Regulatory Affairs

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for the Fine Chemicals, Cosmetics & Toiletries, Food and Pharma
Industries & Medical Institutions

REACH

Regulation (EC) No 1907/2006 (REACH)

Regulation (EC) No 1907/2006 (REACH) is a framework for chemicals. Manufactures and importers of substances as such and of substances in preparations & articles are obliged to assess the safety of the substances for humans and the environment before entering the European market.. The compliance provisions include a technical registration dossier with exposure scenarios and, when manufacturing or importing substances in quantities of 10 tonnes or more, a Chemical Safety Report. In case of proven risks potentials authorities will further evaluate and they may impose partial or complete restrictions.

CONUSBAT provides all services to comply with the REACH Regulation:

 

Cosmetics Directive

Council Directive 76/768/EEC – EU Cosmetics Directive

Council Directive 76/768/EEC – EU Cosmetics Directive is regulating the requirements for cosmetics & toiletries. It has negative and restrictive lists for cosmetic ingredients and positive lists for colorants & preservatives & UV filters. Additionally, specific requirements concerning safety testing and maintenance of safety data files exist.

CONUSBAT provides all services to comply with the Cosmetics Directive:

 

Other - EU

EU Regulatory Frameworks in CONUSBAT’s Key Industry Sectors

In the areas Food, Nutrition, Chemical Products and Pharmaceuticals numerous regulatory frameworks exist on both levels, the EU and the member states.

CONUSBAT offers for the time being services for all aspects of the following frameworks:

 

International

US Food & Drug Administration - FDA

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.

CONUSBAT offers services for all aspects of the FDA requirements: