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触及你的钱包: Eric Johnson和Russell Heinen对欧盟化学工业法规运行作出回应

[ 2003-06-16 ] 来源于: 中国化工信息网

    Recently the European Commission (EC) unveiled proposals for its new chemicals policy Reach (registration, evaluation and authorisation of chemicals) that is expected to take effect in 2004. Reach will expand chemicals regulation by an order of magnitude, from currently about 3000 substances to more than 30000 in the coming decade.

    The centerpiece of Reach will be exposure testing on an unprecedented scale, paid for by industry The EC itself estimates this will cost at least (euro)2bn ($2.34bn) and perhaps as much as (euro)6bn over the coming ten years. In general, the costs are fixed and one-off, and the tab could run as high as (euro)1m each for some individual chemicals.

    This article reviews how Reach will work and what it will cost, but it starts with a brief look at the present system.

    EU policy today

    Current European Union (EU) chemicals policy started with a series of directives on 'dangerous substances' and 'dangerous preparations'. In more than two decades, some 2700 chemicals have been registered, about 800 have been evaluated and about 80 of those have been authorised. For those 80, this has meant modifications to the classification and labelling of the substance, to the Safety Data Sheet or to the recommended handling methods and precautions. In some cases, substances have been withdrawn from the market by voluntary agreement with the company that registered the chemical. For 'a number of substances', the EU says that restrictions of marketing and use are 'under discussion'.

    According to the regulators, this is woefully inadequate. EU policy makers contend that all significant chemicals should be assessed for risk and hazard, and usage of each chemical should be regulated in accordance with this assessment. All significant chemicals means about 30000 substances that are not covered under the current system. These account for about 90% of the chemicals on the market.

    Method & responsibility

    The procedure for Reach is similar to that for chemicals under the current chemicals policy. The biggest difference is the number of chemicals to be regulated, up to 30000 from about 3000.

    Under Reach, chemicals produced at volumes greater than 1 t/year must be registered. The registration dossier will be similar to that for new chemicals currently, covering:

    production quantities:

    the properties of the substance including test data on physico--chemical, toxicological and ecotoxicological properties;

    intended uses and estimated human and environmental exposures for these;

    proposals for classification and labelling of the substance;

    a safety data sheet;

    a preliminary risk assessment covering intended uses; and

    proposed risk management measures.

    After review and registration of the 30000 dossiers, the EC estimates that regulators will require 5000 of them to undergo more detailed evaluation (such as risk and hazard assessments). These 5000 will include all chemicals produced at volumes greater than 100 tonnes/year, which will by definition be subject to evaluation, Of the 5000, about 500 are expected to be classified as carcinogenic, mutagenic or reprotoxic (CMR). These 500, plus another 850 chemicals considered to be of very high concern must be authorised for use. The latter include CMRs, persistent, bioaccumulative and toxic substances, and very persistent and bioaccumulative substances.

    In procedural terms, the main differences in Reach to the current system are as follows. An 'accelerated risk management process' is planned for substances that do not trigger authorisation, but still pose unacceptable levels of risk. This is a sort of 'authorisation lite'.

    Uses of chemicals must be registered by downstream consumers. The focus is on so-called unintentional uses, which should have been named 'unintended' uses. Those seen as too risky will by subject to authorisation.

    There is a presumption of danger, as in guilty until proven innocent. Current policy is the reverse, such that chemicals are presumed safe until proven dangerous, and the burden of proof is on the regulators.

    Costs and funding

    According to a study done for the EC that drew heavily on inputs from the European Chemical Industry Council (Cefic), implementing Reach will cost industry between (euro)2.2bn and (euro)6.1bn over the next decade. Most of these will be direct costs, to be spent on generating test results for registration or evaluation.

    The broad range of the cost estimate is due to uncertainty over: the scope of Reach -- how many chemicals must be registered; the extent to which data already exist and new data will need to be generated; and, the extent to which duplicate effort can be avoided. In any case, the cost of (euro)200-600m/year dwarfs industry's outlays for the current system, which is perhaps (euro)30-50m/year.

    On a per-chemical basis, the cost of Reach to industry varies widely (see Figure). In the case of the 1200 chemicals for which all dossier information is available already, the cost of 'less demanding' registration will be (euro)10000-30000 each. Generating base-set data costs about (euro)30000 for a low-volume chemical, but (euro)150 000 for a high-volume chemical. Generating level I data costs more than (euro)400 000 and nearly (euro)700 000 for level II.

    In contrast to those for registration and evaluation, costs of accelerated risk management and authorisation are relatively modest; (euro)70000 for each of the former and (euro)50000-65000 for each of the latter.

    Eric Johnson is with Atlantic Consulting, Switzerland, Atlantic@ecosite.co.uk, and Russell Heinen is with SRI Consulting, US, rheinen@sric.sri.com.

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