-
pH Adjusters & Incidental Ingredients
I was discussing a troublesome product with my supervisor and he said something I’d like a third opinion on.
For context, I’m reformulating an old shampoo that was OOS for viscosity and pH. The original formula had no pH adjuster. In previous production batches, they would first add citric acid until the pH was within range then add SLES (already present in the formula) to increase the viscosity. They did this with every batch they produced. In this case, I agree the citric acid is an incidental ingredient and did not need to be disclosed on the product’s label. I could argue that the product should have been reformulated after the third consecutive OOS batch but that’s not the issue at hand.
Now, years later, I’m reformulating this shampoo and I’ve altered the formula to include citric acid and increased the SLES from the start. Everything is in spec, everyone’s happy. However, I say that we need to reach out to the client to let them know that the labels would need to be changed to include citric acid. My supervisor says that pH adjusters are exceptions to the labeling regulations and they are optionally disclosed. News to me. So, I read over labeling section of the 21 CFR and I couldn’t find anything relating to pH adjusters being exceptions to anything. In fact, they don’t mention pH anywhere in this section. What’re your thoughts?
@Perry44 @Graillotion @PhilGeis @Microformulation @Bobzchemist
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701
-
15 Replies
-
Hello,
If the substance is used for pH adjustment only, you do not need to list it. You never know how much you will need to use to achieve the correct pH. It can vary batch from batch.
However, if you use it as a functional ingredient, e.g. neutralising polymer or similar, you need to list it.
Hope that helps 🙂
-
Hi paprik,
Thank you for your time.
Why is pH adjusting not considered functional? Whereas adjusting the viscosity or clarity of a product is?
Do you know where I can find a source for not including pH adjusters in the LOI?
-
I suppose if an ingredient is not considered functional it would fall under § 701.3 (L) (2) (iii) as a processing aid? I wouldn’t exactly call the level used insignificant (0.65%) but I can see it being called so.
“Substances that are added to a cosmetic during the processing of such cosmetic for their technical and functional effect in the processing but are present in the finished cosmetic at insignificant levels and do not have any technical or functional effect in that cosmetic.”
-
-
You never know how much you will need to use to achieve the correct pH. It can vary batch from batch.
Ingredients after 1% line can be listed in any order, so I don’t think this is a good argument.
-
-
I’d put it on ingredient label. Why do you think it’s on so many shampoo labels?
e.g. it’s on the Pantene shampoo ingredient label with the explanation on P&G’s website ” An AHA that comes from citrus fruits. It is usually used as a helper ingredient to adjust the pH of the formula.’
-
I’d also like to put it on the label, but it doesn’t seem like they’re going to go that route. All ingredients should be on the label in case someone wants to avoid citric acid for whatever reason (allergies, chemophobia, or esperidoeidiphobia)
-
-
I would put it on the label in case it’s sold in other markets that have more stringent labeling requirements.
-
That would be the most prudent course. But that would also be the more costly one since they’d have to get rid of their existing labels or place a label over the old ones.
-
When I change ingredients and can’t afford relabeling, I highlight it very strongly on my website lol. However, when I worked in the industry as a contractor, I called NIST and spoke directly to the director who provided very valuable information. Never underestimate the power of calling people 🙂
-
When I change ingredients and can’t afford relabeling, I highlight it very strongly on my website lol.
Seems a bit illegal, no?
-
during covid there were significant distruptions in the supply chain so I put in a disclaimer. Not sure if i’d be sent to el salvador but its looking likely
-
-
-
-
-
If it’s of any help, the EU says “All ingredients have to be labelled on the packaging. An incomplete listing of ingredients is
considered to be misleading.
However, there is a provision whereby certain materials are not considered as ingredients. The
relevant extract from Article 19.1(g) states:
“For the purpose of this Article, an ingredient means any substance or mixture intentionally used
in the cosmetic product during the process of manufacturing.
The following shall not, however, be regarded as ingredients:
(i) Impurities in the raw materials used;
(ii) Subsidiary technical materials used in the mixture but not present in the final product.”
These definitions are reasonably clear. Subsidiary materials not present in the final product
would include filtration aids and decolourising agents, both of which could be added during
manufacturing but would subsequently be removed.“-
Thank you for the information. Now I know there are no loopholes to hide behind for EU markets. Unfortunately, this is being marketed in the US so they’ll be able to legally have their way.
-
-
That’s wishful thinking. If you put Citric Acid in a formula, it should be listed. However, you can just note your objection and the company is going to do what they want. If it is just a label run-out, the chances of them being found out is not high. Make sure they change it when the next round of labels are printed. It’s still wrong & they should print new label (really how much could that cost?) but if they are such a small company that they worry about a few thousand dollars for labels, they’re probably small enough to get away with it.
-
I agree, I’ll send an email out so my objection is documented.
This is one of our larger clients who have around two dozen SKUs and millions of pieces/year. They can afford some new labels.
-
This reply was modified 6 days, 9 hours ago by Adamnfineman.
-
This reply was modified 6 days, 9 hours ago by
-
Log in to reply.