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Reclassification of Augeo Diffuser Base: Comprehensive Update on Fragrance Bases

by Craftovator Studio 08 Dec 2023 2 Comments

UPDATE 6/12/2023:

After conducting a thorough and official evaluation of the mechanistic studies performed in Augeo by the toxicology team, they have made some important observations. In the second study, they did not observe any adverse effects on the development of the tested species, even at the same high dose used in the first study. As a result, they believe that classifying Augeo as having reproductive toxicity is not justified.
Therefore, based on these findings, they have decided to revise the classification of Augeo. It will no longer be self-classified as CMR2, and it will revert back to its previous classification.
ORIGINAL ARTICLE:

Craftovator presents an updated guide shedding light on the recent reclassification of Augeo Clean Multi and Augeo Crystal, two popular fragrance bases in the industry. This comprehensive update aims to provide crucial information to suppliers, vendors and customers alike. We will delve into the reclassification process, testing requirements under the European Union's REACH regulations, potential outcomes, safety considerations, customer perception, compliance guidance, and available alternatives.

Reed Diffuser made with Augeo Base

Understanding REACH and the Testing Process:

REACH is a European Union regulation aimed at ensuring the safe use of chemicals and protecting human health and the environment. Although the United Kingdom (UK) left the European Union (EU) officially on 31/01/2020, the classification and labelling regime is still based on the existing EU regulatory regime during a transition period to provide continuity for businesses. Therefore, when a substance surpasses a certain production volume threshold, additional testing is required to assess its potential impacts. Augeo Clean-Multi and Augeo Crystal, both containing the chemical compound dimethyl 1,3-dioxoline, or CAS number 100-79-8, underwent a development study following OECD-414 guidelines. This study revealed adverse effects on development at high dosages, leading to the reclassification of the substances.

Reclassification and Self-Classification:

In June 2023, Augeo Clean Multi and Augeo Crystal Base received a new classification: "H361d - suspected of damaging fertility or the unborn child." This classification applies to the chemical substances themselves, regardless of brand names. The manufacturer of Augeo promptly self-classified the substances based on the latest test results. This self-classification process enables immediate action based on new data, complementing the more formal and time-intensive classification through legislation. Both self-classification and classification through legislation play crucial roles in ensuring chemical safety.

H361d

The Upcoming Retesting and Potential Outcomes:

The reclassification has triggered further scientific studies to validate the initial test results. These upcoming tests, scheduled for later this year, aim to confirm or refute the adverse effects observed in the previous study. Depending on the retesting results, the classification of the substances could be confirmed or reversed. It is important to acknowledge that the self-classification may change once the retesting is completed.

Period of Uncertainty:

During the ongoing retesting process, a period of uncertainty persists. However, it is crucial to understand that the current labeling and safety data sheets serve as precautionary measures. Augeo Clean Multi and Augeo Crystal remain safe for their intended use in various applications, including reed diffusers, air fresheners, car air fresheners and room sprays.

Available Alternatives to Augeo:

Perfumers alcohol represents a commonly used base in the fragrance industry. It primarily consists of ethanol and serves as a suitable substitute. Craftovator has tested this in reed diffusers and whilst the scent throw is superior, the diffuser formula does tend to not last as long, due to it's fast evaporative properties.

Additionally, Dowanol DPM Base provides an alternative option, as it's slow-evaporating although it may have a distinct odor that may not complement all fragrances.

Vendors have the flexibility to consider these alternatives temporarily or permanently, depending on their preferences and specific needs. As always, we recommend testing extensively with your range of fragrance oils before commencing any batch production.

Safety and Compliance Considerations:

The safety of the products for their intended use remains unaffected. The adverse effects observed in the tests were associated with oral ingestion of the substances at high dosages. In typical use, such as with diffusers and room sprays, ingestion at high doses does not occur. Previous studies on the substances did not reveal the adverse effects observed in the recent test. The upcoming retesting will provide further clarity and contribute to a better understanding of these unexpected results.

Products containing equal to or greater than 3% of the substances will carry the new classification label, in line with the precautionary measures set by CLP regulations within the European Union. It is crucial to emphasize that this classification does not imply that the products are unsafe for their intended use.

Essentially, all home fragrance products (which typically contain anywhere between 75-95% Augeo) will be impacted by the above.

Understanding Risk and Customer Perception:

The risks associated with Augeo and Augeo Crystal are primarily linked to oral ingestion at high dosages, which is not a typical route of exposure when using reed diffusers, air fresheners, and room sprays. CLP labels primarily indicate hazards rather than specific product risks. Their purpose is to inform about potential dangers and hazards associated with a substance, regardless of the likelihood of those dangers occurring under normal use conditions.

However, customer perception plays a significant role, and the new CLP label could lead to concerns or misconceptions among customers. It is important to address these concerns through clear and accurate communication.

Recommendations for Vendors

As of this update, Craftovator will continue to sell existing Augeo products that are currently stocked, with the previous labeling. Safety data sheets (SDS) will be promptly updated to reflect the new classification, and all new batches of both Augeo and Augeo Crystal will feature the revised labels. During this transition, there may be a period of overlap where batches with both old and new labels are in circulation.

Craftovator reiterates its commitment to customer safety and transparency. While uncertainties surround the final classification due to ongoing retesting, Augeo Clean Multi and Augeo Crystal remain valuable materials in the fragrance industry. The retesting initiatives reflect the continuous evaluation and improvement of these bases. Vendors can confidently continue using the bases while adhering to the new labeling requirements or explore alternative bases temporarily or permanently. Craftovator remains vigilant, actively monitoring the situation, and will continue to provide updates and support to its customers throughout this change.

Your Options Moving Forward

To maintain compliance and ensure a smooth transition, vendors are advised to follow these recommendations:

  1. Use Existing CLP Labels: For existing stock with the old labels, continue selling these products with the existing CLP labels. This practice aligns with industry norms to prevent confusion and discrepancies between labels on materials and the actual labels on products.

  2. Update Product Labels: Once your existing stock is depleted, and you create new batches containing the reclassified substance, you'll need to update the CLP labels to reflect the new classification. Craftovator will be slowly updating the SDS and CLP templates for each fragrance oils during the transition period, and customers purchasing custom CLP labels will receive the new labels in due course.

  3. Be Aware of Tactile Warning Labels: For products classified as H361d and sold to the general public, be mindful of the need for tactile warning labels. These can be purchased from a number of outlets, including Amazon.

  4. Switch to an Alternative Base: You may find it worthwhile to use this as an opportunity to test different bases, either temporarily or permanently.

This article provides an updated and comprehensive overview of the reclassification of Augeo Clean Multi and Augeo Crystal Vegan base, reflecting the latest information as of July 2023. The content is based on the most recent understanding of the situation and information provided by manufacturers. Craftovator remains committed to ensuring the safety and compliance of its products and will continue to provide updates as and when new information becomes available.

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2 Comments

02 Nov 2023 Vitje

Thanks for this detailed information.
My perfume maker said that he understands it as if Augeo would be no longer legal to be used for diffusers in the EU. Do you think this is true or will getting a new UFI code and updating the warning label be ok?

02 Nov 2023 Alison Powell

Hi, ive just read the information re the reclassification of Auego, can I ask if we need to use tactile labels on current stock ?
Thank you .

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