New Labeling for Common Grease Antioxidant
August 2023
Author: Casey Budd
Co-Author: John Sander
Navigating Regulatory Change
Most in the lubricant industry would agree that in recent years it has become increasingly difficult for chemical manufacturers, lubricant producers and marketers, industry regulators, and end-users to navigate the complex regulatory landscape. Seemingly every day there is a new hazard reclassification of a long-established chemistry that sends ripples through the industry and creates questions as to what’s next.
In early 2022, the final results of a reproductive/developmental toxicity study were released to industry for a prolific antioxidant chemistry. The study concluded that the antioxidant in question may cause a fertility impairing effect, resulting in a change to the classification and labelling of the substance. The new classification of the substance – Reproductive toxicity, Cat. 2. H361f; Suspected of damaging fertility – is now required on all products containing ≥ 0.1% in the United States and Canada, and ≥ 3% in the rest of the world. Safety Data Sheets (SDS’s) and product labels must now include the hazard statement as well as the Health Hazard GHS Pictogram, commonly known as the “exploding chest” pictogram, if the concentration of the newly classified substance exceeds the thresholds set forth.
Commonly known by several trade names, and generically called octyl-butyl diphenylamine (OBDPA), the reclassification of this industry staple creates new challenges and poses important questions for the industry to consider. Should industry regulators, such as NSF or European Commission (EC), ban such substances for use incidental food contact (H1) or environmentally sensitive applications? Should formulators reformulate to create so called ‘label free’ products, potentially at the expense of lubricant performance and life? Should chemical manufacturers invest significant R&D into developing ‘label free’ alternatives even though a proven solution already exists? Should end users stop using products that contain potentially hazardous ingredients even though such ingredients significantly increase lubricant life, or should they become further educated on the proper handling procedures of such substances?
Hazard classification changes can be challenging for industry regulators, such as NSF and EC. There is not always unanimous agreement on what to do about a new classification. Is the new data strong enough to support the ban of such substances, or is a milder response more appropriate? At the time of this writing, there seems to be a mixed response for OBDPA. After review of the data, NSF has decided to maintain the HX-1 approval status at the same 0.5% concentration limit, whereas the EC has removed it from the Lubricant Substance Classification (LuSC) list altogether. It is clear that not all industry regulatory agencies agree on the interpretation of the data, but formulators must take note and respond in a way they feel is appropriate.
It can be difficult for formulators to navigate regulatory changes such as this. The simple response might be “just change the SDS and labeling and move on.” For some end-users, this could be an acceptable response. For others, products considered hazardous are immediately frowned upon and may be placed under some sort of sales control or possibly banned entirely. Not only is OBDPA used in a wide array of lubricant formulations, making the scope of the potential R&D project large, but the list of suitable alternatives is relatively small, especially for H1 approved lubricants. Changing any ingredients can throw off the balance and negatively affect the performance, therefore simply replacing OBDPA with another antioxidant to provide a “label free” product may not result in the desired field performance. Change presents risk, and it is up to the companies to manage the risk and determine whether or not to kick off such a project.
A company could consider only reformulating certain products where the recognition of a reproductive hazard may be especially burdensome. Companies who have EAL products labeled with EU Ecolabel, for example, have no choice but to reformulate if they want to maintain that distinction and labeling. H1 lubricants are not as straightforward, because OBDPA is still HX-1 approved, yet many customers that buy H1 lubricants are sensitive to hazardous labeling. They may not be willing to purchase a product if it contains such labeling, even though more education on the proper handling may mitigate the risk entirely. To some, it is rather contradictory to sell a lubricant into food plants that contain an ingredient that is a potential reproductive hazard.
Some lubricant companies may determine that the potential reproductive risk OBDPA presents to those using lubricants is overall minimal as long as they are used responsibly and with proper personal protective equipment. This is a fair consideration because the presence of pictograms on lubricants is becoming quite common. Therefore, it may be best to just update the SDS’s and labels and make no changes to the formulas. Responsible consumers should always review product labels and SDS’s for hazards they may be exposing themselves to. For lubricant companies who choose this option, it would be advisable to prepare to train customers about a hazard, since it is likely that some may notice the new pictogram and ask questions. In some ways, choosing to accept the pictogram may be the best option. The EU has made it no secret that they plan to continue testing materials for unknown hazards. It is likely that more chemicals may require labeling in the future and reformulating now may be a short-term solution as another ingredient, or several ingredients, could result in pictograms later. NLGI provides a collaboration platform for us in the grease industry to openly share information that helps the membership and users. For those who may not have been aware, hopefully this information has been helpful. For those who may have been aware, perhaps this article provides additional insight to consider for finalizing plans for best managing hazard classification changes moving forward