The review programme in the European Union for existing biocidal active substances—outcome of the notification process
Abstract The European Commission Biocidal Products Directive 98/8/EC lays down rules and procedures concerning the placing of biocidal products on the EU market. Based on the Directive, a First Review Regulation was adopted for the review of existing biocidal active substances. These substances had to be either identified or notified (two different processes) to the European Chemicals Bureau (ECB) by 28 March 2002. More than 1000 companies took part in the review programme. In total 953 different existing active substances were identified and 372 different substances were notified. This article presents an analysis of the notified substances regarding the number of notifications per substance, notifiers per substance and per Member State and number of notified substances per product type. The results are compared with data from former statistics.
Application of the Three Rs Principle in the Compilation of “Technical Guidance Document in Support of Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market, Part I, Guidance on Data Requirements for Active Substances and Biocidal Products”
In fulfilment of the aims of the European Union Biocidal Directive (Directive 98/8/EC), Technical Guidance Documents are currently being compiled. Part I of these Technical Guidance Documents covers data requirements for active substances and biocidal products. The Three Rs principle has been applied in certain parts of the toxicity and ecotoxicity testing scheme for pesticides, such as testing for acute oral toxicity, skin and eye irritation, skin sensitisation, and dermal absorption. Further recommendations on how to proceed with regard to the continuing replacement, reduction and refinement of animal experiments in this field of regulatory testing are included for consideration. In this context, besides stressing the necessity to validate and accept further alternatives, emphasis is placed on providing the possibility of waiving unnecessary tests and on the continuous evaluation of whether certain tests are needed at all.
IUCLID: A Database on Chemical Substances Information as a Tool for the EU-Risk-Assessment Program
A database on so-called “Existing Chemicals” is being developed at the European Chemicals Bureau (ECB). The database IUCLID contains all data sets submitted by Industry following Council Regulation (EEC) 793/931 on the “Evaluation and Control of the Risks of Existing Substances”. The Regulation obliges Industry to submit all readily available data on “High Production Volume Chemicals”, using the HEDSET software package, to the ECB. Copies of the database are being used by the European Commission and in the EU-Member States Authorities as the data source for selecting priority substances and for carrying out the risk assessment on them. The outcome of the risk assessment process will be a validated IUCLID data sheet which includes a summary risk assessment report for each priority substance. The multilingual database is available from the ECB, in IUCLID format or as an easy to use CD-ROM version, including the original data submitted by Industry and later the validated data and the risk assessment reports.