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Have your say – revisions to the Categorisation Guidelines in 2027

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What’s this about

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.

Summary of revisions open for feedback

  • Addition of 57 test methods that introducers can use to show that a chemical does or does not have a human health or environmental hazard characteristic.
  • Removal of 3 test methods from the acceptable test guidelines.
  • Addition of one information source to the list and removal of one information source relating to endocrine disrupting substances.

We invite your feedback on the revisions by 23 November 2026.

Proposed updates to acceptable test guidelines – open for comment

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.

Additional acceptable test guidelines

Test guidelines for human health hazard characteristics that will be added to appendix 8.4.1 of the Guidelines

Hazard testedTest guideline to be added in 2027
Chromosomal abnormalities – in vitroEU Annex V test method B.67 
Developmental toxicity – in vivoEU 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 vitroEURL 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 vitroEU Annex V test method B.69 
EURL ECVAM DB-ALM protocols No. 164, 190, 191
OECD test guideline 492B
Gene mutation – in vivoOECD test guideline 470
EU Annex V test method B.62
Heritable germ cell mutagenicity – in vivoOECD test guideline 483
EU Annex V test method B.23
OCSPP 870.5380
OPPT 798.5380
OPP 84-2
Reproductive toxicity – in vivoEU Annex V test method B.63
EU Annex V test method B.64
Skin corrosion – in vitroEU Annex V test method B.40bis
EURL ECVAM DB-ALM protocol No. 213
EU Annex V test method B.65
Skin irritation – in vitroEURL 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:

  • Part 6.13.2 (eye damage) – Results from an acceptable test guideline for eye damage – defined approach (combination of tests) for serious eye damage and eye irritation that does not result in effects on the eye, as described for eye damage (category 1) in chapter 3.3 of the GHS.
  • Part 6.21.2 (eye irritation) – Results from an acceptable test guideline for eye irritation – defined approach (combination of tests) for serious eye damage and eye irritation that does not result in changes in the eyes, as described for eye irritation (category 2) in chapter 3.3 of the GHS.

Test guidelines for environment hazard characteristics that will be added to appendix 8.4.2 of the Guidelines

Hazard testedTest 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
BioaccumulationEU Annex V test method C.46
EU Annex V test method C.30
BioconcentrationOECD 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 coefficientEU Annex V test methods A.23
EU Annex V test methods A.24
Ready biodegradabilityEU Annex V test method C.29
Transformation in aquatic sediment systemsEU 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 testedTest guideline to be added in 2027
Water solubility – chemicals or polymersEU Annex V test method A.6
OCSPP 830.7840
OPPTS 796.1840
OPP 63-8
Water solubility – polymersEU Annex V test method A.20 

Test guidelines that will be removed

Test guideline for a human health hazard characteristic that will be removed from appendix 8.4.1 of the Guidelines

Hazard testedTest guideline to be removed in 2027Reason for removal
Skin corrosion – in vitroEU Annex V test method B.43This 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 testedTest guideline to be removed in 2027Reason for removal
Acute aquatic toxicity – in vivo (fish)ISO 10229This test guideline is not suitable for the acute aquatic toxicity hazard characteristic.
BioaccumulationOCSPP 850.1710This 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.

Proposed updates to sources of the list of chemicals with high hazards for categorisation (list) – open for comment

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.

Add one information source

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.

Remove one information source

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.

For information only

Adding new entries

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.

Updating existing entries

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: 

  • identified on another source of information
  • given an additional hazard by the same source.

Correction of entries

We will correct the CAS numbers on the list for these 4 entries:

Chemical nameCorrect CAS number
Citric acid, ammonium nickel salt18283-82-4
Citric acid, nickel salt22605-92-1
Doxorubicin hydrochloride (see Adriamycin)25316-40-9
Tellurium dioxide7446-07-3

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 nameCorrect CAS number
Phenol, 4,4'-(1-methylethylidene)bis-; 2,2-Bis(4-hydroxyphenyl)propan; 4,4'-isopropylidenediphenol; Bisphenol A80-05-7

How will this impact introducers?
They can use more accurate and up-to-date entries on the list.

Download

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.

Improve naming of test guidelines

To improve how we present the names of test guidelines in appendix 8.4, we will:

  • Order and name test guidelines consistently.
  • Clarify the previous name in parentheses, as shown:
    • OPPT 798.1100 (previously OPPT 798.110)
    • OCSPP 870.5450 (previously OPPT 870.5450)
    • OCSPP 870.5460 (previously OPPT 870.5460)
    • OCSPP 830.7840 (previously OPPTS 830.7840)

Simplify tables that show the acceptable test guidelines

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 8.4.3Proposed 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

Hazard tested OECD test guidelinesEquivalent test guidelines
Acute inhalation toxicity – in vivo403 or 436 or 433

EU Annex V test methods B.2 or B.52

OCSPP 870.1300, OPPT 798.1150, OPP 81-3

…  

8.4.1 Acceptable test guidelines for human health hazard characteristics

Hazard tested Acceptable test guidelines
Acute inhalation toxicity – in vivoOECD test guideline 403
OECD test guideline 436
OECD test guideline 433
EU Annex V test method B.2
EU Annex V test method B.52
OCSPP 870.1300
OPPT 798.1150
OPP 81-3
… 

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.

Clarify when data from deleted or superseded test guidelines can be used

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 8.4Proposed text in appendix 8.4

The acceptable test guidelines for each hazard characteristic and property are set out in the tables below. They include:

…

  • deleted and superseded OECD test guidelines if the study was done before the guideline was deleted or superseded

…

The acceptable test guidelines for each hazard characteristic and property are set out in the tables below. They include:

…

  • deleted and superseded OECD test guidelines if the study was done before the guideline was deleted or superseded

…

Clarify the route of exposure

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 6.22.2Proposed 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.

Clarify that the list is a point-in-time compilation of chemicals from the information sources

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.

Update links to external sites

PartDescription or previous linkNew link
8.1United Nations Environment Programme scientific knowledge on endocrine disrupting chemicalshttps://wedocs.unep.org/items/4f037d4d-dc5f-448d-9f74-5d525cf7c2fd
Footnote in part 6.14.2https://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. 

Italicisation of certain words

Certain terms such as definitions will be italicised, where they are not already.

Use of bold for emphasis

Where not already used, the updated version will bold:

  • terms such as the names of hazard characteristics in part 6
  • the words ‘not’ or ‘no’ to demonstrate the absence of hazard characteristics to add emphasis.

Symbols

Where appropriate or needed, the updates will:

  • replace letter ‘x’ with the × symbol
  • insert the missing ‘]’ symbol from footnote in Part 6.5.2
  • add missing full stops
  • remove full stops from tables
  • correct ‘read across’ to ‘read-across’
  • add commas to numbers greater than 1,000 where not already present
  • superscript the number 2 in ‘mm2/s’
  • replace ‘EC10’ with ‘EC10’
  • represent blank cells in tables with a dash for consistency.

Spacing

We will standardise spacing in tables and the spaces around hyphens and dashes.

Wording

Our updates to wording will:

  • replace ‘information to demonstrate’ with ‘information that demonstrates’ 
  • merge paragraphs that have been incorrectly separated, and vice versa
  • apply correct use of capital letters
  • show optional plurals using ‘(s)’
  • use the correct naming conventions for schedules to the Rules (rather than ‘of’ the Rules).

Linking other documents

We will link the list of chemicals with high hazards for categorisation in appendix 8.1 to our website for users to access it.

Next steps

We will analyse all the feedback we receive and announce changes to the next version of the Categorisation Guidelines by 1 March 2027.

Have your say by 23 November 2026

Do you support the proposed updates to the acceptable test guidelines in Part 8.4 of the Guidelines

Tell us your comments about the proposed updates to the acceptable test guidelines in Part 8.4 of the Guidelines:

After you submit this consultation form, we will contact you with the next steps for how submit a document or file via email.


Do you support the addition of one source and removal of another source on the list of chemicals with high hazards for categorisation?

Tell us your comments about the proposed addition of one source and removal of another source on the list of chemicals with high hazards for categorisation?

After you submit this consultation form, we will contact you with the next steps for how submit a document or file via email.


Other feedback

Tell us any other comments about the proposed revisions to the Categorisation Guidelines for 2027:


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