Regulatory Affairs


Regulatory Frameworks covered by CONUSBAT for the Fine Chemicals, Cosmetics & Toiletries, and Borderline Product Industries

Cosmetics In Europe

Regulation (EC) No 1223/2009 – EU Cosmetics Product Regulation

This European framework, which replaced in July 2013 the former Cosmetics Directive, defines rules and requirements for placing cosmetics & toiletries on the EU’s internal market. The Regulation is immediately enforceable in all EU Member States; therefore, a central product notification platform [CPNP] at EU Commission level was established which is replacing all earlier existing national notification procedures. Key elements for the proof of safety are the Cosmetics Product Safety Report [CPSR] and the Product Information File [PIF]; detailed requirements towards contents are laid down in the Regulation for each element. Further provisions are addressing product labeling, specific requirements for nanomaterials and CMR substances, as well as criteria for claims, etc. Most ingredients are free to use, however, specific substance requirements are laid down in the Regulation’s Annexes 2-6. Surveillance of compliance is performed via a system of in-market control which was re-enforced by a reporting scheme for ‘Serious Undesirable Effects [SUE]’. The central legal responsibility lies with the so-called ‘Responsible Person’ and every product in the market has to have an RP assigned.

Chemicals in Europe

Regulation (EC) No 1907/2006 – REACH

Regulation (EC) No 1272/2008 – CLP

Regulation (EC) No 1907/2006 (REACH) is the European Union’s framework for chemicals and is applying to manufactures and importers of substances as such and of substances in preparations & articles. These actors are obliged to assess the products in respect to their safety towards humans and the environment before placing these on the EU’s common market. The requirements include the registration of substances through submitting a technical dossier with defined data on the intrinsic properties and, when manufacturing or importing substances in quantities of 10 tonnes or more per year, a Chemical Safety Report, incl. the exposure scenarios. In case of risks assigned to a substance further evaluation, authorization or restrictions may apply.

Regulation (EC) No 1272/2008 – CLP is the European Union’s adaptation of the GHS (Globally Harmonized System) and replaces the EU Directives for Dangerous Substances and for Dangerous Preparations. Since December 1, 2010 manufactures and importers of chemicals have to classify, label and package their substances according to CLP, the deadline for preparations is June 2015. In preparation for a publicly accessible Classification and Labelling Inventory, CLP has its own notification provisions (CLP Article 40), which are also effective since December 2010.

Please contact CONUSBAT for all Regulatory Affairs related to Cosmetics and Chemicals in ASEAN, China, Japan, Korea, etc.