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Are GRAS Ingredients Always Safe?

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sanidadexterior

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Posted 03 May 2025 - 04:21 PM

The GRAS system was established in 1958 as an exception to the FDA's regulation of food additives.

This allowed certain substances commonly added to foods without causing problems to be considered Generally Recognized As Safe (GRAS) and excluded from food additive regulation.

The first GRAS list was published in 1959, which included salt, garlic, spices, and so on.

Voluntary GRAS notification was introduced in 1997.

Companies can determine whether a new substance is GRAS themselves or request a safety evaluation from the FDA.

Therefore, many substances are introduced onto the market as GRAS without being evaluated by the FDA (either as GRAS or as a food additive).

This occurred with tara flour, which caused 113 hospitalizations in the USA in 2022.

 

For more information, see the attached file.

 

 

 

Attached Files


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SQFconsultant

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Posted 03 May 2025 - 10:20 PM

As we  roll back to being a Republic in America again ALL programs in every US agency are being reviewed, all I can say at this point is that there are massive changes coming and that includes the so-called GRAS..

 

We were just looking at an ingredient that may be on a safe list in the US known as IRON OXIDE - banned in Germany and may be so in EU as well - a  German company by the name of Horbaach uses this as a coloring agent for capsules of Co-Q-10 and while they can not sell it in Germany, they export it to the US market for consumption - and what does this nifty ingredient do?  Clase 4 harm to the Kidney's and Liver.

 

There are many changes coming, many.


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sanidadexterior

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Posted 04 May 2025 - 12:12 PM

I don't think we should worry about iron oxide.

Iron oxide is a color additive.

It has been evaluated by JECFA, which assigned it the INS number 172.

In the EU, it is authorized by EC Regulation 1333/2008 as a color additive (E.172) with a quantum satis use level in the food groups where its use is authorized.

In the EU, E.172 must meet purity requirements, according to EU Regulation 231/2012.

There are three chemical forms: yellow iron oxide (C.I. pigment yellow 42 and 43), red iron oxide (C.I. pigment red 101 and 102), and black iron oxide (C.I. pigment black 11).

 

You can see the EFSA evaluation at the link.

 

https://www.efsa.eur...ournal/pub/4317


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GMO

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Posted 04 May 2025 - 01:10 PM

We were just looking at an ingredient that may be on a safe list in the US known as IRON OXIDE - banned in Germany and may be so in EU as well.

 

Did you mean Titanium Dioxide?  That has been banned.

 

It's slightly baffling to those of us in Europe how many ingredients are no longer routinely used in food but widely so in the US.  Petrochemical dyes might be a hot topic in the US right now but I remember over two decades ago taking them out of some confectionery.  Part of the reason seems to be that while in the UK some things are not outright banned, consumer pressure has pushed for their removal often ahead of precautionary labelling or bans later.  It's curious how that never seems to have happened in the US.

 

But there's nothing sinister if German companies are exporting to the US under US current legislation and norms.  They're following the rules set are they not?


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jfrey123

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Posted 05 May 2025 - 04:21 PM

One of the things I think Europe does right is the food regulations, especially when it comes to ingredients.  The GRAS system in the US is a joke: unless we can prove beyond doubt that something is actually harmful, the default is GRAS.  A study comes out showing harm from an ingredient and the Big Food makers fund 10 counter studies to cast sufficient doubt and the item stays GRAS.  The whole recent point about Canadian cereal vs American versions should be shocking to people.  Personally, I'm tired of having to hunt for non-fresh items that contain wholesome ingredients and mainly finding ingredient labels that read like a science experiment.

 

Eager to see how much of this crap RFK can sort through in his time at his new role.


Edited by jfrey123, 05 May 2025 - 04:22 PM.

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GMO

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Posted 05 May 2025 - 04:28 PM

It's interesting comparing the two.  Sometimes the EU stance leads to frustration.  I have to admit I saw no reason for the move on Quaternary Ammonium compounds and feared that it could lead to more Listeria outbreaks (I'd love to see the data but have to admit it "feels" like I may have been wrong).  Sometimes though, like the quats thing, it's something we'd never have done without it.  

 

And actually why should chemical residues ever be there that aren't part of the ingredients?  That's actually a pretty good challenge.


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