Water-Soluble CBD and Nano technology
Regulation

Water-Soluble CBD and What Every EU Seller Should Know to Remain Compliant

This is an introduction to water-soluble CBD and everything you need to know as a responsible seller.

We will go into what types of water-soluble CBD products there are, which are legal and why. Even if you are using a compliant raw material, you could leave yourself liable to criminal prosecution.

Water-soluble CBD has a list of undeniable benefits. Our bodies are 75% water (polar) and CBD is an oil (non-polar). As a result, the absorption of CBD by the human body is limited because oil and water don’t mix. As with many other vitamins and supplements, the encapsulation of oil-based compounds increases their bioavailability and you can get much higher absorptions rates from a water-soluble CBD product over its oil counterpart.

When CBD oil is consumed orally, very little CBD is actually absorbed by your body.  Most of the beneficial compounds completely bypass your blood system.

Due to the body’s ability to soak up the benefits of water-soluble products like a sponge, and consumers becoming wiser to the cost saving benefits of consuming CBD in this way, it’s no wonder water-soluble CBD products have seen a rise in popularity in recent years.

While the benefits are clear, the legalities that surround many products on the market are one of the biggest concerns that currently face the CBD industry in the UK and Europe. Though there are only a couple of suppliers here in Europe producing water-soluble material, many resellers using these products are failing the presentational compliance required by EU Food Law.

What is a Water-Soluble CBD Product?

It should be a stable emulsion of oil in water, which are tiny droplets of oil suspended in water.

Before we proceed, it is essential to understand that while emulsions are possible with agitation only, over a short amount of time they will separate into their polar and no polar counterparts.

A good example of this would be to take a jam jar, fill it half way with water and put a couple of drops of oil in there. Shake it vigorously and the solution will turn milky white, but wait! A while later you will slowly see the tiny oil particles joining together and the solution separating, leaving the oil floating on the top of the water.

So, how does an emulsifier help?

Water is Hydrophilic – it’s attracted to water.

Oil is Hydrophobic – it repels water.

Getting oil to mix into water is no easy task and is only achievable with a surfactant, or more commonly known as an emulsifier.

Emulsifiers are amphiphilic, having a hydrophilic head and a hydrophobic tail.

Water-Soluble CBD Emulsifier in CBD Oil explanation image

The positive head of the emulsifier is attracted to the hydrophobic oil particle, leaving negative tail encapsulation it forms a negative ring which is attracted to the hydrophilic water particles.

Take that jam jar and add some washing up liquid (your emulsifier) and shake it some more! This time you will see that the solution will remain stable.

The emulsion now remains stable with the bonds that are provided by the emulsifier, which ultimately restricts the particles from attracting to each other and recombining.

So that’s what they are, now what do you need to know…

1) Nano Emulsion or Micro Emulsion:

First up, let’s hit the complex science bit…

What is the difference, what’s legal and what’s not? To cut a long story short, Nano Emulsions are illegal in Europe and Micro Emulsions are not.

So, what is a Nano Emulsion?

It is an emulsion of oil in water where the oil particles are less than 100 nanometres in diameter, generally these types of products can be identified by their clarity. Due to their particle size being so small within the solution you can’t even see them.

EU Food Law states that any food product that uses a process to reduce the size of particles below 100 nanometres would be classified as Novel under the Novel Foods Act. Click here to read the FSA’s description of Novel Foods.

The process used to create Nano emulsions is sonification. This is the utilisation of sonic vibrations that breaks the particle size below 100 nanometres. At this size it remains stable and the particles do not recombine and separate from the polar solvents (water) in the solution.

What is a Micro Emulsion?

A micro emulsion is an emulsion where the particle sizes are between 100 nanometres and 1000 nanometres. Unlike Nano emulsions, micro emulsions are not completely transparent.

Depending on the concentration of CBD in the aqueous solution, the clarity will go from an undetectable slightly cloudy water to an opaque milky white.

So, if Nano emulsions are created using sonification, how are micro emulsions made?

Firstly, you need to agitate the solution just as you would with the sonification, but not so rigorously! A basic micro emulsion can be achieved with a whisk…and a fair bit of effort.

To sum it up, to stay legal you need to verify with your supplier that the product you are purchasing is not a Nano emulsion.

Currently, the majority of products from the US are Nano and would not be permitted for use in food. You must perform the due diligence as a food business operator to ensure your products are compliant.

2) Bioavailability Claims & False Representation:

 “£10 x the bioavailability of oil”

“100% bioavailable”

“This 5% is the equivalent of 50% oil…….”

This practice is in breach of the Trades Descriptions Act. If you don’t have the data. Don’t make the claim. It’s as simple as that!

There have been studies into the bioavailability increase achieved with other compounds, such as vitamins. However, there is no relevant data to show the increased bioavailability from micro emulsions of CBD.

Just because you competitors have it on their website, doesn’t mean that its carte blanche to use as well. If it cannot be supported with evidence. You cannot say it.

“But who’s going to know…?” You may be thinking of ignoring this advice and continue to make false claims…

The law does not get much simpler than this. The law provides protection for consumers not to be duped by unscrupulous businesses. This is not just unethical, but it is illegal. Unless you can back up your claim with credible evidence, you’re breaking the law.

 What you can do, is be clever with the wording of the claim you’re trying to make….

“Designed for the maximum absorption of CBD”, or “developed for increased bioavailability”.

These factual claims can be made if they are true!

3) Know Your Ingredients:

From a compliance and risk point of view, the most important of all do’s and don’ts is ensuring you are listing the correct ingredients in your water-soluble product. There are many products on the market using compliant water-soluble material that fail to list the full ingredients.

This carries massive risks, not just for you, but the consumer too!

One of the main emulsifiers used for the creation of water-soluble products is derived from a known allergen. We have seen some of the biggest suppliers be completely unaware that an ingredient in their products is classed as an allergen.

As such you would need to not only have the emulsifier listed on the ingredients, but it would need to be in bold. Also, unless you have rock solid cross contamination procedures in place, all products you sell would need to carry a warning i.e. may contain name of allergen.

Should you not get this complex part of food labelling law correct and a member of the public was to have an adverse reaction, recent cases in the media have demonstrated that ignorance is no defence.

With food operators being convicted of manslaughter and spending 6 years at her majesty’s pleasure. This is one mistake you do not want to make.

Your responsibility to get this right is not just an ethical one, or even one that will have financial repercussions. You could be criminally liable if you get this wrong.

Make sure you list all the correct ingredients on your products. This means if you have a water-soluble extract in your formulations you need full disclosure from your supplier regarding the ingredients.

Listing these ingredients as, Water-Soluble Hemp Extract, Aqua CBD Oil or CBD Active…is not just a massive commercial risk, but against food labelling regulations.

You must list all the active ingredients of the water-soluble extract, this will include the emulsifier, and other ingredients that are used to develop the formulation

If you are looking to stock a water-soluble CBD product, make sure the first thing you ask for is a full ingredients list, including the emulsifier that is used.

Here at BRITISH CANNABIS® we are spearheading change in the industry, and ensuring 100% transparency across all areas of our operations.

We provide a full product specification document, Safety Data Sheet and an Analytical Report for every product we supply. This contains all cannabinoid information and a list of ingredients within your product, so you can be sure you are presenting your product in the right way.

4) Stability, Stability, Stability:

Stability is paramount when you are looking for a reliable source of water-soluble material to use in your products. The fundamental basis for the benefits in an oil in water suspension is that it remains stable.

It is essential that the emulsion does not separate before it is absorbed by the body. Or you might as well be taking ordinary CBD oil orally.

Through the development of our products and the analytical testing of others on the market, stability is the biggest issue that many products fail on.

Water-souble CBD comparison

The process for testing stability is quite simple and has been the benchmark that underpins the formulation process for us.

After mixing the water-soluble CBD into water, you take a sample from the top layer and the bottom layer. As oil is less dense than water, it will float to the top. We tested the products in intervals, one test after 5 minutes and another test after 1 hour.

When comparing the formulation to other EU compliant water-soluble products it became quite clear early on that most, if not all other products on the market are completely unstable.

To achieve 100% stability, we expect to see the concentration of CBD on the top layer to match the bottom layer.

So…50%:50% would be a completely stable solution

Water-Soluble CBD Stability Testing Bar Chart.

As you can see, the results are quite shocking. These products do not do what they should do.

We are now seeing new products enter the market from the USA. While there are concerns over the use of Nano technology and levels of controlled substances, we hope that we will see better levels of stability.

Our water-soluble CBD formulation is available for bulk purchase and can be used in a wide range of formulations, from CBD water, drinks, gels and straight out of the bottle. It is the most stable we have ever tested!

We would like to help your business make the right choice in its purchasing of water-soluble CBD formulation. We would welcome the opportunity to do the same stability testing in our labs for any water-soluble CBD product you are thinking of purchasing.

There is only one way to make an informed purchasing decision, and that is to have the supporting data to back up the efficiency of the products.