Propolis extract labelling

[dclewis]

Does anyone know if there are labelling requirements for propolis 30% w/v extract in 70% ethanol?

Is it much as honey or are there various hazard warnings that need to be included too?

 

[Midland Beek]

I bet my life on it there are EC Regs, like clear labelling, raised triangle for poorly sighted, and child proof cap.

 

[Hivemaker.]

I bet my life on it there are EC Regs, like clear labelling, raised triangle for poorly sighted, and child proof cap.

And may contain nuts.

 

[victor meldrew]

I bet my life on it there are EC Regs, like clear labelling, raised triangle for poorly sighted, and child proof cap.

If classed as medicinal, I suspect a whole extra bunch of regs' kick in !
VM

 

[alanf]

Does anyone know if there are labelling requirements for propolis 30% w/v extract in 70% ethanol?

Is it much as honey or are there various hazard warnings that need to be included too?

Not food, so not like honey. A starting point would be the alcohol. If you could find surgical spirit packed in the right size they would have the right lids, hazard triangles and so on. For a pilot batch you could relabel repeating the warnings such as external use only, not near naked flame etc.

 

[dclewis]

Seeing as the label will have to fit the bottle and they are very small (10ml) I presume it would be alright to refer to a notice provided with the bottle rather than try and get everything on the label itself.

In that the extract will be used both internally and externally I'm not sure that using surgical spirit as a base for the label would be useful.

I am not convinced that propolis can be considered as a medicine (but stand to be corrected) and so would think that food labelling regs should apply.

I have emailed Defra to see if they have an opinion. Pending their response I have also come up with the following for the notice to accompany the bottles.

Extract of Propolis

Directions:
Internally:
For internal disorders like coughs and colds etc. A few drops in warm water can be used as a mouthwash/gargle for mouth ulcers, sore throats, infections etc. Mix 3-5 drops in water and gargle and/or swallow or add 3-5 drops to sugar lump and suck. Alternatively a few drops can be taken on wholewheat bread.

Externally:
For cuts, abrasions, burns. Swab the area directly with the extract using a cotton wool swab or lint as required. The alcohol evaporates quickly on the skin leaving a covering of propolis.

WARNINGS:

Propolis may cause severe allergic reactions. If irritation or swelling of the mouth or throat occurs or treated area of skin, discontinue use and seek medical advice

Ingredients:

Propolis, alcohol

Store:

Preferably in a cool, dry, dark place. Keep out of reach of children.

Made in UK
by the beekeeper from Propolis harvested from his hives in XXXshire.
10 ml.

Use before end of 31/10/13.

Made by:
Mr Beekeeper, Rose Cottage, Hambridge, XXXshire, UK.


Does anyone have any experience of selling propolis, if so what label and notice have you used please.

 

[iombeeman]

dodhy ground,you are not allowed to sell alcohol unless you have a licence,like a pub.
propolis is not food it is medicinal.
do not use isopropyl internally it is an irritant as well as flamable,it can used externally with propolis for cuts and burns, not sure about ethanol.
for internal use,mouth ulcers,use normal drinking alcohol(vodka is ideal),but not as strong as mixing propolis with isopropyl.it has been called bee tcp.
but dont break the law.....

 

[Strength_10]

"dodhy ground,you are not allowed to sell alcohol unless you have a licence,like a pub."

True, but you can sell products containing alcohol if they are not classed as a beverage (or other licensed product). For instance, your local DIY store doesn't have an Liquor Licence to sell Methylated Spirits and Boots doesn't have a licence to sell Rubbing Alcohol.

"propolis is not food it is medicinal."
I think it's a food item. Sometimes marketed as a natural medicine but it's not classed as a pharmaceutical.

"do not use isopropyl internally it is an irritant as well as flamable,it can used externally with propolis for cuts and burns, not sure about ethanol."

Ethanol is the alcohol found in most alcoholic drinks...it's also very flammable as are all alcohols in sufficient strength.

"for internal use,mouth ulcers,use normal drinking alcohol(vodka is ideal),but not as strong as mixing propolis with isopropyl.it has been called bee tcp.
but dont break the law...."

I think the OP suggested mixing with Ethanol 70% not Isopropyl.




---
I am here: http://maps.google.com/maps?ll=51.411467,-2.606262

 

[alanf]

In that the extract will be used both internally and externally

Now that's tricky, you will have to proceed very cautiously. Regulations have changed recently,

Try here for background: http://www.bbc.co.uk/news/health-13215010
and for regulations: http://www.mhra.gov.uk/index.htm

Most of the legislation concerns 'herbal' medicine - propolis is plant origin but processed by bees so not sure exactly how it's covered. If you're just getting into it, I'd think producing something for 'external use only' as a pilot would get you started with simpler regulation.

Alcohol is in many medicines, often as a solvent. You'd have to look up the permitted bottle size and strength to avoid duty if it's drinkable quality. There may be 'pharmacy only' limits that are higher, there are in some countries. Alcohol sold as surgical spirit, meths etc is not intended for drinking and contains isopropyl or methyl alcohols in addition to the ethanol. Not a good idea drinking them, although some are desperate enough to try. Oh, and technically, if something is supplied dissolved in alcohol it is a 'tincture' not an 'extract'. You could a lot worse than invest 5 quid in a professionally produced bottle and look at what's on the label it might mention licence numbers and issuing authorities.

But, your choice what you do with your bees brown goo. You will have to do thorough research if you are going to make your own retail products rather than supplying raw materials to an existing producer. It's a lot more complex than cleaning products or food. Might be worth having a trawl for a trade association, the BBC report lists some websites. Don't forget to us know how you get on.

 

[dclewis]

Thanks for your replies.

As I said in my first post I have used 70% ethanol in the preparation of the ‘tincture’, it was sourced from a pharmacy so its purity and strength should be unquestionable.

I am proposing to sell in 10 ml bottles, so I don’t think that that volume can be considered as a beverage, particularly at the price I am thinking of charging. Vodka would be substantially cheaper and far easier to source by anyone looking for the effects of the alcohol.

I have seen honey sold with propolis added, (I assume that the added propolis is in the form of an extract or tincture and not raw chunks). Would that not be subject to the same regulation as the tincture itself, or is it down to the quantity/dose, does that then get into homeopathic levels of dilution. Do homeopathic levels of dilution escape the herbal medicine regs? There’s something else to look into.

I am somewhat surprised that there is no-one out there who has gone down this road already and found out the position as the beekeeping retailers have been selling propolis grills for some time and so there must be others out there who have chosen to do similar with their bees' brown goo.

Thanks for the suggestions of where to direct my further research, and I’ll be back when I find out something for definite.

In closing for the moment, I ask myself also about all those selling pollen, royal jelly and bee venim. Where do they fit in to the scheme of things for foods, medicines, herbal medicines and what production, labelling and licencing regs do they fall under? None of this seems to be covered in the standard bee literature that I have seen to date.

 

[jakethedog]

Thanks for your replies.

I am somewhat surprised that there is no-one out there who has gone down this road already and found out the position as the beekeeping retailers have been selling propolis grills for some time and so there must be others out there who have chosen to do similar with their bees' brown goo.

I've just found the same thing with my question re candle labelling. Hopefully the weekend will bring a few more people to the table...

 

[drstitson]

The italian forum has covered some of this. registering with the powers that be re the alcohol etc.

end result of all the discussions: "I flaconcini di propoli che compriamo ai mercatini sono venduti sottobanco."

 

[dclewis]

I might get by with the French but Italian I am afraid is past me. Any chance of a translation?

 

[pbh4]

The italian forum has covered some of this. registering with the powers that be re the alcohol etc.

end result of all the discussions: "I flaconcini di propoli che compriamo ai mercatini sono venduti sottobanco."

According to Google translate:
The vials of propolis to the markets that we buy are sold under the counter

I think we get the gist!

 

[greatbritishhoney]

I notice that you live in France - remember that you will also have to consider the transport regs if you intend to sell abroad (flammable liquid).
Transporting by road or rail is unlikely to present any problems as you will probably have "limited quantity" exemption, but transporting by air could be problematic - you would need to consult the IATA regs.

However, my DGSA qualification is about 7 years out of date, so the regs may well have changed significantly in that time.

 

[drstitson]

"but transporting by air could be problematic"

yes - tin of gloss paint confiscated from hold baggage actually at the apron. yet i would have been allowed a case full of spirits no problem.

 

[greatbritishhoney]

"but transporting by air could be problematic"

yes - tin of gloss paint confiscated from hold baggage actually at the apron. yet i would have been allowed a case full of spirits no problem.

The transport regulations are very odd. They often focus on the size of the container rather than the the total volume of the consignment.
Example: until relatively recently you could have filled an artic with 1 litre containers of petroleum without having to adhere to the regs at all. Whereas you would have had to if you wanted to transport one 110 litre drum.

 

[alanf]

As I said in my first post I have used 70% ethanol in the preparation of the ‘tincture’, it was sourced from a pharmacy so its purity and strength should be unquestionable.

Absolutely sure? I don't know what French pharmacies sell but UK ones don't stock 70% ethanol (aka ethyl alcohol) which is the drinkable stuff in vodka. They have what is described as 'alcohol' or 'denatured ethanol'. These are either part other alcohols or ethanol with additions specifically to discourage drinking. Most of it is either industrially made from oil or distilled under conditions that don't exclude harmful impurities such as methanol as they would be for legal drinking spirits. Intended for sterilizing, solvent or external use, not internal. In practice the quantities are unlikely to harm but you have to be 100% sure before you sell anything. If in doubt, use only food grade ingredients for anything internal. Vodka?

As to your points about collecting other bee products. Bee books could not keep up with the legislation for marketing all the possible variants. Even if they did, the regulations are different in every country where the book might be read. Gathering them is also labour intensive. It's not a coincidence that royal jelly you can buy commercially comes from China.

 

[drstitson]

Italian supermarkets sell 95% for making liqeurs.


eg limoncello

8-10 sorrento lemons
1 litre 95%
1 litre water
1 kg sugar

 

[susbees]

Does anyone have any experience of selling propolis, if so what label and notice have you used please.

All the honey stalls we saw on a recent holiday in central Portugal had small bottles of propolis for sale: labelled "propolis" and a couple had the beekeeper's name and address. I like Portugal