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
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
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
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
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
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,
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
The safety of toys is constantly under scrutiny of Authorities. Certain substances might be carcinogenic, mutagenic, or toxic for reproduction. Therefore, it is crucial to keep analyzing the safety of such substances and introduce bans or limitations when necessary. One of the latest news in the toy industry concerns the
Construction products are essential assets of many industries, and construction industry is one of the biggest globally. Especially, in the European Union only it involves over 430.000 EU companies, with a total turnover of 800 billion euros and gross value added of 240 billion euros. The European Union regulates
The Spanish competent authority (AEMPS) has updated as of May 2022 its instructions for requesting authorisation for commercialising personal care products on the Spanish market. To clarify the procedure, the Spanish competent authority newly allows the possibility to separate the information in the application process [AMORD1] depending on the type
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
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
