Save the date for our webinar “In vitro diagnostic devices for self-testing – what will change under IVDR?”
We are happy to invite you to the next instalment of our webinar series.
In vitro diagnostic medical devices (IVD) are tests performed on human samples (such as blood, urine or tissues) to provide information on a person’s health. Until 2017 IVDs were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). In May 2017 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into force.
The IVDD-to-IVDR transition period will end in May 2022. Get ready for the upcoming changes by attending our webinar!
Date: 22 September 2020
Time: 3 pm CEST
Exemption for health claims in trademarks and brand names ends – get prepared
For nearly 15 years, trademarks and brand names that have existed in the EU before January 1, 2005 were granted a temporary exemption to the Nutrition and Health Claims Regulation (EC) No 1924/2006 (Article 27(2) NHCR). This means that names that imply a health claim, e.g. “Vital”, “Healthy” etc, were permitted to be used without being accompanied by a specific authorized health claim. The transition period ends on January 19, 2022.
With the end of the transition period, all companies, including those that have so far enjoyed the exemption, will need to comply with the NHCR in full. This means that all brand names and trademarks that imply a health claim will then need to be accompanied by a specific authorized health claim, or they can no longer be used.
While no particular guidance exists, these specific health claims should be relevant to the implied non-specific health claim, e.g. if the brand name implies immune health, the accompanying authorized health claim should also involve immune health. If this is not possible, because no corresponding authorized health claim exists, e.g. in the case of names including the word “probiotic”, then the name can no longer be used. This may be subject to EU Member States’ individual legislation.
The specific claim should also be located next to or following the general statement, if necessary by use of an asterisk.
Do you have questions or do you need advice on how to achieve full compliance for your brand name or trademark as the transition period ends? Contact us today at firstname.lastname@example.org!
EFSA consultation: draft technical guidance on nanoparticles
Calls are open for consultation on the new EFSA guidance on nano-particles and the nutrient definition.
EFSA’s Scientific Committee has launched an open consultation on its draft EFSA Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. This document sets out information requirements for applications in the regulated food and feed product areas, and establishes criteria for assessing the presence of a fraction of small particles. These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. This Guidance on Particle-TR complements the Guidance on Nanoscience and Nanotechnology adopted by the EFSA Scientific Committee in 2018.
Interested parties are invited to submit written comments by 09/09/2020.
a&r will take part in Vitafoods’ virtual event held 7 – 11 September.
In addition to providing a space for the nutraceuticals community to keep connected, the Virtual Expo will also provide the opportunities that an online environment affords, including algorithm-driven ‘matchmaking’ with industry experts and thought leaders, one-to-one secure video meetings, and an innovative digital platform that makes networking, learning, sourcing, selling and sharing feel entirely seamless.
Novozymes acquires PrecisionBiotics Group
PrecisionBiotics is a Cork-based firm that has developed a portfolio of probiotics aimed at improving human gut health. The company holds a leading position in the probiotics market with a revenue of €13.4 million in 2019. Through this partnership, Novozymes expects to gain access to the €5 billion human probiotic supplements market. This acquisition agreement will benefit both Novozymes and PrecisionBiotics as it will enable Novozymes to orchestrate a globalized release of probiotics solutions that target the appropriate markets. Depending on future market trends, the deal may prove to provide an advantageous, long term bolt-on solution to its biotech portfolio.
2 July 2020 • Source
Verfora consolidates its leading position in the Swiss CHC market
On 1 July, Galenica acquired the Hedoga Group with its well-known brands Osa®, Osanit® and Carmol®. Verfora has thus secured the rights to strong brands and marketing authorisations with potential that are an ideal complement to the current portfolio. Accordingly, Verfora can consolidate its leading position in the Swiss consumer healthcare (CHC) market and strengthen its positioning as the most important partner for pharmacies and drugstores for over-the-counter medicines and health products. The export business will also be expanded in a targeted manner.
The Hedoga Group includes Swiss-based Iromedica Ltd. and Austria’s Dr. Schmidgall LLC, each with some 20 employees. The focus of the Group is on marketing over-the-counter (OTC) medicines, medical devices, food supplements and cosmetics. In 2019, the Group as a whole generated net sales of CHF 25 million, of which almost half in Switzerland and the remainder in Austria, Germany and selected export markets in particular.
2 July 2020 • Source