The legislation takes the form of a seventh amendment of the 1967 Directive on the classification, packaging and labelling of dangerous substances. Its predecessor, the 1979 "Sixth Amendment", imposed a new duty on chemical manufacturers and importers to carry out specified tests on new substances and to notify the results to the authorities before they were first placed on the market, and it is principally this regime which is modified by the Seventh Amendment.
The main changes in this area are as follows:
The Seventh Amendment makes a number of changes to these arrangements. It provides that a notified substance may be placed on the market only "in the absence of any indication to the contrary" from the authorities no sooner than 60 days after they receive a dossier which conforms to the Directive. Should an authority consider a dossier to be unsatisfactory, the 60-day period will begin only from the time any further information requested is received. The authorities are also required for the first time to inform notifiers within 60 days of receiving notifications whether these have been accepted.
Under the limited announcement arrangements, the full battery of tests required by the Sixth Amendment did not have to be carried out on such chemicals, although the authorities had the discretion to order such tests if they wished. In practice they have tended to impose divergent testing requirements, and it is these which the Seventh Amendment will now harmonise.
A three-tier arrangement will now apply to substances placed on the market. For those so placed in quantities of less than 10 kilos per year per manufacturer, a reduced notification containing the identity of the substance and details such as its composition, proposed uses and recommended handling methods and precautions will suffice.
The second tier will apply to substances in the 10-100 kilo per year range. For these, tests will be required to determine their flash point, flammability, and acute toxicity as determined by an oral or inhalation study.
Thirdly, for substances in the 100-1,000 kilos per year per manufacturer range, a more extensive set of tests to deter-mine physico-chemical properties will be required, together with skin and eye irritation, skin sensitisation and mutagenicity tests. On the ecotoxicological side, a biotic degradation test will be mandatory, and Member States will be able to demand an acute toxicity study on daphnia if they consider it necessary for the purpose of a risk assessment. However, all these requirements are subject to the qualification that an authority may accept that particular tests need not be carried out where they are technically impossible or the information is not scientifically necessary.
Additional testing requirements will be triggered as the quantity of these substances placed on the market increases. For example, for a substance in the 10-100 kilo per year per manufacturer range, the extra tests required in the 100-1,000 kilo tier will have to be carried out either if the 100 kilo per year threshold is exceeded or when the total quantity placed on the market reaches 500 kilos per manufacturer.
A positive "acceptance" procedure will not apply to substances in the 10-100 and 100-1,000 kilos per year ranges. Instead, manufacturers will have to wait for 30 days after their notification is received by the authorities before they can place a substance on the market unless they are asked for further information or otherwise receive an "indication to the contrary."
The Directive also introduces amended provisions for new substances placed on the market for R & D purposes. It is now stipulated that they may be placed with a limited number of registered customers in quantities limited to the purpose of "process-orientated research and development." This is defined as the "further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance", which appears to be a more generous definition than that in the European Commission's original proposal (ENDS Report 181, pp 37-8).
These substances will be exempt from notification provided that the manufacturer informs the authorities of basic information on their identity and the R & D programme and customers concerned. However, the authorities will be able to demand data derived from the tests which are normally required for substances placed on the market in the 10-1,000 kilos per year range. The exemption will run for one year, but may be extended for a further year if the company convinces the authorities that it would be justified.
One of the main changes in this area concerns the previous exemption for substances intended for "research and analysis" purposes. The Sixth Amendment provided that these could be placed on the market for the purpose of determining their properties without specifying a quantitative limit, or placed solely with laboratories at up to one tonne per year per manufacturer.
The Seventh Amendment has replaced these provisions with a single exemption for substances placed on the market at a maximum of 100 kilos per year per manufacturer for the purpose of "scientific research and development." This is defined as "scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development." Record-keeping requirements are laid down for substances covered by this exemption.
The existing exemption for polymers is maintained, but for those subject to notification specific provisions for the contents of the notification dossier are to be laid down at a later date.
The Seventh Amendment also provides for the first time that new substances for exclusive use in a product sector for which EC notification or approval procedures imposing equivalent data submission requirements exist may also be exempted from notification. The Commission is to draw up a list of such legislation by 30 April 1993.
Although a notifier will be entitled to provide in his dossier a preliminary assessment of the risks, based on the EC principles, the legislation imposes for the first time a positive duty on the authorities to carry out a risk assessment. It also provides that the assessment "shall include recommendations on the most appropriate method of testing the substance" - presumably in order to determine whether additional tests are necessary - "and, where appropriate, also include recommendations on measures which will enable the risk for man and the environment in connection with the marketing of the substance to be lessened."
Some national authorities would doubtless claim they do all or most of these things already, but EC legislation has a tendency to push even the best authorities into new territory, and these provisions are likely to be no exception.
Indeed, the Seventh Amendment is likely to be a force for consistency in risk assessment practices by obliging national authorities to submit their risk assessments or summaries thereof to the Commission, which will in turn circulate them to the other Member States. For their part, they will be able to suggest that a particular risk assessment is modified, and in the event of a disagreement the matter will be referred for resolution to a committee of expert national officials.
One important change from the Commission's original proposal will serve to put pressure on companies to agree on sharing of test data. It provides that Member States may introduce legislation obliging notifiers and prospective notifiers based in their territories to share data.
Detailed criteria for determining whether a substance should be classified as "dangerous to the environment" were elaborated in a Directive published last year (ENDS Report 198, pp 39-40), and more will follow.
Separately, the Commission has just published a Directive containing an updated list of substances classified as "dangerous" at Community level, along with packaging and labelling requirements.2