Obelis service development department, is honoured to introduce a new regulatory area within Obelis consultancy and regulatory services!Food supplements are regulated under EU legislative framework as foodstuff. The Directive 2002/46/EC defines food supplements as ‘’ foodstuffs the purpose of which is to supplement the normal diet and which
The first corrigenda to MDR and IVDR have been discussed and released by the European Union. Some of the corrections changed the MDR and IVDR formally, whilst some others intervened on the content of the Regulations. No major changes occurred with regards to timelinesfor Medical Devices and In Vitro Diagnostics
On April 30th this year, the European Commission published three amendments to the Cosmetics Regulation (EC) No 1223/2009:· Update of Annex VI by indicating that Phenylene Bis-Diphenyltriazine can be used as UV Filter at maximum concentration of 5% (as previously agreed by SCCS in 2018) except in applications that
The sub-working group on claims released the updated Technical document on cosmetic claims in July 2017. The document serves as a collection of best practices and aims at providing guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used
The medical device industry in Europe will experience a major change in the upcoming years due to the implementation of the new Medical Device Regulation (MDR), to become applicable in May 2020.The biocompatibility of materials will be a principal challenge to be faced. The compliance with the MDR will
We would like to inform you that a new regulation has been published to amend Annexes II, III and V of Regulation (EC) No 1223/2009 on cosmetic product.The new regulation comes into force effective 10th of June 2019 with EEA impact.What are the changes that the new
As of 26 May 2020, only medical devices (all classes) in conformity with the Medical Devices Regulation - MDR (EU) 2017/745 can be placed on the market as foreseen by the Article 123 of the MDR.However, according to the ‘’sell-off’’ provision (Art.120.4), devices - compliant with
Microplastics are synthetic, water-insoluble polymer items smaller than 5 mm, which are of particular concern for the aquatic environment. The potential impact of microplastics on the (aquatic) environment and human health have generated concerns in Member States of the European Union and worldwide.On spring 2018 the Commission asked ECHA
As of 21 April 2019, only Personal Protective Equipment in conformity with PPE Regulation 2016/425 can be placed on the market as foreseen by the transitional period (article 47) of the PPE Regulation.Therefore, it will be no longer possible to place on the market products in compliance with
The substance Phenoxyethanol is a preservative frequently used in cosmetic products regulated in Annex V/28 of the Cosmetic Regulation (EC) n. 1223/2009. It corresponds to the CAS number 122-99-6 and is authorized in cosmetic products in a maximum concentration of 1.0%.This substance has been on the
The NB-MED recently published the results of a survey performed between 2018 and January 2019 on the applications of Notified Bodies to be designated under the IVDR.Among the 37 Notified Bodies, currently only 19 are designated for IVDD; most of them have up to 50 Certificates each. The survey
Time for an update on CannabidiolUse of cannabis in cosmetic products is getting more and more diffused. It is easy to spot numerous advertisements on these products, especially for products containing cannabidiol, but a lot of confusion persists on many different levels, from manufacturers to consumers. Therefore, we decided to
