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Cannabidiol in food: regulatory status in the European Union

Cannabidiol, or CBD, is one of the most common cannabinoids, which are found in the hemp plant Cannabis sativa L. Extracts of Cannabis and related products are considered (not yet authorised) novel foods. According to European legislation, Novel Food is food not consumed significantly by humans in the EU before

Safety of children’s products (excluding toys) – Draft Commission Decision

References to European standards complying with the general safety requirements of the General Product Safety Directive 2001/95/EC (GPSD) provide a presumption of safety for products. It must be pointed out that the current standards for childcare articles other than toys are based on the 1997 mandate, which  is

Food supplements in Italy: updates on the use of turmeric

On August 1, 2022, the Italian Ministry of Health published an update on Curcuma longa(turmeric) and spp (multiple species) in food supplements. Operators must comply with these new requirements before December 31, 2022. Botanicals in food supplements In Italy, Annex 1 to DM 10 agosto 2018 sulla disciplina dell'impiego

MDR: Notice to Manufacturers for Implementation

According to Article 120 MDR 2017/745 medical devices that have obtained CE Certificate under the MDD 93/42/EEC can circulate in the EU market until the expiration of the Certificate or at the latest until 26th May 2024. Amid this context, the Medical Device Coordination Group released in

Silver Zinc Zeolite: Request for a scientific opinion on its safety

In June 2022, the European Commission requested the Scientific Committee on Consumer Safety (SCCS) to issue an opinion on the safety of Silver Zinc Zeolite. What is Silver Zinc Zeolite (SZZ)?Silver Zinc Zeolite (CAS 130328-20-0) regardless its beneficial antimicrobial properties cannot be used in cosmetics placed on the EU

The cosmetics industry encourages a global treaty to address plastic pollution

What is plastic pollution?Plastic pollution is the accumulation of plastic objects and particles in the earth's environment that adversely affects humans, wildlife and natural habitats. Nowadays, it is one of our planet's greatest human-made threats. This crisis requires a coordinated global response to address it adequately. Facing this situation,

HPRA alert on dangerous Melanotan 2 in self-tanning products

On June 27, 2022, the Health Products Regulatory Authority (HPRA) published an alert about the serious health risks linked to the substance Melanotan 2. The HPRA is the Irish Competent Authority responsible for cosmetics, medicines, and medical devices, and as such, it is in charge of post-market surveillance. Melanotan 2

Safety of toys: European Commission opens consultation on the use of titanium dioxide

Toys play an important role in children’s development. In the European Union, it is essential that toys are safe for children and that all possible risks are minimized. Therefore, the assessment of toys is a crucial process and competent authorities might request experts’ opinions regularly.   Safety of titanium dioxide

Compliance Success Stories: Meet Samsara Vision!

Obelis Group and Samsara Vision started working together back in 2019 and the relationship grew stronger in 2020 when the company was looking to register their new medical devices in Europe. The collaboration led to a notification of their devices with national registrations in several European markets. We have had