There are 2 types of undesirable events according to Regulation (EC) No 1223/2009 on cosmetic products: “undesirable effects (UEs)” are defined as “adverse reactions to human health attributable to the normal or reasonably foreseeable conditions of use of a cosmetic product”; “serious undesirable effects (SUEs)”…
What is a PIF? PIF stands for a Product Information File. A dossier must be prepared for every cosmetic product in the EU. 2. How long should it be stored? The responsible person should store it for 10 years following the date on which the…
In the EU cosmetic products have several symbols. Some of them are mandatory by the EU Cosmetic Regulation No. 1223/2009, others are voluntary. The most common symbols are: Related to its stability. In this case, you can find the Period After Opening or Hourglass Symbol.…
Regulation (EC) No. 1223/2009 on cosmetic products is aimed at harmonizing the 27 EU Member States and 4 European Free Trade Association (EFTA) countries covered under this legislation. Please see below which language you should use on a cosmetic product if you sell it in…
Certain cosmetic products have an extremely low (or non-existent) risk of microbiological contamination because of their inherent characteristics, which create an environment hostile to the survival and growth of microorganisms. Products classified as "hostile" and manufactured in accordance with Good Manufacturing Practices (GMPs) pose minimal…
A challenge test, also known as a preservative efficacy test, is an essential component of the safety evaluation process for cosmetics. The requirement for conducting a challenge test is outlined in the SCCS NoG 12th Edition, which specifies the demand for this test. In addition,…
Commission Regulation (EU) 2023/2055 on microplastics was published on 27th of September 2023 under the EU REACH Regulation (amending Annex XVII, Regulation (EC) No 1907/2006). The restriction on intentionally added microplastics in cosmetic products has different transition periods. Please note that products that have been…
Commission Regulation (EU) 2023/1545 was published in July 2023. In the past, we had 24 allergens that needed to be mentioned in the list of ingredients when their concentration exceeded 0,001% in leave-on products or 0,01% in rinse-off products. This new regulation identified 56 additional…
The European Union (EU) and the United Kingdom (UK) had undergone significant changes in their cosmetic regulations due to the UK's departure from the EU (Brexit). The UK Cosmetics Regulation automatically adopts the Annexes of the EU Cosmetics Regulation, as implemented until 31 December 2020.…
In the EU when it comes to cosmetic products a microbiology test is a must. The only exception are low-risk products. For more information on when a product can be considered as low-risk, you should consult ISO 29621 Guidelines. Recently SCCS Notes of Guidance 12…
