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Methyl-N-Methylanthranilate: New UK Regulations and What They Mean for the Cosmetic Industry

Introduction: Why This Matters for the Beauty Industry

As regulations evolve, cosmetic manufacturers and brands must stay ahead of compliance changes to ensure their products remain marketable and safe. One of the latest ingredients to face stricter regulations is Methyl-N-Methylanthranilate (M-N-MA), a fragrance compound commonly used in perfumes, deodorants, body sprays, and skincare products. While its floral, fruity aroma makes it a popular choice for fragrance formulations, growing concerns about phototoxicity and its potential to form nitrosamines have led regulatory bodies to impose usage restrictions.

In the UK, a transition period has been in place since July 6, 2024, allowing brands time to adapt to these new regulations. However, the final deadline is fast approaching—by July 6, 2026, all non-compliant products must be removed from the market. This means that after this date, any cosmetic product containing M-N-MA above the permitted limits will no longer be legally sold in the UK.

For cosmetic manufacturers and brands, this is a critical moment to reassess formulations, ensure compliance, and avoid potential disruptions. But what exactly is M-N-MA, and why is it being restricted?

The Role of Methyl-N-Methylanthranilate in Cosmetics

Methyl-N-Methylanthranilate is an aromatic compound that has been widely used in the fragrance industry for decades. It is valued for its soft, sweet, and slightly fruity scent, which blends well with other ingredients to create complex and pleasant aromas. Naturally present in small amounts in some essential oils—particularly in citrus-based oils like mandarin and orange—it has found its way into a variety of cosmetic products where fragrance plays a key role.

Due to its ability to enhance fragrance longevity, it is frequently incorporated into perfumes, body sprays, and personal care items such as deodorants, shampoos, and even some skincare formulations. However, despite its widespread use, scientific research has raised concerns about its safety, leading to increasing regulatory scrutiny.

The Concerns Behind the Restrictions

The primary concern associated with M-N-MA is phototoxicity. This means that when applied to the skin and exposed to sunlight or artificial UV light, it can lead to adverse skin reactions. Phototoxic reactions occur when certain chemical compounds absorb UV light, producing reactive oxygen species that can damage skin cells. This can result in redness, irritation, increased sensitivity, and, in severe cases, persistent pigmentation issues.

In addition to phototoxicity, another major issue is nitrosamine formation. M-N-MA is classified as a secondary amine, meaning it has the potential to react with nitrosating agents to form nitrosamines—compounds that have been linked to carcinogenic activity. Although nitrosamines are not directly present in M-N-MA, the risk of them forming over time, particularly in products stored under certain conditions, has raised concerns among regulators. Because of this, restrictions on M-N-MA not only limit its concentration in cosmetics but also place additional requirements on storage conditions and formulation practices.

How the UK is Regulating M-N-MA

To address these safety concerns, the UK implemented new regulations on July 6, 2024, under The Cosmetic Products (Restriction of Chemical Substances) Regulations 2023. These rules introduced strict concentration limits for M-N-MA use in cosmetics:

  1. Leave-on products, such as perfumes and creams, can contain a maximum of 0.1% M-N-MA.

  2. Rinse-off products, such as shampoos and body washes, can contain up to 0.2% M-N-MA.

Additionally, there are several important safety conditions attached to its use:

  1. It cannot be included in sunscreens or any products intended for UV exposure, due to its phototoxic potential.

  2. Formulations must not contain nitrosating agents to prevent nitrosamine formation.

  3. The maximum allowable nitrosamine content is limited to 50 μg/kg.

  4. M-N-MA must be stored in nitrite-free containers to reduce the risk of unwanted chemical reactions.

While these rules came into force in 2024, the UK government provided a two-year sell-through period, allowing products already on the market before the regulation was implemented to continue being sold. However, this grace period ends on July 6, 2026. From that date forward, any non-compliant product must be completely removed from store shelves, online listings, and distribution channels.

The European Union's Stance on M-N-MA

For businesses operating in both the UK and the EU, it’s important to note that similar restrictions have already been in place within the European Union. The EU introduced its M-N-MA restrictions in August 2022, under Regulation (EU) 2022/135. These regulations mirror the UK’s approach, enforcing the same concentration limits and banning M-N-MA from sun-exposed products.

This means that brands that have already reformulated their products to comply with EU regulations are well-prepared for the UK changes. However, those who have not yet addressed these issues need to act quickly to ensure compliance in both markets.

What This Means for Cosmetic Brands and Manufacturers

As the July 6, 2026 deadline approaches, brands must take action to avoid regulatory penalties and potential market disruptions. If your products still contain M-N-MA at levels exceeding the permitted thresholds, now is the time to reformulate, test, and ensure compliance.

Failing to meet these requirements could result in product recalls, legal consequences, and damage to brand reputation. It’s crucial for manufacturers to work closely with regulatory consultants, reformulation experts, and quality assurance teams to navigate these changes smoothly.

How to Stay Compliant and Future-Proof Your Products

For businesses affected by these regulations, the best course of action is to conduct a thorough review of product formulations and identify any ingredients that may exceed the new limits. Reformulating with alternative fragrance ingredients or reducing M-N-MA concentrations to compliant levels will be necessary for continued market presence.

Additionally, brands must ensure that manufacturing, storage, and packaging conditions align with regulatory guidelines. Proper storage in nitrite-free environments, avoiding nitrosating agents, and maintaining low nitrosamine levels will be key compliance factors.

Need Expert Guidance? Annel Can Help!

Regulatory changes can be complex and time-consuming, but you don’t have to navigate them alone. If you need assistance in reformulating your products, ensuring compliance, or understanding the latest regulatory updates, Annel is here to help.

Get in touch today to secure your market position and future-proof your formulations!

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