New chemicals inventory suggests German, UK lead in innovation

The UK is running behind only Germany in the number of new chemicals notified to the authorities under EC legislation, according to the latest Community inventory of notified new substances.1 Confidentiality rules have been invoked to keep secret the chemical identity of more than half of the notified substances - and a new EC Recommendation has paved the way for similar confidentiality provisions to be applied to the dangerous constituents of preparations.

The inventory, known as Elincs, lists the substances notified to national authorities under the 1979 EC "Sixth Amendment" Directive between 18 September 1981 and 30 June 1991. The Directive provides that new substances which were not on the EC market before 18 September 1981 must be subjected to safety and other tests and the findings submitted to the authorities at least 45 days before they are placed on the market.

Elincs is a key reference source for chemical manufacturers and importers together with its companion volume, Einecs, which lists some 100,000 "existing" substances - those on the Community market before 18 September 1981. Any substance placed on the market after 15 August 1991 which does not appear either in Einecs or the latest edition of Elincs must be notified to the authorities.

Elincs also provides useful insights into the development of new chemicals across the Community. The first edition revealed that just over 400 new substances had been notified under the Sixth Amendment to 30 June 1990. The second shows that the total had risen steeply to 592 by 30 June 1991.

The Directive provides that a new substance must be notified even if it has been previously notified by another company. In practice, this has meant that as many as 50 repeat notifications have been made in respect of a single new substance, although in general the number is in single figures. However, in order to minimise unnecessary tests, the Directive permits second and subsequent notifiers to use the results of tests carried out by the first notifier if they can obtain his permission.

Germany easily holds the lead in both first and repeat notifications. A total of 209 first notifications had been received by the German authorities to mid-1991, while both first and repeat notifications submitted in Germany totalled 352. The UK was second, with 145 and 288 first and total notifications, respectively. First notifications totalled 85 in France, 75 in the Netherlands and 25 in Italy, with the other seven Member States sharing the remaining 53 between them.

Although these figures suggest that chemical innovation is running most strongly in Germany and the UK, they need to be interpreted with caution, since multinational companies may choose to notify a new substance in a Member State which they believe will give them an easier ride when considering whether to order additional tests or institute any control measures.

The Directive provides that the full chemical identity of a notified substance need not be disclosed if this would prejudice commercial confidentiality, and Elincs suggests that this safeguard has been invoked for 364 of the 592 notified substances.

Similar confidentiality provisions were built into the 1990 Directive on dangerous preparations, but initial experience in operating this legislation has pinpointed the need to clarify how these should be applied. This issue is addressed in a new Communication from the European Commission drawn up in collaboration with the Member States and the European chemical industry federation, CEFIC.2The Recommendation is in two parts. The first spells out the information which should be submitted to the authorities in a declaration claiming confidentiality for the constituents of a dangerous preparation. This includes the full chemical names of the constituents concerned, together with an "alternative designation", which must be sufficiently informative when used on a label to "ensure risk-free handling."

Provision is made for one declaration of confidentiality to cover a number of preparations where these contain the same dangerous constituents in the same concentration range, and have the same classification, labelling and intended uses. A justification for confidentiality must also be made with the declaration.

Secondly, the Recommendation provides guidelines for selecting an "alternative designation." In general, this will involve placing a constituent in a family or sub-family of chemicals on the basis of the presence of either a chemical element or a functional group within a substance.

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