Why does Europe not use compulsory food fortification
Received on May 28, 2009
This text was transmitted electronically. Deviations from the original are possible.
BM for health
Alois Stöger diplômé
President of the Federal Council
houses of Parliament
Vienna, May 27, 2009
GZ: BMG-11001/0099-I / 5/2009
Dear Mr President!
I answer the parliamentary written letter addressed to me Question No. 2664 / J-BR / 2009 by Federal Councilors Jürgen Weiss, Edgar Mayer and Ing.Reinhold Einwallner according to the information available to me as follows:
The constitutional service of the Federal Chancellery announced the following:
From a constitutional point of view, the question of mandatory flour fortification with folic acid should be examined in accordance with the objectivity requirement (Art. 7 B-VG, Art. 2 StGG), in particular whether, on the basis of the new findings, another approach for achieving the goal of avoiding Health damage from folic acid deficiency could be chosen. Furthermore, the encroachment on freedom of employment (Art. 6 StGG) associated with this obligation would have to be objectively justified and the mildest means of achieving the health policy objective. With regard to any interference with private and family life (Article 8 MRK) or personal freedom (Section 1 PersFrG), the BKA-VD believes that an obligatory flour fortification with folic acid does not seem to be of particular relevance. The BKA-VD points out that the questions should primarily be answered on a scientific-empirical level.
The government program contains the express passage that “risk studies on the fortification of flour with folic acid will be continued.” As shown in the answer to questions 2 and 3, the outcome of further studies should first be awaited before a comprehensive constitutional opinion is obtained must be able to rely on precisely these study results.
The final report of the overview work “Risks and benefits of folic acid fortification in flour in Austria” prepared by the Ludwig Boltzmann Institute Health Technology Assessment on behalf of the Ministry of Health is now available. The work summarizes the current state of knowledge. There is currently no clear recommendation for mandatory flour fortification to be derived from this.
Folic acid is a water-soluble B vitamin that occurs in its natural form (dietary folate) in foods or is increasingly being added to foods as synthetic folic acid (pteroylmonoglutamic acid - PGA) (e.g. breakfast cereals, beverages, ready meals, sweets). The biological activity of the various forms of folic acid is different, which is why an international agreement has been reached to use so-called folate equivalents (sum of folate-active compounds) as quantities in order to avoid different indications that cannot be compared with one another.
The folic acid requirement per day depends on age and gender. The recommendations of the German, Austrian and Swiss Nutrition Societies for the intake of folic acid (DACH reference values) take into account the basic requirement, a safety and a precautionary surcharge. The following table gives an overview of these DACH recommendations.
µg equivalent / day
Additionally in women
From 10 years on
400 µg PGA / day in the first trimester *
* Women who want to or could become pregnant should take an additional 400 µg synthetic folic acid (= pteroylmonoglutamic acid / PGA) per day in the form of supplements in order to prevent neural tube defects as best as possible. This increased folic acid intake should take place no later than 4 weeks before the start of pregnancy and should be maintained during the first trimester of pregnancy.
At the international level (IUNS-International Nutrition Society) there is currently discussion about lowering the general recommendation for adults from 400 µg to 200 µg folate equivalents. This value is also given in the current draft regulation of the European Commission on the labeling of food (“EU information regulation”) as a “daily recommendation”.
In Austria, folic acid is one of the "critical" nutrients, i.e. many Austrians do not achieve the recommended intake levels (DACH reference values). This can have problematic consequences, especially for girls and women who become pregnant, because a particularly high amount of folic acid is required in the first few weeks of pregnancy. If there is an undersupply during this time, this can result in severe malformations in the child (neural tube defects).
In many other countries, too, nutrition surveys indicate a critical supply of folic acid. Numerous countries have therefore dealt with the role of folic acid in the development of diseases, especially neural tube defects, in the last few decades. The frequency of neural tube defects varies greatly from region to region. A reduction in the incidence of neural tube defects through additional periconceptional folic acid administration has been proven by studies. Some non-European countries have therefore decided to make it mandatory to fortify certain foods with folic acid. This measure has also been discussed in some EU countries, but has not yet been introduced by any EU country.
In Austria, the legally mandatory fortification of flour with folic acid was discussed as a measure to reduce neural tube defects. At the same time, however, there were repeated doubts about the safety and appropriateness of this measure. Therefore, last year the Ministry of Health commissioned the above-mentioned overview, which is intended to serve as a scientific basis for a decision in favor of or against an obligatory folic acid fortification of flour in Austria. The aim of the systematic review was to provide the latest knowledge on the benefits and risks, effectiveness and safety of folic acid fortification.
The effectiveness of folic acid supplementation on the one hand and folic acid enrichment on the other hand in relation to the reduction of neural tube defects and other malformations was examined. Questions about the effect of enrichment on the folate status in the serum, the risk of miscarriages and twin pregnancies, the prevention of cardiovascular diseases, breast cancer and colorectal cancer, and the safety with regard to masking a vitamin B12 deficiency and anti-epileptic therapy were examined . In addition, the nutrition report presented in April provides more recent data on the nutrient supply of Austrians.
As the nutrition report shows, the folic acid intake in Austria is below the recommendations in all population groups (based on the DACH reference values for nutrient intake). It should be noted, however, that this data can be traced back to nutrition interviews. The information is extrapolated accordingly with the average content values available in nutritional databases for a wide range of foods. Many fortified foods available today are not included in the calculation databases. The next Austrian Nutrition Report will provide meaningful status data, in which, for the time being, blood analyzes are also planned on a broad basis. This report is currently being drafted and will be presented in 2012.
Nevertheless, it can be deduced from the available data that Austrian women of childbearing age and pregnant women have a supply of folic acid that is in need of improvement. (Younger) women of non-Austrian origin and low socio-economic status are more likely to have particularly low folic acid intakes. This collective is therefore the main risk group with regard to neural tube defects and must therefore be the main target group for measures.
On the incidence of neural tube defects and the effectiveness of enrichment in neural tube defects: The incidence of neural tube defects in Austria cannot be specified precisely. Extrapolated from international data, around 60 “cases” (live and stillbirths as well as induced abortions) can be assumed in Austria each year. Around 12 children are born alive with neural tube defects each year. In countries with mandatory folic acid fortification of a staple food (USA, Canada or Chile) there is a relative risk reduction of neural tube defects averaging 35%, which corresponds to an absolute reduction of 1 - 4 prevented neural tube defects per 10,000 births. With a total of around 77,000 births per year in Austria (2008 figure), such a measure (fictitiously) could prevent 7-30 neural tube defects per year. The effectiveness of the measure with regard to the prevention of neural tube defects can therefore be regarded as high.
Knowledge of possible adverse effects of fortifying flour with folic acid: An increase in risks such as masking a vitamin B12 deficiency in older people or the development of neurological disorders or the frequency of seizures in anti-epileptic patients has neither been proven nor refuted. The data on the risk of twin pregnancies associated with increased folic acid intake are contradicting one another. The hypothesis that folic acid increases the incidence of abortions is not sufficiently supported by study results.
The rise in folate levels in the blood as a result of folic acid fortification in the USA is significantly higher than originally forecast. In addition to this, many other foods in the USA are (voluntarily) fortified with vitamin cocktails, most of which also contain synthetic folic acid. The effects associated with exceeding the permissible upper limit for folic acid are currently unclear.
Evidence on folic acid and cardiovascular diseases: At present, no statements can be made regarding the effectiveness of a folic acid intervention on cardiovascular diseases. So far, no significant risk reduction for cardiovascular diseases has been proven in either primary or secondary prevention; a risk reduction has only been shown for stroke.
Evidence on folic acid and cancer diseases: Synthetic folic acid (the typical form for food fortifications and supplements) in high amounts may have a dual effect on tumor development: an inhibiting effect on tumor development in normal tissue and a progressive effect on pre-existing tumors. There is limited evidence that food containing folate protects against colorectal cancer. Findings on the association between folic acid and breast cancer are inconsistent. A study carried out on the occurrence of prostate cancer is associated with some uncertainties and in some cases of limited informative value. Follow-up studies would be necessary here in order to be able to derive more precise statements.
To question 3:
With the current state of knowledge, ensuring a sufficient folic acid status prevents any specific damage to the fetus in pregnant women.
The recommendation that women who want to (or could) become pregnant before conception up to and including the eighth week of pregnancy should take an additional 400 µg of synthetic folic acid (PGA) in the form of supplements, regardless of whether there is a food in the country concerned (e.g. flour) is mandatory to be fortified. The most important and urgent measure is therefore to make this fact well known and to make it easier for girls and women to access folic acid supplements.
For all other population groups, it is not possible to make a reliable statement for or against folic acid supplementation in the sense of mandatory food fortification.
The mandatory folic acid fortification of a staple food would lead to an increase in the folate status in the general population and, with a high degree of probability, to a decrease in neural tube defects, although the order of magnitude is uncertain. However, the mandatory fortification of a staple food would possibly also lead to the upper safety limit being exceeded for a (not clearly defined) number of individuals - especially because the range of products that are voluntarily fortified with folic acid is steadily increasing. However, a ban on voluntarily fortified products in Austria is not possible under EU law.
Due to the uncertainties mentioned, the question of the overall health benefit of a mandatory fortification of flour, a circumstance that would affect the general population over long periods of time in the sense of chronic intake, as for example provided in the draft of the Folic Acid Act, cannot currently from a scientific point of view finally answered.
Regarding the actual effectiveness of an Austrian going it alone with regard to the mandatory flour fortification, the question remains whether this will reach the main risk group for neural tube defects (young girls, socially disadvantaged classes, girls with a migration background), since fortification is only available in Austria manufactured flours can be prescribed and products that are not made in Austria - and are usually the cheaper products - are not fortified (e.g. foreign dough pieces). The extent of the resulting reduced effectiveness of the measure cannot be estimated on the basis of the currently available data.
There is currently insufficient evidence from randomized controlled studies to allow a conclusive assessment of the benefit or risk of mandatory folic acid fortification with regard to chronic diseases such as cardiovascular diseases or the risk of cancer.
The EU countries that have come furthest in terms of introducing mandatory flour fortification (Great Britain and Ireland) have currently put the measure on hold due to the uncertain data situation regarding the risk of chronic oversupply. A continuation of the targeted education and information to improve the periconceptional folic acid intake is therefore of essential importance.
In any case, folic acid studies on cancer and the prevention of embryonic damage as well as other positive effects such as angioprotective effects should continue to be closely monitored in order to better clarify a benefit / risk relevance.
I would also like to point out that a working group has been set up at the European Food Safety Authority (EFSA) to deal with the topic of folic acid fortification.
To question 4:
The answer results from the previous answers and is: currently no. The discussions and the result of the EFSA working group should in any case be awaited. A mandatory fortification of a staple food should be accompanied by a simultaneous restriction of the voluntary fortification in the sense of avoiding a chronic oversupply of individual special groups. The latter is currently not possible under EU law. A joint approach at EU level is therefore preferable to an Austrian solo effort.
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