We provide a wide range of services and support for manufacturers, importers and users of chemicals, mixtures and articles in the practical implementation of the requirements arising from the EU and national legislation on chemicals.
We undertake the preparation and submission of the registration dossiers required by your company and any other obligations arising from the regulation. We undertake the role as Only Representative for non-EU-manufacturers according to art.8 of the REACH-regulation. We also represent your company according to art. 4 of the REACH-regulation.
The biocide regulation (EU) No 528/2012 that came into force in September of 2013 has replaced the Biocidal Products Directive 98/8/EC (BPD).
We are at your service on your obligations under the biocidal products regulation. We take over the tasks associated to the preparation of dossiers for active agents to be submitted for authorization and supervise the authorization procedure.
We prepare European Active Substance Master Files and complete proposal documents for the grant of a Certificate of Suitability of the European Pharmacopoieia (CEP) by the EDQM. We submit the documents on your behalf and supervise the procedure up to the grant.
We check your Active Substance Master Files before submission on accordance with relevant guidelines and prepare a quality overall summary.
The import and export of hazardous chemicals is subject to regulation (EU) No. 649/2012 which was set in force on March, 1st of 2014. In addition to general restrictions being in place for export of hazardous chemicals, other listed chemicals need to be notified to the European Chemicals Agency. For certain further substances also a declaration of consent of the competent authority of the destination state is needed which will be transferred to the national competent authority of the exporting state.
Useful Links & Information
Classification, Labelling and Packaging
Helpdesks - REACH & CLP
European Chemicals Agency
Biocides
Prior Informed Consent
Active Pharmaceutical Ingredients