23 Apr 2018 --- Two commonly used grill flavors [Grillin’ 5078 and Grillin’ CB-200SF] are no longer allowed in the EU as of yesterday [April 22, 2018]. Despite efforts from the supplier Red Arrow Products [a Kerry business since the end of 2015] for a last minute reprieve for the flavorings, this has not been successful.
Red Arrow has now launched a new grill flavor that is approved for use in the EU and that it says is identical in flavor characteristics to the legacy grill flavors. It will also continue to push for a reauthorization of the grill flavors impacted by the regulatory change.
It comes as Symrise, which previously bought the raw material from Red Arrow, before selling it on in a blend for customers, launches a new solution called Grillicious that meets the new laws. Grill flavors are most frequently used in snack foods such as crisps and coated nuts. Other major application areas include sauces such as BBQ and processed meat products, such as burger patties.
In two separate opinions adopted on July 25, 2017, a European Food Safety Authority (EFSA) Panel concluded that on the basis of the data provided by the applicant the safety of Grillin’ 5078 and Grillin’ CB-200SF cannot be established. The products are derived from heat-treated high oleic sunflower oil and intended to be used as a food flavoring with charbroiled or grilled aroma in a wide variety of food categories either in liquid or powder form.
The opinion read: “Only information on a number of constituents of the flavoring and data on toxicity of several thermally treated fats and oils were provided by the applicant. However, the Panel considered the time-temperature conditions that were applied in the preparation of the substances tested as not comparable to those applied in the course of the production of the flavoring.”
In a detailed recent interview with FoodIngredientsFirst, Steffen Grothe and Ute Woelke, Vice President Strategic Regulatory Affairs Flavors at Symrise explained the background to a re-categorization that saw grill flavorings fall short of the EC approved list.
The regulatory changes go back to the implementation of the new flavor regulation in the EU in 2008 [Regulation (EC) No 1334/2008], where all categories of flavorings were laid down. This meant a categorization for flavoring substances, whether natural or not derived from nature, process flavorings and flavoring preparations that fall under different categories. Amid this Regulation, the European Commission (EC) established one category that is unique to EU regulations. “Other flavorings” is effectively a basket that collects everything that doesn’t fit into one of the other categories.
“The question then was, what fits here? It was identified that grill flavorings and rum ether are materials covered under this category,” Woelke notes. “Regulation 1334 also laid down the materials for which a safety evaluation is mandatory, which is the case for the flavoring substances covered by the Union List [some of which are still pending]. For the other categories, where they are not derived from food, or those using processes not laid down as permitted by the regulation. And it is mandatory for ‘other flavorings’ in all cases. So this means that grill flavorings and rum ether needed to undergo a safety assessment by EFSA.”
In 2012, when the Union List of Flavoring Substances was published [Regulation 872/2012] additional implementing regulation was brought out [Regulation 873/2012]. In this Regulation, the timeframe for safety evaluation for all other materials that are not flavoring substances was laid out. “So there it is clearly mentioned that anything that falls within this list needs to be evaluated before April 22, 2018. It was necessary to submit dossiers for those materials that you wanted to have in the evaluation by October 22, 2015,” Woelke explains. “It was not laid down specifically how quickly EFSA was supposed to conduct these evaluations, so it just states that it is evaluated as safe until that point in time can then be included in the Union List and is permitted in the EU,” she adds.
Amid this transitional period, Symrise persistently asked their suppliers for grill flavors on updates on how the correspondence with EFSA was progressing. But without feedback, both parties simply had to wait for the Authority’s conclusions. “This continued until September 11, 2017, and then EFSA published two opinions on the two grill flavorings, with the conclusion that they couldn’t publish the safety evaluation because the data sets were not sufficient,” she notes.
For Symrise, the opinion was the starting phase for an intense phase to understand what it meant and whether there was an option to submit materials in order to get these substances approved before April 22, 2018. Or which alternatives can be produced in case this is not possible? “So then the machine really kicked into gear quite heavily, with the timeline to find alternatives rather tough or even to submit data for EFSA to conclude that these materials are safe,” Woelke notes.
Red Arrow advocated for an extension of the transitional period so that the materials could be used until further data has been submitted and evaluated. “We supported the supplier with additional information on use levels and food categories where they are used. They negotiated with the EC and were in a dialogue with many of the Member States, which we monitored, but the more time that it moved on, it became clear that this was not realistic,” she added.
In a statement to FoodIngredientsFirst, Red Arrow Products said that it is “committed to providing safe, quality, and compliant ingredients,” stressing that “grill flavors have been safely consumed for over 30 years.”
“Regardless of the recent, unfortunate rejection by the EU Commission to extend the use of Grillin’ 5078 and Grillin’ CB-200SF, Red Arrow supports the continued safe use of these grill flavors. We continue to demonstrate our due diligence with an extensive safety evaluation plan, initiated in 2017, to go above and beyond answering any questions that EFSA had cited in their opinions of 2017 which indicated that more data was required.”
According to Nancy Higley, Ph.D., Vice President Regulatory and Toxicology External Affairs, the Red Arrow program is designed to meet the global standards of food safety evaluation.
Red Arrow says that the following studies are being conducted:
Characterization of Unknown Fraction: Although it can be inferred from the manufacturing process that the majority of the product is derived from the starting oil material, Red Arrow has an extensive analytical program using state of the art reference libraries to further identify the unknown fractions of Grillin’ 5078 and Grillin’ CB-200SF.
Preliminary, Unaudited Results: As expected, the >400 constituents in these Grillin’ flavors are fatty acids and phospholipids typically found in the starting oil material.
Exposure Refinement: Although there is a history of safe use of Grillin’ flavors, Red Arrow has revisited the use levels and engaged an expert third party to estimate the consumption of these grill flavors. There are several acceptable methods to determine exposure to flavoring substances. Red Arrow has chosen the Added Portions Exposure Technique (APET). APET was developed by EFSA and is an adaptation of the method acceptable by the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization (WHO).
Preliminary Unaudited Results: Based on the normal and maximum use levels for adults and children, the exposure estimates continue to indicate adequate margins of safety for the current consumption of Grillin’ flavors. In addition, the results support the doses planned for the feeding study.
Toxicology Study: Reverse Bacterial Mutation Using Preincubation: Although previously the external scientists had advised that this study was not necessary, Red Arrow has since conducted this study for both Grillin’ 5078 and Grillin’ CB-200SF.
Preliminary Unaudited Results: Confirmed results indicate no increase in revertant colonies, therefore, no demonstration of genotoxicity. The laboratory draft report is in review.
Toxicology Study: Micronucleus Study: Although previously the external scientists had advised that this study was not necessary, Red Arrow is conducting this study for Grillin’ CB-200SF.
Preliminary, Unaudited Results: No preliminary data is currently available.
Toxicology Study: Subchronic Study: Although EFSA has not indicated the necessity of this study, Red Arrow is demonstrating its commitment to the safety program by conducting this study for both Grillin’ 5078 and Grillin’ CB-200SF.
Preliminary Unaudited Results: Confirmed that a dietary route of exposure is acceptable by the animals and technically feasible. The 14-day, dose-range study on Grillin’ CB-200SF indicated no in-life adverse effects and no adverse macroscopic observations upon necropsy.
Red Arrow said it is proceeding to conduct the 90-day study in accordance with global standards and consideration of the completed exposure assessment (outlined above).
“All unaudited data and reports reviewed to date demonstrate no safety concerns. Red Arrow continues to complete this very extensive program and continues to support that Grillin’ 5078 and Grillin’ CB-200SF are safe under the conditions of intended use. Red Arrow Products will continue to keep the industry updated as more results from these studies become available,” the statement concluded.
The company has now created a new grill flavor that is approved for use in the EU and that it says is identical in flavor characteristics to the legacy grill flavors: Grillin’ CB-200SF. “Grillin’ RA18016 is a natural flavoring that brings the authentic grill impact customers have come to expect from the creators of the gold standard for grill flavors,” the statement notes.
Kerry bought Red Arrow Products at the end of 2015, as a leading supplier of natural smoke flavors and authentic natural savory grill flavors serving meat, culinary and food industry markets worldwide. Headquartered in Manitowoc (WI), Red Arrow operates from manufacturing facilities in Manitowoc (WI) and Rhinelander (WI) supported by Application & Development Centres in Germany and Sweden. At the time, a Kerry statement read: “Combined with Kerry’s recent acquisition of Wynnstarr Flavors and KFI Savoury (the US-based savory business of Kraft Food Ingredients), the acquisition of Red Arrow will further strengthen Kerry’s taste, technology and savory flavor industry leadership.”
Grothe of Symrise noted that with the publication of the EFSA opinion, the company started to develop alternatives. “This is not necessarily easy as the products that we talk about are well known and have quite a strong and typical taste. So we started the development of best possible alternatives, which took some time. The result is the products that we are now using to replace these grill flavorings in our flavor formulations. They do not provide exactly the same taste, but it comes very close to it. You have to consider that our solutions are not treated with such high temperatures as the traditional grill flavors. This has an influence on the taste, which we can compensate with flavor creations added, but as well on the presence of critical components estimated to be contained in the traditional grill flavorings. If you look into all the key aspects of permissibility & safety, performance and costs, we have really a very good and highly competitive alternative to offer.”
Speaking about the development process which took just 3-4 months [September 2017-January 2018), Woelke noted how in the beginning it looked like a big challenge to get the taste profile. But Symrise was ultimately able to come very close to the original taste profile. “What I heard from the development teams is that if you compare the materials directly, you can identify the alternative in some cases, but in a later food matrix, the differences in taste are hard to detect in most cases,” she claims.
When it became obvious that the traditional grill flavors would have a very little chance to be used beyond April 22, Symrise began informing customers about the likely regulatory changes and assisting them in adjusting formulations. This was in order to ensure that the taste profile of existing products was maintained. “We took a careful look at labels, for everything containing ‘grill flavoring.’ We needed to take care that there is no change in label as it would have huge impacts on customer products in designing new packaging with another labeling, which was not an option. So that was an essential part of the development to ensure that we are keeping the labeling, as is the case for the final product,” she notes.
In spite of the comparable cost in use, the solution additionally provides a natural advantage over the grill flavors that Symrise previously used. The base of the flavoring preparation is regarded as “natural” according to the EU legislation and if a natural top note is used, the customer has the advantage of labeling this as a “natural flavoring” on the product. “This is an important point of difference as when you look at the trends in the convenience foods market, many customers and consumers are looking for products with a natural labeling. That applies to culinary convenience products and snack foods. We would be able to support front-of-pack labels that refer to natural ingredients,” says Grothe.
“For us, it is a new segment that we can offer. We used grill flavors before but we were not producing these materials ourselves. Now we do and we have extended the portfolio beyond a mere flavor labeling to those with a natural flavor labeling. We will even offer some products that fall into the category of food, where you can have a very transparent labeling list on the package that informs the customer of the detail. That fits perfectly in our strategy of having full a bandwidth from flavors to foods for taste solutions,” he adds.
“The option is always there that you file a new application under [EC Regulation] 1331/2008, which means a totally new dossier. The usual timeframe if everything goes smoothly is 2 years, if not longer. Our products are now so close to the taste profile that for us we are comfortable with them and are therefore not looking for a change back to these materials,” says Woelke.
She admits that this is a clear example of how regulation and other external influences are driving the portfolio and R&D agenda. “It’s not that industry on its own would have perhaps initiated this idea. But it shows that there are interesting opportunities when thinking out of the box. That is something that we do, when looking at the way safety evaluations are managed, in order to anticipate where there might be any critical candidates and to think outside of the box whenever possible,” she explains.
The initial focus for Grillicious will understandably be Europe, in order to protect existing customers and be in line with regulation. “Nevertheless the nice labeling option that we can create now depending on the markets we are going to will surely lead to launches,” says Woelke. “Grill flavorings do not offer a natural labeling and what we might well see is that countries may look into adapting these regulations around the permissibility of grill flavorings. And we have countries where customers produce products that they export to the EU and these will, of course, need to be aware of the changes too,” she adds. In the US, grill flavors are natural anyway, so this is not a market that will be targeted, Woelke adds. “But for markets in Asia there are a lot of countries that monitor closely the developments in EU and these new flavorings have potential there too,” she concludes.
By Robin Wyers