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topic 10881

Seeking supplier of anodized aluminum with FDA approval


 

Q. Greetings,

We are a distributor of pharmaceutical production machinery and manufacturer of support equipment of same.

Since finished aluminum is used extensively in our machines and those of our competitors we have taken FDA approval for granted.

More recently our customers have been asking for documentation pertaining to FDA approval of our finished aluminum parts for direct and incidental product contact.

We have 2 companies that finish our aluminum parts in standard clear, hard coat and teflon hard coat.

Sadly neither one of our suppliers can shed any light on the subject.

Our customer is willing at their expense to have all parts remanufactured and refinished if necessary for this assurance and we are willing to switch finishers. Hopefully one of you are in our area. Any quick response would be greatly appreciated.

Don S [last name deleted for privacy by Editor]
- N. Huntingdon, Pennsylvania, USA


 

A. I have done a fair amount of research into this topic. You would think that with all the anodize and hardcoat used in cookware, food processing equipment, and medical equipment that the FDA issues would be well settled. According to my research, they are not. I contacted industry organizations and large manufacturers of these items. No one could document any sort of FDA approval for anodizing. So I contacted the FDA ......... it is a long story. Stay tuned for Chapter 2.

Chris Jurey, Past-President IHAA
Luke Engineering & Mfg. Co. Inc.
supporting advertiser
Wadsworth, Ohio

luke engineering banner


 

A. I bounced around FDA, talked to various people, and visited a number of their websites. The most helpful was vm.cfsan.fda.gov/ I was not able to get a completely clear understanding of what FDA approval means. Of course, I am not an attorney, so do not depend on anything I say. This is my layman's interpretation of the FDA requirements.

Getting something FDA approved takes a lot of time, a lot of money, and a lot of testing to prove a product's safety. Or an exemption can be obtained from the FDA if one can prove that the food contact product is not added to the food above a very low threshold level. This can also take a lot of time, money, and testing. These approvals or exemptions are very product specific. (i.e., Product Number 123 from Company XYZ)

Another exemption is available, but it is not "approved" by the FDA. That is, it is up to the company to demonstrate that their product meets the conditions for exemption without FDA review. This type of product would be FDA "compliant" and the FDA would only ask for the documentation if a significant health problem were discovered. I think the majority of products, including anodize, would fall under this category. It appears that many companies have not developed the necessary data but absent a health threat, the FDA is not asking. So, no problem. Chapter 3 ... conditions for exemption.

Chris Jurey
Luke Engineering & Mfg. Co. Inc.
Wadsworth, Ohio

 

A. There are two methods to be exempt from FDA regulation.

The first is called "Prior Sanction". To claim this exemption, you must be able to show that a substance was commonly used in food prior to January 1, 1958 and was generally recognized as safe. I suspect anodize and hardcoat meets this requirement but I cannot site any specific data or documentation. I would like to see any anyone has on this.

The second method is called GRAS or Generally Recognized As Safe. Each company is responsible to demonstrate that their products meet this requirement. The FDA has published several lists of GRAS substances. Inclusion on these lists is not the same as an approval but would tend to support your claims of GRAS. Most of these lists were developed a long time ago. It is almost impossible to add new substances as the requirements are similar to receiving an actual FDA approval. I could not find specific reference to anodize on these lists. However, things like Alumina, Aluminum Oxide, and Aluminum Hydroxide are listed. Occasionally, the FDA would issue an informal non-binding opinion letter. There is one dated October 18, 1963 which states "We see no food additive problem involving an anodize oxide surface ..." But it is referring to a specific company's anodized product.

I think a good case can be made that anodize and hardcoat meet the GRAS standard for exemption. But I hope I never have to prove it.

Chris Jurey
Luke Engineering & Mfg. Co. Inc.
Wadsworth, Ohio

 

A. Chris was very precise and informative.

I'd just like to state that what he said was accurate. In the past I did a very substantial amount of work for the disposable medical parts industry (oxygen regulators to be exact) and they were looking into anodizing them with color to differentiate not only the product but as a "spice up" to the thing. Something to do with a study saying how color improves your health and so on and so forth. Basically the dyes for anodizing are not FDA approved and nothing could be done on that front to approve them. But the anodizing itself is generally accepted as being safe and harmless when properly done. People would breath oxygen through these units, so they had to be safe. In a 5-6 year period of time with working with them and doing some countless # of parts I never once had any issues arise from my work. So apparently, time tested truth is the only way to say that it is safe and I just wanted to lend that to the discussion.

Matthew Stiltner
plating company - Toledo, Ohio



 

Q. Please inform me if there are any updates for and FDA approvals on anodizing.

Dan Patel
- Paterson, New Jersey, USA

 

Q. Mr. Shaffer,

May I ask why your customers have asked for coatings on your aluminum parts? I.E., is the reason a perception issue or a health/safety issue?

We have held that bare aluminum is generally accepted as safe for packaging manufacturing equipment parts. The follow up posts from Mr. Jurey make sense regarding the coatings, but do not address the premise of the question: that bare aluminum is not FDA compliant. Is it?

Michael Filiatrault
packaging material manufacturer - Telford, Pennsylvania


(2007)

Q. I'm not sure how I ended up at this site, however, I am a food caterer and want to know if anodized cookware is SAFE?

Donna Jill Boyett
- Okmulgee, Oklahoma


(2007)

A. I don't quite understand the question, Donna. Calphalon and a bunch of other brands are in every store in the country. Haven't you also seen people cooking in anodized aluminum pots & pans from your very earliest memories? And haven't hundreds of millions of people been using anodized cookware around the world since before you were born?

See letter 19624 for a copy of an old reply from the FDA on the subject. See letter 8962 which contains excerpts from a position paper by the Alzeimer's Association.

But if you do large studies you'll find that the absolute safety of everything remains forever in question because there theoretically can always be a bigger study which will find some relationship. For example, what do you think of the safety of coffee and red wine and mammograms? There is perpetually a new study that each of these marginally reduces danger from X but marginally increases the danger of Y, and it will always be thus. Yes anodized aluminum is safe to the extent that anything is "safe".

Luck and Regards,

Ted Mooney, finishing.com Teds signature
Ted Mooney, P.E. RET
finishing.com
Pine Beach, New Jersey

(2007)

Q. As yet, I have not seen definitive data regarding the safety of anodizing as it relates to cookware. While I am willing to accept that aluminum oxide (the anodize layer) is probably stable and safe, I have not seen any information regarding dyes, and particularly nickel acetate, the sealer which locks the dyes into the pores of the anodize layer. Do the sealer and dyes remain stable under boiling and frying conditions?

John Best
- State College, Pennsylvania, USA


(2007)

A. Hello, John. I don't think there would be any dye involved in anodized cookware. The dark grey or charcoal color of hard anodized cookware is a natural part of the anodizing process rather than a dye. It is probably due to silicon, copper, and other alloying materials. Although I can't speak for the internal operations at any given cookware manufacturer, I think hot water sealing would be done. Thanks for your inputs.

Ted Mooney, finishing.com
Teds signature
Ted Mooney, P.E. RET
finishing.com
Pine Beach, New Jersey


September 10, 2008

Q. Why do you think nickel acetate seal is not acceptable for cookware? Aren't many hot water seals also including nickel acetate? We want an anodizing that is less expensive than hardcoat. After extensive testing clear anodizing is doing well, but it is sealed. My anodizer says unsealed would nearly sticky? Aren't many hard anodized cookware products sealed as well? Your forum pops consistently as I seek answers. Great job and thank you.

Follow-up- ALSO very curious about RAW aluminum being FDA compliant- it may not be as abrasive resistant and stain resistant as hardcoat or clear anodize, but isn't it all alumina oxide in the end?

Brad

Brad Barrett
- Cartersville, Georgia


September 11, 2008

A. Hi, Brad. I'm just a generalist in metal finishing, without inside info on what cookware manufacturers do. I would have guessed that they use hot water or steam sealing to avoid any possibility of soluble nickel being found in their cookware, but a mini lit search reveals that some use steam but some use nickel acetate.

I don't know for sure if raw aluminum is FDA compliant, but I do know that it's not very satisfactory :-)  I recently bought a Bialetti capucino percolator, the inside of which is raw aluminum, and it gets very dicey looking corrosion if not immediately washed and carefully dried.

Regards,

Ted Mooney, finishing.com
Teds signature
Ted Mooney, P.E. RET
finishing.com
Pine Beach, New Jersey



June 13, 2012

Q. What is an acceptable coating for aluminum components that will be in a pharmaceutical lab environment? We are considering teflon hard coat anodizing but we are not sure if it is allowed. Based on the first few threads, coated aluminum might be ok. We can't have any particulate or corrosion. Thank you in advance for any advice.

Richard Spencer
- Exton, Pennsylvania, USA


June 30, 2012

A. Hello, many years ago we used a product called Alodine (if my memory serves me correct) and not sure of the exact product number/ID - they made one that turned the aluminium slightly yellow/gold - the other clear - it was touted as 'chemical anodising' - we used/experimented with it on all sorts of stuff on aircraft - motorcycles - and to stop methanol attacking aluminium - I've even heard of it used inside an aluminium fuel tank on a race boat. But - be careful as it's certainly not a 'safe for use in the kitchen' type product. I assume once the process is finished and the surface rinsed - it's safe, but I'm sure the maker can assist you with the answers.

William John
- Melbourne. Australia


July 3, 2012

A. Hi William.

Alodine is a Henkel trade name long used for chromate conversion chemicals for aluminum. Traditionally most of these would be hexavalent chromium and unsuitable for food services. There are some trivalent Alodine formulations, but I doubt that even these are appropriate for food surfaces.

Regards,

Ted Mooney, finishing.com
Teds signature
Ted Mooney, P.E. RET
finishing.com
Pine Beach, New Jersey



October 22, 2012

Q. Are food dishes with colored anodized coating permitted if they are for serving only and not for cooking?

Assaf Binyamin
design studio - Modi'in, Israel


Retro aluminum tumblers

October 22, 2012

A. Hi Assaf. This would be a matter of regulatory rulings in the various countries, but to my knowledge a clear and understandable ruling has never been given in the USA. When I was a child, colored anodized drink tumblers were common, and they are back as a "retro" item. I doubt that anything changed, except the fact that most people put their 'glassware' into automatic dishwashers these days, which would ruin anodized aluminum.

Obviously I can't swear to the accuracy of assumptions, but I've never heard of follow up rulings despite running this website where the question has been repeatedly asked for 17 years, and where the questions read by tens of thousands if not hundreds of thousands of people, and where no updates have been offered.

I don't think the FDA does much actual investigation of this kind of thing anymore and doubt that you'd actually run into regulatory problems today. But we're moving into REACH requirements in Europe that may effectively eliminate the use of colored anodizing eventually. Further, a dishwasher will probably ruin the product the first time it's used, and I don't know if you'd be able to prevent that. Good luck.

Regards,

Ted Mooney, finishing.com
Teds signature
Ted Mooney, P.E. RET
finishing.com
Pine Beach, New Jersey


October 17, 2014

A. This string of entries started with a question on pharmaceutical equipment, and then diverged to hard coat frying pans and color anodized aluminum tumblers. The FDA does not approve materials that are used for pharmaceutical machinery and they do not have a registry of approved manufacturers who make them. There is a list of non-binding Current Good Manufacturing Practices (CGMPs), however firms are afforded the flexibility to select equipment that best satisfies their particular needs and that is capable of meeting the relevant CGMP requirements.

The FDA is responsible for approving food additives and color additives, including Food Contact Substances (FCS) that may migrate to food due to contact. They define an FCS as "any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food" I'm not sure if this definition includes household items like frying pans and tumblers particularly since I couldn't find any premarket approvals for such items. You can find many such items certified by the National Sanitation Foundation (www.nsf.org). There are several varieties of hard coat frying pans and items made with color anodized aluminum certified to "Food Equipment" or "Food Equipment Material" ANSI standards. NSF certified products receive guaranteed regulatory acceptance in N. America.

Mark Jozefowicz
- High Point, North Carolina, USA



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