Regulatory & Compliance

Ingredient Restrictions in Cosmetics — Banned and Limited Substances Explained

One of the most important — and most frequently overlooked — aspects of cosmetics compliance is ingredient restriction. Most people are aware that cosmetics cannot contain certain substances. Fewer understand the layered structure of cosmetics ingredient regulation: the difference between absolutely prohibited substances, conditionally permitted substances with concentration limits, positively listed substances (only these are permitted in specific applications), and substances that vary in status between different markets. Getting this wrong can result in product seizure, regulatory action, or — most seriously — consumer harm.

The structure of cosmetics ingredient regulation

EU Regulation 1223/2009 and the aligned GCC technical regulation (GSO 1943) organise ingredient restrictions into several annexes. Annex II lists substances prohibited in cosmetic products — these may not be used at any concentration. Annex III lists restricted substances — substances that may be used but only under specified conditions, including maximum concentrations, specific product types in which they may be used, and mandatory label warnings. Annexes IV, V, and VI contain positive lists — colourants, preservatives, and UV filters respectively — where only listed substances at permitted concentrations may be used in those functional roles. Substances not on the positive lists for those functions may not be used in those functions, even if not explicitly prohibited.

Absolutely prohibited substances

Annex II of EU Regulation 1223/2009 lists over 1,300 prohibited substances. These include heavy metals at specified limits (lead, mercury, arsenic, cadmium), specific hormones (including corticosteroids and androgens), specific carcinogens, mutagens, and reprotoxic substances (CMRs), a range of organic compounds identified as unsafe for cosmetic use, and ingredients derived from human body parts. The GCC prohibited list aligns with these in the main, though there may be differences in specific entries. For practical purposes, working with a manufacturer who maintains an up-to-date prohibited substance database and screens all raw materials against it is the most reliable approach.

Heavy metals — the most common enforcement focus

In GCC markets, heavy metal contamination is a major regulatory enforcement priority, particularly in skin-lightening and whitening products. Mercury compounds are absolutely prohibited in cosmetics globally, yet products containing mercury — often marketed as skin-whitening or anti-ageing creams — continue to appear in markets. SFDA, MOHAP, and other GCC authorities have taken significant enforcement action against mercury-containing products. Hydroquinone, while not a heavy metal, is regulated similarly due to its skin-lightening action: it is restricted to very low concentrations in general cosmetics in some markets and banned altogether for OTC cosmetics in others, including some GCC member states. If your products are formulated in the whitening, brightening, or lightening category, understanding the specific restrictions on actives in each of your target markets is essential before finalising any formula.

Restricted substances — conditions of use

Annex III substances can be used, but only within specified limits. The conditions of use typically specify: the maximum concentration permitted; the product types in which use is permitted (leave-on, rinse-off, hair products, oral care — with different products sometimes having different limits for the same substance); mandatory label warnings; and sometimes the form in which the substance must be present. Common restricted substances that brand founders frequently encounter include: hydrogen peroxide (different limits for hair bleaching products vs nail hardeners vs oral care); formaldehyde and formaldehyde-releasing preservatives (subject to maximum concentration limits and mandatory ‘contains formaldehyde’ labelling above 0.05%); retinol and retinoids (subject to concentration limits in leave-on and rinse-off products); specific AHA compounds such as glycolic acid (concentration limits with mandatory SPF recommendation warnings on pack); and salicylic acid (different limits for different product types).

Positive lists — colourants, preservatives, UV filters

For these three functional categories, only substances on the relevant positive list may be used. This is a stricter approach than the general prohibited/restricted framework. If a colourant, preservative, or UV filter is not on the permitted list, it cannot be used in those functions in cosmetics regardless of its general safety profile. Positive lists are regularly updated — both to add newly approved substances and to amend concentrations or remove substances that have accumulated new safety concerns. Your manufacturer’s quality team should maintain current versions of all three positive lists and screen formulas accordingly. For UV filters in particular, there are significant differences between the EU-permitted list and the US-permitted list (the US FDA list is much more restrictive), which affects brands planning to sell in both markets.

Nanomaterials — a special category

EU regulation has specific provisions for nanomaterials in cosmetics. Nanomaterials — defined as materials with one or more external dimensions in the 1–100 nm range — require pre-notification six months before the main CPNP notification if they are present in the formula. Some nanomaterials are permitted in specific applications (certain nano-titanium dioxide and nano-zinc oxide forms in sunscreens, for example), while others are prohibited. GCC regulation is still developing its approach to nanomaterials — check current requirements with your regulatory adviser for each target market.

Market-specific variations

Ingredient restrictions are not uniform globally, and this creates complexity for brands targeting multiple markets. The EU-permitted UV filter list includes substances not permitted in the US and vice versa — a formula compliant for EU sunscreens may need reformulation for the US market. China has its own cosmetics regulation (CSAR) which has prohibited substances, restricted substances, and positive lists that differ in specific entries from EU and GCC lists. Japan regulates cosmetics through the PMDA with a quasi-drugs category that covers some products treated as cosmetics elsewhere. If you are planning international distribution beyond the GCC and EU, ingredient review for each target market is a necessary step before finalising formulas.

How a manufacturer protects you from ingredient restriction issues

A GMP-certified manufacturer with a rigorous quality management system will screen all raw materials against prohibited and restricted substance lists before use, maintain current positive lists for colourants, preservatives, and UV filters, apply concentration controls through batch manufacturing and QC testing, provide full ingredient documentation enabling label compliance and regulatory review, and proactively inform clients when regulatory changes affect existing formulas. This screening and documentation capability is a core function of GMP manufacturing and one of the most practical reasons for working with a certified manufacturer rather than a non-certified contract facility.