Cosmetic Ingredient Review

Before a cosmetic product reaches a consumer in the European Union, every ingredient it contains must survive a stringent scientific review. The EU’s approach to cosmetic safety is proactive and evidence‑based: manufacturers are legally required to conduct an expert safety assessment on each formulation, and that assessment must cover every single ingredient. Regulation (EC) No 1223/2009 [3] sets out this obligation, and failing to carry out a proper ingredient review can block market access. For brands based in Europe or exporting into the single market, understanding what a cosmetic ingredient review entails—and how it differs from the US system—is the foundation of compliance.

The EU Regulatory Backbone: Regulation (EC) No 1223/2009 and the Mandatory Safety Assessment

Cosmetic ingredient review in Europe is not a single checklist item; it is embedded in the comprehensive product safety report that every cosmetic must have before it is placed on the market. The regulation is unequivocal: the manufacturer is responsible for ensuring that the cosmetic product has undergone an expert scientific safety assessment before it is sold [1][4]. This safety assessment must consider all ingredients, their toxicological profiles, the exposure conditions, and the final formulation.

The product safety report is structured according to the guidelines in Annex I of Regulation (EC) No 1223/2009 [3]. Commission Implementing Decision 2013/674/EU [3] provides further detail on how to prepare that safety report, giving manufacturers a clear framework for ingredient review. Every substance, from primary actives to fragrance components and incidental contaminants, must be documented and assessed. The responsibility remains with the manufacturer throughout the life of the product, and national authorities in each EU country are empowered to review those safety dossiers and inspect products already on the market [1].

How the Scientific Committee on Consumer Safety Informs the Review

Ingredient safety in the EU is not left to manufacturers alone. The European Commission relies on the Scientific Committee on Consumer Safety (SCCS), an independent expert panel, for opinions on the health and safety risks of cosmetic ingredients and other consumer products [1]. The SCCS evaluates ingredients—often those that have raised safety concerns or are novel—and publishes scientific opinions that manufacturers must factor into their ingredient reviews.

The Committee’s “Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation” [1] is a pivotal document. It sets out the essential information that must be included in a safety file submitted for evaluation, along with recommended testing methodologies. The guidance is regularly updated to incorporate new scientific knowledge and practical experience from safety evaluations [1]. For a brand conducting an ingredient review, these notes help determine what toxicological data, exposure modelling, and safety margins are required. Ignoring an SCCS opinion on a restricted or borderline ingredient can lead to a safety assessment that national authorities will reject.

The CosIng Database: A Starting Point, Not an Authorisation

One of the most frequent misconceptions in cosmetic ingredient review is that a listing in the EU’s CosIng database means an ingredient is approved for use. CosIng is the European Commission’s online information repository for cosmetic substances, covering ingredient names, regulatory references, and links to SCCS opinions [2]. However, the Commission itself issues an important notice: CosIng is informative and has no legal value. Only Regulation (EC) No 1223/2009 and its Annexes determine whether an ingredient may be used in a cosmetic product, and under which conditions [2].

For a rigorous ingredient review, CosIng serves as a preliminary fact‑checking tool. You can verify the correct INCI name, check whether the substance has been evaluated by the SCCS, and see if it appears on any restriction or authorisation list. Crucially, for ingredients used as colourants, preservatives, and UV‑filters in cosmetics, only those explicitly authorised in Annexes IV, V and VI respectively are permitted [2]. An ingredient appearing in CosIng that is not listed in the relevant Annex cannot simply be used because it appears in the database. Furthermore, even if an ingredient is authorised, its use must still be supported by a product‑specific safety assessment [2]. An ingredient review that stops at CosIng is incomplete.

The Product Safety Report as a Structured Ingredient Review

The ingredient review culminates in the cosmetic product safety report (CPSR), which is divided into Part A (cosmetic product safety information) and Part B (cosmetic product safety assessment). Part A requires quantitative and qualitative details of the formulation, physical and chemical characteristics, the stability of the product, and a toxicological profile for each ingredient. Part B gives the reasoned safety assessment, the warnings and labelling statements needed, and the assessor’s conclusion.

Every ingredient under review must be shown to be safe at the concentrations and exposure conditions in the finished product. The CPSR process in the EU is thus far more than cross‑referencing a restricted list. It demands a substance‑by‑substance analysis, often supported by literature data, in‑vitro tests, or read‑across from structurally similar compounds. The regulation’s introduction of the notion of a “responsible person”—a legal entity within the EU who ensures compliance and maintains the product information file [3]—means that ingredient review is not optional at any point in the supply chain.

When the Ingredient Review Crosses the Atlantic: FDA Restrictions

For European brands exporting cosmetic products to the United States, the ingredient review must be conducted under a different set of rules [5]. U.S. law does not require FDA approval for cosmetic products or ingredients (other than colour additives) before they go on the market, but it does hold manufacturers legally responsible for product safety and labelling [5]. The FDA can, and does, take action against non‑compliant cosmetics already on the market.

A distinct feature of the US system is the list of specifically prohibited or restricted ingredients set out in the Code of Federal Regulations. Among them:

Bithionol is prohibited because of photocontact sensitisation risk [5].
Hexachlorophene may only be used when no other effective preservative is available, at a concentration not exceeding 0.1%, and it must not be used on mucous membranes [5].
Mercury compounds are limited to eye area products at no more than 65 parts per million (0.0065%) calculated as mercury metal, and only if no other effective and safe preservative is available; any other cosmetic containing mercury is adulterated unless the mercury is present as an unavoidable trace below 1 part per million (0.0001%) [5].
Chloroform and methylene chloride are both prohibited because of carcinogenicity concerns [5].
Vinyl chloride is banned in aerosol products, and zirconium‑containing complexes are prohibited in aerosol cosmetics due to lung toxicity in animals [5].

An ingredient that passes the EU’s comprehensive safety assessment may still run afoul of one of these explicit US prohibitions or concentration limits. Therefore, a cosmetic ingredient review for transatlantic commerce needs to map the entire formulation against both the EU positive and negative lists (via the Annexes of 1223/2009) [2] and the US 21 CFR 700 series [5]. The responsibilities differ: the EU requires a designated responsible person and a pre‑market safety assessment, while the US relies on post‑market surveillance and the manufacturer’s own safety substantiation, yet both demand a defensible, science‑based ingredient review.

Bringing It Together: Practical Steps for a Compliant Ingredient Review

A methodical ingredient review that works for both the EU and US markets can be broken down into concrete, repeatable actions.

Collecting ingredient identities. Obtain exact INCI names, CAS numbers, and purity profiles for every substance in the formula. Use CosIng to cross‑check that the INCI name matches the regulatory lexicon [2].
Verifying regulatory status in the EU. Check whether the ingredient appears in Annex II (prohibited), Annex III (restricted), or Annexes IV–VI (colourants, preservatives, UV‑filters) of Regulation (EC) No 1223/2009 [3][2]. If it is restricted, confirm that the use level, product type, and warnings comply exactly.
Reviewing SCCS opinions and guidance. Search the SCCS opinion list for any relevant safety evaluation [1]. If the ingredient has been scrutinised by the Committee, incorporate the findings and any recommended restrictions into the CPSR.
Conducting the toxicological safety assessment. Build the product safety report around the ingredient data, exposure scenarios, and safety margins. This step is mandatory before the product enters the EU market [1][3].
Assessing US requirements for export. Systematically verify the formula against the FDA’s prohibited and restricted ingredients list [5]. Pay particular attention to concentration limits for mercury compounds, hexachlorophene, and any ingredient that might be caught by the bovine material restrictions. Colour additives are the exception: they require FDA approval before they go on the market [5].
Documenting and maintaining records. Keep the safety assessment, raw material specifications, and test reports in the product information file. The responsible person must make these available to national authorities on request [3].

A comparative view highlights the structural differences that shape the review:

Aspect	European Union	United States
Pre‑market approval	No pre‑market approval, but mandatory product safety report and CPNP notification before placing on the market [3][4].	No pre‑market approval for cosmetics (except colour additives). Manufacturer responsible for safety [5].
Ingredient authorisation	Ingredients must comply with Annexes of Regulation (EC) No 1223/2009; colourants, preservatives and UV filters are authorised via positive lists [2].	No formal positive list for general cosmetic ingredients; specific prohibitions and restrictions in 21 CFR 700 [5].
Safety assessment	Expert safety assessment required for every product, covering all ingredients [1].	Safety substantiation is required, but no prescribed CPSR format. FDA can challenge adequacy.
Mercury limits	Restricted under Annex III; limits apply to specific uses (detailed in the Annex).	Eye area products: maximum 65 ppm; all other cosmetics: must not exceed 1 ppm trace level [5].

Navigating dual‑market ingredient reviews demands careful regulatory scoping. Care Europe provides EU and UK regulatory consulting and coordinates testing for brands.

Sources

[1] Scientific and technical assessment (single-market-economy.ec.europa.eu, accessed 2026-10-08)
[2] Cosmetic ingredient database (single-market-economy.ec.europa.eu, accessed 2026-10-08)
[3] Legislation (single-market-economy.ec.europa.eu, accessed 2026-10-08)
[4] Cosmetics (single-market-economy.ec.europa.eu, accessed 2026-10-08)
[5] Prohibited & Restricted Ingredients in Cosmetics | FDA (fda.gov, accessed 2026-10-08)

Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Cosmetic Ingredient Review: EU Safety Assessments and FDA Comparisons