Packaging and labelling requirements for biocidal products
The GB Biocidal Products Regulation (GB BPR) sets out the requirements for how biocidal products should be packaged and labelled once they are authorised.
Action for authorisation holders
If you are the authorisation holder for a biocidal product under GB BPR, you are responsible for ensuring it is packaged and labelled in accordance with GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation and the Summary of Biocidal Product Characteristics (SPC) which forms part of the GB BPR Certificate of Authorisation (CoA).
Unless expressly stated, phrases given in the SPC do not need to appear word-for-word as long as the meaning is the same.
Your label must not describe the biocidal product in any way which is misleading in relation to:
- the risks to human health
- the risks to animal health
- the risks to the environment
- its efficacy
Phrases that are considered to be misleading and must not be used include:
- low-risk
- non-toxic
- harmless
- natural
- environmentally friendly
- animal friendly
- any similar terms
Whenever your authorisation is changed or renewed, phase-out periods are granted to allow existing stocks of the product to be phased off the market. This allows any product already labelled according to the previous SPC to be supplied and used during the phase-out periods without needing to be re-labelled according to the new SPC.
Label elements
The following elements must be shown clearly and indelibly, in English, on the labels for your biocidal product, where applicable:
- classification, including hazard and precautionary statements, in accordance with GB CLP
- the identity of every active substance and its concentration in metric units
- any nanomaterials contained in the product followed by the word 'nano' in brackets, and any specific related risks
- the authorisation number allocated by HSE and appearing on the CoA
- the name and address of the authorisation holder - even if marketed by a different company
- the type of formulation *
- the relevant authorised uses of the biocidal product
- directions for use, frequency of application and dose rate, (given in metric units) for each relevant use * - presented in a way which is meaningful and comprehensible to the user
- details of any likely, direct or indirect, adverse side effects *
- any directions for first aid *
- the sentence 'Read attached instructions before use' and any warnings for vulnerable groups - if the label is accompanied by a leaflet
- directions for the safe disposal of the biocidal product and its packaging, including any prohibition on the reuse of packaging *
- the formulation batch number or identification *
- the expiry date relevant to normal conditions of storage *
- the required period of time for the biocidal effect *
- the required interval between applications of the biocidal product *
- the required interval between application and the next use of the product that has been treated *
- the required interval between application and the next access by humans or animals to the area where the biocidal product has been used *
- details of decontamination means and measures *
- the required period of time for ventilation of treated areas *
- instructions for adequate cleaning of equipment *
- details of precautionary measures required during use and transport *
- the categories of users that the biocidal product is restricted to
- information on any specific danger to the environment * - particularly for protection of non-target organisms and avoiding the contamination of water
- for biocidal products containing micro-organisms, labelling requirements in accordance with the Control of Substances Hazardous to Health Regulations 2002 (COSHH)
In some cases, it may be physically impossible to put all of this information on the label (due to the size or the function of the biocidal product). The information marked with an asterisk (*) may instead appear on an accompanying leaflet that is integral to the packaging.
Packaging
The packaging of a biocidal product must:
- minimise any risk of it being mistaken for food, drink or feed
- not be attractive to children
If there is a risk that your product may be mistaken for food, drink or feed, and it is available to the general public, it must contain a substance to discourage consumption such as a bittering agent.
Advice on packaging and labelling
When you apply for product authorisation under GB BPR, you will be required to submit details of the packaging and the draft label which will be considered as part of the assessment process.
Packaging will only be considered in terms of its chemical compatibility with the type of product and, if available to the general public, the appropriateness of any fastenings in relation to GB CLP.
Labels will only be considered in terms of whether they correctly and appropriately describe the product:
- label claims are supported
- terms such as non-toxic, natural, environmentally friendly etc are not used
Labels will not be considered in terms of other aspects of the label, such as marketing or graphics, unless it impacts on the key information.
HSE does not approve, authorise or endorse labels under GB BPR.