New Spanish cosmetic guidance: microbiologically safe cosmetic products

The Spanish Agency of Medicines and Medical Devices (AEMPS), together with the National Association of Perfumery and Cosmetics in Spain (STANPA), has published a guide on manufacturing of safe raw materials and cosmetic products in terms of microbiological and conservation characteristics.

The AEMPS promotes scientific knowledge guaranteeing safe cosmetic products. Likewise, the STANPA represents and advocates for a cosmetic industry committed to the wellbeing of the community. With this aim, along with the cosmetic industry experts in formulation, conservation, toxicology, microbiology and good manufacturing practices, they all have participated in the elaboration of the guidance.

The guide upgrades the conservation of ingredients and cosmetics products as a global process while respecting the main requirement of carrying out a correct microbiological risk assessment considering the raw materials, its phytochemistry characteristics, as well as the process and conditions of their manufacture and packaging.

One of the purposes of the guidance is to avoid the overuse or addition of preservatives that do not benefit the stability of the cosmetic product, while they increase the cost of the formula, with a chance of increasing toxicological risks as well. This guidance might be useful for manufacturers using preservatives, as it gathers information related to the selection of an appropriate preservative system pointing out the importance of defining a correct concentration according to the cosmetic’s nature and needs.

Furthermore, it includes a section devoted to efficacy trials of selected preservatives.

The guidance also refers to two essential legal requirements: the assessment of the safety of the substances and cosmetics products and good manufacturing practices maintaining the microorganisms to a safe level while avoiding cross-contamination.

The positive collaboration of the cosmetic industry, the STANPA and the AEMPS has led to this technical documentation meant to help cosmetic formulators, microbiologists and the cosmetic industry in general, contributing to the formulation and manufacture of safe raw materials and cosmetic products in the best interest of the society.

Are you a cosmetics manufacturer making use of preservatives in your products? Reach out to us to assess the best compliance path in the European Union!


Leyre Carrasco Alonso

Regulatory Affairs Department

19/08/2021


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REFERENCES:

Agencia Espanola de Medicamentos y Productos Sanitarios. (2021). La AEMPS, STANPA, y expertos de la indsutria cosmetica elaboran una guia para producer materias primas y productos cosmeticos microbiologicamente seguros. Retrieved on 17/08/2021 from https://www.aemps.gob.es/informa/notasinformativas/cosmeticoshigiene/2021-cosmeticoshigiene/la-aemps-stanpa-y-expertos-de-la-industria-cosmetica-elaboran-una-guia-para-producir-materias-primas-y-productos-cosmeticos-microbiologicamente-seguros/?lang=en