Ascorbic Acid Specifications

Hi guys,

I'm trying to compile all available specification standards (i.e. CODEX, EU REGULATIONS) of Ascorbic Acid from different country for our reference. So far, the only standard I stumble is from EU regulations. And I didn't found any CODEX standard yet. 

I hope somebody will share their file.     

Thanks.

Hi LLR,

I assume you meant Food Grade, (L+), Official Specifications -

 Spec. food grade (L+)-ascorbic acid ,Ph.Eur,BP,USP,EU.pdf   500.65KB   45 downloads

Codex is not a Country. I interpret as FCC (Food Chemicals Codex).

 specification ascorbic acid EP7,USP34,FCC7,E300.pdf   254.77KB   39 downloads

Hi Charles,

Thank you for your input. But upon review, the attached files are from suppliers and not from statutory and regulatory authority. 

What I'm looking for are the official specifications issued by statutory and/or regulatory authority which will served as basis for all manufacturers and consumers.

Example: CODEX

                European Pharmacopeia (EP)

                United States Pharmacopeia (USP)

                Food Chemicals Codex (FCC)

                E300

Thanks.

Joan

Maybe I am confused here, but what exactly are you asking for?

What a supplier says their specification for what Ascorbic Acid is or what some random government functionary says Asorbic Acid "should" be?

Marshall

Hi Marshall,

It's "what some random government functionary says Asorbic Acid "should" be".

I think that's more legit compared to supplier specification.

I mean, Ascorbic Acid, is in essence, Vitamin C.
Are you looking for a percentage of purity? Or the source of Vitamin C?

Percentage of Purity including the maximum level of contaminants, i.e. lead,mercury, any heavy metals.

Ascorbic Acid is what it is. I don't understand why you need some government to tell you what it is?

One would assume that something as simple as Vitamin C would have been thought out by producers of whatever product they are making to ensure they are selling a product that contains "Ascorbic Acid".
Is there some process that you absolutely need to know where and from what source the vitamin was produced from?

For what's it worth, the FDA here in the USA says there are

no Biological, Chemical or Physical hazards associated with Organic Acids.

Marshall

Okay, I don't think you understand my point here. According to BRC Clause 3.6.1 "Specification of raw materials and packaging shall be adequate and accurate and ensure compliance with relevant safety and legislative requirements.The specifications shall include defined limits for relevant attributes of the raw material which may affect the quality or safety of the final products (e.g. chemical, microbiological or physical standards".

That's why I'm looking for all available standards so that I can compare if the specification of Ascorbic Acid from our supplier really meet the requirements set by statutory and regulatory authority.

This is just a matter of specifications review to ensure the authenticity of the raw materials.

In the absence of a regulatory requirement, the supplier spec is perfectly acceptable under BRC. 

It's up to you as the end user of the ingredient to determine if the ingredient is "acceptable" or not, based upon risk.

Marshall

Don't over think it. If there is no absolute governmental required spec for an ingredient, which, generally, there will not be, don't look for one, especially for something as low risk as Ascorbic Acid.

Marshall

In the absence of a regulatory requirement, the supplier spec is perfectly acceptable under BRC. 

 

It's up to you as the end user of the ingredient to determine if the ingredient is "acceptable" or not, based upon risk.

 

Marshall

I don't think so. Based on my experience, the BRC auditor always refer to existing regulatory standards. Determining if the ingredient is "acceptable" or not, based upon risk is not enough to ensure safe usage of the product. The company shall always refer to safety and legislative requirements since it is law of the country/land that you should be following and not merely the supplier specifications. 

That's why we do internal verification of the raw material (i.e. purity testing) and refer these results to existing regulatory requirements to ensure that both the company and supplier are compliant with the standard.

Hi Charles,

 

 

Thank you for your input. But upon review, the attached files are from suppliers and not from statutory and regulatory authority. 

 

What I'm looking for are the official specifications issued by statutory and/or regulatory authority which will served as basis for all manufacturers and consumers.

 

Example: CODEX = non-existent afaik in respect to BCP detailed specifications other than defined items in their list of standards, eg salt. Seems  ascorbic = nil

                European Pharmacopeia (EP) = log in required

                United States Pharmacopeia (USP) = subscription website

                Food Chemicals Codex (FCC) = subscription website

                E300 - i assume this "name" refers to the E number of ascorbic acid

 

 

Thanks.

 

Joan

Hi Joan,

You can see the difficulty via the "horse's mouth".

Direct copies may also not be shareable unfortunately.

Hi Charles,

You're right. I have difficulty logging in since all sites require a membership payment. Well, luckily I stumbled on some previous version that are downloadable. 

These will be enough for the meantime.

But still, thanks for the input.

Regards,

Joan

Hi Joan,

Personally, I have found specs like those i attached are usually auditor-friendly.

Some locations( US, Canadian, other ?) are perhaps more likely to generously maintain free databases (but not USP apparently).

An additional option where available is to go off-line (!) and visit a local technical library. IMEX these frequently stock hard copies of compilations such as USP, FCC Codex.

maybe usefull (?)

Please find some information from EU

https://webgate.ec.e...u/foods_system/     click on Additivs (TOP of the page)  Ascorbic Acid (E 300) and click on it

https://webgate.ec.e...w&identifier=97

http://europa.eu/rap...O-11-783_en.htm

https://webgate.ec.e...D_userGuide.pdf

https://webgate.ec.e...pdf_version.pdf

The authorisation procedure for food additives is laid down in Regulation (EC) No 1331/2008

How is the consumer informed about the use of additives?

Additives in foodstuffs are labelled according the rules set out in Directive 2000/13/EC . Food additives are food ingredients and should be mentioned in the ingredients list. The additives must be designated by the name of their functional class, followed by their specific name or EC number. For instance: "colour – curcumin" or "colour: E 100" .

This E-number can be used in order to simplify the labelling of substances with sometimes complicated chemical names.

Teresa Gonçalves

Hi teresa,

Thank you for the details regarding EC database. Unfortunately, as i understand, the OP was seeking BCPA product specifications for ascorbic acid. I cannot see any such  specifications in the additives database ?

I don't think so. Based on my experience, the BRC auditor always refer to existing regulatory standards. Determining if the ingredient is "acceptable" or not, based upon risk is not enough to ensure safe usage of the product. The company shall always refer to safety and legislative requirements since it is law of the country/land that you should be following and not merely the supplier specifications. 

 

That's why we do internal verification of the raw material (i.e. purity testing) and refer these results to existing regulatory requirements to ensure that both the company and supplier are compliant with the standard.

Hi Lelouch_Rayne,

Based on my past BRC experience, I agree with Marshall. Granted, I can't say what happens in your country as opposed to the US. We do some exporting of products, and we have to provide different tests for certain things as they are compulsory based on regulations in those countries.

During our audits, we have never had to provide regulatory specs; unless for higher risk products where regulatory specs are known. If you're working with dairy or meats, I could see having to provide regulatory specs over supplier specs. However, I work in a sector of the industry where supplier specs are valid for BRC.

I'd be inclined to think that ascorbic acid would fit into the category where supplier specs would be valid for BRC. We use ascorbic acid infrequently, but is listed in our ingredients and never came across the question of whether it meets regulatory specifications. I know that the FDA in the US does have a list of ingredients that are considered "Generally Recognized as Safe" (or GRAS). The FDA has a list of certain ingredients (food additives permitted for direct addition to food for human consumption) with statements of the percentage of the ingredient allowed in a finished good as well and other requirements -- such as purity. There's also a basic definition for what a standardized finished product should contain to meet the standard of identity of the product.

The FDA had the following about ascorbic acid:

(a) Product. Ascorbic acid.

(b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

QAGB