Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
While efforts to improve U.S. chemical safety legislation have been at, shall we say, a stand-still for the past few months, our European counterparts have been buzzing with activity. U.S. NGOs, industry, regulators and lawmakers should be paying really close attention to all that buzz as they deliberate the shape of U.S. chemicals policy in the new Congress.
The European Chemicals Agency (ECHA) is currently in the thick of processing registrations received by the first major deadline under REACH, the European Union’s chemicals regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals. November 30, 2010 was the first of three deadlines for registering existing chemicals (termed “phase-in substances” under REACH); it applied to the highest-volume and most hazardous chemicals on the market. Some 4,700 new and existing chemicals have now been registered under REACH since it took effect in mid-2008, including about 3,500 existing chemicals subject to that first deadline based on high volume or toxicity.
In contrast to Las Vegas, what is happening in Europe is not staying in Europe. That alone makes it worth paying attention to.
REACH’s global reach
REACH affects not only chemicals made in the European Union, but also chemicals imported into the EU. But its effects are being felt even more broadly: REACH has contributed to the international momentum for chemical reform and a number of its core principles are going global, shaping or showing up in new policies and regulations in places as various as South Korea, China and Turkey.
The emergence of such enhanced regulations across the globe means:
(1) US chemical manufacturers and processors that operate globally are facing a vastly different market than they were a decade ago; and
(2) it is becoming increasingly difficult for U.S. companies to reconcile radically different chemical management regimes at home and abroad – including how to address growing concerns by American and global customers and consumers that they may be placed at greater risk from hazardous chemicals in U.S.-made products compared to citizens and businesses of other nations – “global guinea pigs”!
At a recent Senate hearing on TSCA reform, American Chemistry Council (ACC) President Cal Dooley stated that “in some ways, … there's always a myth here that REACH is a gold standard here. Nobody knows how well it's going to work yet.” But that statement misses the point: However one views REACH on the merits, it is already changing the global face of chemicals management. We met with a senior official from Australia just recently who said they are already seeing an increase in the amount of data coming in with new chemicals notified to them, data that were clearly generated to comply with REACH requirements.
Environmental Defense Fund’s 2007 report Not That Innocent compares legislative and regulatory frameworks in the U.S. and the EU, as well as Canada. Four key innovations advanced by REACH are apparent, and are already having an impact even this early in REACH implementation. REACH:
- systematically addresses the huge number of never-before-assessed existing chemicals (termed “phase-in chemicals” under REACH because their registration is to be phased in over an 11-year period), including requiring basic safety data as a condition for remaining in commerce (“no data, no market”);
- shifts the burden onto industry to demonstrate the safety of its chemicals;
- mandates the flow of information in both directions between producers and users of chemicals to increase the accuracy of risk characterizations and the adherence to needed controls to address potential risks throughout the supply chain; and
- requires use-specific authorizations to continue using particularly dangerous chemicals.
Status of REACH implementation
So, what’s come in under REACH, now that the first major deadline has passed? Information has been trickling out over the past few weeks, and enough is now available to do an initial assessment of the information submitted under REACH to date.
ECHA has published the basic statistics on registrations received under REACH as of the November 30th deadline. Since REACH took effect on June 1, 2008, a total of 4,725 chemical substances have been registered, and are contained in 26,185 individual registrations. (Each registration is submitted by a company, or jointly acting companies, on a single chemical.) These totals include about 3,480 existing (“phase-in”) chemicals and about 1,250 new (“non-phase-in”) chemicals.
One of the first, clear lessons to emerge from REACH’s first phase is that ECHA quite accurately forecast the number of registrations it would receive in this round, despite fears (based erroneously on preregistration numbers) that the agency would be overwhelmed. ECHA predicted that it would receive 25,000 to 38,000 registration dossiers for 4,700 substances – right on the money!
Included in these registrations were proposals to conduct 1,548 tests that were submitted in 580 dossiers. REACH registrants are required to submit testing proposals, rather than test data, with their registrations when any of the required hazard data are not already available and generating them would involve animal testing. ECHA reviews the proposals before companies begin testing in order to minimize animal use. About 60% of the proposed tests involve vertebrate animals (see attachment #2 of this report).
What we know about the registered chemicals
Three categories of substances were required to be registered by the first REACH deadline:
(a) Carcinogenic, Mutagenic or Reproductive toxins (CMRs) produced in amounts greater than or equal to 1 metric tons/year;
(b) Substances classified as very toxic to aquatic organisms and that may cause long-term damage in the environment (classifications R50-53 under the Dangerous Substances Directive 67/548/EEC) produced in amounts greater than or equal to 100 metric tons/year; and
(c) Substances produced in amounts greater than or equal to 1000 metric tons/year.
ECHA’s December 1st press memo notes that 400 of the approximately 3,400 phase-in substances registered are Carcinogenic, Mutagenic or Reproductive toxicants (CMRs) and more than 150 are R50-53. Among the substances in these two categories, 27 are already on the REACH Candidate List for Substances of Very High Concern (SVHCs). CMRs are one of the hazard categories for substances under REACH that qualify as SVHCs, which may ultimately lead to their being subject to authorization. Authorization decisions determine the extent to which a given SVHC can be produced and used in the EU.
ECHA is gradually posting information received in registration dossiers on its website. As of March 17th, it had posted registration dossiers for 1,552 chemicals, which contain varying levels of detail on chemical properties, uses and test results.
How many of the registered chemicals are produced and used in the U.S.?
Of the nearly 3,500 registered phase-in substances, unique CAS numbers were available for approximately 2,900 of them. We compared these CAS numbers to two U.S. lists: the public version of the TSCA inventory, and the public version of the 2006 Inventory Update Reporting database (which includes chemicals, not otherwise exempted, reported to be produced in or imported into the U.S. commerce in amounts over 25,000 pounds per year per site). Here’s what we found:
- 80% of these 2,900 chemicals appear on the public U.S. TSCA Inventory; and
- just over 60% of them appear in the public 2006 Inventory Update Reporting database.
We in the U.S. are clearly dealing with many of the same chemicals as is REACH, although there appears to be considerably less than complete overlap.
REACH has the potential to usher in a new era of enhanced information about chemicals, increased flow of that information through chemical supply chains, better control of hazardous substances, and reductions in the use of the most dangerous substances. At this stage it’s certainly fair to say that it remains to be seen the extent to which the strong principles of REACH translate into the intended improvements in chemical safety data available to, and decisions made by governments, the market and the public.
One thing can be said with certainty at this point, however: REACH is more than a few steps ahead of us and is dominating the global stage of chemical policy, and other countries are casting their votes for it by strengthening their chemical policies with the principles of REACH in mind.