ECHA Modifies REACH Tonnage Calculations

In REACH news, the European Chemicals Agency (ECHA) has modified its methodology for calculating “total tonnage” bands. Make a note of it if you haven’t already.

The shortcomings in the legacy calculation methodology, ECHA is saying, arose from the fact that the REACH Regulation is based on the concept of legal entities rather than companies. To make a long story short, in some situations the old way could lead to involuntary disclosure of confidential business information.

So the agency has decided to modify the envisaged methodology for calculating aggregated tonnages.

The modification removes the “four registrants rule” before publication of tonnage band data on the ECHA website. As it was, the tonnage data— claimed confidential by a given registrant— would still be included in the calculation of aggregated tonnages if there are four or more registrants in a joint submission. This would threaten the Confidential status.

Tonnage amendment already in place  The publication of tonnage bands on ECHA’s registered substances database that took place for the first time in June.  Repeat: ECHA already took the modifications in the calculation method into account.

The “total tonnage band” is published together with other substance-specific information on ECHA’s website.

Total tonnage bands will be displayed for substances on ECHA’s registered substances database from those listed in the following table:

Tonnage chart REACH new
Table source: courtesy ECHA

 

Tonnage data will be extracted from the latest disseminated dossier of each full (non-intermediate) registration, aggregated, converted to a total tonnage band, and published on ECHA’s registered substances database. The total tonnage bands will be published for joint submissions and for inpidual submissions. Tonnage data will not be extracted from dossiers for intermediate registrations under REACH Articles 17 or 18. Tonnage data will also not be extracted from dossiers for full (non-intermediate) registrations where the tonnage band is claimed to be confidential in accordance with REACH Article 119(2)(b).

Claiming confidential Registrants have had the facility to claim their tonnage band confidential in accordance with REACH Article 119(2)(b) since June 2008. If registrants have not done so but wish to claim confidentiality for their tonnage band, they should submit an updated dossier with a confidentiality claim on the tonnage band as soon as possible.

For confidentiality claims under REACH, please note that the claim must be justified in accordance with Data Submission Manual 16, and will attract a fee. Confidentiality will only be granted where the claim is accepted as valid by ECHA. Notably, tonnage data will not be extracted from dossiers where the tonnage band is claimed confidential while the confidentiality claim is under assessment.

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About Kal

Kal Kawar, CIH, PE, has a bachelor's in chemical engineering and a master's in industrial hygiene. His professional experience includes serving as staff industrial hygienist for IBM's New York semiconductor manufacturing facility, and as industrial hygienist for IBM’s US headquarters. Now executive vice president of Actio, Kal taps more than 20 years' worth of chemical engineering, industrial hygiene, and environmental engineering experience. His far-reaching expertise with global regulatory challenges created by EPA, TSCA, REACH, RoHS, WEEE – and hundreds of others – aid in developing Actio software solutions for MSDS management, raw material disclosure compliance, and product stewardship in a supply chain.