The Importance of Toxicological Assessment for Beauty and Personal Care Companies

The growing demand from consumers for safe, effective, and ethical products has driven the cosmetics and personal care industry to adopt stricter practices for toxicological assessment. In this context the toxicological dossier merges as an essential tool to guarantee the safety of products, comply with national and international regulations and strength the brand's image in the market.

Toxicological Assessment of Cosmetics

Toxicological assessment of cosmetics is a structured scientific process that verifies a product is safe for consumer use and meets global regulatory requirements such as MoCRA, EU Regulation 1223/2009, and ANVISA guidelines. It involves a detailed review of every chemical ingredient in the formula to identify potential risks, including irritation, allergies, or more serious adverse effects.

This evaluation is especially critical for sensitive populations, like pregnant women, infants, and older adults, where clinical trials are rarely performed. By analyzing toxicological profiles, safety margins, and cumulative exposure, brands can ensure product safety for all intended users.

The process combines laboratory studies, in vitro methods, and clinical testing to determine how each ingredient interacts with the body through skin contact, eye exposure, or inhalation. The goal is to detect and quantify any potential hazards, confirm safe use under recommended conditions, and produce regulatory-ready documentation that supports both compliance and market-facing claims.

The assessment involves:

1. Identification of the formula ingredients, including active ingredients, excipients, and any raw materials, with full INCI, CAS, and EINECS references for regulatory accuracy.
2. Individual toxicological assessment of each ingredient using validated scientific literature, regulatory databases, and targeted laboratory testing.
3. Evaluation of the complete formula to detect potential interactions or cumulative effects between ingredients that could impact safety or stability.
4. Safety tests, such as skin and eye irritation, sensitization, and toxicity studies, following applicable regulatory standards.
5. Determine the Margin of Safety (MoS), ensuring that the ingredients are at safe concentrations.
6. Prepare a technical dossier, which gathers all the data and conclusions about product safety.

This report is fundamental to prove that the cosmetic is safe under normal use conditions. It is also required by national and international laws, as in European Union, and must be developed by a qualified toxicologist.

What is a Toxicological Dossier?

A toxicological dossier is a technical document which gathers detailed information about composition, use, exposure and safety of a cosmetic product. Toxicological dossiers are developed by qualified toxicologists to demonstrate that a product is safe under normal and foreseeable conditions of use.

Among the included data are:

• Qualitative and quantitative composition with INCI, CAS, and EINECS references
• Physico-chemical and microbiological properties
• Intended use and exposure details
• Toxicological profiles for all raw materials
• Margin of Safety (MoS) calculations
• Efficacy and skin compatibility reports

Global Regulations

• European Union (EU): A Closer Look at Exports

In the European Union, the production and sale of cosmetics are regulated by Regulation (EC) No. 1223/2009, which requires every product to be proven safe for consumers before it can be placed on the market.

To meet this requirement, a technical document must be prepared with a detailed assessment of potential risks to human health. This evaluation is conducted by a qualified safety assessor, usually a certified toxicologist, and considers factors such as the formula’s ingredients, method of application (for example, to the skin or eyes), and expected exposure time.

Since March 11, 2013, the European Union has prohibited animal testing for cosmetics and their ingredients. This ban also applies to products tested on animals outside the EU, which cannot be marketed within its borders.

All cosmetics sold in the EU must include a safety assessment report prepared in accordance with SCCS (Scientific Committee on Consumer Safety) guidelines, covering data such as exposure levels, NOAEL, SED, and MoS. This approach reflects a broader global shift toward ethical, scientifically robust alternatives to animal testing, including in vitro methods and computer modeling, now adopted in many countries.

In addition, EU Regulation 2023/1545, published on July 27, 2023 in the Official Journal of the EU, introduced stricter labeling rules for allergenic ingredients in cosmetics and personal care products. These transparency measures ensure that consumers are informed about potential allergenic substances present in product fragrances.

• USA: MoCRA Requirements and the Global Impact on the Cosmetics Industry

To sell cosmetics in the United States, brands must comply with FDA requirements, including approved colorant lists, labeling rules, and documented safety validation for formula ingredients. Since December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has introduced significant changes to strengthen product quality and safety.

Effective December 2023, MoCRA, as federal law, supersedes all state and local regulations in areas such as facility registration, adverse event reporting, safety testing, recalls, good manufacturing practices (GMP), and product listings.

Main MoCRA requirements:

Identification of a Responsible Person (RP): The "Responsible Person (RP)" is the individual or entity whose name will appear on the label of a cosmetic product. This could be the manufacturer, packer, or distributor.

Facility Registration: All establishments, both national and international, involved in any stage of cosmetic production must register with the FDA. This registration must be renewed every two years.

Product Listing: Responsible persons (RPs) must register each cosmetic product marketed in the US with the FDA. Products launched after 2023 must be registered within 120 days. Updates can be submitted annually.

Adverse Event: All adverse events must be collected and upon receiving a report of a serious adverse event (SAE), the RP must report it to the FDA within 15 business days. Records should be maintained for 6 years (there are provisions made for small businesses to only retain information for 3 years).

Recall Authority: Under MoCRA, the FDA may directly access all records pertaining to the manufacturing and safety data of cosmetic products. Additionally, it grants the FDA authority to mandate recalls if a responsible party (RP) fails to voluntarily cease the sale or distribution of a product.

Person Responsible for Labeling: Since December 29, 2024, the label of each product must include the contact information (address, phone number, website, or email) of the person responsible for receiving adverse event (AE) reports. This information allows the RP to receive AE reports directly.

Safety of Ingredients (immediate): The RP shall ensure and maintain records supporting adequate substantiation of safety of such cosmetic products.

No matter where they come from, all cosmetics sold in the US fall under the scope of MoCRA, including imports. Although implementation has already begun, different aspects of the legislation are being phased in over the course of 2025. These changes in regulations are evidence of an important advance towards consumer protection and clarity in market practices.

• Brazil: Law Prohibiting the Use of Animals in Cosmetic Tests and ANVISA Determinations for Hair Ointments

On July 9, 2025, Brazil’s Chamber of Deputies approved Bill 3062/2022, prohibiting the use of live vertebrate animals in testing ingredients or finished products for personal hygiene, cosmetics, and perfumes. The measure was signed into law on July 30, 2025, amending Laws 11.794/08 and 6.360/76, which had previously governed the scientific use of animals in clinical testing.

After the new legislation comes into force, the agencies responsible for health will have a period of up to two years to put into practice actions that involve, among other aspects, the official recognition of alternative methods. With this change, new scientific strategies must be adopted to ensure that these items continue to be safe and effective for consumers. Among these alternatives are in vitro tests (carried out on cells and tissues grown in a laboratory), in vivo tests with alternative models, computer simulations (in silico) and clinical trials on humans, all developed with the aim of replacing animal tests.

Furthermore, the law allows products and substances produced before its enactment to continue being marketed. However, under the new rule, the testing of animals for the development of new products will be prohibited. This decision represents an important step forward in the defense of animal rights and signals a significant evolution in the way the cosmetics industry operates in Brazil.

In 2025, ANVISA (the National Health Surveillance Agency) published a specific manual for proving the skin and eye safety of hair ointments. The survey must include in vitro studies (OECD 491 and 492B), clinical irritability and sensitization tests, as well as an assessment of impurities in raw materials such as PEGs and petrolatum.

The aim of this measure is to ensure that products are regulated on the basis of scientific proof of safety. This requires the preparation of a technical report, which must gather all relevant information, including data and studies that support safety for human use.

Given the scope of information and consumer demands, the methodologies have been validated by national and international regulatory agencies, and reflect a global trend to promote more ethical, sustainable and technologically advanced practices in assessing the safety of cosmetics.

Strategic Applications of Toxicological Assessment

1. Children's Products - Care from the First Moment

Items intended for babies require the highest level of safety. The survey should include skin compatibility and acceptance studies, with specific clinical assessments. Babies' skin is more sensitive and permeable, which requires gentle and rigorously tested formulations.

2. Cosmetics for Pregnant Women

During pregnancy, the safety of cosmetics must consider both mother and baby. Ingredients with teratogenic, mutagenic or carcinogenic potential must be strictly avoided. The toxicological dossier ensures that products such as anti-stretch mark creams and moisturizers are safe for this sensitive population.

3. Licensed Brands - Disney, DC Comics, Marvel, Brands of Influencers and Other Personalities

Articles with children's characters need additional certifications. Toxicological assessment is mandatory to ensure that the use of the product is in line with high safety standards, protecting both the health of the consumer and the reputation of the licensing brand.

4. Teen Universe: Cosmetics on the Rise among the Alpha Generation

With the increased use of skincare and make-up by teenagers, driven by digital influencers, it is essential to ensure safety for young skin. The assessment analyzes potentially irritating or sensitizing ingredients, in addition to considering the frequency of use and cumulative exposure.

5. Assessment of New Raw Materials

The introduction of new plant extracts or blends requires a thorough toxicological assessment. This includes tests for acute toxicity, irritation, sensitization, skin absorption and genotoxicity, as well as defining the safety margin.

6. Food Supplements: An Expanding Market

Although they are not cosmetics, supplements require toxicological assessment to determine safe intake limits. The document compares ingredient levels with acceptable daily intake (ADI) values, ensuring consumer safety.

7. Veterinary Hygiene Products

Pet shampoos, lotions and soaps also require toxicological assessment. Efficacy is assessed based on the perception of the animal's guardian, while safety is proven by clinical studies specific to veterinary cosmetics.

Competitive Advantages of a Toxicological Dossier

Regulatory Compliance: Satisfies ANVISA, FDA, the European Union and other international market requirements.

Consumer Confidence: Signals a brand’s commitment to product safety and user well-being.

Safe Innovation: Enables safe introduction of new ingredients with validated data.

Reduced Legal Risks: Minimizes the possibility of recalls, lawsuits and reputational damage.

Brand Strengthening: Positions the company as a benchmark for quality and responsibility.

Ensuring Product Safety, Regulatory Compliance and Market Prominence

A toxicological dossier is a competitive advantage for brands seeking to stand out in the beauty and personal care market, not just a technical requirement. By confirming that products are safe, effective, and innovative, companies build consumer trust and strengthen their position in an increasingly demanding marketplace.

Toxicological assessment involves various medical specialties and can be applied individually or in an integrated manner, depending on the product category. This is a strategic asset for brands looking to expand their presence, explore new markets and build customer loyalty.

Investing in safety and transparency strengthens the brand's reputation and paves the way for sustainable and responsible growth. If your goal is to build a solid image and gain lasting competitive advantages, contact ALS and find out how we can support your journey.

beauty.usa@alsglobal.com

(310) 214-0043

Useful links:

Regulation (CE) no. 1223/2009 of the European Parliament and of the Council of 30 November 2009: http://data.europa.eu/eli/reg/2009/1223/oj

FDA - Modernization of Cosmetics Regulation Act of 2022 (MoCRA): https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra

Cosmetic Products Assessment Guide – ANVISA: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/cosmeticos/manuais-e-guias/guia-para-avaliacao-de-seguranca-de-produtos-cosmeticos.pdf

Congress approves bill banning the use of animals in cosmetics tests - Source: Agência Câmara de Notícias: https://www.camara.leg.br/noticias/1178349-camara-aprova-projeto-que-proibe-uso-de-animais-em-testes-de-cosmeticos/

Law that forbids animal use in cosmetic tests is sanctioned: https://www.gov.br/planalto/pt-br/acompanhe-o-planalto/noticias/2025/07/presidente-lula-sanciona-lei-que-proibe-uso-de-animais-em-testes-cosmeticos#:~:text=O%20presidente%20Luiz%20In%C3%A1cio%20Lula,higiene%20pessoal%2C%20cosm%C3%A9ticos%20e%20perfumes

Manual for proving the skin and eye safety of hair ointments - ANVISA: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/cosmeticos/manuais-e-guias/manual-de-seguranca-de-pomadas-capilares.pdf