When a cosmetic product, before it is brought to market, it is first applied to a child population, it is necessary to have previously demonstrated that it is safe to use. So the question is: ?What tests can be carried out on children? to assess its safety? The answer is unequivocal: none. A child must not be exposed to even the slightest risk in order to assess the safety of a cosmetic product. This means that studies involving children cannot be carried out.
Cosmetics for children should be tested on adults whose cutaneous pathophysiological response is as similar as possible to that of infants. For this reason, subjects with sensitive skin are used, and the product is applied to delicate areas, such as the inner side of the arm. Furthermore, the following must be carried out:complementary studies on mucosal sensitisation and tolerance (HET-CAM).
Once the risks associated with the product have been assessed and its safety in adults has been verified, a paediatric trial, in accordance with the protocols established for this population. Under no circumstances may the toxicological parameter study, which is not incompatible with being monitored by a paediatrician and/or dermatologist, so that action can be taken in the event of any adverse effects.
«A child must not be exposed to even the slightest risk in order to assess the safety of a cosmetic product.».
Further information on studies involving children:
A person’s paediatric years are generally considered to span, roughly speaking, the first 14 years of life. In other words, before the onset of puberty. During this period, the body’s anatomical and physiological characteristics undergo continuous change.
A child’s skin during the first three years of life exhibits characteristics that make it much more vulnerable to external factors. It has a very thin, poorly keratinised epidermis and is therefore more sensitive to physical (scratches) and environmental irritants. Sebum secretion, which contributes to its acidification, is greatly reduced, as is the immune response due to a lack of antibodies. A child’s skin also has a higher level of hydration which, combined with its lower lipid content, promotes the absorption of certain substances
Differences between children and adults with regard to the safety of a cosmetic product
All these features mean that Children’s skin is much more vulnerable than that of adults. Both in relation to external factors (micro-organisms, potentially toxic water-soluble substances, mechanical agents or radiation), and in maintaining the balance necessary to ensure skin and body hydration. That is why it is so important to avoid the studies on children. From the age of 3, these characteristics begin to change and, by the age of 6, the skin already has properties more similar to those of an adult.
Another characteristic that differs between children and adults is the relationship between the weight and the body surface area. During growth, body surface area follows a quadratic relationship, whilst volume – and weight – follow a cubic one. This is why, for example, the ratio of body surface area to body weight is 6.57 dm²/kg in a newborn. In contrast, it is 2.86 dm²/kg in an adult. This would explain the greater ability to lose water in children.
When applying a cosmetic product, if we consider that the absorption and potential uptake of its components depend on the surface area to which it is applied, and that both toxicity and the dose-response relationship, the the risks associated with the use of the application are much higher among children, particularly during the period of the breastfeeding. Another risk factor is the possibility of application to damaged (irritated) skin, which is sometimes seen in infants. In some cases, this can affect a very large area.
Studies involving children: a step-by-step guide
The safety of a cosmetic product intended for children, step by step
It is clear that special care must be taken before marketing a cosmetic product aimed at children. This is particularly true for children under the age of 3. Of all the functions of a cosmetic product described in the Regulation 1223/2009, whilst those aimed at children are practically limited to two. Clean y to protect the skin’s surface.
In view of the assessment When it comes to this type of make-up, you need to start with a analysis a very comprehensive account of his formula. It is necessary to check that there are no substances from the Annex II and the Annex III. And the restrictions for children under the age of 6 or 3. We must also analyse those that present a range of activity, such as detergents. And make sure you choose those with the lowest activity, as these tend to cause fewer undesirable effects.
Special attention should also be paid to the stability, particularly microbiological immunity, as young children’s ability to defend themselves against microorganisms is greatly reduced. Another important factor is the absence of impurities, particularly the water-soluble ones. Given their ease of absorption and unfavourable surface-to-weight ratio, they could cause systemic toxic effects. Given the weakness of the immune system, particular attention will need to be paid to the absence of substances with allergenic properties.
A solution to prevent studies being carried out on children
Given the ethical and legal impossibility of conducting studies on tolerance amongst children, Tests on cosmetic products must be carried out on adults. It is best to select adult subjects with reactive skin for the test, and to apply the product to areas with minimal keratinisation. Firstly, it would be advisable to carry out a test (Patch test), a open-label tolerance study and a sensitisation test. If the products are applied to the entire body surface – which is often the case – a test must be carried out to determine their effect on mucous membranes. For example, one could use a HET-CAM.
Bearing in mind that, on certain occasions, the cosmetic product may be applied to damaged skin, it would be advisable to carry out a cytotoxicity study by direct contact. In all cases, it is important to bear in mind that the results of these tests must show a zero injury rate, or very small on the HET-CAM.
Conclusions
Caution is required before developing a cosmetic product for children, particularly those under the age of 3. A number of considerations must be taken into account, and the standards are much stricter than those for adults. It is important to take an expert’s opinion into account before developing any cosmetic product. And in the case of products aimed at children, this recommendation becomes a necessity.
Do you need more information on how to ensure the safety of a cosmetic product intended for children? Avoid conducting studies on children and do not hesitate to contact us to seek expert advice. Our proposal? Solutions!
- The Expert opinion It was drafted in 2012 for the former GTF M. Camps website. This coincided with a period of uncertainty regarding the interpretation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. To this day, these issues remain of great relevance to the cosmetics sector.