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Ingredient Labelling
Say I have 5% Lauryl Glucoside and 4% Glycerin in my formula. However, the LG is at 30% solid level according to the SDS. Would I declare LG first on my ingredient list, or would I need to declare glycerin ahead of LG? The 21CFR is not very clear on the subject, IMO.
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7 Replies
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You are supposed to label things by concentration based on % Activity. So, if you use 5% Lauryl Glycoside that is a 30% solution, you actually only have 1.5% in the formula. In your example, Glycerin would come first.
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Thank you for your quick response! I was having discussions with my coworkers, and we realized that with two differing opinions, we needed clarity!
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The rule actually makes sense. Without that rule someone could take an extract, put a few drops in water and call that their main ingredient. Listing by % Activity is the most useful to consumers.
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It does make sense.
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What about cases where you have a blend of materials and no exact composition statement? There are many cases where I ‘know’ that part of a blend is less than 1%, or less than 50% of that blend. Should I leave everything grouped together without substantiation, or use my knowledge of the materials to get a slightly more accurate listing?
ex I have a blend of materials preserved with potassium sorbate. Even if I use the blend at 3%, the potassium sorbate level is no more than 3-4% of that raw material.
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Per 21 CFR 701.3 a,d,f2,f3 “The compounds of the proprietary antioxidant mixture dissolved in propylene glycol must be integrated into the product formulation and declared individually in order of decreasing predominance without the term “(and).””
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@EVchem - we always got the information from our suppliers if we were using an ingredient that was going to go over 1%. Ultimately the point of the legislation is to list your ingredients in order of concentration. If you know part of the blend is less than 1% in your formula, then you can list it wherever you like after the 1% line.
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