I get a lot of questions about safety and safe ingredients, and I’ve made multiple videos on the topic and have answered thousands of questions on safety over the past 4 years, so the written word is probably a better way to communicate this. This post deals with the regulations and then the safety concerns, which is what “food grade” tries to define.
The first thing to understand is that if you are just experimenting at home as a hobby or working on your formulations for future use, the regulations do not apply to you. You have complete, unimpeded freedom do whatever you want. If you want to try non-GRAS (generally recognized as safe) ingredients in your food and drink, like sassafras or nopyl acetate, you can. Even if the supplier gives the “perfumery trade only,” you, as an individual, can do what you want. Often, these statements just mean the supplier doesn’t understand what I’ve written below. But you should understand what I’ve written below.
Compounds, like nopyl acetate, that are not approved for food use but often have tasting notes provided by suppliers. Why? Because that’s the first step in getting new flavour compounds approved, you need to taste them. Why aren’t more compounds approved? Mostly paperwork and the cost to seek approval, and the fact that there are related compounds that taste similar, have reliable suppliers and have better properties like solubility. It has very little to do with potential toxicity. But do stick to pure compounds (things with a CAS number, and yes essential oils have a CAS number) and avoid “fragrance oils” or anything with DPG in it. More on this later.
Now, I walk a line between two worlds, the “I’m doing this as a hobby” crowd and the “I want to use this info to serve people things I make” group. The fun part for me is formulating interesting flavours in the hobby sense. The hard part is knowing that many of you will take this info and serve drinks at a bar or possibly produce a commercial product, so I feel obligated to guide you down the proper path to do this safely.
If you are in the hobby or formulator group, please feel free to skip on down to the “Toxicity = dose/time” section, though understanding what food grade is can be helpful, especially if you are anxious about this. If you are in the “I plan on serving my drinks to the public” group, then here is a quick guide on what you need to know. This isn’t all-encompassing; it is not that complex, but each section can lead you to where you can get more information, or you can use this info to fire questions at an AI with the specifics needed to get the proper answer.
Food Grade?
Food Grade is basically a made-up, catch-all phrase with limited meaning. You are unlikely to find things labelled as “Food Grade”, though some companies are starting to do it, but it does not have a legal definition. For many compounds, a “food grade” equivalent is an FCC designation or a supplier including the FEMA number.
FCC = Food Chemical Codex
An FCC designation on a supplier label has you covered for about 1280 compounds that can be used in food, though only about 450 to 500 are flavours, and these are the high volume ones like vanillin, limonene and benzaldehyde. The majority of FCC compounds are functional ingredients (colours, preservatives, sweeteners, etc.). If the supplier sells it as FCC grade, you are good to go.
There are over 3000 flavour compounds allowed to be used, so what about those 2500 that can’t be bought with an FCC designation?
Flavor & Extract Manufacturers Association (FEMA)
If the compound you want to use doesn’t have an FCC designation, most major suppliers (BASF, Berjé, Firmenich, Givaudan, IFF, Sigma, Symrise, Takasago, Vigon, Ventos, etc.) will include a FEMA number with their product, usually alongside a CAS/EINECS number. This at least indicates they are aware it is intended for use in food and beverages, and that the manufacturer is producing it for that purpose. The world of flavour manufacturing is fairly small, so buying from a reputable company/supplier can help.
It is important to remember that many chemicals are used in both food and cosmetics/perfumes. They are the exact same chemical. Most major companies manufacture a single chemical compound to serve both markets. Modern techniques make this easy, and having two different processes to make one compound is expensive and bad for business, so smart chemists design a manufacturing process to kill two birds with one stone. Look for a FEMA number.
JECFA and Certificates of Analysis
Here is what you do if a compound has a FEMA number but is not available as an FCC product, or you are unsure that the FEMA number means anything. Again, this only applies if you are making your product for public consumption.
Whenever you source an ingredient, you want to have a quality control paper trail. Anytime you order from a supplier, you would request a Certificate of Analysis (CoA or C of A, sometimes called Specifications). It is almost standard practice that a CoA is supplied by default, though smaller companies may make you request one. If you need one, just email them with the batch or lot number (found on the bottle/container). Companies keep this data for long periods of time, so you could request a CoA years after you bought the product, as long as you have the lot number.
The CoA is a supplier’s assurance that the product has been analyzed and meets specifications. You would stick that CoA in a file folder and hold on to it so that if you were ever asked to prove that what you are producing meets regulations, you could prove it. This is often requested by insurance companies, major customers (restaurant chains), and wholesale distributors such as Sysco.
Usually, a CoA has only a few details on it, the most important ones are:
Assay: the purity, usually listed as a percentage
Colour/Appearance (just how it looks, e.g. white powder or yellow liquid)
For liquids, the key details are:
Density: sometimes labelled as Specific Gravity
Refractive Index: this is how a liquid bends light, like water and is specific to each compound.
If the product is a solid, such as vanillin, you will see the Melting Point instead.
You may also see a Heavy Metals analysis, but not always; the supplier may simply provide a statement confirming it meets specifications. There are always a few additional details, depending on the company. Some have extensive data; others have only the basics.
If a chain restaurant wants your product but needs to do a quick check to see if you are legit, they may ask to see your suppliers CoA’s, and you’ll have them. But what if you want to verify your suppliers? Then you’ll compare the CoA against the FCC data, or the JECFA data.
If you’ve ever played the Match card game as a kid, this is all it is.
Here is what JECFA is, according to them: “The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international scientific expert committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). It has been meeting since 1956, initially to evaluate the safety of food additives”.
JECFA maintains a database of over 2500 food flavours/ingredients with specifications that are specific for food safety, which you can compare with the supplier CoA.
If you want to see if your suppliers are legit, take the CoA they provided you, pick one of the details, like refractive index, and compare it to the JECFA data.
Example: Sigma supplies a CoA for Ethyl Butyrate and states their product has a refractive index of 1.392 and the JECFA database says the refractive index range should be between 1.391 and 1.394. In this case, 1.392 is between 1.391 and 1.394, it is a match. And the JECFA purity specification says greater than 98% and the CoA says 99.9%, again, it is a match. It is that simple.
Oddball Flavours
Sometimes a product has a FEMA number but doesn’t have any specification (FCC/JECFA), so what do you do then? At this point, you are entirely dependent on the supplier’s specification and your common sense. Some compounds are produced in small quantities, perhaps a few kilograms per year (e.g., mercaptans), so they don’t attract much attention. The purity (assay) of these oddball compounds can vary widely, even as low as 80%, like methyl-beta-ionone. Just because it is 80%, does not mean the other 20% is dangerous, but ask the supplier about what the other 20% is, and they’ll be able to tell you. Then, if you need to, look up those compounds in the FEMA/FDA/EU/JEFCA databases. If you find the other 20% are compounds used in food already, then you are good. If the 20% is some unknown compound, you might want to find something else. That is a common-sense approach.
Essential Oils and Other Natural Products
Essential oils may include a CoA, but JECFA does not specify a standard because any essential oil used in food and beverages must be 100% natural (no solvents or diluents). Good suppliers, like New Directions Aromatics, provide all of the documentation on their website, including the CoA, Pure & Natural statement, GC/MS data and all of the relevant documents for FCC heavy metal compliance statements. If you want to see what good documentation is, this is it. And yes, many of the documents are just statements, but that is how the system works, it is a trust chain, and the reason I trust them is that they provide all the relevant documents in an easy-to-find manner.
Repackaging Companies
Many companies specialize in food and beverage products (Vigon, Sigma, Ventos, etc) but they often only sell in large volumes, well in excess of what we need for experimentation. There are smaller companies, like Fraterworks, BulkAroma and Perfumers/Flavor Apprentice (see Suppliers List) that repackage these products into smaller amounts. The problem with these smaller companies is that they may not understand all the regulations or that the compounds they sell are allowed to be used in food and beverages (Perfumers Apprentice does), because they supply for the perfume hobbiests. I’m writing this long document because this information is not easy to find, or at least provided in a common sense approach; most of it is written by lawyers and politicians, so it can be hard for anyone to understand.
For hobby level or formulation experiments, these repackagers are a perfectly fine source of compounds. For commercial production, you’ll want to ensure they can provide a CoA and the original supplier info. Typically, repacking doesn’t break the quality chain, but you do need to trust the company doing the repackaging if you are selling a product.
It is definitely a gray area, because this is a new thing. At the end of the day, it is still up to you to evaluate the companies you buy from. If you are investing money to create a commercial product, ask your suppliers questions.
What If You Have Trust Issues?
If you plan to go commercial, but need absolute certainty that what you are buying is what you asked for, the answer is simple: lab equipment. The following three pieces of equipment are more than enough to validate a CoA. They are simple to use and relatively inexpensive.
Abbe Refractometer: This will measure refractive index and works pretty much like a BRIX meter. You simply put a drop of the liquid on the prism, look into the eyepiece, dial in the refractive index and read the number.
Density Meter: This measures density and you simply inject the liquid into a port using a disposable pipette and it will give you a reading. You’ll want an Oscillating U Tube type. They come in hand-held and bench-top versions with various price points.
Melting Point Apparatus: another simple device that you place a sample on/into and as it heats up there will be point where the sample goes from solid to liquid, and that is the value. Pure samples have a sharp transformation. Impure samples will either be slower or not fully melt. Some compounds are hydrates (water liking), like citric acid, so the melting point can change depending on whether it is a hydrate (wet) or anhydrous (dry).
Add to this a visual inspection (appearance) and it is almost impossible to create a fake compound that would match the results required for any two readings. Using any two of these pieces of data will confirm with the JECFA/FCC data.
Again, these are simple pieces of equipment, scientifically proven with reference standards, relatively inexpensive and most companies that sell them have excellent support and training videos. But anyone can use this equipment; you don’t need any chemistry experience at all.
This level of confirmation is more than most companies do.
Production of Your Product
Most of the time you will start off working with a copacker and I’ve had a lot of questions about this, and it can be complicated depending on how informed your copacker is. Most copackers are small business that package your product, their key understanding is Good Manufacturing Practices and how to make your product safely. They tend not to do flavour development, instead preferring to work with “flavour houses” who have expertise in developing flavours and understanding flavour regulations.
Flavour houses want you to use their pre-made flavours or contract them to develop a flavour for you. I am truly of the belief that anyone can develop their own flavours and do not need a flavour house to do it for you. Copackers want to work with a Flavour House because it is a known quantity, and the copacker assumes the Flavour House knows what it is doing with regards to regulations.
As you can see, we have entered a loop, so how do you break into this? It can be difficult, but understating everything above, and below, is important. It really comes down to providing a paper trail of validated suppliers, and understanding what can be used in food and beverages, because that is what flavour houses do. Showing you understand these matters can be helpful to assuage the fears of a copacker.
And here is an absolute fact, most companies know a narrow thing they are good at, they don’t understand other areas. So if a copacker asks if something is “food grade” that can indicate they don’t understand this part of the development process, or they believe you don’t.
Toxicity = dose ÷ time (T=d/t)
When it comes to working with flavour compounds, there is a lot of chemophobia, the fear of chemicals. I have studied chemistry and worked in research labs for over 16 years, including at the University of Western Ontario. I have also written about beverages for over 20 years. Everything is a chemical, and you are just a bag of chemicals. So let’s talk about what is important, when something becomes toxic or dangerous.
When it comes to formulating with flavour compounds, the FDA says this: “They are used in the minimum quantity required to produce their intended effect.” The FDA relies on the fact that most flavour compounds are self-limiting; you can even read this in the original FEMA GRAS document. Because flavours are so potent, adding too much doesn’t make the food unsafe; it makes it taste gross. Flavour compounds have a built-in safety limiter.
When it comes to toxicity, in chemistry, we use the equation T=d/t as a simple representation of how something becomes toxic. If your dose (d) is small and your exposure time (t) is long, then toxicity (T) is low. When talking about flavours, our dose is always low, usually in the 10 ppm (mg/L) range for each compound. About 75% of flavour compounds are used below 10 mg/L. Some are used at higher levels, like vanilla, cinnamon, clove, anise, lemon, benzaldehyde, etc. but overall, flavour levels are quite low. And we can never get too high because, as noted above, it will just taste terrible, and our body may respond (gag reflex). There is a narrow range where compounds taste good and anything above that the body usually rejects or tries to convince you not to consume it. Trust your senses; if something doesn’t taste right, don’t eat or drink it.
Our exposure time tends to be high. Drinking a litre of soda can take a day or two for most people. Some drink more per day, but even then, because the flavour levels are low, it does not present a problem. So even at 2 litres per day (64 oz Big Gulp, no ice), you are still only getting 20 mg of each flavour compound.
Even cyanide is not considered an issue in European food regulations. For example, marzipan (bitter almond paste) is allowed to have 50 ppm of cyanide in the EU. So a 1 kilogram tube of marzipan can legally contain 50 mg of hydrogen cyanide. If you ate 100 grams of marzipan, you’d consume 5 mg of cyanide. In reality, analysis shows there is only 20 mg/kg in marzipan. And this is an important fact: reputable companies want to sell safe products, so they are going to take precautions in their manufacturing processes to minimize issues.
Evil Math Demonstration
First, imagine I’m evil and strangely determined to poison you. We’ll use cinnamaldehyde as an example, which has an average maximum use level of 9 mg/L (9 ppm) in a beverage. But because I’m being evil, I’m going to add ten times that amount, so 90 mg/L (90 ppm) of cinnamaldehyde. At this exaggerated level, this drink would be hot, unpleasant, and of questionable drinkability.
But that’s not evil enough. So, I’m going to add 20 grams of cyanide into my kilogram bottle of cinnamaldehyde, so 98% cinnamaldehyde and 2% cyanide.
At this villainously irresponsible level, even when I use my devious cinnamaldehyde mixture at 90 mg/L (10x the average max) we are only going to get 1.8 mg of cyanide in a litre of beverage. Less than eating 50 grams of EU legal marzipan. Even if you drank a 64 oz (2L) Big Gulp without ice, the cyanide level does not present an immediate issue. Eating cassava root will expose you to more cyanide.
At normal flavour levels, you are in the microgram or nanogram quantities for any potential containments when you use these compounds. So if you see a CoA that reads 98% pure, even if that 2% is potentially toxic (it never is, it is usually water, food-safe solvent or isomers of the compound), it is at such a low dose that the effect is negligible on the body. The magnitude of exposure is important, and these levels are like a 1.0 magnitude earthquake, not meaningful.
Why is this important? Because none of the 3000+ flavour compounds represents an immediate health concern at the recommended levels, which are in-line with the levels found in nature. The safety limits are for long-term exposure, meaning decades, and this is a key misunderstanding by most people who promote fear. We monitor things to see if a particular ingredient can cause a health issue over years or decades.
For example, safrole, methyleugenol, anethole, myristicin and a few other alkenylbenzenes do represent a long-term issue, usually decades, and they may cause cancer. Most of these compounds still exist in our food supply, like natural spices (clove, cinnamon, nutmeg, anise, basil, tarragon, etc.), but what regulators did was remove the largest sources of these materials. The best example is sassafras oil, which is 80% to 90% safrole. Another example is myristicin, which is found in nutmeg at about 2% to 3% of the oil content. But myristicin was never approved as GRAS, just like safrole was never approved. Myrcene, found in hops and a few other things, is another example; it did have GRAS status, but now only natural sources of myrcene are allowed. This removed synthesized versions, not because synthesized versions are different; they are molecularly the same, but it reduces the total amount of myrcene in the food supply, reducing the population’s total exposure.
Remember, T=d/t, so lowering the total dose of a compound throughout the food supply reduces toxicity. And yes, regulators just look at the total food supply of compounds and average individual exposure. Mass of compound divided by total population.
Some people quote LD50 (lethal dose that kills 50% of the test subjects) as if it indicates serious toxicity, but every compound has an LD50. I think some people are confused by this because it is in metric, and goes by milligrams or grams per kilogram, which means the toxicity per kilogram of body weight. I weigh 80 kg (if you use pounds, just divide your weight in pounds by 2.2 to get kg), so something like cinnamaldehyde with an LD50 of 3400 mg/kg (3.4 g/kg) will require 272 grams (1 cup+) in a short period of time to kill me 50% of the time. That would be practically impossible to ingest. Now this doesn’t mean lower doses don’t have issues; they definitely can, but at the levels we’re working, the safety margin is exceedingly high.
The perfume world has many regulations as well (IFRA), because the products are being applied to the skin (transdermal absorption) as well as vapourized (inhalation hazards). These external routes can create more issues than ingesting a compound, like sensitization (skin contact) and bypassing your liver. When you ingest something, it is directed through your liver (first pass metabolism) where enzymes (like CYP450) break down foreign compounds before they hit sensitive organs. Your liver is literally a detoxification organ. For example, diacetyl (butter aroma) is perfectly safe to ingest; the liver handles it just fine, but it can be a serious inhalation hazard if you are exposed to high levels continuously, you could develop popcorn lung. The example is working at a microwavable popcorn factory where you have high, continuous exposure daily, not just smelling samples or working with them in a well-ventilated space. So don’t confuse ingestion with external concerns.
Perfume sprays skip the “first pass metabolism” of the liver and can enter your system without the liver doing a safety check. This is why you should take basic safety precautions, like working in a well-ventilated space, washing your hands afterwards, and even wearing gloves (nitrile gloves work great) when handling compounds if you are sloppy. Literally nothing you wouldn’t do when working in a restaurant prep kitchen.
Health supplements, like vitamins and herbals, have made their way into “functional beverages,” and yes, those compounds can cause issues if consumed in excess, like Vitamin B6. But, that is outside of my purview for flavour development, though I get a lot of questions about it.
Solvents
Sometimes compounds come diluted for easier handling. Only a few solvents are allowed for use in food; specifically, ethanol (alcohol), propylene glycol (PG), triacetin, triethyl citrate (TEC), and glycerin are the most common.
Some compounds come diluted in DPG (dipropylene glycol), which should be avoided because it is not GRAS. Now, DPG is relatively safe to ingest (low acute toxicity), but chronic exposure (constant use) can cause problems. It is always best practice to work with compounds that are considered GRAS. Plus, solvents like TEC and PG are better for flavour purposes anyway.
Other solvents are allowed, but less common and usually for specific applications: propanediol, diacetin, isopropyl alcohol, ethyl acetate, benzyl alcohol, benzyl benzoate, 1,3-butanediol and tributyrin. And that is mostly it.
The first 5 solvents listed are really all you need, and here is a video on it: Alcohol Alternatives.
Heavy Metals
There is a growing trend for concern about heavy metals, but for flavour use, there is no real concern. Why? Because, let’s say there was 1 mg of lead (Pb) (highly unlikely) in a litre of concentrated flavour compound, and you used that flavour at 10 mg/L (10 ppm) in your final beverage, that would equate to 0.00001 mg of lead, or 10 parts per trillion (ppt). Tap water has a safe level of 5 parts per billion (ppb), so your flavour has 500x less lead than the water used to make the drink. It is background noise. Your time is better spent focusing on the quality of your water.
If you see the less than sign, e.g. <1 ppm, it means it is below that value, but may not be present at all. There are limits to what lab equipment can detect, and 1 ppm may be the limit.
My View
Being a content creator on YouTube and Patreon is tough, and my goal has always been to teach people interesting things safely. I am not a regulatory expert or a safety guru. I do not know every safety regulation in every country. I take safety seriously enough to mention it in my videos.
All of this information doesn’t stop people from creating fear of chemicals because, let’s face it, fear sells, especially on the Internet. Scary things are engaging, engagement creates views, and views equal profit. But as you experiment with all these new flavours, realize they are safe. The best way to deal with chemophobia is education and exposure. Making cool flavours is far more engaging than fear.
At this point, I think I’ve done enough regarding safety, and let’s face it, safety and food regulations make for terrible content. It is the equivalent of having a lawyer, a politician and a religious scholar debate the meaning of a comma in a piece of text. Going forward, the plan is to point to this post if anyone has safety concerns.
If you truly need the exact regulations on a specific thing, look at the resources below, hire a consultant, or join the Drink Maker/Benefactor level on this Patreon for simple directions, and I’ll continue to provide guidance, but so many of the safety questions can be answered with everything above or in the Resources section below. In fact, when people ask me a safety question, I often feel I’m doing a lot of hand-holding and helping them overcome fears created by the Internet. It is not that complicated; nothing that is considered GRAS is unsafe, and even if you try to use unsafe levels, it will be a terrible drinking/eating experience, not a safety concern.
The Toxic Twins
If you have any more doubts, please remember the Toxic Twins: Steven Tyler (age 77) and lead guitarist Joe Perry (age 75) of the band Aerosmith. These two were renowned in the 1970s and 80s for their excessive use of drugs, alcohol, smoking and the rock ‘n roll lifestyle. They are still alive and, other than a vocal cord injury, still kicking. Keith Richards is 82 and still going.
Humans are not as susceptible to chemicals as the Internet makes it seem; people do horrible things to their bodies and live into their 90s. Nothing in the flavour world can compete with the abuse of smoking, drugs, alcohol, poor diet and lack of exercise. Remember, magnitude matters.
Resources
Videos
How to Identify Safe Ingredients in Food and Beverages
Know These Details to Use Essential Oils to Flavour Food & Drinks Safely
Formulating Your Own Flavours to Make Syrups, Sodas and Beverages
Regulatory Resources
FEMA Flavor Library
FDA Substances Added to Food
EAFUS: A Food Additive Database
JECFA Specifications for Flavourings
International Organization of the Flavour Industry
EU List of Flavourings
FDA PART 172—Food Additives Permitted for Human Consumption
Books
Fenaroli’s Handbook of Flavor Ingredients by George A. Burdock (CRC Press)
Chemistry and Technology of Soft Drinks and Fruit Juices (2016, Wiley Blackwell)
Dictionary of Flavors by Dolf De Rovira, Sr. (2016, Wiley Blackwell)
Food and Beverage Packaging Technology (2011, Wiley Blackwell)
Food Flavour Technology by Andrew J. Taylor and Robert S.T. Linforth (2010)
How Flavor Works: The Science of Taste and Aroma, Choi & Han (2015)
Innovative Technologies in Beverage Processing by Aguiló-Aguayo & Plaza (2017)
Natural Flavors, Fragrances, and Perfumes (2023, Wiley VCH)