APPENDIX 3

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Notes of Guidance

Appendix 3

Advertising and Promotion of Consumer Products Making Anti-microbial Claims

Introduction
These guidelines were initiated and developed by a Working Group formed by British Association of Chemical Specialities (BACS). They have been agreed and endorsed by UK Cleaning Products Industry Association (UKCPI).

Scope
These guidelines relate to the advertising and promotion of cleaning, hygiene, disinfectant and similar consumer products (as defined in the Annex) which are intended, or claim explicitly or implicitly, to deliver a benefit by destroying or controlling harmful or otherwise undesirable micro-organisms – ‘anti- microbial products’.

Principles
Anti-microbial products must be formulated, promoted and advertised in a way that:

  • Constitutes responsible use of biocides and other ingredients from safety, health,environmental and microbiological perspectives;
  • Complies, where applicable, with the provisions of the EU Biocidal Products Directive:
  • Seeks to deliver real benefits in terms of reducing the risks of infection or reducing other adverse effects of micro-organisms;
  • Does not exaggerate the threat from or play upon the fear of infectious disease, germs,bacteria, etc.;
  • Properly conveys product capabilities, important limitations and usage instructions such that the consumer expectations created are likely to be met in normal use;
  • Does not mislead consumers, particularly in a way that could create a false sense of security;
  • Reinforces, rather than undermines, good hygiene practice.

Promotion and Advertising Claims

A General

1. Products should not be promoted or advertised as having anti-microbial properties or in a way that claims or implies anti-microbial benefits unless:

  • Their anti-microbial performance, in the context of their intended use, significantly exceeds that of comparable products which do not have an anti-microbial action;
  • They offer a significant consequent benefit in terms of reduced risks of infection or of other adverse effects of micro-organisms

The anti-microbial performance must be demonstrated by appropriate microbiological tests, particularly in relation to the claimed or implied scope,extent and duration of action as set out under B, C, D and the Annex. Simple reliance on the inclusion of a limited quantity of an anti-microbial is not sufficient.

2. Language, images, and other contextual material which might suggest an anti-microbial benefit should not be used with products which do not deliver such a benefit. Any use of medical or nursing images etc. must be appropriate. The word ‘hygiene’ and its derivatives are in many contexts likely to imply anti-microbial benefit (e.g. hygienically clean). Such words should only be used a s a synonym forcleanliness (e.g. kitchen hygiene) if care is take not to express or imply anti-microbial activity or benefit.

3. Products should not claim anti-microbial superiority over other similar products unless the superiority is shown to be significant (by appropriate micro-biological tests) and likely to translate to an improved benefit for the consumer. Anti-microbial superiority should not be claimed simply on the basis of an increased concentration of anti- microbial ingredient.

4. Anti-microbial products can help reduce the risks from harmful micro-organisms and infectious disease if used appropriately as part of a sound hygiene regime. Their advertising and promotion should not, however, claim or imply tht their use directly promotes or improves health, nor will that increased use automatically brings further reductions in infection risks.

5. Any description or portrayal of the product, its use and likely benefits in advertising and promotional material, including pack copy, should be clear, accurate and sufficiently complete that consumers are guided to ue it in a way in which their expectations of anti-microbial activity and benefit are likely to be met.

The above would apply, for example, to:

a) Any communication of the product’s purpose, the recommended area, mode and conditions of use and the extent, scope and duration of its micro-bial action (as further required below), including any significant limitations within the context of use;
b) Any directions on how to use the product, particularly when this requiressomething other than normal consumer practice;
c) Any directions for dilute use including suitable highlighting of any significantly reduced performance or scope of applicability;
d) Not in appropriately implying instant action or instantly achievable results.

B Extent of Action

1. Products must deliver reduction or control of microbial contamination to an extent that represents a significant benefit in terms of hygiene or of mitigation of other undesirable effects and that is appropriate to the microbial control needs for the intended area of use. Products whose benefits are limited to mitigation of undesirable effects or aesthetic improvements must take care not to imply control of hazardous organisms or hygiene benefits.

2. The extent of this action must be established by appropriate tests relevant to the intended conditions of use, bearing in mind likely consumer habits and be clearly and appropriately communicated including any significant limitations

3. A clear distinction is to be made between products whose performance is regarded as adequate to render the area or object to which they are recommended to be applied ‘microbiologically safe or normal intended use’ (e.g. a surface disinfectant),and those of lesser performance which, while achieving a significant improvement in microbiological status, would not meet this criterion. Accordingly

a) Products claiming or implying microbial decontamination to an extent which delivers a microbiologically safe result must, bearing in mind conditions of use and consumer habits, either:

  1. i. Pass a recognised (i.e. internationally, nationally or peer-reviewed)microbiological test relevant to the intended use as defined in Table 1 of the Annex, or;
  2. ii. Demonstrate achievement of a microbiologically safe result by other laboratory simulations or ‘in-use’ field studies appropriate to intended conditions of use and consumer habits. This must include justification of why standard tests defined in Table 1 of the Annex were modified, or deemed irrelevant. Provided the provisions onScope of Action in C below are also met, such products may usewords such as ‘kills’, ‘disinfects’, and ‘makes hygienically clean’.

b) Products which deliver a significant benefit in terms of microbial count reduction, but cannot demonstrate achievement of microbial safety as in a)above must demonstrate the extent of their action in similar ways. Their claims must clearly indicate that they make only a partial improvement inmicrobial status. They should not claim or imply a microbiologically safe result. Their claims should thus be qualified by ‘helps’ or equivalent phrase.Any claim to improve microbiological status must be clearly related to the status before using the product and not inappropriately imply superior performance versus other products.

c) Products claiming or implying microbistatic activity must similarly demonstrate their anti-microbial benefit bearing in mind intended conditions of use, consumer habits and the levels below which microbial contamination needs to be maintained. Microbiological safety must not be claimed or implied unless this is appropriately substantiated. (See also section D –description of the duration of action).

d) Microbiocidal or microbistatic effects that may be measurable, but represent only an insignificant improvement in terms of hygiene or of mitigation of other undesirable effects, should not be claimed. A list of standard tests and other criteria to substantiate claims for different uses is given in the Annex.

C Scope of Action

1. Scope of action, in terms of the types of micro-organisms (e.g. bacteria, viruses,fungi, protozoa, algae etc. or sub-sets of these against which the product is effective,must be:

a) Appropriate to the intended use, i.e. the product should be effective against all hazardous or undesirable micro-organisms normally likely to be encountered in the circumstances of use for which the product is promoted, or a relevant sub-set of them;

b) Clearly and appropriately communicated. Terms should be chosen as far as possible to clarify consumer understanding of the different types of germs; In particular, advertising and promotion, including pack copy, must not imply action across a broader spectrum of micro-organisms than can be substantiated (bearing in mind the Extent of Action claims under B above), for example, by inappropriately using broad terms such as‘germs’, ‘bacteria’ or ‘viruses’ (e.g. ‘germs’ should not be used when not all type of micro-organisms relevant to the intended use are controlled),or by comparison with the effect of other broad spectrum products or ingredients;

c) Whereas tests against recognised sets of standard organisms would be adequate to substantiate claims of activity against generic types (e.g.bacteria), claims for activity against particular organisms (e.g.Campylobacter, Listeria, E.coli) must be supported by tests against those organisms (or accepted surrogates where direct testing is impractical),bearing in mind likely consumer expectations.

D Duration of action

1. Products claiming lasting action should
a) Be suitably reliable and robust in use in the face of normal patterns of re-growth and/or re-contamination in relation to the intended use;
b) Be promoted in a way that does not undermine good hygiene practice based on active intervention, particularly at high-risk sites where the risks of hygiene failure are high.

2. Claims for lasting action must

a) Be meaningful and relate to a significant benefit in normal use;
b) Properly communicate both scope and extent of kill or control as above;
c) If the extent and/or scope of the lasting action is less than that of the claimed initial activity, the parameters of the lasting action must be clearly and appropriately indicated.

Annex to Appendix 3

Current Scope
These guidelines and their detailed provisions are currently developed to apply to consumer products for use on hard surfaces and other household sites, for dishwashing and for textile cleaning and ancillary treatment. The guidelines may be further developed to cover other products in the future.

Explanation of Selected Terms
The following notes explain the intended meaning of some terms used within the guidelines and the Appendix:

“microbiologically safe for normal intended use” – “microbiologically safe” means a condition in which the number of micro-organisms is reduced to or maintained at a level that will minimise the risks of transmission of infection or of other undesirable effects;

“benefit in terms of reduced risks of infection” – signifies that there must be a significant improvement in microbial status in an area that is significant potential for transfer of infection. It is not to be taken to require evidence from clinical trials or epidemiology.

Table 1

Anti-microbacterial Claims Support – Parameters for Testing

This table sets out, for some common combinations of product types, target sites and claims, the parameters of recognised tests which would be appropriate to substantiate those claims via option i) under Section B3a (or where appropriate B3b or c) of the Guidelines.

Inclusion of a product type in the Table simply defines test parameters for the combination of target site and claims listed. It thus does not preclude other claims or other target sites for the same product type.
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Product Type Target Site Claimed Extent of Action Claimed Scope of Action Recommended Use Conditions Test Parameters
(Anti-microbial) Hard Surface Cleaner (Liquid in bottle, trigger or aerosol sprayHousehold surfacesDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousNeat or diluteExtent of kill should be demonstrated by Bacterial, Fungal, Viral Surface Tests for the claimed types, using the application methods intended for use and/or delivery devices provided. Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or Minimum Kill Concentration (MKC) test including any specific claimed organisms
(Anti-microbial) Hard Surface Cleaner (liquid in bottle, trigger or aerosol sprayBathroom surfacesDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousNeat or diluteAs above but all tests use hard water
(Anti-microbial) Hard Surface Cleaner (liquid in bottle, trigger or aerosol sprayBathroom surfacesDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousNeat or diluteAs above but all tests use hard water
Anti-mildew/mould bathroom cleaner (liquid in bottle, trigger or aerosol sprayBathroom and other damp surfacesMould and Mildew controlFungiNeat or diluteExtent of kill should be demonstrated by Fungal Surface Tests. Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms. All tests should use hard water
(Anti-microbial) Fabric SprayFabricsDisinfects, Bacterididal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousNeat, one step processExtent of kill should be demonstrated by Bactericidal, Fungicidal, Virucidal Test for the claimed types on fabric using the delivery system
(Anti-microbial) Dishwash liquidDishcloths and spongesControls (microbial) growthBacteria, FungiApply neat after washing upExtent of control – for claimed organism types, demonstrate significantly slower growth or no growth compared to control should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms
(Anti-microbial) Dishwash liquidThrough the wash, crockery, cutlery, utensils etc.Disinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousProduct used dilute, one step processExtent of kill should be demonstrated by Bacterial, Fungal, Viral Surface Tests for the claimed types reflecting typical use conditions (high soil, hard water). Claimed Spectrum of control should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms
(Anti-microbial) Surface wipesHousehold SurfacesDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousWipe surfaceExtent of kill should be demonstrated by Bacterial, Fungal, Viral Surface Tests for the claimed types using the wipe according to on-pack instructions. Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms
(Anti-microbial) Laundry DetergentLaundered fabricsDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousUse for main washExtent of kill/removal should be demonstrated by Bacterial, Fungal, Viral Fabric Wash Tests for the claimed types on fabric under simulated wash conditions (high soil, hard water). Claimed spectrum of kill should be demonstrated by e.g. Suspension tests or MKC test including any specific claimed organisms
(Anti-microbial) Laundry SoakLaundered fabricsDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousSoakExtent of kill should be demonstrated by Bactericidal, Fungicidal, Virucidal Test for the claimed types on fabric under recommended soaking conditions (high soil, hard water). Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms
(Anti-microbial) Laundry DetergentMachine interiorDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.VariousUse in main/special washExtent of kill should be demonstrated by Bacterial, Fungal, Viral Surface Tests for the claimed types under simulated wash conditions (high soil, hard water). Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms
(Anti-microbial) Toilet Bowl CleanerBowl waterDisinfects, Bactericidal, Fungicidal, Virucidal Microbicidal, Germicidal etcBacteria and/or virusesUse in bowlExtent of kill should be demonstrated by Bacterial, Viral Suspension Tests for the claimed types. Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms. Tests at in-use concentrations, hard water, high soil
(Anti-microbial) Toilet Bowl CleanerToilet bowl water, sides, rim etc.Disinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.Bacteria and/or VirusesUse on sides, rim etc. and in waterExtent of kill should be demonstrated by Bacterial, Viral Surface Tests for the claimed types. Claimed spectrum of kill should be demonstrated by e.g. 110 Suspension Tests or MKC test including any specific claimed organisms. Tests at in-use concentrations, hard water, high soil
(Anti-microbial) Toilet Bowl/Cistern/Rim Blocks etc.Bowl waterDisinfects, Bactericidal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.Bacteria and/or VirusesUse in bowlExtent of kill should be demonstrated by Bacterial, Viral Suspension tests for the claimed types. Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms. Test at in-use concentrations, hard water, high soil, for a period reflecting continuous presence of biocide
(Anti-microbial) Toilet Bowl Cistern/Rim Blocks etc.Toilet bowl water, sides, rim etc.Disinfects, Bacterididal, Fungicidal, Virucidal, Microbicidal, Germicidal etc.Bacteria and/or VirusesUse on sides, rim etc. and in waterExtent of kill should be demonstrated by Bacterial, Viral Surface Tests for the claimed types. Claimed spectrum of kill should be demonstrated by e.g. Suspension Tests or MKC test including any specific claimed organisms. Tests at in-use concentrations, hard water, high soil, for period reflecting continuous presence of biocide.
(Anti-microbial) Toilet Bowl Cleaner (Anti odour only)Toilet Bowl water, sides, Rim etcOdour controlBacteria, funghiUse on sides, rim etc and in waterDemonstrate significantly slower growth (vs exponentially growing control organisms) or no growth, for relevant odour causing organisms on surfaces. Hard water, high soil conditions

Table 2

Relevant Micro-organisms for Anti-microbial claims

This table is to be read in conjunction with Section C1B) of the guidelines. It lists types of micro- organisms that are generally relevant to particular target sites and sources of contamination. Note that the sites and sources of contamination listed will differ in importance, and in each case some of the relevant types of organisms may also be more important than others.

The purpose of the Table is to guide use of broad terms such as ‘germs, bugs, or microbes’ in advertising and/or pack copy. It may also help guide portrayals of product use.

It does not, however, imply that products should necessarily be formulated to control all relevant types as Section C1a) simply requires that products control a relevant sub-set of organisms and C1b) that the scope of action is properly described.

a) Relevant Micro-organisms for particular Target Sites
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Target Site Relevant Micro-organisms
  G+ve G-ve Respiratory Enteric Moulds Yeasts
General household surfaces + + + + + +
Frequent hand contact surfaces e.g. taps, knobs, switches, handles + + + +    
General bathroom surfaces + + + + + +
Toilets + +   +    
Toilet seats + + + +   +
Showers + +     + +
Drains + +     + +
Laundry + + + + + +
Non-washable fabrics + + + + + +
Kitchen – food contact surfaces (including worktops) Refer to table 2b according to source of contamination
Other kitchen surfaces (non-food contact) Refer to table 2b according to source of contamination
Kitchen sinks Refer to table 2b according to source of contamination
Dishcloths, sponges and other washing utensils Refer to table 2b according to source of contamination
Dishwash water Refer to table 2b according to source of contamination

b) Relevant Micro-organisms for particular sources of contamination
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Source of Contamination Relevant Micro-organisms
  Bacteria Virus Fungi
Substances G+ve G-ve Respiratory Enteric Moulds Yeasts
Food (inherent contamination)            
* Meat +          
* Shellfish   +   +    
* Eggs + +        
Mouldy food + +     + +
Faeces + +   +    
Vomit + +   +    
Nasal secretions + + +      
Saliva + + + +    
Ill People + + + + + +
Diarrhoea + +   +    
* Flu     +      
* Colds     +      
* Other Respiratory Infections         + +
* Skin/Scalp Infections         + +
From other sites and surfaces            
Floors and outside areas + + + + + +
Hands + + + + + +
Mouldy surfaces         + +
Dishcloths and sponges + +        
Cleaning cloths + + + +    
Drains + + + +    
From sites mentioned in part a) Organisms listed

Table 3

Correlation between Recommended Use Conditions and Test Conditions

This table is to be read in conjunction with Table 1. It specifies variations in parameters for testing corresponding to common variations in use regimes.
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Use of Conditions Test conditions
One-step Rinse off High Soil, short contact time
  No rinsing High Soil, long contact time
Clean first Rinse off LowSoil, short contact time,Hard water
  No rinsing Low Soil, long contact time, Hard water

Claims Language

This list contains examples of claims language which are considered to indicate significantly different extents of anti-microbial action or end-result, or to indicate lasting action. This in no way precludes the use of other language not on the list but should be taken as a guide for the use of such other terms.

1.Extent of Action

Words indicating disinfection standard performance and/or a result that is microbiologically safe for intended purpose:

  • Disinfects
  • Kills
  • Eliminates
  • Completely removes
  • Gets rid of
  • Banishes
  • Makes safe
  • Anti-bacterial
  • Anti-viral
  • Anti-fungal
  • Anti-microbial
  • Bactericidal
  • Fungicidal
  • Virucidal
  • Microbicidal

Words indicating lesser performance – a significant step towards but not achieving, a safe result:

  • Helps
  • Helps remove
  • Reduces
  • Cuts
  • Limits
  • Fights

Words indicating microbistatic action:

  • Growth
  • Controls growth
  • Prevents growth
  • Inhibits
  • Retards
  • Stops…breeding
  • Anti-bacterial*
  • Anti-fungal*

*Use of anti-bacterial or anti-fungal to denote bacterio-/fungi-static activity must be accompanied prominently (i.e. on front of pack or equivalent prominence) by a clear statement explaining that the product’s function is to ‘control growth’

2.Words indicating lasting activity


*Guards
*Protects
*Fights
*Keeps away
*Defends
*Resists
Lasts
*Prevents


*The implication of some of these terms can be different according to whether action is e.g. guarding/protecting surfaces against microbes, which would tend to imply lasting action, or guarding/protecting people against disease, which may not.