Which chemicals are eligible for self-assessment applications?
You can submit a self-assessment application for a PLC, non-hazardous chemicals and non-hazardous polymers. However, your application will not be accepted if the chemical or polymer can be predicted to be persistent and bioaccumulative, or if there are breakdown products that can be predicted to be persistent and bioaccumulative.
You can download the necessary forms and guidance documents for a self-assessment application.
Prepare your application using the appropriate electronic template (this does not mean you submit online, but rather that the form is available as an online form to be downloaded). You must complete all sections of the template.
Record all information to support your application on the electronic template. Other than the (M)SDS, do not send any supporting data—such as physicochemical and toxicological studies—with the application. If supporting data are submitted, NICNAS will not consider the application to be self-assessed.
Even though you do not submit it with your application, as a notifier you must hold supporting data for a period of five years for audit purposes.
Variation of data requirements
You cannot vary data requirements with self-assessment applications, including waivers of test requirements or substitution of analogue or product results. NICNAS needs to examine these case-by-case.
Data requirements that are not feasible or relevant (for example, particle size when a polymer is not extracted from solution) are not considered to be a variation.
Joint self-assessed applications
The Act makes no provision for joint self-assessed applications.
Third party confidential information
Under the Act, you must keep records to support any statement, based on third party information, made in, or in connection with, your self-assessed application. As such, NICNAS cannot accept an application where data are provided by a third party and confidential from the notifier.
Changing from the self-assessed to non self-assessed category
If your application is not accepted as a self-assessment, NICNAS will write to you explaining why. You can ask for your self-assessment application to be moved to the non-self assessed category, provided you pay the difference in fees. NICNAS may require more information if you do so.
Requesting additional information
There may be cases where a polymer fully meets the PLC criteria, but NICNAS requires additional information to address residual concerns. This is mostly in cases where exposure is high—such as where polymers with significant water solubility are released directly to the environment (for example, cosmetic or water treatment applications) or where polymers are constituents of products deliberately applied to the body (for example, cosmetics) or in food contact applications. Residual concerns can also relate to effects observed during toxicological or eco-toxicological studies, if these are relevant to exposure conditions.
NICNAS can ask you for additional information to address these types of concerns. You will generally be informed of this need 14 days after NICNAS receives your application.
If NICNAS identifies a significant health or environmental concern during screening, the self-assessment process will lapse and the assessment will revert to the normal 90-day timeframe (assessment clock).
Assessment process and outcomes
NICNAS will prepare a self-assessment report, including the public report and certificate for the applicant/notifier and will, in general, forward these by day 28 of the assessment clock.
A self-assessment report could also contain information prepared by NICNAS on other matters, such as residual concerns. On receiving this report, you can advise NICNAS of confidentiality concerns within 14 days, after which time the public report is published on the NICNAS website.
Annual reporting and record keeping
You must keep records to support any statement made in, or in connection with, your application for five years from the date your certificate is issued.
You must submit a report to NICNAS before or on 28 September of the following registration year, stating:
- the name of the chemical for which the certificate is issued
- the volume of the chemical introduced during the year
- any adverse effect of the chemical on occupational health and safety, public health or the environment of which you have become aware during the year.
Health criteria for non-hazardous chemicals and polymers (non PLC)
For self-assessment applications, you must establish that a chemical (other than a polymer) is a non-hazardous chemical with respect to mammalian toxicity and have available the data listed below in Table C4: OECD test guidelines and indicative results for toxicity testing - regardless of import volume.
Although NICNAS might not require full toxicological data for current limited category notifications, data will be required for self-assessments.
For each test, the result must lead to the chemical not being considered hazardous according to the NICNAS definition.
With genotoxicity testing, you need the results of two genotoxicity tests, and both must be independently negative.
You also have to list the relevant test guidelines, which are normally obtained from the Organisation for Economic Co-operation and Development (OECD). These are listed, along with indicative results for toxicity testing, in the following table: OECD test guideline and indicative results for toxicity testing.
Indicative results for toxicity testing
|1. Rat, acute oral**|
LD50 >2000 mg/kg bw
OECD TG 401
OECD TG 423
|2. Rat, acute dermal|
LD50 >2000 mg/kg bw
OECD TG 402
|3. Rat, acute inhalation (aerosols or particulates) (gases or vapours)|
LC50 >5 mg/L/4 hour
LC50 >20 mg/L/4 hour
OECD TG 403
4. Rabbit, skin irritation**
slightly to non-irritating
OECD TG 404
5. Rabbit, eye irritation
slightly to non-irritating
OECD TG 405
6. Skin sensitisation
no evidence of sensitisation
OECD TG 406 (Buehler and Maximisation tests)
OECD TG 429 (local lymph node assay )
7. Rat, repeat dose toxicity*
oral no observed adverse effect level (NOAEL) >50 mg/kg bw/day
dermal NOAEL >100 mg/kg bw/day
inhalation NOAEL >0.25 mg/L, 6h/day
OECD TG 407–409, 422
OECD TG 410–411
OECD TG 412–413
8. Genotoxicity—bacterial reverse mutation**
OECD TG 471–472
9. Genotoxicity—in vitro
OECD TG 473, 476, 479–482
* You only need data from one repeated dose mammalian toxicity test.
** For synthetic polymers with an NAMW ≥1000 Da, you are normally only required to have data items 1, 4 and 8 in the table. However, where the polymer contains one or more high concern RFGs with a functional group equivalent weight <5000, as defined in the PLC criteria (except un-substituted positions ortho and para to phenolic hydroxyl or partially-hydrolysed acrylamides), you are also required to show evidence of item six test results.
For a polymer, all the requirements in the table hold for biopolymers and low molecular weight synthetic polymers (with an NAMW <1000 Da).
If you have data other than that included in the table, you must report it. NICNAS will not accept the chemical for self-assessment if any such data leads to the chemical or polymer being classified as a hazardous substance.
You cannot request waivers of test requirements or substitution of analogue or product results with self-assessments, as these would require case-by-case NICNAS assessment.
You are not required to submit acute inhalation toxicity results if the chemical:
- has a vapour pressure <1.5 kPa
- (as introduced) has <25% of particles having <10 μm diameter
- is not purposely aerosolised during use (except where this constitutes a 'controlled use').
You are required to list the results of the toxicity testing in the report template, along with any discussion of observed results below classification thresholds. NICNAS may ask that your notification be changed to a non self-assessed category if the information reveals concerns that need further assessment.
In the above table, 'slightly irritating' refers to irritation test results where the effects observed are below classification thresholds. 'Non mutagenic' and 'non genotoxic' refer to negative results as defined for individual test guidelines.
Environmental criteria for non-hazardous chemicals and polymers (non PLC)
You must establish that the chemical or polymer is non-hazardous with respect to environmental toxicity. The chemical or polymer must:
- have one of these characteristics:
- dissolves in water without dissociation or association and is not surface‑active and the partition coefficient (n‑octanol/water) at 20oC as log Pow does not exceed 3
- solubility in water is >1 mg/L
- molecular weight (or number‑average molecular weight (NAMW) in the case of a polymer) is >1000
- be readily biodegradable
- have a very low aquatic toxicity to fish, aquatic invertebrates and algae, that is, LC50 or EC50 100mg/L or greater.
NICNAS will not accept chemicals meeting criteria for persistence and/or bioaccumulation for self-assessment.
You must present all relevant environmental data and a full set of physico-chemical data in the self-assessment report.
Last update 29 July 2018