FDA-FSMA,GRAS Status Glass Manufacturing Plant

Question, we are going to get our FSSC 22000 certificate because our customers want us to have it, however I am a bit confused by the law. I am a glass manufacturing plant and am considered GRAS by the FDA. I believe I am only have to comply with 21 CFR part 117 subpart b, which is CGMPs. The only thing I can find to support this is as follows from the FDA website:

FPM.1 Are food packaging manufacturers required to register with the FDA and comply with the preventive control requirements for Human Food?

In general, subparts C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and G (Requirements for a Supply-Chain Program) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 FR 55908)(CGMP & PC rule) apply to an establishment that is required to register with FDA as a food facility.  For purposes of registration, food-contact substances are not considered “food,” and therefore do not trigger the requirement to register (see 21 CFR § 1.227). 

FPM.2 Are food packaging manufacturers required to create and maintain a Food Safety Plan? 

The manufacturing of food packaging is not subject to subparts C (including the requirement for a food safety plan) and G of the CGMP & PC rule.  Other activities, such as placing food in the packaging, would require registration and be subject to subparts C and G, unless an exemption applies.

FPM.3 Do the Current Good Manufacturing Practices apply to a food packaging manufacturer?

The CGMP regulations in 21 CFR part 117, subpart B apply to the manufacturing of food packaging.  These regulations address, among other things, the taking of adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, and food-packaging materials with microorganisms, chemicals, filth, and other extraneous material.  Also, appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable (see 21 CFR § 117.80(a)(2)).

Am I right to assume that by law I am covered with just the CGMP but for a certificate I have to be HACCP based but that is going above and beyond the law.

Question, we are going to get our FSSC 22000 certificate because our customers want us to have it, however I am a bit confused by the law. I am a glass manufacturing plant and am considered GRAS by the FDA. I believe I am only have to comply with 21 CFR part 117 subpart b, which is CGMPs. The only thing I can find to support this is as follows from the FDA website:

 

FPM.1 Are food packaging manufacturers required to register with the FDA and comply with the preventive control requirements for Human Food?

In general, subparts C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and G (Requirements for a Supply-Chain Program) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 FR 55908)(CGMP & PC rule) apply to an establishment that is required to register with FDA as a food facility.  For purposes of registration, food-contact substances are not considered “food,” and therefore do not trigger the requirement to register (see 21 CFR § 1.227). 

FPM.2 Are food packaging manufacturers required to create and maintain a Food Safety Plan? 

The manufacturing of food packaging is not subject to subparts C (including the requirement for a food safety plan) and G of the CGMP & PC rule.  Other activities, such as placing food in the packaging, would require registration and be subject to subparts C and G, unless an exemption applies.

FPM.3 Do the Current Good Manufacturing Practices apply to a food packaging manufacturer?

The CGMP regulations in 21 CFR part 117, subpart B apply to the manufacturing of food packaging.  These regulations address, among other things, the taking of adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, and food-packaging materials with microorganisms, chemicals, filth, and other extraneous material.  Also, appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable (see 21 CFR § 117.80(a)(2)).

 

Am I right to assume that by law I am covered with just the CGMP but for a certificate I have to be HACCP based but that is going above and beyond the law.

Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

 

^^ Glass ?

Charles-

I have found this....Glass is the only widely-used packaging material considered by FDA to be GRAS. consumption for food use by a significant number of consumers. 21 C.F.R. ... substances generally recognized as safe in or on food.”)

http://www.gpi.org/a...ackaging-issues

GRAS  Generally Regarded As Safe

you are correct. you still need to ensure your facility isn't contaminating the glass (like using mercury in your process somewhere that gets embedded in the glass during manufacture), and yes in order to become FSC 220000 certified you'd being going above and beyond to prove your facility is producing a top notch safe glass vessel

I am a glass manufacturing plant and am considered GRAS by the FDA

....  Please show me where on the GRAS list is GLASS???

• Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.

https://www.fda.gov/...RAS/default.htm

Since glass has been used since well before 1958 it falls under this provision

See also

https://www.accessda...c&search=silica

Glenn- The  ingredients (184.1742 sodium carbonate,184.1191 calcium carbonate) are  on the GRAS list which makes the end product of the Glass GRAS, is what I found when researching. 

It is apparent that "GRAS" is an extremely flexible acronym.

I anticipate that "glass" is nowhere explicitly  listed as "GRAS"  (eg category 186) however this does not seemingly prevent it from being referred to as a "GRAS substance".

Neither seemingly does its description of being "GRAS" require to be explicitly approved by FDA.

This illustrates how packaging materials may "ascend" to GRAS -

https://www.packagin...-food-packaging

here is an equally strange example -

https://www.packagin...considered-gras

and an expanded, almost laughable, scenario -

 GRAS.PNG   157.55KB   1 downloads

and, in general usage -

http://www.gpi.org/l...lass/what-glass

I daresay everyone was correct

PS - However I am not sure if above /  previous Posts answer the OP or not ? Can a Manufacturing Plant be "GRAS" ?

no, a manufacturing plant cannot be GRAS (although PCA sure thought so!)  Gotta love it when laypeople try to explain terms they don't understand (your 3rd attachment)

RAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

I personally find the FDA laughable no matter how you slice it!  

And i have to tell you that MOST glass used for food is manufactured in an Asian country which I will not name, but that none of us should trust due to their track record, so probably the FDA should revisit this one

no, a manufacturing plant cannot be GRAS (although PCA sure thought so!)  Gotta love it when laypeople try to explain terms they don't understand (your 3rd attachment)

 

RAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

 

I personally find the FDA laughable no matter how you slice it!  

 

And i have to tell you that MOST glass used for food is manufactured in an Asian country which I will not name, but that none of us should trust due to their track record, so probably the FDA should revisit this one

I understand a plant cannot be but the products manufactured? We make glass bottles that are sold to the food/beverage industry and are based in the United States.

Hi Laura

You're good. Glass is GRAS under the FDA

Hi Laura

You're good. Glass is GRAS under the FDA

^ Where ?

(pre-1958 only, explicitly, refers to  ingredients afai can find)

By default ?

Charles,

as per the links I had attached earlier

Charles,

 

as per the links I had attached earlier

I could not find any explicit evidence in 1st or 2nd link. Sorry.

This (2018) document seems to imply that some glassware may not be currently regarded as GRAS -

 food-contact-and-fda-1.pdf   175.23KB   26 downloads

I also noticed this -

The FDA classifies glass in general as GRAS (Generally Recognized as Safe).
 
Origin:
Federal Register/Vol 48, No. 27/Feb. 08.1983/page 5718, Rules and Regulations
 
Citation:
“The agency has traditionally considered materials such as ceramics, glass, and stainless steel
as GRAS for food-contact use, based on their safe history of common use as food-contact
materials before 1958. However, because the use of these materials has been so widespread,
the agency has never considered it necessary to list these materials as GRAS”
(2017)

Hmmmm.

Also found this document (uses Scampi's links in Post 6) -

 GRAS Compliance of Glass Packaging.pdf   473.13KB   28 downloads

As far as the OP goes, if you are unsure, I'd contact someone at the FDA that is in the FSMA side of the house.

While FDA does put out tons of guidance to industry, they do have people that answer your questions via email or on the phone.

Marshall

As far as the OP goes, if you are unsure, I'd contact someone at the FDA that is in the FSMA side of the house.

 

While FDA does put out tons of guidance to industry, they do have people that answer your questions via email or on the phone.

 

Marshall

Good Idea.

To be clear, we pack in glass jars, and NO ONE has ever asked to see proof that glass is safe for food contact

Not SQF, not CFIA, not Pro Cert (organic) No one

To be clear, we pack in glass jars, and NO ONE has ever asked to see proof that glass is safe for food contact

 

Not SQF, not CFIA, not Pro Cert (organic) No one

Nonetheless, random caveats are still feasible, eg from my previous attachments -

 Massachusetts Lead Poisoning Prevention and Control:
Massachusetts has a lead prevention and control
regulation that requires total immersion of the decorated
glassware of ceramic drinkware, with a lead limit of 2 ppm.
The FDA test is performed on the interior only, so this is a
more stringent test.

 

Charles, that second post is regarding PURCHASING ceramicware to use at home. That is not the same as manufactured glass jars. Ceramic is not clear glass

No sense fear mongering when not comparing apples to apples please. The waters get muddy enough on their own when it comes to following the rules and doing the right thing, adding confusion isn't helpful

The attachments is no different that knowing not to purchase crystal at a yard sale and then store your whiskey in it. Crystal used to contain high enough levels of lead to put the contents over the ppm threshold (items like spirits that may sit for a long time)

Charles, that second post is regarding PURCHASING ceramicware to use at home. That is not the same as manufactured glass jars. Ceramic is not clear glass

 

No sense fear mongering when not comparing apples to apples please. The waters get muddy enough on their own when it comes to following the rules and doing the right thing, adding confusion isn't helpful

 

The attachments is no different that knowing not to purchase crystal at a yard sale and then store your whiskey in it. Crystal used to contain high enough levels of lead to put the contents over the ppm threshold (items like spirits that may sit for a long time)

Hi Scampi,

I daresay you may be right however the OP has not detailed what is actually being manufactured.

I am ultra-cautious when the process is "generic".

https://ireadlabelsf...ssware-options/

From my glass supplier

" Soda-lime-silica Glass contiainers were recognized long before September 6 1958 as being generally recognized as safe )GRAS) for their intended purpose and hence enjoy a prior sanction status. At CFR 170.3(1), one can find the definition of "prior sanction". The authority for this status is found in the enabling act at 21 USC 321(s) (4) where materials commonly in use before January 1 1958 are not considered food additives.

FDA acknowledged the use of glass for food contact as being GRAS in the February 8, 1983 issue of the Federal Register (see Vol. 48, No. 27 and page 5718). There is no direct citation for the use of glass as a food contact surface. However, glass containers, as all food containers, are subject to 21 CFR 110 and 21 CFR 174.5."

https://ireadlabelsf...ssware-options/

 

From my glass supplier

" Soda-lime-silica Glass contiainers were recognized long before September 6 1958 as being generally recognized as safe )GRAS) for their intended purpose and hence enjoy a prior sanction status. At CFR 170.3(1), one can find the definition of "prior sanction". The authority for this status is found in the enabling act at 21 USC 321(s) (4) where materials commonly in use before January 1 1958 are not considered food additives.

 

FDA acknowledged the use of glass for food contact as being GRAS in the February 8, 1983 issue of the Federal Register (see Vol. 48, No. 27 and page 5718). There is no direct citation for the use of glass as a food contact surface. However, glass containers, as all food containers, are subject to 21 CFR 110 and 21 CFR 174.5."

^ See Post 15

The level of "perfection" of glass is also elaborately spelled out in 2nd attachment Post 15 (prepared for the Glass Packaging Institute).

Even though presumably unrequired, the source article (pharmaceutical/food) for my quote in Post 15 also had this additional data -

Declaration of Conformity
The heavy metal contents, e.g. lead, cadmium, mercury and hexavalent chromium of both our special glass tubing and our packing are below 100 ppm, i.e. considerably below the limit values of the US and EC regulations (article 11 of stipulations 94/62/EC).

 

Perhaps the OP would like to clarify his Product/Process description.

We manufacture glass bottles for the liquor industry and some jelly jars. We o metal testing monthly and have never had any issues.

We manufacture glass bottles for the liquor industry and some jelly jars. We o metal testing monthly and have never had any issues.

Hi Lauralsaiah,

Thks for response.

Do you have  Product Specifications for yr finished bottles-jars/raw materials ?

What kind of metal testing ?

What is the Process ?

Is the Product/Process subject to FDA surveillance ? (Apologies for my ignorance, not in USA)