REACH Activities in progress in ITALY UNICHIM - Milano Registration, Evaluation, Authorisation and restriction of CHemicals Activities in progress in ITALY Luciano Cavalli UNICHIM - Milano V International Conference Technical Regulations and Standards Experience of Russia and Italy 18 - 19 November 2009, UNI, v. Sannio 2, Milano

Old EU legislation on chemicals Before REACH Problems Several different Directives and Regulations Different rules for “existent” and “new” chemicals “Existent” chemicals before 1981: >100000 (ca. 30000 at >1 t/y) registered as EINECS “New” chemicals (>1 t/y) after 1981: ca. 4000 (ca. 3% of total chemicals on the market) Risk Assesment (RA): “comprehensive”, too slow RA responsability allocated to Public Authorities RA process completed for only ca. 50 of ca. 140 identified priority chemicals Information on chemicals only from Producers/Importers (not from Downstream Users)

New EU legislation on chemicals: REACH Regulation (CE) 1907/2006 (18.12.06 ad modified on 29.05.07) Objectives Improve the protection of human health and the environment from the risks that can be posed by chemicals Enhance the competitiveness of the EU chemicals Industry, a key sector for the economy of thr EU Promote alternative methods for the assessment of hazards of substances Ensure the free circulation of substances on the internal market of the European Union

Key elements of REACH “Non phase-in” (not marketed before REACH) and “phase-in” (listed in EINECS) substances Registration to ECHA (EU central Agency in Helsinki) of ca. 30000 chemicals in 11 years providing with: - technical dossier (>1 t/y) - CSA/CSR report (>10 t/y) - “targeted” RA t>10 t/y) Registration: responsability to Producers/Importers; Downstream Users brought into the system for the uses Evaluation: allocated to ECHA with the help national competent Authorities Authorisation and Restriction: to substances of very high risks (SVHC), namely CMR, PBT and vPvB chemicals

REACH Processes Scope. Which substances? Substance identification: fundament of REACH Pre-Registration SIEF (Substance Information Exchange Forum) formation. Aim of SIEF: to exchange data; to agree on C&L; to prepare for joint submission Joint submission of registration One SIEF ↔ One substance ↔ One registration Evaluation Authorisation and Restriction Classification and labelling inventory Communication in the supply chain

Timing of REACH EU Central Agency ECHA Pre-registration for chemicals 1 June 2007 Introduction 1 June 2008 application 1 December 2008 30 november 2010 EU Central Agency ECHA for chemicals Pre-registration Registration of: ≥1 t/y: CMR (cat. 1 and 2) ≥100 t/y: R50/53, substances highly toxic to aquatic organisms ≥1000 t/y 31 May 2013 31 May 2018 100-1000 t/y 1-100 t/y New substances

Present situation of the REACH processes (early November 2009) Pre-Registration: ca. 2.750.000 (EU); ca. 118.000 (Italy) Pre-registered substances: ca. 146.000 Substances already registered: 156 Substances estimated to be registered at the end of 2010: 9.000 SIEF with LR (Lead Registrant): 1974

Main Organisms in ITALY involved in REACH activities Centro REACH (Federchimica - Milano) Società Chimica Italiana (SCI) UNICHIM (National Standardisation Body for chemistry affiliated to UNI) Universities (Milano, Pavia, Genova, Padova…) Competent Authorities (Istituto Superiore della Sanità - ISS; Ministero del lavoro, della salute e delle politiche sociali; Ministero dell’ambiente)

Centro REACH S.R.L. (www.centroreach.it) Established in February 2007 by Federchimica and Assolombarda Members: 11 Institutions as the representatives of the national productive sectors Linked to: ECHA, EU Commission, national Competent Authorities,….. Activities on: Consulence Formation (3 general Conference and 12 different strategic courses hold so far) SIEF and consortia formation Projects of R&D Information of Events and News

Centro REACH S.R.L. (www.centroreach.it) Recent event: the 3° REACH Conference (Milano, 29 October, 2009) “Application of REACH: problems, experiences of enterprises and the obligations of the Competent Authorities”

Società Chimica Italiana (SCI) www.soc.chim.it/ WG SCI-REACH established in 2008 Development of the Report (October 2009) entitled: “Innovative Chemistry in support of REACH” Content: - REACH-oriented innovative methods - Tools and methodological approaches – Exsperimental works of national laboratories on REACH-oriented methods

UNICHIM (www.unichim.it) WG “Activity for REACH” (established in february 2008) Mission: National interface with the EU Standardisation Body (CEN) for any activity to sustain REACH processes Collection and harmonisation of standards to be used under the scope of REACH Promotion and use of calculation models (EUSES and ECETOC TRA) to develop exposure scenarios of chemicals and to estimate their risks 4. Formation in collaboration with Centro REACH

UNICHIM (www.unichim.it) Activities carried out: Pubblication of the Report No. 204 “Physico-chemical Methods – Guide to the choice of national and international standards to be used under the scope of REACH” Two courses in collaboration with Centro REACH - “Dossier of registration – The physico-chemical parameters” - “How to prepare a chemical safety assessment and report (CSA/CSR) – Workplace exposure scenarios by EUSES and ECETOC TRA”

Detailed and updated information on the REACH process at any stage http://echa.europa.eu http://ecb.jrc.it/REACH/ www.centroreach.it

Thanks for your attention