Using AICIS approved chemical names for protecting confidentiality

This is a reforms consultation on guidance for the proposed new scheme

Published: 27 September 2018
Due date for comments: 26 October 2018

This guidance is for:

• businesses who want to protect their chemical’s identity
• members of the public who wish to understand what an AICIS Approved Chemical Name (AACN) is

We are seeking feedback on the:

• clarity of the guidance and
• approach to masking a chemical name

On this page:

• what is an AACN
• how to create an AACN from a chemical name
• how we check your proposed AACN is valid
• how we use the AACN instead of the chemical name
• masking levels and justification of

What is an AACN?

An AACN is a generic or masked chemical name. We publish it instead of the chemical’s full name to protect a chemical’s identity. We will use an AACN if we’ve approved an application to protect a chemical’s identity as confidential business information (CBI). This occurs under Part 6 Division 4 (Confidentiality and disclosure) of the Industrial Chemicals Act and associated Rules.

Similar systems of generic naming are also used in other jurisdictions such as the US, Canada and the EU. This guidance is based on the chemical masking schemes used for industrial chemicals in Canada and the US.

When you apply to us for CBI protection of your chemical’s identity, we’ll expect you to include a suggestion of a proposed AACN. If you don’t suggest one, we’ll create one for you (if we approve your CBI application). We’ll do this by changing only one part of the chemical’s name. We call this an AACN with one level of masking.

Creating a masked name

You create a masked name by replacing specific parts of a chemical name with a related generic name that could represent various specific parts.  The way you mask a chemical’s name depends on the type of chemical.

In summary, an AACN must:

• use the minimal amount of masking that will protect anonymity (these are called masking levels and start at level 1)
• not mask the part of the chemical known to cause toxicity or environmental fate concerns (unless you can justify why this is needed)

If you mask your chemical higher than level 1, you’ll have to justify why to us.

Note an AACN can:

• be the same as a masked name for the same chemical from an overseas jurisdiction
• only apply to one chemical. If you have another chemical that could end up with an existing AACN, an appended modifier (such as a number) will be applied to distinguish it

How we check a proposed AACN is valid

We’ll check your proposed AACN to determine whether it is acceptable, including whether it has been created following this guidance. We may also consult with risk managers to make sure they can effectively implement any risk management recommendations using the proposed AACN. If it is acceptable and your CBI application is approved, we will use this AACN when referring to the chemical. If we have already issued an AACN for the same chemical to a previous introducer, we will provide you with that same AACN (as each chemical can only have one AACN).

When do we use an AACN instead of the full chemical

We will use an AACN whenever we publish information about the chemical for the 5 years from when we approve the application for CBI (unless the approval is revoked). This includes publication in any subsequent assessment statements relating to introductions of the chemical by other introducers.

AACNs on the chemical Inventory

If we have an AACN for a chemical, we’ll use that on the Inventory listing and make it clear that the name on the listing is an AACN.

Even though the AACN is a generic chemical name, it only corresponds to one chemical. You cannot assume that the Inventory listing covers any chemical that could have that AACN. If you are intending to introduce a chemical that you think may be covered by an Inventory listing with an AACN then you will need to contact us to confirm whether the listing covers your chemical.

If CBI protection is removed, we’ll change the listing to include the CAS name instead of the AACN.

When it’s time to review a chemical’s CBI status

We review CBI status 5 years after initial approval. We will only review whether continued protection with an AACN is still needed and will not consider changes to the approved AACN.

Example of chemical masking process

Specific chemical name:  “chloromethane”

“chloro” is replaced with the generic term “halo”. The element “chlorine” is a member of the “halogen” family of elements and thus related.

Masked chemical name: “halomethane”

The full chemical identity of a substance whose name is protected by the masked name “halomethane” could be “fluoromethane”, “bromomethane” or “iodomethane”, because the elements “fluorine”, “bromine” and “iodine” are also members of the “halogen” family. Hence the masked name provides some protection of the chemical’s identity. Moreover, because the generic term “halo” is chemically meaningful, “halomethane” still provides stakeholders with useful information concerning likely chemical structure, reactivity and potential toxicity without revealing the chemical’s identity.

Basing the generic name on a systematic chemical name (such as a CAS name or IUPAC name) keeps some degree of order to the masked chemical name. This allows a person to understand the “generic” structure of the chemical.

This is different to protecting the identity of the chemical by using a trade name. A trade name may not provide any indication of the chemical’s structure.

Masking

How masking levels work

One level of masking hides one feature of a chemical’s name. This includes repeats of that feature.

Two levels of masking hide two features, and so on.

You do not need to justify one level of masking but for any higher masking, you must justify why this is needed. The exception to this is if you are proposing an AACN that is the same as a masked name from an overseas jurisdiction that uses a similar system of masking chemical names.

How you justify additional levels of masking

If one level of masking won’t protect your CBI, you will need to provide a justification for additional levels of masking. You will do this when applying for CBI and proposing the AACN.

In your justification you will need to consider all possible one level AACNs and why they would not result in adequate protection for the identity of your chemical. For example, a one level AACN may only cover a small number of chemicals or, the masked name may still reveal information that formed the basis of the CBI claim.

When you can justify that one level of masking isn’t enough to protect your CBI, you can then follow our guidance for proposing an AACN with 2 levels or more. You need to provide justification at every level as to why a particular level is not enough to protect your CBI.

There is no limit to the number of levels of masking that you can propose, as long as the number of levels is the minimum necessary to adequately protect the identity of your chemical.

Rules for masking your chemical's name

The proposed AACN for your chemical must:

• be based on a CAS (our preference) or IUPAC name
• use the least amount of masking to achieve anonymity
• not mask any part of the chemical responsible for toxicity or environmental fate concerns, unless you can justify that:
  • you don’t know which parts are responsible; or
  • revealing this information would significantly compromise your CBI

If we have agreed to give your chemical an AACN, but the first choice of AACN is unavailable, we encourage you to propose an alternative. If an alternative AACN does not protect your CBI, we can approve an AACN that uses the same generic name as an existing AACN with an appended modifier (such as a number) to distinguish it.

The way you apply masking to create an AACN depends on the type of chemical.

Different types of chemical are named with varying precision under the CAS and IUPAC naming systems. For some chemicals, the full chemical identity may not always be obvious from their CAS name.

The following information will help you follow and understand masking rules for:

• Discrete chemicals
• Polymers
• UVCBs
• Enzymes

Discrete chemicals

Skip to polymers

Discrete chemicals have a definite chemical structure that can be represented by a definite molecular formula and chemical structure diagram.

The names of chemicals with a distinct chemical identity normally reveal the following structural information:

1. identity of the parent structure
2. identity, number, and position of chemical group(s) attached to the parent structure(s) or to other chemical groups
3. identity and number of counter ions (for salts)
4. stereochemical relationships

You can create an AACN for substances with a distinct chemical identity by masking structurally descriptive parts of the proper chemical name (i.e. CAS name or IUPAC name).

You can substitute non-descriptive terms for distinctive parts of the proper chemical name.

The structurally descriptive parts of a chemical name that you can mask are:

1. a suffix that specifies the position of a single chemical group (or locant)
2. the locant and multiplicative prefixes (e.g., di-, tri-, tetra-) that together specify the number and position of a given chemical group
3. the identity (but not position and number) of a given chemical group
4. the identity of a given parent structure, and locants of a substituent chemical group
5. the identity and multiplicative prefixes (specifying the number) of a given simple cation or anion of a salt
6. the stereochemical or isomeric identifiers (e.g., D- or L-, R- or S-, E- or Z-, cis- or trans-)

We are likely to accept as single level masked AACNs those that are created by eliminating stereochemical indicators (if appropriate) from the proper chemical name and by masking one other structure detail.

Parent structure

You can mask a parent structure that’s a chain of carbon atoms or a ring system in the chemical name using only the following masked terms:

• alkyl or alkane
• alkenyl or alkene
• alkynyl or alkyne
• aryl
• carbomonocyclic or carbomonocycle (e.g., benzene, cyclopentane)
• carbopolycyclic or carbopolycycle (e.g., naphthalene, spiroundecane)
• heteromonocyclic or heteromonocycle (e.g., pyrrole, p-dioxane)
• heteropolycyclic or heteropolycycle (e.g., indole, benzothiazole)

You should only mask one such parent group or multiple occurrences of the same parent group. You need to justify masking additional parent groups.

Chemical group

You can mask the identity of an attached chemical group in your chemical’s name using only the following masked terms:

• alkyl, alkenyl, alkynyl
• aryl
• carbomonocylic or carbopolycyclic
• heteromonocyclic or heteropolycyclic
• halo or halide for halogens
• “substituted’’ for substituents where no generic name can be established (e.g., amino, hydroxyl, oxo); ‘heteroatom-substituted” can also be used for heteroatom-based chemical groups
• “stereoisomer(s) of’’ for isomers where the specific stereochemistry should not be revealed

You cannot mask a chemical group that includes a carbon atom having more than one single free valence if the carbon is:

• directly attached to an acyclic carbon atom
• included within a ring system.

In these circumstances, you can only mask the atom or group of atoms attached to the carbon atom (see Example 3).

In the case of inorganic and organic metal salts and organometallics, you can mask the identity of the metal atom by substituting with the terms:

• “metal”
• “transition metal”
• “alkali metal”
• “alkaline earth metal”

The following examples show how you can mask a discrete chemical with 1 or 2 levels of masking.

Or skip to polymers

Example 1

Example 2

Example 3

Example 4

Polymers

Skip to UVCBs

CAS names for polymers are either structure-based or source-based.

Structure-based names — These specify the structural repeating unit(s) (SRU) (comprised of one or more subunits) in the polymer. This includes any modifiers (such as the structure of capping units).

Source-based names — These specify the individual monomers and any other reactants that make up the polymer.

You can apply the same masking guidance for discrete chemicals to the parts of a polymer name as the SRUs, modifying units (structure-based names) and the monomers/other reactants (source-based names) are generally discrete structures/chemicals.

You can create an AACN for a polymer named using:

• the source monomers/other reactants by masking only 1 monomer or other reactant
• SRU(s)/modifiers, by masking only 1 subunit of a SRU or modifying structure

With justification, you can apply 2 or more levels of masking to a source-based polymer name by following these points:

• 2 levels of masking in one monomer or other reactant (effectively 2 levels of masking)
• 1 level of masking in two monomers/other reactants (effectively 2 levels of masking)
• 1 level of masking to three monomers/other reactants (effectively 3 levels of masking)
• 2 levels of masking to 1 monomer/other reactant and 1 level of masking to 1 monomer/other reactant (effectively 3 levels of masking)
• 3 levels of masking to one monomer/other reactant (effectively 3 levels of masking)

With justification, you can apply 2 or more levels of masking to a structure-based polymer name by following these points:

• 2 levels of masking to 1 subunit of an SRU or modifying structure (effectively 2 levels of masking)
• 1 level of masking to 2 subunits/modifying units (the subunits may be in different SRUs) (effectively 2 levels of masking)
• 1 level of masking to 3 subunits (effectively 3 levels of masking)
• 2 levels of masking to one subunit/modifying structure and 1 level of masking to 1 subunit/modifying structure (effectively 3 levels of masking)
• 3 levels of masking to 1 subunit/modifying structure (effectively 3 levels of masking)

Example 5

Specific polymer name: 2-Propenoic acid, 2-methyl-, polymer with cyclohexyl 2-methyl-2-propenoate, methyl 2-methyl-2-propenoate and phenylmethyl 2-methyl-2-propenoate, 2,2'-(1,2-diazenediyl)bis[4-methoxy-2,4-dimethylpentanenitrile]-initiated

Acceptable AACN with 3 levels of masking could be:

• 1 level of masking in each of 3 monomers/other reactants

2-Alkenoic acid, 2-methyl-, polymer with cyclohexyl 2-alkyl-2-propenoate, methyl 2-methyl-2-propenoate and phenylmethyl 2-methyl-2-propenoate, 2,2'-(1,2-diazenediyl)bis[4-methoxy-2,4-dimethylalkanenitrile]-initiated

• 1 level of masking in 1 monomer and 2 levels of masking in another monomer

2-Alkenoic acid, 2-methyl-, polymer with cycloalkyl 2-alkyl-2-propenoate, methyl 2-methyl-2-propenoate and phenylmethyl 2-methyl-2-propenoate, 2,2'-(1,2-diazenediyl)bis[4-methoxy-2,4-dimethylpentanenitrile]-initiated

• 3 levels of masking in 1 monomer

2-Propenoic acid, 2-methyl-, polymer with cycloalkyl 2 -alkyl-2-alkenoate, methyl 2-methyl-2-propenoate and phenylmethyl 2-methyl-2-propenoate, 2,2'-(1,2-diazenediyl)bis[4-methoxy-2,4-dimethylpentanenitrile]-initiated

Example 6

Specific polymer name: Poly[imino-1,6-hexanediylimino(1,13-dioxo-1,13-tridecanediyl)]

Acceptable AACN with 2 levels of masking could be:

• 1 level of masking in 2 different subunits of the SRU

Poly[imino-1,6-alkanediylimino(1,13-dioxo-1,13-alkanediyl)]

• 2 levels of masking in 1 subunit of the SRU

Poly[imino-alkanediylimino(1,13-dioxo-1,13-tridecanediyl)]

The first AACN arguably provides weaker protection than the second AACN. This is because retaining the locant “1,6” means that the “alkane” term must include at least a hexane group (i.e. is at least 1,6-hexanediyl) but with possible unspecified alkyl branching on the hexanediyl unit.

The second AACN example provides arguably stronger protection. This is because disguising both the locant and the chain length means the alkane segment between the 2 nitrogens could be of any length greater than 1 carbon.

UVCBs

Skip to enzymes

Unknown or Variable Composition, Complex Reaction products and Biological Materials (UVCBs) have some uncertainty in their chemical identity. They don’t have definite molecular formulas or chemical structure diagrams. They often have variable structural elements that are undefined or have unknown structural elements.

Some substances can only be represented by partial or incomplete chemical structures. In other instances the composition can only be described in terms of a complex combination of several different known or unknown components.

The method of manufacture can also identify a substance. For a substance manufactured by a chemical reaction, you can state in terms of the:

• immediate precursor substances and other reactants that participate in the final reaction sequence used to manufacture the substance
• the nature of the reaction (e.g., ethoxylation or bromination)

For a substance derived from a source without chemical reaction, processing information identifies the source and method of derivation (e.g., distillation).

Although the chemical name of UVCBs may be based on variable types of information, you can apply procedures similar to those used for discrete chemicals.

To mask manufacturing or chemical processing methods, you can use a more generic, structure-based descriptor or a more generic descriptor of the method. For example:

• “methoxylated” or “ethoxylated” substituted with “alkoxylated”.
• “oxidised” or “hydrogenated” substituted with “modified”
• “fumerated” or “maleated” substituted with “functionalised”

To mask source information, you can use a more generic descriptor of the source. For example:

• “Oils, catnip” substituted with “plant-based oils,” and
• “Fatty acids, tallow, sodium salts” substituted with “animal-based fatty acid salts”

If the UVCB substance is described based on the immediate precursors and other reactants, you can propose an AACN following some of the polymer guidance. You can use the rules for polymers named after the source monomers/other reactants. In this case, for 1 level of masking you would mask one precursor or other reactant (see below).

For example, you could mask the “1-chloronaphthalene” reactant in “Formaldehyde, reaction products with 1-chloronaphthalene” by substituting with “halonaphthalene” (one level) or “halocarbopolycycle” (two levels).

The following examples show how you can mask a UVCB with one or two levels of masking.

Example 7

Example 8

Enzymes

You can create AACNs for enzymes by disguising the fourth level Enzyme Commission number description. This description is designated by the International Union of Biochemistry and Molecular Biology (IUBMB)’s nomenclature committee.

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Last update 28 September 2018