As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.
Key Changes in Cosmetic Labeling Regulations
In 1933, the US Department of Agriculture and the US Food and Drug Administration (FDA) staged their ground-breaking “Chamber of Horrors” display at the Chicago World’s Fair. It highlighted the shortfalls or complete absence of regulation in the food, drug and cosmetics industries. Lobbying to regulate cosmetics had intensified after it was found that the product Lash Lure, manufactured to dye eyebrows and eyelashes, was causing severe allergic reactions and even blindness. Five years later, the US introduced its first cosmetics regulation, the 1938 Food, Drug and Cosmetic Act. In 2022, this received its most significant extension: the Modernization of the Cosmetics Regulation Act 2022 (MoCRA). It came into force in December 2023 (although some provisions were pushed back).
MoCRA brings with it significant documentation changes. In terms of labeling, key changes include requiring statements that the cosmetic is intended for use by professionals (if this is the case), providing a “responsible person” contact for adverse event reporting, and disclosing fragrance allergens. The direction the FDA is taking for cGMP is one towards ISO 22716:2007 (Cosmetics Good Manufacturing Practices) in Europe.
Within the European Union (EU) and European Economic Area (EEA), Regulation (EC) 1223/2009 (Cosmetic Product Regulation; CPR) provides the framework for the regulation of cosmetics manufacture and marketing. This was amended in 2023 by Regulation (EU) 2023/1545, covering the labeling of fragrance allergens in cosmetic products [1], and Commission Regulation (EU) 2024/858 [2], which regulates the use of specific nanomaterials in cosmetics products. As new products and substances become available, cosmetic product labeling standards and regulations are being updated.
Cosmetics regulations are changing to meet new demands
On a regulatory level, like the pharmaceutical sector, cosmetics labeling is also moving towards electronic labeling (e-labeling). At the same time, we are seeing a shift towards the Fast Healthcare Interoperability Resources (FHIR) standard for managing and exchanging data between manufacturers/distributors and regulatory bodies. A good example of where the industry is heading in this regard is provided by the MoCRA requirement for cosmetic product listings and the registration of production facilities. These are now within the FDA’s Structured Product Labeling (SPL) framework, which in itself is gradually moving towards HL7 SPL on FHIR.
It is imperative that cosmetics manufacturers engage with e-labeling and FHIR proactively today to future-proof their business. For more on how these two factors are interacting and influencing industry, see here.
Forces driving change in cosmetic labeling
Some key factors behind regulatory and consumer-driven change are:
• Scientific knowledge
Toxicological and environmental studies are deepening knowledge of substances in humans and our environment, while advances are allowing non-animal testing and replacement of natural substances with artificial ones to protect plants and animals – e.g. squalene (a natural lipid found in shark liver oil) and used in cosmetics.
• Greater cosmetic ingredient transparency requirements for labeling
Following on from this, consumers are demanding greater transparency, whether it is on the use of animals in testing, on nanomaterials or “forever chemicals.” The trend is towards more-detailed information on labeling and packaging, augmented by further online resources (e-labeling and additional product information).
• Globalization, growth and harmonization in expanding markets
Cosmetics manufacturers must have efficient processes in place to work across different markets, languages, subsidiaries and regulatory jurisdictions. Many related forces are in play here: regional free-trade zones (e.g. EU) offer great opportunities for expansion into markets, supported by harmonized regulations. But differentiation is also a factor as companies expand into new markets with differing labeling requirements. Accurate multiple-language labeling versions must be produced and managed across subsidiaries and markets.
• Sustainability factors
Driven by consumers and regulators, demands for greater sustainability mean closer scrutiny. This heightens the risk of damage to product and company reputation due to an error in labeling. Cruelty-free testing, biodegradable ingredients, and claims to sustainability come under the microscope. Regulators in the EU and elsewhere are keeping a watchful eye on greenwashing (i.e. unsubstantiated claims), whether that be in product labeling or in promotional material. If claims are true, are they consistent and correctly worded across all your labeling and documentation for the product? You need to be 100% sure.
How Compliance Software Meets These Demands
- Enables more-frequent updates
In digital environments (online and apps), consumers and regulators expect real-time updates to product labeling, promotional material and other product or production facility documentation. At the same time, you need to achieve consistency across your many different formats. New efficiencies are required to reduce workload and achieve faster turnarounds, reducing the cycle times. - Manages a greater volume of information efficiently
The volume of information is increasing, further heightening the risk of non-compliance. Labeling mistakes due to human error in an environment where resources are overstretched; false claims in promotional material; inconsistent messaging and labeling across markets and languages; lack of differentiation where market requirements diverge – avoiding these pitfalls requires excellence in managing data and versions, greater accountability (audit trails), and complete transparency throughout the workflow. - Integrates and automates workflows
Your workflows must be automated and future-proof by being designed for expanding, globalized markets in changing regulatory and consumer landscapes.
Compliance Software to Futureproof your Business
- Automates Proofreading ➡️ Downstream documents verified against approved versions in seconds. Higher employee productivity, accurate content, faster approvals.
- Verifies digital content / documents in any format, promoting consistency across your labeling, e-labeling, promotional and production documents ➡️ Whether online, in a desktop app, in SPL or FHIR format, irrespective of language for single, multiple and even very large documents, they can be compared to the approved original to identify any deviation quickly.
- Reduces Cost ➡️ Higher productivity means fast ROI.
- Promotes Compliance ➡️ Automated proofreading highlights the smallest deviation between approved and downstream versions. Avoids human error.
- Reduces workflow complexity ➡️ Can be used as standalone solution or integrated into any workflow system.
- Verifies artwork, spelling and barcodes (e-labeling) ➡️ TVT add-on modules verify graphic elements, spelling (e.g. create customized terminology for ingredients or production site lists), and barcodes (essential for e-labeling).
How TVT works
TVT automates the proofreading of labeling and any other document type or format by comparing your approved original version with a downstream document version for errors and deviations. For example, if a particular allergen has been omitted, spelt incorrectly, appears in the wrong order in the ingredients list or deviates in any other way from the approved document, it will be immediately recognized and highlighted. You can then annotate the document for corrections. All actions are documented along the way and captured for a full audit trail, providing transparency and accountability in proofreading workflows. The TVT user interface is intuitive, and training, support and resources are available for simple and easy implementation, including extensive e-learning and direct support.
TVT supports SPL and FHIR, and online formats (e.g. you simply copy the URL of a web page), positioning you for future changes in terms of e-labeling, submissions and exchanging data (interoperability).
Cosmetic labeling regulations are continually evolving. Are you prepared for the changes? By automating your proofreading workflows, you can achieve greater speed, accuracy and consistency, while reducing workloads and compliance risks.
Find out for yourself by booking a demo with us.
1. https://eur-lex.europa.eu/eli/reg/2023/1545/oj/eng
2. https://eur-lex.europa.eu/eli/reg/2024/858/oj/eng
