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Hand Cleaning and Sanitising Products (such as liquids, gels and soaps)

May 2020

Presented by Tom Penton – Trading Standards Practitioner

The Good, The Bad and The Ugly

• The difference between a biocide product, cosmetic product, and a medicine.

• Identifying the active substances and labelling checks on hand cleansing products.

• WHO Formulations for alcohol hand rubs.

• HSE Article 55 Derogation

• How to check on the effectiveness of claims made.

• Enforcement powers

Learning Outcomes

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Biocidal Products

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•Products claiming to kill germs, disinfect or sanitise or prevent cross-contamination are likely to be classed as a biocidal product.

Cosmetic Products

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• Products primarily used to clean, protect, condition skin or any other cosmetic enhancement, whilst providing a secondary antimicrobial effect such as a liquid soap, solid soap bars, sun lotion and moisturising hand creams are likely to be classed as cosmetic products.

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Medicines

• Products presented as principally preventing or treating a disease or adverse condition are likely to be classed as a medicinal product.

Online description:

KILLS 99.9% OF GERMS & KNOWN FLU VIRUSES: The natural formulas proven to kill 99.9% of surface Germs, bacteria and known flu viruses. This alcohol free sanitiser is tested to kill Swine Flu, H1N1, Bird Flu H5N1, MRSA & the active ingredients have been tested positively for killing SARS & Norovirus

Email MHRA:

borderline_medicine@mhra.gov.uk

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 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 described in

Annex V of the BPR.

Defining a Biocide

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Biocides

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Biocidal products are regulated under the Biocidal Products Regulation 528/2012/EU (BPR), the Health and Safety Executive (HSE) are the UK Competent Authority. Local authority Trading Standards in Great Britain and Environment Health in Northern Ireland enforce some of the requirements for biocidal products when they are made available at retail level or otherwise made available to members of the public. HSE enforce for business use, including the NHS.

The exception is advertisements for biocidal products, which are

enforced by TS even if business to business.

Biocides – Product Types

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• 4 Main Groups : 22 Product Types :

e.g.

• 1. Disinfectants Human Hygiene - PT1

• 2. Preservatives Wood preservatives - PT8

• 3. Pest Control Repellents or Attractants -PT19

• 4. Other Antifouling products -PT21

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Product type specific:

Can be placed on the market:

• Active substance under review (in transition - still being evaluated) e.g. ethanol.• Active substance approved - can only be placed on the market once biocidal product has been

authorised or derogated (time limited). e.g. Propan-2-ol.

Can not be placed on the market:

• New active substance intended to be used in a biocide - can not be placed on the market.• Not approved active substance - can not be placed on the market e.g. glutaral.• Not authorised or derogated biocidal products.

Checking Active Substance Status

A biocidal product cannot be made available on the EU market unless either the

substance supplier or the product supplier is included in the Article 95 list for the

product type to which the product belongs. European Chemicals Agency(ECHA)

updates the Article 95 list on a regular basis. The purpose of this list is to "ensure the

equal treatment of persons placing active substances on the market".

However, during this exceptional time of increased demand, due to the COVID-19

outbreak, it may be necessary for hand sanitiser manufacturers to find alternative

suppliers of raw ingredients to supplement those obtained via regular supply chains.

Therefore, HSE has temporarily altered its approach to the enforcement of Article 95.

www.hse.gov.uk/news/hand-sanitiser-manufacture-supply-coronavirus.htm.

Sourcing active substances - Article 95 Suppliers

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Checking status of active substance

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https://echa.europa.eu/information-on-chemicals/biocidal-active-substances

Glutaral – not approved for use in Product Type 1

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Check 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.

Any TS questions email HSE: CRDEnforcement@hse.gov.uk

Alcohol-based hand sanitisers can be made using:

Propan-2-ol (also known as Isopropanol or Isopropyl alcohol/IPA), Propan-1-ol, or Ethanol.

Public Health England has advised that hand sanitisers should have 60% or higher alcohol content to be effective against the Covid-19 virus.

Other active substances are available for use in hand cleaning products e.g. • Didecyl Dimethyl Ammonium Chloride

• Chlorhexidine Gluconate• Alkyl (C12-18) dimethylbenzyl ammonium chloride (ADBAC (C12-18))

Alcohol-based hand sanitisers

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• Where a product contains more than one active substance, product authorisation is

not required until all of 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.

• For example, a biocidal product containing both ethanol and propan-2-ol, would not

require autorisation until ethanol was also approved.

Products containing more than one active substance

WHO Recommended Handrub Formulations

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Derogations from product authorisation requirements for hand sanitisers containing Propan-2-ol and Propan-1-ol

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Suppliers need to email: biocidesenquiry@HSE.gov.uk

Approved active substance (ingredient)

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• The following elements of EU BPR will apply

• Packaging and labelling requirement for biocidal products – Art. 69

• Advertisements

• Record keeping, e.g. safety data sheets, specs of active substances and other ingredients used for manuf. the biocidal product

• The active substance(s) must be sourced from a BPR approved Article 95 listed supplier

• Provide information to the National Poisons Information Service.

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Alcohol-based hand sanitisers containing Propan-2-ol (also known as Isopropanol or Isopropyl alcohol/IPA)

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The derogation permit stipulates the following, labelling or packaging shall include:

• Name of formulating company/institution

• Date of production and batch number

The following phrases:

• WHO-recommended handrub formulation

• For external use only.

• Avoid contact with eyes.

• Keep out of the reach of children.

• Use: Apply a palmful of alcohol-based handrub and cover all surfaces of the hands. Rub until dry.

• Composition: Isopropanol, glycerol and hydrogen peroxide.

• Flammable: keep away from flame and heat.

In addition, companies/institutions making the product available, shall comply with any relevant classification,

packaging and labelling requirements of Regulation (EC) No 1272/2008 (the Classification Labelling and Packaging Regulation).

Derogation labelling

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Isopropyl alcohol/IPA – not labelled correctly

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Active substance (ingredient) not yet approved e.g. ethanol

The following elements of EU BPR will apply:

• Advertisements

• Record keeping

• Source the active substance(s) from a BPR approved Article 95 listed company

• Provide information to the National Poisons Information Service.

The following element will not apply, because active substance not yet approved?

• Packaging and labelling requirements for biocidal products

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Biocide Advertisements

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The advertisement requirement in Article 72 of the EU BPR states that:

Any advertisement for biocidal products shall, in addition to complying with Regulation (EC) No 1272/2008, include the sentences ‘Use biocides safely. Always read the label and product information before use.’

The sentences shall be clearly distinguishable and legible in relation to the whole advertisement.

Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type being advertised.

Classification, Labelling and Packaging of substances and Mixtures (CLP)

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Overview of hazards that trigger child-resistant fastening or tactile warnings

Classification, Labelling and Packaging of

substances and Mixtures (CLP)

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“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 or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.”

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Classification, Labelling and Packaging of substances and Mixtures (CLP)

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Hand cleaning products that don’t contain alcohol

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Checking the effectiveness (efficacy) of a product

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The EU Biocides Regulation 528/2012 (EU BPR) is enforced by local weights and measures authorities, as if it were a safety regulation made under section 11 of the Consumer Protection Act 1987, by virtue of Regulation 18 (4) of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013.

The CLP Regulation is also enforced by the local weights and measures authority, as if it were a safety regulation made under section 11 of the Consumer Protection Act 1987(*).

Enforcement Powers

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• Check intended use/claims made to determine if, biocide, cosmetic or medicine;

• If biocide, check what active substance(s) appear on the label;

• Check if active substance(s) is approved, in transition, or not approved (banned) for particular product type e.g. human hygiene;

• If AS is approved, such as Isopropyl-2-ol, check if product authorised or derogated;

• Check if complying with biocidal advertisement requirements;

• Check if labelled correctly in accordance with CLP & Biocides if applicable, – obtain safety data sheet.

• Check efficacy of product by requesting evidence to verify claims or send product for analysis;

• Upload information to relevant intelligence databases, including OPSS product safety database.

Checklist

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Any Questions?

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