘transitional arrangements’, that is, the legislated pathways to get your current authorisations and entitlements under NICNAS duly recognised under AICIS.
Now we’re going to look at the new scheme through the lens of introducer obligations – what do you have to do, and when do you have to do it, and how that changes from what you’re used to with NICNAS.
So here’s another nifty circular diagram for you. This time we’ll move clockwise around the sequence of introducer obligations.
Just looking at them quickly in order, we start with all industrial chemical introducers having to register with the regulator. Then at step 2, you need to know some details about the chemicals you’re introducing, which leads you to step 3, where you have to understand the category that each chemical introduction falls into – this is a critical new concept in the new scheme, which we’ll spend more time on, and another whole presentation coming up.
Then, depending how your introductions are categorised, you may need to apply to AICIS for a pre-introduction risk assessment, or for other kinds of introductions you might need to submit a report or declaration, either before or after the introduction.
Finally, you’ll need to keep certain records relating to your introductions, and you may be obliged to give us information that we ask for in specific circumstances set out in the legislation.
Now let’s look at each section of this wheel of obligations in turn.
The obligation to register as a chemical introducer will remain unchanged, for all importers or manufacturers of ICs in Australia. There will continue to be a fee and a charge for registration, and the costing model for this is something we’ve been developing and consulting on (at the time of making this presentation).
This next major obligation might sound obvious – to know what it is you’re introducing – but when it comes to knowing all the ingredients in all your products, and what regulatory treatment each of them attracts, it’s a bit more of a big deal.
The big difference is that, in the new scheme, you’re checking the Category of Introduction for each ingredient, which is a new concept that we’ll go into in much more detail here and in other presentations.
Checking your ingredients against our chemical Inventory remains the crucial first step, just like it is now.
The other significant difference in the new scheme is that there will be an offence associated with not knowing what you’re introducing (or not having access to the required information from a supplier).
Now we come to the really different aspect: Categorisation. In a nutshell, there are 5 Categories that your introduction can fall into, each with its own criteria and associated regulatory obligations.
Listed introductions are where your chemical is on the Inventory, and your introduction and use are within any and all terms of the Inventory listing, including any conditions. There’s a whole separate presentation on the Inventory with details of what the listings will include and how the terms will operate to authorise your introduction and/or confer further obligations.
If your introduction is not Listed, then there are 4 Categories it could fall into. 3 of them are based on the indicative risk profile of your introduction, with associated obligations that are proportionate to that risk.
Very low risk introductions fall into the Exempted category, which requires a once-off post-introduction declaration.
Low risk introductions fall into the Reported category, which requires you to submit a Report before you start introducing.
Medium and high risk introductions fall into the Assessed category, which will create a much smaller cohort of introductions that require risk assessment by us before you get a certificate authorising you to start introducing. This is also the only category that leads to getting your chemical listed on the Inventory.
Finally there remains, as there is now under NICNAS, a separate category for introductions that are for the sole purpose of commercial evaluation. This also requires pre-introduction risk assessment by us, in a shorter time frame, for a more limited authorisation to introduce.
For completeness, I should mention that there’s also a category called an Exceptional Circumstances Authorisation. As the name suggests, this is expected to be used only very rarely, and would be issued by the Minister.
Just like now, if you introduce industrial chemicals then you’ll have to keep records about them, for 5 years. The records you need to keep will be a bit different, in keeping with the different approach of categorisation.
So you’ll need to keep records to show what information you relied on to determine the category of your introductions, and how you worked out your registration level and charge.
If you’re introducing cosmetics or cosmetic ingredients, you’ll need to keep records relating to animal test data (or the lack thereof).
There may also be specific information requirements on an Inventory listing, or information you’re required to give to us in certain circumstances relating to your assessed chemical.
Finally, there are some circumstances in which the Executive Director of AICIS can ask you for information, and you’re obliged to give it.
The ED can request any information that you’re obliged to keep under the record keeping requirements we talked about in the previous slide.
The ED can request information in relation to your certificate application, or in relation to an evaluation that we do of any industrial chemical in Australia.
You can also be requested to give information as part of monitoring and compliance activities.
If the ED makes a formal request for information that has to be complied with, the request has to be in writing, with a deadline of at least 20 working days.
So here’s the wheel of obligations again, summarising which bits are the same as NICNAS, and which bits are changing.
In brief: Registration will be the same, Knowing your introductions will be a bit different, Categorising your introductions is a new thing, Applying for a pre-introduction assessment will be a bit different, Declarations and reports in relation to other introduction categories is new, Record keeping is a bit different, and giving us information when we ask is basically the same.
Now here’s a new sounding thing: Evaluation. It sort of is new, and it sort of really isn’t.
Evaluation is what we’re calling risk assessments that AICIS will do off its own bat, not in response to an introducer’s application for a certificate or authorisation.
NICNAS does this sort of thing in a few different ways, each of which has its own particular restrictions and limitations. The new Evaluations framework for AICIS aims to create a flexible framework that provides for a comprehensive program of risk assessment of industrial chemical introductions in Australia, including the ability to respond to emerging issues and new information.
Under the new Evaluations framework, AICIS can respond to a range of triggers.
The biggest source of Evaluations will be ongoing Prioritisation activity, essentially a continuation of the work done under NICNAS’s IMAP program, which has to date assessed thousands of chemicals on our Inventory, though under administrative arrangements due to a lack of legislative provisions.
Evaluations could also be triggered by post market monitoring and compliance activity, such as an audit or individual case work.
AICIS will be able to initiate Evaluations in response to nominations from risk managers, such as the ACCC or State and Territory agencies; this can also encompass nominations from the public; or in response to international actions.
Evaluations can occur in response to information we receive from introducers who have obligations to tell us if certain circumstances occur.
Inventory activities that may trigger an Evaluation can be the inclusion of chemicals on the Inventory that were previously regulated by another agency; or the identification of wrongly added or misidentified chemicals on the Inventory.
The Subject of an Evaluation can be, basically, any industrial chemicals. This can include industrial chemicals that are excluded from other obligations, such as naturally-occurring chemicals that do not need to be categorised and don’t count for determining your registration charge.
An Evaluation can be based on a class or group of ICs, and it can get specific about a particular Hazard, Exposure or Use, Circumstances of introduction, or a kind of Risk.
When we conduct Evaluations, we can make ‘calls for information’, asking specific people, such as those who have introduced certain chemicals, for information about those introductions. Those calls for information can, in limited circumstances, be mandatory.
Whilst doing an Evaluation, we can – and sometimes must – consult, be that with certificate holders, the public, or with risk managers.
There’s also a range of what can come out at the end of an Evaluation.
We have to publish an Evaluation Statement, and this has to include any risk management recommendations we conclude are necessary. These recommendations will also be published on a Risk Recommendation Register, which will record the progress of those recommendations in terms of actions by risk management agencies.
Our Inventory listings will also include access to any Evaluation statement published for that chemical.
Less frequent outcomes are varying the terms of an assessment certificate or Inventory listing, such as adding, removing or changing a condition of introduction or use.
An Evaluation can also result in AICIS adding a misidentified chemical to the Inventory, adding chemicals that were previously regulated by another agency, or reviewing approval of protection of Confidential Business Information.
Finally, the ‘risk manager of last resort’ powers I referred to earlier, that we expect will only be used rarely, are the ability to cancel a certificate or remove an Inventory listing, if this is the only way to manage risks associated with the introduction of that IC.
Thank you very much for your attention this far. This overview has covered a lot of ground, and you’ll find more explanation and details in our single-topic presentations. We hope this has helped you understand the new scheme, and how we’re going to get there. For further information, including guidance material and links to our legislation, please visit our website.
Transitional arrangements from NICNAS to AICIS
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This video will provide a general overview on Transitions. That is, for those of you who already deal with the current scheme, NICNAS, how will your current dealings transfer across to the new scheme, AICIS?
First we’ll have a look at what it is that we call ‘Transitional Arrangements’ – what they are, what they’re supposed to do, and how they do it.
Transitional Arrangements arise when we change from one legislative framework, the IC(NA) Act of 1989 (let’s call it the ICNA Act), to its replacement, the Industrial Chemicals Act of 2019. When this happens, we have to adopt a posture of looking at both the past and future at the same time, in order to plot a course from one to the other. Our mascot then is our friend here Janus, the Roman god of gates, duality and transitions.
Let’s look at the purpose of Transitionals, before we get to the nuts and bolts. This will also go some way to explaining some of the – shall we say – oddities and complexities of transitional arrangements.
As stakeholders under NICNAS, you will have acquired certain rights under the ICNA Act. That might be registration as an introducer; and authorisation to introduce a chemical due to an Inventory listing or a certificate or permit. It might mean that, as a member of the public, you have the right to see what industrial chemicals are being used in Australia, what risks might be associated with them and how those risks can be managed. Introducers also have certain obligations under NICNAS.
Those rights and obligations will, in general, continue to arise under the new Act and the new scheme. However, the new legislation isn’t retrospective, and the new rights and obligations won’t be exactly the same as before.
The fundamental purpose of transitional arrangements then is to preserve rights and entitlements that existed under the old scheme; however this has to be done within the framework of the new scheme, whilst being careful not to abrogate any rights in the old scheme that may not be fully realised in the new scheme. This does mean that, because the new scheme is different, transitional arrangements often have the job of fitting a square peg into a round hole (though it will be a round hole of approximately the same size).
Now here’s the detail of how to read Transitional Law, for those of you who like to be across the legislative basis for what we’re telling you to do.
Ordinarily, if you want to know what the law is, you find the relevant section in the relevant Act and take it from there. You might have to also look at some delegated legislation, like Regulations or Rules, if the Act tells you to.
However, for transitional arrangements, you first have to identify where you start from in the old Act, the ICNA Act. Then you go to the Transitional Act [full name: Industrial Chemicals (Consequential Amendments and Transitional Provisions) Act 2019] to see what it says about your particular issue. At this point you also need to look at the Transitional Rules, even if the Transitional Act doesn’t tell you to, because in Transitions Land, delegated legislation can actually change the operation of the primary legislation it’s made under. This can include essentially contradicting what the Transitional Act says, with Transitional Rules that say something different.
Then, once you’ve tracked through the transitional provisions, you have to go to the new Act to see how your issue will be treated in the new scheme. To complete the story you may have to follow through to delegated legislation both old and new – the IC Rules for the new scheme, and the ICNA Regulations for the old scheme.
So when reading Transitional Law, the key message is that to do it properly, you need to be reading 4 to 6 pieces of legislation at once.
Here comes the good news. As the people with the rights and obligations being transitioned, you don’t actually have to DO anything about it. Transitional arrangements are set up to just make it so, by essentially saying, ‘This old thing over here, we’re now going to treat it as though it’s that new thing over there, with these few modifications to make it fit in with the other new things, but without losing any important aspect of having been the old thing’.
You don’t need apply for any kind of transitional treatment, such as a new registration or assessment certificate; and by the same token we don’t need to send you any official notice to make it happen.
Of course, the one thing you remain wholly responsible for, is making sure you know exactly how your rights and obligations are transitioning, and ensuring you remain compliant at all times with the new law including as it applies to transitioned thing.
And now here’s how we’re going to help with that, by explaining transitions in the key areas of the scheme. The first is the Inventory.
These are the main differences between the old and new Inventories, with more detail in the following slides.
Under NICNAS we have the AICS, the Australian Inventory of Chemical Substances, which as the name suggests is not limited to industrial chemicals. The new Inventory, which is the Australian Inventory of Industrial Chemicals (but will be known as ‘the Inventory’ rather than by its acronym) is explicitly limited to industrial chemicals, so the non-industrial chemicals currently on NICNAS’s Inventory will NOT transition across to AICIS’s Inventory.
The AICS has listings with various kinds of conditions, including secondary notification requirements where introducers of certain chemicals on the Inventory have to call us to check whether they need to notify their introduction for risk assessment; while the new Inventory will have a clearly codified system of terms and conditions, with clear consequential regulatory obligations attached to each type.
NICNAS maintained 2 separate Inventories: the public AICS and the confidential AICS, which comprises listings that no-one can see, unless you’re a prospective introducer who can’t find your proposed chemical on the public AICS – in which case you need to call us and there’s more back and forth in terms of what we can tell you about any conditions of introduction or use. Listings on the Confidential AICS often follow from assessment certificates that include what’s currently called ‘Exempt Information’, which is masked when we publish our assessment statements.
In the new scheme, there will be only 1 Inventory. There won’t be listings completely hidden from view. We will instead have a new system of partially masking chemical names and specific end use details with AICIS Approved Chemical Names (AACNs) and Generalised End Uses (GEUs). This will be part of our new framework for protecting Confidential Business Information (CBI), including 5-yearly review of all CBI approvals for AACNs and GEUs.
In view of this major difference between completely hidden and only partially masked Inventory listings, there will be a transitional type of Inventory listing for chemicals that are currently on the Confidential AICS.
As mentioned previously, only industrial chemicals on NICNAS’s Inventory will transition across to be listed on AICIS’s Inventory. Here at NICNAS we’ve recently run a process to identify over 1600 non-industrial chemicals to be removed from the Inventory, with a public consultation that ends on 31st March 2020, in case any of those proposed non-industrial chemicals does in fact have an industrial use that we didn’t know about.
The bits and pieces that make up the ‘particulars’ of each listing on NICNAS’s Inventory will be sorted in to the more clearly defined ‘terms’ of listing on the new Inventory. Specifically, they’ll be sorted into either the ‘defined scope of assessment’ or a condition of introduction or use. Defined scope of assessment and conditions of introduction or use have different regulatory consequences for introducers of those chemicals, and for the full run down of what that means, you’ll need to have a look at the dedicated presentation on the Inventory.
Suffice to say it’s important to know which is which – which particulars on AICS are going to transition into conditions of introduction or use, and which particulars on AICS are going to transition into a defined scope of assessment. The answer to this is in the Schedules to the Transitional Rules, essentially a table of all the particulars on AICS listings, and what they’ll turn into. In broad terms, particulars on AICS that relate to how a chemical has been assessed in the past, for example listings of chemicals that came onto the AICS from being previously regulated by, say, the TGA as a medicine, will become a defined scope of assessment, as the particulars are related to how the chemical was previously defined and/or assessed.
Meanwhile, particulars that come from a NICNAS risk assessment, such as from a Priority Existing Chemical (or PEC) report, will generally become conditions of introduction or use, as these particulars relate specifically to management of identified risks associated with introduction of that chemical.
The other thing you will commonly see on AICS listings is a ‘secondary notification’ condition, which requires you to tell us about your introduction so we can decide whether it needs a further risk assessment. On the new Inventory these will become what’s called ‘specific information requirements’, which is another kind of term of an Inventory listing. Secondary notification as we currently know it will not continue in the new scheme.
NICNAS maintained 2 Inventories side by side: 1 with the listings fully visible to the public, and with the listings fully hidden from the public. AICIS will have only 1 Inventory, with all the listings available to the public. The aim is to make information about risks associated with industrial chemical introduction and use accessible, whilst using other means to protect Confidential Business Information (CBI) that is not necessary to disclose for the purpose of managing chemical risks.
Our primary means of protecting CBI will be by using AICIS Approved Chemical Names (AACNs) and Generalised End Uses (GEUs) as substitutes for terms of listing and in linked assessment statements. These AACNs and GEUs will have come about when introducers have applied for assessment certificates, and also apply to have these generalised substitutes approved for any subsequent publications by AICIS, including eventual listing on the Inventory.
However when we go to the listings on NICNAS’s Confidential AICS, they don’t have AACNs or GEUs, they’re just completely hidden from view. Even if we could go back and retrospectively give them all AACNs and GEUs, we would still be revealing information that had been lawfully protected under the old scheme.
The way we’re going to continue this protection, to avoid abrogating the rights of confidence holders over Confidential AICS listings, is to have a separate kind of listing: a Transitional Confidential Listing, where the word ‘confidential’ replaces each term of the listing on the Inventory. This will operate very much like the Confidential AICS, in that would-be bona fide introducers can ask us whether their proposed chemical is covered by one of these ‘confidentialised’ listings, and we will continue to review these listings every 5 years to decide whether they need to remain confidential, or can be listed with all details accessible.
This slide sets out which chemicals will either automatically get, or be eligible for an application for, Transitional Confidential Listing, where every term of the listing is replaced by the word ‘confidential’.
Firstly and most obviously, all listings on the Confidential AICS – NICNAS’s current hidden Inventory – will automatically transition into Transitional Confidential Listings on the new Inventory. If you have an application for Confidential AICS listing pending on 30th June, then on the 1st July it will become an application for Transitional Confidential Listing on the new Inventory.
Then there are the people who can apply for Transitional Confidential Listing. These are the people who haven’t had an opportunity to apply for an AACN or a GEU to mask their chemical identity or end use. This includes, firstly, holders of assessment certificates under NICNAS that are current at 30th June and transition into AICIS assessment certificates; and, secondly, notifiers of chemicals for assessment under NICNAS whose notification is pending at 30th June and who end up getting an assessment certificate issued by AICIS. These people will be able, 5 years after their certificate was issued, when it is time for listing the chemical on the Inventory, to apply for Transitional Confidential Listing.
If nobody applies, then these chemicals will be listed in full on the new Inventory.
Now we’ll look at specific transitions for New Chemicals – as they are known under NICNAS – and which will become known as Unlisted Introductions under AICIS.
If you’ve got an assessment certificate issued by NICNAS that is still in force on 30th June, then it may not surprise you to find out that on 1st July you’ll be considered to have… an assessment certificate issued by AICIS. Not so complicated, this one.
If you’ve got an Extension Certificate, the one where your certificate is an extension of someone else’s original assessment certificate, then you turn into something else, because in the new scheme we won’t have Extension Certificates any more. What we have – what you’ll become – is a ‘person covered’ by the original certificate. This has largely the same effect, namely that you continue to be authorised to introduce the chemical in accordance with the terms of the original certificate (including any alteration made to accommodate your extension).
If your NICNAS certificate had Secondary Notification obligations, where you have to tell us if certain circumstances occur so we can decide whether to do another risk assessment, these will turn into specific information obligations, with essentially the same effect.
When it comes to varying an assessment certificate, in the new scheme this can happen after an application by a certificate holder, or an Evaluation initiated by the ED. In the new scheme, we would then publish an updated assessment statement and/or evaluation statement. For transitioned certificates, we won’t do that, and if a trade name has been used for the old certificate, we will continue to use that name during any variation process.
Slightly more complicated are assessment certificate notifications that are pending on 30th June, and will become assessment certificate applications under AICIS.
Firstly, let’s be clear about what exactly is a ‘pending’ notification. That means a notification that has been accepted by NICNAS as complete, with notification fees paid in full. It also includes a notification with a data variation request still on foot – that is, where you don’t have the complete data set but you’ve provided us with reasons why you want us to accept the notification without certain data.
When that notification becomes an AICIS certificate application, the transitional arrangements ensure that a lot of the NICNAS processes are carried over, and some new processes in the new scheme won’t occur. If you’ve applied for, and we approve, Exempt Information, to cover up your chemical identity and/or other information, we’ll continue using the Exempt version – for example, we’ll use the trade name when we issue your certificate, not an AACN.
If we need to put conditions of introduction or use on your certificate, we won’t have to consult with risk manager agencies (as is required in the new scheme), and we’re not restricted in the type of condition we can impose (as is the case in the new scheme).
The new scheme has a new power for the ED to refuse to issue an assessment certificate if we conclude the risk can’t be managed. This power will not apply to transitioned notifications, as it wasn’t a power that existed under NICNAS.
When the application is finalised and it’s time to issue the certificate, we’ll issue an assessment report like we would have done under NICNAS; it won’t be a new-scheme Assessment Statement. We also won’t include a ‘defined scope of assessment’, which is a new-scheme feature that will end up as a term on the subsequent Inventory listing for this chemical.
Moving along to permits, where things get a bit more complicated again.
There aren’t any permits in the new scheme. So if you’ve got a permit from NICNAS, and it’s in force on 30th June, it’ll magically turn into something else on 1st July.
If you’ve got a Low Volume or Controlled Use permit, it’ll turn into an assessment certificate. It won’t be a regular AICIS assessment certificate; it’ll be a special kind of certificate, designed solely for transitioned permits. It’ll have the same terms and conditions as were the requirements for the permit under NICNAS. It’ll be limited in duration to either the time left on the original permit, or until 30th June 2022, whichever is later. This means you’ll have at least 2 years to re-categorise your introduction to ensure continued compliance with the new scheme once the transitioned certificate expires. And just like a NICNAS permit, these special time-limited certificates won’t lead to the chemical being listed on the Inventory.
If you’ve got a Commercial Evaluation (or CEC) permit from NICNAS, it’ll transition into the newly created category of ‘Commercial Evaluation Authorisation’ under AICIS. These authorisations serve a similar purpose, in a similar way, to CEC permits. Your transitioned authorisation will last as long as your permit was going to.
One major difference between CEC permits and CEAs, is that the permits could be renewed, and CEAs can’t be renewed; however CEAs can last up to 4 years, compared to the 2 years for a CEC permit. If you had a CEC permit that you wanted to renew, then after it transitions into a CEA, you can apply for a variation of the terms of the CEA to lengthen its duration. Similarly, if you had a permit renewal application pending on 30th June, it will be treated as an application to vary the transitioned CEA to lengthen its duration.
Still heading upwards on the scale of how complicated things are, we come to Exemptions.
To be clear, we’re talking about how, under NICNAS, certain introductions are exempt from pre-market notification if they meet certain criteria. The 3 main types are often referred to as ‘R&D (less than 100 kg)’, ‘No Unreasonable Risk in cosmetics (less than 100 kg)’ and ‘Non Hazardous in cosmetics (less than 1%)’.
As a point of nomenclature, this is a good time to make a clear distinction between Exemptions under NICNAS, which we’ve just described, and the Exempted category under AICIS. They’re not the same thing, and it’s important to remember which is which when discussing transitional arrangements.
NICNAS Exemptions, under transitional arrangements, will basically continue to be authorised for introduction for 2-and-a-bit years (to see out the registration year) after the start of the new scheme. This is to give everyone plenty of time to re-categorise these introductions to comply with the new scheme.
The way the transitional law does this is by saying that introductions complying with these 3 types of NICNAS Exemptions are ‘taken to be’ in one of the relevant categories in the new scheme. The category they are ‘taken to be’ in, is the category that those introductions are most likely to fall into when categorised under the new scheme.
So unlisted introductions of less than 100 kg per year to be used solely for Research and Development are ‘taken to be’ in the Exempted category in the new scheme.
Unlisted introductions of cosmetic ingredients either at less than 100 kg per year posing no unreasonable risk, or non hazardous at less than 1% concentration, are ‘taken to be’ in the Reported category in the scheme. However, you don’t have to submit a pre-introduction report for these, unless and until you are actually introducing under the new scheme in the Reported category.
Now we’re back into considerably less complicated transitions.
If you have an approval from NICNAS to import or export a chemical subject to the Rotterdam Convention, then that approval is essentially authorised under the new scheme.
When it comes to making your Annual Declarations regarding your IC introductions for the year, AICIS requires that to be done for the registration year, i.e. from September to August. Transitional arrangements provide that for the first year of the scheme, 20/21, you can include the period from 1st July to 31st August 2020. That is, you don’t have to make a separate Annual Declaration in the new scheme just for those 2 months in between commencement of the scheme and commencement of the next registration year.
Finally, we’re going to briefly talk about the continuing work of transitional arrangements, as we don’t assume that every possible transitional scenario has been thought of and comprehensively dealt with in advance. Because of this, there are ongoing mechanisms to address any shortfalls in the transitional arrangements that are already in place, to ensure nobody loses out in the transfer to a new scheme.
Transitional legislation being the funny thing that it is, we can continue making additional Transitional Rules for up to 2 years after commencement of the new scheme, about any aspect of transitioning to the new scheme.
What’s more, these Rules can continue to modify the operation of the Transitional Act – so if a legislated transitional arrangement has unforeseen and unintended adverse consequences, new Transitional Rules can fix it.
Transitional Rules can even be retrospective, which is generally a BIG no-no for legislation, but can be necessary to sort out going from one system in the past to another new system.
There are some things Transitional Rules can’t do: they can’t create an offence or penalty; they can’t impose other enforcement powers; and they can’t impose a tax or appropriation.
Other than that though, for 2 years we’ll have the ability to respond to any problems that arise because of moving to a new regulatory scheme.
Thank you for your attention! We hope this has helped you understand the new scheme, and how we’re going to get there. For further information, including guidance material and links to our legislation, please visit our website.