Allison Tracy is a Chemicals Policy Fellow.
Posts to this blog concerning REACH – the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals – have dealt mainly with the “R” and “A”. A few weeks ago, the European Chemicals Agency (ECHA) took a first big step to capitalize on the “E” (Evaluation).
Specifically, the final 2012-2014 Community Rolling Action Plan (CoRAP) was published on February 29th (see ECHA’s press release). After many months of consultation with the Member States, ECHA has released the list of 90 chemicals that will be the first to undergo REACH’s substance evaluation process in 2012, 2013, and 2014.
Existing data guided the prioritization process that led to the production of this list, but REACH’s authorities granted for substance evaluation will allow ECHA and the Member States to gather new information to fill data gaps. This new information will help to improve both governmental and public knowledge about the risks these chemicals may pose to human health and the environment.
Where does the CoRAP come from?
The text of REACH calls for the development of the CoRAP to identify “substances for which there is a suspicion that their manufacture and/or use could pose risks to human health or the environment.” Working together, ECHA and the Member States used the guidelines in REACH to develop the 2011 CoRAP Criteria.
Hazard criteria: The 2011 criteria require ECHA and the Member States to consider the following types of chemicals when prioritizing hazard characteristics in the selection process:
- Suspected Persistent, Bioaccumulative and Toxic substances (PBTs), very Persistent and very Bioaccumulative substances (vPvBs) and PBT-like substances
- Known PBTs/vPvBs
- Suspected endocrine disruptors
- Suspected Carcinogenic, Mutagenenic and Reprotoxic substances (CMRs) (e.g. based on structural similarities)
- Known CMRs (Category 1A , 1B and 2 according to the Regulation on Classification, Labeling, and Packaging)
- Suspected sensitizers (e.g. based on structural similarities)
- Known sensitizers (skin and especially respiratory sensitizers)
Exposure criteria: The 2011 criteria require ECHA and the Member States to consider the following exposure characteristics in the selection process:
- Wide dispersive use (number of sites of use, use in mixtures or articles used by the public, etc.)
- Number of using sites if emission due to industrial use
- Consumer use and exposure of sensitive subpopulations such as children
- Aggregated tonnage
Risk criteria: The 2011 criteria require ECHA and the Member States to consider the following risk characteristics in the selection process:
- Whether the estimate of exposure is below the threshold at which the substance is considered hazardous
- Whether individuals may be exposed to the chemical in combination with structurally similar chemicals that could compound the effects
What does the CoRAP do?
The 90 CoRAP chemicals that ECHA and the Member States selected using the 2011 criteria are those that were deemed to warrant the most suspicion as to their risk, based on existing information. As such, the EU is driving relatively rapid evaluation on these chemicals. Member States will submit draft substance evaluations for the 2012 batch of CoRAP substances (36 chemicals) by February 28th, 2013. The registration dossiers submitted under REACH thus far will be valuable sources of information for evaluation of these substances. Thirty of the 36 substances for 2012 and 79 of the total 90 chemicals have registration dossiers.
Once Member States submit their drafts, ECHA will forward them to the registrants of the chemicals in question to provide them with an opportunity to comment. (It is not clear whether other stakeholders will have access to these draft evaluations in order to provide their input, although any decisions to require development of more information and the final evaluations will be made public.) The final conclusion of evaluation may be that no further action is needed, but evaluation may also lead to the introduction of new risk management measures if the suspected risks are supported by new information.
The numbers game
The draft CoRAP from October listed 91 substances, one of which (1,1-bis(tertbutyldioxy)-3,3,5-trimethylcyclohexane) has been removed in the final list because existing information was deemed to be sufficient (Chemical Watch, subscription required). However, according to an earlier Chemical Watch article on the draft CoRAP, ECHA and the Member States had planned to evaluate 50 substances in 2012 and 100 substances per year from there on out. The limited resources of Member States convinced ECHA that a list of 250 chemicals was too ambitious for the first CoRAP, leaving only 90. Still, the Agency has noted that it is possible that the CoRAP for 2012-2014 will be expanded in February of 2013. The final CoRAP lists 36 chemicals for 2012, 23 for 2013, and 31 for 2014.
Chemicals of concern
ECHA notes that “in many cases the initial concerns are related to PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive use or consumer uses.” Some of the noteworthy chemicals included in the CoRAP are:
- triclosan (part of the 2012 batch),
- tetrachloroethylene (part of the 2013 batch),
- formaldehyde (part of the 2013 batch), and
- three phthalates (part of the 2014 batch).
Each of these chemicals or group of chemicals already has earned a degree of notoriety based on associated adverse effects on human health.
The forest through the trees
The big-picture message is that the CoRAP is a powerful supplement to ECHA’s Candidate List of Substances of Very High Concern (SVHCs). The Candidate list puts SVHCs on a track towards Authorization, which is likely to lead to elimination or significant reduction in use, but it can only address chemicals for which there is sufficient information.
That’s where the CoRAP comes in. ECHA does not assume that a chemical with insufficient information does not pose a risk. In fact, ECHA states in the 2011 CoRAP criteria that: “In general, a suspected property is considered by default to be more important criterion than a known property [as a trigger for evaluation], as it is more obvious that some further information is needed to confirm the existence of the property in case of suspicion.” As is evident from this statement, substance evaluation is essential to living up to REACH’s “no data, no market” motto because it allows ECHA and the Member States to fill data gaps about chemicals. Substance evaluation also informs the market, which can itself lead to improvements in the safety of chemicals and bolster consumer confidence in the products of the chemical industry – a win-win situation.
Many of the chemicals listed in the CoRAP are in commerce in the United States:
- 84 of the 90 CoRAP chemicals are present on the public version of EPA's Toxic Substances Control Act (TSCA) Inventory, which lists approximately 67,000 chemicals that have been in commerce in the U.S at some point since 1979. That includes 34 of the 36 chemicals in the 2012 batch, 19 of the 23 chemicals in the 2013 batch, and all 31 of the chemicals in the 2014 batch.
- 75 of the 90 CoRAP chemicals were publicly reported in the 2006 cycle of the Inventory Update Reporting rule (IUR), which required companies to report information on chemicals manufactured or imported in amounts exceeding 25,000 pounds per year. This includes 29 of the 36 2012 chemicals, 19 of the 23 2013 chemicals, and 27 of the 31 2014 chemicals.
As with the comparisons we’ve done with REACH’s Candidate and Authorization lists, this comparison again shows that there is no shortage of chemicals in U.S. commerce that are being flagged for potential or actual concerns under REACH.