PHA-30045 - Module Specification
School of Pharmacy and Bioengineering
Faculty of Medicine & Health Sciences

Programme/Approved Electives for 2024/25

Available as a Free Standing Elective

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2024/25

The marketing of cosmetic products around the world is an area that is heavily regulated. It considers the honesty of claims made for what cosmetic products do and requires detailed scientific evidence to substantiate those claims. This module focus on the area of ¿claim substantiation¿ in the cosmetics industry (and also in the related Home and Personal Care market, both of which are often viewed as part of the Fast-Moving Consumer Goods Market). This module will focus on the claims made for cosmetic products in several major territories (the UK, the EU, the USA and the Association of South-East Asian Nations) and also on how claims can be made (for example, by social media) and understand the roles of regulators and producers in making fair and honest claims for their cosmetic products.

This module aims to address the current professional and regulatory requirements for claim support in the UK and other major territories (EU, USA, ASEAN). This will be based in Article 20 of the UK Cosmetics Regulations (Schedule 34 of the Product Safety and Metrology Statutory Instrument), which is mirrored in Article 20 of the EU Cosmetic Products Regulation. Specifically, shared text in both these sources state that "in the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or function that they do not have" and this framework will provide the background to this module, along with the common UK-EU Common Criteria framework for cosmetic claims (under Regulation 655/2013). Suitable contextualisation under OECD / ICH will also be provided to develop the context of internationalisation across and between key markets, and will focus on the Six Common Criteria for Cosmetic Claims: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.
The module will also focus on professional guidelines from the industry (e.g. the CTPA Guide to Advertising Claims) and regulators (e.g. the UK Consumer Protection from Unfair Trading Regulations 2008 and the EU Unfair Commercial Practices Directive 2005/29/EC, amended as (EU) 2019/2161) and focus on the science underpinning claims substantiation.

Intended Learning Outcomes

appreciate the regulations governing the manufacture, marketing and sale of cosmetics and associated fast-moving consumer goods, and to apply this knowledge to pre-existing cases and new cases;: 1,2
appreciate and critically compare the similarities and differences in cosmetic product regulations across major territories in the context of social media;: 1,2,3
appreciate the key common criteria for marketing cosmetic products in multiple territories and within the context of international frameworks (e.g. OECD, ICH);: 1,2
appreciate and apply key scientific concepts to the claims made for cosmetic and similar products;: 1,2,3
appreciate the role of the Responsible Person in leading the marketing of cosmetic products;: 1,2
xritically evaluate the underpinning scientific nature of cosmetic products to develop new claims for novel formulations;: 1,2,3
recognise the key concepts in consumer marketing and how they are contextualised within the regulatory and legal frameworks in multiple markets, and how this influences product manufacture and sales of cosmetic products, and how different cultures and territories differ in their approach to approving and licensing cosmetic products.: 1,2,3

Study hours

50 hours contact teaching, 100 (98) hours self-directed learning and 2 hours related to assessments.
50 hours to be comprised of:
- 24 hours of lectures
- 26 hours of workshops which are mostly discussions on case studies and preparation for the assessments
- 2 hours for the assessments

School Rules

None

Description of Module Assessment