News

Scientific Opinion on the use of AVO in cosmetic products

The SCCS recently evaluated the use of Acetylated Vetiver Oil (AVO) in cosmetic leave-on and rinse-off products. AVO is an oil originating from the fresh or dried roots of Vetiveria zizanioides, a perennial bunchgrass frequently used in productions for the fragrance industry.Evaluating the use of AVO, the SCCS considered

Zinc Pyrithione under review by SCCS

The safety of the cosmetic ingredient, anti-dandruff agentand preservative, Zinc Pyrithione (ZPT) (CAS No. 13463-41-7, EC No. 236-671-3), will be re-assessed by the Scientific Committee on Consumer Safety (SCCS). The request was published from the European Commission following the proposal of European Chemicals Agency's Risk Assessment Committee to classify the

SCCS Final Opinion on the safety of Butylphenyl methylpropional (p-BMHCA)

SCCS Final Opinion on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products - Submission IIThe ingredient Butylphenyl Methylpropional with the CAS No. 80-54-6 (p-BMHCA) is a synthetic fragrance compound used in aftershave lotions, bath products, bubble baths, cleansing products, hair care products, moisturizers, perfumes and colognes, shampoos and skin

New amendments to the Cosmetics Regulation

On 30th of April 2019 the Commission adopted  Regulation (EU) 2019/680, Regulation (EU) 2019/681 and Regulation (EU) 2019/698, amending Annexes VI, II and III and V of the Regulation (EC) No 1223/2009 (Cosmetics Regulation) respectively.  The amendments aim to address the recommendations of the Scientific Committee

Newly banned ingredients under the EU Cosmetics Regulation

This summer the Commission adopted Regulation 2019/831, amending Annexes II, III and V of the Regulation (EC) No 1223/2009 (Cosmetics Regulation).What are the amendments to Annex II?The new Regulation introduces 226 new ingredients and replaces one entry in Annex II of the Cosmetics Regulation. These ingredients

New Borderline and Classification Manual published

A new version of the “Manual on borderline and classification in the community regulatory framework for medical devices” has been published by the European Commission on the 22th May 2019.This manual serves as a tool to manage borderline cases, described as the situations where it is not clear whether

UDI designating entities: EU Commission implementing decision released

On the 7th of June 2019, the European Commission released an Implementation Decision listing the issuing entities designated to operate a system for assignment of Unique Device Identifications (UDIs). In fact, Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 both envisage a UDI system, respectively in

The Basic GMDN membership is made available as a free service

The GMDN Agency has announced in their News Article that from the 1st of April 2019 a basic membership plan is available for all users.The GMDN Agency is responsible for the maintenance of the Global Medical Device Nomenclature (GMDN), a global standard for identifying medical devices. The Agency will

French Competent Authority bans various types of breast implants linked to cancer

On the 2nd April 2019, the French Competent Authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) adopted a decision regarding the ban of certain types of breast implants linked to cancer.Breast implants are classified as Class III medical devices according to the Directive 93/

Food Supplements Services launch!

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