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Disinfectants (hospital, household and commercial grade)
The following letter was sent to stakeholders in July 2005. The consultation closed on 30 September 2005.
Revised regulatory requirements for hospital, household and commercial grade disinfectants
This is to advise you of proposed changes to the way the Therapeutic Goods Administration (TGA) regulates hospital, household and commercial grade disinfectant products and to seek your comments on the attached draft revised Therapeutic Goods Order 54 (TGO 54) and its Guidelines.
In October 2002 the TGA introduced a new regulatory system for medical devices following implementation of amendments to the Therapeutic Goods Act 1989 (the Act) and the implementation of the Therapeutic Goods (Medical Devices) Regulations 2002. These changes resulted in:
- Sterilants and instrument grade disinfectants being regulated as Class IIb (medium to high risk) medical devices under the new system; and
- Hospital, household and commercial grade disinfectants, hereafter simply referred to as 'disinfectants', continuing to be regulated as therapeutic devices.
Following a comprehensive review into the regulatory requirements for disinfectants there are a number of recommended amendments to the regulatory requirements for these products (see Attachment 1).
1. Disinfectants (with specific claims) to be listable
Most therapeutic devices imported, exported or manufactured in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied. Registered devices undergo a full evaluation for quality, safety and efficacy prior to entry in the ARTG. Listable devices are not subject to a formal pre-market evaluation although information is required that reasonably demonstrates the safety and quality of the goods for the intended use.
- hospital, household and commercial grade disinfectants (with specific claims) are categorised as registrable therapeutic devices, and must comply with TGO 54, 54a and 54b;
- hospital grade disinfectants (without specific claims) are regulated as listable therapeutic devices, and must comply with TGO 54, 54a and 54b; and
- household and commercial disinfectants (without specific claims) are exempt from entry on the ARTG but must comply with TGO 54, 54a and 54b.
Industry, through the TGA/Industry Disinfectant Working Group, and the National Coordinating Committee on Therapeutic Goods (NCCTG) a subcommittee of the Australian Health Ministers Advisory Committee, have endorsed the proposal that the Therapeutic Goods Regulations 1990 (the Regulations) be amended so that all hospital, household and commercial grade disinfectants (with specific claims) would be regulated as listable therapeutic devices. The TGA proposes to implement this recommendation on the understanding that higher risk disinfectants will undergo a pre-market 'safety evaluation' in the following circumstances:
- listable disinfectants for which specific sporicidal, virucidal, tuberculocidal, fungicidal and other biocidal claims are made as detailed in the attached Allowable Claims document developed by the TGA/Industry Disinfectant Working Group (Attachment 2); and
- any disinfectant product containing a new chemical entity will require a toxicological evaluation.
The TGA is now ready to amend the Regulations to implement the agreed new requirements for hospital, household and commercial grade disinfectants (with specific claims).
- It is proposed that the regulation amendments to make all hospital, household and commercial grade disinfectants 'listable' take effect from 1 January 2006.
- Regulation 10B(5) of the Regulations provides that after the date of effect of these amendments, sponsors can apply to the TGA to transfer their registered disinfectants to the part of the ARTG for listed goods. Sponsors can also retain the entry in the part of the ARTG for registered goods.
- After the date of effect of the Regulations all new applications for ARTG entry for hospital, household and commercial grade disinfectants (with specific claims) will be processed as listing applications.
2. Exempt household/commercial grade disinfectants (containing a new chemical entity) to be listable
Currently, under the Act, listable or registrable disinfectants that contain a new chemical entity (as defined in the attached TGO 54) undergo a toxicological evaluation by the TGA as part of the pre-market assessment. In the case of disinfectants excluded from TGA regulation, the toxicological evaluation of new chemical entities is undertaken by the TGA's Office of Chemical Safety under the National Industrial Chemicals Notification Assessment Scheme (NICNAS) and under Trade Practices legislation.
There is an anomaly for household and commercial grade disinfectants (without specific claims) that are exempt from entry on the ARTG in that there are no provisions under the Act to undertake a toxicological evaluation for new chemical entities. This raised public health and safety concerns about the potential impact on the Australian environment of unevaluated new chemical entities. NCCTG have considered this anomaly and recommended that disinfectants which are exempt from inclusion on the Australian Register of Therapeutic Goods (ARTG), should be the subject of appropriate safety assessment of their active ingredients via TGA liaison with NICNAS to establish appropriate safety assessment for such ingredients.
It is therefore proposed to amend the Regulations to ensure that any exempt disinfectant that contains a new chemical entity will be regulated as a listable disinfectant and subject to a pre-market toxicological safety evaluation.
- It is proposed that the amendments to the Regulations to make household and commercial grade disinfectants that contain a new chemical entity 'listable' take effect from 1 January 2006.
- It is proposed that sponsors of currently exempt disinfectants that incorporate a new chemical entity be given two years to apply for listing on the ARTG.
- After the date of effect of the Regulations any new household and/or commercial disinfectants to be supplied in Australia that contain a new chemical entity will have to be listed on the ARTG prior to supply.
3. Disinfectants Excluded from Regulation under the Act
The draft Therapeutic Goods (Excluded Goods) Order of 2004 for household and commercial grade disinfectant products making low level microbial claims (Attachment 3) has been agreed by the TGA/Industry Disinfectants Working Group. This Order aims to exclude low risk sanitisers and deodorisers from regulation by the TGA.
The Order will be used to assist industry in determining whether disinfectant products fall within the TGA's regulatory scope. Products excluded from TGA regulation (and therefore included in the Order) will be treated as consumer goods and subject to the controls of the Australian Competition and Consumer Commission (ACCC).
The Australian Consumer and Speciality Products Association (ACSPA), in cooperation with specialist microbiologists and the ACCC, has developed an industry Code of Practice for Household & Commercial Products Claiming Antibacterial Action. The Code provides guidance on technical requirements, standards for product efficacy, labelling and claims, assisting companies wishing to make antibacterial claims for products excluded from TGA's regulatory scope. The Code can be accessed at http://www.accord.asn.au/members/resources/docs/codes/481/482.
- It is proposed that currently exempt sanitisers and deodorisers will become excluded from TGA regulation from the day the new Excluded Goods Order is signed.
4. Therapeutic Goods Order 54 and Guidelines
TGOs 54, 54A and 54B - Standard for Disinfectants and Sterilants and Guidelines for the Evaluation of Sterilants and Disinfectants (the Guidelines) specify the standards for performance of disinfectants and sterilants as well as the standards for packaging and labelling. These documents have undergone a major review after detailed consideration by the Disinfectant Working Group.
Due to the introduction of the new regulatory system for medical devices the revised TGO 54 and Guidelines has been further reviewed and split into:
- a new draft TGO 54 (Attachment 4) and Guidelines (Attachment 5) for disinfectants; and
- a Medical Device Standards Order (MDSO) for sterilants and instrument grade disinfectants.
The new TGO 54 and Guidelines are attached for your comment. The TGA will be consulting on the new MDSO as a separate exercise.
It is proposed that the transition arrangements for the implementation of the revised TGO 54 and Guidelines be aligned with the implementation of the new regulatory system for disinfectants and sponsors will have two years to meet the requirements of the new standard.
Australia/New Zealand Therapeutic Products Agency
The TGA will be moving to a trans Tasman Joint Agency on 1 July 2006. Under the trans Tasman Joint Agency proposal it has been agreed that disinfectants will be regulated by the joint agency as an Australian only requirement. While the administrative arrangements for including products on a joint agency register may differ slightly the regulatory requirements for disinfectants, which will be referred to as Related Therapeutic Products, will remain as detailed in this proposal.
The legislation for underpinning the Australia-only regulatory arrangements for these "related products" will be contained within an "Australia-only" part of the Australian Therapeutic Products Bill, Regulations made under this Bill and in "related products" Orders.
Your comments on the proposed legislative amendments for disinfectants, as well as comments on the attached draft TGO 54 and Guidelines, would be appreciated by.
Office of Devices, Blood and Tissues
31 July 2005
- Attachment 1 - Summary of regulation of disinfectants and sterilants (pdf,34kb)
- Attachment 2 - Draft allowable claims guide for hospital grade & household/commercial grade disinfectants (pdf,40kb)
- Attachment 3 - Draft Therapeutic Goods (Excluded Goods) order for Disinfectants 2005 (pdf,35kb)
- Attachment 4 - Draft Therapeutic Goods Order 54 - Standard for Household/Commercial and Hospital Grade Disinfectants (pdf,86kb)
- Attachment 5 - Draft Guidelines for the Evaluation of Household/Commercial and Hospital Grade Disinfectants (pdf,201kb)