The European Union has a well-established and stringent regulatory framework for cosmetics, with clear and detailed requirements regarding ingredient safety, labeling compliance, and market access. As one of the world's key export markets for cosmetics, the EU attracts significant international trade. However, companies that are not fully familiar with EU regulations on cosmetic substances may face serious risks, including product detention, import refusal, or recalls.
This article provides a concise overview of the EU's List of Substances Prohibited in Cosmetic Products, designed to help businesses proactively ensure compliance, avoid the use of banned ingredients, and reduce the risk of product recalls when entering the European market.
The EU Prohibited Substances List, formally titled "Annex II List of Substances Prohibited in Cosmetic Products" under Regulation (EC) No 1223/2009 on Cosmetic Products, specifies the chemical substances that are not permitted in cosmetic products marketed within the European Union.
This list is primarily established based on the toxicity and potential hazards of chemical substances. Substances that may pose a risk to human health are assessed for safety by the Scientific Committee on Consumer Safety (SCCS), which relies on scientific data, submissions from industry and EU member states, and other relevant sources. Based on the SCCS's evaluations, the European Commission drafts proposals for the regulation, which are then published on the EU's official website for public consultation. Once finalized, the regulation comes into effect, often with a transitional period.
It is important to note that trace amounts of prohibited substances may occasionally be present in cosmetic products due to technical limitations, either from the substances themselves or from the manufacturing process. Provided that good manufacturing practices are followed and the product is safe under normal or reasonably foreseeable conditions of use, the presence of small amounts of prohibited substances is permitted. For example, during the production of polyols such as glycerin, propylene glycol, or ethylene glycol, impurities like diethylene glycol may form. When technically unavoidable, the EU regulation considers diethylene glycol safe at concentrations not exceeding 0.1%.
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As of May 2025, the European Union prohibits 1,703 substances in cosmetic products. Annex II of Regulation (EC) No 1223/2009 covers a wide range of chemical groups, including:
Organic compounds
Heavy metals and their compounds
Pesticides and insecticides
CMR substances (Carcinogenic, Mutagenic or Toxic to Reproduction)
Colorants not approved for cosmetic use
Nanomaterials of concern
Endocrine-disrupting chemicals
Per- and polyfluoroalkyl substances (PFAS)
Petroleum- and coal-tar-derived substances
CMR substances (Carcinogenic, Mutagenic, or Toxic for Reproduction) are chemicals that may cause cancer, genetic mutations, or reproductive toxicity. Under Annex VI of the CLP Regulation (Regulation (EC) No 1272/2008), CMR substances are classified into three categories:
Category 1A: Proven to cause carcinogenic, mutagenic, or reproductive toxic effects in humans.
Category 1B: Presumed to have these effects in humans, based on animal studies.
Category 2: Suspected of having these effects, based on limited evidence from human and/or animal studies.
According to Article 15 of the EU Cosmetics Regulation (EC) No 1223/2009, the use of substances classified as CMR 1A, 1B, or 2 is prohibited in cosmetic products. However, two exceptions apply:
a. Category 1A or 1B substances may be permitted if they comply with EU food safety requirements under Regulation (EC) No 178/2002, have no suitable alternatives, are intended for specific uses with known exposure levels, and are assessed by the Scientific Committee on Consumer Safety (SCCS) as safe, taking into account total exposure, particularly in vulnerable populations.
b. Category 2 substances may be permitted if the SCCS has evaluated and concluded that their use in cosmetics is safe.
Common CMR substances include benzene, formaldehyde, boric acid, sodium perborate, hydroquinone, glyoxal, salicylic acid, and methyl salicylate.
On 13 May 2025, the European Commission adopted Regulation (EU) 2025/877, amending Annex II of the Cosmetics Regulation (EC) No 1223/2009 to include a new group of CMR substances identified in the CLP Regulation amendment (EU) 2024/197.
Endocrine disruptors (EDs) are defined as exogenous substances or mixtures that can alter the function of the endocrine system and cause adverse health effects in an organism or its offspring. Even at very low concentrations, EDs may interfere with normal physiological processes.
The EU Cosmetics Regulation (EC) No 1223/2009 does not contain specific provisions dedicated to endocrine disruptors or potential endocrine disruptors in cosmetics. Instead, the European Commission relies on scientific opinions from the Scientific Committee on Consumer Safety (SCCS). Based on SCCS assessments, substances identified as endocrine disruptors or potential endocrine disruptors may be included in the lists of prohibited or restricted cosmetic ingredients.
Common potential endocrine disruptors include parabens such as methylparaben, propylparaben, and butylparaben, as well as triphenyl phosphate and benzophenone-3. In late June 2025, the SCCS published final scientific opinions on several potential endocrine-disrupting substances, confirming the safe use concentrations of ethylhexyl methoxycinnamate and benzophenone-5 in cosmetics, while concluding that the safety of benzophenone-2 could not be established.
Under the EU Cosmetics Regulation (EC) No 1223/2009, a nanomaterial is defined as "an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale of 1 to 100 nanometres."
The EU places strong emphasis on the safety of nanomaterials in cosmetics, particularly regarding risks that may arise from their nanoscale properties. Before being placed on the market, nanomaterials must undergo a safety assessment by the Scientific Committee on Consumer Safety (SCCS) and require authorization from the European Commission.
For example, on 14 March 2024, the European Commission adopted Regulation (EU) 2024/858 amending Regulation (EC) No 1223/2009, which added the following nanomaterials to the list of prohibited substances: styrene/acrylates copolymer (nano), sodium styrene/acrylates copolymer (nano), copper (nano), colloidal copper(nano), colloidal silver(nano), gold (nano), colloidal gold(nano), gold thioethylamino hyaluronic acid (nano), acetyl heptapeptide-9 colloidal gold (nano), platinum (nano), colloidal platinum(nano), and acetyl tetrapeptide-17 colloidal platinum (nano). In addition, hydroxyapatite (nano) was added to the list of restricted substances.
Currently allowed nanomaterials in cosmetics include titanium dioxide (nano), zinc oxide (nano), and methylene bis-benzotriazolyl tetramethylbutylphenol (nano), among others.
In September 2024, the use of perfluorohexanoic acid (PFHxA), its salts, and related substances in cosmetics became restricted under Regulation (EC) No 1907/2006 (REACH).
PFHxA belongs to the broader group of per- and polyfluoroalkyl substances (PFAS), which are widely scrutinized in the EU due to their persistence, bioaccumulation potential, and environmental concerns.
Common PFAS used in cosmetic formulations include perfluorooctylethyl triethoxysilane, perfluorohexane, and perfluorononyl dimethicone.
Annex II also includes a large number of substances that are prohibited only under specific conditions:
a. When used as a substance in hair dye products
Over 100 ingredients are prohibited when used in hair dye formulations. Most of them are colorants, such as CI 44045, CI 14700, and CI 10020.
b. When used as a fragrance ingredient
More than 30 substances are banned when used as fragrance ingredients. According to opinions issued by the former Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP), these substances are not permitted as fragrance ingredients due to skin sensitization, phototoxicity, or other dermal toxicities. For example, verbena essential oils (Lippia citriodora Kunth.) and their derivatives are banned as fragrance ingredients, except for the absolute.
c. If they contain certain impurities
Over 200 substances are prohibited if they contain specific impurities above defined thresholds. The main categories include:
Substances derived from petroleum gasoline, petroleum residues, hydrocarbons, or alkanes, when they contain more than 1% (w/w) butadiene (e.g., propane, butane).
Substances derived from coal tar, pitch, or creosote oils, when they contain more than 0.005% (w/w) benzo[a]pyrene.
Substances derived from heavy paraffins (petroleum), light paraffins (petroleum), or hydrogenated heavy paraffins, when they contain more than 3% (w/w) of dimethyl sulfoxide (DMSO) extract (e.g., mineral oils).
d. Depending on refining process and carcinogenic potential
More than 40 substances are banned unless the full refining process is known and it can be demonstrated that the final material is not carcinogenic. Common examples include petrolatum and C18-21 alkanes.
Companies planning to export cosmetics to the EU should familiarize themselves with local ingredient regulations and stay updated on enforcement actions and product notifications. Timely internal compliance checks are recommended to ensure products meet regulatory requirements before entering the market, minimizing the risk of recalls, product destruction, and potential economic or reputational damage.
We provide comprehensive support for cosmetic exports to EU markets. For inquiries, please contact us at info@zmuni.com.
