Regulatory Affairs

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for the Fine Chemicals, Cosmetics & Toiletries, Food industries

Cosmetics In Europe

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

Council Directive 76/768/EEC – EU Cosmetics Directive

These frameworks are defining rules and requirements for placing cosmetics & toiletries on the EU market. The actually applying Cosmetics Directive will be replaced and repealed by the new Cosmetics Regulation in July 2013. Contrary to a directive, a regulation becomes immediately enforceable as law in all EU Member States. Therefore, one major change coming with the new regulation is a EU central product notification procedure. Other areas of revision include detailed provisions towards content and format of the product safety assessment and the product information files (PIF), specific requirements for nanomaterials and CMR substances, criteria for claims and reporting of serious undesirable effects, etc. Remaining pillars include the responsibility for the safety of products lying with the actors in the supply chain, the free utilization of the majority of the ingredients and a post-market surveillance system, etc.

Manufacturers and importers need to comply with these provisions before placing their products on the common EU market. CONUSBAT provides all services towards compliance:

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.

CONUSBAT provides all services to comply with the REACH and CLP Regulations:

Food in Europe

EU Regulatory Frameworks for CONUSBAT’s Key Industry Sector Food

CONUSBAT offers services for all aspects of the following frameworks:

Cosmetics & Food International

US Frameworks from the Food & Drug Administration [FDA] and the Environmental Protection Agency [EPA]

The Center for Food Safety & Applied Nutrition of the US governmental agency FDA is responsible for protecting the public health by assuring the safety of foods, nutrition and cosmetics & toiletries. EPA develops and enforces regulations that span many environmental categories, amongst the American Toxic Substances Act (TSCA).

CONUSBAT offers services for all aspects of the FDA requirements in the sectors mentioned , as well as for the EPA’s Toxic Substances Control Act::

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