Information gathering for CLP classification.

Regulation 1272/2008 includes provisions for two types of classification: harmonised classification and self-classification. The harmonised classification of substances is decided at Community level and a list of harmonised classifications is included in the Annex VI of the classification, labelling and packaging Regulation (CLP). If a chemical substance is not included in the harmonised classification list it must be self-classified, based on available information, according to the requirements of Annex I of the CLP Regulation. CLP appoints that the harmonised classification will be performed for carcinogenic, mutagenic or toxic to reproduction substances (CMR substances) and for respiratory sensitisers category 1 and for other hazard classes on a case-by-case basis. The first step of classification is the gathering of available and relevant information. This paper presents the procedure for gathering information and to obtain data. The data quality is also discussed.

Exponential growth of new chemicals and evolution of information relevant to risk control.

The number of new chemicals synthesized and marketed increases exponentially. The database CAS REGISTRY at present contains more than 33 million organic and inorganic substances. However, the little information regarding the potential hazard associated with a large amount of chemicals is an old known problem in the European Union and also in the United States. This critical problem may find a solution in the collaboration of the different involved countries and in a planned task setting at international level. Both in the United States (e.g., the "Gore Initiative") and in European Union (the REACH policy) a big effort has been dedicated to this solution, within standardized procedures and an appropriate collaboration.

The ISS National Inventory of Chemical Substances (INSC).

The INSC (Inventario Nazionale delle Sostanze Chimiche), a factual data bank, produced by Istituto Superiore di Sanità (ISS), consists of an electronic tool on chemical information developed for routine and emergency purposes. Historical background, current status and future perspectives of INSC are discussed. The structure and the feature of INSC are briefly examined. Aspects of information retrieval and the criteria for inclusion of data and priority selection are also considered.

The ISS Carcinogens Data Bank (BDC).

The Data Bank on Carcinogens (Banca Dati Cancerogeni, BDC) is a factual data bank, available on the Istituto Superiore di Sanità website, aimed at supporting the risk management decision making of central and local administrators. It can also represent a valuable tool for industry. The available information on carcinogenicity evaluations/classifications produced by European Union and by other institutions (IARC, USEPA, NTP, CCTN) is presented in a concise form accompanied by bibliographic references enabling the users to consult the original sources and, in some cases, to be directly connected to the relevant website. The classifications carried out by each organization in accordance with its own criteria assign the examined agents to specific qualitative categories and do not include quantitative assessment. BDC intends to provide an easy tool for experts, researchers and risk managers dealing with carcinogenic agents.

The ISS Sensitizing Agents Data Bank (BDS).

The Istituto Superiore Sanità has developed a data bank on sensitizing substances (Banca Dati Sensibilizzanti, BDS), available on website (www.iss.it/bdse/), sharing complete, controlled and updated information coming from different sources, such as scientific publications, international agencies and governmental or non governmental organizations. It is worthwhile that the main objective of the BDS is not the classification of sensitizing or potentially sensitizing agents within specific risk classes, but it is essentially to provide concise and non confidential information related to this endpoint. At present, the BDS includes: all the substances officially classified by European Union, (Annex I to Directive 67/548/EEC), some substances listed in I (Directive 67/548/EEC) for endpoints different than "sensitization" but indicated as sensitizers by other relevant institutions, all the substances indicated as sensitizers by relevant agencies or institutions (ACGIH, DFG), some substances indicted as sensitizers by industry and other non-governmental organizations (ETAD and HERA), all the substances regarded as "potentially sensitizing dyes" by the Commission of the European Community for the award of the eco-label to textile products, some substances for which, even in the absence of any categorization by Union, ACGIH or DFG, it is not possible to exclude a sensitizing potential on the basis of reliable documents.

The ISS Reclamation Data Bank.

Since the issue of the first regulations concerning the remediation of contaminated sites, the Istituto Superiore di Sanità, on the basis of specific requests, has drawn up various technical opinions regarding the proposed reference values (quality standards) for soils and underground waters, to be achieved when remediating contaminated sites, for substances for which no standard limit values did not exist at that time. These reference values, widely used throughout the country and accepted and adopted as "remediation aim" values by various territorial bodies responsible for the approval and monitoring of remediation projects, have been collected in a specific reclamation oriented data bank known as the "Banca Dati Bonifiche (BDB)" (Reclamation Data Bank). The BDB contains the related standardized "rationale" for each reference value, in order to serve as a useful reference for the national bodies concerned with the remediation of contaminated sites.

[Management and development of the dangerous preparation archive]. / Gestione e sviluppo dell'Archivio preparati pericolosi.

In the year 2000 an archive of dangerous preparations was created at the National Health Institute (Istituto Superiore di Sanità), following a principle included in the Directive 88/379/EEC on dangerous preparations, subsequently modified by the Directive 1999/45/EC, concerning the creation of a data bank on dangerous preparations in each European country. The information stored in the archive is useful for purposes of health consumer's and workers protection and prevention, and particularly in case of acute poisonings. The archive is fully informatised, therefore the companies can send the information using the web and the authorized Poison Centres can find the information on the archive using the web. In each Member State different procedures are in place to comply with the 1999/45/EC Directive; therefore an international coordination could be useful in order to create an European network of national data-banks on dangerous preparations.

Development of carcinogenicity classifications and evaluations: the case of formaldehyde.

In this paper carcinogenicity classification and evaluations case of formaldehyde made by national and international agencies and organizations (such as European Union, International Agency for Research on Cancer, World Health Organization) both in occupational (such as American Conference of Government Industrial Hygienists, National Institute of Occupational Safety and Health and Occupational Health and Safety Administration) and non occupational environment (such as United States Environmental Protection Agency) are proposed. The differences in the database and consequently in the conclusion are described in a short historical review since formaldehyde was considered for the first time as regard as health effects.