The response to the new GRAS Self-Determination Inventory Database (GSID) has been “overwhelmingly positive and supportive”, according to its creator AIBMR Life Sciences, which has helped dozens of firms prepare for GRAS determinations.
GSID, which you can access here , attempts to address concerns about a lack of transparency in the process by collating publicly available data on GRAS self-determinations from trade publications and other sources and putting it all in one central database that AIBMR hopes the industry will help it update.
Speaking to FoodNavigator-USA a week after launching the GSID at the Supply Side West show, AIBMR Life Sciences senior research director Dr Alex Schauss said: “Just this morning we had two ingredient supplier companies contact us with over half a dozen GRAS self-determinations for us to add to the database.
“Our original objective in having companies add to the database is materializing, and we urge ingredient suppliers to let us know if they have a GRAS determined substance not in our database.
“Each time additions are made, and the database updated, the date for that update will appear on the first page at the top. We will also take a substance off the list if it has successfully received a ‘no comment’ letter from the Food and Drug Administration (FDA) and added to the agency's voluntary notification GRAS database.”
2012 may end with the most GRAS self-determinations reported for any year since the proposed rules were published
Some initial data crunching of the GSID has revealed that “entities based in 17 countries had affirmed substances as GRAS-determined, led by the US, followed by Japan, Switzerland, Canada, France, the Netherlands, India, Denmark, the UK, and eight other countries”, revealed Schauss.
“The peak year for substances determined GRAS is 2010, which saw twice as many determinations as in 2009.
“At the current pace of determinations, which has surpassed 2011 already, 2012 may end with the most determinations reported for any year since the proposed rules were published.”
The FDA is not ‘completely in the dark’
Responding to claims by Tom Neltner, director of the food additives project at The Pew Charitable Trusts, that GSID was "was not detailed enough to be of use ”, Schauss added: “Quite the opposite.
“It has brought previously unknown GRAS determined substances into the public domain and provided hyperlinks to the manufacturer whose substance was affirmed and information announcing that a determination has been made linked to publications such as yours [FoodNavigator-USA and NutraIngredients-USA ].
He added: “We gave considerable thought to what information to provide for each substance. The decision was made to provide a hyperlink to the manufacturer, as they had far more information available that they could tailor in response to a particular inquiry.
“From experience, inquiries vary in terms of what information is desired. According to conversations we have had since the launch this is exactly what manufacturers are experiencing.”
The perception that companies are keeping FDA or anyone else in the dark is unfounded
Schauss said he was also “puzzled” by Neltner’s claim that the FDA has no knowledge of “at least 1,000 chemicals” that have been added to foods. “How did they come up with the number 1,000?”
He added: “We found well over 90% of the GRAS determinations were reported to news media via press releases and placed into the public domain.
“Hence, the perception that companies are keeping FDA or anyone else in the dark is unfounded simply based on our ability to find the information, albeit a time consuming process, until now.”
The manufacturer has no influence on who serves on the expert panel
Many of Pew’s attacks reflect “some misunderstandings about the self-affirmation process”, notably, that manufacturers can effectively judge their own products, claimed Schauss.
“Our experience with so many substances that have been submitted to expert panels convened by AIBMR is that the manufacturer does not serve on the panel, nor someone they would like to have on the panel.
“They have no influence on who serves on the panel. Instead the panel consists of scientists who meet the qualifications set forth in the proposed rules who by experience and training are qualified to serve on such panels."
FDA can challenge and remove GRAS self-determined substances
Meanwhile, it is also important to point out that the FDA has the authority to remove self-determined GRAS substances from the food supply, he added: “This was illustrated in 2010 when FDA learned of a self-determination that led to adding caffeine to certain alcoholic drinks.
“Upon learning of this use FDA sent a letter to four manufacturers and requested they submit a GRAS notification for the self-determined ingredient.
“One manufacturer submitted the GRAS notification, which the FDA found insufficient upon review. Thereafter, all four manufacturers were warned to stop adding caffeine to alcohol drinks as the caffeine included in various malt alcoholic beverages as a separate ingredient was an ‘unsafe food additive’.”
To get your GRAS self-determined substance added to the GSID, contact AIBMR chief scientific officer John R. Endres at firstname.lastname@example.org .