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Cosmetics in Europe are regulated by Legislation (EC) No. 1223/2009, which requires that cosmetic products must be safe for use before being placed on the market. This must be done through a safety assessment contained in a single product dossier (PIF, Product Information File), which must be prepared by a qualified and certified safety assessor. The evaluation of final cosmetic products in Europe is based on the risk assessment of each ingredient that makes up the product formula, taking into account its route and exposure time. This scientific exercise has always been carried out based on data obtained from experiments carried out on animals. Since March 11, 2013, animal testing and the marketing of ingredients and products tested on animals have been banned in Europe. This means that No-observable-Adverse-Effect-Levels (NOAELs), obtained through sub-chronic toxicity studies carried out on animals, are no longer accepted by European legislation, thus turning innovations into new almost impossible molecules. I said ALMOST IMPOSSIBLE.
New ways to ensure the safety of cosmetic products can be explored. And a revolution in relation to new knowledge and understanding about the Toxicology of substances or mixtures of substances for the cosmetic market is happening right now. This is what is meant today by TOXICOLOGY of the 21st CENTURY. Therefore, the topic of New Generation of Risk Assessment (NGRA) of cosmetics has been discussed in new publications and which I will bring to you during my free lectures.
Several reasons can be given that require a correct and error-free safety assessment of cosmetic ingredients and products; where the professional responsible for the evaluation must be an evaluator with a high degree of experience and very well trained. Humans are being exposed to cosmetic products at an earlier age. For example, newborns take their first bath shortly after leaving their mother's womb. Parents apply diaper rash cream to their folds so they don't suffer from skin irritation caused by urine and feces. The diaper rash cream must be effective in protecting and must not penetrate the baby's skin causing any toxic effect. Babies take at least one bath with shampoo, conditioner, and liquid soap (or bar soap) every day. Some use perfumes to make them smell like a baby and others use moisturizing lotion. In these few lines I mentioned 6 different products, with different galenic formulas, with the baby being exposed to countless molecules every day. So that cosmetic products do not contain substances that can cause harm to humans, the safety evaluator of these products must be aware of the interactions of these molecules with skin tissue and current legislation.