1. 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
November 2009, UNI, v. Sannio 2, Milano

2. Old EU legislation on chemicals Before REACH
Problems
Several different Directives and Regulations
Different rules for “existent” and “new” chemicals
“Existent” chemicals before 1981: > (ca at >1 t/y) registered as EINECS
“New” chemicals (>1 t/y) after 1981: ca (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)

3. New EU legislation on chemicals: REACH
Regulation (CE) 1907/2006 ( ad modified on )
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

4. 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 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

5. 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

6. 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
t/y
1-100 t/y
New substances

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

8. 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)

9. 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

10. 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”

11. 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

12. 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

13. 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”

14. Detailed and updated information on the REACH process at any stage

15. Thanks
for your attention