Substances that can be used in cosmetic products are limited by legislation; Lists of prohibited and restricted substances should be followed regularly.
While the formulation was being developed; It should be verified that it does not contain prohibited substances, the use of restricted substances within allowed limits, and the compliance of colorants, preservatives and UV filters with positive lists should be checked.
Incompatible products may be withdrawn from the market. ONAY Mühendislik evaluates formulation-regulatory compliance and safety.
Prohibited and restricted substance lists
Cosmetics legislation; It works through lists of prohibited substances, restricted substances and allowed preservatives, colorants and UV filters. If a component appears in one of these lists, the condition of use and maximum concentration are also defined there.
Lists vary
These lists are updated regularly; A protection allowed today may be restricted in the future. Screening the portfolio against the current list at least once a year greatly reduces the risk of market withdrawals.
Formulation and label relationship
If a restricted substance is used, a special warning on the label may be required. Whenever the formulation changes, the label also needs to be reviewed; Having separate teams manage two documents creates problems at this point.
What should be in the file
The usage rate for each restricted component, the limit in the relevant list and the justification for conformity must be written in the product information file. What is asked in the audit is the evidence of compliance with the limit, not the existence of the component.
Separation of Prohibited, Restricted and Permitted Substances
Cosmetics legislation considers substances in three separate lists. Prohibited substances cannot be used under any circumstances. Restricted substances may only be used in the specified product type, at maximum concentration and with a mandatory warning statement. Dyes, preservatives and UV filters are on the positive lists; A non-listed protector or UV filter cannot be used. Confusing this distinction leads to a complete remaking of the formulation.
Verification of Raw Material Declaration
The INCI name on the technical data sheet from the supplier does not always correspond exactly to the substance description in the restriction list. Different impurity profiles or different derivative forms may exist under the same INCI name. For this reason, CAS number and full composition declaration should be requested when accepting raw materials, and comparison with the threshold values in the restriction list should be made through CAS.
Monitoring Regulatory Changes
Restriction lists are updated regularly and the restriction of a substance often imposes different transition dates for placing on the market and keeping on the market. When the time allowed for products already on the shelf is mixed with the time given for new production, there is a risk of product recall. Listing all ingredients used in formulations and periodically comparing them with regulatory updates eliminates this risk.
Formulation Screening for Prohibited and Restricted Substances
When the Prohibited and Restricted Substances lists are updated, all formulations must be rescreened on an ingredient-by-ingredient basis. Scanning should be done by CAS number, not by commercial raw material name; Different derivatives may exist under the same INCI name. The dated record of the Prohibited and Restricted Substances screening is the strongest document the company has against the risk of product recall.
Related pages
Contact ONAY Mühendislik for your process.
Official full text of the regulation: KKDIK Regulation - Official Gazette.