EU Cosmetic Regulation Consultancy
Are Your Products Compliant?
From July 11th 2013 cosmetic products that are placed on the market will be obligated to comply with the European Cosmetic Safety Regulations 1223/2009 which will be implemented as national law within the EU.
The aim of the new regulation is to provide assurance to consumers health by ensuring that they are well informed by monitoring the composition and labeling of products. The regulation also enforces the assessment of product safety and the prohibition of animal testing.
There are certain tests that cosmetic products need to undergo before they can be proved to be safe:
All cosmetic products need to undergo stability and pack compatability testing to ensure that the product remains stable during its shelf life. The minimum requirements for stability testing is to expose samples of the product to different temperature conditions (such as 5C, 25C ad 40C) and to assess them for various parameters in order to observe any changes during a 12 week period.
Microbiological Challenge Testing
For all water based cosmetic products it is necessary to subject the product to a microbiological challenge test which invloves innoculating a sample of the product with a selection of bacteria and fungi for a period of 28 days. The test will show if the preservative system that has been chosen for the product is effective enough to inhibit bacterial growth, preventing contamination.
Heavy Metal Testing
Many heavy metals are banned from being used in cosmetic products such as Mercury, Arsenic, Cadmium and Lead. However they are naturally occuring elements and minute traces may be carried onto the product during manufacture. There are certain tests that can be carried out to assess if any of these heavy metals are present within the product and wheather the presence of them is within acceptable levels.
Cosmetic Product Safety Report
The cosmetic product safety report is a requirement within the regulations under annex 1 which consists of two parts; Part A Safety Information and Part B The Safety Assessment. Part A contains information about the product composition, stability and microbiological specifications, evidence of forceable use of the product. Part B is a toxocological assessent carried out by a qualified person who has a European degree in Pharmacy, Toxicology, Medicine or a similar dicipline. Most Cosmetic Safety Assessors within the UK have either Chartered Status in Chemistry or Biology.
There are many different labeling requirements that are compulsory in order to be compliant with the Cosmetic Safety Regulations EC 1223/2009. This also requires good proof reading to ensure that all information is present on the product component or gift back of pack. The main requirements are the following:
•Complete ingredients list using appropriate INCI nomenclature
•Company address and web address must be present
•Fill weight of product displayed in g/ml and presence of the 'e' mark
•Where the product was manufactured (eg. Made in China)
•Directions of use
•Period After opening Symbol
•Apropriate declaration of allergens with the ingredients list if they are present within the product
Product Notification to Member States
The Cosmetic Products Notification Portal is an electronic system that is part of the new cosmetic regulation EC 1223/2009. This part of the regulation requires that the responsible persons and under certain circumstances, the distributors of cosmetic products to submit their product information though the CPNP before the products are placed on the European market. This notifcation portal makes product information available to the Competant Authorities, for the purposes of medical treatment, market surveillance, market analysis, evaluation and consumer information and to the poison centres established by Member States.