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What is a COA and how do I get one for my product (also covers product specifications)

April 9, 2016

One of the questions I get asked a lot by smaller brands who begin exporting their products is ‘I’ve been asked to provide a C of A with my products and I don’t have one or know what one is, can you make me one and how much will that cost?’

This is how I answer.

So a COA or C of A is a ‘Certificate Of Analysis’.

Basically it is a piece of paper that gives actual test results for the batch of product that you are exporting.  The test results are usually reported against the typical specification.

A Specification for a product is a piece of paper that gives guidelines of the physical and maybe chemical parameters of a product.  The figures on a specification are generally ranges whereas a C of A gives absolute, batch specific figures or a figure that confirms the batch has been tested to and meets the requirements of the spec.

Here is an example of a C of A for Hyaluronic Acid.   Finished products and cosmetic ingredients all go through the same procedure for creating a spec/ COA but the data given might differ between the two.  I’ll explain that in a moment.

hyaluronic acid c of a and spec

The point of a specification (which on this C of A would be represented by the ‘standard’ data column)  is to give the ingredient (or finished product) maker quality guidelines.  When a new batch of product is made it must be tested to find out if that batch is acceptable (within spec).  Specification guidelines usually give some leeway of results to enable a bit of room for batch-to-batch variations. How much leeway is given will totally depend on the product and how critical each factor is to the quality of the finished goods.  Medicinal products usually have a tighter spec than cosmetics due to a greater need for precise batch-to-batch consistency.  Organic cosmetic products may have a much wider specification for things like colour and sometimes odour than a regular cosmetic due to the fact that the oils and waxes that go into organic cosmetics are more likely to vary in colour over time and depending on where they are sourced from.

So how do you get one?

You can’t have a COA without a spec.

The first thing is to get a spec.

In an ideal world and in the real world of cosmetic manufacturing you can’t create a spec without a batch history and stability data.

When you first make a product that product will have a ‘temporary spec’ based on the parameters of the first batch you have scaled up.  You must make a couple more batches to get a good idea of the typical range for your product.  This is important as if you have only one batch that you have made in your lab and you use that to make your spec there is no guarantee that a manufacturer who has scaled up your product can achieve what you have.

In the world of kitchens, markets and small-batch manufacturing this procedure may not be as rigorously followed.  This is a risk, as you won’t know as much as you probably ought to know about your product before committing to a spec but sometimes it has to do.   Basically the consequences of creating a spec and subsequent C of A’s on limited scale-up data is that the batch-to-batch variability may be quite high and you might find yourself either constantly fiddling with the spec (which is not ideal) or rejecting product.  Then again, it may never be a problem.

So what should go onto a finished product spec?

The minimum data that usually goes onto a cosmetic spec is a description of the appearance,  odour,  pH (if the formula contains water), viscosity,  specific gravity.

The viscosity is particularly important for most products as it gives you a numerical range for how thick or thin the product is and this will directly impact how the product performs in use.  Will it come out of the final packaging, will it leak, will the customer be able to dose the product correctly, has the product been manufactured correctly?

Specific gravity is another key measure as it tells you how dense the product is in relation to water – is it lighter or heavier?  This is a very useful measure for your stability also as changes in the SG over time means that the product is either losing or gaining moisture.

If you have no laboratory equipment to test SG and viscosity at home you can get these measured at a third-party lab.  If you are doing that I would suggest you try to send three batches and use the data from that to set a specification for yourself.  One batch is not illegal but there is always the danger that the batch you sent was not representative of what normally happens.

If you want to create a very, very basic spec then you can get away with just listing pH, appearance and odour.  There is no law against doing that but the downside in not specifying viscosity for example is that you have no record of what it should be and customers may complain or feel dissatisfied with the batch that you have sent them.

Once you have created your specification you then use that to measure each batch against in order to create a batch specific C of A.

So a C of A becomes part of your quality control program and as it requires a batch number you need to have a batch number system in place.  This can be as simple or complex as you like but it needs to be there so that you can track back each C of A to the manufacturing date, the batches of the materials you used to make the product and who made it (ideally) and where it was made.

What about micro?

So far the above has only gone into the basic physical test results usually present on a spec.  As you can see from the spec for Hyaluronic Acid micro data is also useful.  The way micro testing works in the cosmetic industry is that we have a separate micro spec for a cosmetic.  Usually this is achieved in the same way as a regular spec, three batches or more sent off for micro counts then a limit is set and other batches are tested against that.

All cosmetics have to be clean and there are regulations in place to outline what ‘clean’ means in terms of Total Viable Count (TVC) for each category of cosmetic.  In addition cosmetic products should be free from pathogenic organisms so that is tested as well.  The last step for a cosmetic formula is a PET (preservative efficacy test).  This is generally done once in a products life time but we do recommend running a PET at the beginning of the products shelf life and at the end, especially for cosmetics with a 20-30 month shelf life.

Batch specific results usually retain their name of ‘micro count results’ rather than ‘C of A’ but essentially they are the same thing.  Micro counts are done on each batch in most cosmetic manufacturing companies.

Anything else to measure?

If you have a product whose efficacy results depend on the presence of a particular active and that active might oxidise or reduce in quality over time then that needs to be tested. A couple of examples are:  Vitamin C serums or creams,  Retinol (or vitamin A) products,  Peptide creams,  Sunscreens.

We might take our batch to an analytical lab and ask them to perform an ‘assay’ on it to tell us how much of the ‘active’ remains in the product after x amount of months.

This is not mandatory testing here in Australia for anything other than sunscreens but I absolutely recommend it as degradation of a key active WILL impact on your product’s efficacy – your product may no longer work.  Also in some cases degradation of the active can lead to the formation of irritating by-products and that needs to be mitigated.

Heavy metal analysis is more relevant to individual ingredients than it is for a finished product but in some cases it might good to get the heavy metal analysis done – remember the lead in lipstick uproar?

So how do you get this started?

Realize Beauty can organise this data for you and complete specifications for finished products or ingredients.

In terms of how much this costs that will depend on what data you want on your spec.  If you need assay results we will have to get a quote for that, if you need a micro spec we will have to factor in the costs of running that too.  As a guide a very basic spec might cost a hundred dollars where as complex spec may be closer to a thousand.  Do also keep in mind that a spec is only as good as the product that we are given to test so if you can only spare us a tiny amount from one batch then we have very little to go on.  The best specs are produced when we can have access to at least three batches of product, we will need 500g of each batch as a rough idea and that should cover SG, viscosity, micro and assay of active.

If you have any further questions drop us an email at hello@realizebeauty.com

Amanda x

 

 

 

 

8 Comments leave one →
  1. January 26, 2018 11:42 pm

    Hi
    I need COA for my depilatory waxing product. I need this for Amazon listing.

    • RealizeBeautyEd permalink*
      January 28, 2018 10:35 am

      Did you read this article? Do you have a product spec? Are you the manufacturer? Do you have a quality system in place? A C of A is the culmination of all of those things.

  2. January 29, 2018 5:26 am

    Hi there! I am a distributor for a international manufacturer, and we are registered with the FDA and they had a lab test done for efficacy and microbial contamination. Would the lab be the ones that could issue a COA? Or would I have to get separate testing for this document to be issued? Sorry – it’s still unclear how to get this. I also need it for Amazon approval. TIA!

    • RealizeBeautyEd permalink*
      January 29, 2018 10:34 am

      Hi there,
      Not really, your manufacturer would be the ones to issue a full product C of A after testing the physical (and maybe chemical) parameters of their product against their spec. The C of A is part of the manufacturing quality assurance documentation. Amazon have separated C of A out from GMP I think which is odd as a C of A is part of a GMP system (you can have certified and non certified GMP systems, many companies have in-house quality systems but don’t get them validated by ISO or another body). Basically your manufacturer should be in control of issuing the spec and C of A and as a distributor you should check each C of A that comes in for a batch against the spec they give you to assure yourself that the product is in spec. You could create your own in-house spec and C of A but if you don’t have the buy-in from your manufacturer, you could reject a batch that you don’t think meets the spec and have the manufacturer argue it over with you. Some customers do have their own specifications and will enforce these onto a manufacturer but you have to be pretty powerful for that to happen. It is all part of the process of assuring the final product is of the right quality.

  3. James Lewis permalink
    February 27, 2018 7:15 am

    Do you have recommendations on how to get spec developed? Article is well written and much appreciated.
    My spouse is trying to start a line of hair care products and while I could probably get really close on specific gravity, Viscosity and pH, it would be nice to have someone (not me) show my spouse the numbers.

    • RealizeBeautyEd permalink*
      February 27, 2018 7:53 am

      Hi James, there is nothing more to this really. You either have the equipment to make these measurements or you don’t. If you don’t have the equipment you could send three representative batches to a third party lab to test and they would confirm the measurements for you (This is something that I can do) but checking each batch after that against your spec is going to be a complete pain if you don’t have the lab close by as it could hold up your manufacturing process and be unduly costly. Basically this is part of your quality control and assurance program and you need to have control over that in order to meet the expectations of the market and its regulators.

  4. Aaron James permalink
    April 4, 2018 8:18 pm

    Hi, if I only have certificate of Conformity instead of certificate of analysis, any way that i can justify this? Our product does not need much lab testing, it is mainly visual checking so i do not see a need for certificate of analysis. But i wish to know how should i justify not not having a CoA.

    • RealizeBeautyEd permalink*
      April 4, 2018 11:07 pm

      If your product conforms, it must conform to something so there must be a spec. A Cert of Analysis gives analytical measurement, a cert of compliance is basically saying ‘yes this meets the spec but we didn’t necessarily measure it’. Either way they need a spec or benchmark to judge against. If you have a supplier asking you for more then just give them that explanation plus the spec and that should be enough. If a quality parameter can’t be analytically measured but it can be observed and checked that should be good enough. If it isn’t then maybe whoever is asking doesn’t understand what they are asking for. That’s not unheard of.

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