Testing Requirements under REACH:
Making Sense of the Proposed Amendments
(Updated on 16 November 2006)
Throughout the legislative process on REACH, several packages of amendments have been advocated and put forward which would make fundamental changes in how the legislation mandates chemical testing. The Risk-based proposals during the European Parliaments first reading, such as the ones advocated respectively by the Insustry and Internal Market Committees were examples of attempts to undermine the basic purpose of REACH. Here, we explain how.
How does testing work under the current system?
- Companies do not have to conduct any safety testing on “existing” chemicals (on the market before 1981). They must do relatively extensive testing of new chemicals .
- Government agencies are responsible for filling in the data gaps on “existing” chemicals.
Under this system, only 70 assessments have been completed since 1994. At this rate, it would take many thousands of years to test all the chemicals that are on the market (30,000 are subject to REACH). Clearly, the current system does not protect people’s health, and there is an urgent need for a different approach.
How does testing work under the original Commission proposal?
REACH requires the same testing system for existing and new chemicals, and prioritises in two ways: by volume and by certain dangerous inherent properties. The highest volume chemicals are tested first, and are subject to the largest number of tests. The reasoning behind chosing such volume-based system is the following:
- People and the environment have a much greater chance of being exposed to chemicals produced in the largest amounts, so it is important to first identify high volume chemicals which are dangerous. Tonnage is already an accepted proxy for exposure in chemicals testing programmes in the USA, the OECD, and the EU.
- Production volumes are easy to measure and legally predictable – making the phasing approach workable for all involved, and especially for industry.
Chemicals that are persistent and bio-accumulative, or that have already been found to cause cancer, mutations, or reproductive hazards, are also prioritized in REACH.
A Risk-based approach: Back to Square One
Risk-based approaches prioritise chemicals based on risk, instead of volume or inherent hazard. Risk-based prioritisation may sound like a reasonable idea – testing where it’s really needed. But this ‘puts the cart before the horse’ because the Agency has to make decisions about further chemical testing based on the information that would result from all of the testing.
What is the Difference between Hazard and Risk?
The term hazard refers to the inherent dangers of a chemical. For example, if a chemical is known to cause mutations in human cells, that is a hazard of the chemical. Risk is a function of both hazard and exposure. For example, if a chemical causes mutations in human cells but it is only found on the moon, then on earth the risk is zero. Chemical testing gathers information about hazards. Exposure data, however, is problematic. (See below)
To assess the risks of a chemical, we need both hazard and exposure data. The many risk-based packages minimise basic safety tests – the hazard information – and increase reliance on very crude ‘exposure’ data. But this will not help us to properly assess the risks, because
- Exposure data are often available for only a small subset of uses of a chemical, or may not be available at all.
- Exposure data is much harder to obtain than hazard data, because it varies so much according to the individual situation: use, time, and place.
- Exposure data generally relies on the information that individual companies provide, and cannot be verified easily .
- Exposure data is of limited use because accidents can always happen, and exposures are almost impossible to control, especially for chemicals in consumer products.
- Scientists do not yet have widely-accepted systems to agree about exposure measurement because it is far less transparent and thus subject to argument.
Without sufficient information on hazard, you cannot tell which chemicals are the most dangerous, regardless of what you know about exposure – even despite all the problems mentioned above.
The consequences of risk-based prioritization are:
- a lack of basic safety information on chemicals used every day in industry and consumer products
- potentially endless argumentation about which chemicals are high-risk
- a Chemicals Agency completely overwhelmed with work and without resources to do it
- a return to the status quo: excessively slow government-led risk assessment
Conclusion
REACH needs a sound testing system in order to be able to identify the most dangerous chemicals. Such a system must have a mandatory set of basic health and safety tests to ensure that this identification can take place in a workable fashion.
Downloads
Download the REACH text (pdf, 1,7 MB)
Facts and controversial issues 2006 (ppt, 1,26MB)
Report:
Implications of
REACH for developing countries
(pdf, 1MB)
Les implications de REACH pour
les pays en développement
(pdf, 1,4MB)