21 October 2024
The Popularity of Lip Balms and Lip Products: Navigating Regulatory Nuances in the EU, US, and Canada
As regulatory experts, it’s evident that lip products, especially lip balms, have become a cornerstone of the cosmetics market in 2024—and projections indicate this trend will continue strongly into 2025. Driven by consumers’ increasing demand for skincare-focused cosmetics, this category has seen impressive growth and innovation.
However, businesses looking to capitalize on the popularity of these products must navigate complex regulatory landscapes, as requirements vary significantly between regions like the European Union (EU), the United States (US), and Canada. This article will provide insights into the key regulatory considerations to keep in mind as you develop and market lip products internationally.
Lip balms and other lip products are now positioned as essential cosmetics, largely driven by consumer priorities around skin health, natural ingredients, and sustainable packaging. According to the latest data from Grand View Research, the global lip care market is expected to grow significantly over the next five years, with the natural and organic lip product segment being one of the fastest-growing areas. As consumers increasingly seek products that protect, hydrate, and enhance their lips with clean, safe ingredients, brands have ample opportunities to innovate. However, businesses must also adhere to evolving cosmetic regulations to ensure product safety and compliance.
Regulatory Overview: EU, US, and Canada
Each region enforces distinct standards for the manufacture, labeling, and marketing of cosmetics, including lip balms and other lip care products. While they share some commonalities, the differences require careful attention to avoid regulatory missteps that could impact market access.
European Union (EU)
The EU enforces stringent regulations for all cosmetics, including lip balms, through Regulation (EC) No 1223/2009, also known as the EU Cosmetics Regulation. This regulation mandates that all cosmetic products, including lip products, must undergo a safety assessment conducted by a qualified person. For lip products, safety concerns around potential ingestion and the use of allergens or heavy metals are heightened, necessitating thorough testing. The regulation specifies that:
- Safety Assessment: All ingredients must be assessed for their safety, particularly due to the likelihood of accidental ingestion of lip products.
- Prohibited Ingredients: The EU maintains a comprehensive list of substances banned or restricted in cosmetics, including certain colorants and heavy metals.
- Labeling Requirements: Ingredients must be listed in descending order by weight, and the product must clearly display the batch number and durability. Claims such as “organic” or “natural” are also subject to stringent guidelines to prevent misleading consumers.
United States (US)
In the US, the FDA oversees the cosmetics sector under the Federal Food, Drug, and Cosmetic Act (FDCA). However, compared to the EU, regulatory requirements in the US are relatively less restrictive. Key points for lip product manufacturers include:
- Ingredient Safety: Unlike the EU, the FDA does not pre-approve cosmetic ingredients, although it prohibits certain harmful substances. Lip products must be safe for consumers, especially given the likelihood of ingestion.
- Color Additives: One exception to the FDA’s generally lenient stance is color additives, which must be approved for use in cosmetics. Only FDA-approved colors may be used in lip products, and they must be certified for safety.
- Labeling and Claims: Labels must be truthful and not misleading. The FDA is increasingly attentive to claims such as “natural” and “organic” and monitors companies to ensure these terms are used accurately. Misleading claims, particularly regarding therapeutic benefits, can result in a product being reclassified as a drug rather than a cosmetic, leading to more stringent regulations.
Moreover, while pre-market approval is not required, businesses should be prepared for post-market surveillance by the FDA. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) also introduced changes, increasing the FDA’s authority to recall unsafe cosmetics and enhancing the requirements for adverse event reporting, which has impacted companies starting in 2024.
Only FDA-approved colors may be used in lip products, and they must be certified for safety.
Canada
Canada’s regulatory framework, managed by Health Canada, closely aligns with the EU’s standards but has its own specificities. In Canada, lip balms and similar products are classified as cosmetics under the Food and Drugs Act and the Cosmetic Regulations. Canadian businesses must adhere to the following:
- Safety and Ingredient Restrictions: Canada maintains a Hotlist of restricted or prohibited ingredients similar to the EU’s list. Ingredients known to be potentially hazardous or allergens are carefully monitored, especially for products like lip balms that may be ingested.
- Labeling Requirements: Canadian regulations require bilingual labeling (English and French) and mandate that all ingredients be listed in descending order by weight. Health Canada also regulates claims on products and monitors for misleading terms, particularly around “natural” and “hypoallergenic” claims.
- Product Notification: All cosmetic products sold in Canada must be reported to Health Canada within 10 days of their first sale. This notification includes a detailed list of ingredients to ensure compliance with safety standards.
Canadian consumers are increasingly knowledgeable and cautious, with rising interest in clean beauty and transparency about ingredients. Health Canada’s recent consumer protection measures reflect this, making compliance crucial for companies targeting the Canadian market.
When Lip Balms Become OTC Products
Lip balms are generally classified as cosmetics, but certain formulations—especially those with therapeutic claims—can fall into the Over-the-Counter (OTC) category, particularly in the U.S. Products containing active ingredients like SPF for sun protection or menthol for soothing lips may be regulated as OTC drugs. This requires compliance with the FDA’s OTC Monograph, covering specific ingredients, concentrations, and labeling requirements, including a “Drug Facts” label.
In the EU and Canada, similar distinctions apply. In the EU, SPF lip balms are still cosmetics but must meet sun protection standards. In Canada, lip balms with therapeutic claims may be regulated under Natural Health Products. Understanding these distinctions is crucial, as minor changes in ingredients or claims can shift a product’s classification and regulatory obligations.
Practical Steps for Businesses
To successfully navigate these varied regulations, businesses should consider the following best practices:
- Work with Regulatory Experts: Regulatory requirements are constantly evolving, and consulting with experts can help your team stay informed and compliant across markets.
- Conduct Thorough Safety Assessments: Particularly for products like lip balms, comprehensive safety testing and a qualified safety assessor are critical in ensuring product safety and regulatory compliance.
- Be Transparent and Accurate in Labeling: Use truthful, non-misleading language and be cautious about claims. Focus on transparency around ingredients and avoid unsubstantiated claims that could raise regulatory red flags.
- Stay Informed on Regulatory Updates: The regulatory landscape is dynamic, especially as consumer expectations and industry standards evolve. Regularly monitoring changes, such as the impact of MoCRA in the US, is essential.
Conclusion
Lip balms and lip products represent a lucrative and growing market segment for 2025, but the regulatory environment for these products is intricate and variable across the EU, US, and Canada. With the right approach, including careful adherence to each region’s specific regulatory requirements and a commitment to product safety and transparency, companies can not only succeed but also build consumer trust. As always, consulting with regulatory professionals to keep pace with ongoing changes is key for a smooth and compliant entry into the market.
This article provides a brief overview of key regulatory considerations; however, navigating the full complexities of international compliance requires in-depth expertise. At Biorius, we specialize in delivering tailored regulatory services that meet the unique needs of your products and brand. Whether you’re entering a new market or optimizing your compliance strategy, our team is here to guide you every step of the way.
Contact us today to explore how we can help you confidently navigate the evolving landscape of lip product regulations.
Author
Biorius
First Class specialists in cosmetic regulations in Europe, United Kingdom, United States, Canada and in more than 60 countries
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21 October 2024
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