When the regulation first came into force on December 31 2008, there were several grey areas that needed to be clarified and issues that needed to be resolved.
Two years down the line, have the creases been ironed out or are debates still raging?
One area that was causing consternation was the manufacturing conditions for thermal process flavours, which are outlined in Annex V. The category did exist under the old directive but the new regulation provides a closer specification of manufacturing conditions, namely, heating the ingredients for up to 15 minutes at 180°C, with a doubling of the time allowed for every 10 degrees Celsius drop in temperature, up to a maximum of 12 hours. Hence, 170°C for half an hour, 160°C for an hour, down to 130°C at eight hours.
This appears to set a default minimum permissible temperature for thermal processing of flavours of 125°C (the maximum time of 12 hours would only be only 1.5 x the eight hour period, hence a drop of only five degrees). But some are concerned by a lack of clarity here and argue that many flavours can be successfully heat treated below that temperature.
"There are some questions surrounding thermal process flavourings as the new regulations do not currently specify a lower temperature limit," says Gerry Naylor, group quality assurance manager with Synergy, Carbery's flavourings and ingredients business. However, he concedes that "the industry is working closely with regulators to resolve this issue and ensure greater clarity".
Mixed grill situation
Another area of the regulation that remains distinctly muddy is the way in which grill flavourings should be labelled. "Essentially the legislation provides flavour houses with a list of positive ingredients, rather than the old negative list," explains Naylor. "Due to the variety of flavour processes, this has meant the classification of some flavours has taken longer than others. For example, the industry is still waiting for clarification of whether 'grill' flavourings can be declared 'natural' or must be labelled as 'other flavourings'.
"A natural products group is working with the European Flavour Association (EFFA) to help resolve this and we are closely monitoring progress in order to update our customers as soon as a decision is made." Until a consensus is reached, it seems it is up to individual flavour firms to apply their own interpretations of how grill flavours should be labelled. Savoury Flavours, for example, says that it is being told by its suppliers that grill flavours can be labelled as 'natural' and that they fall under the definition of 'flavouring preparations'.
It appears confusion is also reigning in the area of smoke flavours. Smoke flavourings are defined within the legislation as primary smoke condensates and are additionally regulated by EC 2065/2003, requiring assessment from the European Food Safety Authority (EFSA). The idea is that this assessment will provide the industry with a positive list of ingredients that can be used as smoke flavourings.
To date, the list has not been completed but Synergy says it envisages that it will be published this year and will allow a transition period. "We are monitoring progress on this topic in order to inform our customers of key developments and aid their formulation needs," says Naylor. But not all in the flavours industry are quite as understanding about the EFSA delays. "With smoke flavours we're in the ludicrous position of the regulation stating that only smoke flavours that have been evaluated by EFSA are permitted, yet EFSA has yet to produce an approved list of smoke flavours," says Geoff White, general manager of Savoury Flavours.
"Effectively we've reverted to a situation where we can only use the smoke flavours from suppliers who have submitted data to EFSA. It's extremely messy because food manufacturers don't know what they can and can't use."
Even once these issues are resolved, the European Commission's (EC's) work on flavourings will be far from done. Article 10 of the regulation states that only flavouring substances included on a positive list will be permitted to be used in the EU. To enable it to draw up this list, the EC has tasked EFSA with carrying out a safety review of 2,067 flavouring substances.
EFSA completed the first round of assessments in November, at which time it reported that 'the majority of flavouring substances (1,667) do not give rise to safety concerns'.
But as Dan Dils, executive director of EFFA, is quick to point out, this does not mean the remaining 400 or so flavourings are unsafe.
"This does not necessarily mean that these substances pose a risk to health, just that EFSA needs further information to be able to complete its safety assessments." According to Dils, since EFSA released this statement, approximately 80% of the outstanding 400 flavourings have been reviewed and deemed safe. The safety authority has until 2014 to complete the evaluation, but Dils expects the EC will publish the positive list around September/October of this year.
Measuring the impact
There has been much speculation about what the implications of the new regulation would be for flavour houses and food manufacturers.
For flavour houses, the challenge has been one of reviewing and, where necessary, reclassifying the raw materials in their databases, as well as adjusting some flavour formulations, according to Christiane Jarke, director strategic regulatory affairs for flavour and nutrition with Symrise.
For food manufacturers, adapting to the new regulation looked like it could involve either reformulation or new labelling/packaging for some products, owing mainly to the loss of the 'nature identical' and 'artificial flavourings' categories, as well as the new '95/5 rule'. "Named natural flavourings, such as 'natural strawberry flavouring', must now adhere to the 95/5 rule, which states that at least 95% of the flavour must come from the named source. The remaining 5% can only be used to modify or standardise the flavour and must also be natural. Those flavourings that contain less than 95% of the named source come under the 'natural x flavouring with other natural flavourings' category," explains Synergy's Naylor. Under the old system, flavourings only had to contain 90% of the named substance to be designated as 'natural flavourings'.
Food manufacturers therefore face the choice of either moving to the longer declaration (natural x flavouring with other natural flavourings) or reformulating.
"Increasing the percentage of natural flavouring substance x from 90% to 95% in order to describe a flavouring as 'natural x flavouring' has meant that food processors have had to make a commercial decision as to whether to change the product declaration or face the potential cost of increasing the natural x flavour content," says Robert Foot, legislation manager at Frutarom. He says new briefs for flavour development have been for flavourings to fall into the 'natural flavouring' or 'natural x flavouring' classifications and to avoid the longer description.
It's a similar story at Synergy, where Gerry Naylor says: "We have been able to aid our customers to make any formulation changes in advance of these regulations coming into place. We have seen with some customers however, that they have decided to switch to using a simpler 'flavourings' declaration in order to avoid the lengthy 'natural x flavouring with other natural flavourings'."
In instances where manufacturers have had to change the wording of their ingredient declarations, they have 18 months from January to make the changes.
Some predicted that the 95/5 rule coupled with the loss of the 'nature identical' category which essentially provided a middle way between synthetic and natural flavours would result in more products being reformulated to contain only natural flavours, pushing up the cost of natural flavours. Opinions as to whether this has actually happened are divided.
On the one hand, Symrise's Jarke says that, as flavourings constitute only a minor part of the finished product, price changes only marginally affect the price of the finished product.