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Last updated: 28/09/2020

When sourcing a product:

  • Check intended use/claims made to determine if, biocide, cosmetic or medicine. (Review introduction)
  • If a biocide, check what active substance(s) appear on the label but also check with the product manufacturer what active substance(s) are present in the formulation, in case any active substances are absent from the label.
  • Check if active substance(s) have been approved, under review, or not approved for the particular product type e.g. human hygiene.
  • If active substance is approved for human hygiene use, check product appears on the Health & Safety Executive (HSE) authorisation/derogation database.
  • Check product is labelled and packaged correctly
  • Ensure biocidal advertisement requirements have been met. (Review introduction)
  • Check efficacy of product by requesting evidence to verify claims.

If a distributor decides they want to ‘own brand’ the product, with their details as the sole supplier, they will be considered the manufacturer (supplier) for the purposes of the legislation and it is suggested they consult the ‘Business companion - bulletin - Hand Cleaning and Sanitising Products - Manufacturers guide’ for further information.

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

Substances

Check product appears on the Health & Safety Executive (HSE) authorisation/derogation database – if active substance(s) approved.

Biocidal databaseCheck HSE database if Biocidal Product has been authorised for those which contain an approved active substance(s), this will include those subject to a derogation e.g. propan-2-ol (also known as Isopropanol or Isopropyl alcohol) or propan-1-ol.

Without authorisation or derogation, those containing approved active substances will not be permitted on the market.

If you don’t find a given product on the HSE database it doesn’t necessarily mean it is being placed on the market illegally, e.g. it might be still under assessment and does not require an authorisation or a derogation at this time. For example, active substances not yet approved i.e. ethanol or a non-alcohol such as DDAC, ADBAC/BKC (C12-16) etc. In such cases, you should contact your supplier to obtain confirmation that the product has been authorised (or a derogation issued).

If an active substance is under review for 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.

Check product is labelled and packaged

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.  To help check if the product has been labelled correctly, request a copy of the safety data sheet as there are some basic checks which can be made, see section on safety data sheets below.

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:

Check the suppliers name, address and telephone number is marked on the label. (the supplier cannot be outside the European Community).

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, and are triggered by either classification under a certain hazard class/category, or by certain substances at specified concentrations.

Waerning triangle
Example - Tactile warning of danger

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 featuring images which could attract or arouse the active curiosity of children, such as cartoon characters, sweets etc, are likely to fail this requirement.

Additional labelling requirements will apply, if a biocidal product contains approved active substance(s), as it will also require authorisation/derogation. Further information can be obtained from the Health and Safety Executive Article 69 BPR labelling & packaging requirements.

Safety data sheets

Suppliers of chemicals that are classified as hazardous under CLP are required to  provide recipients (except for consumers) with a safety data sheet (SDS) that has been compiled to Registration, Evaluation, Authorisation & restriction of CHemicals (REACH) requirements. Chemical products that are not classified as hazardous do not usually require a safety data sheet, though there are some exceptions.

Safety data sheet

Some simple checks you can make if you have the product and safety data sheet. Check Section 1 matches what is printed on the product:

  • suppliers name, address and telephone number. (the supplier cannot be outside the European Community).
  • Product identification.

Section 2 covers the hazard identification of the product, and much of this information should appear on the product label, with a few exceptions:

  • Signal word
  • Pictograms
  • Hazard statements
  • Precautionary statements

Check efficacy of any product claims

You may want to ask your supplier how they can demonstrate the efficacy (effectiveness) of the product, for instance “kills 99.9% of bacteria”. The product might be marked with the following applicable standards or you may want to consider asking to see any supporting efficacy test reports:
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.

Further reading:

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

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