Regulatory Update: 03/2010
Issued: 28 January 2010
Background
This Update replaces Regulatory Update 30/2009 issued on 9 September 2009. It clarifies the use of the 'child and pet logo' for products other than lawn treatments and amends the timetable for changing labels that do not comply with the new rules. In addition it clarifies the use of scatter diagrams and written instructions for slug pellet products. Revised sections are highlighted with a vertical line on the right of the text.
A large number of incidents reported to the National Poisons Information Service (NPIS) involve garden pesticides and children. Children under 12 account for around 60% of all reported poisoning incidents and children under 4 represent the great majority of these. Although most of these incidents are not considered to be serious, the Advisory Committee on Pesticides (ACP) has made a series of recommendations to reduce children's exposure to home garden pesticides, which have also been discussed with the Crop Protection Association's (CPA) Garden Committee.
Regulatory action
In response to these recommendations, the Chemicals Regulation Division (CRD) is introducing the following package of controls. Some of these controls are changes or extensions of existing controls and some are new provisions. The regulatory changes will be introduced at re-registration of the relevant product, or by 31 December 2011 where re-registration would be after this date. Products which have already been re-registered must comply by 31 December 2011.
Changes applicable to all amateur products
All amateur pesticide products must carry the following short message on the front of the pack:
This phrase should be in bold type, upper case and white text on black background. The font type should be Helvetica Neue Bold Condensed.
For a pack with a front facing label under 100mm wide, the minimum font size should be 9pt.
For a pack with a front facing label between 101-200mm wide, the minimum font size should be 13.5pt.
For a pack with a front facing label over 200mm wide, the minimum font size should be 18pt.
Links to images for label printing can be found under 'Further information'.
For label clarity, a distinction must be drawn between safety phrases concerning storage (eg 'keep out of reach of children and pets') and those directed at 'after use' (eg 'keep children and pets away from treated area until granules have been watered in'). Storage safety phrases must be in the 'storage and disposal' section of the label, and the 'after use' phrases must be in the 'instructions for use' section of the label.
Changes regarding lawn treatments
- Child and pet pictorial labelling will not be allowed except for the following 'industry standard' logo (where this is supported by a risk assessment). Links to images for label printing can be found under 'Further information'.
- This logo must now be accompanied by a relevant imperative label phrase on the lines below:
"Keep children and pets away from treated area [until granules have been watered in]"
The precise phrase will be determined at re-registration depending on the nature of the product. This phrase replaces the former passive version ("children and pets need not be excluded from the treated area") which will no longer be allowed.
In some cases a risk assessment for pets may be undertaken by CRD for new or re-registered lawn treatment products. The risks to cats and dogs are likely to be minimal, but risks to herbivorous animals like rabbits might be a concern. However, in many cases it is likely that amateur products will be covered by the assessment undertaken in relation to the equivalent professional product. Additional data is not required from companies on this aspect unless specifically requested by CRD.
Use of the child and pet logo and imperative phrases on products other than lawn treatments
- Some non-lawn products have previously been assessed where non-standard logos and passive forms of phrase were agreed and approved by CRD. These must be amended to the standard logo and the phrase changed to the imperative form within 2 years (no application is required for this). However, the standard logo and imperative phrase cannot be added to products where the non-standard forms have not already been agreed and approved by CRD.
- The appropriate form of logo/phrase for new or re-registered products will be considered as part of the risk assessment conducted by CRD.
- There may be a very few low risk products (such as ferric phosphate slug pellets) where child/pet labelling is currently permitted but where the new form of imperative labelling would be inappropriate (given that the pellets need to remain intact to be effective). The appropriate form of labelling for special cases like these products will be considered by CRD on a case-by-case basis via an application.
Changes applicable to metaldehyde and methiocarb slug pellets and other bait-based products of equivalent toxicity
Metaldehyde slug pellet products already have to carry the following phrase:
"SINCE THIS PRODUCT CONTAINS METALDEHYDE, WHICH CAN KILL IF EATEN, IT MUST BE KEPT AWAY FROM CHILDREN AND PETS";
This phrase (amended to reflect the active substance) is now required to appear on all slug pellet products containing metaldehyde or methiocarb and any other bait-based products of similar toxicity.
- Some existing products carry a phrase on the lines "this product contains an animal repellent to reduce attractiveness of pellets to domestic animals". There is a risk that this phrase undermines the general warning to keep the pellets away from pets. Given that there are occasional instances of fatal poisoning of dogs, CRD now require this phrase to be removed.
- Child resistant containers are required for metaldehyde products and will be required for methiocarb slug pellets and any other bait-based products of equivalent toxicity.
- Pellets should normally be in the form of mini-pellets to limit the risk of serious exposure through accidental ingestion. This links with the findings of the 'reverse reference scenario' for metaldehyde products (see below) and thus, each pellet should not be over 40mg in weight if they contain 3% metaldehyde. A reverse reference scenario will need to be performed for methiocarb pellets (not currently on the market) and for any other bait-based products of equivalent toxicity before they are placed on the market.
- These products must be supplied in some form of packaging that restricts the flow of pellets from the container.
- Products will also need to have a clear 'scatter diagram' or picture illustrating the correct method of application. Companies are free to develop their own approach. The important point is to back up any written description of how to use the product with a clear visual image. If there is room on the label it would be helpful if this diagram could be accompanied by another one showing incorrect use (ie a pile of pellets) accompanied by a cross, with a tick accompanying the correct use diagram.
- The product must give a clear indication on how the recommended rate equates to the number of pellets applied over the required area. Information must be given on the appropriate spacing between individual pellets eg 'pellets should be scattered 10-15 cm (4-6 inches) apart. Additional useful information would be the total area treated by the pack and/or an indication of the number of pellets per m2 that should be applied. (Please also refer to Regulatory Update 04/2005 regarding limitations on maximum pack sizes for garden pesticides). A 'reverse reference scenario' to assess the safety implications of accidental ingestion of a product will become part of the pre-approval assessment process for slug pellets or other baited products.
Changes to approvals
An Amendment Notice covering child resistant closures and other changes for metaldehyde products is attached. No amendment notice is being issued in respect of the required labelling changes since all existing approvals already require approval holders to follow the requirements of the Labelling Handbook and subsequent regulatory changes such as those introduced in this regulatory update.
Contact information
If you have any queries concerning this update, please contact us: Link to Contact details page.
Further information
Industry guidance for using and positioning of the vector printing images