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Aynosens and Toxicologist Expert
We all wish the best for our children.
Isn’t getting back to basics the best solution? This is what we believe at Aynosens. Today we have alternatives! Making our own products? Use nothing but soap and water? But are we sure that these alternatives are safe for our children?
Aynosens has decided to have all of these unique and 100% natural formulas tested to make sure they are safe.
Our Toxicologist will explain everything to you.
A toxicologist is responsible for assessing the safety of the cosmetic product. However this evaluation can be done by a doctor, a pharmacist or any person holding an equivalent diploma.
A formula necessarily goes through a safety assessor (who is not necessarily a toxicologist). This step is mandatory according to cosmetic regulations. It ensures that the cosmetic product is safe for the consumer, under the expected and foreseeable conditions of use.
The product safety assessment is mandatory, which includes the formula (the safety assessment is done on the product and not just on the formula). The conclusion of this assessment can be positive (the product does not present a risk for the consumer), positive conditionally (the product is safe for the consumer provided that the warnings are followed) or negative, the product is not safe for the consumer under the planned or foreseeable conditions of use. In this case, it is up to the person responsible to take the necessary measures to ensure consumer safety (withdrawal from the market, reformulation, etc.).
It is necessary to update the cosmetic file with each change (change of supplier, pack, formula, labeling but also change of regulations, new toxicological information, etc.). This update will be an opportunity to reassess the safety of the product as well as its compliance with the regulations. Indeed, it is not because a product has been validated and its evaluation complies with safety requirements that it will still be validated after a change.
Interview with our toxicology expert
1/ What do you think of the approach of dividing products by age groups?Is it really useful? Why is it useful?
It is essential to clearly define the class of consumers most likely to be in contact with the product in order to properly assess safety. In this sense, dividing products by age group gives a precise idea of the consumer category and allows the safety assessment to be adapted to their weight, body surface area and the quantities applied. However, it is also necessary to think about the foreseeable uses of the product (will a product intended for 0-3 year olds not be used by parents as well, will a product for over 6 year olds be used on a younger population etc.).
Certain ingredients are not permitted in products intended for an infant population (for example, salicylic acid cannot be used in products for children under 3 years old except for shampoo). The formulations must therefore be adapted to the target population.
This approach therefore makes sense, both to comply with the regulations and to allow a more accurate safety assessment, but also in terms of the needs of the different target populations.
According to the SCCS (Scientific Committee on Consumer Safety), when children are born at term, their skin has all the structures of adult skin and these structures are not subject to major changes after birth. Dermal absorption for newborns with intact skin is similar to that of adults. This is the position adopted by the SCCS.
However, according to some authors, the skin of newborns is not fully developed before 6 months, as the skin is thinner the penetration of certain substances could be increased and the water losses too. The development of the structure and density of the skin would be fully achieved around 1 to 2 years.
In addition for young children, the bottom area is a sensitive area. At birth, no difference between this zone and the others is noticed, but this area is subject to special conditions and differences are quickly visible (from 14 days). The pH is higher and so is the hydration. The hydration is slightly higher in the stratum corneum, and the variations are more important until about 1 year. The pH is maintained between 5 and 6, which is comparable to adults, but this area is more susceptible to inflammation, which can call the buffering capacities of the skin into question. Therefore, special attention should be paid to cosmetics used in the bottom area on children up to 3 years.
As for the other age groups, there are no noticeable differences.
For the toxicological / regulatory side, the difficulties are to respect the maximum concentrations that can be used to protect consumers while arriving at a stable, non-irritating formula, with an effective preservative system that is pleasant to use.
4/ In general, what are the cosmetic formulation prerequisites when the products are intended for children?
Some ingredients are not allowed for children under 3 years old, so make sure they are not included in the formulas. It is also necessary to ensure a superior microbiological quality. In terms of safety assessment, it must be ensured that the products will be safe for use by children, in relation to the quantities used, the weight of the subjects and the frequency of use.
In addition to ingredients prohibited for any population, it is necessary to exclude ingredients prohibited in products for children under 3 years old (salicylic acid, silver chloride, Iodopropynyl butylcarbamate) and avoid allergens for children under 3 years old. As with any product, the ingredients must also be considered on a case-by-case basis depending on the formula and use.
In oily formulas such as dry oils and formulas with very little water such as cleansing oils, there are no antimicrobial preservatives as the risk of bacteria, yeast and mold growth tends to zero.
Regarding formulas containing an aqueous phase, the Cosmos standard authorizes a limited number of preservatives, some of which are prohibited for children under 3 years old. Our choice then fell on potassium sorbate and sodium benzoate as well as a preservative booster for the diaper cleanser.
For both adults and children, alcohol can increase skin penetration and thus facilitate the absorption of other molecules.
They do not require antimicrobial preservatives.
The diaper cleanser formulated does not contain lime water. Its pH is closer to the baby’s skin than conventional liniments.
Aloe vera for hydration, Italian helichrysum extract to soothe, oils to nourish and inulin to limit tightness and bring softness.
The oils are emollient, they will form a protective film on the skin and nourish the skin.
They gently remove fat-soluble dirt (cleansing oils, bi-phase and diaper cleanser).