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:
- Consulting
- Substance Inventory Compilation
- Only Representative / Third Party Representative
- Registration Dossier Preparation & Submission
- Exposure and Risk Assessment
- Customized Training
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:
- Consulting
- Compliance Evaluation
- Safety Assessment
- Dossier Preparation
- Notifications
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:
- Regulation (EC) No 178/2002 - Food Safety
- Council Directive 89/107/EEC - Food Additives
- Regulation (EC) 258/97 – Novel Foods
- Regulation (EC) No 1924/2006 – Nutrition, etc.
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:
- Consultancy
- Compliance Evaluation
- Safety Assessment
- GMP
- Voluntary Registrations