According to Article 3 of the Cosmetic Regulation; a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking into account the product’s presentation, labelling, instructions for use and disposal and any other indication or information provided by the responsible person defined in Article 4.
The safety of a cosmetic product is first achieved by selecting the raw materials used in its formula.
The formula refers to the quantitative and qualitative composition of the cosmetic product, including the chemical identity of the cosmetic product (including INCI, CAS, EINECS/ELINCS, and the chemical name, if any) and their prescribed functions. Quantitative values should not be given in the form of range unless justified in formulations. Both legislative and toxicological evaluations and calculations must be performed at maximum value for the concentration values given in a range. It is important to specify the composition of the mixtures that used in the formula for correct evaluation. All raw materials in the formula should be evaluated according to the Cosmetic Regulations as the first condition.
ANNEX II: LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS
The raw materials in Annex II are the raw materials that should not be included in the formulation, and their inclusion is sufficient to qualify the product as unsafe.
ANNEX III: LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT LIMITATIONS AND CONDITIONS
As long as the raw materials in this annex meet the specified limitations and conditions, there is no problem in having them in the product formulation. The raw material must comply with all given conditions, whether in terms of concentration, type of product or other specified limitations.
ANNEX IV: LIST OF COLORANTS ALLOWED TO USE IN COSMETIC PRODUCTS
Cosmetic colorants in this list are listed by color index number or by name in the common components dictionary. The colorants that used in the formulation must comply with all limitations given, such as the raw materials listed in Annex III.
ANNEX V: PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
The raw materials used for “preservative” purposes in the product formulation are included in this list. Preservatives that used in the formulation must comply with the conditions in this Annex of the regulation.
ANNEX VI: LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS
Compliance with this Annex is sought for UV filters that used in sunscreen products.
The second requirement is the calculation of the safety limit (MoS) of raw materials after obtaining the formulation that ensures compliance with the Annexes of the regulation. It is determined by this calculation whether the raw materials contained in the formula are safe in that product at the given concentration.
MoS = NOAEL / SED
SED (mg/kg body weight/day): Systematic exposure dosage
NOAEL: No observed adverse effect level
If these toxicological evaluation results made according to the product type and target group are found appropriate, the formulation can be accepted as appropriate and the safety tests required for the formulation can be started in order to make a final decision for placing on the market. Our services include examining your formulations on the basis of regulatory compliance with all this information.
