Universitat Internacional de Catalunya

Policy and Regulations of Cosmetics

Policy and Regulations of Cosmetics
3
15732
1
First semester
OB
Main language of instruction: English

Other languages of instruction: Catalan, Spanish,

Teaching staff


Dra. GARCÍA DEL VALLE, Alba - agarciade@uic.es

Alba García del Valle: agarciade@uic.es

Tamara Martínez Valverde: tmartinezv@uic.es

Introduction

This course aims to give an understanding on the steps required from cosmetic product conception to launch to market. Students will learn on the regulatory basis that a cosmetic product needs to comply and aspects that need to be followed during cosmetic product development;  efficacy and safety tests to be conducted, labelling preparation and manufacturing and quality control. Finally, all this information is compiled in the product dossier that is required by authorities before product launch.

Pre-course requirements

Not applicable

Objectives

- Understand the regulatory basis for cosmetic products and the requirements cosmetic products should comply with before launch to market.

- Learn the manufacture and quality control of cosmetic products.

- Prepare the product dossier of a cosmetic product.

- Discover how to design claims according to the regulation 

- Know which studies are available to establish the tolerance of a product

- Learn the test or clinical studies to establish the product efficacy  

- Know the cosmetovigilance procedure


Learning outcomes of the subject

After finishing this subject, the student will be able to:

  • Learn the applicable regulation for cosmetic products and apply the regulation to the different stages of cosmetic product development.

  • Understand the principles of GMPs in the manufacture and control of cosmetic products.

  • Prepare the product dossier of a cosmetic product.

  • Design claims in compliance with current regulations

  • Choose the necessary clinical studies to support the efficacy and tolerance of a cosmetic product

  • Analyze and prepare a response for a possible cosmetovigilance reaction

Syllabus

  1. Regulatory Background / Guideline

    1. Cosmetic regulations: introduction and evolution 

  2. Product design

    1. Claims and labeling of cosmetics: ecological & sustainable labeling 

    2. Mandatory ingredient declarations and warnings 

    3. TESTING: Validation assays: safety, compatibility, efficacy and sensorial 

    4. Safety 

  3. Manufacture

    1. GMP in the cosmetic industry and ISO guidelines 

    2. Manufacturing and packaging of cosmetic products 

  4. Quality control

    1. Guarantee and quality control 

  5. Dossier compilation and submission

    1. Product dossier 

    2. Regulatory bodies and control agencies in different countries 

    3. European Portal Notification

  6. Post-commercialization

    1. Cosmetovigilance

Teaching and learning activities

In person



Lessons contain theory  and practice. First part of the lesson will cover the theory related to the topic under discussion. Second part of the lesson will contain cases or exercises to apply the theory in real cases and situations.

Evaluation systems and criteria

In person



1) First Assignment: 35% (7th November and 10th December)

7th November - Exercise 1 presentation: New product. Claims design and efficacy and safety studies. Deadline: 14 November 

10th December - Exercise 2 presentation: Cosmetovigilance. Case analysis. Deadline: 17 December


2) Second Assignment: 65% (3rd and 5th December)

3rd December - Exercise  1 presentation. Deadline: 9th December   5th December - Exercise 2 presentation. Deadline: 11th December

Bibliography and resources

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

Print version