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: email@example.com.
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 […]