Hand Sanitiser Regulations

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Hand Sanitiser Regulations

 

Do you sell hand sanitisers gels, hand wash or hand rubs?  Read on to learn how to comply with hand sanitiser regulations or watch the video.

 

Regulatory framework

 

The regulatory framework that applies to a hand sanitiser depends largely on the ingredients and marketing claims made on the label. Typically, a hand sanitiser falls into one or both of the following regulations:

 

  • Regulation (EC) No 1223/2009 for Cosmetics
  • Regulation (EU) No 528/2012 for Biocides

 

How to comply with hand sanitiser regulations

 

Follow the step by step guide to help you comply with applicable regulations for hand sanitisers:

 

Step 1: Collate information on your product

 

Formulation

List your ingredients and CAS or EC number with corresponding quantities (%) in a table.

 

Documentation

Request the Safety Data Sheets (SDS), Certificates of Analysis (CoA), and efficacy lab testing documentation from suppliers. Any marketing claims such as “kills bacteria” or “kills viruses” should be supported by evidence (see next step).

 

Step 2: Marketing claims

 

Consider the marketing claims you wish to make on the label. The phrases and words that appear on your pack will determine which  regulatory framework applies and some terms will require additional lab testing. Phrases like ‘kills 99.99% bacteria’ require special hand sanitiser testing that conform to BS EN standards.

 

Avoid words that you cannot support with evidence and only claim ‘kills viruses’ if you have the evidence to back it up.

 

Words to mean cleaning, perfuming or protecting skin fall in scope of cosmetics regulation. Marketing claims will be assessed for validity in the next step.

 

Step 3: Submit your documents for compliance review

 

Compliance with Biocide regulations

 

Request a compliance review to ensure your hand sanitiser is compliant with biocidal regulations (EU) No 528/2012. We will check ingredients and labelling, among other things and advise on compliance status.

 

Safe to use as a skin product

 

Order a cosmetic safety assessment on your product to ensure the product is safe to use. The safety of the product will be assessed based on the ingredients, quantities and marketing claims, among other things.

 

Next Steps

 

Depending on the outcome of the compliance review, any of the following may apply:

 

  • registration as a biocide
  • notification as a cosmetic
  • premarket authorisation as a biocide

 

Note: Regulations differ slightly market to market.

 

What guidance does the UK Government provide on producing hand sanitisers?

 

Refer to the UK government webpage found here.

The Health and Safety Executive also provide information here.

 

World Health Organisation (WHO) Information on producing hand sanitisers

 

The WHO recommend two formulations for alcohol-based hand sanitisers with manufacturing instructions. Click here to learn more.