New category Reported 10kg

[Mike Dewhirst]

AICIS published new rules in late November 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 ingredient lists.

These will give rise to specific tickets here.

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")

The word "known" implies that the person introducing the chemical would say so if the characteristic of interest to AICIS was known to exist.

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.

Program flow

There is no difference in categorisation program flow because the new rules start with the Reported category.

At that point, if the total volume is <= 10kg, auto-categorisation as REPORTED10KG should commence.

User intiation by selecting REPORTED10KG would be incompatible with current program flow which must calculate the category.

There are category user-selections (Commercial evaluation and Exceptional circumstances) which are respected, but they bypass the categorisation software.

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 is_awful(chemical_hazards)

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

For this we need a new is_banned_for_cosmetics() method

and

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

Not (known) to be nanoscale

We now have a new physical form of Unknown and nanoscale data is always respected.

and

Not (known) to contain Fluorine or

IS known to be an inorganic salt

We already have element detection methods and organic/inorganic detection

and

Not (known) PBT

Already detected via CAS number or added hazards

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 to provide to the Executive Director of the person reasonably believed to know the information.

Section 46 - record keeping

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

Section 56A - specific records to retain

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

However, there is no relaxed rigour around knowing the product names and chemical volumes introduced.

In summary, AICIS is not going to follow up on any of this unless something goes wrong.

[Mike Dewhirst]

All sub-tickets of this ticket are now closed and so this ticket is now complete.