Baby & Children's

Products for babies and young children are held to the most cautious assessment in all of cosmetics. A child is not a small adult: the skin is thinner and more permeable, the ratio of body surface area to weight is higher, and behaviour, hand-to-mouth contact, time in a nappy, means exposure has to be modelled differently. The assessment reflects all of that rather than scaling down an adult product.

Age-specific exposure and the margin of safety

The SCCS Notes of Guidance sets out exposure factors specific to children by age, the body weights, surface areas and product quantities that apply to infants and young children rather than adults. The safety report uses these, and a higher margin of safety is expected, because the same systemic exposure represents a larger dose relative to a child’s body weight. For products intended for children under three, Annex I requires a specific assessment of their suitability, and that specific reasoning has to be in the file.

Restricted ingredients and warnings

A number of ingredients carry child-specific limits, prohibitions or warnings. Triclosan and triclocarban carry restrictions and warnings against use for young children; fluoride toothpastes require the child-supervision guidance; phenoxyethanol has been scrutinised for use in the nappy area; and ingredients such as camphor, menthol and certain essential oils are treated with caution for young children because of their physiological effects. The fragrance-allergen load is kept to a minimum, and the assessor weighs every ingredient against a child’s lower tolerance rather than an adult’s.

Microbiology and formulation

Children’s products are held to stricter microbiological standards and formulated for low irritation potential. A “no tears” or low-sting performance is a formulation quality, not a substitute for the safety assessment, and the preservative system still has to be both compliant and proven effective by challenge testing, which is harder to achieve in the mild formulations the category demands.

Claims

Claims are tightly constrained. “Hypoallergenic” may only be used where the allergenic potential has genuinely been minimised and can be evidenced, under the Commission’s Technical Document, and gentleness or suitability-for-babies claims must be substantiated and must not stray into implying a medicinal benefit such as treating eczema or cradle cap.

How we help

We assess baby and children’s products to the child-specific exposure factors and the higher margin of safety the category requires, provide the specific under-three assessment, keep restricted ingredients and warnings correct, design and challenge-test a preservative system that works in a mild formulation, and hold gentleness and hypoallergenic claims to the evidence the guidance demands.