Registrants under the second REACH deadline for phase-in chemicals (May 31) must update their dossiers “immediately” if they neglected to include confidentiality claims for information that should not be made public, the European Chemicals Agency says.

“Most of the information in your registration dossier will be published on the ECHA website,” the agency notes in materials posted to its website June 3.

Firms may request that certain elements be treated as confidential – such as company name, tonnage band “or in some cases the identity of the substance” – but such requests need to be “justified” and assessed by ECHA and may carry fees at this stage if updates to dossiers are necessary.

ECHA offers a dissemination plug-in tool through its IUCLID website/software platform, which can help companies simulate what information of theirs will be published. They can use the agency’s fee-calculator plug-in to determine how much confidentiality requests will cost.

According to ECHA’s release, 9,084 registration dossiers were submitted by 3,215 companies under the May 31 deadline for chemicals manufactured or imported in the European Union in volumes between 100 tons and 1,000 tons each year, representing 2,923 substances in total.

Large companies were responsible for 80% of dossiers, with the balance submitted by micro, small or medium-sized companies, ECHA says. More than a fifth (23%) of registrations were handled by “only representatives” on behalf of non-European companies, and of the 26 EU member states that participated, the greatest percentage of registrations came from Germany (31%), followed by the U.K. (12%), with Italy, France and the Netherlands each accounting for 8%.

ECHA’s Executive Director Geert Dancet states: “Overall, the registration process worked well and industry responded actively to the 2013 registration deadline, although a significant number of lead registrants registered in the final days, which has put some members under unnecessary time pressure.”

A portion of the 2013 registrations are still undergoing completeness checks, ECHA says.

Firms whose dossiers fail the technical completeness check, which confirms that all fields in the dossier template are filled, have just one chance to address omissions and successfully resubmit before having to start the registration process over, with inevitable disruptions to their business. ECHA also provides a software tool for companies to self-assess the technical completeness of their registrations.

Based on feedback the agency began collecting in November 2011, ECHA estimates that 984 substances intended for registration have not been registered as of May 31. That list is downloadable from the agency’s website, as is a list of registered chemicals.

Firms subject to the May deadline that did not register are prohibited from manufacturing or importing their substance into the EU until they do so. “You are advised to register as a matter of urgency,” ECHA says.

Downstreamers Must Heed Updated Info

The agency urges downstream users to consult the list of registered substances and contact their suppliers with concerns about missing items or specific chemical uses.

Once a substance is registered and assigned a registration number, firms that use it as such or in a mixture should receive an up-to-date safety data sheet from their supplier, which they can use to compare updated exposure scenarios with their own use models to confirm that their conditions of use are in line with those outlined in the SDS.

“You will also need to take this information into account when preparing communication on safe use for the products that you place on the market,” ECHA notes.

According to the agency, completeness checks will continue through August 2013, and it will report the final 2013 registration outcome in early September. Non-confidential information from this year’s registrations will be made publicly available by year-end, ECHA says.

In its remarks, the agency stresses that “‘complete’ does not mean ‘compliant,’” and “complying with REACH does not end at registration. It’s only the start.”

Going forward, the agency will check at least 5% of registration dossiers in the 100 tons-1,000 tons band to ensure compliance with REACH requirements, examining any test proposals included therein, by June 1, 2016.

Next up for registration are manufacturers and importers of chemicals in the smallest amounts (less than 100 tons), which must submit dossiers to ECHA by May 31, 2018.

ECHA launched a draft five-year plan at the end of May to improve its dossier-evaluation process and strengthen REACH guidance and training programs in anticipation of that final deadline for phase-in substances, among other objectives ([A#02130603001]).

The first REACH deadline – Nov. 30, 2010 – pertained to firms working with chemicals in excess of 1,000 tons annually, as well as substances identified as posing the greatest hazards Also see "First REACH Deadline Accumulates Data On "Most Problematic" Chemicals" - HBW Insight, 13 December, 2010..

Since the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals program launched in 2008, a total of 6,598 substances have been registered, according to ECHA.

ECHA Advises Registrants, Downstream Users Post-May REACH Deadline

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