Several Opinions were recently issued by the Expert Committees in regard to the use of fragrances in cosmetic products, as serious concerns were raised over their allergenic potential.
News
Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460
DNV GL Nemko Presafe NB2460 began operating in May 2017, a merger of former Norwegian notified bodies DNV GL Business Assurance Norway and Nemko AS NB 0470.
New limits for BPA in toys
New EU Commission Directive 2017/898 is set to enforce higher restrictions on Bisphenol A (BPA) in toys in the interest of consumer safety in Europe.
Products without medical purpose within the scope of MDR
The new EU Medical Devices Regulation 2017/745 (MDR) officially entered into force on 25th May 2017 amending the Directive 93/42/EEC and will be fully applicable after a transition period of three years (2020). One of the most relevant changes introduced by the new Regulation lies in the extension of its scope, now including certain “products without an intended medical purpose”.
Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) restricted in the EU
Silicones like Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) have been restricted in cosmetics products. Read about the major changes here.
New countries admitted to the Hague Conference
Dominican Republic, Colombia, Kazakhstan and Lebanon have been added to the Hague Conference on Private International law taking place in June 2017.
Expiration date and PAO for Cosmetics
One of the key requirements towards cosmetic products is their safety for human health. Find out what evaluates the stability testing.
New Responsibilities of EAR under the new MDR
Learn more about the new responsibilities set in force in May 2017 for European Authorized Representatives under EU medical device regulation 217/745.
Additional requirements in the EMC Directive 2014/30/EU
Find out more about new manufacturer requirements and obligations under recent EU EMC directive 2014/30/EU. Talk to our regulatory experts about compliance.
The new EU UDI codes for Medical Devices
The Unique Device Identifier system and codes have been introduced to Europe under the new medical device and IVD regulations. Find out more with Obelis.