REACH Expands Its Range

Achieving compliance with the European Union’s registration, evaluation and authorization of chemicals (REACH) legislation — whose primary aim is protecting human health and the environment from unwanted consequences of exposure to chemicals — could require €9.5 billion ($13.4 billion) worth of tests on 54 million vertebrate animals over the next 10 years. And this is a best-case scenario.

That’s the startling finding of a paper published in the September issue of ALTEX, Alternatives to Animal Experimentation (Altex 26, 3/09, www.altex.ch/resources/t4_RovidaHartungfinal.pdf ).

The authors are Constanza Rovida, a private consultant based in Varese, Italy, and Thomas Hartung, Doerenkamp-Zbinden Professor and chair for Evidence-based Toxicology and director of the Center for Alternatives to Animal Testing (CAAT) at the Bloomberg School of Public Health, Baltimore, Md.

The two argue that current annual use of approximately 900,000 animals and €600 million ($847 million) to evaluate new chemicals, drugs, pesticides and food additives will swell enormously. They say that this will happen because current estimates for the number of chemicals to be covered by REACH range from 68,000 to 101,000 — which is substantially higher than the earlier estimate of 29,000 chemicals upon which existing figures are based.

Rovida’s and Hartung’s analysis was based on the 68,000 figure, so overall cost and requirement for animals could still be 50% higher than their estimates.
Their results indicate that 90% of projected animal use and 70% of projected cost would come from research into reproductive toxicity testing. This often requires data from two species of test animals and their offspring, although U.S. Environmental Protection Agency regulations don’t include two-species provisions.

“REACH will struggle to meet its implementation deadlines.”

“As a toxicologist, I support the aims of REACH — it is the biggest investment into consumer safety ever,” says Hartung. “However, I am concerned that we have underestimated the scale of the challenge. Investment into developing alternative research methods to meet REACH goals is urgently needed. A revision of test approaches, especially for reproductive toxicity, is essential. There is no alternative to REACH, but there will be no REACH without alternatives.”

Without such an investment into high-throughput methodologies, the authors say that REACH will struggle to meet its implementation deadlines.

They conclude that the challenge will be to do the testing sensibly within REACH’s context while using all information and experience we have — and recognizing that most chemicals have been produced and used safely for many years without extensive testing on animals.

Rovida and Hartung, who mis-define REACH as “registration, evaluation, authorization and restriction of chemicals” in the first sentence of their paper, admit to making a number of assumptions where no hard facts were available. However, they express gratitude for input and critical reviews from various organizations, including DuPont, Shell, Exxon-Mobil, BASF and the German Federal Institute for Risk Assessment.

Ironically, the European Chemical Industry Council (Cefic), Brussels, Belgium, has just welcomed a proposed revision of the Biocidal Products Directive (BPD) 98/8/EC which could itself reduce animal testing.

Biocides are found in preservatives, disinfectants, anti-microbrial soaps and insect control products.

Among proposed revisions are a harmonized fee structure and the introduction of a central agency to manage evaluation of low-risk products and new active substances.

This agency could grant EU-wide product registrations which will reduce administrative burden on member states while harmonizing the evaluation process. This should accelerate low risk products’ time to market, thereby providing industry with an incentive to develop innovative and even safer products to Europeans.

The new regulation would close a loophole, which allowed materials treated with substances that hadn’t been approved in Europe via the BPD to enter the European market from other countries.

“The proposed regulation would require companies to share data and prevent unnecessary animal testing. When linked with an equitable compensation scheme and data protection for those who have invested in conducting such tests to demonstrate product safety, Cefic supports this initiative,” says the organization.

Cefic believes that measures to strengthen regulation enforcement are essential because any delays allow unevaluated or even banned substances and products to remain on the market and potentially present unknown risks to people and the environment, which is totally inconsistent with the legislation’s overall aim.

“A few biocidal active substances may be inherently hazardous. However, the benefits of their use and measures taken to minimize exposure to man and the environment can still enable these substances to be used in biocidal products that address serious threats to public health and hygiene, without compromising human health or the environment. These elements have been recognized in the draft regulation,” concludes the organization.

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Seán Ottewell is Chemical Processing's Editor at Large. You can e-mail him at sottewell@putman.net.