The resources below address the European Chemicals Agency (ECHA) Risk Assessment Committee (RAC) opinion on the proposed reclassification of 2-amino-2-methylpropanol, adopted on 4 December 2025, and published on January 7, 2026. The RAC opinion proposes changes to the harmonized classification of 2-amino-2-methylpropanol in the European Economic Area (EU, Norway, Liechtenstein and Iceland), including new classifications for reproductive toxicity (Repr. 1B; H360D) and specific target organ toxicity following repeated exposure (STOT RE 2; H373 – liver), modifications to skin and eye hazard classifications, and removal of the current aquatic chronic toxicity classification.
While the RAC opinion does not create immediate legal obligations, it represents a critical step in the regulatory process that will ultimately result in binding classification changes once formally adopted by the European Commission and published in the Official Journal of the European Union. The Frequently Asked Questions (FAQs) below are designed to help customers, downstream users, and stakeholders understand the implications of these proposed changes and prepare for the transition ahead.
Does the proposed future reclassification apply to all 2-amino-2-methylpropanol on the market, or only to 2-amino-2-methylpropanol produced by Advancion?
The proposed classification change is specific to 2-amino-2-methylpropanol as a chemical substance / individual CAS No. and is not dependent on a manufacturing process, purity level or product grade. Once it is legally binding, the proposed classification change would cover all products and mixtures on the European Economic Area (EEA) market that contain ≥0.3 wt% 2-amino-2-methylpropanol, regardless of any supply chain considerations, such as the original manufacturer, distributor or formulator.
Will the proposed future reclassification of 2-amino-2-methylpropanol impact the classification of other Advancion chemistries that do not contain 2-amino-2-methylpropanol?
No. The future reclassification for 2-amino-2-methylpropanol proposed in the RAC opinion is specific to that substance / CAS No. and will only impact products and mixtures containing ≥0.3 wt% 2-amino-2-methylpropanol.
Will the classification and labeling of 2-amino-2-methyl-propanol products change in countries / regions where the proposed new classification is not mandatory?
The RAC opinion issued by the European Chemicals Agency (ECHA) relates specifically to the EU Classification, Labelling and Packaging (CLP) Regulation and reflects proposed future EU classification only. It does not, by itself, create legally binding requirements and has no direct regulatory effect outside of the European Economic Area (EEA), which includes EU Member States plus Iceland, Liechtenstein and Norway.
Advancion will continue to monitor the situation as the ECHA opinion evolves and remains committed to ensuring that all Advancion products are labelled and handled appropriately. Before any changes are made to the classification of 2-amino-2-methylpropanol in a specific jurisdiction, customers will be notified in advance and supported through the transition.
Does Advancion plan to self-classify 2-amino-2-methylpropanol and change the labels to align with the proposed future classification?
At this time, Advancion does not plan to self-classify 2-amino-2-methylpropanol or change product labels to align with the proposed future classification before it becomes legally binding.
My company wants to replace 2-amino-2-methylpropanol in our formulations with a different chemistry in the future. Does Advancion have recommendations for alternative chemistries that perform similarly to 2-amino-2-methylpropanol?
Yes. In 2024, Advancion introduced a next-generation portfolio of multifunctional additives built on a new technology platform. These new ingredients were developed over a decade of rigorous research and product testing and are the only standalone chemistries that deliver true 1:1 replacement performance for 2-amino-2-methylpropanol.
These new-to-the-world ingredients were specifically engineered to meet and exceed the performance of 2-amino-2-methylpropanol in formulations across all known market applications while also offering a best-in-class safety and toxicological profile. The portfolio is commercialized under the following product families by end market:
- Personal care and cosmetics: ELEVANCE™ ULTRA multifunctional additives(INCI: Amino Methylisobutanol) provide superior hair fixative resin performance and pigment dispersion and are compatible with a wide range of commonly used natural and synthetic formulating ingredients supporting cleaner and more effective personal care products. ELEVANCE™ ELITE Bio65 (INCI: 3-Amino-2-Butanol) is a 50% bio-based multifunctional additive and delivers high-efficiency neutralization, emulsion stabilization, and pigment dispersion. It serves as an ideal alternative to AMP particularly where bio-based content and / or compliance with Cruelty Free International (CFI) standards are preferred.
- Paints and coatings, and general industrial markets: OPTIMINE™ multifunctional additives provide exceptional performance as high-efficiency stabilizers, pigment co-dispersants and neutralizers / alkaline buffers, and are ideal for advanced waterborne coatings formulations with a low-VOC (volatile organic compound) and emissions profile.
- Metalworking fluids: CORRGUARD™ SELECT multifunctional additives excel in multi-metal compatibility, provide high in-use pH buffering and excellent foam control, delivering outstanding performance in the most demanding metalworking fluids applications.
Our technical teams are available to support product selection, formulation guidance, and transition planning to support timely substitution of all 2-amino-2-methylpropanol products. For more information, please contact your Advancion Account Manager or send an inquiry via the contact us page on the Advancion website.
When can we expect a final revised harmonized classification of 2-amino-2-methylpropanol?
The European Commission, Competent Authorities for REACH and CLP (CARACAL) and other stakeholders will prepare a delegated act on the revised harmonized classification of 2-amino-2-methylpropanol. Once adopted, the Council and the European Parliament will amend Annex VI of the CLP Regulation through an ATP (Adaptation to Technical Progress). This process typically takes a minimum of one year from the time of publication of the RAC opinion.
- The revised classification of 2-amino-2-methylpropanol would become official in the European Economic Area (EEA) only if and when an ATP is published in the Official Journal of the EU (OJEU).
- Until then, the current classification for 2-amino-2-methylpropanol remains in effect.
- Once the ATP is published in OJEU, SDS and labels of impacted products typically need to be modified throughout the supply chain within an 18-month period.
Today, can I continue using and selling 2-amino-2-methylpropanol in our company’s or our customers’ applications?
Yes. You can continue using / selling 2-amino-2-methylpropanol in your existing applications. The RAC opinion is a scientific proposal that does not introduce any new legal obligations or use restrictions for the chemical substance / CAS No.
However, customers are encouraged to proactively review their applications and formulations to anticipate and understand any potential implications. Once the potential classification change becomes legally binding, certain applications will become subject to use restrictions in the European Economic Area (EEA), based on REACH, the European Union (EU) Cosmetic Products Regulation (CPR) and other EU regulations. This includes assessing your own uses, downstream/customer uses, and any regulations with application-specific restrictions. It also includes assessing whether your Company wants to continue using 2-amino-2-methylpropanol or substitute it with one of Advancion’s high-performance alternatives.
Will the proposed reclassification affect products containing 2-amino-2-methylpropanol that are used in the European Union (EU) Ecolabel program?
Yes. Once the proposed classification becomes legally binding, products containing 2-amino-2-methylpropanol will likely face restrictions under the EU Ecolabel program. Substances classified as CMR Category 1B (which includes the proposed Repr. 1B classification) are generally excluded from EU Ecolabel products.
This means that coatings, cleaning products, and other formulations seeking EU Ecolabel certification will need to reformulate to remove 2-amino-2-methylpropanol or use alternative ingredients. Advancion has developed next-generation multifunctional additives specifically designed to meet Ecolabel requirements while delivering equivalent or superior performance to 2-amino-2-methylpropanol.
Are you planning to seek an exemption from future use restrictions that apply to 2-amino-2-methylpropanol, such as in Personal Care products or Ecolabel uses?
No. Advancion does not plan to seek an exemption for the use of 2-amino-2-methylpropanol in any applications. Under EU regulations, a substance classified as CMR Category 1B may be considered for exemption only if there are no suitable alternative technologies available and a positive safety opinion is issued by scientific experts, such as the Scientific Committee on Consumer Safety (SCCS) for cosmetics.
Advancion has already developed and commercialized viable alternative chemistries to 2-amino-2-methylpropanol that deliver equivalent or improved performance with more favorable safety and regulatory profiles. Given the commercial availability of these alternatives, Advancion does not believe that any exemption request would be accepted.
Advancion’s strategy is to support customers in transitioning to next-generation multifunctional additives designed to meet performance, sustainability, and regulatory expectations for all uses of 2-amino-2-methylpropanol impacted by the proposed future classification (most notably in personal care and Ecolabel coatings applications).
We manufacture products / blends containing 2-amino-2-methylpropanol. Do we need to make changes to our product labels and SDS?
Currently, no changes to the product labels and / or SDS for products / blends containing 2-amino-2-methylpropanol are required, and the current classification for the chemical substance / CAS No. remains in effect.
However, customers are encouraged to proactively review their applications and formulations to anticipate and understand any potential implications. Once the potential classification change becomes legally binding, certain applications will become subject to use restrictions in the European Economic Area (EEA), based on REACH, the European Union (EU) Cosmetic Products Regulation (CPR) and other EU regulations. This includes assessing your own uses, downstream/customer uses, and any regulations with application-specific restrictions. It also includes assessing whether your Company wants to continue using 2-amino-2-methylpropanol or substitute it with one of Advancion’s high-performance alternatives.
Does the proposed classification change impact the U.S. Food and Drug Administration’s (US FDA) Food Contact Notification (FCN) or other regulatory approvals or classifications for 2-amino-2-methylpropanol?
Not at this stage. The following US FDA FCN and other regulatory approvals for 2-amino-2-methylpropanol remain unchanged and were granted following exhaustive testing and evaluation, including toxicological assessments:
- U.S. Food and Drug Administration (FDA) Sections 175.105, 176.170, 176.180, 175.300, 175.380, 175.390, 177.1210, 177.2260
- Positive listing in BfR Recommendation XXXVI for Paper and board for food contact
- Positive listing in Annex 10 on packaging inks, of the Swiss Ordinance 817.023.21
- VOC-exempt status granted by the U.S. Environmental Protection Agency (EPA), Environment Canada and South Korea’s National Institute of Environment & Research (NIER)
- EPA registered as an inert ingredient
- Listed as inert ingredient in approved drug products
I want to stop using of 2-amino-2-methylpropanol immediately, will Advancion accept a return of the material I have in stock?
No. Advancion cannot accept returns of 2-amino-2-methylpropanol based solely on anticipated regulatory changes.
As a reminder, the current classification for 2-amino-2-methylpropanol remains fully in effect. Any future classification proposed by ECHA would apply only within the European Economic Area (EEA) and only if and once an Adaptation to Technical Progress (ATP) is formally published in the Official Journal of the EU (OJEU).
Today, 2-amino-2-methylpropanol remains compliant for sale and use under its existing classification. There are no regulatory requirements to discontinue use or return existing inventory.
For customers who wish to proactively transition away from 2-amino-2-methylpropanol, Advancion can provide guidance on suitable alternative chemistries, including next-generation multifunctional additives designed to deliver equivalent or improved performance with an enhanced safety and regulatory profile. Our technical teams are available to support product selection, formulation guidance, and transition planning.
Do I need to recall any of my products currently using 2-amino-2 methylpropanol because of the proposed future classification change?
No. There is currently no requirement to recall products using 2-amino-2-methylpropanol. The RAC opinion reflects a proposed classification only and does not change the current legally binding classification or the approved end uses of 2-amino-2-methylpropanol. As such, there is no regulatory need for product recalls, withdrawals, or market actions at this time.
However, customers are encouraged to proactively review their applications and formulations to anticipate and understand any potential implications. Once the potential classification change becomes legally binding, certain applications will become subject to use restrictions in the European Economic Area (EEA), based on REACH, the European Union (EU) Cosmetic Products Regulation (CPR) and other EU regulations. This includes assessing your own uses, downstream/customer uses, and any regulations with application-specific restrictions. It also includes assessing whether your Company wants to continue using 2-amino-2-methylpropanol or substitute it with one of Advancion’s high-performance alternatives.
Will Advancion continue to produce 2-amino-2-methylpropanol?
Yes, Advancion has been the only commercial scale producer of 2-amino-2-methylpropanol for several decades. The Company has no plans to discontinue production and sale of 2-amino-2-methylpropanol and will continue to serve global market demand with a secure, sustainable supply of this essential ingredient from our two manufacturing sites in the U.S. and Germany.
Will Advancion continue to provide technical support for 2-amino-2-methylpropanol?
Yes. Advancion will continue to provide full technical support to support customers using 2-amino-2-methylpropanol in approved, existing end-use applications, including formulation guidance, troubleshooting, performance optimization, and assistance with SDS and regulatory interpretation as applicable.
For customers who wish to proactively transition away from 2-amino-2-methylpropanol, Advancion can provide guidance on suitable alternative chemistries, including next-generation multifunctional additives designed and manufactured by Advancion to deliver equivalent or improved performance with an enhanced safety and regulatory profile. Our technical teams are available to support product selection, formulation guidance, and transition planning.
For more information, please contact your Advancion Account Manager or send an inquiry via the contact us page on the Advancion website.