Aminomethyl Propanol (AMP), a versatile pH adjuster, is facing a regulatory path likely to lead to its restriction in the European cosmetic market. With the recent proposal for its harmonized classification as a Reprotoxic 1B (CMR) substance under the CLP Regulation, the crucial question for the industry is no longer if the substance will be restricted, but with what timeline such measures will become binding.

What is Aminomethyl Propanol and why is it so widespread?

Used primarily to stabilize formulation pH, AMP ensures the efficacy and compatibility of ingredients over time. Its presence in a wide range of products – from hair gels to creams and make-up – makes it an ingredient that is often complex to replace in the short term.

RAC Opinion and the CMR Classification

In early 2026, ECHA’s Committee for Risk Assessment (RAC) identified AMP as:

• Toxic Reproduction (CMR 1B)
• Corrosive to skin
• Harmful to the eyes, Category 1 (Eye Dam 1)
• Toxic to the liver following repeated exposure.

While not yet legally binding, this scientific opinion triggers the regulatory framework under Article 15 of the Cosmetics Regulation (EC) No. 1223/2009, typically leading to a ban for cosmetic uses.

What happens after the classification?

Once the classification is adopted via Adaptation to Technical Progress (ATP), AMP will be included in the “CMR Omnibus” Regulation. Under Article 15 of the Cosmetics Regulation, CMR 1A and 1B substances are prohibited by default. While derogations are theoretically possible following an SCCS evaluation, the current toxicity profile makes a total ban for cosmetic uses the most likely regulatory outcome.

The timelines under discussion: 2028 or 2029?

The European Commission is currently discussing the inclusion of AMP in the 25th ATP of the CLP. Two scenarios are under consideration:

• 25th ATP scenario: publication by Q1 2027, with a potential ban on cosmetics by September 2028.
• Postponement request: industry associations have formally requested to shift AMP to the 26th ATP.

The discussion within the CARACAL expert group is ongoing. If the request is accepted, the deadline would shift to September 2029, granting an additional year for essential reformulation and stability testing.

What does this mean for operators

Companies using AMP should consider its replacement a strategic priority to ensure commercial continuity. It is essential to:

• Audit the product portfolio to identify the presence of AMP.
• Test functional alternatives and evaluate their impact on stability.
• Plan for immediate transition: CMR Omnibus regulations typically do not provide for sell-through provisions; once the restriction is effective, it generally applies simultaneously to production and products already on the market.

>>> Complife supports economic operators with strategic regulatory consultancy and dedicated testing services, assisting companies through the reformulation process and the evaluation of safe, effective alternatives.

SOURCE:

• ECHA (European Chemicals Agency)