GHS Labeling? and Incidental Ingredients
Hey All,
I have two questions that I am having a hard time answering. First is with the upcoming GHS compliance and its regards to labeling. What has to be listed out on product containers to be compliant? Do we need to invest in new color printers with bar code capabilities to be complaint?
Second is in regards to incidental ingredients. I work for a flavor manufacturer and we tend to have ingredients within ingredients. We declare our flavoring ingredients with a GRAS statement, list out allergens and non flavoring portions. But some ingredients in our flavors are used at 4% by weight and may have a non food ingredient at which would contribute to 2% or lower in the final product. Would this non flavor ingredient need to be pulled forward onto the label? I read that if an ingredient contributes no technical function and is not an allergen it need not be labeled but this sounds open for interpretation which leaves me confused. Thanks for the help!
Pandy,
Remember, label errors can get your product recalled and generate fines. (see recalls on FDA website)
My mantra is "if it's in there, it goes on the label". Sometimes this creates an extra line or two on the ingredient statement but why take a chance.
I type it in exactly the way it is given to me on the ingredient nutritional from the supplier.
That's my two cents worth anyway. :-)
Phil
Phil,
Thanks for the response. As far as the recalls go, i totally understand that and make sure that there arent any allergens or sensitizers in the products. What i am referring to is an ingredient that is in the product at such a low percent, lets say .5% and poses no risk or technical function. I am of the same thought process of "better safe than sorry" so i agree to list it out when in doubt. Just trying to wrap my head around this as i have heard multiple people stating this.
Hi Pandy,
While i agree with Phil's reply with the "if it's in there, it goes on the label" philosophy I have worked with flavor suppliers that use both methods. Personally I prefer to have all bases covered and list everything as a precaution.
Below are a few snipets from in regards to flavor labeling noting the points you mentioned. Definitely check out the links and give a thorough read. While one says if it contains 2 or more ingredients it should be listed, the other states that insignificant levels with no functional or technical effect need be listed. This info would lead me to first see if it falls into the insignificant/no functional technical effect, then go from there.
It would be interesting to see how others with more labeling experience would handle this. I included the links below if you'd like to give them a read.
"(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients)"....
"(3) Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food. For the purposes of this paragraph (a)(3), incidental additives are:
(i) Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect..."
http://www.accessdat....cfm?fr=101.100
"1) If the flavor consists of one ingredient, it shall be declared by its common or usual name.
(2) If the flavor consists of two or more ingredients, the label either may declare each ingredient by its common or usual name or may state “All flavor ingredients contained in this product are approved for use in a regulation of the Food and Drug Administration.” Any flavor ingredient not contained in one of these regulations, and any nonflavor ingredient, shall be separately listed on the label."
I presume GHS = Globally harmonised system ?
Rgds / Charles.C
I'm also wondering if GHS means the OSHA Globally Harmonized System of Hazard Communication.
1. Hazard Communication (which is what GHS usually refers to) is only for hazardous chemicals. For example, if you have ethanol in your flavors, and you are selling to a manufacturer, you would need to include the GHS information of flammability.
2. The GHS does not care about anything that is not hazardous. So you only have to worry about FDA regulations for other items, if they apply.
3. If your product is not destined for retail sale, your labeling requirements are only the OSHA regs, not the FDA regs.
4. None of the GHS labeling requirements uses a bar code, but the pictograms would need to have a red border. Again, only if you have a component that requires a pictogram.
If your flavors are sold in a retail store and not to a manufacturer, then you don't have to worry about GHS labeling. It only applies where an employee may be exposed.
Martha
That is correct, im referring to the hazard communication standards for labeling. As far as labeling the containers, i talked to our MSDS provider whom also has training info on this subject and they state that all products regulated under the FDA do not need to be labeled according the HCS. SDS's will change in accordance but as labeling is already regulated by the FDA then the HCS does not apply.
Lisa, thanks for the info. I guess i will have to continue the labeling on a case by case basis and consult with our flavor developers to see if there is any functional/technical reason or effect from these lower percentage ingredients and shoot from there.
Dear ALL,
This topic is completely outside my knowledge base but the declared FS intentions, ie with respect to hazards, of the related standards seem to be rather side-lined in above discussion, eg -
http://en.wikipedia....cation_Standard
http://www.grainger....hazard-standard
Rgds / Charles.C
Dear ALL,
This topic is completely outside my knowledge base but the declared FS intentions, ie with respect to hazards, of the related standards seem to be rather side-lined in above discussion, eg -
http://en.wikipedia....cation_Standard
http://www.grainger....hazard-standard
Rgds / Charles.C
The OP asked about labeling with regard to GHS requrements. The HazCom standards include a section on mandatory label information that manufacturers/imiporters must put on the chemicals, something that the articles you referenced do not emphesize. In the US, the labeling requirement for the GHS HazCom standard from OSHA kicks in this year, and all chemicals that contain hazardous materials are required to conform to the new label requirements by June 1. For those outside the US, this may not have been a matter of concern, but to anyone who sells a hazardous chemical in the US, and some food ingredients would fall under that umbrella, this has been a big deal.
But, if the material is not going to expose workers to hazards, but is for sale to consumers, then it is exempt from that rule. So then it falls under the FDA labeling requirements.
As I understood, that is the question that the OP posed.
Martha
The OP asked about labeling with regard to GHS requrements. The HazCom standards include a section on mandatory label information that manufacturers/imiporters must put on the chemicals, something that the articles you referenced do not emphesize. In the US, the labeling requirement for the GHS HazCom standard from OSHA kicks in this year, and all chemicals that contain hazardous materials are required to conform to the new label requirements by June 1. For those outside the US, this may not have been a matter of concern, but to anyone who sells a hazardous chemical in the US, and some food ingredients would fall under that umbrella, this has been a big deal.
But, if the material is not going to expose workers to hazards, but is for sale to consumers, then it is exempt from that rule. So then it falls under the FDA labeling requirements.
As I understood, that is the question that the OP posed.
Martha
Dear MWidra,
Ahh! Interesting. Thanks for that.
Rgds / Charles.C