New category Reported 10kg

[Mike Dewhirst]

AICIS published new rules last week for a Reported category for chemicals with an annual volume of 10kg or less.

The main effect is relaxation of the rigour surrounding provision of information; low volume being recognised as reducing absolute risk.

The chemical does need to be categorised as Reported 10kg.

Some extra characteristics are declared such as not containing Fluorine or being an inorganic salt and not being on the banned or restricted EU or USA lists of cosmetic/flavour ingredient lists.

The reduction in rigour mentioned above needs to be considered and reflected in new 10kg versions of the Chemintro Pre-Introduction Report and the Memorandum of Understanding.

These will give rise to specific tickets here.

Other specific tickets will cover 10kg links to checklists etc for both Reported and Listed.

This ticket will remain open as a summary of the changes until all work is done. Further study will result in edits hereto.

[Mike Dewhirst]

REPORTED10KG

Subsection 27(6) new subsection relaxes rigour by using the word "known"

For example, if the software did not independently detect mutagenicity, carcinogenicity or reprotoxicity then it can be accepted as not known by the introducer to be so. This is because the user can add such hazards and the software would thereby "know" such a characteristic exists.

In practice, health and environment categorisation volumes are irrelevant - they are less than 10kg. Exposure and release factors are also irrelevant for such a small quantity.

The entire purpose of the new 10kg category is to relax information provision requirements which are so difficult for Australian introducers with taciturn overseas suppliers.

Program redesign

We have a set_category() method which first eliminates excluded, prohibited and other possible categorisations including Listed set according to Circumstances defined by AICIS Rules and selected by the user and then tests for risk to determine Exempted, Reported or Assessed.

If the risk is actually very-low, we could ignore REPORTED10KG and categorise as Exempted. The reasoning might be that if REPORTED10KG is used AICIS would need to be notified in future if volumes increased beyond 10kg.

However, an introducer would probably opt for REPORTED10KG simply to avoid having to obtain studies to prove an Exempted or Reported category.

We need a mechanism for the user to opt for REPORTED10KG. See Ticket #36

In any case, if the chemical fails any of the set of rules for <= 10kg then it will be Exempted, Reported or Assessed.

Rules

For REPORTED10KG category, the software must ensure:

Not (known) mutagenic or
Not (known) carcinogenic or
Not (known) reprotoxic or

For these three we need a new method which simply returns True if any of GHS hazards H340 or H341 or H350 or H351 or H360 or H361 are attached to the chemical. Likewise for PBT. See ticket #37.

If used in a cosmetic, it must not be prohibited or restricted in cosmetics by EU or USA

For this we need a new is_banned_for_cosmetics() method which scans the index for a chemical (CAS and/or name and/or EC number) and if detected returns True if prohibited or restricted.

There are chemicals on the EUR-Lex Cosmetics lists which are allowed with conditions. That means they are not banned by AICIS for REPORTED10KG.

As an aside, some of those cosmetic conditions may concern AICIS. When/if they list the chemical on the Australian inventory, the listing may carry similar conditions. See Ticket #34

and

Not (known to be) a solid or a dispersion or

Physical state of 'Unknown' is already treated by the software as equivalent with 'Solid' and/or 'Dispersion' for nanoscale processing. See Ticket #30.

Not (known) to be nanoscale

Nano-material already has a selection 'Not known' which AICIS (and the software) treats as 'Yes' but without needing a study report on nano particle dimensions. See Ticket 28#comment:3 which implements this.

and

Not (known) to contain Fluorine

We do need a has_fluorine() method which returns True if the molecular formula has a symbol 'F' or there is 'fluo' in the names. Returning False means it is not known to contain Fluorine. See Ticket #32.

OR IS known to be an inorganic salt

We already have element detection methods and organic/inorganic detection. See Ticket #33

and

Not (known) Persistent, Bioaccumulative and Toxic (PBT)

Already detected via CAS number search of the high hazard chemicals for regular categorisation - or the user has added the hazard data. See Ticket #37

Section 42A (relaxes rigour by using the word "reasonably")

Identification is identical with all other introductions. The difference is relaxed rigour in providing it - or not, if "reasonably practicable" to find out only when asked.

We will not need the MOU. Introducer can merely keep contact details of the person reasonably believed to know the information to provide to the Executive Director on request.

Section 46 - record keeping

We only need a useful link pointing to the AICIS record keeping checklist for REPORTED10KG. See Ticket #38

Section 56A - specific records to retain

A relaxed rigour around the actual name of the chemical. Just retain the "known" names.

However, there is NO relaxed rigour around knowing the product names and chemical volumes introduced. See also Ticket #38.

We will need to review the Introduction Report to adjust output based on REPORTED10KG. See Ticket #39