The European Union has been at the forefront of consumer protection across industries. While its digital privacy laws have made the most headlines, the EU’s European Commission has also enacted significant changes to cosmetics regulations.
What Is Annex III?
The EU’s early efforts to improve cosmetics safety began with its Cosmetics Directive in 1976. Three decades later, much of that early work shaped key elements of modern regulations. EU established its Cosmetics Regulation standards in 2009 with a list of restricted and banned cosmetics ingredients. This addendum included a list of substances that required additional approval and would need to meet specific conditions or concentration level restrictions.
The EU’s regulatory body, the European Commission, updated its original Cosmetics Regulation several times over the past decade, including notable changes in 2020, 2022, and most recently in 2023 with Annex III.
Annex III is the latest addendum to the European Union’s industry guidance on cosmetics and personal care products.
Read more: Food Regulations in Europe vs. the US
Changes to the EU’s Cosmetics Regulation: Annex III and Allergens
Annex III picks up where Annex II left off by reducing the allowed concentration levels of several common ingredients and adding to the list of cosmetics ingredients banned in the EU.
New Ingredient Concentration Changes
Some of the most notable ingredients in Annex III changes include Vitamin A, triclosan, and kojic acid. And for the first time, two previously unregulated compounds, genistein and daidzein, face concentration limits.
Vitamin A – Vitamin A and the broader retinol category faced a rumored ban in the month leading up to the Annex II release. Instead, the vitamin and its core derivatives, retinyl acetate and retinyl palmitate, face concentration restrictions between 0.05% and 0.3%, depending on the application.
Kojic acid – The somewhat controversial skin-lightening substance will be limited to a 1% concentration in face and hand products and is now banned from other products.
Genistein and daidzein – These previously unrestricted skin conditioning ingredients now have usage limits of 0.007% (genistein) and 0.02% (daidzein). These substances represent marquee changes to EU cosmetics ingredients regulation; check the most up-to-date list.
New EU Cosmetics Labeling Regulations
Since its inception, the Cosmetic Regulation program has focused on consumer awareness, especially around potential allergens. Over time, many ingredients, including dozens of fragrance ingredients in cosmetics, must be labeled on consumer packaging.
In all, Annex III added 45 new fragrance substances to its required labeling list, removed 10 ingredients, and updated or replaced 17 ingredients.
What’s the Timeline?
Existing products exported to EU countries must meet the new cosmetic labeling requirements by July 2028 and include allergen information whenever the ingredients exceed concentration amounts over 0.001% in leave-on products or 0.01% in rinse-off products. These warnings must be included on the label of all EU-approved cosmetics.
New cosmetics products must meet concentration limits and labeling standards by July 2026.
This may push manufacturers and suppliers to expand their product documentation to cover new allergens in detail.
The new level of transparency will make EU regulatory compliance and consumer safety easier to maintain, especially as new products reach the marketplace.
International Expertise Matters in the Personal Care Industry
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