Life Sciences
Novel Food: New entries into the Union list
Three new novel food entries have been made in the Union list: The dried fruits of Synsapalum dulcificum, Implementing Regulation (EU) 2017/2470 Frozen, dried and powdered Locusta migratoria, Implementing Regulation (EU) 2017/2470 3-Fucosyllactose (3-FL), Implementing Regulation (EU) 2017/2470 You can find the complete Union list here: List of all authorized novel foods (It is recommended to open the consolidated Union list, therefore [...]
First German Higher Regional Court refers the question of the interpretation of medically required nutrient requirements for FSMP to the CJEU
OLG Düsseldorf, 28.06.2021, I-20 U 178/20 - Reference for a preliminary ruling on the interpretation of the medically required nutrient requirement for FSMP. It was only a matter of time before the question of medically required nutrients within the meaning of the Delegated Regulation on foods for special medical purposes was referred to the CJEU. After three German Higher Regional Courts have, as far as can be seen, opposed the legal opinion [...]
Questions and answers about the health risks of hemp-containing foods.
Publication of the German Federal Institute for Risk Assessment (BfR) - July 16, 2021. Since in many cases Austrian authorities also rely on assessments by German authorities and institutions, we would like to draw your attention to the publication "Questions and Answers on the Health Risks of Foods Containing Hemp" by the German BfR. The document contains many important questions. Here you can find the treated questionnaire: [...]
Prohibition of the Marketing of a Hemp Seed Oil containing cannabidiol Hemp Aroma Extract
OVG Lüneburg, decision of 4.2.2021, 13 ME 545/20 - Prohibition of the marketing of a hemp seed oil with cannabidiol-containing hemp flavor extract. "A product is not to be regarded as an "aroma" or "aroma extract" if it itself has a particular odor and/or flavor, or if it can impart or modify a particular odor and/or flavor to food. Rather, what is required is that the [...]
New ECJ ruling: indication of intended use & precautions for use of cosmetic products
CJEU, Judgment of 17.12.2020, C-667/19 - Intended use of a cosmetic product and information on special precautions for use: Consumer language and product catalog. The decision is based on the case of an owner of a Polish beauty salon who purchased American cosmetic products from a sales representative, on the packaging of which the intended use did not appear. Instead, there was a symbol depicting a [...]
NEW: Medical Device Regulation since 26.05.2021
Regulation (EU) 2017/745 - Medical Device Regulation. For more than 4 years, we have been concerned with the new European Medical Device Regulation (Regulation (EU) 2017/745). Now it has finally entered into force on 26.05.2021, this after the start of validity was postponed by another year from 2020 to 2021 due to Corona. The Medical Devices Regulation comprehensively changes the legal area, the Austrian legislator has also [...]
Distribution of free samples of non-prescription drugs to pharmacies
BGH, judgment of 17.12.2020, I Zr 235/16 - Distribution of free samples of non-prescription drugs to pharmacies. CJEU decision on free samples C-786/18 of 11.6.2020 The distribution of free samples of non-prescription medicinal products to pharmacies is in principle permissible according to decision C-786/18 of 11.6.2020. NEW: Decision of the German BGH In the German original proceedings of this ECJ decision, the BGH has now made the second decision, and the matter [...]
Pharmacological effects of a product for the treatment of cystitis and urinary tract infections
Judgement of OLG Köln of 23.12.2020, 6U18/20 - Pharmacological effects of a product for the treatment of cystitis and urinary tract infections. An interesting ruling on the classification and effect of D-mannose. A product for the treatment and prevention of cystitis, whose essential active ingredient D-mannose as a simple sugar binds the adhesin FimH of the Escherichia coli bacterium so that it can no longer adhere to the bladder wall and penetrate human cells, has a pharmacological and [...]