Advertising and Promotion of Consumer Products Making Anti-microbial Claims

Guidelines - Revised Jan 2003

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).

It is envisaged that any further work in development of the Guidelines will be carried out by a Working Group comprising members of both BACS and UKCPI.

Scope
These Guidelines govern 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 antimicrobial 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 antimicrobial agent is not sufficient.

2. Language, images and other contextual material which might suggest an antimicrobial 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 antimicrobial benefit (e.g. hygienically clean). Such words may only be used as a synonym for cleanliness (e.g. kitchen hygiene) if care is taken not to express or imply antimicrobial activity or benefit.

3. Products should not claim antimicrobial superiority over other similar products unless the superiority is shown to be significant (by appropriate microbiological tests) and likely to translate to an improved benefit for the consumer. Antimicrobial superiority must not be claimed simply on the basis of an increased concentration of antimicrobial ingredient.

4. Antimicrobial products can help reduce the risks from harmful microorganisms and infectious disease if used appropriately as part of a sound hygiene regime. Their advertising and promotion should not, however, claim or imply that their use directly promotes or improves health, nor that increased use will automatically bring 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 use it in a way in which their expectations of antimicrobial 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 antimicrobial 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 requires something 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 inappropriately 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 for 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:
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;
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 not relevant.

Provided the provisions on Scope of action in C below are also met, such products may use words 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 they make only a partial improvement in microbial 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) Microbicidal 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 as 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 types 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.

M. Saul, J. A. Pickup
20.11.02

Annex to Appendix 6

Current Scope
The 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 microorganisms 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”.
Reference to “benefit in terms of reduced risks of infection” in Section A1 and thereafter signifies that there must be a significant improvement in microbial status in an area that has significant potential for transfer of infection. It is not to be taken to require evidence from clinical trials or epidemiology.

Table 1
Antimicrobacterial 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 this 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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Notes:
1. Where possible, tests should be conducted using recognised standard tests. Applicable standard tests may in due course be specified in the table under “test parameters” where these are agreed to be appropriate and reliable.
2. Test conditions as per Table 3 unless otherwise specified.

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, and
b) Relevant Micro-organisms for Particular Sources of Contamination

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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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For dilute use, testing must be conducted using hard water.

List 1. 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
Antibacterial
Antiviral
Antifungal
Antimicrobial
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”.

List 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.