On June 1, 2007 a new chemical control law went into force in Europe. It is popularly called REACH, which is an acronym for Registration, Evaluation, and Authorization of Chemicals (there is also a Restrictions phase, but it didn't fit well into the acronym). REACH is fundamentally different from how chemicals are regulated in the United States (especially for "existing" chemicals). But is it better?
Chemical control in the US
In the US, the Toxic Substances Control Act (TSCA) is our regulatory mechanism for chemicals. Shortly after it was enacted in 1976, approximately 63,000 chemicals that were already on the market at the time were grandfathered onto a list referred to as the TSCA Inventory. No assessment of these chemicals was done at the time, since it would have been logistically impossible, so the idea was TSCA would deal with these existing chemicals on a case-by-case basis. Meanwhile these existing chemicals would remain on the market. Anyone wanting to manufacture any chemical already on the Inventory may do so without informing anyone. New chemicals, i.e., those not already on the market, would have to go through a review process before being placed on the market through a process called PreManufacture Notification (PMN). It falls to the US EPA to determine whether they think there is a likelihood of unreasonable risk from the chemical. Since TSCA doesn't require basic health and safety data to be submitted with these PMNs, EPA primarily relies on computer programs and experience to estimate potential risk. And they have only 90 days to do this; if they don't inform the notifier within this time frame the company is free to begin manufacturing the chemical.
Other parts of TSCA give EPA further authority to request additional data or exposure information, however, many in the US believe that bar is too high for EPA to effectively identify and control chemicals they feel are a potential problem. Some reviews of existing chemicals have been made, but the number banned or severely limited have been few.
Chemical control in Europe
Prior to REACH, the European system was similar in that they established an Inventory of existing chemicals (called EINECS, with an addendum called ELINCS) and a premarket review for new chemicals. But Europe required a large "base set" of actual data to be provided in support of new chemicals. This put a disproportionate burden on companies doing business in Europe over those in the US. Under REACH, there are expanded data requirements not only for new chemicals, but existing chemicals as well. Companies must "register" their chemicals (new and existing) by certain deadlines approximately 3, 6 and 11 years into the future depending on the production volume of the chemical. More risky chemicals and higher production chemicals are to be registered first, with smaller volume and less risky chemicals having less priority. Companies provide dossiers of summaries for each of the health and safety studies that have been conducted or will be conducted to support their chemicals.
One big change under REACH is that if an existing chemical is not adequately supported by being registered within the allotted time frame, it will no longer be allowed to be manufactured or imported into Europe. So, REACH will effectively evaluate all existing Inventory chemicals in Europe.
So which is better?
Many point to REACH as the wave of the future with respect to chemical control around the world. But will it really protect human health and the environment better than TSCA? While every chemical will have to have a dossier of data summaries provided for it to stay on the market, approximately 95% of those dossiers will be filed away for "possible" future review. Keep in mind that we are talking about approximately 30,000 chemicals (and possibly 200,000 registrations, since each manufacturer/importer must register even if it is the same chemical as others are registering). So there simply will not be the resources available to review everything submitted. Instead the new Agency in Helsinki will focus on the 5% or so of chemical dossiers that they deem to be of the highest risk. In practice, this will mean the emphasis will be on the relatively small number of chemicals that already are under scrutiny.
Still, REACH will be a mechanism for collecting into readily reviewable packages all of the current information on every chemical, so if there is some "smoking gun" it might be identified and addressed.
Another interesting facet of REACH is that it actually broadens its domain of acceptable data. In the past they wanted real testing, much of which was animal testing. But REACH specifically discourages unnecessary animal testing. It does this by requiring registrants to "propose" any animal testing they feel is necessary, then wait for several years until the Agency has a chance to review the proposal and agree, or disagree, that testing is in fact necessary. REACH also allows the use of computer modeling and non-animal testing, as well as read-across from similar chemicals, to fulfill data requirements. These are exactly the techniques that EPA has been using for years in the PMN process, so apparently the methods are not so bad after all.
So, the question is....Will REACH better protect human health and the environment better than the current systems in the US and Europe, or is it just another burden on industry without any real gain...or worse, a waste of resources that could better be used elsewhere to more effectively address the few chemicals that are actually dangerous?
What do you think?
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Comments: 27
I think any effort to identify potentially harmful chemicals before they are let lose on the population is good. I hope some good comes from this.
Traditionally Europe has been very precautionary-minded and has banned chemicals that the US and others do not restrict. My honest feeling is that much of the concern is based on fear rather than actual risk. The ramifications for human health and the environment, as well as for business viability, are incredibly important.
Chemical risk is a function of both the inherent hazard (e.g., toxicity) and the exposure (whether the use will bring it into contact with anyone). So very toxic chemicals may not be much risk if there is little or no exposure. On the other hand, chemicals with very low toxicity might have some risk if there is very high exposure. This is the basis of risk assessment.
REACH considers both inherent hazard and exposure in that the registrations must include an analysis of the uses of the chemical. Sometimes chemicals are used as non-isolated intermediates only, i.e., they are formed in a big enclosed vat and exist only briefly as they are reacted again to form something else. Clearly if a chemical only exists in a big enclosed vat it really doesn't matter much how toxic it might be (unless, of course, the vat breaks and the material spills out).
REACH attempts to do this by forcing companies to provide these dossiers of data and analysis of use and exposure. Eventually the information will be put on the internet for anyone with interest to review. However, much of this information will be way too technical for the general populace. Which begs the question of who will be interpreting the data and communicating the information to the public trying to make an informed opinion while shopping for tub and tile cleaners at Wal-Mart?
Have you considered submitting this to the Earth Hour group here on Gather. This is a perfect example of what the group is interested in. And you wrote it so well. Great piece.
However, the "Authorization" portion of REACH will effectively put some of the more hazardous chemicals on a black list of sorts. These are not necessarily more risky (because their use and exposure may be limited), but because they are inherently hazardous they will effectively be ostracized and the market will shy away from them.
We've already seen where Wal-Mart has started a list of chemicals it will not allow in any product it sells. So the formulators of those products have to go back to the manufacturers of the individual targeted ingredients and ask them to come up with a "safer" alternative. So we will begin to see more and more "subsititution" of chemicals with theoretically safer chemicals. REACH explicitly supports this substitution principle.
A big THANK YOU for my sister Elaine for taking over the moderator duties of BEST ORIGINAL PHOTOS, ART AND WRITING and I thank YOU for posting your original work to this group.
Best of luck in you work in Europe!
I don't understand enough about REACH to have an opinion on it.
Larry commented that laws won't make much difference, that whatever makes money will be done regardless of laws. I don't think that's true, do you?
My impression during the short time (4 years) I was an environmental technical writer is that people ARE concerned about following the laws. The reason I had that job was just for that purpose, to ensure that environmental laws were complied with. I wrote reports about the necessary assessments and possible remedial actions to take in order to comply with the laws.
Even if money, not the environment or safety, is the concern, my impression was that's it's more expensive to NOT comply with the laws.
The greater problem is that it is incredibly difficult to prove "safety." Aspirin can kill you if you take too much, as can water. We've gone from measuring very obvious effects (mortality) to very subtle effects (gene markers). But we don't really know if the tiny effects we see at that level simply show exposure or if they mean anything. In most cases they probably don't mean anything since our bodies' biochemictries are constantly adapting and fluctuating to deal with stress, pollen, etc. The trick is to figure out which ones mean something, and with the goalposts constantly moving that's a very difficult thing to do. We've seen way to many cases where one chemical is replaced by a "safer" chemical only to find out that the problem just changed from one thing to another. Very difficult.