Monday, January 10, 2011

Several Hundred Chemicals Classified as Carcinogens, Mutagens or Reproductive Toxins under REACH

As I noted last week, the European Chemical Agency (ECHA) received 3,114,835 notifications of 24,529 substances under its Classification, Labelling and Packaging (CLP) regulation. The deadline for notifying chemical classifications was January 3, 2011.  This includes those substances notified separately as well as classifications included in the November 30, 2010 REACH registration deadline.

The REACH registration deadline was for all substances manufactured or imported in the EU at greater than 1000 metric tons per year, but also for substances that met certain "very high concern" criteria no matter what tonnage at which they were on the market.  According to the ECHA registration numbers, about 400 substances registered met the criteria for being at least one (and possibly all three) of carcinogenic, mutagenic or a reproductive toxin (called CMR for short).  Another 150 or so were considered highly toxic to aquatic life.  These "substances of very high concern" (SVHCs) will get particular scrutiny as ECHA turns to evaluating the data dossiers received.  In fact, nearly 30 of these have already been identified by ECHA in their series of candidate list proposals.  Substances on the candidate list are likely then move to the Authorization Annex of REACH, which requires manufacturers to apply for "authorization" to continue producing the substance - though any authorization will be both time-limited (with a requirement to find a substitute within a short transition period) and use-limited (i.e., will only be authorized for very specific uses in which suitable health and environmental protections will be required to limit exposure during the transition period).

The next registration deadline under REACH is June of 2013 for substances of medium levels of production and use in the EU.  But in the interim REACH is undergoing an evaluation of the program to determine if changes are needed to improve both logistics and effectiveness.  Enforcement by the member states will also now be occurring, which likely will raise other issues in need of being addressed.

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