Aligning US Compliance with International Standards

The Modernization of Cosmetics Regulation Act (MoCRA) 2022 has introduced significant changes to US cosmetics regulations. This new law modernizes how the FDA oversees cosmetics, addressing safety, reporting, and manufacturing standards for the first time in decades. For cosmetics companies, mainly those operating globally, MoCRA compliance is critical. Yet, it is only one piece of the puzzle when managing international regulations in markets like the European Union (EU), China, Japan, and beyond. 

Aligning US compliance with global standards helps streamline operations and reduce regulatory risks, especially for brands that market across multiple regions. This blog will explore MoCRA’s alignment with global regulations and how companies can effectively manage compliance across various markets. 

Key Features of MoCRA 

MoCRA brings several important changes to US cosmetics regulations: 

• • Companies must now register their manufacturing facilities with the FDA and provide a list of all cosmetics they sell. 

• • Serious adverse events, such as hospitalizations or deaths related to cosmetics, must be reported to the FDA within 15 business days. 

• • MoCRA introduces mandatory GMPs for cosmetics, ensuring products are manufactured in safe and sanitary conditions. 

• • Companies must maintain records demonstrating their product’s safety, including toxicological assessments and ingredient safety data. 

These changes aim to improve consumer protection in the US, but for global cosmetics brands, MoCRA’s requirements must be considered in the broader context of international regulations. 

Comparing MoCRA with EU Cosmetics Regulation 

The European Union’s Cosmetics Regulation (EC No. 1223/2009) is one of the world’s most comprehensive regulatory frameworks for cosmetics. The EU’s stringent standards focus heavily on ingredient safety, product labelling, and bans on animal testing. Here’s how MoCRA compares to EU regulations: 

Ingredient Restrictions 

The EU has a long list of banned and restricted ingredients, including over 1,300 chemicals prohibited in cosmetics. In contrast, the US has traditionally had fewer restrictions, but MoCRA empowers the FDA to take a more active role in regulating harmful ingredients. While MoCRA does not introduce specific ingredient bans, we may see future alignment as the FDA evaluates more substances for safety. 

Animal Testing 

One significant difference between MoCRA and the EU’s regulations is their stance on animal testing. The EU has wholly banned animal testing for cosmetic products and their ingredients. Although MoCRA does not ban animal testing, consumers and advocacy groups increasingly pressure the US market to adopt cruelty-free alternatives. As more brands move towards cruelty-free practices, the gap between US and EU regulations may narrow. 

GMPs and Safety Substantiation 

MoCRA and the EU require cosmetics to be produced under Good Manufacturing Practices (GMPs) and backed by safety assessments. However, the EU’s system is more detailed, requiring a Cosmetic Product Safety Report (CPSR) that includes comprehensive data before a product can be sold. MoCRA’s requirement for safety substantiation is similar but less prescriptive, which may provide more flexibility for US companies while ensuring product safety. 

MoCRA and China’s Cosmetics Regulation 

China is one of the largest and most complex cosmetics markets, and its regulatory system has undergone significant changes in recent years. The Cosmetics Supervision and Administration Regulation (CSAR), which came into effect in 2021, introduced stricter rules for product safety and adverse event reporting, similar to MoCRA’s approach. 

Ingredient Safety 

Like MoCRA, China’s CSAR strongly emphasizes ingredient safety. However, China has additional “special cosmetics” categories, such as hair dyes and sunscreens, which require more extensive testing and approval. This categorization means US companies exporting to China must provide specific safety data tailored to these “special” products. 

Adverse Event Reporting 

Both MoCRA and CSAR require companies to report serious adverse events linked to their products. By implementing a unified reporting system that tracks safety issues across multiple markets, companies can ensure they meet the requirements of both US and Chinese regulators. AI-driven systems like Datafoundry’s mSafety can help streamline this process, making managing compliance data for multiple countries easier.  

Animal Testing 

While MoCRA does not address animal testing, China has historically required animal testing for cosmetics, mainly imported products. Recent changes to China’s regulatory framework allow some “ordinary” cosmetics (e.g., shampoo, perfume) to avoid animal testing if certain conditions are met, such as providing detailed product safety data. This creates an opportunity for brands to avoid animal testing in China by aligning their safety substantiation efforts under MoCRA with the more stringent requirements of China’s CSAR. 

Strategies to Navigating Global Compliance 

For global cosmetics companies, aligning US compliance under MoCRA with international regulations can be challenging. However, harmonizing compliance practices can reduce complexity, improve efficiency, and help brands stay competitive in multiple markets. Here are three key strategies for managing global compliance: 

1. Centralized Compliance Systems 

One of the most effective ways to align compliance across different regions is to implement centralized systems that track regulations, safety data, and adverse event reports. AI-driven platforms like mSafety can help automate these processes, ensuring that companies meet the reporting requirements of MoCRA, the EU, China, and other markets. These systems can track regulatory changes in real-time, flagging potential risks and helping companies stay compliant globally. 

2. Harmonized Ingredient Safety 

Consumers worldwide demand greater transparency about the safety of ingredients in their products. Aligning safety assessments with the most stringent global standards, such as the EU’s list of banned substances, can help reduce regulatory risk and ensure products are safe for all markets. By maintaining high standards for ingredient safety, brands can build consumer trust and reduce the likelihood of regulatory challenges in any market. 

3. Adapt to Local Market Nuances and Idiosyncrasies 

While alignment is essential, adapting to local regulations is crucial. Each market has unique requirements that global companies must account for, such as China’s rules for special cosmetics or the EU’s specific labelling mandates. Having a flexible compliance approach allows companies to make the necessary adjustments while maintaining consistent safety and transparency across all markets. This is done before accounting for local language and regional differences to guidance. 

Conclusion 

MoCRA has introduced a new era of cosmetics regulation in the US, bringing it closer to international standards. For global cosmetics brands, aligning US compliance with the requirements of the EU, China, and other markets is key to staying competitive and maintaining consumer trust. 

By adopting centralized compliance systems and AI-driven platforms like mSafety, companies can streamline their reporting processes and ensure that their products meet the safety requirements of each region. Harmonizing ingredient safety and adapting to local market nuances will help brands minimize risk and maximize their global reach. 

As MoCRA continues to evolve, businesses prioritizing alignment with international standards will be well-positioned to thrive in the complex world of cosmetics regulation in 2024 and beyond.