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Standards Development
This document specifies the requirements and tests for personal lubricants used during sexual activity. It covers water-based and silicone lubricants.
It is not applicable to lubricants applied to condoms at the time of manufacture, or to products intended solely for use as massage oils.
The use of personal lubricants in sexual activity has grown dramatically over the last 25 years. In developed countries, these products are now widely available in supermarkets as well as pharmacies (which were the original source). The range of choice available to consumers has increased from ten to two hundred or more in most developed market economies. A wide variety of different properties exist in those developed markets.
In developing countries, where condoms are provided by aid agencies, a demand for additional lubricants has arisen, and now the aid agencies often make additional lubricants available as an adjunct to condom supply.
This growth in demand has occurred because, with more frank, open discussion of sexuality, the need for personal lubricants has become apparent from user feedback. It is now accepted that sexual activity should be pleasurable. A considerable proportion of users suffer discomfort or pain with a higher risk of breaking condoms during intercourse if they don’t use lubricants. Clearly identifiable user groups likely to suffer from these issues include:
1. Older people (e.g. post-menopausal women) who continue sexual activity but do not have adequate natural lubrication
2. Women who are required to have intercourse when they are not sexually aroused (including, but not limited to sex workers)
3. Men who have sex with men
4. Fertile women whose natural lubrication is insufficient.
Excessive dryness during sexual activity is likely to result in wear, irritation, abrasion, bruising increased risk of broken condoms and infection, especially with STIs.
Thus personal lubricants have followed condoms in emerging from hiding, and are being recognized as an important contributor to human well-being.
Yet these products have no standard for safety, usability, formulation, contamination, or efficacy. In order to procure lubricants for UN purchases, WHO has published a specification for the products they order. This specification is suitable for a sub-group of users, but is quite inappropriate for most high-risk users in developed economies. In fact, most of the products on the retail market in developed countries do not comply with the specification, and would probably lose market share if they did!
The existence of WHO’s specification has caused considerable confusion among regulatory and certification bodies, and some of them believe that the manufacturers should make all their products in accordance with WHO’s specification. If this happened, it would be counter-productive for a large of users increasing their risks of harm without increasing usability. Vaginal dryness is dramatically more prevalent in the developed world with regional changes needed for some key high risk market segments.
The development of a standard would provide guidance to regulators and certifiers about the key issues related to the usability, safety and efficacy of personal lubricants. It would ease the work of compliance for manufacturers if a standardized set of risks, tests and claims were developed.
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