Under COPR products are approved subject to specific Conditions of Approval; these are legal requirements which must be observed. The Approval Conditions Relating to Use are specified on the Schedule sent to the Approval Holder, and should be reproduced on the product label, either inside or outside a Statutory Box. The Statutory Box highlights to enforcement authorities those Approval Conditions Relating to Use where lack of compliance can be easily identified.
A user of a biocidal product approved under COPR must comply in full with all the Conditions of Approval, including instructions specified inside the Statutory Box and asterisked phrases outside the Statutory Box. If the product is being used at work users should also be aware of any requirements of the COSHH Regulations.
The Statutory Box should be a single-lined, clear and separate box. Within the Statutory Box the following should be included:
The information below must be included on your label, but outside of the statutory box:
If the product is classified under the CHIP Regulations the following information should also be included outside the Statutory Box:
Approval Holders should be able to substantiate any claims made on a product label, if required to do so at a later date.
The container label must be strong, durable and attached securely. These qualities should be sufficient to meet all conditions under which the container is likely to be transported, stored and used. The container label should be resistant to both the contents of the container and of other substances with which it might be expected to come into contact.
The container label must be in prominent position and, for dangerous products, it must be so placed that it can be read horizontally when the container is set down normally.
Text size: The label must be in a type size that is sufficiently easy to read.
Choice of units for application rate / directions for use: Metric Units (litres, kilogrammes, metres) must be used on labels.
HSE endorsement: Under COPR, HSE does not actually approve pesticides as this task falls upon Government Ministers from certain Departments / Assemblies / Parliaments (DEFRA, DWP, DoH, Welsh Assembly and Scottish Parliament). Therefore, statements such as "HSE APPROVED" are not acceptable on labels, associated literature or advertisements.
Safety claims: Statements such as ‘safe for babies’ and ‘safe for pets’ etc are unacceptable and statements specifically referring to claims of safety are prohibited under COPR in Schedule 1 Part 1 (2) regarding Consents to advertise.
For words such as ‘non-toxic’ or ‘natural’ HSE usually advises removal of these phrases from the product label as they give a misleading indication of the safety of the product. However, if you wish to make these claims then we would suggest that you discuss this with your Trading Standards Officer, as they are the enforcing authority for advertisement and sale.
Questionable statements: Claims such as a product is "ozone" or "environmentally friendly" in order for companies to claim their products give an edge in terms of performance, secondary functions etc over competitors products on their label are unacceptable and contentious. Such phrases should be removed unless the applicant is satisfied that they can substantiate their claim if it were to be challenged.
Medicinal claims: It should be noted that companies should not make any medicinal claims on a pesticide product label. For example, whilst products used against mites (acaricides) require approval under COPR and their labels can claim control of house dust mites, companies may not state that such control helps to prevent asthma.
If your product is applied to animals you should establish whether it requires authorisation under the Veterinary Medicine Regulations. The criteria for judging whether a product makes veterinary medicinal claims are described on the Veterinary Medicines Directorate website in Annex A of VMG Note 23.
Pictures on labels: Any pictures included on the draft label must not contradict agreed precautions, efficacy claims, application use methods, target pests as given on the approval conditions specified in the Schedule.
Mixing approved pesticides with other substances / materials: tank mixing claims (with other pesticides) are acceptable if suitable documentation has been provided and specific details have then been listed on the Schedule.
Small pack sizes / minimal packaging: Where an applicant indicates that it would be physically impossible to place all of the required information on the pack due to its small size, (i.e. when marketed in small tubes / vials / bait stations / sachets), it is accepted that the label content must be restricted in order to retain legibility but the minimal label must still carry:
However, minimal labelling can only be permitted where the container carrying the minimal label will be supplied with outer packaging (such as a box or card backed blister pack) where the full label requirements are met.
Alternatively, "concertina" labelling (where full labelling requirements are printed onto a label that is repeatedly folded and which opens outwards from a fixed panel on the container) may be used.
Containers supplied in two or more parts: Occasionally, where an applicant may wish to market a product whose container consists of more than one pack. For example, the container may consist of a card sheet with 2 blister packs on the front, which has been perforated so that the contents of 1 blister pack can be used, followed by the other at a later date. The problem with this type of packaging is that, unless there is complete duplication of label information on both portions of the pack, the label may be lost / destroyed when the first portion is used. In these cases, there should be some degree of commonality between the separable parts of the container but its extent must be determined by the layout, amount of space available etc.
HSE has recently reviewed its biocidal product label guidance in order to clarify to users and enforcement authorities the legal requirements for use of the product. This has led to some changes in the regulatory information to be included on product labels, including:
From 2010 HSE will use the revised criteria to assign precautionary phrases to Schedules to new approvals and to existing approvals undergoing a major amendment. Changes to label text triggered by major amendments should be implemented by suppliers at the next label reprint.