The landscape of global regulations affecting personal care brands is complex and can vary widely by region. As a case in point, Europe bans more than 2,500 ingredients, while the US only bans 30. Understanding and staying ahead of this mosaic of international, regional, and local laws is not just a legal obligation—it’s a strategic necessity for cosmetic and fragrance brands. As the industry faces growing demands for transparency and safety, adhering to the highest standards of these rules ensures market access, builds consumer trust, and protects brand reputation. Moreover, the potential risks of non-compliance, such as hefty fines and damaging public relations incidents, can be mitigated, preserving customer loyalty and financial performance. And, in a sector where innovation and sustainability are becoming key differentiators, swiftly adapting to regulatory changes can bring a clear competitive advantage.

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In this guide, we’ll explore the regulations governing cosmetic and fragrance ingredients across different regions and provide insights on how brands can navigate them effectively.

The Modernization of Cosmetics Regulations Act “MoCRA was the first update to the federal cosmetics regulatory landscape in over 80 years. It created a modern cosmetics regulatory framework designed to advance sound science, safety, innovation, and consumer confidence.”

–Perfumer & Flavorist+

Key personal care regulations across the globe

This section will cover the key policies that affect cosmetic and fragrance brands across various regions. Typically, these rules aim to protect consumers and the environment. This includes ingredient bans and requirements around safety testing, labeling, harmful substances, and making claims. By mastering these regulations, companies can achieve compliance and build trust. We’ll start with Europe, which has set the bar by implementing the most rigorous standards.

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Cosmetic and fragrance regulations in Europe

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1. EU Cosmetic Regulation 1223/2009 and subsequent amendments: This law requires cosmetic manufacturers to submit a detailed safety report and register each product through the Cosmetic Products Notification Portal (CPNP) prior to market release. All cosmetic products must clearly list ingredients in descending order of concentration on their labels. Fragrance ingredients are an exception unless they are one of 24 known allergens that must be disclosed (originally 26, but two are now banned). Otherwise, “parfum” or “aroma” can denote scent ingredients without listing each one. The regulation also prohibits certain substances and all forms of animal testing. Products containing nanomaterials or substances identified as carcinogenic, mutagenic, or toxic to reproduction (CMR) are subject to additional requirements. Finally, some EU nations, such as France and Germany, may enforce extra country-specific regulations for cosmetics.

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2. EU Fragrance Allergen Labeling 2023/154: This rule expands the Cosmetic Regulation 1223/2009 on the disclosure of fragrance allergens from 24 to 80+ known allergens. The ingredients must be included on the label if they are above 0.001% for leave-on and 0.01% for rinse-off products.

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3. EU chemical regulations (ECHA), including REACH: The European Chemicals Agency (ECHA) oversees chemical safety policies in various areas, such as product and occupational safety, waste management, and persistent organic pollutants. Of these, the REACH regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) is of particular concern for cosmetic and fragrance brands. It requires any company manufacturing or importing specific chemicals in quantities of one metric ton or more annually to register these substances with ECHA. The registration process requires detailed documentation on the chemical’s properties, uses, and associated risks. Furthermore, there is a mandatory disclosure requirement for any Substances of Very High Concern (SVHC) that comprise more than 0.1% of a product’s weight. REACH also restricts or bans certain hazardous substances to protect human health and the environment. Altogether, the EU bans or restricts the use of more than 2,500 chemicals from personal care products. 

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4. EU Microplastics Ban 2023/2055: Microplastics, or plastic particles smaller than 5 mm, are in many products, including fragrance goods such as air fresheners, laundry detergent, deodorant, and body washes. There are various environmental and human health impacts from microplastics, such as respiratory issues and, genetic changes, and an increased risk of cancer. As a result, ECHA enacted this rule, which bans the intentional addition of microplastics to consumer products. A phase-in period through 2035 is allowed for certain products. Companies must reformulate products to eliminate intentional microplastic additions or switch to alternative biodegradable ingredients within the required timeframe.

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5. EU Classification, Labeling, and Packaging (CLP) Regulation No 1272/2008: This regulation mandates classifying and labeling chemical substances and mixtures based on their hazardous properties. For fragrance brands, this initially required natural essential oils and related products to be assessed under the same criteria as synthetic chemicals. However, a 2023 revision introduced a five-year exemption from the mixture rule for natural essential oils. During this time, the EU will conduct a scientific review that may impact the future use of these ingredients. The revision also added new hazard classes and incorporated provisions for digital labeling. To stay compliant, personal care brands need to monitor any ongoing developments and potential changes to this rule.

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6. EU anti-greenwashing: In January 2024, the EU approved the Green Claims Directive, which mandates how brands can communicate and substantiate sustainability claims about their products. Companies that want to make environmental-related claims must submit scientific evidence via a verification system for approval. In June 2024, the EU published more details on how the verification process will work. 

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7. UK Regulations: The UK has adopted its own versions of the EU laws, including the Cosmetic Regulation, REACH, microplastics ban, CLP, and anti-greenwashing guidance. While these rules generally align with their EU counterparts, some differences exist. For example, the UK version of the Cosmetic Regulation adds a few restricted chemicals and labeling requirements. It also only requires disclosure of the original 26 fragrance allergens rather than the expanded EU list. These differences may require additional attention and resources for brands operating in both the UK and the EU.

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8. Supply chain transparency and disclosures: The EU has several other regulations mandating supply chain transparency, due diligence, and sustainability disclosures for large companies. These include the Corporate Sustainability Due Diligence Directive (CSDDD) and Corporate Sustainability Reporting Directive (CSRD). These regulations can significantly impact the operations of large companies, as they may require extensive reporting and verification of sustainability claims. Some countries also have their own supply chain due diligence laws, such as Germany (LkSG), Switzerland (VSoTr), and Norway (NTA).

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Cosmetic and fragrance regulations in the US

In the US, fragrance brands must navigate a complex landscape of federal and state regulations covering ingredient transparency, chemicals, and labeling.

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1. Food, Drug, and Cosmetic Act (FD&C): The US Food & Drug Administration (FDA) regulates but does not approve cosmetic products before market release. The FD&C Act, enacted in 1938, requires companies to ensure that cosmetic ingredients are not adulterated or misbranded and that product labels list all ingredients. Like the EU, however, the law allows proprietary fragrance ingredients to be listed as “fragrance” to protect trade secrets. The Act also restricts or prohibits eleven ingredients and has additional requirements for asbestos, antimicrobials, plastic microbeads, and color additives. It’s important to note that the Consumer Product Safety Commission (CPSC), rather than the FDA, regulates fragranced products not applied to the body. Examples include laundry detergents, air fresheners, and dryer sheets.

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2. Modernization of Cosmetic Regulation Act of 2022 (MoCRA): MoCRA is a significant update to the FD&C Act that expands the FDA’s authority over cosmetic products. It stipulates that fragrance brands must register their manufacturing facilities and products via the FDA’s electronic portal Cosmetic Direct for any products sold in the US. Companies must also maintain documentation substantiating the safety of each product and report any serious adverse events within 15 business days. MoCRA also requires companies to follow Good Manufacturing Practices (GMP) and disclose fragrance allergens, although the FDA has yet to publish guidance on both.

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3. Fair Packaging and Labeling Act (FPLA): The FPLA mandates that consumer goods display certain information on product labels, including the product’s identity, the manufacturer’s name and address, and the net quantity of contents. However, the FDA, rather than the Federal Trade Commission (FTC), enforces these rules for cosmetics.

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4. The Toxic Substances Control Act (TSCA) and subsequent amendment: The Environmental Protection Agency (EPA) administers the TSCA and other regulations aimed at protecting human health and the environment. To comply, brands must ensure their ingredients are in the TSCA inventory or register any new chemicals or intended uses. Additional requirements govern the import and export of chemicals. Unlike the EU, however, the burden of proof is on the government rather than companies—meaning chemicals are considered safe unless the EPA can prove otherwise. As a result, of the 86k+ chemicals listed in the TSCA inventory, the EPA has only banned or restricted 14 substances. This stance has drawn criticism from some industry groups and journalists, who note that the US lags behind other countries in protecting consumers from toxic chemicals. Some states are addressing the gap by introducing stricter policies, as highlighted below.

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5. Microbead-Free Waters Act of 2015: This rule bans plastic microbeads in rinse-off cosmetics. 

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6. State-specific policies: Many states have introduced or adopted their own policies governing ingredient transparency and hazardous substances. Here are a few notable ones:
   
   1. California requires cosmetic and fragrance brands to disclose harmful ingredients through the California Safe Cosmetics Program (CSCP). The state will also ban 24 toxic substances starting in 2025 and an additional 26 toxic substances beginning in 2027. Additionally, for chemicals known to cause cancer or reproductive harm, businesses must include a warning label on products (Proposition 65). Fragrance allergens must also be included on product labels for cosmetics and cleaning products. 
   2. Oregon and Washington have also passed Toxic Free Chemical Acts similar to California’s, banning specific hazardous substances.
   3. Maryland will ban 24 toxic substances starting in 2025.
   4. New York bans 1,4-Dioxane and mercury. 
   5. Volatile Organic Compounds (VOCs) are restricted in six states: California, Illinois, Indiana, Michigan, Ohio, and Utah.
   6. Per- and poly-fluoroalkyl substances (PFAS) are restricted in ten states: California, Colorado, Connecticut, Maine, Maryland, Minnesota, Oregon, Rhode Island, Vermont, and Washington.

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Cosmetic and fragrance regulations in Canada

The Food and Drugs Act and Cosmetic Regulations require cosmetic and fragrance brands to notify Health Canada and provide a list of ingredients prior to market release. Companies must also ensure they comply with the Cosmetic Ingredient Hotlist, which details banned and restricted substances (as of Dec 2024, there are 597 banned and 99 restricted substances). Health Canada also has policies governing product labeling (including fragrance allergens), toxic substances, microbeads, a ban on animal testing, and the handling of new substances. An amendment introduced in April 2024 established new stipulations, including more comprehensive ingredient disclosures and stricter safety assessment standards.

Cosmetic products are regulated under the Australian Industrial Chemicals Introduction Scheme (AICIS), and brands must register their business, products, and ingredients with the AICIS before they are released to the market.

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Cosmetic and fragrance regulations in Asia and Oceania

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1. Australia: Cosmetic products are regulated under the Australian Industrial Chemicals Introduction Scheme (AICIS), and brands must register their business, products, and ingredients with the AICIS before market release. The Australian Competition and Consumer Commission (ACCC) oversees product labeling rules. Like other nations, Australia considers fragrance blends to be trade secrets and doesn't require full disclosure.  

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2. Japan: The Pharmaceutical and Medical Devices Agency (PMDA) in the Ministry of Health, Labour, and Welfare (MHLW) approves cosmetic products prior to market release. To secure approval, brands must comply with the Standards for Cosmetics and other rules. Ingredient labeling is mandatory, and products must be free from banned substances. Fragrance allergen disclosure is not currently required. The Japanese Cosmetic Industry Association (JCiA) provides recent updates on regulations affecting the sale of cosmetics in Japan. 

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3. ASEAN nations: The ASEAN Cosmetic Directive governs the regulation of cosmetic products across ten member countries (Singapore, Brunei Darussalam, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Laos, Cambodia, and Myanmar). It sets forth requirements for product notification and labeling, banned and restricted ingredients, safety assessments, adverse event reporting, good manufacturing practices, and maintaining documentation. Fragrance allergen disclosure is not currently required.

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4. China: The Cosmetic Supervision and Administration Regulation (CSAR), adopted in 2021, is the primary rule governing the sale of cosmetic products in China. The National Medical Products Administration (NMPA) administers the law and guidelines for registration and filing, efficacy testing, safety assessments, product labeling, and quality and safety information on all ingredients. Mandatory animal testing is no longer required for general cosmetics, but products containing ingredients not listed in China’s database of existing ingredients require market pre-approval. Companies must disclose fragrance allergens in the precautions section of the label, with additional stipulations for products marketed to children.

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5. Taiwan: The Taiwan Food and Drug Administration (TFDA) regulates fragrances under the Cosmetic Hygiene and Safety Act. Companies must provide a product notification with detailed ingredient lists, labeling, and safety warnings. Taiwan has also banned several substances in cosmetics but does not currently require fragrance allergen disclosures. Notably, brands must support any claim with scientific evidence, and there are restrictions on animal testing similar to those in the EU.

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6. South Korea: The Ministry of Food and Drug Safety (MFDS) oversees the regulation of cosmetic products, primarily under the Cosmetics Act. Brands must register their business and products and comply with MFDS requirements for ingredient safety and labeling. South Korea has also introduced safety and efficacy requirements for certain functional cosmetics, and brands must provide detailed ingredient disclosures, including fragrance allergens.

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In summary, cosmetic and fragrance ingredients are governed by a complex web of regulations that vary by region. Recent and upcoming rules, such as proposed expansions to EU chemical laws and US MoCRA, indicate a movement toward greater transparency in ingredient disclosure. Companies must stay informed about and comply with the relevant laws in each market to ensure product safety, legal compliance, and consumer trust.

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Mastering global compliance: Essential strategies for success

Ensuring compliance across various regions may be a challenge, but some success strategies can help brands stay ahead. These practices empower companies to navigate global regulations effectively while strengthening their competitive advantage.

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• Stay informed: Monitor regulatory changes in the regions in which you operate or plan to in the future by subscribing to industry newsletters, attending conferences, and joining trade associations. For example, several conferences focus on cosmetic and chemical regulatory compliance. Joining industry organizations, such as the International Fragrance Association (IFRA), can also help you stay in the loop. Watch for announcements from the leading regulatory bodies in your target regions, such as ECHA in the EU and the FDA in the US. You may also want to maintain a compliance calendar for regulatory deadlines and requirements across the markets where your products are sold. This should include registration deadlines, labeling updates, and submission dates for safety assessments.

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• Tap into tools and experts: Leverage software tools for regulatory compliance, such as those that automatically track regulatory changes or screen ingredients against specific policies. Tools like the Novi Ingredient Screener can help you quickly identify non-compliant ingredients and find alternatives. Consider hiring or consulting with regulatory experts specializing in cosmetic and fragrance laws. This can include legal advisors, compliance officers, or consultants with expertise in specific markets, such as the EU or Asia.

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• Engage your supply chain: Ensure all suppliers and partners are informed of and aligned with regulatory requirements. This includes regular audits and training to uphold standards throughout your supply chain. 

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• Implement rigorous testing and documentation: Conduct thorough testing of products to meet safety standards and keep detailed records as proof of compliance. This includes testing for allergens and banned substances and ensuring that product labels accurately reflect the ingredients used, particularly for fragrances. Additionally, document all compliance activities, including safety assessments, product registrations, and ingredient sourcing. Establishing practices like these is essential for regulatory reviews, preparing your brand for audits, and minimizing the risk of non-compliance.

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• Embed safety and sustainability into your business: Position your brand as a leader in safety and sustainability by going beyond minimum compliance requirements. This could include dropping controversial but legal chemicals from your products, embracing green manufacturing processes, or complying with more stringent legal standards in a different region. By proactively exceeding compliance norms, your company can boost its credibility, foster responsible innovation, and stand out in a competitive marketplace.

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Streamline your compliance journey with Novi

Navigating the complex landscape of global cosmetic and fragrance regulations is a key element of any successful brand’s strategy. It’s not just about dodging legal pitfalls—mastering these rules can significantly bolster your brand’s credibility and deepen customer trust and loyalty. Each region brings its own flavor of policies to the table, making a deep understanding of these rules essential for brands striving to stand out in a crowded market. Novi simplifies this process with a comprehensive set of tools that streamline compliance, ingredient analysis, and transparency. By choosing Novi, you ensure that your products meet the highest safety standards and adapt quickly to regulatory changes.