IADSA News Briefs

Trans-fatty acids and advertising decisions
The Codex Alimentarius Commission (CAC) adopted this month the definition of trans-fatty acids, which will be integrated into the Codex Guidelines on Nutrition Labelling. This definition was proposed by the Codex Nutrition Committee and agreed upon this year by the Food Labelling Committee with some minor changes to allow for the review of the definition should new scientific information become available:

?2.9 Trans Fatty Acids: For the purpose of the Codex Guidelines on Nutrition Labelling and other related Codex Standards and Guidelines, trans fatty acids are defined as all the geometrical isomers of monounsaturated and polyunsaturated fatty acids having non-conjugated, interrupted by at least one methylene group, carboncarbon double bonds in the trans configuration.?

Codex Members may, for the purposes of nutrition labelling, review the inclusion of specific trans fatty acids (TFAs) in the definition of TFAs if new generally accepted scientific data become available.

At the same meeting, CAC endorsed new work on a definition of advertising, following a question on the need for such definition coming from the Food Labelling Committee. This definition will relate only to nutrition and health claims.

A definition proposed by Canada during the last Food Labelling Committee meeting is currently open for comment and will be considered at its next meeting in 2007:

'Advertising - means to make any visual or aural communication or representation, other than a label, to the public or a section of the public, to convey information (expressed or implied) to influence choices, impressions, opinions or behaviours towards products and their features, product classes, companies or organizations, to promote directly or indirectly the sale of a product'.

Further information: [email protected]

Trans Fat Task Force
Canada's Minister of Health has welcomed the release of the final report of its Trans Fat Task Force. The Task Force was formed in 2005 from representatives from government, industry and the public, to provide guidance on how to reduce the trans fat content of foods sold in Canada.

New nutrition labelling regulations already mean that most pre-packaged foods must identify the content of 13 core nutrients, including trans fat. Now Health Canada will be working with other federal departments and agencies to assess the Task Force's recommendations and determine what further action should be taken.

The risk analysis of CoQ10
In Japan, the medicinal dosage of CoQ10 is 30 mg/day, but it is more commonly taken as a dietary supplement at the daily dosage (permitted since 2001) of between 100 mg to 200 mg.

About a year ago, Japan's Ministry of Health, Labour and Welfare (MHLW) asked its Food Safety Committee to carry out a risk analysis of CoQ10 and its conclusions have recently been announced.

The Committee stated that it was difficult to decide an upper daily safe dose because of lack of data. The Committee also noted that the level of CoQ10 contained in many food products marketed in Japan exceeded the medicinal dosage. Therefore, its view was that MHLW should take risk-management action to:

  • require manufacturers and distributors to confirm the safety of the dose in long-term use
  • to provide information to consumers on any warnings or cautions as to intake
  • to document information on adverse reactions, etc.

The MHLW is due to receive the final conclusion from the Committee, after which the notice will be published.

Black cohosh: EMEA warning statement
On the basis of a review of 42 case reports of hepatoxicity, only four of which showed a temporal association between black cohosh and liver damage, the European Medicines Agency (EMEA) and its Committee on Herbal Medicinal Products have issued a public statement.

The statement warns of the potential connection between herbal medicinal products containing black cohosh root (Cimicifugae racemosae rhizome) and hepatotoxicity and gives the following advice:

  • Patients should stop taking black cohosh root and consult their doctor immediately if they develop signs/symptoms suggestive of liver injury (tiredness, loss of appetite, yellowing of skin/eyes, severe upper stomach pain with nausea and vomiting or dark urine).
  • Patients using herbal medicinal products should tell their doctor.
  • Health care professionals should ask patients if they use products containing black cohosh.
  • Suspected hepatic reactions should be reported to the national adverse reaction reporting schemes.

As a result of the EMEA statement, the UK Medicines and Health Care Products Regulatory Agency has announced that it will require warning labels on black cohosh products, and in Sweden, discussions are being held on improving the information currently required on product leaflets by listing the symptoms of liver damage. In Australia, warnings on black cohosh products are already mandatory.

Association to complain to courts
The French dietary supplements trade association, SDCA, is to make an official complaint to its administrative courts about the French decree on maximum levels for vitamins and minerals in food supplements. This decree, made in advance of the European Union levels yet to be set by the European Commission, sets low national maximum levels for vitamins and minerals.

It is expected that SDCA's complaint, made without prejudice to other complaints to the European Commission by European operators, will be lodged at the end of this month.

Commission pressure over herbal ingredients
Earlier this year the European Commission decided to continue its proceedings against Spain over infringements of single-market rules on products containing herbal ingredients.

The Commission sent Spain a 'reasoned opinion' to the effect that there are obstacles in Spain to the marketing of products containing herbal ingredients, which are legally marketed and/or manufactured as food or dietary supplements in other member states. Among the products concerned are those containing guarana, ginseng, soy isoflavones and alfalfa, legally sold as food supplements elsewhere in the European Union, but classified as medicines by the Spanish authorities when they enter their market.

The response of the Spanish authorities to the Commission is now awaited.

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