European Union's Chemical Registration Law Pre-Registration Deadline Passes

December 1, 2008, Pre-Registration

The new European Regulation on Registration, Evaluation, Authorization, and Restriction of Chemicals No. 1907/2006 (REACH) affects any producer, manufacturer, or downstream user of a chemical (substance); mixture of chemicals (preparation); or object such as clothing, toys, or computers (article) in quantities of one ton or more in the European Union (EU). Any import into the EU will be regulated by REACH and subject to the same registration, information exchange, and enforcement as substances manufactured within the EU.

Companies were allowed to pre-register substances currently imported into the EU until December 1, 2008. Once pre-registered, the company could take advantage of extended deadlines to submit the full registration dossier while enjoying uninterrupted manufacture and import of the currently imported substance.1 The EU has reported receipt of nearly two million applications.2 A list of pre-registered substances will be online by January 1, 2009.

Failure to Pre-Register by December 1, 2008

Effective December 1, 2008, the EU is no longer accepting pre-registration applications and has disabled the pre-registration function in REACH-IT, the online pre-registration program for phase in substances. Entities that failed to pre-register the phase in substances can no longer rely on the extended registration deadlines, but have to seek an approved full registration dossier prior to importation, selling, or marketing within the EU.3

In limited circumstances, REACH-IT will be enabled for late pre-registrations beginning January 5, 2009. Qualifying substances for a late pre-registration are those that are manufactured or imported after December 1, 2008, for the first time or intended to be released after December 1, 2008, for the first time since promulgation of the REACH regulation. The exception is limited only to those existing substances that will be placed into the EU market for the first time since REACH was promulgated in June 1, 2007.

If eligible for the late pre-registration, entities must provide the pre-registration information within six months of the first EU import and no later than 12 months before the relevant transitional registration deadline.

Potential Enforcement

Failure to pre-register existing substances will result in a mandatory cessation of all manufacture, import, and distribution of the substance until a full registration dossier has been approved by ECHA. Any entity that continues to import, manufacture, or distribute an un-registered substance could be subject to administrative fines, criminal charges, and/or exclusion from the EU market. Member countries are also in the process of enacting similarly local regulations that may have additional penalties.

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¹  Pre-registration extends the deadline for full registration until or November 30, 2010, for substances greater than one ton/year/importer or producer if the substance is carcinogenic, mutagenic, or toxic; May 31, 2013, for substances greater than 100 tons/yr/producer or importer; or May 31, 2018, for substances exceeding one ton/yr/importer or producer. 

²  Chemie.de Information Service, Companies submitted over two million pre-registrations by the deadline, http://www.chemie.de/news/e/91090/ (last visited December 3, 2008). 

³  A full registration dossier requires that a company fully assess environmental and health properties of each substance, risk from the properties, and identify how the company will manage those risks.