Video Launch: Regulatory Challenges in Natural Food Colouring

08 March, 2012
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Video Launch: Regulatory Challenges in Natural Food Colouring

 

Louisville, KY, USA – March 7, 2012 — “There’s no simple solution to replacing synthetic colours but consumers are demanding that they be replaced with natural colours,” said Jennifer Guild, Global Food Science and Regulatory Manager, during her presentation at the Fi Conference, “Advances in Natural Colour,” which was held in London last month.

[youtube http://www.youtube.com/watch?v=DPWaehjtvik&w=560&h=315]


Thank you, for allowing me this opportunity to speak today on behalf of my employer, DDW, The Colour House. where I serve as Global Food Science and Regulatory Manager. Let’s get a little exercise, please, to start the morning. Or afternoon. My time clock’s a little off. Please raise your hand if you have ever worked with trying to replace synthetic colours in your product formula.

Okay. And how many of you tried to do so using natural colours? How many using colouring foodstuffs? Okay, not so many. And how many of you tried to formulate a food or beverage for multiple regions of world? Okay. I bet those of you who raised your hands did not find your task easy. There’s no getting away from the fact that food manufacturers often need to add colour to processed food products.

The colour of food is a surprisingly large part of its appeal and is closely associated with consumer perceptions of flavor and quality. My son loves pineapple and pineapple flavored foods, so I was asking him what he would do, if I gave him a red pineapple flavored ice cream. And he told me that he would probably turn it away, thinking that I had mistakenly given him And strawberry ice cream.

And I said, “Well, you like strawberries and strawberry flavored food. So, what if I gave you the best tasting strawberry flavored ice cream, but it was a bit of a brownish red colour?” And he explained to me that, no, he’d probably still turn it away because he’d think it was yucky. So definitely, as we all know, colour plays a large role in consumer perceptions of the foods they’re about to eat.

The demand for natural colours has outpaced that of synthetics. While synthetic colours are of lower cost and more stable than natural colours, natural colours are on the rise, fueled by consumer concerns over health and improvements in the functionality of natural colours. What are you going to hear today?

You’re going to hear about the regulatory challenges facing colours. I’m going to speak a little bit to the Southampton study, which you’re very all familiar with, a little bit about the challenges that have faced caramel colour this last year, the issues related to sensitivity and allergenicity maybe of carmine and cochineal extracts and the next challenge facing colours, which is potentially adulteration.

We’re also going to question whether or not the challenges facing colours are easily avoided by using colouring foodstuffs. And when we decide that’s not the case and we return to using natural colours, we will question what regulatory considerations we need to take into account when using natural colours — such as the regional approval of the colours in the markets you’re trying to develop product for. And we’ll talk about the application limitations on the use of those colours. And the labeling options, both in the ingredient declaration and the principal display panel or PDP.

The Southampton study. There have been worries about the toxicity of some Azo dyes for at least 50 years, and many are no longer approved for use in foods in Europe, or are subject to new Acceptable Daily Intakes, or ADIs. As recently as 2007 the EU suspended the use of red dye 2 G in response to its breakdown to aniline, which is a known carcinogen.

The European Food Safety Authority or EFSA, is currently reviewing the safety of all European food additives, and as a matter of priority they were asked by the European commission to review, first, the Southampton Six colours, and then followed by the other colours and other food additives. EFSA has advised the commission in parliament to reduce the acceptable daily intakes for three of the colours in question, of the Southampton Six: the quinoline yellow, the sunset yellow and ponceau 4r.

Although EFSA concluded that the South Hampton study did not substantiate a causal link between the hyperactivity and six colours, there are still consumer concerns over this relationship. The UK Food Standards Agency or FSA, which funded the Southampton study still decided that the findings were sufficiently worrying for it to call for a voluntary ban on the use of the Southampton Six colours in the UK food and drink industry.

In 2008, the European Parliament reacted to the findings of the South Hampton study by adding to a provision of new food additive regulations which came into force in 2010. The requirement that the synthetic colours in question here represented here be identified by the name or the E number followed by the phrase, “may have an adverse effect on activity and attention in children.” At the same time, it should be noted that many in the colour industry find the results of the Southampton study to be inconclusive, and an FDA panel recently voted against warning labels for synthetic colours in the USA. However, the panel did call for more studies to determine if their is a link between hyperactivity and these colours.

While not an outright ban on the use of these colours or requiring labeling in all these regions, it is certainly encourage manufacturers to consider replacing these colours, not only in Europe but in the United States and other countries as well.

Caramel colour.
This year caramel colours have been under attack because of a chemical known as 4-methylimidazole (or 4-MeI) that is formed in the manufacture specifically of Class III and IV caramel colours.

On January 7, 2011, based on a technical report by the National Toxicology Program also known as the NTP, the California Office of Environmental Health Hazard Assessment or COEHHA listed 4-methylimidazole as a carcinogen under Prop 65. As a result, a group of plaintiffs filed a lawsuit against COEHHA for what they claimed to be a wrongful listing.

However, 4-MeI is ubiquitous in foods in the food supply and is a common trace element commonly created in the natural heat processing of many foods — including roasted coffee, chocolate, baked goods and class 3 and 4 caramel colours. However, it was still listed on Prop 65, despite all this use. Caramel class III and IV have been tested for rodent toxicity and have been found not carcinogenic.

Furthermore, on March 8, 2011, EFSA released its report that assessed the safety of caramel colours. Based on all available data, including the NTP report that formed the basis of the 4-MeI Prop 65 listing, the EFSA panel concluded that caramel colours “are neither genotoxic nor carcinogenic and there is no evidence of any adverse health effects on human reproduction or the developing child.”

However to help those customers that still try to avoid the Prop 65 labeling of their products using Class III and IV caramels in California, D D Williamson now offers multiple low 4-MeI versions of class III and IV caramel colours in both liquid and powder form. In addition, although conventional Class I caramels do not contain 4-methylimidazole, Class I caramels are not traditionally stable at low pH, so DD Williamson has developed a DDW 520 — which is an acid-proof class one caramel colour that is stable below pH 2.5. This is an innovation for the soft drink industry in particular, because Class one caramel is normally only stable down to pH 3.5.

This new innovation recently earned the company a Finalist position in the Beverage Innovation category for the Food Ingredients Excellence Award of 2011, which was a competition for innovative ingredients at Food Ingredients Europe.

Carmine sensitivity.
In January 2011, the US FDA required food companies to label cochineal colour or carmine colour, instead of the generic term “colour added,” which is permitted by the US FDA regulations.

The requirements were reportedly revised in response to, severe allergic reactions to these colourings. Canada is considering similar label requirements for cochineal colour. Sourced from the ground bodies of the female cochineal beetles, the colourings are used in a variety of products, including meat, ice creams, yogurts, beverages, and candies.

Product developers use cochineal extracts when replacing synthetic colours. These natural colourings provide a characteristic pink, red, or purple hue, and demonstrate excellent heat and light stability. However, in addition to the issues with sensitivity, cochineal also raises issues for product developers who are interested in kosher, vegan, or vegetarian labels.

Over the past few years, all colourings have frequently been in the spotlight: the Southampton study with the Southampton Six; EFSA colour reviews of the various colours (which are still on ongoing); caramel colouring chemical subject to Prop 65; allegations of sensitivity or allergenicity not only only against carmine and cochineal but also against annatto; Codex Committee on Food Additives, or CCFA; colour use level reviews; just to name a few with the recent regulatory challenges facing colours. Now, concerns are being raised that since natural colours are gaining popularity with improved functionality and stability, they may be at increasing risk for adulteration.

Natural food colours have been the target for adulteration through the addition of synthetic colours to raise the apparent quality, or the addition of inert materials to increase available quantities through dilution. The United States Pharmacopeia or USP has dedicated efforts to modernize the Food Chemical Codex or FCC, but is challenges in developing a method to identify all potential adulterants.

Industry is encouraging the USP and other governments to recognize that control of adulteration through improved supply chain relationships and supplier qualifications would be much more success-able than trying to develop a monograph to exclude all potential adulterants. This raises a good point, when selecting between natural colours.

Please make sure that you are comparing apples to apples. Natural colours are a very high-value item, and individual colours can come in short supply because of crop failure or political issues. Limited availability and high demands lead to high prices which creates an environment for adulteration. The adulteration of natural colours within expensive synthetic colours and other dyes may be tempting for the less-than-ethical suppliers.

And this has occurred in the past and undoubtedly will occur in the future. There are cases in Europe where chili powder and paprika were adulterated with Sudan Red. Not surprisingly, adulteration of the expensive spice saffron with Gardenia Yellow has also occurred. And it’s your responsibility to know the quality of what you are purchasing and the easiest way for you to do this is to work with an ethical and responsible supplier.

So, food product developers are increasingly being asked to replace synthetic colours with natural colours, but as we have heard, natural colours can bring a whole new set of problems, without necessarily dispensing with all of the old and some now see colouring foodstuffs as the easy answer but we’re questioning whether or not it’s really that simple.

Colouring foods are derived or are supposed to be derived from recognized foods. They do not require further approval for food use and do not need to be identified by an E number. An additional selling point of some colouring foodstuffs is that they can deliver not just colour but also health benefits.

However, according to the term colour as it is used in regulation 1333 – 2008, colouring food stuffs are commonly consumed food stuffs as such, and should be normally used as characteristic ingredients in food. In addition, if a foodstuff is subject to selective extraction, then it should be classified as a colour additive.

If it is not subject to selective extraction, it can quality as a colouring foodstuff. A small working group has been set up, comprising five EU member countries: Denmark, France, Finland, Sweden, and the UK. This group has been charged with the challenging task of agreeing on a definition for selective extraction.

On the 5th of July, 2011, during an EP Plenary debate on food information to consumers, Commissioner Dali made a commitment that he expected a guidance document defining colouring foods would be available in the second half of 2012. The objective of this expected guidance document is to give official guidance for differentiating food colour additives from colouring foods.

The document is expected to define the criteria that determines the difference between selective and non-selective extraction for the classification of colour additives versus colouring foods, and it plans to do so by a proposed decision tree as well as a checklist which will facilitate this classification.

So, are colouring foodstuffs the simple solution to the challenges of synthetic and natural colours? No, there are challenges facing colouring foodstuffs as well. They too lack globally harmonized definition, and they are often derived from the same sources as natural colours, so they have the same stability problems associated with natural colours.

especially in regards to heat and light. Colouring food stuffs are not selectively extracted for colour, so they will contain other components, such as flavor carry-over, which will cause a haze. Often colouring foodstuffs have to be used at a much higher level than a natural colour to have the same effect as the corresponding colour additive, and this will compound any flavor contribution or haze.

So since there is no perfect solution to replacing synthetic colours, what should you do? Last month Nielsen conducted an international consumer research survey regarding natural colours. They conducted this survey with 5,000 consumers in ten different countries, and the responses were: 90% answered that they are concerned about synthetic colours.

88% stated that naturally derived colours will add value to foods, and 78% said they’re willing to pay a premium for foods that are using naturally derived colours. So, it sounds like we’ve identified what we need to do to meet consumer expectations. We need to replace the synthetic colours with naturally derived ones.

So let’s explore some of the regulatory challenges of using natural colours. We need to consider the regional approval, the application that we’re trying to colour and the labeling options.

Regional approvals.
There are two principles that current colour regulations are really based upon: the additive must not be harmful, and the use of the colour additive must not mislead the consumers.

However, regulatory bodies across the globe interpret these principles very differently. Thus, the list of approved food colours varies by country. For example, the European Union approves the use of sodium copper chlorophyllin in a broad range of foodstuffs. However, although sodium copper chlorophyllin is an approved food colourant in the USA, it’s use is presently limited to dry citrus beverages and it can’t be used at levels above 0.2%.

In addition, vegetable carbon black, is used as a colour in Europe and other countries and although one time it was approved for use in the USA, it’s no longer approved. Gardenia Yellow is permitted for use in Japan and China, but not in the USA or Europe. Marigold extracts with lutein concentrations as high as 20% are approved for use as dietary supplements in the USA — as GRAS but not for use as food colour additives. In the European Union, lutein preparations are approved food colour additives.

And here you’ll find a list of the regulations which can help you identify which colours are approved in some regions. There’s more information on the DD Williamson website (http://www.ddwilliamson.com).

Regional limitations on use: Many countries have adopted the approved applications and usage levels posted by Codex Alimentarius and colour additive specifications published by JECFA. However, other countries independently regulate the use of colour additives, as you can see here: the USA, EU, Canada, Japan, and People’s Republic of China all specify how colours can be used, in which applications, and whether or not maximum use levels are permitted.

Labeling. The customer requirements, either the retailer or the end consumer, should be considered at an early stage to lessen the struggle of identifying what natural colour options can be considered for your product. The customer may have religious requirements such as kosher or Halal. Or they may have dietary requirements such as organic, natural, non-GM, vegetarian or vegan.

Let’s speak momentarily on the highly sought after natural claim. Generally, the use of the term natural is not permitted in a product’s ingredient list with the exception of the phrase “natural flavorings.” And there’s a few other exceptions that Sebastian identi
fied as well.

However, the principal display panel is quite another monster.

The principal display panel is regulated in various regions. But few global regions have defined the use of the term ‘natural’ in relation to food colours. The USFDA currently has no definition for natural, although it is not objected to its use on food principal display panel labels, provided that it is used in a manner that is truthful and not misleading, and the product does not contain added regardless of source, artificial flavors, or synthetic substances.

Warning letters have been issued by the FDA to enforce this policy as it is spelled out Federal Register preamble language from 1993. The FDA, however, still might be more willing to accept some natural claims than others, as long as you non-misleading as possible. One option might be made with naturally-derived ingredients, if that’s appropriate, as opposed to made with all natural ingredients.

Similar to the U.S. FDA informal position, the Canadian Guide to Food Labeling and Advertising indicates that a Canadian natural food or natural ingredient of a food is not expected to contain or to have ever contained an added vitamin, mineral, nutrient, artificial flavoring or food additive such as colour.

However, unlike the U.S. FDA, the Canadian authorities do acknowledge that some food additives are naturally derived. And they do allow for these ingredients to be regarded as natural ingredients. In addition, Canadian permits foods in which these natural ingredients are used to claim that the food contains natural ingredients, or contains only natural ingredients, as appropriate.

In 2008, the UK Food Standards Agency published a revised criteria for use of the terms “fresh”, “pure”, “natural”, etc. in food labeling. The term “natural” without application should only be used, according to this document, in certain cases, including to describe permitted food additives that are obtained from natural sources by appropriate physical processing, including distillation and solvent extraction, or traditional food preparation processes.

This position was further clarified in a 2011 UK FSA guideline on approaches to the replacement of the Southampton Six colours in food and beverages. In the 2011 public publication, the UK FSA distinguished between naturally derived colours that are selectively extracted, such as anthocyanins, being the more natural, and those that are selectively extracted, and then chemically modified, such as sodium copper chlorophyllyn extracts.

NATCOL, the Natural Colour Manufacturers Trade Association, is working on an industry definition of natural, but it’s in line with flavor regulations and these other global policies. The definition includes a colour classification scheme based traditional domestic and industrial practices. The working draft was presented at a pre-FIE session, but it still needs needs to be finalized and approved by members before it’ll be published on the NATCOL website.

Both the D.D. Williamson and NATCOL websites have a vast amount of credible information available to you, to assist your colour learnings.

http://www.ddwilliamson.com/standards

http://www.natcol.org
Closing thoughts: what are the take home messages? All in all, it has been busy if not a somewhat tumultuous year for all food colourings and I expect the future to continue to be colourful.

There’s no simple solution to replacing synthetic colours but consumers are demanding that may be replaced with natural colours. It is your responsibility to work with an ethical and responsible supplier, so you can know you’re working with safe, quality colours. It’s important to identify which countries a product is likely to be sold before you select your colours.

It is currently very challenging to have one colour formulation that will be globally acceptable. The customer labeling requirements, either the retailer or the end consumer, should be considered at an early stage of your product development to lessen the struggles of identifying what natural colour options are available to your project.

And utilizing the resources of a quality colour supplier will save you time and accelerate you achieving your goals. Considerable energy is expended in the corporate world in attempting anticipate changes in food colour regulations, because a possible de-listing or ADI reduction of a colour, based on new or lack of information relating to its safety, toxicity, or allergenicity, can induce frustration and anxiety in the workplace.

For ease of world trade, harmonization of colour regulations would be advantageous — but it’s highly unlikely.

Thank you.
Any questions?

 

Jennifer Guild, Global Food Science and Regulatory Manager, DDW“It’s important to identify [in] which countries a product is likely to be sold before you select your colours,” Guild says, offering the following advice for food product designers:

 

“It is currently very challenging to have one colour formulation that will be globally acceptable. The customer labeling requirements, either the retailer or the end-consumer, should be considered at an early stage of your product development to lessen the struggles of identifying what natural colour options are available to your project.”

 

Download a PDF of Jennifer Guild's Powerpoint presentation on Natural Colouring in FoodstuffsHer presentation, entitled “Natural Colour & Colouring Foodstuffs: Successfully Navigating Through an Uncertain Regulatory Environment and Preparing for Future Legislation,” provides a fresh update on the “Southampton Six,” carmine and cochineal sensitivity, adulteration risk, colouring foodstuffs, caramel colour, regional approvals, application limitations, and labeling guidelines – including the term “natural.”

 

In addition to watching Jennifer Guild’s full presentation, you can also download a PDF version of her Powerpoint slides here.

 

To learn more about Jennifer Guild, read her full biography. || To learn more about natural colours, visit NaturalColours.com

 

More information about the Fi Conference “Advances in Natural Colour” can be found at http://www.ficolour.com

 

View all videos in the Expert Answers series:
http://www.youtube.com/expertanswerstv

Natural Replacements for Synthetic Food and Beverage Colour Southhampton Six
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