REACH knowledge base – REACH obligations of manufacturers and importers
Steps of determining the registration obligation:
For manufactured or imported substances, the hazard classification is the responsibility of the manufacturer or importer. Classification is mandatory irrespective of the quantity!
After examining the appropriate conditions, the classification of the substance can take place in the following ways:
If the substance is listed in Annex VI of Regulation (EC) No 1272/2008. the classification given therein is mandatory.
In case of using a different classification, a report (with appropriate justification) shall be submitted to the Agency.
In case of substances not listed in Annex VI of Regulation (EC) No 1272/2008 classification can be made based on own tests or on the recommendation of the supplier.
Checking the substances in Annex XVII of REACH.
Materials in the above Annex might be limited to certain uses, which also means that the substance may be used without limitation for non-designated uses.
For more information, check out our article about the authorization of SVHC substances.
The manufacturer or importer might have obligation to notify the substance, when all the following criteria are met:
within 1 month
If the substance has already been notified to the Classification and Labeling Inventory during the registration.
Registration of substances in articles is required when all conditions listed under Article 7 of the REACH Regulation are fulfilled:
* In calculating the quantity, it is necessary to calculate not only the quantity of the substance to be released, but also its total quantity in the article.
** The intended release does not occur during the primary function of the product.
Examples for the interpretation of the statement above:
However, we may be exempted if someone has registered that substance (you can check the pre-registered or actually registered substances on the website of the Agency).
If there is a registration obligation for a substance, a chemical safety assessment must be also made (over 10 tonnes / year).
Based on Annex XVII to REACH.