Aluminum

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Changed on: 05.07.2016

Aluminium is the most abundant metal in the Earth’s crust, making up 8 percent of the crust’s mass. The only elements that are more common are oxygen and silicon. Aluminium occurs predominantly in Aluminium silicates, hydroxides, phosphates and sulphates, as well as Cryolite (WHO, 1997). Aluminium makes its way into soil and water via natural erosion and human activities. It is part of the soil’s clay minerals. AGES examinations of soil specimens show a natural aluminium level of up to 30 grams per kilogramme of soil. Plants ingest aluminium through the soil and water, which results in a natural aluminium content in plants and plant-based foodstuffs.

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Aluminium is the most abundant metal in the Earth’s crust, making up 8 percent of the crust’s mass. The only elements that are more common are oxygen and silicon. Aluminium occurs predominantly in Aluminium silicates, hydroxides, phosphates and sulphates, as well as Cryolite (WHO, 1997). Aluminium makes its way into soil and water via natural erosion and human activities. It is part of the soil’s clay minerals. AGES examinations of soil specimens show a natural aluminium level of up to 30 grams per kilogramme of soil. Plants ingest aluminium through the soil and water, which results in a natural aluminium content in plants and plant-based foodstuffs.

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Food

Aluminium Levels in Food

Humans ingest aluminium mostly via food. Drinking water is only a minor contributor. The aluminium in our food is both a result of plants’ natural aluminium levels, as well as the use of food additives containing aluminium. An additional source is dishes and packaging material which might transfer aluminium, although this makes up only a fraction of the aluminium found in food under normal conditions.

Aluminium Levels in Food

Aluminium Levels in Food

Food contains aluminium because this substance occurs naturally in soil. Most unprocessed food contains fewer than 5 mg aluminium/kg. Higher concentration levels (5-10 mg/kg on average) are found in cereal products, baked goods, and dairy products, as well as in some types of vegetables, offal and seafood. Average concentration levels of more than 10 mg/kg were measured in cocoa, tea and herbs.

The EFSA evaluated EU-wide research data on aluminium in food as part of a study in 2008 (http://www.efsa.europa.eu/de/press/news/afc080715.htm). However, no specific source can be inferred from the total aluminium levels presented in this study, which means there was no differentiation between natural concentrations and contamination through processing.
An evaluation by the EU Rapid Alert Systems RASFF shows that some goods had to be rejected because of too high aluminium content during import controls in 2008. There were only 12 alerts because of overly high aluminium levels inside the EU region. One sample of pasta was rejected because of overly high aluminium levels in Austria in 2009 and 2010, respectively.

Reasons for increased aluminium levels in lye rolls and pretzels

Lye rolls and similar baked goods are coated with a lye solution (2 to 6 %) before baking to achieve the specific browning effect during baking that gives them their characteristic flavour. Pieces of dough are dipped into the lye solution during this process before they are put on a baking tray and into the oven. In most cases, bakeries use aluminium trays, due to their thermal conductive and corrosion resistant properties. Once the lye comes into direct contact with the aluminium, the protective oxide layer on the aluminium tray will be affected, releasing aluminium particles which can be absorbed by the baked goods.

Examinations find aluminium concentrations of more than 10 mg per kilogramme in lye rolls on a regular basis. It cannot be excluded that consumers ingest increased amounts of aluminium by eating lye rolls and similar baked goods. Thus, the German Institute for Risk Assessment (BfR, 2002) has recommended reducing aluminium contamination to technically unavoidable values. This could be done by brushing the surface of the dough only partly with lye solution, instead of dipping the entire piece, for example. Moreover, using silicon layers, baking paper or a non-stick coating on the aluminium trays could help avoid or reduce contamination with aluminium.

Maximum Limits for Aluminium in Lye Rolls and Pretzels

There are still no EU-wide or even Austrian maximum levels for aluminium in lye rolls to date. Bavaria has introduced a maximum limit of 10 mg aluminium per kilogramme of lye rolls and similar products, as part of administrative procedures in 1999. The BfR uses this value as a guideline and has recommended avoiding lye rolls with aluminium levels of 10 mg / kg since 2002. Aluminium levels of 5-10 mg / kg are found in bread and baked goods in general (EFSA, 2008). Higher concentrations are believed to be avoidable from a technological perspective (BfR, 2002, 2015).

Situation in Austria

A monitoring initiative for aluminium in lye rolls and pretzels was carried out in Austria from February 2015 to the end of July 2015. This monitoring initiative was designed to determine typical aluminium levels of lye rolls and similar products in Austria and introduce measures to eliminate contamination sources in the production process, as necessary.

A total of 71 samples have been taken at producers in retail and wholesale across Austria and examined for aluminium content, to date. Fifty-seven samples (82.2 percent) were below 10 mg/kg (Bavarian benchmark for aluminium in lye rolls – levels under 10 mg/kg can be ensured via appropriate production techniques). Aluminium levels between 10 and 60 mg/kg were measured in 12 samples (15.1 percent). Two samples (2.7) showed concentration levels of over 90 mg/kg.

The regional food safety agencies were informed about the increased levels and are investigating the origin of these concentration levels. Consequently, potential measures to reduce such concentration levels will be introduced in the manufacturing process and monitored via follow-up controls.

Risk Evaluation – Example

A 60 kg person will ingest 0.007 to 0.04 mg of aluminium per kg bodyweight when eating one 40 g lye pretzel with an assumed aluminium concentration of 10-60 mg/kg. This is 0.7 to 4 percent of the tolerable weekly intake (TWI value). As a result, the daily consumption of one such pretzel will use up 5 to 28 percent of the TWI. Eating such pretzels or rolls to this extent does not result in exceeding the threshold value. However, it has to be taken into account that many other foods and consumer products also contain aluminium. Some Europeans ingest higher amounts of aluminium that exceed the TWI value even without consuming lye pretzels and rolls (EFSA, 2008). Thus, avoidable sources should be refrained from or, at least, minimised. A maximum limit for lye rolls and pretzels should be set at 10 mg of aluminium/kg.

Sources

BfR, 2002 Erhöhte Gehalte von Aluminium in Laugengebäck
EFSA, 2008  Safety of aluminium from dietary intake
BfR, 2015 Fragen und Antworten zu Aluminium in Lebensmitteln und verbrauchernahen Produkten

Additives containing aluminium

Additives containing aluminium

Additives containing aluminium are licenced in great numbers. The use of these additives contributes significantly to people’s aluminium intake.

Regulation No 380/2012 modified usage and lowered the quantities for food additives containing aluminium, including aluminium varnish, as a result of the EFSA reducing the tolerable weekly intake from 7 mg/kg bodyweight to 1 mg/kg.

Commission Regulation (EU) No 380/2012 on conditions of use and use levels of aluminium-containing food additives

Regulation (EC) No 1333/2008 on food additives.

Aluminium in drinking water

Aluminium in drinking water

Certain aluminium compounds (e.g. aluminium sulphate and aluminium polychloride) can be used as flocculants in drinking water treatment, predominantly in the treatment of surface waters. The aluminium levels in drinking water are monitored to make sure that no unsafe residues are left following treatment. The indicator value 0.2 mg/l must not be exceeded.

The appropriate regulations can be found in the Austrian Food Code, Chapter B 1, Drinking Water.

Exposure of the European population

Exposure of the European population

The most comprehensive data on food-related aluminium exposure in the European population stems from 2008. At that time, the EFSA defined the tolerable weekly intake value (TWI) as 1 mg aluminium per kg bodyweight based on toxicological reports (EFSA, 2008). A “provisional tolerable weekly intake” (PTWI) of 7 mg per kg bodyweight had been in place up to then.

At the same time, the EFSA determined the amounts of aluminium that were really contained in the food consumed by different population groups. The average person had a weekly aluminium intake of 0.2 – 1.5mg per kg bodyweight, although there were significant regional differences. Thus, the TWI value of 1 mg per kg bodyweight was exceeded by a significant portion of the population.  These exposure data included ingestion via food additives and food contact material, in addition the natural amount of aluminium contained in the food itself.

Some consumers are also exposed to aluminium through cosmetics, in addition to the aluminium intake via food.

The European Commission lowered the amounts permissible for various additives (Regulation (EU) No 380/2012), given the fact that food additives contribute considerably to the aluminium levels of many foods. It is believed that the exposure of the population to aluminium could be reduced with these measures, although there is no exposure data available for the time after 2008.

Safety

Sicherheit von Aluminium

Aluminium Intake via Food

The vast majority of the aluminium ingested via food passes through the gastrointestinal tract without being absorbed. Only about 0.1 % of the aluminium in food and 0.3 % of the aluminium in drinking water are absorbed via the intestinal wall, on average. This is because the aluminium is released from most food in the stomach (acidic pH), but forms a precipitate in the intestine (neutral pH) which cannot be absorbed. Aluminium intake from individual meals may vary considerably as different ingredients in the food may affect absorption levels positively or negatively. Aluminium absorbed via the intestine disperses over the entire body and will be eliminated via the kidneys over time. Some tissues will hold higher levels of aluminium than others (e.g. bones and kidneys).

Toxicology Reports

The safety of substances containing aluminium has been evaluated for animals. Tests showed that certain amounts resulted in potential damage to the nervous system (mice and rats), male fertility (dogs) and the foetus (mice), as well as in the development of the nervous system (rats and mice). The European Food Safety Agency concluded that the amounts consumers are exposed to via food or consumer products do not represent a risk for the human health, with respect to questions on potential adverse genome and carcinogenic effects.

The EFSA established a value of 1 mg aluminium/kg bodyweight (Tolerable Weekly Intake, TWI), which can be ingested from various sources on a weekly basis without fear of adverse health effects caused by aluminium, based on the existing data and including a high safety factor of 100. 

Aluminium and Alzheimer’s

Aluminium exposure has been linked repeatedly with Alzheimer’s disease. This assumption stems from the fact that the brain regions affected in Alzheimer’s patients showed evidence of increased aluminium concentrations. However, it is still unclear whether these increased levels are a cause of the disease or merely a symptom.

Studies carried out to find a potential connection between Alzheimer’s disease and aluminium concentrations in drinking water yielded contradictory results. The EFSA did not use these studies in its assessment, as they do not include the intake of aluminium via food. One important factor that may explain a possible involvement of aluminium in the development of Alzheimer’s disease is dialysis patients, whose aluminium elimination was not only inadequate, but who also had received drugs containing aluminium or were given water that had not been purified enough during dialysis. While negative effects on the central nervous system were observed, the actual symptoms were clearly different to those of Alzheimer’s. Additionally, no increased cases of high aluminium levels could be found in aluminium workers. Thus, the EFSA concluded – as did the German Federal Agency of Risk Assessment and the French Food Safety Agency – that there is no causative link between Alzheimer’s disease and aluminium intake from food, drinking water or other products intended for human consumption, based on the knowledge available.

(Aluminium and Alzheimer's disease. Fact sheets. Alzheimer Society.
 http://www.alzheimers.org.uk/site/scripts/documents_info.php?documentID=99
 Accessed: 19 November 2012) 

Recommendations for Consumers

The following recommendation is given in the Code Alimentarius Austriacus (The Austrian Food Code, Sub-Committee Commodities) “Use of aluminium in everyday items” (Einsatz von Aluminium in Gebrauchsgegenständen): There is no general ban for the use of everyday items made of aluminium. Aluminium and aluminium alloys are used in many items with great success.
Only cooking dishes made of untreated aluminium should not be used when they could get in contact with acidic or salty foods for a longer period of time because of the rather high levels of aluminium transfer that can be expected. This is also true for tin foil used to cover such foods. The use of aluminium trays should also be avoided when making lye rolls and pretzels, given the danger of aluminium being transferred to the food.

Aluminium particles transferred to food pose no real health risk to consumers. However, individuals with seriously dysfunctional kidneys (e.g. dialysis patients) should avoid ingesting increased amounts of aluminium.

AGES and its predecessor agency made relevant contributions to this recommendation.
Both the European Food Safety Agency (EFSA 2008) and the BfR (2007) recommend avoiding contact between acidic and salty foods and aluminium, as dishes or food contact materials.
The Federal French Agency for pharmaceuticals and cosmetics recommends using cosmetic products solely on healthy, not recently shaved skin.

Pharmaceuticals

Aluminium und Arzneimittel

Aluminium as an active substance

There are a total of 16 medicines containing aluminium or aluminium in combination with other mineral salts or plant-based substances licensed for the Austrian market. The license of three expired by the end of 2012. The use of aluminium hydroxide as a sole ingredient applies to one medical specialty. Homeopathic substances contain aluminium in the form of kaolinum poderosum (aluminium silicate hydroxide = white clay) in addition to other active substances in 11 licenses.

These 15 or 12 -- from 2013 onwards -- medicine specialties have nation-wide licenses and are used in the following fields:

Aluminium hydroxide is used to treat increased serum phosphate levels and in the prophylaxis of phosphate stones, if other medical therapies have shown inadequate effects.

Aluminium salts are used as antacids for the symptomatic treatment of stomach acidity in heartburn, gastritis, gastroesophageal reflux disease and peptic ulcers in the stomach or duodenum in combination with magnesium salts.

Compounds containing magaldrate are available without prescription and licensed for the symptomatic treatment of heartburn and acidic reflux. 


Combinations of aluminium salts with plant-based substances are used in the treatment of swellings and inflammation of the oral mucous membrane.

A compound with a combination of aluminium salt mixed with calcium salts and tartaric acid is licensed for the topical treatment of swellings, sprains, contusions and insect bites.

The three licenses that run out at the end of the year contained aluminium in combination with other active substances for the treatment of haemorrhoids and as a cream used for the nose during rhinitis etc.

Aluminium as an adjuvant in vaccines

Adjuvants containing aluminium have been used in vaccines since the 1930s. They are among the most commonly used adjuvants worldwide. Adjuvants are agents that optimise the immune response to inactive vaccines such as diphtheria, tetanus, whooping cough, hepatitis A/B and so on.

Modern vaccines contain highly clean antigens, which results in a reduced immune response. This is where adjuvants, such as aluminium salts, are used to enhance the desired immune response. Aluminium salts have the most extensive data material of all the adjuvants used. Thus, more than three billion single doses of vaccines administered worldwide over the past 80 years show a positive risk-benefit profile. All adjuvants, including aluminium salts, are tested as part of the licensing process for each vaccine. In addition, the European Pharmacopoeia – this code has quasi-legal character – defines a maximum limit for aluminium per vaccine dose.

Risk of vaccine adjuvants containing aluminium

A total of 130 cases of microscopically minute tissue lesions with so-called macrophagic myofasciitis (MMF) have been examined. These were minute aluminium inclusions in cells (macrophages, serve the elimination of foreign substances) only visible through an electronic microscope.

These patients suffered from muscle and joint pain and tiredness. However, no evidence was found to connect the presence of aluminium and MMF and its symptoms (Vaccines, 6th ed. Plotkin, Orenstein, Offit, page 63).

Moreover, there is a recent report by the World Health Organization (WHO) for the assessment of the safety of vaccines with adjuvants containing aluminium:

The amount of aluminium present in food and ingested via the gastrointestinal tract was compared to the amount of aluminium administered through vaccines. The aluminium contamination for the body via vaccinations is clearly below the safety limits of aluminium intake via food, even for babies with low birthweight. This is confirmed by the findings of recent clinical studies and epidemiologic data on the safety of aluminium salts in vaccines (http://www.who.int/vaccine_safety/topics/adjuvants/Jun_2012/en/).

Furthermore, studies found that children who were administered vaccines with aluminium adjuvants showed aluminium levels far below the toxic limit (Vaccines, page 1474).

Drug Safety

Aluminium only has a toxic effect in high dosages. In general, we ingest about 10 to 15 mg per day via food. Higher levels of aluminium are found in pharmaceuticals such as Atazida, in particular, if administered below the permitted maximum dosage of up to about 3 g/day. However, the aluminium is rarely reabsorbed and the remains are bound to plasmaproteins and eliminated via the kidneys. Thus, there are usually no health problems when normal dosages are administered.

Pharmaceuticals are a product category with special additional benefits, as opposed to foodstuffs. As a result, it is acceptable and justifiable to have higher maximum levels for such ingredients/substances than in food. Only in patients suffering from kidney problems or those who are treated with such substances over a longer period of time may experience the storage of aluminium in the brain and the bones, as higher cumulative dosages are reached. However, this situation is widely known and is described in detail in professional literature and in package information.

Almost all of these substances are only available on prescription (Acidrine, Maalox, Tepilta), with the exception of talcite (including the natural mineral hydrotalcite (Mg, Al)) and Riopan (Magaldrat), which can be obtained without prescription. The latter two have lower aluminium levels than those only obtainable on prescription and there is no noteworthy resorption inside the gastrointestinal tract.

The BASG / AGES Division for Medicines and Medical Devices has received no notifications of any side effects caused by aluminium content in pharmaceuticals.

Recommendations for Medical Staff / Patients

Medical staff and patients are recommended by the BASG to read the relevant professional literature and package information carefully and follow the instructions given. Patients should always turn to their doctor or pharmacist for advice before taking pharmaceuticals containing aluminium that can be obtained over the counter over a longer period of time.

Thiomersal (also thimerosal in the U.S.) is the sodium salt of an organomercury compound (chemical name: sodium ethylmercuric thiosalicylate) and is used as a preservative in cosmetics and pharmaceuticals to prevent microbial growth. It is already effective in very small concentrations.

Thiomersal is degraded into thiosalicylate and ethylmercury in the body. The ethylemercuric cation (particle with a positive charge) blocks the activity of enzymes. This results in an antimicrobial effect (see Wikipedia Article Thiomersal https://en.wikipedia.org/wiki/Thiomersal) even at low dosages.

Thiomersal is a preservative licensed for use in cosmetic products in Austria. Its maximum limit is 0.007 % (calculated as mercury) -- i.e. 0.07 mg/g or ml. Should other mercury-containing compounds be used, the maximum level of mercury must not exceed a total limit of 0.007 %. Its application in eye cosmetic products (eye make-up and eye make-up removal products) is limited. Furthermore, the product must be labeled with a warning such as "enthält Ethylquecksilberthiosalicylat" (contains ethylmercuric thiosalicylate) or "enthält Thiomersal" (contains thiomersal). While the substance is basically licenced on the Austrian market under the conditions mentioned above, the use of thiomersal in cosmetic products in Austria is not that common.

In terms of medical applications, thiomersal is still used as a preservative in the influenza vaccines “Daronrix”, ”Pandemrix”, “Prepandrix”, “Pumarix” and the combined vaccine “Tritanrix HepB” used to treat diphtheria, tetanus, pertussis (whooping cough) and hepatits B. All such vaccines are licenced centrally for all EU Member States and are – with the exception of Tritanrix HepB – pandemic/pre-pandemic vaccines, which are not used on a routine basis. “Daronrix” contains 0.05 mg, “Pandemrix” 0.005 mg, “Prepandrix” 0.005 mg and “Pumarix” 0.005 mg thiomersal per packaging unit.

Thiomersal could also be present in traces as a residue from manufacturing. However, this would affect only very few products, if any, and would very likely be below levels where it could be detected. There are no maximum limits or test methods defined in neither the European Pharmacopoeia nor other European guidelines. Even so, manufacturers are obliged to state the presence of thiomersal in a product.

First doubts on the harmlessness of thiomersal were raised at the end of the 1990s: firstly, because of increasing reports of undesired effects, such as hypersensitivity reactions, but also because of accumulating mercury contamination in children caused by routine child vaccinations, which was feared to cause adverse neurologic effects, such as autism. Governmental agencies in the U.S. and Europe recommended removing thiomersal and other organic mercury compounds from vaccines for newborns and infants as a preventive measure, without any conclusive evidence of neurologic toxicity1. As a result, children under the age of six are only administered vaccines that contain no thiomersal or only traces of the substance in the USA. In general, most vaccines in individual dosage packaging in the USA are thiomersal-free2.

The European Medicines Agency committee revised its assessment of thiomersal in vaccines in 2004. The evaluation of epidemiologic studies led to the conclusion that there is no connection between neurologic development disorders and thiomersal in vaccines. Still, the development of vaccines without mercury-containing auxiliaries should be encouraged further, also from an ecological point of view. The Agency stressed that the advantage of vaccinations would far outweigh any theoretical risks posed by thiomersal3.

Thiomersal has been linked to the occurrence of autism by some scientists, anti-vaccine activists and some parents of autistic children, in particular in the USA. However, a link between thiomersal and autism is considered to have been disproved, from today’s perspective. Meanwhile, the World Health Organization (WHO), the U.S. Institute of Medicine and the European Medicines Agency (EMA) have arrived at the conclusion that all existing studies indicate no such connection independently. Nevertheless, pharmaceutical companies have reacted quickly to the heated debate: mercury-free vaccines are now available for all generally recommended protective vaccinations4.

Thiomersal is still used in medicinal care products for contact lenses. However, AGES has no knowledge of such a manufacturer in Austria. Additionally, there is no information as to whether this substance may be used as a preservative in liquid medicinal products.

The safety of substances containing aluminium has been evaluated for animals. Tests showed that certain amounts resulted in potential damage to the nervous system (mice and rats), male fertility (dogs) and the foetus (mice), as well as in the development of the nervous system (rats and mice). The European Food Safety Agency concluded that the amounts consumers are exposed to via food or consumer products do not represent a risk to human health with respect to questions about potential adverse genome and carcinogenic effects.

The EFSA established a value of 1 mg aluminium/kg bodyweight (Tolerable Weekly Intake, TWI), which can be ingested from various sources on a weekly basis without fear of adverse health effects caused by aluminium, based on existing data and including a high safety factor of 100. In 2008, the EFSA determined the amounts of aluminium that were really contained in the food consumed by different groups in the population. The average population had a weekly aluminium intake of 0.2 – 1.5mg per kg bodyweight, although there were significant regional differences. These exposure data included ingestion via food additives and food contact material, in addition the natural amount of aluminium contained in the food itself. Thus, the TWI value of 1 mg per kg bodyweight was exceeded by a significant portion of the population. The European Commission lowered the amounts permissible for various additives (Regulation (EU) No 380/2012), given the fact that food additives contribute considerably to the aluminium levels of many foods. It is believed that the exposure of the population could be reduced with these measures.

Reports of mutually reinforcing negative effects (so-called synergisms -- i.e. two (toxic) substances ingested at the same time will reinforce their (toxic) effects in a way that the overall effect is much stronger than the sum of the effects of the two individual substances) in relation to thiomersal and aluminium  come almost exclusively from one individual or group around this individual, namely Boyd E. Haley, a now retired, former professor at the Chemistry Department of the University of Kentucky, USA, in particular in connection with autism and other neurologic disorders. Haley5 describes an experiment with neurons in a cell culture (in-vitro experiment): aluminium amounts that did not cause significant cell death within six hours were combined with amounts of thiomersal that would only cause a small increase in neuron degeneration on their own. The combination resulted in a 60% increase in the cell death rate, which presented an astounding effect and clear evidence for a synergism, according to the reports published.  However, the vulnerable point in these results, which would usually entail further experiments, is that they are only published in biased reports by apparent supporters of a “mercury-autism hypothesis” or journals that have no scientific reputation, and without any details of the experimental process, which in turn can lead to conclusions about the quality of the work performed. The same has to be said about an advocate of the mercury-autism and even Alzheimer’s hypothesis, Donald W. Miller, a surgeon at the University of Washington/Seattle, USA: he presented his opinion in a daily online journal6 without any details or description relating to the actual experimental process: “A small dose of mercury that kills 1 in 100 rats and a dose of aluminum that will kill 1 in 100 rats, when combined have a striking effect: all the rats die. Doses of mercury that have a 1 percent mortality will have a 100 percent mortality rate if some aluminum is there.” This statement is often quoted by supporters of the hypothesis mentioned above, although it has been published without giving any evidence and citations. However, there is another suspect statement which attributes the same toxicity enhancing qualities found in mercury to lead.

Summary

We can conclude that no profound and comprehensible study has found evidence for a reinforced negative effect from simultaneous exposure to mercury and aluminium, which exceeds the sum of the individual effects (synergism), to date. A causal link with neurologic diseases, such as autism, is believed to have been disproved with regards to the risk potential of thiomersal, in particular in vaccines and potentially in combination with aluminium compounds. Additionally, legal or consensual actions have been taken to avoid the exposure of children to organic mercury compounds via vaccines in their first few years of their lives.

Nevertheless, mercury can get past the blood-brain barrier and cause toxic effects in the brain. Aluminium is also believed to be able to break this barrier and accumulate in specific brain and neuronal regions. Thus, both metals reach very sensitive areas of the human body. This is why there are programmes in place in the European Union designed to reduce mercury levels in the environment and the exposure of humans, in particular to methylmercury in fish. However, more scientific assays will have to be carried out at the current level of knowledge to keep examining the effect mechanisms and any potential accumulation of the effects relating to both metals.

Literature

1European Agency for the Evaluation of Medicinal Products. EMEA Public Statement on Thiomersal Con-taining Medicinal Products. EMEA/20962/99; London, 8 July, 1999 http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003902.pdf
2US Food and Drug Adminstration. Thimerosal in Vaccines. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
3European Agency for the Evaluation of Medicinal Products. EMEA Public Statement on Thiomersal in Vaccines for Human Use – Recent Evidence Supports Safety of Thiomersal-Containing Vaccines. EMEA/CPMP/VEG/1194/04/Adopted. London, 24 March, 2004
http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003904.pdf
4Robert Koch-Institut. Schutzimpfungen – 20 Einwände und Antworten des Robert Koch-Instituts und des Paul-Ehrlich-Instituts. Stand: 10.05.2007. http://www.rki.de/DE/Content/Infekt/Impfen/Bedeutung/Schutzimpfungen_20_Einwaende.htm
5Haley BE, 2005. Mercury toxicity: Genetic susceptibility and synergistic effects. Medical Veritas 2: 535-542
6Miller DW. Mercury on the Mind. http://www.lewrockwell.com/2004/09/donald-w-miller-jr-md/the-curse-of-mercury-in-vaccines/

 

 

Everyday Items

Aluminium in Gebrauchsgegenständen, die direkten Kontakt mit Lebensmitteln haben

Aluminium is used in pans, cooking utensils, coffee pots, but also in food packaging, such as food trays and, in particular, drinks cans, although direct contact with the foodstuff is usually prevented by a specific coating. Furthermore, aluminium is used in metal alloys and colour pigments.

Aluminium is relatively resistant to corrosion, as its surface forms a thin aluminium oxide layer immediately when in contact with oxygen, protecting the pure aluminium beneath it from further oxidisation and chemical attacks.

Aluminium can react with acidic, salty and alkaline food, resulting in the frequent use of coatings. A recommendation by the Austrian Code Commission (Enactment 31.910/30-IV/B/1b/98) also indicates this problem and a resulting limitation of uses. Drinks cans with internal coatings pose no risk, even after longer periods of storage.

Uncoated cooking utensils in pure aluminium should only be used for short contact periods and not as standard cooking utensils, as aluminium can already be released in increased levels in  contact with slightly acidic tap water (pH lower than 7). There are no objections to the use of aluminium dishes for a few days per year, as part of camping equipment, for example.
Aluminium layers are among the most effective barriers against migrating chemicals in multilayer packaging materials, together with ceramic materials. Thus, aluminium coated primary packaging (internal packaging) does actually provide protection against contaminates from secondary packaging made of recycled cardboard, for instance.

Even the German Federal Institute for Risk Assessment (BfR) does not see any health risk to consumers from aluminium intake via food utensils.

Safety aspects

The JEFCA (2006) set a PTWI of 1 mg/kg BW for total intake, including food additives. The EFSA confirmed this value as its TWI in 2008.

There is no recommended, health-related value for drinking water, according to the WHO (1993). Yet, there is a standard value of 0.2 mg/l in the Drinking Water Directive 98/83/EC on the quality of water intended for human consumption, as a compromise on the use of aluminium salts in water treatment.

The average intake via food is 10 mg/person/day in the UK (MAFF, 1998). Certain pharmaceuticals may result in a higher aluminium intake.

The INRA estimated a daily intake of 1.6 mg/day in its study in 2001.

There are two sources of aluminium sources in food, assuming that the average consumer eats 1kg of food per day, which has been in contact with metallic packaging or metallic materials during processing and taking into account that these food products include food additives with metal components. The expert committee of the European Council recommends a SML AL of 3.5 mg/kg LM based on this approach.

Sources

Draft amendments of the “GUIDELINES ON METALS AND ALLOYS USED AS FOOD CONTACT MATERIALS” (RD 4/1-48) of the European Council

Assessment No 033/2007 of the BfR of 13th December 2005, updated on 22nd July 2007

Recommendation by the Code Commission, Decision 31.910/30-VI/B/1b/98

 

 

Cosmetics

Aluminiumchloridverwendung in Antitranspirantien

Antiperspirant cosmetic products have perspiration-retardant characteristics. They narrow the sweat pores using aluminium salts so that the body exudes less sweat. Deodorants, on the other hand, use antibacterial or aromatic substances to cover body odour. Antibacterial agents reduce the growth of sweat-degrading bacteria. However, cosmetic products often combine both effects and are then labelled as “Antiperspirant Deodorants”.

A link between the application of antiperspirants and breast cancer has been assumed on a repeated basis in some online publications and press reports for quite some time. This assumption is mainly based on a study that found aluminium in breast cancer patients, who had used antiperspirants, in the breast region, the breast glands and, in particular, close to the armpits (1). However, the scientists could not clearly state whether this was caused by the use of antiperspirants or based on cells’ property to accumulate aluminium from the body. Another research study demonstrated that aluminium compounds present in antiperspirants have a (hormonal) effect similar to oestrogen (2), which might influence the growth of breast cancers cells.

A review article from 2008 summarising all studies on this topic up to this point found that no conclusive scientific evidence had been found to link the use of antiperspirants and breast cancer (3). Additionally, epidemiologic surveys in a larger number of breast cancer patients and women without a breast cancer history could not find any evidence of such a link, too (4). Moreover, the French Health Agency (Afssaps) concluded that the existing data does not suffice to establish a direct link between breast cancer and antiperspirants containing aluminium (5).

A recent study with human breast cell cultures indicated an adverse effect of aluminium chloride on cells under laboratory conditions. The cells showed abnormal behaviour comparable with the first stage of a tumour-like mutation (6). The aluminium chlorides used in this study were injected directly into the cell culture. The natural human skin barrier was not taken into account in this study. A direct connection to the increasing number of breast cancer cases in industrialised countries was not established by this scientific study.

Aluminium – in bound form – is a very common element found in the Earth’s crust. Natural exposition is merely a result of this fact. However, only tiny amounts of aluminium are absorbed by the body via healthy skin, according to current knowledge – much less than via food, for example.

Overall, we can say that more research is required to get a better understanding of aluminium intake following dermal application and to clear up the potential role of aluminium in breast cell mutation, given the very differing results found.  Even though there is no need to recommend avoidance of the use of antiperspirants to reduce potential breast cancer risk, individual aluminium intake could be decreased in general. Cosmetics containing aluminium, such as antiperspirants and creams, contribute to the overall intake. Aluminium intake via antiperspirants can be reduced, in particular, by not applying them immediately after shaving or on damaged armpit skin. In addition, deodorants free of aluminium salts are also available in stores.

Selected Literature

(1) Exley C, Charles LM, Barr L, Martin C, Polwart A, Darbre PD. Aluminium in human breast tissue. J Inorg Biochem. 2007, 101(9):1344-6

(2) Darbre PD. Aluminium, antiperspirants and breast cancer. Journal of Inorganic Biochemistry 2005; 99(9):1912–1919.

(3) Namer M, Luporsi E, Gligorov J, Lokiec F, Spielmann M. The use of deodorants/antiperspirants does not constitute a risk factor for breast cancer. Bull Cancer. 2008;95(9):871-80.

(4) Mirick DK, Davis S, Thomas DB. Antiperspirant use and the risk of breast cancer. Journal of the National Cancer Institute 2002; 94(20):1578–1580.

(5) Risk assessment related to the use of aluminum in cosmetic products -Summary (17/11/2011)  auf
www.afssaps.fr/Infos-de-securite/Points-d-information/Evaluation-du-risque-lie-a-l-utilisation-de-l-aluminium-dans-les-produits-cosmetiques-Point-d-information

(6) Sappino AP, Buser R, Gimelli S, Béna F, Belin D and Mandriotab SJ. Aluminium chloride promotes anchorage independent growth in human mammary epithelial cells. J. Appl. Toxicol. 2012; 32: 233–243

Further Information

US National Cancer Institute: www.cancer.gov/cancertopics/factsheet/Risk/AP-Deo

Bundesinstitut für Risikoforschung (BfR): 73., 74. und 75. Sitzung der vorläufigen Kommission für kosmetische Mittel, 20 November 2008, Seite 6-7.
www.bfr.bund.de/cm/343/73_74_und_75_sitzung_der_vorlaeufigen_kommission_fuer_kosmetische_mittel.pdf

BfR opinion No. 007/2014, 26 February 2014
Aluminium-containing antiperspirants contribute to aluminium intake

Toys

The Toy Safety Directive specifies maximum limits for aluminium for each category of toys. AGES has no knowledge of any issues reported in connection with aluminium in toys. Additionally, there are no objections to aluminium in toys in the alerts by the European Rapid Alert System RAPEX.  (Federal Law Gazette II No. 203/2011 – based on Directive 2009/48 EC by the European Parliament and the Council on the safety of toys, TSD).

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