Regulatory Compliance

Though not directly concerned by substance registrations, under REACh downstream users have to fulfill many obligations. Our specialists in Regulatory Compliance at Dr. Knoell Consult GmbH are highly motivated to take care of your obligations. We analyse your products and derive the obligations by which you are affected. For example we contact your suppliers on your behalf or evaluate the potential critical presence of candidate substances in your products.

Since REACh entered into force in June 2007 manufacturers and importers of chemical substances in the European economic area are obliged to provide data on the physico-chemical, ecotoxicological and toxicological properties, compile robust study summaries. Based on these data the potential hazard of a substance is determined thru the application of the criteria laid down in Regulation (EC 1272/2008). This results in communication tools like labels and Safety Data Sheets. Additionally, REACh also covers a risk assessment based on the uses of substances during their complete life cycle. In the value chain substances, pre-registered or registered under REACh, are further processed into mixtures and/or articles.

Actors downstream the supply and value chain have several obligations to be fulfilled under REACh

Basically actors in the supply chain need to differentiate whether they obtain their raw materials inside or outside the european economic area (EEA), since this determines their role under REACh. If raw materials are obtained from outside the EEA the actor acts as an importer (as long as there is no Only Representative) and has the obligation to register the substances used. In case the supplier has implemented an Only Representative that covers the amount of substance handled by the actor, the actor is considered to be a downstream user without registration obligations.

Articles are basically not subject to REACh. There are no obligations to register articles in the EEA for manufacturers or importers of articles. However, the use of hazardous substances as such or in mixtures used for the production of articles has to be communicated upstream to the suppliers, since these uses have to be included in the risk assessment. Additionally, it has to be known whether candidate substances are present in articles in concentrations above 0.1%. In these cases and when the uses are not already covered in the registration dossier of the substance, the article manufacturer or importer has to notify ECHA if the candidate substance in the product is present in more than one ton per year.

Dr. Elisabeth Wekel Head of Business Unit Industrial Chemicals & Biocides - Product Safety
+49 621 718858-135 +49 621 718858-100 send mail

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