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Rivendell offers strategic and practical marketing and regulatory advice to cope with upcoming and actual legislation for food supplements, botanical products and health claims in the EU and the Netherlands.
4 April 2018
Recommendation on the monitoring of metals and iodine in seaweed, halophytes and products based on seaweed
See (EU) 2018/464
8 December 2017
Dutch Ministry of Health notifies maximum B6 with EC in Brussels
The decision by the Dutch Ministry of Health to set a maximum for vitamin B6 in food supplements is caused by health problems mentioned by consumers. The reason is not yet clear but research by the University of Maastricht leads to the possibility that the type of vitamin B6 has an influence.
The maximun allowed dosage for B6 will be 21 mg for adults from October 1, 2018 and lower dosages for several age groups of childeren. Also a warning statement for all food supplements with B6 will be mandatory from that date, above 7 mg per day: this food supplement should not betaken by childeren up to 17 years.
27 October 2017
Ministry of the Health from the Netherlands gives up setting a maximum for melatonin
In the past years the Dutch Ministry of health focussed on setting a maximum for melatonin in food supplements of 0,3 mg per day. Because EFSA / EC made health claims for up to 1 mg per day possible within EU Health Claim Directive 1924/2006 the health food industry did not agree with this and court cases took place about the intention of Ministy of Health. These court cases were won by the industry. On the website of VWS is now stated that there is no maximum for melatonin in food supplements in the Netherlands. For safety reasons however some warning statements are necessary due to the HACCP obligation.
10 March 2017
The Global Marketplace for Medicinal & Aromatic Plants
Exhibition and Seminar: 'The Plants with Medicinal & Aromatic uses'. The MAP-EXPO will be held in Eindhoven, (see link below) in the Netherlands on 29 & 30 March. Visitors from over 20 countries are expected. In the NVF seminar (in English) an update will be given about the quality of production of herbs, extracts, technology:
Dr.Henrie Korthout, Fytagoras: The importance of robust extraction procedures for active compound identification;
Ir. Theo van Rooij, Rivendell Health Food Consultancy: Regulatory aspects of Herbal (Traditional) Medicines and Botanical Supplements in EU / the Netherlands;
Dr Maria Groot, RIKILT Wageningen University & Reserach: Use of herbs in production animals;
Dr Kees Beukelman, PhytoGeniX BV: Provided by Nature, Proven by Science;
Drs Christine Catlender and/or Dr Stephan Horsten, NVF: Escop-monografiën (Nederlands/Dutch);
Dr. Marij Schüsler, NVF: “ Postion of NVF; Waar staat de NVF voor anno 2017?” (Nederlands/Dutch);
Dr. Herman van Wietmarschen, Researcher Nutrition & Health Louis Bolk: Systems Biology and herbs.
Zie: NVF-SeminarExhibition and Seminar
16 December 2016
The Netherlands sets Maximum B6 at 21 mg through National Legislation!
The Dutch Ministry of Health published today the decision to set the maximum daily dosage for vitamin B56 in food supplements at 21 mg. Untill now there was no maximum level in The Netherlands and since some years the Dutch Health Food association NPN proposed a warning statement for products above 25 mg. This decision for setting a maximum of 21 mg is based on a recent report by the internal risk assessment office of the Dutch Food Safety Authority NVWA. For children there will be a maximum varying 3-13 mg per day depending on age. Also some mandatory warning texts are envisaged for high dosed products. This decision is a result of several complaints of peripheral neuropathy per year by users of high dose vitamine B6 supplements and the fact that the industry itself did not take the necessary measures to lower the dosage in self-regulation. The Netherlands will notify the EC about this decision and expects that the new standard will enter into force on July,1 2017.
5 October 2015
New EU norm for PAH contamination in botanical supplements
Since about 10 years the Netherlands was the only country in the EU that enforced a maximum level for polyaromatic hydrocarbons (PAH) in herbal supplements, namely 10 ppb. This has lead in the past to several recalls. The reason for these recalls were also due to the lack of interest in the PAH contamination outside of the EU including the US. Due to this the Dutch supplement industry and Rivendell has experience with PAH risks of products. As the EU is taking over the PAH maximum levels in EU law next year the experience from the Dutch industry can be of help to prevent a lot of analytical tests. PAH contamination may occur during drying or if herbs are grown along a highway or in an industrial area. Mainly products from Africa, Asia and Latin America are at risk and there are a few herbs that generally show a risk for high levels of PAH. To control this risk for too high PAH levels suppliers must be informed about this new legal requirement and regular PAH tests are needed as part of HACCP: especially in the high risk herbs PAH is a Critical Control Point (CCP).
September, 1, 2015
Melatonin untill 5 mg can remain in the Dutch food supplement market for the time being!
Last friday August 28 the Dutch Health Food Association (NPN) won a court case against the Ministry of Health (IGZ) of the Netherlands, which had the intention to forbid all food supplements of melatonin with a dosage of 0,3 mg and higher from October 1, as was the intention. The ruling was that based on the EU HechtPharma arrest the Dutch authorities must determine case by case if a product with melatonin is a food supplement or a medicinal product.
The outcome of this courtcase allows melatonin between 0,3 mg and 5 mg on the Dutch market for the time being. Still the threat of a ban of melatonin of 0,3 mg and higher is possible, see our news message of February 25, as IGZ and NPN are still in proceedings on the merits/substance of this case, which can take several months. IGZ has still the opinion that dosages higher than 0,3 mg should not be a food supplement.
June 12, 2015
Claims Directive remains in force
The European Court of Justice (ECJ) has rejected a joint plea from the UK Health Food Manufacturers' Association (HFMA) and the Dutch NPN for the permitted health claims list regulation to be annulled.
The plea by HFMA, NPN and some food supplements company concerned the imbalanced implementation by the EC of this Regulation, the publication of 432/2012, by which 220 health effects of mainly vitamins and minerals were approved while on the other hand due to unexpected high demand for scientific substantiation for dossiers for probiotics, Cranberry, co-Q10, glucosamine, isoflavonoïden etc. led to a total rejection of these dossiers. The court case was also about the uncertainty of the future of health claims for botanicals. The demand of HFMA and NPN was to nullify the implementation that would result in a complete change of the use of health claims since 2012. The European Court of Justice rejected all aspects of the plea and in fact approved the implementation by the EC. Due to this the current practice of the use of health claims in the EU does not change.
Zie: Nutra Ingredients
February 25, 2015
Dutch Ministry of Health sets maximum level for melatonin in food supplements
Already for years the Dutch Ministry of Health and the Inspection for Medicines showed the intention to create a clear line between food supplements and medicinal products in the Dutch market re. melatonin products. Last year and last month the Inspection for medicinal products - IGZ made it clear: it will be < 0,3 mg per daily dosage. The Dutch melatonin market is quite big, estimated at more than 20 Million, and as the Inspection did not, or was not able to regulate and controll the market, products of up to 5 mg per day are widely spread. But it seems this comes now to an end due to a court case about the <0,3 mg level this week IGZ has won. IGZ has from now the legal power to remove food supplements from 0,3 mg and higher from the market. Companies with higher dosages in their products have the choice to lower the dosage or to start registration as a medicinal product before March 15, 2015. A big question remains how the market and consumers will react. Mailorder companies from abroad might take over a big part of the market. It is also possible that companies go to court based on the Mutual Recognition principle of the EU as in other EU memberstates they have the same product legally on the market as a food supplement. So a next chapter in the melatonin story in the Netherlands will be created in the coming months.
October 7, 2014
Quality of food supplements and superfoods needs extra attention
Investigations in the Netherlands and Czech Republic show that some supplements contain forbidden active pharmacological substances, too high contaminant levels etc... Dutch Food Inspection NVWA found too high pesticide residues in superfoods. This makes it clear that the health food, superfood and food supplement industry need to focus more on quality. Especially products produced outside of the EU have a higher risk on contamination, in the EU not allowed substances and inferior quality. HACCP, strict quality requirements of especially herbal products and regular independent checks are necessary in this industry.
August 15, 2014
Italian request for the term Probiotics
The Italian Ministry of Health (following application of two Italian associations) has submitted to the European Commission an official dossier to request authorisation for the term probiotico as a generic descriptor in the EU.
In the past years discussions about the possible health implications of the term probiotics has led to the fact that several Member States did not allow the word in labelling and advertising any more. In the Netherlands this is not the case and products with living bacteria can called probiotica for the time being.
July 14, 2014
Organic food better
Organic food contains a higher content of antioxidants and lower Cadmium and pesticide residue levels. This is shown by a meta-analysis of 343 peer-reviewed publications by researchers from Newcastle University. The average levels of the antioxidants in organic food are 19% (phenols) to 69% (flavanonen) higher, than of non-organic food. Other antioxidants are in between: stilbenes +28%, flavones +26%, flavonols +50 % and anthocyanides +51%. According to Newcastle University would be a transition to organic fruits, vegetables and grains and foods thereof, provide an additional amount of antioxidants equal to 1 or 2 extra servings of vegetables and fruit per day.
July 8, 2014
German court disagrees with ban kava-kava.
More than 10 years ago kava-kava was forbidden in Europe. At that time publications about serious side-effects led to the qualification that kava in food supplements and medicinal products was forbidden in a short time all over Europe. Recently a court in Munich ruled this ban as unjustified. Besides this court case also some positive scientific papers were published about the positive effects of the use of kava-kava. The question is now what effects all these developments will have on the herbal market in Germany and the rest of the EU.
July 4, 21014
Safe use of red yeast rice requires a warning text
Recent scientific publications in France and Belgium show that food supplements with red yeast rice should never be combined with the use of statins because of the risk of overdosing, liver problems and muscle toxicity. The use of red yeast rice should also never be started in case of earlier problems with statins. It is also important that the use of red yeast rice only starts after consulting the doctor and regular follow-up controls take place. This is the result of recent pratical cases.
June 20, 2014
Authorities issue high fines for unacceptable claims for food supplements
In Italy as well as in the Netherlands high fines are submitted (respectively € 100.000 and € 30.00) recently for too heavy claims on children supplements and on website. In both cases disease symptoms and medical claims were used. More and more it becomes clear that authorities act strongly especially against medical claims.
April 14, 2014
New Folate salt approved in the EU!
The new allow folate ingredient, a glucosamine salt of (6S)-5-methyltetrahydrofolate is structurally analogous to the reduced and active form of folic acid. Developed by Gnosis S.p.A and also called Quatrefolic, it represents the fourth generation folate providing greater stability, higher water solubility and multiple ingredient formulation flexibility compared to 5-methyltetrahydrofolate calcium salt guaranteeing an improved bioavailability.
April 7, 2014
EFSA gives negative opinion about fatburning claim for Guarana / green tea product
Due to this recent negative opinion of EFSA it becomes more and more clear that the weight management and fatburning claims as often used in the sports and slimming area will be quite likely forbidden in the future in the EU as soon as the EC will make a final judgement about health claims for botanicals.
March 31, 2013
Simple check for Ginkgo developed
As Ginkgo extracts are expensive and the market is big adulteration in the raw material field can take place. Australian reserachers did develop a new quality check to prove the authenticity of the extract.
February 21, 2014
Negative opinion EFSA for sterols in food supplement!
Sterols are very popular in foods, the approved claim is helps lowering cholesterol for products with a sterol dosage of 2 gram per day. Untill now the EU however did not allow food supplements to use the same claim. Sanofi submitted a dossier to get the approval for a powder product together with a study confirming the efficacy. EFSA gave a negative opinion with the reason that one study is not enough to prove efficacy of the food supplement!? The food supplement industry needs to stand up against this way of judging supplements!
February 10, 2014
Alertness claim caffeine only at 75 mg per day
By giving a negative opinion for a product with 40 mg EFSA confirms again that the effective dosage for the claim "improving alertness" must be 75 mg per day.
January 21, 2014
Extra magnesium helps volleyball players to jump 3 cm higher!
A recent study in Brazil shows that extra magnesium helps volleyball players to jump higher. Based on the EU approved health claim for magnesium (support of muscle function) and the other allowed claims for vitamin C (immune system support with intense physical exercise) and related claims for Iron and some B-vitamins this makes promotion of sports products possible.
January 15, 2014
EFSA gives positive opinion for oligofructose on blood glucose
The opinion of EFSA makes clear that non-digestive carbohydrates like oligofructose and inulin from cichory reduces the blood glucose level if these carbohydrates replaces sugar in the food or drink with 30 %.
January 7, 2014
What will 2014 bring for the supplement and healthy food industry?
1. HACCP: More quality and HACCP: Inspections will controll companies more strict on HACCP procedures. Especially webshops are often not aware of this mandatory requirement. Especially when importing from the US strict HACCP procedures are essential as the EU has more strict rules for safety than the US.
2. SUPER foods and raw foods will continue to grow.
3. GROW: Supplements for seniors (cognitive and physical vitality) and children keep growing.
4. SAFETY: The supplement industry shall have to watch also the safe use of the supplements and warn users on the label if necessary. This is essential for the creditability of the product and the company.
5. MAX LEVELS: It is possible that the ECwill harmonize at the end of 2014 the maximum levels of vitamins and minerals in supplements, but at what levels?
6. BOTANICALS: And will the EC take a decision this year for the on hold claims of botanicals? This can change the marketing of botanical supplements drastically.
December 6, 2013
All health claims for probiotics and glucosamine from end of this year finally forbidden.
Due to publication 536/2012, which must be implemented fully in January 2014, all health claims for probiotics, glucosamine but also luteine, MSM, soy isoflavons and peptides/amino acids are forbidden. The question is now how on the product information can be written without making a prohibited health claim. It cannot be denied that Acidophilus can be found in the colon. Is that from now also forbidden? The health food industry needs creativity and a clear guidance to be able to inform consumers about their products.
December 2, 2013
EFSA: Ephedra is unsafe
EFSA issued a new opinion on Ephedra and judges it is unsafe for use in food and food suopplements. Already for years Ephedra is not allowed in the EU. This EFSA opinion justifies the ban of Ephedra ans ephedrine. The next question is what impact this opinion can have on Ephedra-replacing botanicals as Citrus aurantium and its extract containing synephrine. Several member states in the EU question the safety and the combination with cafeine.
November 22, 2013
MHRA UK implements 2004/24 fully by april 2014
2004/24 the EU Traditional Herbal Medicinal Products directive allows herbal products to be marketed as medicinal products. The UK registration agency MHRA announces that unlicensed medicinal herbal products should by april 2014 be registrered or marketing should be discontinued. Since 2004 several hundreds of products got a new approval.
November 19, 2013
TNO will make a new proposal for maximum permitted levels for vitamins and minerals in the EU
November 15, 2013
Food supplement status glucosamine tested in UK
A chinese pharmaceutical company, having registrations for glucosamine as a medicinal product in all EU countries, questions the status of glucosamine as a food supplement in a UK court case against the MHRA. This important case can have consequences for all ingredients in food supplements that also have a medicinal status. HFMA supports the MHRA and made a judical review about the supplement status of glucosamine. The court case will take place mid 2014.
November 8, 2013
EFSA positive about extra health claims for children
Recent positive opinions of EFSA for children claims were: magnesium and bones; iodide and cognitive development, vitamin A and immune system; pantothenic acid and riboflavin for the energy-yielding process.
October 31, 2013
EFSA judges the influence of hydroxanthracene positive for bowel function
The daily dosage of 10 mg hydroxyanthracene derivatives from Rheum palmatum L., Rheum officinale Baillon, Cassia senna L., Cassia angustifolia Vahl, Rhamnus frangula L , Rhamnus purshianus D.C. and Aloe barbadensis Miller, Aloe ferox Miller and its hybrids are effective in improving bowel function. This is a positive sign of EFSA in the direction of active ingredients in botanicals for the use in botanical supplements. Let us see how the member states react!
October 27, 2013
ANSES France questions the safety of red yeast rice
The safety institute of France received 25 cases of side effects, mostly muscle and liver damage. ANSES investigates these cases and asks imput from companies, instutes and member states. Also the citrinin content in red yeast rice products is discussed within the EU.
Contributions can be sent to the following address: consultation-LRR@anses.fr
Sport supplements a threat for image food supplements
The last month in the US and Europe sport supplements showed ot be either not pure or having side effects. OxyElite Pro Super Thermo Powder is removed from the US market because of possible liver damage; it contained the forbidden DMAA. In the Netherlands the product Craze contained Craze N-diethylenylethylamine, a substance close to methamfetamine. The US FDA found aegeline in the muscle product VERSA-1. FSA UK continues to warns for dinitrophenol (DNP) an illegal ingredient in supplements but on the Internet still for sale. It is clear that the sport supplement industry should be aware of its responsability and use only safe ingredients that are allowed in the EU!
October 16, 2013
Documentary Numen about Medicinal plants
Watch during October 20-30 for free the inspiring documentary Numen, the Healing Power of Plants: https://numenfilm.leadpages.net/8min/
October 15, 2013
Safe level vitamin D is 100 mcg, for children untill 10 years the UL is 50 mcg!
EFSA has raised last year the UL of vitamine D to 100 mcg for all groups of the population, including pregnant and lactating women. For children untill 10 years the UL is determined at 50 mcg, this was 25 mcg. In the Netherlands the maximum level for supplements is 25 mcg, for children 15 mcg.
September 9, 2013
Combination of synephrine and cafeine unsafe?
The Finnish Safety Authority EVIRA concludes that the combination of syneprhine ( from eg. Citrus aurantium) and cafeine is not safe. Health Canada issued last year another opinion and concluded that up to 40 mg synpehrine in combination with max. 320 mg cafeine is safe, Germany (Bfr) found earlier this year that the combination is unsafe for general use in food supplements. The products concerned have an unsure future in the EU!
August 30, 2013
EC published regulation for the justification of cosmetic claims
In EU regulation 655/2013 six criteria are mentioned regarding the justification of cosmetic claims: legal compliance, truthfullness, evidential support, honesty, fairness and informed decision-making.
August 21, 2013
Dutch and UK authorities ban Dexaprine
Dexaprine is a fat burning product from California. Due to 11 users with serious side effects in the Netherlands the Dutch and UK authorities banned the product. Looking at different ingredient lists on the Internet it looks like that several ingredients (DMAA, high cafein content, DNP, Rauwolfia, green tea with a high theofyllin content) could be the cause of the health problems
August 9, 2013
EFSA proposes to increase the RDA for manganese from 2 mg to 3 mg per day!
August 1, 2013
EFSA approves cholesterol lowering claim for a combination product
According to EFSA the product Limicol®, a combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate has proved to lower on blood LDL-cholesterol concentrations.
It is now up to the EC to decide if this will be an official allowed health claim.
July 29, 2013
EFSA refuses again an Urinary Tract Infection art. 13.5. health claim for a Cranberry product
July 26, 2013
EFSA confirms that yohimbe is not safe for use in food supplements
Pausinystalia yohimbe, also called simply yohimbe, is investigated by EFSA with the conclusion that its safety cannot be established as also not a safe daily dosage in food supplements. In the Netherlands and most other EU member states yohimbe is prohibited for use in food supplements. Webshops however have it on sale via Internet.
July 19, 2013
Quality of red yeast rice a serious issue!
Red yeast rice (RYR) products with monacolin K are rewarded by the EC/EFSA with a cholesterol lowering claim, however the quality of RYR products can vary greatly. Besides the monacolin level also quality problems can arise if citrinin is in the product. Citrinin can be produced by other fungi during the fermentation process. Citrinin is not safe. The EC discussing what extra quality requirements must be set to protect the consumers.
July 17, 2013
New research confirms: Cranberry inhibits bacteriae responsible for UTI
Prof. Tufenkji and members of her laboratory report that cranberry powder can inhibit the ability of Proteus mirabilis, a bacterium frequently implicated in complicated UTIs!
July 3, 2013
Dietary supplement market fastest grower!?
A new market report from Transparency Market Research, Albany, NY, has found that the global nutraceutical product market reached $142.1 billion in 2011 and is expected to reach $204.8 billion by 2017, growing at a CAGR of 6.3% from 2012 to 2017. Asia Pacific (including Japan) is expected to have the second largest market share after North America by 2017.
The report, “Nutraceuticals Product Market: Global Market Size, Segment and Country Analysis & Forecasts (2007-2017),” also cited that in 2011, the functional food and beverage market reached USD 93.0 billion, registering a growth rate of 6.0% from 2007 to 2011. North America enjoyed the highest market share for nutraceutical products at USD 56.4 billion in 2011.
According to Transparency Market Research, the global nutraceutical market is growing primarily on account of growth in dietary supplement segment, however functional foods and beverages also make up a significant market segment.
The global nutraceutical market is estimated to have a growth rate of 6.6% during the forecasted period (2012-2017) in protein and peptides segment of dietary supplement market. The non-herbal segment of dietary supplement market will have a growth rate of 6.3% from 2012 to 2017. The omega fatty acid fortified food segment of functional food market will have a growth rate of 6.7% during the forecasted period.
The North America and Asia Pacific nutraceutical market is expected to have a market share of 39.2% and 30.4% respectively in 2017. The dietary supplement market will be the fastest growing market from 2012 to 2017 as it helps in improving the body ability to heal and protect itself.
This report categorizes the nutraceutical market into six geographic regions namely: North America, Western Europe, Eastern Europe, Asia -Pacific Latin America and Middle East & Africa. -
See more at: http://www.nutraceuticalsworld.com/contents/view_breaking-news/2013-06-26/nutraceuticals-product-market-forecast-to-reach-2048-billion-by-2017/?email_uid=76f44d110d/list_id=396c189146/#sthash.hHwfwtir.dpuf
June 26, 2013
Italy sets the maximum level for melatonin in food supplements at 1 mg per day.
At the moment there are products with up to 5 mg per day. These products must be adapted before the end of September.
The Dutch media announce the Dutch Food and Medical Inspection NVWA and IGZ will take action against melatonin food supplements with a higher dosage than 0,3 mg per day.
June 20, 2013
Monk fruit not allowed as natural sweetener in the EU!
Monk fruit or Siriatia grosvenorii or in Chinese Luo Han Guo is a often used table-top sweetener and also as a herbal remedy. Recently it is also [ermitted as sweetener in Canada. In the EU it is however not allowed. Products with this sweetener can not be imported into the EU.
June 18, 2013
Protein slimming product from US spiked with drug
In the US FDA removed a protein product from the market as it contained the illegal drug sibutramine. Sibutramine was removed from the U.S. market in October 2010 because it can substantially increase blood pressure and pulse rate in some individuals, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Besides that it is completely illegal to have ingredients in a product without labelling it.
June 13, 2013
Safety of red yeast rice - Monacolin K questioned
In the last Standing Committee Meeting of the EC member states discussed with the Commission the safety of red yeast rice. EFSA approved a health claim but the member states have safety concerns. In France there are already mandatory warning statements for red yeast rice. Also the citrinin content should be maximised according to some member states. The EC investigates this issue further.
June 4, 2013
Discussion about safety of Ginkgo extracts in the US
The US Center for Science in the Public Interest (CSPI) informed the US FDA about its standpoint that Ginkgo biloba leaf extract did cause cancer in animals and urges the FDA to take action and to remove Ginkgo out of food and botanical supplements. The reaction of the American Botanical Council (see Herbalgram May 2013) is that the extract in the study on which the standpoint of CSPI is based concerns a quite different Chinese Ginkgo biloba extract than normally used in the food supplement industry and that a lot of safety studies were done on this extract in the past. Reaction of a FDA spokesman:
Although CSPI has begun to make its case to the FDA, the final decision rests with the Administration. As reported in an article from The New York Daily News, FDA Spokesperson Tamara N. Ward hinted that more evidence might be needed for the Agency to take any drastic action.
“While FDA is concerned about the findings of the studies, and will consider the implications it may have for the safety of dietary supplements containing gingko biloba [sic], it is not scientifically valid to conclude with certainty that dietary supplement products containing gingko biloba are unsafe based solely on data from the new NTP study,” Ward was quoted as saying in the Daily News article. [Emphasis added] “In the study, rats and mice were fed amounts of gingko biloba extracts (by body weight) that may be considerably greater from those which a consumer would normally ingest from a dietary supplement product containing gingko biloba. In addition, there may be differences in the extract used in these studies in contrast to what is available on the market for gingko biloba dietary supplements.”
May 29, 2013
EC publishes draft regulation energy drinks
To regulate the sales and promotion of energy drinks with caffeine the EC published a draft with the intention to enter it into force from January 2014.
May 17, 2013
SAM-e: not a medicinal product but a food supplement!
The Dutch authority questioned the import of a SAM-e ( S-adenosyl-methionine ) product from the US. In a recent court case it is confirmed that, due to its physiological effects and the facts that there were no medicinal claims on the label, the product is not a medicina product and can be imported as a food supplement.
May 16, 2013
European Commission will publish a guidance for substantial equivalence procedure of Novel Foods
May 9, 2013
French authority proposes warning text on red yeast rice products
French Medicine Agency (ANSM) investigated eventual risks of the use of red yeast rice as food supplements. ANSM has published label and other recommendations related to the use of red yeast rice-based supplements.
Recently the EFSA reconfirmed that the minimal effective dosage to lower cholesterol is 10 mg monoacolin K from red yeast rice.
April 29, 2013
EU will quite probably forbid health claims for probiotics and glucosamine!
The European Commission proposed the European Parliament (EP) to reject definitvely all claims for probiotics and glucosamine and remove these claims from the on hold list. The result will quite probably be that the EP will accept this proposal with the result that end of 2013 all health claims for these two groups of ingredients in food supplements must be removed. Botanicals and cafeine claims stay on hold and can still be used based on national regulations and the claims mentioned in the on hold list.
April 20, 2013
BELFRIT initiative for a positive list of allowed botaniclas / herbs in food supplements: a risk?
As a reaction to the Italian list of approved herbs in food supplements Belgium, France and Italy decided to work on one total list. In principle a logic next step, but as the EC is also interested the result could be a positive list for all of Europe. While some typical Ayurvedic and TCM herbs are at the moment not in the lists of these 3 countries this could have a negative effect on the marketing of Ayurvedic and TCM products in the future. As Ayurvedic and TCM products are very common in the UK and the Netherlands it would be wise that these countries gave their input too and that all parts of the health food industry would be involved.
A list like this also blocks innovation.
April 10, 2013
Citrus aurantium (bitter orange) in combination with caffeïne unsafe?
The German risk assessment group BfR states that the combination of bitter orange and caffeïne could have undesired cardiovascular effects. The dosage of synefrine from bitter orange should not be higher than 6,7 mg per day according to BfR. In other EU states higher amounts of synefrine are accepted!
March 29, 2013
Cafeïne safety debate continues and hinders the puiblication of health claims in the EU
In the US the safety of energydrinks and energyshots by youngsters is questioned more and more, at the same time there is an internal debate in the EU about approval of quite interesting health claims for cafeïne. A lot of member states have the opinion that if these health claims will be possible this would encourage the use of these energy products by youngsters, leading to more overuse.
March 21, 2013
Italy allows higher vitamin D, B6 and iron levels in food supplements
March 14, 2013
Norway institute publishes review about safety of free aminoacids
The Norwegian Institute VKM published recently a report about the safety of free aminoacids in supplements. Four aminoacids are categorised at high risk: histidine, methionine, tryptophane and SAM-e. For tryptophane and methione the VKM proposes maximum levels. This report can be used to formulate safe products and substantiate the safety within HACCP. Another good report is the more than 10 years ago published official report about the safety of aminoacids in food supplements in the Netherlands. Also this report contains clear maximum safe levels. Especially in sport supplements free aminoacids are popular.
March 11, 2013
New European Food Supplements Lobby group founded.
Food Supplements Europe (FSE) is quite probably initiated by CRN UK and ERNA to be able to build credible and trustful relationship with EU regulators. Besides CRN and ERNA also the big European ingredient suppliers DSM, BASF, Kemin and Lonza are already members as also some national food supplement assciations. It seems a reaction to the changes within EHPM in fall of last year of which was CRN was a member while cooperating with ERNA out of the Brussels office of EAS. EAS stopped working with EHPM since fall of 2012. EHPM is now setting up its own Brussels office and is mainly guided by HFMA (UK), NPN (Netherlands) and Naredi (Belgium).
March 7, 2013
Norway doubles RDA/RDI vitamin D from 10 to 20 mcg per day for the entire population!
March 1, 2013
What is the best bio-avilable omega-3 source?
When formulating omega-3 products price and dosage (to be able to make approved health claims) are important, but also bio-availability can be important to be able to have a better product compared with the very cheap fish oil products.. There are three forms of omega-3 fatty acids: the triglycerid form as in fish oil, the free fatty acid form or the phospholipid form as in krill. All have a different bio-availability. Good to know that quality claims as better bio-availability or high dosage are possible and not controlled by 1924/2006 (nutrition & health claim regulation), but of course such statements must be based on clear and scientific data.
January 18, 2013
Question about high dosage vitamins in food supplements raised in UK Parliament due to lobby of the health food shops.
January 7, 2013
Beta-carotene safe up to 15 mg / day, also for heavy smokers!
EFSA concluded recently that exposure to β-carotene as food additive and in food supplements at a level below 15 mg/day do not give rise to concerns about adverse health effects in the general population, including heavy smokers. Above 15/day heavy smokers should not use the product.
December 24, 2012
EFSA rejects again several health claims
Again only negative opinions were published by EFSA, a.o. weight management for a combination of green tea and Guarana; joint health and krill oil.
December 21, 2012
EC postpones final decision on caffeine and glucosamine claims
Due to different opinions between EU member states the EC did not publish the final approval of five caffeine claims and also not the final rejection of the joint claims for glucosamine. The result is that joint claims for glucosamine can still be made based on national regulations. As soon as the EC publishes the final rejection companies must remove joint health claims from their products and in marketing within 6 months.
D-day for health cliams in the EU
EU health claims directive 1924/2006 + 432/2012 must be fully implemented on all products with health claims. Only for the main part of botanicals and glucusoamine there are some on hold claims.
December 12, 2012
EFSA negative about traditional health claims for botanicals
New EFSA chief Prof. Ambroise Martin sees traditional health claims for botanicals as not realistic within 1924/2006. On the other hand he sees approval for claims for probiotics as possible in the coming 1-2 years.
December 11, 2012
EFSA opinion: betacarotene safe up to 15 mg/day, even for heavy smokers
EFSA, based on a review article from 2010, concluded that exposure to β-carotene in food and food supplements at a level below 15 mg/day does not give rise to concerns about adverse health effects in the general population, including heavy smokers. Based on an earlier Finnish study, about 10 years or more ago, there was concern of extra lung risk cancer risk of heavy smokers who used betacarotene and due to this the EFSA came to a safe level of 4,8 - 7 mg. It is advsied to use the 15 mg as a maximum level for betacarotene in food supplements from now on.
November 27, 2012
EFSA gives positive opinion for chromium-yeast ingredient Chromo-Precise
EFSA gave a positive opinion for ChromoPrecise®, a cellular bound chromium yeast, as a source of chromium in food supplements. The next step is that the EC confirms this in legislation.
November 27, 2012
UK HMRA will classify herbals preferably as traditional medicinal products
After a quality problem with black cohosh - Cimucifuga as a menopause product in which not Cimicifuga racemosa but Cimicifuga foetida was present the UK MHRA announced it will look more in detail of the classification of herbals and sees for instance black cohosh not as a herbal supplement within Food Law but as a traditional herbal medicinal product. See the MHRA website for recent information. Suppliers of herbal products should see this as a clear indication in which regulatory environment a lot of herbal products will be placed in the near future.
November 26, 2012
EU will quite probably approve cafeine health claims but reject glucosamine joint claims
Recent information makes it quite obvious that the EC will approve in the coming weeks the five positive opinions of EFSA for cafeine. At the same time it is expected that health claims for glucosamine will not be accepted.
November 14, 2012
Belgium and Portugal publish principles in how far the exact approved EU claims can be changed or not
The 12 principles from Belgium are a good guideline what is possible and in how far variations are acceptable.
November 7, 2012
FSA-UK warns for fatburners /sport supplements with DNP
After having removed DMAA out of sport supplements the FSA UK warns for another possible ingredient in products for body builders: DNP - 2,4-dinotrophenol. It can have serious side effects and is found in fatburners.
November 3, 2012
All medical claims must be removed from homeopathic products in the Netherlands
The Dutch Ministry of Health decided some months ago to remove all medicinal claims from homeopathic products by which the industry is shocked. The big question is what can be done to inform the consumer. In general, non-product information about homeopathic substances claims can be used. This is a task of all organisations active in the homeopathic field. Besides that it is possible to register mother tinctures as traditional herbal medicinal products under 2004/24 and a few may be as medical device. This is a long term solution for some products. For the short term it is possible for not potentiated ingredients to use health claims on the basis of the on hold list within 1924/2006. Than the product must be sold under Food Law.
November 1, 2012
Adulteration of herbal extracts
The American Botanical Council published its fourth article about adulteration of herbal extracts. In the past articles about Scutellaria laterifolia, Teucrium canadense (gamander) and Grapefruit seed extract were published, now you can find in Herbalgram a peer reviewed articlel about possible adulteration of Billberry extracts. These articles stipulate the importance of good quality procedures to be sure to offer the consumer the right product.
October 22, 2012
Word Probiotic is not a health claim?
Some EU member states and also the EC questioned if the word probiotic could be used without an approved health claim for these type of products. Of course the industry does not agree with this interpretation as this word, as for prebiotic, is seen as a clear description of the category of products containing colon bacteriae without referring to a health effect. A german dispute about this issue has ended in a court case where the judge ruled that the word probiotic as such is not a health claim.
October 20, 2012
MHRA-UK questions the safety of Berberis aquifolium and Hydrastis canadensis for children and adolscents.
MHRA decided to withdraw a product form the market containing Berberis aquifolium and Hydrastis canadensis, to be intended for juniors, as the safety of the alkaloids berberine and hydrastine has not been established for children and adolescents.
October 15, 2012
UV skin protection claim rejected by EFSA
The European Food Safety Authority (EFSA) has rejected a health claim for a proprietary blend of the antioxidants lycopene, vitamin E, lutein and selenium regarding the protection of the skin from UV sun rays.
Synthetic zeaxanthin approved by EFSA
After an ealier rejection EFSA approved now synthetic nature-identical zeaxanthin for use in food food supplements up to a dosage of 0,75 mg/day/kg body weight. This is about 50 mg for an adult.
October, 1, 2012
Community EMA monographs documents can be found on the website: Community Herbal Monographs
Information for consumer available
Herbal Information Sheets for consumers (in English) from the American Botanical Council are available at the Dutch page in Kruidenmonografieën.
September 23, 2012
ESCOP Herb Reference iPhone ® App
The ESCOP Herb Reference is an app that lists over 100 herbs and their uses for a range of everyday conditions. It is distilled from ESCOP's reference texts, used to set standards for those manufacturing herbal medicines officially licensed by medicines regulators in Europe. You can search for the condition that most interests you. In each case there will be a list of herbs that are appropriate, by either English or scientific name. When you choose a herb you will see from its lists of uses how it matches your personal needs. For each herb there is also useful information on minimum quality standards and relevant safety and dosage information. This is particularly useful when so many herbal products are sold without quality standards and clear information to users.
See: Links: ESCOP.
September 11, 2012
From 14 December no health claims for Cranberry, MSM and co-enzyme Q-10
Companies must be aware that all health claims for Cranberry, one of the best researched botanical ingredients, are not allowed from end of this year. Although most claims for botanicals are put on hold Cranberry was not put on this on hold list while it was seen not as a botanical but a food juice. Also from products based on MSM and Co-enzyme Q-10 all health claims must be removed. From end of this year only quality claims will be allowed for these active ingredients. Combinations with other active ingredients with an approved health claim is another option to keep these products on the market with a health claim.
Health claims on botanicals still allowed?
Companies must check the on hold situation of botanicals as not all botanical ingredients are on the on hold list. Legally also must be checked if the dosage in the product is in line with the submitted dossiers. Only than products based on botanicals are in line with 1924/2006.
New website with the list of approved EU claims in all languages: www.healthclaimslist.com
What will be the maximum levels for Vitamin B3
There are two active forms of Vitamin B3, nicotinic acid and nicotinamide. The EU RDA is 16 mg per day.
Germany ( by the official health risk institute BfR) recently issued a warning for high dosages of nicotinic acid with risks for skin reddening, itching or even liver damage. BfR reports also that nicotinamide does not have these side effects and informs also that the average diet contains already 13-18 mg per day and questions the need of suppletion. In this light it will not be easy that the EC will together with the EU member states come to a mutual decision about the maximum level. In the past risk scientists proposed a maximum daily dosage of 820 mg. It seems logical to prefer nicotinamide in food supplements.
UK MHRA bans DMAA definitively
DMAA, an active substance added to some sport food supplements as a stimulant, is now finaly completely banned by UK MHRA. Since several months the use DMAA is under discussion in the EU and the US and forbidden in several EU member states. It lead also to one doping problem during the Olympic Games in London. MHRA considers DMAA as an unlicensed medicine, which means that MHRA classifies the activity as pharmacological, also the safety is questioned. MHRA won a law suit against the producer of the product Jack3D concerning DMAA. Due to this the status of DMAA is now clear in the UK, it is completely forbidden.
August 8, 2012
Again all probiotic health claims for Lactbacillus strains rejected by EFSA
EFSA published this week again only negative opinions. Lactobacillus strains are the best reserached probiotics, so this is a big disappointment for the probiotic industry, the probiotic researchers and the consumers that are in need of strengthening their intestinal flora.
Also the dossiers for soy isoflavons (menopause help and bone mineral density) and polyphenols (cholesterol) were classifed negatively.
August, 1, 2012
EFSA has reviewed the Tolerable Upper Intake Levels (ULs) for calcium and vitamin D.
For vitamin D, the UL for adults and adolescents has been raised from 50 micrograms (50µg) a day to 100 µg; the UL for children aged 1-10 has been increased from 25 µg a day to 50 µg a day.
For calcium, the Panel concluded that no new data have become available which would require a revision of the UL for adults of 2,500 mg a day. As long as the EC not publishes maximum levels for vitamins and minerals in food supplements officially the national authorities determine the allowed levels in food supplements per EU member state. Still in al ot of EU member states the allowed level for vitamin D is 5 -15 mcg which is not enough for optimal support of health especially for the elderly.
July 31, 2012
EFSA sets safe dosages for supplementing omega-3
EFSA has published the safe intake levels of omega-3 fatty acids in food supplements. The total supplemental intake of combined products with EPA+DHA should not exceed 5 g/day; the supplemental intake of EPA alone is safe up to 1,8 g/day and for DHA alone 1 g/day.
July 27, 2012
UK MHRA removes 84 sports products from the market because of forbidden substances!
The 84 products that must be taken from the market contain substances like ephedrine, synephrine, yohimbine and DMAA. Some of them are on the doping list. The products concerned have fantastic names, but the contents are less wonderful.
18 July 18, 2012
Cocoa gets a health claim from EFSA!
“Cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow”. In order to obtain the claimed effect, 200 mg of cocoa flavanols should be consumed daily. The target population is the general population. By eating 10 gram dark chocolate this can be achieved....
July 17, 2012
Cranberry claims refused by EU but it works according to scienticts
EFSA and the EC refused health claims for cranberry and companies must remove all health claims on cranberry products by 14 December 2012. However researchers from National Taiwan University Hospital and the National Taiwan University College of Medicine analyzed the results of 13 studies that included 1,616 people to demonstrate the link between cranbery intake and decreased UTI (Urinary Tract Infection) risk. Specifically was found that women who get recurrent UTI seem to be benefit especially from cranberry products. How can European consumers be informed about this good news now that all health claims must be removed!
July 10, 2012
How to promote a product without health claims?
If the EC has finally rejected all health claims what can a company do to promote such a product in the EU? Of course neutral information about ingredients can always be given, if it is without a direct or indirect connection with the product. By giving clever information about the uniqueness of the product it can still be promoted.
July 6, 2012
Grapefruit seed extract (GFSE) may contain added chemical substances
Herbalgram 94, 2012 (ABC) warns for Grapefruit seed extracts because of adulteraration of chemcial substances like benzalkonium chloride, benzethonium chloride or methyl p-hydroxybenzoate. Producers may claim these substances are naturally part of grapefruit extract but this is chemical impossible according to the author Cardellina in Herbalgram. In the EU these substances are forbidden.
See: Article here
July 3, 2012
HFMA and NPN start a court case against the implementation of the food and health claim directive!
The action will be in the General Court of the European Union with the goal to seek the annulment of Regulation (EU) No 432/2012, the ‘Permitted List Regulation’ as published in May 2012 and which results int he fact that a lof of health claims are prohibited. Companies must change all their labels and advertising by December 14, 2012. See for more information the websites of HFMA-UK and NPN-Netherlands.
July 2, 2012
ORAC values removed by USDA from a website
The USDA has removed its USDA Oxygen Radical Absorbance Capacity (ORAC) Database from its NDL website, citing “mounting evidence that the values indicating antioxidant capacity have no relevance to the effects of specific bioactive compounds,” and the claim ORAC values are “routinely misused” by food and dietary supplement manufacturing companies to promote their products and by consumers to guide their food and dietary supplement choices.
“There are a number of bioactive compounds which are theorized to have a role in preventing or ameliorating various chronic diseases such as cancer, coronary vascular disease, Alzheimer’s, and diabetes,” the USDA said in its statement. “However, the associated metabolic pathways are not completely understood and non-antioxidant mechanisms, still undefined, may be responsible.”
June 20, 2012
New scientific website to differentiate natural and chemically produced trans fatty acids
June, 16, 2012
Proposal: New Regulation on food for certain vulnerable persons
The Council agreed a general approach on a new EU regulation on foods considered essential for certain vulnerable persons such as babies and young children, pending the adoption of a first-reading position by the European Parliament (10086/12). It will replace Directive 2009/39/EC
The Council's general approach covers the following four categories of food:
– infant formula and follow-on formula;
– processed cereal-based foods and baby foods for infants and young children;
– foods for special medical purposes;
– total daily diet foods for weight control.
Proposal and /or press release
June 12, 2012
Italian Ministry of Health is not against probiotic health claims!
Already in January of this year the Italian Ministry of Health published guidelines regarding health claims including probiotic claims. Now that the EFSA has again disapproved a lot of probiotic health claims the question is what will happen in Italy as soon as the EC will publish these EFSA decisions. Will it still be allowed to use the word probiotic and that these bacteriae can be found abundantly in the colon of human beings, or will the EC try to forbid this 100 % true statements also. This is food for thought for marketeers and lawyers in Italy.
June 7, 2012
EFSA rejected again 75 probiotic dossiers but approved prune bowel movement claim!
Also the second evaluation of a lot of probiotic dossiers by EFSA, as requested by the EC, did not lead to a change in the opinion of EFSA regarding the health claim: support of the immune system in the colon. What now? It must be clear that politicians and the EC understand that this way of evaluation blocks innovation in the EU.
Luckily the relation between bowel transit and prunes was approved by EFSA. But everybody knows this aleady for ages. But it is fine that EFSA approves it.
June 6, 2012
EFSA rejects again the lutein-eye dossier, industry is baffled.
For the 3rd time the EFSA gave a negative opinion for lutein and the health claim: lutein protects the retina and the lens against oxidation. The submittors, Kemin and DSM, are baffled, they understand what is needed to support a claim scientifically! Again a proof that EFSA is not understanding the need of innovation and an appropriate evaluation of new active ingredients. If the EC does not intervene the industry will start innovation outside of the EU.
May 30, 2012
What will be the allowed dosage for melatonin in the EU?
Now that the EC has published that the effective daily dosage for the health claims jetlag and sleep are respectively 0,5 and 1 mg and the EFSA gave a range of 0,5 - 5 mg for efficacy, the question is if the EC will harmonize the dosage and if so at what level. Before 14 th of December 2012 products based on melatonin need to be revised to an effective dosage, so guidance of the EC and national auhtorities are urgently needed.
May, 29, 2012
Lactoferrin is safe
EFSA studied on the basis the safety and novel food aspects of bovine lactoferrin and the conclusion is that it is safe and can be sued in food supplements and foods
May 21, 2012
Glucosamine, Lactobacillus and collageen health claim again rejected by EFSA
May 20. 2012
First Traditional Chinese Medicinal ( TCM) product a...