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REACH: a new chemicals testing regime.

On December 13, the European Council voted to adopt the second reading of the European Union's contentious REACH (regulation, evaluation, and authorization of chemicals) regulation, setting the stage for its adoption by the European Council later this month and its enactment in June 2007.

REACH is one of the most comprehensive and ambitious laws to regulate chemicals as it shifts the burden of proof of substance safety to manufacturers and seeks to ascertain the safety of the approximately 30,000 chemicals already on the market in the EU in quantities over one ton. Scheduled to take full effect in 2018, the legislation will impact chemical producers worldwide as well as downstream users of chemicals.

It will also affect analytical testing laboratories. Every new chemical sold in the EU after June 1, 2008, and all chemicals on the market before 1981, must be registered with the European Chemical Agency (ECA). Headquartered in Helsinki, Finland, and scheduled to begin operations in June 2008, the ECA will manage the administration, including technical and scientific requirements, of REACH. Depending on the volume of the chemical to be produced, physico-chemical tests, as well as toxicological and eco-toxicological data could be required as part of the registration process.

However, as stated in the legislation itself, REACH aims to reduce testing requirements. Existing data from credible sources will be accepted for registration and evaluation, and the ECA can grant waivers of testing requirements, for example, based on how the substance will be used. In order to reduce animal testing, companies are required to share data from studies on vertebrate animals and data from other tests must be shared on request. Also, companies are encouraged to form consortia to submit information and to use in vitro testing to replace in vivo tests in order to reduce animal testing.

In addition, testing is also expected to be reduced by utilizing alternative techniques such as (Q)SAR (quantitative structure activity relationship) modeling and "read across." (Q)SAR methods use software to analyze the chemical structure of substances to determine molecular properties. "Read across" approaches employ information about one chemical to determine the properties of a similar chemical.

REACH will require the registration of all substances manufactured or imported in quantities exceeding one ton. Some substances, such as polymers and substances regulated by other legislation, such as biocides and pharmaceuticals, are exempt. For substances produced in quantities of one ton or more, a technical dossier containing information on the substance's properties, uses, classification and guidance for safe use will be required. For substances produced in quantities of ten tons or more per year, a chemical safety report (CSR) will be required. The CSR contains information on the substance's hazards, classification and safety assessment.

Substances classified as CMRs (carcinogens, mutagens, toxic to reproduction) categories 1 or 2, PBTs (persistent, bioaccumulative or toxic) or vPvBs (very persistent, very bioaccumulative), or identified as having serious effects on humans or the environmental equivalent, will require authorization. The authorization process includes the decision on the substance's permitted uses. In its application for authorization, the manufacturer must show that the substance's risk is adequately controlled or that the socio-economic benefits outweigh the risks and that there are no suitable alternatives.

REACH is estimated to impact 30,000 existing substances at a cost of 2.8 [euro]-5.2 billion [euro] ($3.1-$5.9 billion), including direct costs of 2.3 billion [euro] ($2.6 billion), to the chemicals industry in its first 11 years, according to a 2003 assessment by the European Commission. This estimate includes testing costs of 1,250 million [euro] ($1,420 million). Several studies have disputed these numbers. A 2004 study by researchers at Tufts University put the total cost of REACH at 3.4 billion [euro] ($3.9 billion) over 11 years, including testing costs of 3,003 million [euro] ($3,412 million), assuming that alternative testing approaches replace around 30% of animal tests in each of the four volume categories.

Effects on testing volumes will be mixed, according to those experts with which IBO spoke. For Intertek Caleb Brett, a provider of laboratory testing and outsourcing services that offers physico-chemical testing services in connection with REACH, REACH will clearly impact business, according to Dr. Julian Cherryman, project manager. "From the analytical side of Intertek's business, we are expecting most of the testing related to new substances and on substances where not enough data is available. Intertek is already doing this type of testing, but we expect certainly more testing as this is a requirement under REACH," he told IBO. Currently, he said, "We're getting lots of inquiries, mainly to get understanding at this stage." He added, "We're seeing these inquiries both from companies that are manufacturing, but also from the whole supply chain using chemicals, such as product manufacturers." For example, he noted, "If you take a large manufacturer, for example a car manufacturer, it will have chemicals in a vast array of their stocks, and they need to actually start understanding what chemicals they've got and what they're using them for."

And while Dr. Cherryman does not expect demand for REACH testing to jump immediately, it could build. "It is unclear if companies wish to generate data to benefit from the pre-registration, but my honest guess is that in 2007 we will see a start of the S-curve in testing because REACH has passed all the way through the European Parliament," he explained. And, he surmised, the majority of REACH physico-chemical testing will be for chemicals currently on the market, not new chemicals. "The estimates are that about 250 new substances [will be introduced] as new chemicals per year, so that's 1% of the 30,000 existing substances." However, testing for new chemicals may initially be higher. "There may be some minor blips in the number of new substances coming through. There have been a few suggestions, which are not all confirmed, but I can believe that some companies are holding back on registering things until REACH comes in," he noted. "New chemicals are 5% of the total costs and workload of REACH over the 11-year period."

Although data are available for substances on the market (so-called "phase-in" substances), testing will be required to fill in data gaps. "We are also expecting physico-chemical testing with the higher volume phase-in substances when datasets are unavailable or incomplete," Dr. Cherryman told IBO. "So, in fact, you might imagine that testing volumes will be building to peak, possibly, in 2015 or slightly earlier, when people will need to register the 20,000 phase-in substances with low volumes. Each of these chemicals will need to have their basic set of measurements, e.g., log P, solubility, and that's probably where there will be gaps in current data," he explained.

Demand could also be generated for method development for physico-chemical tests. "One area where Intertek is extremely well placed, because it actually services the specialty chemicals and the healthcare sectors, is to deal with quite complex chemicals where there will be continuing demands for analytical method development. We've seen this through the biocides product directive, where for the biocides, they've actually got to show--register a method--to detect biocides at the ppm, if not the ppb level," said Dr. Cherryman. "These services are highly specialized and high-end and, although likely not required in high volumes, there are certain drivers to, for example, identify the chemical itself at low levels and to be able to track where the chemicals go from an exposure risk and environmental fate perspective," he said.

Dr. Cherryman also expects (Q)SAR methods to be used. "The (Q)SAR modeling is something we do through our computational chemistry group. For the physico-chemical side, those (Q)SAR models are fairly well-established through various commercial software companies. The trick is having the skill and knowledge to apply them," he told IBO. "There are working groups that are making recommendations [to the EU for use of (Q)SAR in REACH]. It's likely that, on the physico-chemical side, some of those tests could actually get recommended as acceptable via a (Q)SAR route in the near term."

However, it is toxicological and eco-toxicological testing labs on which REACH is expected to have the biggest impact. "REACH will lead to a reduction in testing requirements for new substances, estimated to be approximately 300 per year, but will lead to increased testing requirements for a very large number of existing chemicals," said Erik Dybing, Ph.D., director of the Division of Environmental Medicine at the National Institute of Public Health in Norway. "The main difference between REACH and the existing chemical registration in the EU is considered to be that, under REACH, only in vitro tests will be required between 1 and 10 tons per year, whereas under the existing chemical registration in EU in vivo tests are required from 0.1 ton per year," he noted. According to a 2003 estimate by the European Commission, development toxicity would account for 30% of testing costs, two-generation reproductive toxicity studies would account for 24% and repeated dose toxicity studies would make up 8%.

"The commitment of manpower, funding and time necessary to fill data gaps is going to impose a significant burden on toxicologists worldwide," said E. Spencer Williams, Ph.D., a health scientist at Chemrisk, a Houston, Texas-based consulting firm. "It is still unclear at this point how much data is available on many of these chemicals, though a review of available data by the European Chemicals Bureau found that the base amount of data is available for less than 15% of the high production volume (HPV) chemicals subject to the regulation, and 21% had no data available at all," he added. However, he noted, additional data may be available in manufacturers' proprietary files. "Additionally, REACH will require an expanded effort in risk assessment," he told IBO, noting that, "In general, risk assessment in the EU has been less quantitative than in the United States."

The development of alternative toxicological and eco-toxicological testing methods will play a crucial role. "New and modified test strategies for the different toxicity endpoints are currently being developed combining (Q)SARs, in vitro tests and in vivo tests," explained Dr. Dybing. "So far there is still a significant lack of validated test methods to meet the intention of reduced animal use for several toxicity endpoints," he said. Recently validated test combining in vitro and in vivo methods, cited by Dr. Dybing include toxicogenomics-based test systems for potential use in regulatory toxicology, a human-skin model for skin corrosivity, and an in vitro micronucleus test that is an alternative to the in vitro chromosome aberration assay for genotoxicity testing.

Among the biggest challenges expected for toxicologists in complying with REACH, according to Dr. Dybing, will be the number of chemicals to be regulated, the increased demand for toxicologists and the development of in vitro tests to replace animal tests. "Although such in vitro tests could well address relevant biological effects, they will have difficulties in taking into account toxicokinetics (uptake, distribution, metabolism and excretion of chemicals). Thus, one other main challenge for toxicologists will be to evaluate test results from new in vitro tests, especially those that involve multiorgan interactions where toxicokinetics may have a profound effect on target organ toxicity." He added, "In addition, it is difficult to see how in vitro tests can replace tests for chronic toxicity with the goal of identifying points of departure for risk characterization and setting safe levels of exposure." He also noted that development of exposure scenarios and the understanding of exposures assessments will be a challenge. "In many cases, exposure assessment may be the weakest part of the risk assessment," he told IBO. However, he noted "Exposure assessments will likely be a central part of the test strategy guiding the evaluation of which tests should be performed on the different compounds."

Dr. Williams noted that other incentives could also drive test development. "In vitro alternatives for toxicological endpoints are in general cheaper and faster than in vivo studies, and so there will be a lot of incentive for industry, testing labs and toxicologists in general to develop more alternative methods," he told IBO. "Other cutting edge technologies might be possibilities for alternative methods, including genomics, proteomics and metabonomics, but these techniques are not yet ready for service in this capacity. None of these techniques is inexpensive, either."
 November 30, 2010

Registration Substances produced > 1,000
Deadline tons/year
 CMRs categories 1 and 2
 substances > 1 ton/year
 Substances very toxic to aquatic
 organisms > 100 tons/year

Estimated number 17 Physico-chemical end-points
of data property 22 Toxicological end-points
end-points 25 Ecotoxicological end-points
required *

 June 2013

Registration Substances 100-1,000 tons/year
Deadline Substances toxic to the aquatic

Estimated number 17 Physico-chemical end-points
of data property 19 Toxicological end-points
end-points 18 Ecotoxicological end-points
required *

 June 2018

Registration Substances 10-100 tons/year
Deadline Substances 1-10 tons/year

Estimated number 10-100 tons/year:
of data property 14 Physico-chemical end-points
end-points 14 Toxicological end-points
required * 7 Ecotoxicological end-point

 1-10 tons/year:
 14 Physico-chemical end-points
 4 Toxicological end-points
 1 Ecotoxicological end-point

* Maximum possible requirements. Source: European Comission, 2003

Estimated % of Phase-In Susbstances
by Registration Category

>1,000 tons/year 8%
100-1,000 tons/year 8%
1-100 tons/year 81%
1-10 tons/year 67%

Source: European Commission, 2006

Note: Table made from pie chart.

Estimated % of Total Testing Cost
of REACH for Phase-In Substances

1-10 tons/year 15%
100-1,000 tons/year 26%
10-100 tons/year 25%
>1,000 tons/year 36%

Source: European Commission, 2003

Note: Table made from pie chart.
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Title Annotation:regulation, evaluation, and authorization of chemicals
Comment:REACH: a new chemicals testing regime.(regulation, evaluation, and authorization of chemicals)
Publication:Instrument Business Outlook
Geographic Code:1USA
Date:Dec 15, 2006
Previous Article:Southeast Asia.
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