COMPREHENSIVE REGULATIONS FOR DRUG AND COSMETICS IN EUROPEAN UNION
DOI:
https://doi.org/10.22159/ijpps.2025v17i2.52827Keywords:
Regulations for drugs and cosmetics, Good manufacturing practices, Qualified persons, Artificial intelligence in cosmetics, Nanomaterials in cosmeticsAbstract
Pharmaceuticals are regulated for quality, safety, and effectiveness by regulators for marketing approval with regard to good manufacturing practices, formulation, labelling, packaging, documentation and qualified individuals. Cosmetics for oneself or others are growing in popularity. The European Union (EU) Cosmetics Directive No. 1223/2009 enforces guidelines for cosmetic preparations. By considering the long-term risks of nanoparticles if misused by researchers and testers, the risk assessment outlined in Article 16 of the cosmetic code provides a framework for increasing the possibilities for innovation in nano-products. On March 14, 2024, the EU Commission published Regulation (EU) 2024/858, amending Cosmetics Regulation European Commission (EC) No. 1223/2009, which updated Annexes II and III regarding the use of certain nanomaterials in cosmetic products. Substances added in Annex II are prohibited from use, whereas those added in Annex III can be used when prescribed restrictions are met like essential conditions under European regulations for the import and sale of cosmetics. In the EU, the manufacturer is responsible for the safety of its products and must ensure that they undergo an expert scientific safety assessment before they are sold. The European Commission is also advised on issues related to the safety and allergenic properties of cosmetic products and ingredients by the Scientific Committee on Consumer Safety (SCCS), administered by the Directorate-General for Health and Food Safety (DG SANTE), informed by independent scientific expertise.
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