Packaging and labelling requirement for biocidal products
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This page provides information about the packaging and labelling requirements under the EU Biocides Regulation 528/2012 (EU BPR), which apply from 1 September 2013.
The requirements relating to packaging and labelling are laid down in Article 69 of the EU BPR. They are activated when the product is authorised under the Regulation.
The draft label will be considered as part of the product evaluation application.
In general, the label will be considered in terms of whether it correctly and appropriately describes the product; for instance in terms of the correct classification and associated symbols and phrases and label claims etc. HSE will not, in general, comment on other aspects of the label, such as marketing aspects or graphics, unless it impacts on the key information.
What are the labelling requirements of EU BPR?
Article 69 of EU BPR states that
“Authorisation holders shall ensure that biocidal products are…labelled in accordance with the approved summary of biocidal product characteristics.”
“Authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications.”
What information should be included on the product label under EU BPR?
Article 69 of EU BPR states that in addition any information required from CHIP (Chemicals (Hazard Information and Packaging for Supply) Regulations) or CLP (Classification, Labelling and Packaging of substances and mixtures Regulations) the following information must be shown clearly and indelibly on the product label.
- the identity of every active substance and its concentration in metric units;
- the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;
- the authorisation number allocated to the biocidal product by the competent authority or the Commission;
- the name and address of the authorisation holder;
- the type of formulation;
- the uses for which the biocidal product is authorised;
- directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;
- particulars of likely direct or indirect adverse side effects and any directions for first aid;
- if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;
- directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;
- the formulation batch number or designation and the expiry date relevant to normal conditions of storage;
- where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;
- where applicable, the categories of users to which the biocidal product is restricted;
- where applicable, information on any specific danger to the environment particularly concerning protection of non- target organisms and avoidance of contamination of water;
- for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.
Where it would be physically impossible to place all of the required information on the label due to the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.
Can my label state that the biocidal product is safe or harmless?
No. The requirements in Article 69 of EU BPR clearly state that the label claims you make must not mislead in respect of the risks of that biocidal product to humans, animals or the environment, and specifically prohibit the use of words such as ‘harmless’ or similar terms.
Can my label say my biocidal product is natural or environmentally/animal friendly?
No. The requirements in Article 69 of the EU BPR clearly state that the label claims you make must not mislead in respect of the risks of that biocidal product to humans, animals or the environment or efficacy, and specifically prohibit the use of words such as natural, environmentally friendly, animal friendly or any similar terms.
What are the Packaging requirements?
The requirements under EU BPR (Article 69) make it clear that the packaging of the product should not give the impression that it contains food, drink or feeding stuff unless the likelihood of such a mistake is minimal. If the product is available to the public it should contains a substance or preparation to discourage its consumption.
The legal text in Article 69 of EU BPR states
“Products which may be mistaken for food, including drink, or feed shall be packaged to minimise the likelihood of such a mistake being made. If they are available to the general public, they shall contain components to discourage their consumption and, in particular, shall not be attractive to children.”