There is a current publication from me regarding food for special medical purposes. The publication is about the definition of dietary management and informs about my opinion, which scientific data have to be prepared to substantiate the dietary purpose of this special food category. Further information: https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1894-6527, Aktuel Ernahrungsmed 2022; 47: 383–389, DOI 10.1055/a-1894-6527, ISSN […]
The current ZLR (Periodical for all Food Law) contains a publication (ZLR0222_2) by me together with the lawyer Dr. Astrid Hüttebräuker on the requirements to be met with regard to “dietary management” and “medically determined nutrient requirements” from a legal and scientific point of view for food for special medical purposes FSMP.
Current publication: Plants and their preparations in medicinal products and foodstuffs (Food supplements, FSM)
In June 2021, a 4-part series of articles started in the Journal of Pharmaceutical Medicine and Quality Management (PM QM) on plants and their preparations in medicinal and food products. The most recent article (December issue: PMQM321-172-178–Phytopharmaka) was largely written by me and deals with the regulatory requirements that must be met when plants or […]
On 18.01.2022 the regulation EU 2022/63 was published: Prohibition of use and sale of titanium dioxide. The regulation comes into force on 07.02.2022. There is a six-month transition period (until 07.08.2022): foodstuffs using titanium dioxide may continue to be manufactured and placed on the market and subsequently sold until the end of the best-before date.
The Member States have expressed a favourable opinionto withdraw the authorisation to use a food additive (Titanium dioxide /Ti02 also known as E171) in food products. In the coming weeks, the Council and the European Parliament will have the possibility to give feedback on the draft Regulation. In order to mitigate the potential impact of […]
On 06.05.2021, EFSA published a new assessment on titanium dioxide. The authority comes to the conclusion that titanium dioxide can no longer be considered as safe when used as a food additive. Titanium dioxide is widely used as a white colorant in cosmetics, medicines and also in food supplements. Since a withdrawal of the approval […]
On 15.03.2021, the German institute BfR published a new opinion with updated maximum levels for vitamins and minerals in food supplements and fortified foods. The approach is still very restrictive. For example, a maximum amount of 6.5 mg is proposed for zinc and of 200 µg for folic acid per daily recommended intake. Download-link for […]
The so-called substance lists (categories plants and fungi) have been published 7th of october 2020. Representatives of the responsible federal authorities, the monitoring institutions of the federal states, Switzerland and Austria as well as experts from the respective fields of expertise from outside the authorities have compiled the extensive lists. With their help, the classification […]
If you would like to obtain comprehensive information about the approval of a novel food, please come to Hamburg, where I will present the regulatory basis and numerous examples together with two other speakers. Content, see behrs NF 2019-10, Registration at: firstname.lastname@example.org.
Maximum values for vitamins and minerals in food supplements and enriched food are not required by national or European law. Recommendations exist, e.g. in Austria or Belgium. The German BfR published recommendations in January 2018, see the following link.
At the request of Denmark, the Committee held an exchange of views on the classification of a product as food for special medical purposes (FSMP). The product in question is a tablet for the dietary management of lack of alphalipoic acid in diabetic neuropathy. Member States noted that similar products are placed on the market […]
12th of September 2016, a consolidated opinion to characterize food for special medical purposes (FSMP) was published by the German authorities BVL and BfArM. This opinion wants to unify complaints from authorities, organized in Germany by the so called “Länder”. I will be glad to prepare a specific paper for your products, marketed as FSMP, […]
There is a workshop at Brussels (HCE program 09-2016) about health claims, food supplements and demarcation between food and drug: 5th Supplement Claims workshop by Health Claims Europe, focusing on the role EU Nutrition and Health Claims could play for Botanical Extracts, Supplements and Herbal Medicines.
If you want to participate, please feel free to contact […]
Because of my partnership with i-dras, I can offer services concerning certification of medical devices and development/marketing authorization of human and veterinary medicinal products. Please ask me for further information.
2 th February 2016, Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes was published.
Important points are
national notification, still open which documents have to be provide
forbidden health and nutrition claims
Don’t hesitate to […]
EFSA has launched an open consultation on its draft scientific and technical guidance for the assessment of products notified as food for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. The guidance is for assisting in the preparation and presentation of well-structured dossiers for food products notified as foods […]
für alle aus der Pharma- und Lebensmittelbranche, die an einem lebensmittelrechtlichen und ernährungswissenschaftlichen update interessiert sind (Einladung 26-03-2015)
Up to now it is allowed to use the following health claim for food supplements:
“Supplemental folic acid intake increases maternal folate status. Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus.”
The claim may be used only for food supplements which provide at least 400 μg […]
9th of october 2014, I moderated together with Prof. Joseph Neulen the symposium “micronutrients for women”. Gynecologists and medical press were lively interested in this topic. There is a low intake of vitamin D and folate in all periods. Additionally, gynecologists should look at the status of special nutrients depending the female age and situation.
Aktuell ist ein Beitrag von mir zum Thema Nahrungsergänzungsmittel erschienen. Sie können ihn hier ansehen und lesen, in welchen Situationen aus meiner Sicht eine Supplementierung sinnvoll ist (Ärztliches Journal Reise & Medizin 08/2014).
Middle of july, EFSA rejected four health claims (art. 13.5). They concluded that a cause and effect relationship has not been established between the consumption of a combination of lutein and zeaxanthin and improved vision under bright light conditions, regarding a special amino-acid combination, between the consumption of Bimuno® GOS and reducing gastro-intestinal discomfort and […]
New EU regulation EU 155/2014 (19th of february 2014) contains rejected health claims according to krill oil and joint function, vitis vinifera and venous blood circulation/swollen legs/diuresis.
EFSA approved infants health claims concerning iodine, iron and vitamin C. A claim for adults about fructooligosaccharides (FOS) from inulin and a reduction of postprandial glycaemic responses was authorised as well. More about the new opinions can be found www.efsa.europa.eu (january 2014).
3th of December 2013, I attended an interesting meeting about the new S2k guidelines concerning the treatment of constipation (Andresen V et al. 2013). Not onlyfibre but also specific probiotic strains are recommended to treat constipationwith a high consens, also for children and for pregnant women.
30th of october 2013, further health claims about glucosamine, hyaluronic acid, rhodiola rosea L. and combinations of antioxidants and minerals have been rejected. For further details, see the regulation EU 1066/2013 or ask me for advice.
26th of September 2013, I participated in a very interesting presentation from the well-known nutritionist Dr. Nicolai Worm with the subject “Non-Alcoholic Fatty Liver Disease”. It is a reason for diabetes II and many further metabolic disorders. It is easy to get a grip on it: exercise and an appropriate dietary management. To calculate the […]
End of july 2013, EFSA authorised new health claims regarding
the maternal intake of folate and reducing the risks of neural tube defectand so called childrens claims concerning
magnesium and bone health
iron and brain health and
vitamin A and the immune system.
Outsourcing IT or PR is usual, strike out in new directions: support of science! I like to support you with my broad range of services in case of medical & regulatory affairs. Contact me, I also support you on-site for special projects or interim positions.
Food for special medical purposes as tube feeding and special dietary supplements have been the main topics during the annual congress of the German „Diätverband“(28th of June 2013 in Berlin). Well-known experts were speaking about the influence of tube and sip feeding treating and preventing the malnutrition, proven by medical and economic facts.
In future, for the […]
11th of june, two important regulatory news have been published at Brussels:
Regulation 536/2013, which contains the authorization of 6 new health claims for food (DHA/EPA), dried prunes, fructose, alpha-cyclodextrin)
The European Parliament gave its green light on a set of clearer rules about dietary food. For example, food for coeliacs will be transferred to the Regulation […]
The uncertainty, how dietary foods will be regulated in future, will come to an end. The European Parliament will vote on PARNUTS changes on June 11. The new legislation is supposed to be published in August or September, giving a provisional date for the regulation going live of August or September 2016, because of a […]
14th of May, I joined the conference from aid/Bonn about the influence of eating and psyche. There were interesting discussions. Above all, I was fascinated about the fact, that food ingredients can influence the activity of brain areas and that patients with eating disorders can learn to influence their brain activities (neurofeedback).
Currently, I give many presentations:
At the 12th of april 2013, I gave a presentation for intensive care nursing staff about “intestinal alert – is enteral nutrition really responsible?”
End of april and beginning of may, there are presentations about malnutrition and dysphagia.
Since 14th of December 2012, the EU-regulation 432/2012 for article 13 claims came into force. Labelling ad advertising messages have to be adapted appropriate to the regulation. For further information look at the homepage of the European Commission (http://ec.europa.eu/nuhclaims/) or ask me for advice.
End of November 2012, I appeared before the court as an expert to evaluate supplements as drugs or food supplements in a case between a consumer and the health assurance to clear the topic of reimbursement.