Ingredient Restrictions Compared: EU vs US vs ASEAN Cosmetic Regulations

Three different regulatory philosophies, not just three different lists

Brands exporting the same formula to the EU, US, and Southeast Asia run into a fact that surprises first-time exporters: these are not three versions of the same list with a few extra entries. They are three different regulatory philosophies. The EU restricts by default and permits by exception. The US restricts a short, specifically enumerated set of substances and otherwise relies on the manufacturer's own safety substantiation. ASEAN sits closer to the EU model procedurally but allows more national variation in enforcement. Formulating for all three at once means satisfying the strictest applicable rule for every ingredient, not averaging across the three systems.

The EU: a positive-and-negative list model under Regulation 1223/2009

EU Cosmetics Regulation 1223/2009 works from prohibited and restricted-use annexes (notably Annex II for banned substances and Annex III for restricted ones, with maximum concentrations and use conditions specified per substance) alongside positive lists for colorants, preservatives, and UV filters — meaning those three categories may only use substances the EU has explicitly authorized. This is the strictest of the three systems in structure: if a colorant, preservative, or UV filter is not on the relevant positive list, it cannot be used in the EU regardless of how it performs elsewhere. The list is also the most frequently updated of the three, with the European Commission adding or amending restrictions multiple times a year as new safety data emerges.

The US: a short prohibited list, now backed by MoCRA recordkeeping

The US has historically restricted or prohibited a much shorter list of specific substances (a small set that includes chloroform, certain mercury compounds, and a handful of others) and otherwise has not required pre-market safety review. This looks permissive next to the EU list, but MoCRA changed the practical picture in 2022 by requiring manufacturers to maintain safety substantiation records for every marketed product and to report serious adverse events on a strict timeline. The US model is now: fewer explicit ingredient bans, but a real and enforceable expectation that a manufacturer can produce evidence of safety for whatever it does use. A shorter prohibited list is not the same as a lower compliance bar once MoCRA's recordkeeping obligations are counted.

ASEAN: harmonized through the ASEAN Cosmetic Directive, anchored to the EU list with local variation

The ten ASEAN member states, including Malaysia, operate under the ASEAN Cosmetic Directive (ACD), which was deliberately built to align closely with the EU's annex structure — many ASEAN prohibited and restricted substance lists mirror EU Annexes II and III directly. Where ASEAN diverges is in national implementation: each member state's regulatory authority (in Malaysia, the National Pharmaceutical Regulatory Agency) can apply additional local requirements around notification, labeling language, and halal-relevant ingredient sourcing on top of the shared ACD baseline. A formula that clears the ACD baseline can still need country-specific adjustment to sell in, say, Malaysia versus Vietnam versus the Philippines, even though all three operate under the same regional directive.

Fragrance allergens: the area with the most genuine divergence

Of all ingredient categories, fragrance allergen disclosure diverges the most sharply across these three systems. The EU requires labeling of 26 (recently expanded toward a longer list under an amending regulation) individually named fragrance allergens above defined concentration thresholds. The US has no equivalent mandatory disclosure list for fragrance allergens on the federal level, relying instead on the general "fragrance" ingredient declaration. ASEAN member states vary, with some adopting EU-aligned allergen disclosure and others not requiring it. A fragrance house formulating for global distribution typically has to track allergen content against the strictest applicable list, which in practice means the EU's, even for product runs that will only ship to markets without a matching requirement.

What this means for formulating one product across multiple markets

The practical consequence for a brand or private label buyer is that "compliant" is not a single target — it is a moving target defined by the destination market, and a formula built for one region can fail a different region's rules even when both regions consider the ingredient generally safe. The two workable approaches are formulating separate regional variants of a product (more accurate to each market's list, more complex to manufacture and inventory) or formulating a single global version to the strictest applicable requirement across all target markets (simpler to manufacture, sometimes more expensive per unit, but avoids maintaining parallel formulas). Which approach makes sense depends on order volume and how many markets a brand is actually shipping into at once.

A practical starting point for new exporters

For a brand entering export for the first time, the lowest-risk approach is to formulate to the EU's restricted and positive lists as the baseline, since EU compliance generally satisfies or exceeds the US and most ASEAN member state requirements for the same ingredient categories, with fragrance allergen disclosure as the main exception worth checking market by market. This is not a substitute for confirming country-specific requirements before shipping — labeling language, halal certification interactions with certain animal-derived or alcohol-adjacent ingredients, and national notification rules still need individual verification — but it prevents the more expensive mistake of formulating to the most permissive list first and discovering the gap after a shipment is already produced.