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EFSA cellulose clearance “critical” to additives industry, says Dow manager

This article is powered by EU Food Law

The positive opinion that the European Food Safety Authority (EFSA) handed down for a range of celluloses is “critical” to the additives sector as health-conscious consumers seek a fibre-rich diet, Michiel Van Genugten, Global Market Manager, Dow Food Solutions told IEG Policy.

In the opinion published on 16 January EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS) concluded that there would be no safety concern at the reported uses and use levels for the unmodified and modified celluloses (E 460(i); E 460(ii); E 461–466; E 468 and E 469).  The Panel was re-assessing celluloses under the EU’s re-evaluation programme for existing additives on the market in January 2009, when the 2008 additives regulation (1333/2008) took effect.

Critically, the Panel concluded that there was no need to set a numerical safety limit – the acceptable daily intake (ADI) - and advised that its conclusions were based on an indicative total exposure (daily consumption value from food additive use) of 660−900 milligrams per kilogram of bodyweight (mg/kg bw) per day.

The Panel found that the “structural, physicochemical and biological similarities, allows for read-across between all the celluloses.”  This means that data generated for one can be used to assess safety of another. 

EFSA’s experts also found that “animal and human data demonstrate that microcrystalline cellulose (E 460(i)) and powdered cellulose (E 460(ii)) are not absorbed intact in the gastrointestinal tract but could be fermented by intestinal microbiota. Chemically modified celluloses are not absorbed intact, nor fermented, but are excreted intact via the faeces.”

More specifically, the opinion states that “using the read-across approach, adequate data on short- and long-term toxicity and carcinogenicity and reproductive toxicity are available.”

It goes on to say that “despite the limitations of some of the studies, the available data do not indicate a genotoxic concern for microcrystalline cellulose, methyl cellulose and carboxy methyl cellulose, and by read-across, of the other modified and unmodified celluloses.”

Moreover, the Panel states that “no adverse effects were reported after repeated doses up to 35 g/person of microcrystalline cellulose or powdered cellulose; oral ingestion of some modified celluloses up to 6,000 mg/person per day for eight months in patients suffering from diarrhoea or constipation was well tolerated.”

In drawing up the opinion the Panel noted that “adequate combined exposure data were available; in the general population, the highest 95th percentile refined exposure assessment estimates calculated based on the reported data from food industry was 506 mg/kg bw per day in toddlers (brand-loyal scenario).”

The Panel further set an indicative high refined exposure assessment of up to 448 mg/kg bw per day for the elderly calculated on the highest intake (95th percentile) among those consuming food supplements.

FSMPs for infants and young children

However, the Panel concluded, that “the available data did not allow for an adequate assessment of the safety of use” of sodium carboxy methyl cellulose (E 466) in infants and young children consuming foods for special medical purposes (FSMP) and special formulae.

The Panel points out that for infants and toddlers only consuming FSMP, “the highest 95th percentile refined exposure estimate was 1,557 mg/kg bw per day in infants.”

Nevertheless, the Panel also noted that “E 466 seemed not to be used in these food categories as no use or use levels were submitted by industry and only very few food belonging to these categories appeared to be labelled with E 466.” 

As with almost all the opinions on additives re-evaluation the Panel recommended that the European Commission considers lowering the maximum limits for the toxic elements arsenic, lead, mercury and cadmium present as impurities in the EU specifications for unmodified and modified celluloses.

Quantum satis use

Welcoming the conclusions, Van Genugten told us: “The EFSA re-evaluation supports the continued use of cellulosics in approved food categories “quantum satis”, meaning no maximum limit is specified.  The re-evaluation supports current uses and use levels by Dow Food Solutions customers.”

The EFSA opinion “solidifies Dow’s continued commitment to utilizing cellulosics food additives,” Van Genugten said.

Van Genugten explained how the celluloses are used in food production and the benefits they bring: “Celluloses’ popularity in food additives has risen due to its versatile properties and wide range of benefits such as its ability to act as a fibre supplement, calorie reducer, thickener or anti-caking agent.”

“Celluloses’ popularity in food additives has risen due to its versatile properties and wide range of benefits such as its ability to act as a fibre supplement, calorie reducer, thickener or anti-caking agent.” - Michiel Van Genugten

He went on to list a few applications driven by consumer food desires and trends, namely: 

  • Fibre supplements that soubise without gritty texture: A major advantage is cellulose’s ability to increase bulk and fibre content without impacting flavour. For example, its impressive solubility allows for end use supplemental fibre products to easily combine with water without a gritty texture or after taste.
  • Diet foods to feel fuller with less caloric intake: Its thickener properties and lack of caloric value leave an individual feeling physically full with a reduced amount of consumed calories.  
  • Thickeners/Emulsifiers for food stabilization and reduced-fat: Cellulose gel stabilizes food while also preventing water from separating. The thickening properties of celluloses allows for more air to be whipped into products, reducing the amount of fat used and leaving consumers with tastier, healthier options. 
  • Anti-caking agent for moisture absorption: Cellulose’s ability to absorb moisture and coat ingredients makes it the ideal choice for anti-caking applications. Powdered cellulose is the most popular form and can found in an array of products, including shredded cheese, powdered drink mixes and spice mixes.

Opinion reinforces cellulosic safety

 “As a heavily relied upon food additive, the re-evaluation of celluloses reinforces the safety of cellulosics and is of critical importance in an environment where consumer preferences on the food they consume are based on perceptions and not scientific evidence,” Van Genugten said.

 “With consumers becoming increasingly conscious of what they eat, the results from the evaluation will have a positive impact on the relationships between consumers and food formulators who utilize these food additives to create healthier food alternatives,” he continued.

“In addition, celluloses play an especially important role to the food and beverage industry generating the highest revenue of the global Carboxymethyl Celluloses market at 33.7%,” Van Genugten said, adding: “With such a large stake in the industry, cellulosic food additives are recognized as valuable pieces in the food production supply chain and will continue to be utilized, potentially even more so moving forward after this re-evaluation.”

“With such a large stake in the industry, cellulosic food additives are recognized as valuable pieces in the food production supply chain and will continue to be utilized, potentially even more so moving forward after this re-evaluation.” - Michiel Van Genugten

Van Genugten went on to look at the effect that the EFSA opinion will have on current trends, telling us: “As consumers become increasingly more conscious of their health they are adopting a more fibre-rich diet due to its believed benefits to reduce the development of diabetes, heart disease and arthritis. To satisfy this new demand, food formulators must adopt new strategies to produce more food products with increased fibre levels.

“This will cause formulators to depend on food additives, like cellulosics, that offer the health benefits their consumers are desiring, while ensuring manufacturing ease and maintaining full-flavour taste.”

EFSA's opinion is an advisory risk assessment. The Commission and EU member states will now need to translate that into EU law.

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