Thirteen More Substances Proposed for EU Ban

This post was written by David Wagner.

As we discussed early in 2011, the European Commission agreed to ban six substances under the European Union’s REACH law. Now, with the year winding down, 13 more substances have been submitted to the Commission for inclusion of the list of banned substances. On December 21, the European Chemicals Agency formally submitted to the European Commission a list of 13 substances it said should be banned under REACH. If a ban is imposed, companies will be able to request authorization to continue to use the substances in specific cases if no alternatives are available.

The substances are seven chromium compounds (chromium trioxide, chromic acid, sodium dichromate, potassium dichromate, ammonium dichromate, potassium chromate, and sodium chromate), five cobalt compounds (cobalt sulphate, cobalt dichloride, cobalt dinitrate, cobalt carbonate, and cobalt diacetate), and the solvent trichloroethylene. These thirteen substances already are listed as “substances of very high concern” under REACH.

REACH: An Enforcement Update

This post was written by Paul Dillon.

In the months leading up to the REACH first registration date on 1 December 2010, the focus of the European Chemicals Agency (ECHA) was understandably on the 25,000 registration dossiers submitted. But the ECHA’s focus is shifting and it is now turning its attention to compliance. This comprehensive client bulletin identifies 10 REACH enforcement trends in Member States and what to expect from regulators in the near future, including site inspections. It then recommends ways to prepare for an inspection.

 

With REACH Registration Less Than Two Months Away, Here's the Latest

This post was written by David Wagner.

At this week’s Fifth Stakeholders’ Day, which was broadcast over the web, the European Chemicals Agency (ECHA) reported that a little less than half of the substance registrations – about 2,000 – have been submitted in advance of REACH's November 30, 2010 deadline. As we’ve discussed on the blog, the European Union’s REACH law requires about 5,000 substances produced in or imported into the European Union to be registered with the ECHA by November 30 or their supply on the EU market will be illegal. Next month’s deadline applies to substances produced in or imported in annual volumes of 1,000 metric tons or more, and to volumes of one metric ton or more of the most hazardous classes of substances that are carcinogenic, mutagenic, or toxic to reproduction.

At the October 4 event, ECHA stated that it expects about 3,000 substances to fall into the high volume category, and between 1,500 and 2,000 to fall into the lower volume hazardous categories. They also reported that the ECHA had received over 4,000 dossiers addressing over 2,000 substances and compared these numbers to an expected total of 38,000 dossiers covering almost 5,000 substances. Recall that, under REACH, companies producing the same substance are required to work together in a Substance Information Exchange Forum (SIEF) and share data. ECHA expects a lot more dossiers than substance registrations because once the lead registrant of a SIEF submits a dossier, other companies manufacturing or importing the same substance must submit supplementary dossiers.

ECHA also reported that, to allow companies to check on the status of substance registrations, they will publish a list of registered substances by the end of October, and update that list weekly. When it’s available, we’ll publish a link to the ECHA’s list on our blog.
 

Another REACH news item from the event was the ECHA’s expectation to add 40 more substances to its candidate list of “Substances of Very High Concern” in 2011. The candidate list is the list of hazardous chemicals that could be restricted or banned under REACH, and 40 additional substances would double the size of the current list.

CLP Notifications Not as Impressive

Regarding upcoming requirements under another EU law, the Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation), ECHA officials indicated that efforts to comply were not as robust. The CLP Regulation requires, by January 3, 2011, companies that manufacture, import, use, or distribute chemical substances or mixtures to notify the ECHA about the classifications of and labels for any substance or mixture, regardless of its annual tonnage, before they place it on the European Union’s market.

On the CLP notifications, the ECHA reported that they expect to receive a few million notifications and had received about 300,000 to date. Not surprisingly, the ECHA encouraged manufacturers and importers to submit CLP notifications as soon as possible, and not rely on being able to piggyback with existing CLP notifications submitted by other companies, which is permitted only by the REACH registration system.

How to Make Valid Confidentiality Claims under EU's REACH Law

This post was written by David Wagner.

On July 30, the European Chemicals Agency (ECHA) released a new guidance manual that gives step-by-step instructions on how to make confidentiality claims for chemical information in a REACH registration dossier. This includes how to make confidentiality claims for chemical names and the estimates of the amount produced. The manual also outlines the procedure that ECHA will follow to assess a registrant’s confidentiality claims and to potentially reject them by formal decisions, as well as the appeal procedure for rejected claims.

The manual explains that, in certain circumstances the International Union of Pure and Applied Chemistry chemical name can be claimed as confidential but registrants who take this approach must provide a “public name” for the chemical. ECHA broadly explains that the public name should disclose a maximum amount of information on the chemical structure of the substance, while protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the registrant. If you are not clear about what that means, stay tuned. ECHA stated that it is analyzing various naming systems and plans to issue a practical guide on how to derive a “public name”.

Keep in mind that, by November 30, 2010, REACH registration dossiers must be submitted for substances manufactured in, or imported into, the EU in volumes of 1,000 metric tons or more per year, and for some hazardous substances at lower volumes.