On 30 June 2011, the European Food Safety Agency (EFSA) published its 5th batch of 73 scientific opinions on general function health claims. Out of the 536 health claims assessed only 17 gained clearance. As before, the majority was rejected as either not sufficiently specific or as referring to food categories that are too broad, or that are not supported by any relevant studies in humans. With another batch of 35 claims expected still in July this year, EFSA will finalise the assessment of general function health claims on substances other than botanicals. This will allow the European Commission to finally establish a positive EU list for these claims.

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Background

Regulation (EC) No 1924/2006 on nutrition and health claims made on foods requires the establishment of an EU list of permitted health claims based on generally accepted scientific evidence. More than 4500 of these claims, also referred to as Article 13 claims or general function health claims, were submitted by the European Commission to EFSA for evaluation. So far, 2187 claims have been assessed in 4 individual batches (see our previous update). In the meantime, 1548 claims on botanical substances were removed from the process until it is decided how to proceed with their evaluation. Although EFSA opinions are not legally binding, they provide a helpful indication as to which claims may obtain formal authorisation in the EU, as the European Commission rarely goes against EFSA's scientific assessment.

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Scope of the 5th batch review

In its 5th batch, EFSA assessed 536 health claims in 73 scientific opinions. Substances subject to evaluation included the following:

  • Probiotics: Lactobacillus rhamnosus GR-1(ATCC 55826) in combination with Lactobacillus reuteri RC-14 (ATCC 55845); Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225); Lactobacillus rhamnosus ATCC 53103 (LGG);
  • Mineral substances: boron; sodium phosphate; folate; sodium bicarbonate; calcium and potassium;
  • Fibres: oat and barley grain fibre; rye fibre;
  • Fatty acids: linoleic acid alpha-Lipoic acid; fructo-oligosaccharides (FOS); n-3 polyunsaturated fatty acid; DHA, EPA and GLA; linoleic acid (LA) in combination with gamma-linolenic (GLA) acid;
  • Other substances: silicon; astaxanthin; arabinoxylan produced from wheat endosperm; creatine; acetyl-L-carnitine; fructose; spermidine; xanthan gum; β-hydroxy β-methylbutyrate monohydrate (HMB); sodium alginate; lactose; polydextrose; L-glutamine; phaseolamine; ribose; L-carnitine; αS1-casein tryptic hydrolysate; partially hydrolysed guar gum (PHGG); glycaemic carbohydrates; L-ornithine; melatonin; chitosan; L-tyrosine; sodium 5-Hydroxytryptophan (5-HTP); capsaicin; casein protein hydrolysates; carbohydrate-electrolyte solution; medium-chain triglycerides; acetic acid; a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene.

The opinions of the 5th batch also included the following foods or food categories: foods with reduced amounts of sodium; fat; foods with reduced lactose content; fruit and/or vegetables and the "Mediterranean diet"; sugar-free chewing gum with pyro- and triphosphates; sugar-free chewing gum with calcium phosphoryl oligosaccharides; sugar-free chewing gum sweetened with xylitol; very low calorie diet (VLCD) and intense sweeteners.

Despite having put the evaluation of claims on botanicals on hold, some of the opinions of this 5th batch refer to botanical ingredients. These included: oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds; raw fruit of Emblica officinalis Gaertn.; caffeine and theobromine in cocoa (Theobroma cacao L.); proanthocyanidins from cranberry (Vaccinium macrocarpon Aiton); anthocyanins from Ribes nigrum L.; formulated palm and oat oil emulsion; supercritical CO2 extracted blackcurrant seed oil; L-theanine from Camellia sinensis; beta-glucans from oats and barley and policosanols from sugar cane wax.

EFSA also published three opinions grouping claims that were not supported by relevant human data, two opinions that referred to foods or food constituents that were considered not sufficiently characterised, and one opinion listing claims that were considered too general and non-specific.

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Approved health claims

The approved health claims included the following:

  • "Oat grain fibre contributes to an increase in faecal bulk"
  • "Barley grain fibre contributes to an increase in faecal bulk"
  • "High sodium intakes increase blood pressure; consumption of foods low or very low in sodium helps to maintain normal blood pressure"
  • "Rye fibre contributes to normal bowel function"
  • "Replacing the usual diet with a very low calorie diet helps to lose weight"
  • "Consumption of beta-glucans from oats or barley contributes to the reduction of the glucose rise after a meal"
  • "Glycaemic carbohydrates contribute to the maintenance of normal brain function"
  • "Sodium contributes to the maintenance of normal muscle function"
  • "Carbohydrate-electrolyte solutions enhance the absorption of water during physical exercise"
  • "Carbohydrate-electrolyte solutions can contribute to the maintenance of endurance performance during prolonged endurance exercise"
  • "Consumption of lactose in amounts exceeding individual tolerances may lead to the occurrence of symptoms of lactose intolerance in lactose intolerant individuals; consumption of foods with reduced amounts of lactose may help to decrease gastro-intestinal discomfort caused by lactose intake in lactose intolerant individuals"
  • "Melatonin helps to reduce the time to fall asleep"
  • "Chitosan may contribute to maintaining normal blood cholesterol levels"
  • "L-tyrosine contributes to normal synthesis of catecholamines"
  • "Fat contributes to the normal absorption of fat-soluble vitamins"
  • "Consumption of arabinoxylan contributes to a reduction of the glucose rise after a meal"
  • "Consumption of fructose leads to a lower blood glucose rise than consumption of sucrose or glucose"

EFSA judged that the above wording reflects the scientific evidence available.

In addition, EFSA pointed out that the following claims, as well as a group of another 11 claims subject to a separate opinion, already obtained a positive assessment from the Authority:

  • A claim on sugar-free chewing gum and plaque acid neutralisation
  • A claim on sugar-free chewing gum and maintenance of tooth mineralisation
  • A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations, and claims on linoleic acid and on alpha-linolenic acid and maintenance of normal blood cholesterol concentrations
  • A claim on linoleic acid and maintenance of normal blood LDL-cholesterol concentrations
  • A claim on beta-glucans and maintenance of normal blood cholesterol concentrations

In view of the above, EFSA did not proceed with their evaluation.  

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Next steps

Following the publication of these opinions, EFSA is expected to finalise the evaluation process in the month of July with the review of the 35 remaining claims. Once the European Commission has received all of the opinions, it will proceed with the establishment, in one single step, of the EU positive list of permitted general function claims other than those referring to botanical ingredients. This process, which is on-going, involves discussions with Member State experts within the Standing Committee on Food Chain and animal Health (SCFCAH) and the preparation of a draft Regulation that will be subject to scrutiny by the European Parliament and the Council of the EU. The European Commission expects that the Regulation establishing a positive list of general function health claims for substances other than botanicals could be adopted by early 2012.