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.
On Dec. 9, 2009, the European Union (EU) published Regulation (EC) No. 1223/2009, which will go into effect on Jan. 11, 2011.1 The first part of this three-column series focused on the Cosmetic Product Safety Report section of the regulation. It appeared in the August 2010 issue of Cosmetics & Toiletries magazine.2 This second part discusses the remainder of the regulation, save for a third part describing issues regarding the Responsible Person (RP). In total, EC No. 1223/2009, often called the Recast or the 8th Amendment, is comprised of a preamble with 71 parts (justification), 40 articles (replacing the old 15) and 10 annexes (replacing the old nine).
While EC No. 1223/2009 goes into effect in January, manufacturers should begin complying with it as soon as possible. Additional effective dates for EC No. 1223/2009 include: Dec. 1, 2010, for regulations concerning carcinogens, mutagens and reprotoxic (CMR) substances; 2011 in general, when automated notifications are expected to begin updating the European Commission (EC) for both business conducted in the EU and poison control information; Jan. 11, 2013, for regulations on nano-sized ingredients; and July 11, 2013, by which all products must be in full compliance with the regulations.
Changes in EC No. 1223/2009
The preamble to the regulation offers a number of justifications for changes made to the Cosmetics Directive 76/768/EEC. As discussed in the previous column, the EU has changed the legislation from being a directive, requiring its incorporation into each country’s national laws, to a regulation, which then becomes uniform across all Member States of the EU.
Notification process: EC No. 1223/2009 aims to simplify the notification process. Previously, poison control information including the manufacturer’s address as listed on the product label was sent to the country in which it would be sold. Further, some Member States such as France and Spain required local notification, with France specifically requiring three poison control center notifications. In this author’s view, reducing the number of notifications and poison control filings to only one, and doing so electronically, indeed does simplify the procedures; however, the remainder of EC No. 1223/2009 makes the process more complex.
Definitions: EC No. 1223/2009 defines cosmetic products, and this legal definition has not changed; however, Annex I of the Cosmetics Directive, which was an illustrative list of cosmetic categories to clarify definitions, is now included as a part of an article rather than being its own annex. Annexes allow for changes to be made by Adaptations to Technical Progress (ATP), which are issued by the EC; articles may only be changed by amendments.