11 replies to this topic

[sanidadexterior]

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

•  tara flour.pdf   2.68MB   4 downloads

[SQFconsultant]

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.

[sanidadexterior]

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

[GMO]

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?

[jfrey123]

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.

[GMO]

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.

[Bo16]

GRAS is an important part of the FDA approval system.  The FDA takes way to long to approve ingredients through the system.  I do have issues with self-affirmed GRAS where the manufacturer does not even have to submit a notice to the FDA and I think that must be removed from the system, but without the GRAS program industry would come to a stand still. If the GRAS notice is filed with the FDA, then they have the ability and responsibility  to look at the documents and require information, testing or to reject the ingredient if they have any issues. I have had experiences where when submitting a GRAS notice, the FDA and the expert review committee have ask us for more information and additional testing.  The FDA needs to step up its game and actually review these notices in a timely manner.

[G M]

The GRAS system as it has been functioning is one of the major reasons I have no confidence in the FDA.  FDA doesn't have the tools in place to examine everything proposed by industry, and in many areas related to food takes decades to make decisions that ought to be handled in a year or two -- but the self-affirming loophole by industry without being requiring the supporting evidence (to be submitted before use) for public review is just stupid.  I have zero doubt that many GRAS additives and other functional ingredients are unfit for prolonged or repeated exposure.

[TimG]

My first experience with a GRAS chemical was in my previous position. When I learned that G stood for 'generally' I kind of chuckled. Like saying: 'no one has really said it's not safe yet. It's fine, don't worry about it. We've been using it forever!'

[GMO]

GRAS is an important part of the FDA approval system.  The FDA takes way to long to approve ingredients through the system.  ...without the GRAS program industry would come to a stand still. 

 

But perhaps then it should?  Then either the FDA gets more resource or better systems to pick up the pace or a novel ingredient isn't yet approved.  But is that genuinely a problem?  What is so time critical that it needs super speedy approval?

[Setanta]

These questions should not be asked with an ALWAYS modifier.  To me, nothing is always safe in food safety. 

[GMO]

These questions should not be asked with an ALWAYS modifier.  To me, nothing is always safe in food safety. 

 

That's true.  But the mindset with EU legislators is very different.  It's very much "don't try and convince me it's safe, convince me it needs to be there and then we'll talk about what you need to do to understand safety if it's essential."

 

Even outside of legislators, companies themselves are far more precautionary.  Lots of colourings are not illegal in the UK but very rarely used.  For about the last 30 years the amounts of artificial food colourings have been reduced or removed.  That's all from consumer pressure.  It's kind of baffling to see that doesn't really exist in the US yet there are people who would bow down on vaccines to an ex Doctor who was struck off in the UK.  Baffling.