Draft code of practice for national retail storage of Schedule 5 and Schedule 6 products
November 2007
Preamble
The purpose of scheduling is to classify chemicals into groups that require similar regulatory controls over their access and availability.
Chemicals are not classified on the basis of a universal scale of toxicity or hazard. Although these are very important factors to be considered, scheduling decisions also take into account many other criteria such as the purpose of use, safety in use and labelling and packaging mechanisms to mitigate any safety concerns.
The Schedules have been developed over a long period of time and ancillary compliance obligations such as retail storage requirements have also been initiated around Australia.
The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) sets out the decisions of the National Drugs and Poisons Schedule Committee regarding the national scheduling of chemicals. It also includes, where necessary, model provisions about packaging and labelling and recommendations about any other relevant controls.
Objective
The objective of this document is to provide guidance to manufacturers and retailers on achieving a consistent safety standard for the storage of Schedule 5 and Schedule 6 products in a retail setting that is commensurate with the risk of accidental ingestion by a child.
This Code of Practice provides for an equivalent safety outcome as intended by State and Territory regulations whilst allowing for national consistency in retail storage that meets the expectations of consumers, regulators and other stakeholders, and is commercially feasible.
Scope
The scope of this document is limited to Schedule 5 and Schedule 6 products when packaged and displayed for retail sale in packs of 5 litre and/or 5 kg or less.
Such Schedule 5 products are labelled CAUTION and Keep out of Reach of Children. The SUSDP summarizes this schedule to include products with a low potential for harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.1
1 Introduction and classification from SUSDP.
Risk management considerations
The following risk management considerations have been taken into account in the development of this document:
- the ease and/or likelihood of children with sufficient time and motivation to gain access to the product and/or its contents and accidentally ingest a sufficient quantity which could result in serious injury and/or permanent damage;
- in limiting the likelihood of such ingestion through barriers to a child readily or delay to opening the product, the Code should also serve to provide limited general exposure to the contents (and potentially improve the products' integrity in the transport and storage prior to retail sale); and
- Schedule 6 products will generally present a higher risk if accidentally ingested compared to Schedule 5 products.
Guidance
Flexible retail storage is possible where the product's storage and/or nature and/or packaging limits the likelihood of accidental ingestion by a child through providing a barrier and/or delay to opening the product as per the risk management consideration set out above.
A retailer, when displaying Schedule 5 and/or Schedule 6 products for sale, where the public has access, should ensure that:
- the area is directly supervised or within the direct line of sight of a manned service counter; or
- products are stored at least 1.2 metres above the floor; or
- the product is presented with a child resistant closure and/or packaging2; or
- the product packaging/presentation limits or delays access.
Examples of presentation and/or barrier packaging features to achieve this are set out below. This list is not intended to be exhaustive and does not preclude product and/or packaging innovations that aim to achieve the same outcome.
- Composite packs e.g. an outer box that contains multiple product packs, or
- Blister or strip packaging, or
- Heat sealed or glued clam shell packaging, or
- Sealed cartons, or
- Aerosol packs, or
- Non-access packaging presentations e.g. bait stations, or
- Shrink wrapped containers and/or closure, or
- Liquid preparations that are presented as a dab on or roller, or
- Powder and/or solid that are in containers that are foil and/or paper wrapped and/or sealed, or
- Products that use tamper evident packaging including
- Film wrappers
- Bubble packs
- Heat shring bands or wrappers
- Pouches, sachets and form fill seal packs
- Container mouth inner seals
- Tape seals
- Breakable caps
- Tear away caps
- Sealed metal tubes
- Sealed plastic/laminate tubes
OR
- Schedule 5 liquid or gel preparations (other than above) that are:
- trigger packs, or
- very viscous, or
- presented with a small orifice or restricted flow insert
- Schedule 5 powder and/or solid preparations (other than above) that are
- presented as shaker packs, or
- reduced flow formulations, or
- presented in a pack with a small orifice
- Schedule 6 liquid or gel preparations (other than above) that are
- trigger packs and presented with another barrier feature to limit access/exposure, or
- very viscous and presented with another barrier feature to limit access, or
- presented in a pack with a small orifice with another barrier feature to limit access, or
- presented with a restricted flow insert
- Schedule 6 powders and/or solid preparations (other than above) that are
- presented as shaker packs and presented with another barrier feature to limit access, or
- reduced flow formulations and presented with another barrier feature to limit access, or
- presented in a pack with a small orifice with another barrier feature to limit access.