EU's REACH Enforcement Project to Target Downstream Users Who Formulate Mixtures

This post was written by David Wagner.

We’ve been discussing the November 30, 2010 REACH registration requirements on the blog, and now it’s time to address upcoming REACH enforcement efforts. On October 15, 2010, the European Chemicals Agency (ECHA) announced a project to inspect formulators of mixtures, that is, companies that purchase chemicals to prepare formulations such as paints, dyes, and industrial compounds. The enforcement project, which is designed to test REACH compliance, is slated for 2011.

In its announcement, the ECHA said that, while formulators of mixtures are not responsible for registering substances under REACH, they have supply chain responsibilities (e.g., safety data sheet requirements) that relate to obligations under REACH and the Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation). In particular, the ECHA stated “inspectors will control the supply-chain related obligations for substances in the mixtures prepared by formulators as well as the CLP notification requirements. They will also check if the substances placed on the market in mixtures are registered or pre-registered. In addition, the inspectors will raise awareness of the future obligations for Downstream Users with relation to the extended safety data sheet.”

The enforcement project, known as “REACH-EN-FORCE 2”, will be implemented by the EU’s Forum for Exchange of Information on Enforcement. Although REACH enforcement is the responsibility of Member State authorities, the Forum is tasked with, among other responsibilities, performing joint inspections and highlighting compliance problems.
 

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.

More Confidentiality Issues For Chemicals in the EU; This Time They Also Involve the Classification, Labeling and Packaging Regulation

This post was written by Todd Maiden and David Wagner.

Earlier this month, the Environmental Law Resource addressed how to make valid confidentiality claims for chemical information in a REACH registration dossier, and reminded readers that the first wave of REACH registration dossiers must be submitted by November 30, 2010. In particular, the November 30 deadline applies to substances that are manufactured in or imported into the EU in volumes of 1 metric ton or more annually and to certain compounds that are particularly hazardous to human health or the aquatic environment. However, upcoming confidentiality issues and deadlines related to chemicals in the EU are not limited to REACH; there are also similar issues for chemicals under the EU’s Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation).

First, some background on the CLP Regulation. It introduces the United Nations’ globally harmonized system for classification and labeling of chemicals into Europe. It also requires, by January 3, 2011, companies that manufacture, import, use, or distribute chemical substances or mixtures to notify the European Chemicals Agency 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. For each substance, information on the classification and labelling will be published.

The link between REACH and the CLP regulation is that both contain hazard communication tools: the CLP establishes labeling rules and REACH establishes rules for Safety Data Sheets. Moreover, the CLP Regulation amended some of the Safety Data Sheet requirements in REACH, and these changes will be phased in over the next 5 years.

On August 13, 2010, the European Chemicals Agency issued an alert explaining that companies not required to register by the November 30, 2010 REACH registration deadline but still obligated to notify regulators on the classification and labelling of substances under the CLP Regulation can, in certain cases, keep the substances name confidential.

To restate, regulated entities with substances that are to be registered after the November 30 REACH deadline, but which must still provide the European Chemicals Agency information about their classifications and labels by January 3, 2011, can claim their chemical’s International Union of Pure and Applied Chemistry (IUPAC) name to be confidential under certain circumstances. Specifically, chemical manufacturers, importers, or distributors can do so if their chemical is new to the European market; if it is an intermediate (i.e., used to make other chemicals); if it is used for scientific research and development; or if it is used in product of process research and development.

Confused? We hope not. But know that EU requirements related to chemicals are picking up again and deadlines are approaching fast. If you have any questions, please send a comment or contact Todd Maiden or David Wagner.