Build a solid foundation in science, formulation and product development—find out more!
Most Popular in:
EU Regulation No. 1223/2009 Part 2: Prohibited Ingredients, Definitions and More
By: David C. Steinberg, Steinberg & Associates
Posted: January 3, 2011, from the January 2011 issue of Cosmetics & Toiletries.
page 4 of 10
The regulation also addresses the need to frequently review the safety of nanotechnology and nano-sized ingredients, and establishes how Categories 1A, 1B and 2 CMR substances, which currently are prohibited from cosmetics, are allowed—i.e., if they are naturally found in foods and there are no suitable replacements.
Product claims: EC No. 1223/2009 states that the EC should determine the criteria for product claims, thereby dictating how companies justify their advertising claims. The criteria will be determined by listing the required tests and results required to make given claims; this author feels this approach will surely discourage innovation.
The New Articles
To coordinate the 40 new articles in EC No. 1223/2009, they are divided into 10 chapters, which are described here.
Chapter I (scope and definitions): Article 1 lists the scope and objective while Article 2 includes 19 definitions for entities including: a cosmetic, substance, mixture, manufacturer—i.e., the company whose name is on the label, distributor, nanomaterial—i.e., an insoluble material manufactured with one or more dimensions from 1 to 100 nm, preservative, colorant, UV filter, undesirable effect and frame formulation, among others.
Chapter II (safety, responsibility and free movement): This chapter includes Article 3 on safety, Article 4 regarding the RP, Article 5 on obligations of the RP, Article 6 discussing obligations of distributors, Article 7 on identification within the supply chain, Article 8 regarding GMPs, and Article 9 on free movement.