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IADSA briefs - July 2009


New self-regulation objectives for industry
The South African Health Products Association (HPA) continues to negotiate with the Department of Health (DoH) to implement acceptable and appropriate regulations for the broader category under which food supplements fall under but is also pushing ahead with plans to set up a self—regulatory structure that will both assist the DoH and protect the industry from unethical practices and unscrupulous marketers.

The self—regulatory initiative is felt to be particularly important as, to quote HPA Chairman Dr. Alan Tomlinson, "until appropriate regulations are put in place, there is currently 'regulatory limbo' with 'certain operators …taking chances with the safety, quality and efficacy of products being placed in the market', creating a '…totally unacceptable' situation."

A series of further meetings are planned to work out the structure, legal basis and objectives of such a scheme, and practical issues such as costs, premises, staffing, etc.


2010 health claims deadline won't be met
EFSA is due to complete the review of all claims submitted by the end of the year, and the publication of the list of Article 13 claims is scheduled for the end January 2010. However, the European Commission has now acknowledged that this deadline is most unlikely to be met, and no further deadline has been set as yet.

The majority of claims submitted under Article 13.5 and Article 14 (for products for children and disease risk reduction claims) have been rejected by EFSA because the substantiating evidence was not considered to be adequate, and EFSA has now published a draft 'Frequently asked Questions' (FAQ) document which addresses the key issues for assessing the evidence for these claims.

The FAQ was discussed at the EFSA 'Technical meeting' to which key industry members were invited, and which EFSA hoped would assist industry understand what their scientific assessors expect in terms of substantiating data.

Technical experts from both ERNA and EHPM attended the meeting which, it was hoped, would also offer the opportunity to discuss the methodology for the review of Article 13 claims. Currently, despite the fact that the Regulation says that the assessment and authorisation process should be different from that for Article 13.5 and 14 claims, EFSA continues to maintain that the same level of assessment will be applied.

As foreseen, EFSA did not want to address the article 13.1 claims during the meeting and provided no opportunity to discuss it, and indicated that it is up to the Commission and the Member States to organise such meeting.

Although the participants were able to put forward a number of technical questions, there was no real and practical new information, apart from a new procedure for a dialogue with applicants. EFSA referred very often to the need for a case by case evaluation and to the impossibility to provide general guidance.

Regarding how EFSA complied with the requirement to weigh the evidence, EFSA indicated that it had decided not to use grading of evidence, but it does underline the degree of quality of the evidence underlying the claim and that it would not change their approach as to if a cause and effect is established (a YES/NO approach).

Source: EHPM / ERNA

EFSA working group on soy isoflavones
The German Federal Institute for Risk Assessment (BfR) has formally requested the European Food Safety Authority to deliver a scientific opinion on the use of isolated isoflavones in food supplements.

An ESCO working Group on isoflavones will be created to collect all the relevant scientific information. The Group will undertake a review of the literature and of the data via a structured search strategy, with the aim of completing the report by the end of the year.

EFSA consults on enzyme guidelines

The European Food Safety Authority (EFSA) has launched a public consultation on draft guidelines for the safety evaluation of food enzymes. The guidelines will specify the type of information that industry should provide to enable EFSA to carry out the safety assessment of enzymes — including description of chemical composition, properties and toxicological tests.

On the basis of this information, EFSA will address the safety of the source materials from which the food enzyme is produced (including the presence of possible impurities), the manufacturing process and dietary exposure.

As an initial phase, EFSA is requested to evaluate food enzymes presently on the market in the European Union (EU). Once completed, an EU list of authorised substances will be established by the European Commission. New enzymes will require safety assessment by EFSA before use.


Belgian and French associations join forces on health claims
The French supplement association SDCA recently attended a meeting with their authorities where it was agreed that evidence of 'tradition of use' could be used in substantiation for some botanical claims — something that EFSA is so far refusing to accept.

SDCA also alerted them to the absence of transparency and absence of guidance for the assessment of article 13.1 (generic) claims, and the need for a different process from that for Article 13.5 and 14 claims. In addition, with the help of detailed and comprehensive written argument prepared by the Belgian supplement association NAREDI, the French government expert was persuaded to liaise with his Belgian counterpart with a view to table the question at an EEC meeting.



COT statement on glucosamine
Following a review of current evidence, the UK Food Standards Agency (FSA) Committee on Toxicology (COT) has concluded that glucosamine is unlikely to cause hepatitis.

The review was brought about as a result of a small number of studies which suggested a link between the supplement and inflammation of the liver. However, COT's view was that although it could not rule out a causal link in relation to these studies, the risk, if there was one, was 'very low'.

Agency warns on arsenic in rice
The UK Food Standards Agency has recently published results from a study of arsenic levels in rice drinks. In a study of 60 samples of rice drinks, the study found levels of total arsenic ranging from 0.0010 — 0.0034 milligram/kilogram, but also levels of inorganic, more harmful arsenic ranging from 0.0005 — 0.020 milligram/kilogram.

None of these levels were over the current legal limit, but the results have led the Agency to warn that toddlers and young children between 1 and 4.5 years should not have rice drinks as a replacement for cow's milk, breast milk, or infant formula. This is because they would drink a relatively large amount of arsenic, greater than that for older children and adults, because of their bodyweight.


New guidance on calcium and vitamin D
The US Food and Drug Administration (FDA) has issued new industry guidance on its recently published final rule which amends the health claims associating calcium with osteoporosis and therefore claims associating calcium and vitamin D with osteoporosis.

The new guidance, presented in the form of a Q & A, explains the specific requirements that must be on the label, the necessary characteristics of the food/food supplement, and gives some examples of the type of wording that may now be used:

  • a claim for calcium and osteoporosis could read: 'adequate calcium throughout life, as part of a well—balanced diet/physical activity, may reduce the risk of osteoporosis in later life'
  • a claim for calcium, vitamin D and osteoporosis could read: 'adequate calcium and vitamin D throughout life, along with a well—balanced diet/physical activity may reduce the risk of osteoporosis in later life'.

Source: AHPA

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