What is Advancion’s position with regard to Austria’s proposed revised classification for 2-amino-2-methylpropanol?
Advancion, together with third-party experts, has built a robust dataset of toxicology testing and proven safe use of 2-amino-2-methylpropanol over more than 80 years. The legacy dataset is much more extensive than that required by the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labelling and Packaging (CLP) Regulations and includes a track record of 70 years of clinical safety related to human ingestion of 2-amino-2-methylpropanol via over-the-counter (OTC) drugs.
On this basis, Advancion strongly disagrees with Austria’s proposed classification outlined in the harmonized classification and labelling (CLH) report as a:
- Reproductive toxicant (Repr.) and Repeated-dose toxicant (STOT RE) because the mechanism of action (MOA) observed in extensive screening studies has been previously determined by the EU to be non-relevant to humans.
- Skin Corrosive (Skin Corr.), because a comprehensive scientific publication reported no irreversible effects after a 48-hour human patch testing with up to 20% 2-amino-2-methylpropanol in water.
Advancion believes the current self-classification of 2-amino-2-methylpropanol is accurate and supported by current data sets: Skin Irrit. 2 and Eye Dam. 1 with no further classifications. All data and discussions supporting the aforementioned conclusions are detailed in the links above, which point to Advancion’s publicly available EU REACH Registration dossier.
Are you planning to challenge Austria’s proposed revised classification for 2-amino-2-methylpropanol?
Yes. In 2023, Advancion submitted several updates to the REACH registration to clarify the dataset for 2-amino-2-methylpropanol and develop our scientific arguments. We will continue to bring forward all relevant scientific information to challenge Austria’s proposed classification for Repr., STOT RE and Skin Corr., notably:
- By having our scientific consultants develop a structured document assessing the human relevance of effects observed in screening studies;
- By generating new data if we conclude that this could bring further support for our arguments;
- By submitting further REACH updates to include new data and/or discussions as soon as these become available;
- By commenting on Austria’s CLH report during the 60-day public comment period;
- By having our consultants participate in the European Chemicals Agency (ECHA) Risk Assessment Committee (RAC) CLH working group (RAC CLH WG), which will take place several months after closing of the 60-day public commenting period on February 14, 2025; and
- By continuing to interact with all stakeholders at all steps of the process.
The above activities will be achieved using our own expertise and the support of well-established industry experts. Customers with toxicological expertise are welcome to participate in the above efforts, most notably the 60-day public commenting period for the CLH report.
How will this proposed classification affect labels or safety data sheets (SDSs) for 2-amino-2-methyl-propanol sold into other countries / regions outside of Europe where the CLP regulation is not applied?
The proposed classification for 2-amino-2-methyl-propanol is an EU issue based on the unique manner in which ECHA evaluates chemical hazards. Regardless of the final outcome of the proposed classification, there are no intended changes at this time to the labels and SDSs for Advancion products containing 2-amino-2-methyl-propanol sold outside of the EU-27. Labelling and SDSs for all Advancion products will continue to be compliant in all countries in which they are sold and used.
Will this proposal impact the classification of other Advancion chemistries?
No. The proposed classification change for 2-amino-2-methylpropanol is specific to that substance / CAS No. and is related only to Advancion products containing 2-amino-2-methylpropanol.
Are you planning to seek an exemption for the use of 2-amino-2-methylpropanol in Personal Care products or Green Label paints?
2-amino-2-methylpropanol has decades of proven safe use in a broad range of pharmaceutical, consumer and industrial applications supported by exhaustive environmental, health and safety data. Depending on the final outcome of the proposed classification, Advancion will pursue all available options to ensure the continued availability and safe use of 2-amino-2-methylpropanol in essential consumer and industrial applications.
When can we expect a final revised harmonized classification of 2-amino-2-methylpropanol?
Austria’s CLH report for 2-amino-2-methylpropanol is an early step in a very long process, during which the classification proposed for 2-amino-2-methylpropanol may evolve, or the proposal may be wholly withdrawn. From the date of the CLH report publication on December 16, 2024, there is an 18-month deadline for the ECHA Committee for Risk Assessment (RAC) to publish their final opinion on the classification of 2-amino-2-methylpropanol. Once the RAC Opinion is published, ECHA forwards the opinion to the European Commission (EC) for a final decision and inclusion of the harmonized classification in Part 3, Annex VI, of the CLP Regulation. An amendment (Adaptation to Technical Progress, or ATP) to CLP regulation is finally issued, making the revised classification official. Based on our analysis of CLH cases over the past 5 years, the timeframe between CLH report publication and ATP publication ranges from 2 to 5 years.
Will Advancion, or my company, need to relabel products containing 2-amino-2-methylpropanol?
Not at this stage. This is a proposal only and there is no change to the current classification of 2-amino-2-methylpropanol. If and once an ATP is published with a revised classification (2 to 5 years after CLH report publication), a 1.5-year period is allowed to update all SDS and labels across the supply chain. Therefore, if ever required, product relabeling would only become mandatory 3.5 years after CLH report publication (as a worst-case). For more information on ECHA’s harmonized classification and labelling (CLH) process, please click here.
Are there new use restrictions in place for using 2-amino-2-methylpropanol?
Not at this stage. This is a proposal only and there is no change to the current classification of 2-amino-2-methylpropanol. Any use restrictions triggered by a change in classification would only become effective once an ATP published, 2 to 5 years after CLH report publication, and there would be an implementation period.
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.
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
Is 2-amino-2-methylpropanol still a safe product to use in my applications?
Yes. 2-amino-2-methylpropanol has decades of proven safe use in a broad range of pharmaceutical, consumer and industrial applications supported by exhaustive environmental, health and safety data. This includes more than 70 years of use in oral over-the-counter (OTC) pharmaceuticals. The safe and effective use of 2-amino-2-methylpropanol is also supported by independent chemical health and safety evaluations performed by internationally recognized third parties, such as the Cosmetic Ingredient Review (CIR), among many others.
Do I need to recall any of my products currently using 2-amino-2-methylpropanol because of the proposed classification change?
No. This is a proposal only and there is no change to the current classification or approved uses of 2-amino-2-methylpropanol.
I currently use 2-amino-2-methylpropanol in my formulations, does Advancion have recommended alternatives to 2-amino-2-methylpropanol and formulation guidance?
For customers who are interested in exploring alternatives to 2-amino-2-methylpropanol in their specific formulations, Advancion’s technical experts can provide the necessary guidance and formulation support for a broad selection of end-use markets. For more information, please contact your Advancion Account Manager or send an inquiry via the contact us page on the Advancion website.