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Food supplements – European Commission

As an addition to a normal diet, food business operators market food supplements, which are concentrated sources of nutrients (or other substances) with a nutritional or physiological effect. Such food supplements can be marketed in dose form, such as pills, tablets, capsules, liquids in measured doses, etc.

The objective of the harmonised rules on those products in Directive 2002/46/EC is to protect consumers against potential health risks from those products and to ensure that they are not provided with misleading information.

With respect to the safety of food supplements, the Directive lays down a harmonised list of vitamins and minerals that may be added for nutritional purposes in food supplements (in Annex I to the Directive). Annex II of the Directive contains a list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.

This list has been amended by the following Regulations and Directive to include additional substances:

The trade of products containing vitamins and minerals not listed in Annex II has been prohibited from the 1st of August 2005.

Directive 2002/46/EC has been aligned with the new Regulatory Procedure with scrutiny by Regulation (EC) No 1137/2008.

Directive 2002/46/EC on food supplements envisages the setting of maximum and minimum amounts of vitamins and minerals in supplements via the Standing Committee on Plants, Animals, Food and Feed ( PAFF Committee) procedure.

The Commission has issued a Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs , which identified the main issues to be considered in this exercise and originated a set of Responses.

Although the Commission has consulted extensively with Member States and interested stakeholders on the issue, no proposal has not yet been presented due to the complex nature of the issue and the divergent views that were expressed. All the available data on the potential effects on economic operators and consumers of the setting of maximum amounts of vitamins and minerals in foods, including food supplements, will be taken into account. Every effort will be made to ensure that the maximum amounts set will take into account the concerns expressed by all interested parties.

The EC commissioned a study on the use of substances with nutritional or physiological effects other than vitamins and minerals in food supplements.

Taking into account this study and other available information, the Commission – in accordance with the requirement set out in Article 4(8) of Directive 2002/46/EC on food supplements – has prepared a report to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements.

The report is accompanied by two Commission staff working documents.

Member States may, for monitoring purposes, request notification to their competent authority of the placing on the market in their territory of a food supplement product in accordance with Article 10 of the Directive. The list of competent authorities may be found here:

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Food supplements – European Commission

Food Supplements Europe

Food Supplements Europe has been created to represent the interests of the European food supplement sector. Its membership includes national associations and companies committed to ensuring that future EU legislation and policy reflects the important role that this sector plays in the health of consumers.

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Food Supplements Europe

The Key to Getting to Mars Could Be in Recycling Astronaut Pee Into Food Supplements – ScienceAlert

Researchers have shown how astronaut urine, poop and even exhaled breath could be turned into 3D-printed plastics and nutrients, the kind of smart waste recycling we’re going to need if humans are to make the long trip to Mars and beyond.

The trick is in a yeast called Yarrowia lipolytica, which scientists have found can feed on the carbon from our breath and the nitrogen in our pee to produce everything from vitamin supplements to polyesters, perfect for the production of space tools.

Due to time and weight restrictions, we can’t just take everything we’re going to need on Mars up in a rocket, which is why the recycling system put together by a team from Clemson University could be vital for future missions to the Red Planet.

“If astronauts are going to make journeys that span several years, we’ll need to find a way to reuse and recycle everything they bring with them,” says one of the researchers, Mark A. Blenner. “Atom economy will become really important.”

Right now, the carbon and nitrogen-eating yeast can only provide small amounts of polyesters and nutrients, but the team is working on increasing its output.

One of the developed yeast strains was engineered to produce omega-3 fatty acids, which help heart, eye, and brain health. The supplements we buy here on Earth have a shelf life of just a couple of years, so astronauts will need a way of making their own.

Another strain was developed to produce polyester polymers, the type of plastic you can find in clothes and which could eventually be repurposed to feed a 3D printer the hope is that astronauts could repair and replace tools while out in space.

If that wasn’t enough, the yeast investigations might help in fish farming and human nutrition on our own planet, through its ability to produce omega-3.

“We’re learning that Y. lipolytica is quite a bit different than other yeast in their genetics and biochemical nature,” says Blenner. “Every new organism has some amount of quirkiness that you have to focus on and understand better.”

As well as boosting the output of the yeast, there are other challenges to overcome: right now the yeast needs an extra ingredient added by the scientists to properly convert carbon, while the polymers are proving tricky to harvest from the yeast (which hangs on to them tightly as a potential food source).

Even with the limitations of the system as it stands though, it shows a promising way of developing the sort of deep space waste recycling we’ll need for long space journeys.

The experiments have been funded with a grant NASA awarded in 2015 to look into this kind of biological processing, and to build on the human waste recycling systems we already have on board the ISS urine and sweat can already be converted back into drinking water, for example.

“Having a biological system that astronauts can awaken from a dormant state to start producing what they need, when they need it, is the motivation for our project,” says Blenner.

The findings are being presented at the National Meeting & Exposition of the American Chemical Society.

The American Chemical Society also put together a video looking at the research, which you can view below:

Link:

The Key to Getting to Mars Could Be in Recycling Astronaut Pee Into Food Supplements – ScienceAlert

Food supplements very popular, but not always healthy: poison information center – NL Times

Food supplements, for example for more energy or slimming supplements, are increasingly popular in the Netherlands. But they are by far not always healthy and some even contain forbidden substances, the national poisoning information center NVIC warned in its annual report for 2016. In some cases the information on the labels don’t match the substances actually in the supplements, ANP reports.

The most risky supplements are those taken for sports and slimming. “Often illegal substances are found that can cause serious health problems”, the NVIC warns. Supplements taken prior to sports can, “in some cases, lead to life-threatening situations”.

The NVICreceived a total of 740 poisoning reports last year. A third involved young children who took an inappropriate supplement, such as melatonin. About 500 were about relaxing supplements, including 64 about people who took hemp oil. Nausea, sleepiness, dizziness, confusion, accelerated heart rate and hallucinations were some of the reported side effects.

Earlier this year Dutch food and consumer product safety authority NVWA already warned against libido boosters and . Over 60 percent of the supplements the NVWA tested contained hazardous supplements such as sildenafil, sibutramine and amphetamine-like substances like synephrine and caffeine.

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Food supplements very popular, but not always healthy: poison information center – NL Times

Astronaut pee can be harvested to make food supplements, scientists find – Telegraph.co.uk

Elon Musk, the SpaceX founder has also laid out plants for a major colony on Mars within the next 50 years, and has warned that humans will need to leave Earth to avoid a doomsday event such as an asteroid strike.

For now, the engineered yeast strains can produce only small amounts of polyesters or nutrients, but the scientists are working on boosting output.

They’re also looking into applications on Earth, in fish farming and human nutrition. For example, fish raised via aquaculture need to be given omega-3 fatty acid supplements, which could be produced by the teams yeast strains.

The research was presented at the American Chemical Societys annual meeting.

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Astronaut pee can be harvested to make food supplements, scientists find – Telegraph.co.uk

Food supplement: Probiotics may not boost gut bacteria for good … – Express.co.uk

GETTY

Probiotics can keep your gut healthy and help your digestion.

They work by replacing the bad bacteria – such as Bifidobacteria – with good bacteria, like Lactobacillus acidophilus.

The idea is that if they nurture beneficial bacteria in the gut, they can stall the growth of unwanted bacteria.

This could improve digestion, boost the immune system, and even lower rates of certain diseases.

You can get the benefits by eating foods such as live-cultured yoghurt, sauerkraut and kefir.

GETTY

Research has found probiotics can be useful for treating symptoms of IBS. But other studies have found they make little difference to gut health.

Taking probiotic supplements has also become popular in recent years.

Research by the University of Chicago has found probiotics can be useful for treating symptoms of IBS, such as bloating and abdominal pain.

However, scientists are now questioning whether probiotics are as effective as previously thought.

“Thirty billion Lactobacillus sounds good, but after going through the stomach acid, only about 43 of them survive,” said Ian Orme, a professor of microbiology and pathology at Colorado State University, to Business Insider.

Getty

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Indeed, a study published last year by the University of Copenhagen found no difference in the gut bacteria between participants who were taking probiotic supplements and others who werent.

This is the same for probiotic yoghurt which a study published in April by the University of Toronto found didnt contain enough beneficial bacteria to make a difference.

Scientists have now been looking at ways to create a more effective option for gut health.

They are working on a new type of supplement – synbiotics – which combine a probiotic bacterial strain with a prebiotic.

Prebiotics feed beneficial bacteria and help it to thrive in the gut.

GETTY

With synbiotics, it is thought that the probiotic pushes out the bad bacteria and the probiotics simultaneously acts as the food supply.

A study published this month showed that newborns who were given a synbiotic were at a substantially lower risk of developing sepsis.

Additionally, it is thought the new type of supplement could also help with obesity, diabetes, and non-alcoholic fatty liver disease.

However, further research is required to confirm the findings.

Excerpt from:

Food supplement: Probiotics may not boost gut bacteria for good … – Express.co.uk

Could high doses of vitamin B supplements raise lung cancer risk? – CBS News

Men, and especially male smokers, appear to be more likely to develop lung cancer if they take high doses of vitamins B6 and B12, new research suggests.

For men taking these vitamin supplements, the risk of lung cancer was nearly doubled. For men who smoked, the risk was between three and four times higher, the study found.

“High-dose B6 and B12 supplements should not be taken for lung cancer prevention, especially in men, and they may cause harm in male smokers,” said study lead author Theodore Brasky. He is a research assistant professor at Ohio State University.

However, the study wasn’t designed to prove cause-and-effect between the vitamins and lung cancer; it only showed an association.

It’s also not clear why only men and current male smokers seem to face an extra risk.

And a trade organization representing the vitamin industry cautioned against reading too much into the study.

Most people in the United States get enough vitamin B6 through their diets, according to the U.S. National Institutes of Health (NIH). Some people with certain health conditions may need supplements.

As for vitamin B12, the NIH reports that most Americans get enough from their diet. But some groups — such as older people and vegetarians — may be deficient and need supplements. The vitamin may also cause interactions with medications.

Dietary sources of vitamin B6 and B12 include fortified cereals and foods that are high in protein.

The new study included more than 77,000 adults, aged 50 to 76, in Washington state. The participants were recruited from 2000 to 2002, and answered questions about their vitamin use over the previous 10 years.

The researchers found that just over 800 of the study volunteers developed lung cancer over an average follow-up of six years.

The study found no sign of a link between folate (a type of B vitamin) and lung cancer risk. And vitamin B6 and B12 supplements didn’t seem to affect risk in women.

However, “we found that men who took more than 20 milligrams per day of B6 averaged over 10 years had an 82 percent increased risk of lung cancer relative to men who did not take supplemental B vitamins from any source,” Brasky said.

“Men who took more than 55 micrograms per day of B12 had a 98 percent increased lung cancer risk relative to men who did not take B vitamins,” he noted.

Men who smoked at the beginning of the study period and consumed high levels of the B vitamins were three to four times more likely to develop lung cancer, he added.

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A new investigation may have you rethinking some of your vitamins. Consumer Reports finds certain ingredients in dietary supplements sold around …

“B6 is typically sold in 100 mg (milligram) tablets. B12 is often sold between 500 mcg (microgram) and 3,000 mcg tablets,” Brasky said.

“In contrast, most multivitamins include 100 percent of the U.S. Recommended Dietary Allowance, which is under 2 mg per day for B6 and 2.4 mcg per day for B12. People should really ask themselves if they need over 1,200 times the RDA (recommended daily allowance) of a substance. There’s simply no scientific backing for these doses,” he said.

The study doesn’t conclusively link higher doses of the vitamins to higher rates of lung cancer. If there is a connection, it’s not clear how the vitamins might influence the cancer risk, Brasky said, although it may have something to do with how the vitamins interact with male sex hormones.

Paul Brennan, head of the genetics section with the International Agency for Research on Cancer, said the study appears to be valid.

However, the findings conflict with his group’s recent research, published July 22 in theJournal of the National Cancer Institute, which didn’t find any links between high blood levels of vitamin B6 and lung cancer in people at large, or men specifically.

“If anything,” Brennan said, “we found a small protective effect that was more apparent among men.”

Still, Brennan added that “there is clearly no evidence that these vitamins have any substantial protective effect. Smokers taking these vitamins should quit smoking.”

Dr. Eric Bernicker, a thoracic oncologist with Houston Methodist Hospital, agreed with that advice and said the study points to a higher risk of lung cancer from higher doses.

“There’s a strong belief that vitamins would never harm you. As in much of nutrition, the story is more complicated than that,” Bernicker said.

In a statement, Duffy MacKay, a senior vice president of the Council for Responsible Nutrition, a trade group for the vitamin industry, urged consumers “to resist the temptation to allow sensational headlines from this new study to alter their use of B vitamins.”

According to MacKay, “The numerous benefits of B vitamins from food and dietary supplements — including supporting cognition, heart health and energy levels — are well-established.”

In addition, McKay said, the study has limitations. Among other things, it required participants to remember what they consumed over 10 years.

The study was published Aug. 22 in theJournal of Clinical Oncology.

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Could high doses of vitamin B supplements raise lung cancer risk? – CBS News

Dietary supplement – Wikipedia

“Food supplement” redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.

A dietary supplement is either intended to provide nutrients in order to increase the quantity of their consumption, or to provide non-nutrient chemicals which are claimed to have a biologically beneficial effect.

Supplements as generally understood include vitamins, minerals, fiber, fatty acids, or amino acids, among other substances. U.S. authorities define dietary supplements as foods, while elsewhere they may be classified as drugs or other products.

There are more than 50,000 dietary supplements available. More than half of the U.S. adult population (53% 55%) consume dietary supplements with most common ones being multivitamins.[1]

These products are not intended to prevent or treat any disease and in some circumstances are dangerous, according to the U.S. National Institutes of Health. For those who fail to consume a balanced diet, the agency says that certain supplements “may have value.”[2] An exception is vitamin D, which is recommended in Nordic countries[3] due to weak sunlight.

According to the United States Food and Drug Administration (FDA), dietary supplements are products which are not pharmaceutical drugs, food additives like spices or preservatives, or conventional food, and which also meet any of these criteria:[4]

In the United States, the FDA has different monitoring procedures for substances depending on whether they are presented as drugs, food additives, food, or dietary supplements.[4] Dietary supplements are eaten or taken by mouth, and are regulated in United States law as a type of food rather than a type of drug.[5] Like food and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer checks the safety of dietary supplements but the government does not; and rather than requiring riskbenefit analysis to prove that the product can be sold like a drug, riskbenefit analysis is only used to petition that food or a dietary supplement is unsafe and should be removed from market.[4]

The intended use of dietary supplements is to ensure that a person gets enough essential nutrients.[6]

Dietary supplements should not be used to treat any disease or as preventive healthcare.[7] An exception to this recommendation is the appropriate use of vitamins.[7]

Supplements may create harm in several ways, including over-consumption, particularly of minerals and fat-soluble vitamins which can build up in the body.[8] The products may also cause harm related to their rapid absorption in a short period of time, quality issues such as contamination, or by adverse interactions with other foods and medications.[9]

There are many types of dietary supplements.

Vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[10] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals. Supplementation is important for the treatment of certain health problems but there is little evidence of benefit when used by those who are otherwise healthy.[11]

Dietary elements, commonly called “dietary minerals” or “minerals”, are the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules.[citation needed]

Amino acids are biologically important organic compounds composed of amine (-NH2) and carboxylic acid (-COOH) functional groups, along with a side-chain specific to each amino acid. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen, though other elements are found in the side-chains of certain amino acids.

Amino acids can be divided into three categories: essential amino acids, non-essential amino acids, and conditional amino acids. Essential amino acids cannot be made by the body, and must be supplied by food. Non-essential amino acids are made by the body from essential amino acids or in the normal breakdown of proteins. Conditional amino acids are usually not essential, except in times of illness, stress, or for someone challenged with a lifelong medical condition[citation needed].

Essential fatty acids, or EFAs, are fatty acids that humans and other animals must ingest because the body requires them for good health but cannot synthesize them.[12] The term “essential fatty acid” refers to fatty acids required for biological processes but does not include the fats that only act as fuel.

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding and athletics. Bodybuilding supplements may be used to replace meals, enhance weight gain, promote weight loss or improve athletic performance. Among the most widely used are vitamin supplements, protein drinks, branched-chain amino acids (BCAA), glutamine, essential fatty acids, meal replacement products, creatine, weight loss products and testosterone boosters. Supplements are sold either as single ingredient preparations or in the form of “stacks” proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public their salience and frequency of use may differ when used specifically by bodybuilders.

In 2013, the global market of vitamins, minerals, and nutritional and herbal supplements (VMHS) was valued at $82 billion, with roughly 28 percent of that in the U.S., where sales increased by approximately $6 billion between 2007 and 2012.[13]

The vitamins and dietary supplements sector in the U.S. grew 4% in 2015, to reach US$27.2 billion. The U.S. market was highly competitive in 2015, as no single company accounted for more than a 5% share of value sales.[14]

According to University of Helsinki food safety professor Marina Heinonen, more than 90% of dietary supplement health claims are incorrect.[15] In addition, ingredients listed have been found to be different from the contents. For example, Consumer Reports reported unsafe levels of arsenic, cadmium, lead and mercury in several of the protein powders that were tested.[16] Also, the CBC found that protein spiking (the addition of amino acid filler to manipulate analysis) was not uncommon,[17] however many of the companies involved challenged their claim.[18]

Among general reasons for harmful effects of dietary supplements are: a) absorption in a short time; b) quality and contamination; and c) enhancing both positive and negative effects at the same time.[19] The number of incidents of liver damage from dietary supplements has tripled in a decade. Most of the products causing that effect were bodybuilding supplements. Some of the victims required liver transplants and some died. A third of the supplements involved contained unlisted steroids.[20] Mild to severe toxicity has occurred on many occasions due to dietary supplements, even when the active ingredients were essential nutrients such as vitamins, minerals or amino acids. This has been a result of adulteration of the product, excessive usage on the part of the consumer, or use by persons at risk for the development of adverse effects. In addition, a number of supplements contain psychoactive drugs, whether of natural or synthetic origin.[21][22]

BMC Medicine published a study on herbal supplements in 2013. Most of the supplements studied were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[23][24]

An investigation by the New York Attorney Generals office reported in 2015 analyzed 78 bottles of herbal supplements from Walmart, Target, Walgreens and GNC stores in New York State using DNA barcoding, a method used to detect labeling fraud in the seafood industry. Only about 20% contained the ingredient on the label.[25][26]

Some supplements were contamined by rodent feces and urine.[27]

Only 0.3% of the 55,000 U.S. market dietary supplements have been studied regarding their common side effects.[20]

Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[28]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[29][30] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[31][32]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[33][34]:10

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration (“FDA”). Pursuant to the Federal Food, Drug, and Cosmetic Act (“the Act”) and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

The European Union’s Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[35] Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.[36]

The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[37]

In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[38] referred to the European Court of Justice by the High Court in London.[39]

Although the European Court of Justice’s Advocate General subsequently said that the bloc’s plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[40] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[41]

Nevertheless, the European judges acknowledged the Advocate General’s concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.[42]

Effects of most dietary supplements have not been determined in randomized clinical trials and manufacturing is lightly regulated; randomized clinical trials of certain vitamins and antioxidants have found increased mortality rates.[43][44]

See more here:

Dietary supplement – Wikipedia

Food Supplements | European Food Safety Authority

Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, whose purpose is to supplement the normal diet. Food supplements are marketed ‘in dose’ form, for example as pills, tablets, capsules or liquids in measured doses etc. Supplements may be used to correct nutritional deficiencies or maintain an adequate intake of certain nutrients. However, in some cases excessive intake of vitamins and minerals may be harmful or cause unwanted side effects; therefore, maximum levels are necessary to ensure their safe use in food supplements.

EU regulatory framework

The European Commission has established harmonised rules to help ensure that food supplements are safe and properly labelled. In the EU, food supplements are regulated as foods and the legislation focuses on vitamins and minerals used as ingredients of food supplements.

The main EU legislation is Directive 2002/46/EC related to food supplements containing vitamins and minerals.

The Directive sets out labelling requirements and requires that EU-wide maximum and minimum levels are set for each vitamin and mineral added to supplements. As excessive intake of vitamins and minerals may result in adverse effects, the Directive provides for the setting of maximum amounts of vitamins and minerals added to food supplements. This task has been delegated to the Commission and is currently ongoing.

In addition, its Annex II contains a list of permitted vitamin or mineral substances that may be added for specific nutritional purposes in food supplements. Annex II has been amended by Regulation 1170/2009 of 30 November 2009.

Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by EFSA. Companies wishing to market a substance not included in the permitted list need to submit an application to the European Commission.

A guidance by the Scientific Committee on Food in 2001 gives information on the data that should be provided in the dossier supporting the application for a new substance.

EFSAs role and activities

EFSA was asked by the European Commission to evaluate the safety and bioavailability of nutrient sources proposed for addition to the list of permitted substances in Annex II of the food supplements Directive. In July 2009, EFSA completed the first comprehensive assessment of substances used as sources of vitamins and minerals in food supplements, which are currently sold in the EU.

Based on EFSAs work, the European Commission reviewed the list of permitted vitamin or mineral substances that may be added in food supplements.

Between 2005 and 2009 EFSA examined a total of 533 applications. Of these, 186 applications were withdrawn during the evaluation process, and EFSA received insufficient scientific evidence to be able to assess around half of the remaining applications. Possible safety concerns were identified in relation to 39 applications.

The evaluations were carried out by thePanel on food additives and nutrient sources added to food (ANS). The Panels evaluations involved judging the safety of a nutrient substance at the intake levels suggested by the applicant based on best scientific knowledge available. The Panel also assessed the bioavailability of the nutrient from the source, which is the effectiveness with which the mineral or vitamin is released from the source into the tissues of the body. Previously the former Panel on food additives, flavourings, processing aids and materials in contact with food (former AFC) was responsible for this work.

Moreover, EFSAs NDA Panel has preformed a comprehensive evaluation of the possible adverse health effects of individual micronutrients at intakes exceeding the dietary requirements and, where possible, established Tolerable Upper Intake Levels (ULs) for different population groups. ULs represent the highest level of chronic daily intake of a nutrient that is not likely to pose a risk of adverse health effects to humans. The ULs defined by the NDA Panel and by the former Scientific Committee on Food (SCF) are used as a reference by the ANS Panel in its evaluations of the safety of nutrient substances added to food supplements. Throughout this work EFSA will provide support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.

Further information: DG Health and Consumers: Food Supplements DG Health and Consumers: Addition of vitamins and minerals DG Health and Consumers: Tolerable upper intake levels for vitamins and minerals

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Food Supplements | European Food Safety Authority

Food supplement: Probiotics may not boost gut bacteria for good … – Express.co.uk

GETTY

Probiotics can keep your gut healthy and help your digestion.

They work by replacing the bad bacteria – such as Bifidobacteria – with good bacteria, like Lactobacillus acidophilus.

The idea is that if they nurture beneficial bacteria in the gut, they can stall the growth of unwanted bacteria.

This could improve digestion, boost the immune system, and even lower rates of certain diseases.

You can get the benefits by eating foods such as live-cultured yoghurt, sauerkraut and kefir.

GETTY

Research has found probiotics can be useful for treating symptoms of IBS. But other studies have found they make little difference to gut health.

Taking probiotic supplements has also become popular in recent years.

Research by the University of Chicago has found probiotics can be useful for treating symptoms of IBS, such as bloating and abdominal pain.

However, scientists are now questioning whether probiotics are as effective as previously thought.

“Thirty billion Lactobacillus sounds good, but after going through the stomach acid, only about 43 of them survive,” said Ian Orme, a professor of microbiology and pathology at Colorado State University, to Business Insider.

Getty

1 of 10

GETTY

Indeed, a study published last year by the University of Copenhagen found no difference in the gut bacteria between participants who were taking probiotic supplements and others who werent.

This is the same for probiotic yoghurt which a study published in April by the University of Toronto found didnt contain enough beneficial bacteria to make a difference.

Scientists have now been looking at ways to create a more effective option for gut health.

They are working on a new type of supplement – synbiotics – which combine a probiotic bacterial strain with a prebiotic.

Prebiotics feed beneficial bacteria and help it to thrive in the gut.

GETTY

With synbiotics, it is thought that the probiotic pushes out the bad bacteria and the probiotics simultaneously acts as the food supply.

A study published this month showed that newborns who were given a synbiotic were at a substantially lower risk of developing sepsis.

Additionally, it is thought the new type of supplement could also help with obesity, diabetes, and non-alcoholic fatty liver disease.

However, further research is required to confirm the findings.

Read more from the original source:

Food supplement: Probiotics may not boost gut bacteria for good … – Express.co.uk

Could high doses of vitamin B supplements raise lung cancer risk? – CBS News

Men, and especially male smokers, appear to be more likely to develop lung cancer if they take high doses of vitamins B6 and B12, new research suggests.

For men taking these vitamin supplements, the risk of lung cancer was nearly doubled. For men who smoked, the risk was between three and four times higher, the study found.

“High-dose B6 and B12 supplements should not be taken for lung cancer prevention, especially in men, and they may cause harm in male smokers,” said study lead author Theodore Brasky. He is a research assistant professor at Ohio State University.

However, the study wasn’t designed to prove cause-and-effect between the vitamins and lung cancer; it only showed an association.

It’s also not clear why only men and current male smokers seem to face an extra risk.

And a trade organization representing the vitamin industry cautioned against reading too much into the study.

Most people in the United States get enough vitamin B6 through their diets, according to the U.S. National Institutes of Health (NIH). Some people with certain health conditions may need supplements.

As for vitamin B12, the NIH reports that most Americans get enough from their diet. But some groups — such as older people and vegetarians — may be deficient and need supplements. The vitamin may also cause interactions with medications.

Dietary sources of vitamin B6 and B12 include fortified cereals and foods that are high in protein.

The new study included more than 77,000 adults, aged 50 to 76, in Washington state. The participants were recruited from 2000 to 2002, and answered questions about their vitamin use over the previous 10 years.

The researchers found that just over 800 of the study volunteers developed lung cancer over an average follow-up of six years.

The study found no sign of a link between folate (a type of B vitamin) and lung cancer risk. And vitamin B6 and B12 supplements didn’t seem to affect risk in women.

However, “we found that men who took more than 20 milligrams per day of B6 averaged over 10 years had an 82 percent increased risk of lung cancer relative to men who did not take supplemental B vitamins from any source,” Brasky said.

“Men who took more than 55 micrograms per day of B12 had a 98 percent increased lung cancer risk relative to men who did not take B vitamins,” he noted.

Men who smoked at the beginning of the study period and consumed high levels of the B vitamins were three to four times more likely to develop lung cancer, he added.

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“B6 is typically sold in 100 mg (milligram) tablets. B12 is often sold between 500 mcg (microgram) and 3,000 mcg tablets,” Brasky said.

“In contrast, most multivitamins include 100 percent of the U.S. Recommended Dietary Allowance, which is under 2 mg per day for B6 and 2.4 mcg per day for B12. People should really ask themselves if they need over 1,200 times the RDA (recommended daily allowance) of a substance. There’s simply no scientific backing for these doses,” he said.

The study doesn’t conclusively link higher doses of the vitamins to higher rates of lung cancer. If there is a connection, it’s not clear how the vitamins might influence the cancer risk, Brasky said, although it may have something to do with how the vitamins interact with male sex hormones.

Paul Brennan, head of the genetics section with the International Agency for Research on Cancer, said the study appears to be valid.

However, the findings conflict with his group’s recent research, published July 22 in theJournal of the National Cancer Institute, which didn’t find any links between high blood levels of vitamin B6 and lung cancer in people at large, or men specifically.

“If anything,” Brennan said, “we found a small protective effect that was more apparent among men.”

Still, Brennan added that “there is clearly no evidence that these vitamins have any substantial protective effect. Smokers taking these vitamins should quit smoking.”

Dr. Eric Bernicker, a thoracic oncologist with Houston Methodist Hospital, agreed with that advice and said the study points to a higher risk of lung cancer from higher doses.

“There’s a strong belief that vitamins would never harm you. As in much of nutrition, the story is more complicated than that,” Bernicker said.

In a statement, Duffy MacKay, a senior vice president of the Council for Responsible Nutrition, a trade group for the vitamin industry, urged consumers “to resist the temptation to allow sensational headlines from this new study to alter their use of B vitamins.”

According to MacKay, “The numerous benefits of B vitamins from food and dietary supplements — including supporting cognition, heart health and energy levels — are well-established.”

In addition, McKay said, the study has limitations. Among other things, it required participants to remember what they consumed over 10 years.

The study was published Aug. 22 in theJournal of Clinical Oncology.

Read more here:

Could high doses of vitamin B supplements raise lung cancer risk? – CBS News

The Key to Getting to Mars Could Be in Recycling Astronaut Pee Into Food Supplements – ScienceAlert

Researchers have shown how astronaut urine, poop and even exhaled breath could be turned into 3D-printed plastics and nutrients, the kind of smart waste recycling we’re going to need if humans are to make the long trip to Mars and beyond.

The trick is in a yeast called Yarrowia lipolytica, which scientists have found can feed on the carbon from our breath and the nitrogen in our pee to produce everything from vitamin supplements to polyesters, perfect for the production of space tools.

Due to time and weight restrictions, we can’t just take everything we’re going to need on Mars up in a rocket, which is why the recycling system put together by a team from Clemson University could be vital for future missions to the Red Planet.

“If astronauts are going to make journeys that span several years, we’ll need to find a way to reuse and recycle everything they bring with them,” says one of the researchers, Mark A. Blenner. “Atom economy will become really important.”

Right now, the carbon and nitrogen-eating yeast can only provide small amounts of polyesters and nutrients, but the team is working on increasing its output.

One of the developed yeast strains was engineered to produce omega-3 fatty acids, which help heart, eye, and brain health. The supplements we buy here on Earth have a shelf life of just a couple of years, so astronauts will need a way of making their own.

Another strain was developed to produce polyester polymers, the type of plastic you can find in clothes and which could eventually be repurposed to feed a 3D printer the hope is that astronauts could repair and replace tools while out in space.

If that wasn’t enough, the yeast investigations might help in fish farming and human nutrition on our own planet, through its ability to produce omega-3.

“We’re learning that Y. lipolytica is quite a bit different than other yeast in their genetics and biochemical nature,” says Blenner. “Every new organism has some amount of quirkiness that you have to focus on and understand better.”

As well as boosting the output of the yeast, there are other challenges to overcome: right now the yeast needs an extra ingredient added by the scientists to properly convert carbon, while the polymers are proving tricky to harvest from the yeast (which hangs on to them tightly as a potential food source).

Even with the limitations of the system as it stands though, it shows a promising way of developing the sort of deep space waste recycling we’ll need for long space journeys.

The experiments have been funded with a grant NASA awarded in 2015 to look into this kind of biological processing, and to build on the human waste recycling systems we already have on board the ISS urine and sweat can already be converted back into drinking water, for example.

“Having a biological system that astronauts can awaken from a dormant state to start producing what they need, when they need it, is the motivation for our project,” says Blenner.

The findings are being presented at the National Meeting & Exposition of the American Chemical Society.

The American Chemical Society also put together a video looking at the research, which you can view below:

Link:

The Key to Getting to Mars Could Be in Recycling Astronaut Pee Into Food Supplements – ScienceAlert

Experts grill health claims of activated charcoal supplements – WRAL.com

You think of charcoal for your grill, but it’s now turning up in face masks, smoothies and even cocktails.

The ingredient is touted as a way to detox your body. But the claims of what some people call a “magic health bullet” might not be backed up by science.

Activated charcoal comes in black pills, and it’s also found in soaps, beauty face masks and supplements as a simple way to remove toxins from your body.

The product is similar to the stuff used to grill, but the activated kind has been superheated into an extremely porous substance. It’s been used in medicine for decades.

“Activated charcoal is sometimes used as an antidote for overdoses of some medicines,” said Consumer Reports’ Julia Calderone. “The porous charcoal traps certain toxins, preventing the body from absorbing them.”

Some activated charcoal supplements claim to remove toxins in a similar way, but Consumer Reports medical experts say theyre not necessary because the body detoxes itself.

“The body already has organs such as the kidneys and liver to filter out impurities,” Calderone said.

In small doses, activated charcoal has no known significant risks, but supplements are regulated much more loosely than drugs approved by the Food and Drug Administration, and they dont necessarily contain whats advertised on the label.

Other products have come on the market recently, too, such as face washes, soaps and masks, but there’s little published scientific evidence to suggest that activated charcoal helps them work better than products without it.

Consumer Reports advice is to keep charcoal in the grill, not the medicine cabinet. Experts say theres no reason to do a fad detox. Instead, just make sure your diet includes plenty of water and high-fiber foods.

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Experts grill health claims of activated charcoal supplements – WRAL.com

Astronaut pee can be harvested to make food supplements, scientists find – Telegraph.co.uk

Elon Musk, the SpaceX founder has also laid out plants for a major colony on Mars within the next 50 years, and has warned that humans will need to leave Earth to avoid a doomsday event such as an asteroid strike.

For now, the engineered yeast strains can produce only small amounts of polyesters or nutrients, but the scientists are working on boosting output.

They’re also looking into applications on Earth, in fish farming and human nutrition. For example, fish raised via aquaculture need to be given omega-3 fatty acid supplements, which could be produced by the teams yeast strains.

The research was presented at the American Chemical Societys annual meeting.

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Astronaut pee can be harvested to make food supplements, scientists find – Telegraph.co.uk

Food supplements – European Commission

As an addition to a normal diet, food business operators market food supplements, which are concentrated sources of nutrients (or other substances) with a nutritional or physiological effect. Such food supplements can be marketed in dose form, such as pills, tablets, capsules, liquids in measured doses, etc.

The objective of the harmonised rules on those products in Directive 2002/46/EC is to protect consumers against potential health risks from those products and to ensure that they are not provided with misleading information.

With respect to the safety of food supplements, the Directive lays down a harmonised list of vitamins and minerals that may be added for nutritional purposes in food supplements (in Annex I to the Directive). Annex II of the Directive contains a list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.

This list has been amended by the following Regulations and Directive to include additional substances:

The trade of products containing vitamins and minerals not listed in Annex II has been prohibited from the 1st of August 2005.

Directive 2002/46/EC has been aligned with the new Regulatory Procedure with scrutiny by Regulation (EC) No 1137/2008.

Directive 2002/46/EC on food supplements envisages the setting of maximum and minimum amounts of vitamins and minerals in supplements via the Standing Committee on Plants, Animals, Food and Feed ( PAFF Committee) procedure.

The Commission has issued a Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs , which identified the main issues to be considered in this exercise and originated a set of Responses.

Although the Commission has consulted extensively with Member States and interested stakeholders on the issue, no proposal has not yet been presented due to the complex nature of the issue and the divergent views that were expressed. All the available data on the potential effects on economic operators and consumers of the setting of maximum amounts of vitamins and minerals in foods, including food supplements, will be taken into account. Every effort will be made to ensure that the maximum amounts set will take into account the concerns expressed by all interested parties.

The EC commissioned a study on the use of substances with nutritional or physiological effects other than vitamins and minerals in food supplements.

Taking into account this study and other available information, the Commission – in accordance with the requirement set out in Article 4(8) of Directive 2002/46/EC on food supplements – has prepared a report to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements.

The report is accompanied by two Commission staff working documents.

Member States may, for monitoring purposes, request notification to their competent authority of the placing on the market in their territory of a food supplement product in accordance with Article 10 of the Directive. The list of competent authorities may be found here:

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Food supplements – European Commission

Food Supplements Europe

Food Supplements Europe has been created to represent the interests of the European food supplement sector. Its membership includes national associations and companies committed to ensuring that future EU legislation and policy reflects the important role that this sector plays in the health of consumers.

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Food Supplements Europe

Astronaut pee can be harvested to make food supplements, scientists find – Telegraph.co.uk

Elon Musk, the SpaceX founder has also laid out plants for a major colony on Mars within the next 50 years, and has warned that humans will need to leave Earth to avoid a doomsday event such as an asteroid strike.

For now, the engineered yeast strains can produce only small amounts of polyesters or nutrients, but the scientists are working on boosting output.

They’re also looking into applications on Earth, in fish farming and human nutrition. For example, fish raised via aquaculture need to be given omega-3 fatty acid supplements, which could be produced by the teams yeast strains.

The research was presented at the American Chemical Societys annual meeting.

Continued here:

Astronaut pee can be harvested to make food supplements, scientists find – Telegraph.co.uk

Hungarian authorities pull more supplements due to banned substances – NutraIngredients.com

Two brands of dietary supplements imported from China have been withdrawn from sale in Hungary after banned pharmaceutical substances were found.

According to the Hungarian, The National Food Chain Safety Office (NBIH), the two Chinese made supplements were found to contain forbidden pharmaceutical ingredients including Sildenafil and its analogues Thioaildenafil and Tadalafil.

All three active pharmaceuticals are banned from use in food products, including dietary supplements, and are the main ingredient(s) in pharmaceutical products to treat erectile dysfunction.

The two products, Ingenium Nutritional and SPX – Nutritional Supplement, were removed from sale by Hungarian authorities and an immediate recall was made for the dietary supplements that had already been supplied to customers.

The presence of drug agents can only be tolerated in medicinal products that are produced under controlled and controlled conditions.The use of these substances in food, including dietary supplements, is strictly forbidden! said the NBIH

In the absence of medical expertise and supervision, drug agents in the human body may cause circulatory or neurological problems, it added.

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Hungarian authorities pull more supplements due to banned substances – NutraIngredients.com

Body Wise Celebrates 28 Years of Making Pharmaceutical Grade … – Markets Insider

IRVINE, Calif., Aug. 21, 2017 /PRNewswire/ –Body Wise started a healthy living revolution in 1989 when it launched pharmaceutical grade nutritional supplements. Over the years the product line has grown from essential nutrition and heart health to immune system modulation, weight loss, and sports performance. Each new product is rooted in the belief that optimal nutrition, together with sensible eating and exercise, forms the foundation for a lifetime of good health.

“I have personally made several Body Wise products part of my daily nutritional routine,” said Dr. Kenneth Petri of Denver, Colorado. “Oxy G2 and AG Immune are both indispensable to me, along with the fabulous Right Choice AM and PM combination that I feel play a role in my continuing excellent health.”

Today, as it was 28 years ago, most nutritional supplements on store shelves are food grade. Body Wise pharmaceutical grade nutrition offers a higher level of purity and potency.

“There is no uncertainty when it comes to the positive benefits of supplements because the evidence is overwhelming. The only uncertainty regarding supplements is their quality, and Body Wise removes that uncertainty,” said Dr. Bradley Wajda of Fresno, California.

The process of creating pharmaceutical grade nutrition begins with the latest scientific research and formulations by doctors and nutritionists. Then, Body Wise manufactures these supplements in an FDA licensed facility to the same rigorous standards used to make medicines, in accordance with the U.S. Pharmacopeia.

Raw ingredients are quarantined and undergo heavy metal and microbiological testing. They are then cold processed to preserve the power of nutrients. A final batch testing by high-pressure liquid chromatography assures consumers that what’s on the label is exactly what’s in the bottle.

It all adds up to enhanced bioavailability at the cellular level and a difference people notice.

“Some of the major results reported to me by my patients have been a better sense of energy and improved sleeping habits,” said Dr. Harold J. Bowersox of Mentor, Ohio. “Those patients with chronic complaints have had great relief, which I feel is the boost in their immune status.”

Since 1989, interest in integrative medicine has skyrocketed. Body Wise is proud to partner with healthcare professionals to help thousands of people across the United States and Canada live healthier and happier lives.

About Body Wise

Body Wise makes pharmaceutical grade optimal nutrition supplements for energy, immune health, weight loss, anti-aging, and sports performance.

For more information, visit http://www.BodyWise.com.

Media Contact: J. P. Sousa 714-368-1253 rel=”nofollow”>jpsousa@bodywise.com

View original content:http://www.prnewswire.com/news-releases/body-wise-celebrates-28-years-of-making-pharmaceutical-grade-nutritional-supplements-recommended-by-doctors-300507035.html

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Body Wise Celebrates 28 Years of Making Pharmaceutical Grade … – Markets Insider


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