Masterarbeit
The Modernization of the US Cosmetic Regulation Act of 2022: An Overview of the New Challenges for Small and Medium Enterprises in the USA ***
Kathleen Grundke (2025)
Summary
Language: English
Cosmetic products have a long history and were used by the upper class
before becoming accessible to the public through industrialization. Due to
harmful ingredients, strict regulations were introduced in the USA and the EU.
In the USA, regulation began with the Federal Food, Drug and Cosmetic Act of
1938 and was significantly expanded with the Modernization of the Cosmetic
Regulation Act of 2022 (MoCRA). The implementation of MoCRA strengthens U.S.
Food & Drug Administration (FDA) oversight of cosmetic products marked in
the USA and requires a documented safety substantiation.
Moreover, MoCRA improves transparency in labeling and packaging,
particularly for fragrance declarations, and introduces the "Cosmetics
Direct Portal" for better product safety and compliance. Moreover, the
companies are requested to adverse event reporting or safety concerns related
to cosmetic products after they are placed on the market to FDA.
In the EU, Regulation No. 1223/2009 governs the market with strict
safety assessments, the Cosmetic Product Notification System, and a complete ban
on animal testing. Compared to the USA, EU regulations are stricter,
particularly regarding animal testing and the use of certain ingredients.
However, MoCRA has brought the USA closer to European regulation, especially in
terms of safety assessments, cosmetic surveillance, and good manufacturing
practices (GMP), while remaining more flexible for small businesses.
Both the USA and the EU focus on preventing misleading advertising
claims to protect consumers, ensuring product information is accurate. However,
they differ in their requirements of cosmetic formulations and ingredient
safety. In the USA, ingredients like UV filters are treated as drugs, while the
EU has no similar regulation. The EU also enforces a full ban on animal
testing, unlike the USA, where animal testing is permitted.
MoCRA has aligned the USA's regulatory framework closer to European
standards, particularly in safety assessments, adverse event reporting and
compliance with GMP guidelines. However, the USA remains more flexible,
especially for small businesses, with some regulations still under development,
such as fragrance labeling and GMP guidelines.
For small- and medium enterprises (SME) companies, the implementation
of these new requirements under MoCRA could pose significant challenges. These
businesses may face increased costs and administrative burdens to meet the new
safety and compliance standards. However, despite these challenges, there are
also potential opportunities for growth. Companies that are able to meet the
new regulatory requirements will be better positioned to build consumer trust,
improve product quality, and ultimately differentiate themselves in an
increasingly competitive market.
One proposed development of a joint registration strategy for a
US-based SME aiming to sell cosmetic products in the EU and US markets involves
several crucial steps. The process starts with market analysis and the creation
of a “green” product line focused on sustainability and organic ingredients.
The strategy includes establishing GMP, TPP, product formulation, packaging
design, safety substantiation through CPSR and PIF, cosmeticovigilance system,
and a marketing strategy. Implementing this strategy means that small companies
will be able to successfully register and sell their cosmetic products in the
European and US markets and provide access to new markets and opportunities.
In summary, MoCRA represents a significant step towards improving
the quality and safety of cosmetic products for consumers in the USA. By
introducing stricter regulations for manufacturing practices, safety evidence,
cosmetic monitoring and labeling, MoCRA is intended to improve consumer
protection and ensure that cosmetics are safer and more reliable. While it may
be difficult for small businesses to comply with the new regulations at first,
the long-term benefits of increased consumer confidence and sector growth
outweigh the costs and effort.
Pages: 77
Annexes:6, Pages:
11