Control of Pesticides Regulations (COPR) label guidance – August 2007
1. Labelling Requirements of COPR and other Regulations
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.
1.1 Text required inside the Statutory Box
The Statutory Box should be a single-lined, clear and separate box. Within the Statutory Box the following should be included:
- An initial statement "STATUTORY CONDITIONS OF APPROVAL RELATING TO USE".
- The restriction of use phrase as detailed in section 3/1 (iii) on each Schedule.
- The application rate as detailed at section 3/1 (iii) of the Schedule. Non-asterisked precautionary phrases stated at section 3/1 (iii) safety phrases(s) of the Schedule. Those precautionary phrases prefixed by an asterisk, should appear outside the Statutory Box.
- The statement "Users must comply in full with all their legal responsibilities under the Control of Pesticides Regulations 1986 (as amended), including complying with all Conditions of Approval "
- A final statement "READ ALL PRECAUTIONS BEFORE USE.
- HSE XXXX" where XXXX is the unique 4 digit HSE number.
1.2 Text required outside the Statutory Box
The information below must be included on your label, but outside of the statutory box:
- The trade name of the product
- A contact name, address and telephone number for the marketing company should be found on the label. If the product is distributed by another company, then their name may also appear on the label, provided that the function of the second company is clear and their details are printed in a smaller type setting than the marketing company.
- The pack size (nominal mass or nominal volume)
- Precautionary phrases stated at section 3/1 (iii) safety phrases(s) of the Schedule which are asterisked (i.e. not to be included in the Statutory Box)
- The phrase "To avoid risks to man and the environment, comply with the instructions for use."
- The batch number
- The Contents Statement, as detailed in section 3/1 (iii) of the Schedule.
- Any additional label wording specified in section 4 of the schedule
If the product is classified under the CHIP Regulations the following information should also be included outside the Statutory Box:
- The appropriate CHIP Hazard symbol(s) and Indication(s) of Danger as specified in section 3/1 of the Schedule.
- The Risk phrase(s) specified in section 3/1 of the Schedule.
1.3 Sample labels
Sample labels for professional and amateur biocidal products approved under COPR are provided to help Approval Holders label their products.
2. General requirements for labels
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:
- The product name;
- The name and concentration in %w/w of all active substances in the formulation;
- The name of any "dangerous" substance whose concentration is at levels which automatically trigger product classification (unless exempted under the CHIP regulations when present in packaging of less than 125 ml);
- HSE Number;
- The appropriate hazard symbol and indication of danger plus any associated risk phrases (unless exempted under the CHIP Regulations for packaging of less than 125 ml);
- Any other relevant information required under COPR, namely precautionary phrases; If there is insufficient space to list recommended precautionary phrases for the product, then a general phrase stating "Read all precautions before use" must be present.
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.
2010 Revision of COPR labelling guidance for biocidal products
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:
- a number of phrases to be be moved from inside to outside the Statutory Box.
- precautionary phrases outside the Statutory Box to be preceded by an asterisk
- additional Conditions of Approval specified in section 4 of the Schedule to be preceded by an asterisk
- instructions relating to compliance with the COSHH Regulations and the use of Personal Protective Equipment to be clarified
- professional users to be directed to task- and product type-specific guidance content where available.
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.