Sampling Regulations for Food Supplements

Hi Everyone,

First post, so I hope it is in the correct place.

I have recently started a new position in which I running the QA side of things for a Nutraceutical supplier in the UK. We source and purchase raw materials and finished products from around the world (mostly China) to sell onto our customers. I am a little out of my depth so any guidance would be appreciated!

They are wanting a sampling process put in place and after reading a bunch of information, I am still a little confused. I have read  Regulation 333/2007 which outlines the requirements for heavy metal sampling in foodstuffs. It states that the aggregate sample should be 1kg/1 litre and table 3 highlights the number of incremental samples required. Is this what we should be following? The samples would be for micro and heavy metals and retained.

Currently, small samples are sent from our suppliers to the UK and we send them off for testing and retain some. However, the weights aren't measured. Does this mean we need to test the sample they send and retain some, then sample the product again when it finally arrives and retain it for any future needs?

Again, any guidance AT ALL would be appreciated.

Please, see attached what I have as per Canadian regulations, hope it'd help a bit.

I have read Regulation 333/2007 which outlines the requirements for heavy metal sampling in foodstuffs. It states that the aggregate sample should be 1kg/1 litre and table 3 highlights the number of incremental samples required. Is this what we should be following? The samples would be for micro and heavy metals and retained.

Welcome to the forum :welcome:

I suspect 333/2007 doesn't apply to you ;)

The key part is the first few words of article 1: "Sampling and analysis for the official control of lead, cadmium..."

"Official control" relates to the activities of member states' regulatory bodies and their agents, rather than to food businesses - see article 2 of Regulation (EU) 2017/625.

If you have a plan for sending "representative" samples, based on risk assessment, then you're doing roughly the same as the majority of "reasonable" business in the UK.

Welcome to the forum :welcome:

I suspect 333/2007 doesn't apply to you ;)

The key part is the first few words of article 1: "Sampling and analysis for the official control of lead, cadmium..."

"Official control" relates to the activities of member states' regulatory bodies and their agents, rather than to food businesses - see article 2 of Regulation (EU) 2017/625.

If you have a plan for sending "representative" samples, based on risk assessment, then you're doing roughly the same as the majority of "reasonable" business in the UK.

Thank you for the warm welcome, pHruit!

I thought 333/2007 would relate to us as we are involved in the sale of food supplements and we need to start testing the heavy metals so that we can confirm the accuracy of the CoA's. There is very minimal information on the microbiology side for food supplements and it seems that most people use the European Pharmacopoeia 7.0 5.1.4 and 5.1.8.

Basically, I need to know if there is a particular sample size that should be taken. Or if there is a regulation I am missing.

In addition to this, I suppose I need to perform some sort of risk assessment on our suppliers and product categories which would determine the testing regimen?

I've never worked in the supplements sector so not an area I've had cause to look at in great detail, but my understanding is that you'd still only really need to be following 1881/2006 on the contaminants side. It gets a bit complicated because the European approach is generally about the raw materials (although e.g. the acrylamide reg obviously diverges from that) and their compliance, so the theory is that if you use "safe" (as defined by regulation) raw materials then the subsequent product will also be safe/legal.

In your position I would do exactly the type of risk assessment you've proposed - what is the history of issues in that type of material, that region, what is the supplier's testing regime, is their choice of lab reliable etc.

Unless someone here has a bit more direct experience of the sector and can add more comprehensive detail than I'm able to, then I'd also perhaps be inclined to get in contact with some industry associations as this is exactly the sort of area on which I'd expect them to have some useful guidance/expertise.

I think that's what you should do. You need to test the sample they send and retain some, then sample the product again when it finally arrives and retain it for any future needs?

I forgot to mention a rather interesting fact. At the moment, fake food additives are being sold on the market. There is a lot of fake shit on sale, so you need to choose it very carefully. I worked in this field for a couple of years, but now everything has changed , but I sometimes follow it and understand what it is about. I remember that there are several sources selling verified and licensed unda. Almost all use the European Pharmacopoeia. I hope you have sorted out this issue and you do not have any problems.