Dear Commissioner Byrne,
we refer to our e-mail of 12 December 2002 which included a press release and other information by a British association, Consumers for Health Choice, providing proof that some of the substances listed as "permitted nutrient sources" in Annex II of the Food Supplements Directive (FSD) are in fact highly caustic forms of the minerals in question, sodium hydroxide, potassium hydroxide and calcium oxide, which would be highly toxic if consumed by themselves.
1. The Commission's reply
1.1 The reply by the Commission services dated 10 January 2003, signed by Paula Testori-Coggi, states that the substances included in Annex II have been evaluated by the Scientific Committee for Food for use in the manufacture of foods, and that these same substances have also been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and are listed as food additives in the Codex Alimentarius Standard 192-1995.
1.2 We have been unable to locate any evaluation of these substances by the Scientific Committee for Foods on the website of the SCF. Can you therefore please specify when and with what results the Scientific Committee for Foods has evaluated these substances and for what type of use they were approved? Please point us to a publication of the SCF that can be located on an internet site, so we may access and study these evaluations.
1.3 You will appreciate that food additives are a substantially different category of ingredients from the sources of nutrients as listed in Annex II of the FSD. For that reason, an evaluation and approval by JECFA of these substances as food additives is of little relevance to their inclusion in a list of nutrient sources, such as the one attached to the Directive. Usually, additives are subject to exact quantitative limitations or at least to a more generic limit such as "quantum satis" levels, meaning the substance may be used only in quantities necessary for obtaining a specific technological result, not in higher quantities. We believe that there is an important distinction between use as an additive and use as a nutrient source. We therefore would like to have information on the specific use the substances were approved for, and whether levels of dosage and methods of use are specified.
1.4 The inclusion of corrosive substances as legitimate ingredients in supplements is a contradiction of "whereas 11" of the FSD which states: "The chemical substances used as sources [our emphasis] of vitamins and minerals in the manufacture of food supplements should be safe." It also contradicts your own press statement of 27 September 2001 where you stated: "We also must make sure that the chemical substances used to produce [or emphasis] vitamin and mineral substances are safe (Safety of food supplements - Commissioner Byrne welcomes political agreement in Council, IP/01/1324 Brussels, 27 September 2001
Is the chemical substance sodium hydroxide safe?
Is potassium hydroxide safe?
Is calcium oxide safe?
2. Missing substances
2.1 Another, equally important point, which we raised in our original e-mail of 12 December is the fact that while sodium hydroxide, potassium hydroxide and calcium oxide were approved for use in supplements, close to three hundred other substances that have been safely used for years in supplements which are currently on the market have been excluded for no valid scientific reason from the "approved nutrient sources" list published as Annex II to the FSD. Reference: http://www.laleva.cc/supplements/forgotten_substances.html
2.2 The response of your services does not address this inexplicable bias in the Directive, in fact Ms Testori-Coggi states that the Commission will put forward proposals to update the list of substances appearing in the Annexes to the FSD "when requests for substances to be added have been evaluated by the European Food Safety Authority", making it appear that updating the list would be a routine type of activity.
2.3 This is quite misleading. The information omitted in the reply is that despite years of experience of safe use for numerous nutrient substances, a "request for substances to be added" must be made in the form of a prohibitively expensive dossier containing exhaustive scientific tests. Ms Testori Coggi also omits to say that to produce such dossiers for all or even a majority of the "missing substances" is financially way out of reach for the companies which are manufacturing food supplements today, utilising these substances in their products.
2.4 The pharmaceutical producers and large food multinationals who have been using the more "simple" (but generally also less bioavailable and sometimes more toxic) forms of minerals in their medicinal and infant formula products have no necessity to overcome such a regulatory hurdle to continue to market their products, while compliance costs to the established companies in the food supplements market will soar and for many will become prohibitive.
2.5 This will squeeze out of the market many companies which are currently manufacturing food supplements using the more advanced formulations that have been omitted from the lists and as a consequence it will limit consumer choice without any compelling necessity for such limitation (except perhaps for the protection of pharmaceutical business interests).
2.6 Small and medium sized businesses are an important part of economic activity in the European Union. Why would the European Union act to decimate a significant segment of the health products market which for the past three decades has grown immensely - thanks to the hard work of small and medium sized companies - and to hand it over to the large pharmaceutical producers on a silver platter? Please explain - we are finding it hard to grasp the motive for this apparently uncharacteristic and inexplicable move!
3. Consumer protection and Consumer choice
3.1 The letter of reply received from your services states that the primary objective of European food legislation is to ensure the highest level of consumer protection, and that the directive on food supplements is fully in line with this objective.
3.2 In theory, if one forbade the use of all supplements, any possible danger to consumers from the use of such products would be eliminated, and the Commission would have achieved its objective of ensuring "the highest level of consumer protection". Taken to such an extreme, the contradictory nature of such action becomes immediately obvious. However, even without any exaggeration, it is quite clear that the directive, while mentioning the maintaining of consumer choice as one of its objectives (in "whereases 4 and 5") clearly falls short of achieving that. Moreover, the directive fails to take into account the potentially life-saving nature of nutritional products and their use as an effective means of prevention.
3.3 By reducing the range of bioavailable forms of nutrients that may be utilized in the formulation of supplements and by subjecting nutrient dosages to severe limits yet to be set, the food supplements directive is slated to practically eliminate the immense potential for improving public health in a decisive way, which is an inherent characteristic of nutritional supplementation. The directive threatens to degrade nutritional intervention into a state of forced inefficiency, a mere "filling of the gap" between current insufficient intake of nutrients from foods and the minimal suggested intake levels which have been consacrated as the RDAs of vitamins and minerals in the EU member states. Its provisions clearly fail to take into account the use of supplementation at high nutrient dosages as a scientifically proven measure capable of improving the health of whole populations and as a cure for a myriad of diseases caused by nutrient imbalances in individuals.
3.4 While consumer protection is a highly desirable objective, it seems hardly wise to "throw out the baby with the bath water", something the food supplements directive is quite obviously set to do. Could you please explain why no emphasis has been given in the directive to the positive side of supplementation? Was this aspect seriously considered when preparing the directive? If it was considered, what was the reason for drafting a directive that clearly is set to negate the important health effects of nutritional intervention?
4. Risk Analysis
4.1 The concept of scientific risk assessment is mentioned in "whereas 14" and in Article 5 of the directive, with reference to establishing maximum levels of dosage to limit the amounts of individual nutrients that may be used in the formulation of food supplements. A key flaw in risk assessments undertaken to date is that they have ignored "whereas 13" which includes the statement that, "Those levels [maximum safe levels] must ensure that the normal use of the products under the instructions of use provided by the manufacturer will be safe for the consumer." Can you please provide us with evidence that the instructions of use provided by the manufacturer have been considered in any risk analysis undertaken to date?
4.2 Risk management is an emerging scientific discipline practiced by an ever growing number of scientific experts, wich has been developed to deal with specific risks. Risk is part and parcel of human activities and it would be presumptuous to think that risks as such can be completely eliminated. Accordingly, the purpose of risk management is not the total elimination of risk, but the reduction of the various risks that present themselves to levels that are "AS LOW AS REASONABLY PRACTICABLE". This is commonly referred to as the ALARP principle, a giudeline that should inform all objective risk management decisions. The qualification "as low as reasonable practicable" is important because without it, risk management by itself would run the risk of creating economic and social havoc, interfering in unnecessarily heavyhanded ways and creating technical barriers to trade.
4.3 Risk analysis is a process for controlling situations where populations or ecological systems could be exposed to hazard. It usually comprises three steps, to be taken in sequence, namely risk assessment, risk management and risk communication.
4.3.1 Risk assessment is generally addressed in four stages, i.e. hazard identification, hazard characterization, exposure assessment and risk characterization.
22.214.171.124 Hazard identification involves the identification of a potential risk posed by any particular practice or situation. In our case this would be the potential risk posed by the consumption of food supplements by an ever increasing percentage of the population, specifically the highly hypothetical risk of "overdosing" nutritionally relevant substances.
126.96.36.199 Subsequent steps (hazard characterization, exposure assessment) would involve an impartial examination of statistical evidence which will show whether there is an actual or potential risk. The level of risk posed by any particular practice, in this case the consumption of food supplements, needs to be identified and compared to the risks that other comparable practices pose. If the level of risk is found to be below a threshold defined as "de minimis", i.e. a minimal risk as compared to other similar practices, nothing further needs to be done, because where there is no appreciable risk, there logically is no need to interfere in order to manage that particular risk. It appears that no effort was made to define what level of risk would be acceptable and what would be the threshold of unacceptable risk. Why has no consideration been given to establishing tolerable/acceptable risks and unacceptable risk levels?
188.8.131.52 In order to perform the final step of risk assessment (risk characterization), before one could establish the actual level of risk posed by supplement use, the "de minimis" level of risk and the acceptable level of risk for the product category would have to be defined. These latter two levels are not necessarily identical. To our knowledge, no risk characterization of supplement use been published to date, although this would be a preliminary step to take before deciding on any risk management options. Can you please explain why not?
4.3.2 Risk management
184.108.40.206 Where risk assessment has identified a risk that is above the acceptable level, several different options are available to reduce that risk below what is defined as acceptable, and in any case to a level approaching "de minimis" levels as closely as possible - the ALARP principle mentioned above. In this step, the social and financial cost of such intervention is weighed before recommending steps to reduce the risk. This means that economic impact assessments are required to ensure that technical barriers to trade are not imposed via unreasonable risk management decisions. Note: The Commission Services have confirmed that the Food Supplements Directive was passed without such an economic impact assessment.
220.127.116.11 In the case of food supplements, risk management options could include warning statements on product labels (examples: keep out of reach of children - do not use while pregnant - do not exceed the recommended dose without consulting a nutritional specialist - use Vitamin B 6 in dosages above 50/100 mg only in conjunction with a product supplying the whole B Complex) voluntary dosage restrictions for certain nutrients, by manufacturers (already in place) imposed dosage restrictions for certain nutrients (to be considered where voluntary restrictions have not been sufficient to bring an identified risk down to the level of ALARP) recommendations for formulation (combining folic acid with Vitamin B 12, associating copper with products containing zinc) restricting certain products for use only after obtaining advice from a nutritional specialist replacing one nutrient source with another which poses a lesser risk prohibiting an ingredient (nutrient source) from being used in food supplements altogether, where warning statements or dosage restrictions would not result in lowering the risk in a satisfactory way.
4.3.3 Risk communication
Risk communication is the means of communicating the risk management message. Where the elimination of a risk through direct intervention is not possible or not desirable, the public needs to be alerted to that particular risk by providing information. This has been used in other areas affecting health and examples such as - eat five servings of fruit and vegetables daily - do not exaggerate in the consumption of alcohol - reduce saturated fats in the diet - smoking is damaging to your health - are common forms of risk communication.
5. European policy on food supplements
5.1 The European directive on food supplements does refer to "scientific risk assessment" in its text, however the actual provisions of the directive disregard the principles and procedures of the science of risk assessment. The directive, while paying lip service to scientific risk assessment omits important steps of the process, proceeding from the identification of a potential risk to the immediate application of a few of the most heavy handed risk management options. A key problem is that the application of the directive assumes that "de minimis" is the maximum limit - it ignores the ALARP principle and ignores manufacturer risk management options via labels as mentioned in whereas 13 of the directive.
5.2 The route chosen is that of wholesale elimination of currently used supplement ingredients from the market, requiring industry to ask for exemptions from the ban if it wishes to continue to operate. The directive also envisions the establishment of maximum dosages for individual nutrients which, judging from the work performed by the Scientific Committee for Food to date, are not designed to lower an actual risk to an acceptable level but to completely eliminate any and all risks connected with their consumption, in violation of the ALARP principle and blatantly ignoring whereas 13.
5.3 The important step of risk assessment, the determination of the severity of the risk, with regard to the field of nutritional supplementation, has been completely omitted. Had the European Commission applied the principles of scientific risk assessment to food supplements from the beginning, that is, in the draft stage of the directive, it would have come to the conclusion that supplements, as a product category, do not present any appreciable risk greater than the "de minimis" threshold. Such an examination, although not specifically referring to the European situation, has been performed. It was done by examining available government statistics and peer reviewed publications, so as to compare the prevalence of various causes of death from official reports. (http://www.laleva.cc/petizione/english/ronlaw_eng.html)
The graphic representation of the relative prevalence of causes of death and the position of food supplements on a scale of increasing severity is striking, to say the least. (http://www.laleva.cc/petizione/ron_law_tables/tabella.html)
5.4 The inclusion of three caustic and clearly toxic (if used by themselves) nutrient sources in Annex II of the FSD might well be a result of "oversight", of using an existing list (established for use in the manufacture of baby foods) for reasons of "convenience". But this obvious inconsistency has led us to examine the larger issue of the legislative treatment of food supplements as envisioned in the EU directive. We see now that consumer protection, which is given by the Commission as the overriding reason for this legislation, is applied in an extremely one-sided way, without considering either the overwhelmingly positive aspects of supplementation or the disruptive effects that legislation will have on the existing market. An evaluation of the impact of EU food supplements legislation on SMEs (Small and Medium sized Enterprises) a document that normally must accompany any proposal for legislation that has relevance to existing commerce and production, was never made, violating established procedure. We also find that scientific risk management, while it is invoked in the text of the directive, has not been applied "by the book".
5.5 The result is that Europe stands to lose, with one stroke of the legislative pen, a very effective and inexpensive tool of prevention and maintenance of health, the nutritional approach to to health care. This nutritional approach could, if properly promoted and managed, at least partially replace the pharmaceutically dominated and increasingly inefficient public health paradigm of allopathic medicine, which has brought practically every national health care system to the brink of bankruptcy. Could it have been the very effectiveness of supplementation for good health that has led to its elimination by EU legislation?
5.6 As it stands, the directive is set to restrict freedom of choice of consumers to manage their own nutritional and preventive regimen. It also endangers the existence of small and medium enterprises in all member countries, which are the producers and distributors of supplements. But what is perhaps most important, it sets a course for the future of European health care which favours clinging to a failing paradigm of health based on symptom-oriented and therefore often inefficient pharmaceutical intervention. Our blind insistence on the "rightness" of this pharmaceutical approach to health has caused immense suffering, it has spread illness and is causing premature death in large numbers every year. It has also clearly shown its capacity to bankrupt national health care systems right across the continent.
6. Is it time to change?
We would appreciate for you to consider the information provided and in any case, we ask that you answer the following specific questions:
1) Please specify when and with what results the Scientific Committee for Foods has evaluated these substances (sodium hydroxide, potassium hydroxide and calcium oxide) and for what type of use they were approved. Please point us to a publication of the SCF that can be located on an internet site, so we may access and study these evaluations.
2) Why would the European Community act to decimate a significant segment of the health products market which for the past three decades has grown immensely - thanks to the hard work of small and medium sized companies - and to hand it over to the large pharmaceutical producers on a silver platter? Please explain.
3) Could you please explain why no emphasis has been given in the directive to the positive side of supplementation? Was this aspect seriously considered when preparing the directive? If it was considered, what was the reason for drafting a directive that clearly is set to negate the important health effects of nutritional intervention?
4) Why have the principles of scientific risk assessment not been applied to the subject of nutritional supplementation as a subject before drafting the directive? If a risk assessment has been performed, what was the outcome of the Commission's evaluation? Have the instructions of use provided by the manufacturer been considered? Have levels of tolerable/ acceptable risk been defined? Please point us to a text we may access and study.
5) Why does the directive start with a general prohibition of the use of substances (nutrient sources) that have been on the market for several years and have shown their safety, forcing industry to prove such safety, by providing expensive "scientific" justification for each substance? How does this tie in with the prior approval by the directive of at least three substances as nutrient sources which would clearly be fatal if ingested by humans in their pure form?
6) Why is no provision made in the directive to apply a gradient scale of risk management options, (as outlined in brief above) in accordance with the severity of actual risks of nutritional supplementation after they have been positively identified?
7) Will the Commission promote a review of the Food Supplements Directive in view of this analysis so that the scientific principles and procedures of risk management may be applied to food supplements legislation? If not, what would be the Commission's reasons for not doing so?
La Leva di Archimede
Association for freedom of choice