SECTION I
THE CLP REGULATION

Preface

The Globally Harmonized Classification and Labelling System (GHS) developed at United Nation level provides a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level and represents an important factor also to facilitate trade. The new classification, labelling and packaging (CLP) Regulation 1272/2008/EC, entered into force on 20 January 2009, implements in the European Union the system of GHS.

The purpose of CLP Regulation is to ensure a high level of protection of human health and environment as the free movement of substances, mixtures and certain articles. The CLP Regulation will progressively replace and repeal the existing European system in 2015, particularly the Council Directive 67/548/EEC of 27 June 1967 on dangerous substances (DSD) and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 on dangerous preparations (DPD).

The contemporary implementation of both Regulations represents a challenge for industry and of course for the Competent Authority too, as it is a revolution in the regulatory frame for the management of chemical products all over Europe.

This section of Annali dell'Istituto Superiore di Sanità will present the main aspects and also some specific issues introduced by the CLP Regulation. The first article is an introduction presenting origin, scope and evolution of CLP Regulation. The second article covers gathering information which represents the first step of classification process when particular attention has to be paid to obtain the information. Another paper reviews the role of the European Chemicals Agency (ECHA) that, founded in 2007, manages the EU REACH Regulation and the new CLP Regulation. An article is dedicated to the application of CLP to nanomaterials, important challenge in the future. CLP is deeply linked with transport in GHS system and therefore an article discusses the relationship among CLP Regulation and transport regulations of dangerous goods. Two papers give an in depth discussion of application of CLP Regulation in Ireland and in Italy. The CLP Regulation requires Member States to establish a national helpdesk to assist the enterprises involved. The ISS Italian CLP helpdesk is settled at the Istituto Superiore di Sanità and the last article describes its way of functioning and also reports some analysis of the number and typology of inquiries received during the last year of activity.

Thanks to Roberto Binetti, former director of the National Center for Chemical Substances, who contributed from the beginning to the development of both REACH and CLP Regulations at European level. He also gave his valuable support to their implementation in Italy through many activities in the field of chemical substances. This monograph benefited greatly from the experience and know-how he transmitted to some of the authors.

Rosa Draisci

Centro Nazionale Sostanze Chimiche,
Istituto Superiore di Sanità, Rome, Italy