126 ANN IST SUPER SANITÀ 2011 | VOL. 47, NO. 2: 126-131 DOI: 10.4415/ANN_11_02_02 The CLP Regulation: origin, scope and evolution 1272/2008 ON I Paola Di Prospero Fanghella and Tiziana Catone T A Centro Nazionale Sostanze Chimiche, Istituto Superiore di Sanità, Rome, Italy EGUL R Summary. The CLP Regulation implements in the EU the UN Globally Harmonised System of Classification and Labelling applying the “building block approach”, that is taking on board the CLP hazard classes and categories which are close to the existing EU system in order to maintain the HE level of protection of human health and environment. This Regulation applies to all substances and T mixtures placed on the market and besides to classification, packaging and labelling it provides for the notification of the classification and labelling of substances to the Classification & Labelling Inventory established by ECHA. It came into force on 20 January 2009 but a transitional period is foreseen until 1 June 2015 for the full application. At the end of this period the “substance” and “preparation” Directives (respectively 67/548/EEC and 99/45/EC) will be repealed. Key words: GHS, CLP, classification and labelling, C&L Inventory, CLP helpdesk, CLP notification. Riassunto (Il Regolamento CLP: origine, scopo ed evoluzione). Il Regolamento CLP traspone nel- l’Unione Europea il sistema armonizzato globale delle Nazioni Unite applicando il criterio del building block approach che consente di adottare alcune classi e categorie di pericolo simili a quelle preesistenti nell’attuale sistema UE per mantenere il livello attuale di protezione della salute umana e dell’ambiente. Questo Regolamento si applica a tutte le sostanze e miscele immesse sul mercato europeo e, oltre alla classificazione, imballaggio ed etichettatura, richiede la notifica della classifica- zione all’Inventario delle Classificazioni dell’ECHA. Il CLP è entrato in vigore il 20 gennaio 2009, ma prevede un periodo di transizione, fino al 1 giugno 2015 per la piena applicazione. Alla fine di tale periodo le Direttive sulle sostanze e sui preparati (67/548/CEE e 99/45/CE) saranno abrogate. Parole chiave: GHS, CLP, classificazione e etichettatura, Inventario C&L, CLP helpdesk, CLP notifica. ORIGIN The United Nations Conference on Environment and The EC Regulation 1278/2008 on classification, Development (UNCED), has adopted on June 1992, labelling and packaging of substances and mixtures, at Rio de Janeiro, Brazil, in the Agenda 21 (Chapter also called CLP [1], establishes a new system on clas- 19) regarding the environmentally sound management sification and labelling of hazardous substances and of toxic chemicals, the need to harmonize the classifi- mixtures by implementing in the EU the Globally cation and labelling of chemicals as one of the six ac- Harmonised Classification and Labelling System tion programmes to be carried on by the year 2000. (GHS) developed by the United Nations Economic The UN Committee of Experts for the Transport and Social Council (UN ECOSOC) [2]. of Dangerous Goods and the Globally Harmonized The purpose of GHS is to define the hazards of chem- System of Classification and Labelling of Chemicals icals connected to the physical, toxicological and ecotox- formally adopted the GHS in December 2002. icological properties of the substances. It is developed in The first edition of the GHS was published in order to apply agreed criteria to classify chemicals based December 2003 and is has been revised every two years on their hazardous effects and to communicate hazard and the most updated version is the third revised edi- information on labels and Safety Data Sheets (SDS). tion which was published on July 2009. The most relevant international organizations in the The GHS document is known informally as The field of classification and labelling of chemicals started purple book and it is made of four parts: an intro- to be involved in the early fifties and the work was com- duction which outlines the scope, the definitions and pleted by technical focal points: the International Labour the hazard communication elements; the classifica- Organization (ILO); the Organization for Economic tion criteria for physical chemical hazards; the clas- Cooperation and Development (OECD); and the sification criteria for health hazards; and the clas- United Nations Economic and Social Council’s Sub- sification of environmental hazards. Committee of Experts on the Transport of Dangerous The process of harmonization started looking for Goods (UNSCETDG). common elements in existing systems/recommenda- Address for correspondence: Paola Di Prospero Fanghella, Centro Nazionale Sostanze Chimiche, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. E-mail: [email protected]. ANNALI_2_2011.indb 126 9-06-2011 14:30:18 CLP REGULATION: ORIGIN, SCOPE AND EVOLUTION 127 tions/legislation in force in different countries and Harmonised classifications of substances are based on international/intergovernmental organizations and Member State proposals or proposals made by manu- four major systems were identified: facturers, importers or downstream users. Mixtures will - the European Union (EU) Directives 67/548/EEC always have to be self-classified. [3] and 99/45/EC [4] for classification an labelling CLP is made of seven titles and seven annexes as 1272/2008 ON respectively of substances and preparations; it is shown below: I T - the requirements of systems in the United States Legal text containing principles and general rules A of America for the workplace, consumers and pes- Title I General issues ticides; Title II Hazard classification EGUL R - the requirements of Canada for the workplace, Title III Hazard communication in the form of consumers and pesticides; labelling CLP - the United Nations Recommendations on the Title IV Packaging transport of dangerous goods. Title V Harmonisation of classification and la- HE The entire system was developed taking into ac- belling of substances and the classifica- T count, among others, some basic agreed principles: tion and labelling inventory - the level of protection of workers, consumers, gen- Title VI Competent authorities and enforcement eral public and the environment was not lowered; Title VII Common and final provisions. - the classification and consequent labelling princi- ples are based on hazards arising from the intrinsic Annexes on technical details properties of chemical substances and mixtures; Annex I Classification and labelling requirements - transitional measures are foreseen in order to imple- for hazardous substances and mixtures ment the globally harmonized new system adopting Annex II Special rules for labelling and packag- the required changes in the existing systems. ing of certain substances and mixtures As a result the aim of GHS is to improve chemical Annex III List of hazard statements, supplemen- safety and health protection giving reliable and com- tal hazard information and supplemen- prehensive information on hazards and protective tal label elements measures to be adopted through labelling and safety Annex IV List of precautionary statements data sheets and also trade in chemicals is expected to Annex V Hazards pictograms be easier. Annex VI Harmonised classification and labelling for certain hazardous substances Annex VII Translation table from classification un- SCOPE der Directive 67/548/EEC to classifica- The CLP Regulation takes on board these principles tion under this Regulation. applying the “building block approach”. According to this principle GHS may be seen as a collection of building blocks, the various hazard classes and cat- FIELD OF APPLICATION egories, from which to form a regulatory approach in This Regulation applies to production and use of the different countries and/or systems. For example chemicals not linked to the quantities which are pro- while physical hazards are relevant in the workplace duced or imported per year. and transport sectors, consumers may not need to CLP applies to all substances and mixtures (includ- know some physical hazard related to different uses ed plant protection product and biocides) placed on the not intended for them. market and to all substances subject to 1907/2008 Regu- The CLP Regulation implements hazard end points lation on the registration, evaluation, authorization that are in the GHS in a consistent way. For instance and restriction of chemicals (REACH), even those not if a substance presents reprotoxic properties the har- placed on the market if they are subject to registration or monized criteria and labelling should be followed. notification under REACH. Additional hazard classes and consequent statements CLP doesn’t apply to the transport of dangerous are provided by CLP (EUHxxx) for the end points goods, but ensures consistency to them, being the crite- which are not covered by GHS, but already existing ria for classification for common end-points the same in the EU Directives on classification and labelling of in the two systems. It applies also to articles containing dangerous substances and preparations. explosive substances which need to be classified and The objective of CLP is to give the criteria to be followed labelled as explosive. to identify and evaluate the properties of substances and The exemptions are: mixtures which lead to a classification as hazardous and - radioactive substances and mixtures; to a proper communication of these hazards. - certain substances and mixtures which are sub- Chemical products have to be classified