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For our next annual release, we have compiled all the planned revisions of the Industrial Chemicals Categorisation Guidelines (Guidelines). These include changes to acceptable test methods for demonstrating a chemical’s hazard characteristics and routine updates to the list of chemicals with high hazards for categorisation (list).
Have your say on proposed changes that will come into effect on 1 September 2027.
We invite your feedback on the revisions by 23 November 2026.
We propose to add test guidelines that we have determined as acceptable for demonstrating the absence or presence of a hazard characteristic or for testing the water solubility of a chemical. These will be added to the tables of acceptable test guidelines in appendices 8.4.1, 8.4.2 and 8.4.3 of the Guidelines.
We also propose to remove 3 test guidelines from appendices 8.4.1 and 8.4.2 of the Guidelines because we have deemed them either unsuitable or to correct an error.
Test guidelines for human health hazard characteristics that will be added to appendix 8.4.1 of the Guidelines
| Hazard tested | Test guideline to be added in 2027 |
|---|---|
| Chromosomal abnormalities – in vitro | EU Annex V test method B.67 |
| Developmental toxicity – in vivo | EU Annex V test method B.53 |
| EU Annex V test method B.64 | |
| Eye damage and eye irritation – defined approaches* | OECD test guideline 467 |
| Eye damage – in vitro | EURL ECVAM DB-ALM protocol No. 127 |
| EU Annex V test method B.61 | |
| EU Annex V test method B.68 | |
| OECD test guideline 496 | |
| Eye irritation – in vitro | EU Annex V test method B.69 |
| EURL ECVAM DB-ALM protocols No. 164, 190, 191 | |
| OECD test guideline 492B | |
| Gene mutation – in vivo | OECD test guideline 470 |
| EU Annex V test method B.62 | |
| Heritable germ cell mutagenicity – in vivo | OECD test guideline 483 |
| EU Annex V test method B.23 | |
| OCSPP 870.5380 | |
| OPPT 798.5380 | |
| OPP 84-2 | |
| Reproductive toxicity – in vivo | EU Annex V test method B.63 |
| EU Annex V test method B.64 | |
| Skin corrosion – in vitro | EU Annex V test method B.40bis |
| EURL ECVAM DB-ALM protocol No. 213 | |
| EU Annex V test method B.65 | |
| Skin irritation – in vitro | EURL ECVAM DB-ALM protocol No. 212 |
| Skin sensitisation – in chemico (1st key event in skin sensitisation) | EURL ECVAM DB-ALM protocol No. 217 |
| Skin sensitisation – in vitro (2nd key event in skin sensitisation) | EURL ECVAM DB-ALM protocol No. 184 |
| Skin sensitisation – in vitro (3rd key event in skin sensitisation) | EU Annex V test method B.71 |
| EURL ECVAM DB-ALM protocol No. 183 |
* We propose to add ‘OECD test guideline 467 – Defined Approaches on Serious Eye Damage and Eye Irritation’ to appendix 8.4.1 as an acceptable test guideline for eye damage and eye irritation. We will reflect this in the following Guidelines sections as extra options for demonstrating the absence of these hazard characteristics:
Test guidelines for environment hazard characteristics that will be added to appendix 8.4.2 of the Guidelines
| Hazard tested | Test guideline to be added in 2027 |
|---|---|
| Acute aquatic toxicity – in vivo (fish) | ISO 7346 |
| OECD test guideline 236 | |
| EU Annex V test method C.49 | |
| EURL ECVAM DB-ALM protocol No.140 | |
| OECD test guideline 212 (if test duration < 7 days) | |
| Acute aquatic toxicity – in vivo (algae or other aquatic plants) | ISO 8692 |
| OCSPP 850.4500 | |
| Bioaccumulation | EU Annex V test method C.46 |
| EU Annex V test method C.30 | |
| Bioconcentration | OECD test guideline 321 |
| Chronic aquatic toxicity – in vivo (fish) | EU Annex V test method C.47 |
| OPP 72-4 | |
| OECD test guideline 212 (if test duration > 7 days) | |
| Chronic aquatic toxicity – in vivo (invertebrates) | EU Annex V test method C.20 |
| OPP 72-4 | |
| Chronic aquatic toxicity – in vivo (algae or other aquatic plants) | OPPT 797.1050 |
| OPP 122-2 | |
| OPP 123-2 | |
| Partition coefficient | EU Annex V test methods A.23 |
| EU Annex V test methods A.24 | |
| Ready biodegradability | EU Annex V test method C.29 |
| Transformation in aquatic sediment systems | EU Annex V test method C.24 |
| OCSPP 835.4300 | |
| OCSPP 835.4400 |
Test guidelines for water solubility that will be added to appendix 8.4.3 of the Guidelines
| Hazard tested | Test guideline to be added in 2027 |
|---|---|
| Water solubility – chemicals or polymers | EU Annex V test method A.6 |
| OCSPP 830.7840 | |
| OPPTS 796.1840 | |
| OPP 63-8 | |
| Water solubility – polymers | EU Annex V test method A.20 |
Test guideline for a human health hazard characteristic that will be removed from appendix 8.4.1 of the Guidelines
| Hazard tested | Test guideline to be removed in 2027 | Reason for removal |
|---|---|---|
| Skin corrosion – in vitro | EU Annex V test method B.43 | This test guideline is not related to skin corrosion and was included in error. |
Test guidelines for environment hazard characteristics that will be removed from appendix 8.4.2 of the Guidelines
| Hazard tested | Test guideline to be removed in 2027 | Reason for removal |
|---|---|---|
| Acute aquatic toxicity – in vivo (fish) | ISO 10229 | This test guideline is not suitable for the acute aquatic toxicity hazard characteristic. |
| Bioaccumulation | OCSPP 850.1710 | This test guideline is not suitable for the bioaccumulation hazard characteristic in line with the Guidelines. |
How would this impact introducers?
These additions mean introducers will have more ways and methods to demonstrate that their chemical does or does not possess a hazard characteristic. The proposed removal of test guidelines is not expected to impact introducers.
This list is a downloadable list of chemicals with at least one hazard characteristic in human health hazard band C or environment hazard band C or D. The list is a screening tool that introducers must use at steps 4 to 6 of the categorisation process when working out if their introduction can be categorised as exempted or reported. The list is based on trusted national and international sources described under appendix 8.1 of the Guidelines.
We propose to add the following information source to appendix 8.1 of the Guidelines:
European Chemical Agency (ECHA) endocrine disruptor (ED) assessment list – Substances included on the list of chemicals with high hazard for categorisation are those with the outcome of ED for human health or ED for environment.
This information source captures chemicals considered by ECHA’s ED Expert Group for which the ED assessment list outcome is that the substance is considered to have endocrine disruption properties that are hazardous for human health or the environment. These chemicals have hazard characteristics corresponding to either human health hazard band C or environment hazard band D.
This will add 10 chemicals to the list in 2027.
How would this impact introducers?
Introductions of these chemicals would generally not be able to be categorised as exempted or reported in steps 4 to 6 of the categorisation process. This is an appropriate outcome for these types of chemicals.
We propose to remove the following information source from appendix 8.1 of the Guidelines:
European Commission Endocrine Disruptors Strategy – Substances included on the list of chemicals with high hazards for categorisation are those listed in Category 1, identified as having endocrine activity in at least one animal study.
Chemicals from this information source were originally included based on a strategy document for addressing concerns about potential endocrine disruptors. The European Commission has now adopted this strategy, and the list of chemicals from this information source have since been superseded by other initiatives for assessing potential endocrine disruptors.
This will remove 24 chemicals from the list in 2027.
How would this impact introducers?
Even if this source is removed, the introductions of these chemicals will generally remain in the assessed category. This is because the chemicals will either stay on the list based on other information sources or fall under one of the categorisation steps as medium to high risk to human health or the environment.
In total, we will add 286 entries to the list in 2027.
How will this impact introducers?
Based on information from pre-introduction reports (PIRs) and post-introduction declarations (PIDs) that we received, we expect that adding these chemicals to the list will only impact a relatively small number of importers or manufacturers. We’ll contact these introducers directly before adding the chemicals.
There will be 548 updates to existing entries on the list in 2027. An entry on the list needs updating because it has been either:
We will correct the CAS numbers on the list for these 4 entries:
| Chemical name | Correct CAS number |
|---|---|
| Citric acid, ammonium nickel salt | 18283-82-4 |
| Citric acid, nickel salt | 22605-92-1 |
| Doxorubicin hydrochloride (see Adriamycin) | 25316-40-9 |
| Tellurium dioxide | 7446-07-3 |
We will correct the CAS number for the following entry that was incorrectly duplicated on the list. We will also correct the formatting of the name and include all associated names:
| Corrected chemical name | Correct CAS number |
|---|---|
| Phenol, 4,4'-(1-methylethylidene)bis-; 2,2-Bis(4-hydroxyphenyl)propan; 4,4'-isopropylidenediphenol; Bisphenol A | 80-05-7 |
How will this impact introducers?
They can use more accurate and up-to-date entries on the list.
See the spreadsheet for the full list of chemicals to come into effect on 1 September 2027:
Chemicals on the list we will add, update or remove in 2027 [XLSX 8.4 MB]
To improve consistency of the Guidelines and make them clearer, our revisions will include fixes of spelling or grammatical errors, formatting and inconsistencies. We explain the details below for information only because they do not change the function or meaning of any aspect of the Guidelines.
To improve how we present the names of test guidelines in appendix 8.4, we will:
We propose to simplify the tables in appendices 8.4.1, 8.4.2 and 8.4.3 of the Guidelines by merging the test guidelines listed in the second and third columns into one column. This will become a single list of acceptable test guidelines for each hazard or property tested, rather than the current list of acceptable OECD test guidelines followed by their equivalent test guidelines. For example:
| Current format of tables in Parts 8.4.1, 8.4.2 and 8.4.3 | Proposed format for tables in Parts 8.4.1, 8.4.2 and 8.4.3 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
8.4.1 Acceptable test guidelines for human health hazard characteristics
| 8.4.1 Acceptable test guidelines for human health hazard characteristics
|
How will this impact introducers?
Simpler tables will be easier for introducers to understand whether the information they have about their introduction can be used to demonstrate the presence or absence of a hazard characteristic during the categorisation process. A single list of acceptable test guidelines for each hazard tested also allows us to write the name of each test guideline in full, which makes searching easier for introducers.
We propose to improve the text at the beginning of appendix 8.4 by removing the word ‘OECD’. This will clarify that this dot point applies to all types of test guidelines, not just OECD test guidelines. This means that studies which were performed according to a deleted or superseded method – but were completed before the method was deleted or superseded – are considered to be acceptable test guidelines.
| Current text in appendix 8.4 | Proposed text in appendix 8.4 |
|---|---|
The acceptable test guidelines for each hazard characteristic and property are set out in the tables below. They include: …
… | The acceptable test guidelines for each hazard characteristic and property are set out in the tables below. They include: …
… |
We will amend the wording of the final bullet point of part 6.22.2 (information required to demonstrate the absence of hazard characteristic ‘Acute toxicity – harmful’) to emphasise that the study is conducted via the oral route. This aligns with the option for demonstrating the absence of ‘Acute toxicity – fatal or toxic’ in part 6.15.2.
| Current text – final option in 6.22.2 | Proposed text – final option in 6.22.2 |
|---|---|
| test results from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL ≥ 1,000 mg/kg bw/day. | test results from an in vivo study via the oral route on the chemical or from suitable read-across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL ≥ 1,000 mg/kg bw/day. |
How would this impact introducers?
Although it is already implied by the type of test required (‘subacute oral toxicity’), introducers will benefit from consistent wording across similar study options. This will also emphasise the route of exposure for conducting this study.
We propose to amend the text at the beginning of appendix 8.1 to clarify that the list is a point-in-time compilation of chemicals identified from the specified sources of information as highly hazardous to human health or the environment. This will make it clearer that, depending on the timing of any updates to the information sources for the list, the list itself may not reflect the chemicals that are present on the information source at any given point in time.
| Current text in appendix 8.1 | Proposed text in appendix 8.1 |
|---|---|
| The list of chemicals with high hazards for categorisation is part of this appendix. It is published as an excel spreadsheet on the AICIS website. It consists of industrial chemicals that are present on the following information sources: | The list of chemicals with high hazards for categorisation is part of this appendix. It is published as an excel spreadsheet on the AICIS website. It consists of industrial chemicals that have been compiled from the following information sources: |
How would this impact introducers?
Amending this text reduces potential confusion. It does not change the function of any aspect of the Guidelines or how the list is to be used to categorise introductions of industrial chemicals.
| Part | Description or previous link | New link |
|---|---|---|
| 8.1 | United Nations Environment Programme scientific knowledge on endocrine disrupting chemicals | https://wedocs.unep.org/items/4f037d4d-dc5f-448d-9f74-5d525cf7c2fd |
| Footnote in part 6.14.2 | https://one.oecd.org/document/ENV/CBC/MONO(2021)11/en/pdf | https://www.oecd.org/en/publications/guideline-no-497-defined-approaches-on-skin-sensitisation_b92879a4-en/support-materials.html |
The following editorial changes are intended to make the Guidelines clearer and more consistent for introducers.
Certain terms such as definitions will be italicised, where they are not already.
Where not already used, the updated version will bold:
Where appropriate or needed, the updates will:
We will standardise spacing in tables and the spaces around hyphens and dashes.
Our updates to wording will:
We will link the list of chemicals with high hazards for categorisation in appendix 8.1 to our website for users to access it.
We will analyse all the feedback we receive and announce changes to the next version of the Categorisation Guidelines by 1 March 2027.