ECHA to Set Up Expert PBT Group

One of the main set of criteria for identifying and classifying substances of very high concern (SVHC) in Europe under the REACH regulation are whether the substance exhibits Persistent, Bioaccumulative and Toxic (PBT) properties or Very Persistent/Very Bioaccummulative (vPvB) properties.  Now the European Chemicals Agency in Helsinki is putting together a PBT expert group.  The group would address scientific issues related to PBT, both those already identified and those yet to arise.

ECHA has already in place at least two guidance documents related to identification of PBTs - Part C and Chapter R.11.  Criteria are also discussed in Annex XIII of the REACH regulation.

The new group would be staffed by experts nominated by each EU Member State, as well as three representatives each from both industry and NGOs.

ECHA Gives "Guidance in a Nutshell" for Identifying Chemical Substances Under REACH

ECHA, the European Chemicals Agency based in Helsinki that manages the REACH chemical registration program, has published another in its series of "Guidance in a Nutshell" documents.  This one is on the "Identification and Naming of Substances Under REACH and CLP."  More detailed guidance documents are also available, but the "Nutshell" documents provide a concise summary of the basic information needed for compliance.  According to ECHA:

The objective of the Guidance in a Nutshell on identification and naming of substances under REACH and CLP is to give guidance for manufacturers and importers on recording and reporting the identity of a substance within the context of the REACH and CLP.  It briefly explains how to name the substance and also gives guidance on whether substances may be regarded as the same in the context of those Regulations.

In addition:

This document has been drafted according to the corrigendum on Guidance for identification and naming of substances under REACH and CLP which has been published at the same time. The corrigendum includes editorial corrections, the replacement of outdated information, the correction of examples and references aiming to improve readability.

The Nutshell guidance document can be downloaded from the ECHA site here.

EPA Makes Public Hundreds of Formerly Confidential Chemicals Studies

On November 28, 2011 the USEPA released an updating showing "EPA's progress reviewing case files submitted to the Agency under TSCA with chemical identities claimed as Confidential Business Information (CBI)."  They provided a series of charts "intended to help those tracking EPA's progress in reviewing CBI and declassifying it, where appropriate."  The move is "part of Administrator Lisa P. Jackson’s commitment to enhance the U.S. Environmental Protection Agency’s chemicals management program and increase transparency."

According to EPA, "Releasing the data will expand the public’s access to critical health and safety information on chemicals that are manufactured and processed in the U.S."

In a statement by outgoing Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, Steve Owens noted that “EPA is increasing the availability of critical health and safety studies on chemicals that children and families are exposed to every day. We are making important progress in making this information public and giving the American public easy access to it...“over the next year, we expect to review several thousand additional studies on industrial chemicals and make many of these more accessible to the public.”

Highlights from the latest release:

• Since the beginning of EPA's efforts to increase transparency two years ago, a total of 577 chemicals have been declassified, resulting in a shift from the CBI portion of the TSCA Inventory to the public portion.
  
• CBI claims for chemical identity are being reviewed, and challenged where appropriate, in 100 percent of incoming TSCA filings that may contain health and safety studies.
  
• As of October 2011, EPA exceeded its FY 2011 goal, set forth in the FY 2011-2015 EPA Strategic Plan, to review, and challenge where appropriate, more than 1,125 existing TSCA cases with CBI claims for chemical identity, potentially containing health and safety studies.

EPA noted that:

 

Consistent with the guidance, the agency will request that the submitter voluntarily relinquish the CBI claims and make the newly available studies available to the public. EPA also challenged the chemical industry to make available information that was previously classified as CBI. To date, more than 35 companies have agreed to review previously submitted filings containing health and safety studies and determine if any CBI claims may no longer be necessary. 

Finally, EPA notes that "the newly available information can be found under a new “declassified tab” using the Chemical Data Access Tool, launched in December 2010 to assist the public in retrieving chemical health and safety information submitted to EPA under TSCA."

More information can be found on EPA's web site.
 

ECHA to Begin Authorizing Biocidal Products

The European Union has reached an informal agreement to allow the European Chemicals Agency (ECHA) to being taking responsibility for reviewing and authorizing biocidal products.  The agreement between the European Parliament and the EU Council would give broad powers to ECHA and update the current EU Biocides Directive.

In addition to allowing ECHA to review certain biocides applications at the EU level, companies would also maintain the ability to apply to individual Member States for authorization, after which they would obtain approval in other Member States through a process called mutual recognition.  This is how the process works under the current Directive, and this move to shift some of the responsibility to ECHA is part of the reevaluation of the Biocide process as the Directive is replaced by a Biocidal Products Regulation.  Like REACH, the new regulation would immediately apply across all Member States, whereas the Directive required each MS to pass its own individual implementation legislation.

ECHA's role is limited to only some of the product types of biocides beginning in 2012, and then by 2017 all of the 23 product types will be eligible for authorization at the EU level through ECHA.  The informal agreement also specifically requires that nanoscale active substances in biocidal products be assessed separately from their non nanoscale counterparts.