When we first reported on the European Union's (EU) Registration, Evaluation and Authorization of Chemicals (REACH) program in 2003, EU officials had just introduced the proposal that would radically transform chemical regulations by placing the onus on industry to demonstrate the safety of virtually all chemicals made or exported to the region (see Capitol Comments, September 2003). When we next reported on the issue at the beginning of 2006, the original REACH proposal had undergone several changes in response to more than 7000 public comments from concerned stakeholders all over the world, and it was still anyone's guess what the final REACH would look like and when it would be completed (see Capitol Comments, January 2006).
Well, it appears the moment of truth is finally upon us. On December 30, 2006, the final version of the REACH was published, setting the wheels in motion for its formal enactment on June 1, 2007. But even with regulatory reality just a few months away, there are still many industry stakeholders who still do not know what their specific obligations under the REACH system will be.
Considering that nonwovens producers routinely use many of the substances that will be covered under the scope of this massive regulation, this article will review several key deadlines and describe what Capitol Comments readers should know about this far-reaching regulatory initiative.
Presently, the EU regime for regulating chemicals is a complex mish-mash of some 40 laws and regulations that has resulted in a dualistic system that places a disproportionate regulatory burden on "new" chemicals and while allowing many chemicals marketed in the EU before 1981 to exist virtually unregulated. Indeed, while all new chemicals must be tested before entering the market, only 140 of the more than 100,000 "existing" chemicals in circulation have been identified as priority substances for risk assessments–a dichotomy that European officials believe could have potentially negative impacts on human health and the environment.
The REACH program, therefore, seeks to change that by replacing the existing patchwork of laws with a single system encompassing all chemicals. Under the plan, all chemical substances that are made or imported into the EU in quantities greater than one ton–some 30,000 chemicals according to European officials—would have to be registered. Substances found in a wide range of finished articles like textiles, clothes, furniture, automobiles and more will also be subject to registration, provided the chemical in finished products exceeds one ton per year and it is "intended" to be released during its normal function, one example of which would be ink from a pen. A number of other chemicals, however, are exempt from REACH requirements because they are known to pose little or no risk. Examples include substances like oxygen and cellulose pulp, as well as polymers and a large number of chemicals used in food and medical products, which are already addressed in other legislation.
To register, manufacturers/importers will have to submit a technical dossier to the European Chemicals Agency (ECA) based in Finland and provide key descriptive information about the substance in question including the name of the manufacturer/importer, its appropriate classification and labeling and its manufacturing process and function. Guidance on how it may be used safely must be submitted to the ECA as well.
Moreover, companies that make or import/export to the EU more than 10 tons of the substance annually will need to supply a Chemical Safety Report (CSR) documenting any known hazards and its appropriate classification. If the substance is either a "persistent, bioaccumulative and toxic" substance (PBT) or a "very persistent and very bioaccumulative" substance (vPvB), registrants will need to supplement their CSR with various exposure scenarios documenting appropriate risk management measures and operational conditions for all identified uses.
And, while downstream users will generally be exempted from registering their chemicals, they will be expected to provide information about downstream uses to suppliers when needed, and will be required to verify that suppliers have registered substances for their intended downstream purposes and follow specified risk management measures identified by their suppliers.
Evaluation, Authorization and Deadlines
The "evaluation" component of REACH refers to both dossier and individual substance review. The ECA will review a percentage of submitted dossiers to verify that they comply with submission requirements and may request additional information if the submission is found to be lacking. Additionally, certain individual substances themselves may be subject to further evaluation when the ECA and EU members states believe the risks warrant additional review, which may lead to these substances being restricted at the EU level or subjected to the rigorous authorization process.
In the meantime, those hoping to use or market "substances of very high concern" or chemicals that are considered particularly risky (i.e., those known to cause cancer, mutations or cause reproductive issues in laboratory animals) will have to receive "use-specific" authorization before they can be cleared for market. Authorization will be granted on a case-by-case basis, and can be facilitated if the applicant can show that the risks associated with the uses of that substance are adequately controlled, or that the socio-economic benefits outweigh the risk to human health or the environment and that there are no suitable alternatives. All applications for authorization will also have to be accompanied by an analysis of substitutes.
Deadlines for registration will be based on the amount of the chemical being made, marketed or imported into the EU. Higher volume chemicals or those above 1000 metric tons will have to be registered by 2010 and will require additional testing. Substances that amount to anywhere from 100 to 1000 tons will have to be registered by 2013, and chemicals used in amounts of 1-100 tons will not have to be registered until 2018.
It is extremely important to note, however, that companies hoping to take advantage of the deadlines described above must pre-register their chemicals with the ECA. The pre-registration requirement was included in the REACH to encourage companies to share information and prepare joint registration submissions later on down the road. The window for pre-registering chemicals is extremely narrow—the ECA will only accept pre-registrations from June 1, 2008 to November 30, 2008—but the importance of meeting this requirement cannot be overstated. Manufacturers or importers who do not pre-register will only have until June 1, 2008 to formally register their chemicals.
Even with implementation looming, numerous uncertainties surround the REACH program. The fee structure for registrations and authorizations has yet to be finalized, for instance, and the ECA is not expected to be fully operational until 2008. Moreover, software intended to help firms format and file their registrations electronically is still in development and not slated to be rolled out until later this year. Perhaps most importantly, no one truly knows the economic impact that this vast chemicals regulation will have throughout the world.
What we can say with some certainty, however, is that REACH is bound to present challenges during the first years of the program's implementation. It is for this reason that INDA, Association of the Nonwoven Fabrics Industry, will continue to communicate new information about REACH as it comes down the pike and to serve as a conduit for its members when questions and issues arise.