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Once again strict limitations for the interpretation of FSMPs by the CJEU

Once again strict limitations for the interpretation of FSMPs by the CJEU

Mar 30, 2023 | Regulatory

On March 2, the Court of Justice of the European Union (CJEU) issued another preliminary ruling (Case C‑760/21) to clarify the classification of foods for special medical purposes (FSMPs), which are defined according to Art. 2(2)g of Regulation (EU) 609/2013...
MDR transition period and deletion of the MDR/IVDR ‘sell-off dates’ officially implemented

MDR transition period and deletion of the MDR/IVDR ‘sell-off dates’ officially implemented

Mar 30, 2023 | Regulatory

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the...
Progress in the authorisation of novel foods and a cholesterol lowering health claim

Progress in the authorisation of novel foods and a cholesterol lowering health claim

Mar 30, 2023 | Regulatory

Latest novel food authorisations In March 2023, the European Commission (EC) granted three more Novel Food authorisations with the publication of the final legal act. The following ingredients are allowed to be placed on the market: Bovine milk osteopontin as...
Botanical extracts are increasingly under pressure due to growing safety concerns

Botanical extracts are increasingly under pressure due to growing safety concerns

Mar 30, 2023 | Regulatory

Recently, various botanical preparations derived from traditional ayurvedic medicine have seen increased use as health-promoting ingredients in food supplements. However, the mere fact that these botanicals are of natural origin does not guarantee their safety as they...
Novel food status of biotechnically produced sodium hyaluronate clarified in consultation request

Novel food status of biotechnically produced sodium hyaluronate clarified in consultation request

Mar 30, 2023 | Regulatory

The consultation request under Article 4 of Regulation (EU) 2015/2283 concerns biotechnologically produced sodium hyaluronate for use in food supplements. Sodium hyaluronate is a product from a non-genetically modified strain of Streptococcus...
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