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Last updated: 28/09/2020

What is a biocidal product?

Article 3 of the Biocidal Products Regulation 528/2012/EU (BPR), states that a ‘biocidal product’ is one which meets the following four criteria:

  • any substance or mixture;
  • in the form in which it is supplied (free of charge or for payment) to the user;
  • consisting of, containing or generating one or more active substances;  
  • with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

In addition, the product should fall within one of 22 product types. Hand sanitisers are product type 1.

What is an active substance and how to check on its approval status?

An active substance (ingredient) is a substance or micro-organism that has an action on or against harmful organisms.

Sanitiser Ingredients

For example:

  • Ethanol or isopropyl are active substances used in hand sanitisers
  • Chlorine is an active substance used as a disinfectant to clean swimming pools
  • DEET is used as an active substance in insect repellents

To check on the status of an active substance, to determine if it can be used in a biocidal product, visit the European Chemicals Agency (ECHA) website, see example below.

ECHA

Once you know the status of all the active substance(s) in a hand sanitiser, the main regulatory requirements that apply are summarised below:

Product type

Certain active substances i.e. active chlorine generated from sodium chloride by electrolysis or active chlorine released from hypochlorous acid for use in human hygiene (hand sanitiser) biocidal products are not part of the review programme and will require an authorisation or derogation before they can be placed on the market.

For more information see: Health & Safety Executive guidance on manufacturing and supplying hand sanitisers

Certain active substances have not been approved or are no longer supported for use in human hygiene (hand sanitiser) biocidal products, for example triclosan, glutaral, and Polyaminopropyl Biguanide (PHMB) are not approved for use in product type 1, and therefore can not be placed on the market, see example below.

Subtances

Do I need to obtain authorisation from the HSE for my biocidal product?

Biocidal products require authorisation under the EU Biocides Regulations 528/2012 (BPR) when:

Due to the Covid-19 pandemic, businesses can apply for a derogation instead of authorisation in certain circumstances, see below for more details.

If an active substance is under review or the relevant product type, i.e PT1 for hand sanitisers, product authorisation is not required, similarly where a product contains more than one active substance, product authorisation is not required until all the active substances in it have been approved. In other words, authorisation is only required once the last of the active substances in the biocidal product has been approved.

Easy to follow World Health Organisation (WHO) formulations

The World Health Organisation (WHO) has issued guidance on basic formulations of hand rub that rapidly and effectively inactivate a wide array of potentially harmful microorganisms on hands. Formulation I is based on Ethanol and Formulation II is based on Propan-2-ol (isopropyl alcohol).

For more information on the formulations: Guide To Local Production: Who-recommended Handrub Formulations - April 2010

Can I obtain a derogation for my biocidal product?

The Health & Safety Executive (HSE) has issued a derogation, in the short term, from product authorisation for hand sanitiser containing isopropyl alcohol (propan-2-ol). Products containing propan-2-ol will not be required to obtain a product authorisation at the current time, if they meet the relevant WHO-specified formulation II. However, manufacturers must contact the HSE via biocidesenquiries@HSE.gov.uk
 
Products should not be placed on the market until the HSE has confirmed that the derogation applies and issued a permit, which is time limited.

WHO-specified formulation I which contains the active substance ethanol, does not require product authorisation or derogation.

In summary:

WHO formulation

If your propan-2-ol based hand sanitiser differs in any way from the WHO specification, you can still apply to HSE for a critical situation permit to obtain temporary derogation from BPR authorisation requirements. This is also possible if you make hand sanitiser containing other active substances that would otherwise need product authorisation now. However, as these fall outside the available WHO specifications, you will need to submit a data package to demonstrate to HSE that your product meets established standards that protect people and the environment, and that your product is effective. This is likely to take HSE longer to assess and will incur a charge.

For more information see: Health & Safety Executive guidance on manufacturing and supplying hand sanitisers

Registering as an Article 95 supplier with the European Chemicals Agency

In addition to the above requirements, Article 95 of the Biocidal Products Regulation (BPR) requires that the active substance(s) in a biocidal product must be sourced from a supplier included on a specific list – known as the Article 95 list. Therefore, either the active substance supplier or the product supplier must be registered on the Article 95 list for the product type to which the product belongs.

The objective of Article 95: “To ensure the equal treatment of persons placing active substances on the market, they should be required to hold a dossier or have a letter of access to a dossier, or to relevant data in a dossier, for each of the active substances they manufacture or import for use in biocidal products.”

For more details on how to register, see:
ECHA Guidance on active substances and suppliers (Article 95 list)
ECHA Practical Guide on Letters of Access

An overview of labelling and packaging requirements for biocidal products, including CLP

  • If a biocidal product contains approved active substance(s) and authorisation has been obtained Article 69 BPR labelling & packaging requirements will apply.
  • If a biocidal product contains the approved active substance propan-2-ol or propan-1-ol which are subject to derogation - specific labelling requirements referred to in the Health and Safety Executive ‘Article 55(1) - Critical Situation permit’ will apply, for more information please contact the HSE.
  • If the biocidal product contains active substance(s) which are under review - Article 69 requirements do not apply and nor does the derogation requirements.

All biocidal products which contain hazardous substances shall comply with the relevant classification, packaging and labelling requirements detailed under Regulation (EC) No 1272/2008 the Classification Labelling and Packaging (CLP) of mixtures and substances.

Many hand sanitiser products will meet the criteria for classification as hazardous under CLP.

CLP requires certain information to be present on the label of any hazardous product (with certain exemptions, e.g. for very small packaging). An example of a CLP label that shows the standard labelling elements required under CLP, for illustrative purposes only:

CLP label

‘Child resistant’ closures/fastenings and/or ‘tactile warnings’ (raised-profile warnings that can be understood by those with impaired vision) are also required in some cases.

Warning triangle
Example - Tactile warning of danger

The requirements to include such elements as part of packaging are triggered by either classification under a certain hazard class/category, or by certain substances at specified concentrations

Article 35 (2) of Regulation (EC) No 1272/2008 Classification, Labelling and Packaging of Substances and Mixtures (CLP) states:

“Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff (which includes drink) or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.”

Bottle lid
Drinks bottle style lid - not suitable

Therefore, container bottles fitted with drinks bottle style lids (see above), or feature images which could attract or arouse the active curiosity of children, such as cartoon characters, sweets etc, are likely to fail this requirement.

For further information regarding CLP, see https://echa.europa.eu/regulations/clp/understanding-clp

Understanding efficacy

To be able to demonstrate the efficacy (effectiveness) of any claims made e.g. kills 99.9% of bacteria, there are a number of standards available, which can help to support any claims, for example:

 

  • EN 1267 - Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas
  • EN 1500 - Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements
  • EN 1650 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas
  • EN 14476 - Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area

 

This is only an indicative guide and further standards are referenced on the ECHA website that may be of use.

In making commercial decisions, manufacturers need to be mindful of maintaining high levels of safety and efficacy of the products they make available to the public and others.

Record keeping

The EU Biocides Regulations (EU BPR) introduces the requirement for manufacturers of biocidal products placed on the Union market to keep appropriate documentation (paper or electronic format) in relation to the quality and safety of the biocidal product to be placed on the market. The documentation shall include as a minimum:

  1. safety data sheets (see example, right)  and specifications of active substances and other ingredients used for manufacturing the biocidal product;
  2. records of the various manufacturing operations performed;
  3. results of internal quality controls;
  4. identification of production batches.

Safety data sheet

Manufacturers of biocidal products shall store production batch samples.

Suppliers of chemicals that are classified as hazardous under CLP need to ensure they provide recipients (except for consumers) with a safety data sheet that has been compiled to Registration, Evaluation, Authorisation & restriction of CHemicals (REACH) requirements.

Traceability

In order to be able to demonstrate due diligence, marking the product with either a batch or serial number (or other identification) which is also referenced on any supporting documentation (such as a safety data sheet or efficacy test report) will enable traceability.
Without this, it is extremely difficult to demonstrate the product and documentation correspond.

National Poisons Information Service

It is recommended suppliers of biocidal products supply information regarding a Biocidal Product to National Poisons Information Service (NPIS) as a matter of good practice so that NPIS can provide information to medical practitioners to help them deal with any incidents involving biocidal products.

For more details on submitting information, visit: https://www.hse.gov.uk/biocides/eu-bpr/informing-npis.htm

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