EU OSHA Bilbao 28 January 2015 Italian initiative on artificial stones silica

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1 EU OSHA Bilbao 28 January 2015 Italian initiative on artificial stones silica Ludovica Malaguti Aliberti and Marco Mecchia Center of Chemical Substances - National Institute of Health Italian Worker Compensation Agency CSC Istituto Superiore di Sanità INAIL 1

2 Italian legislation Law n. 455/1943 e T.U. INAIL Silicosis must be a lung fibrosis with or without pulmonary TBC due by inhaled silica crystalline dust, with bronchitis and emphysema and cardiovascular effects and micronodular widespread dissemination in Radiographs Law n. 780/1975 has defined the amount of compensation of silicosis D.P.R. 648/1956 Ministerial Decree 9 th april 2008 occupational diseases for which compensation is mandatory Silicosis and Lung cancer in polmunary silicosis Ministerial Decree 10 th June 2014 duty to report a occupational diseases 2

3 D.M. 14 JANUARY 2008 SILICE LIBERA CRISTALLINA FIRST LIST high probability Second LIST low probability Third LIST Possibility Polmunar Silicosis Lung Cancer Sclerodermia Arthritis LES vasculitis Wegener s Granulomatosis 3

4 4 Occupational Diseases

5 RECOGNITION OF SILICOSIS (PERIOD ) YEAR COMPLAINTS DECREASING TREND 5

6 Compensation for SILICOSIS Annual report INAIL

7 On the occasion of the 3rd International Symposium on Silica, Silicosis, Cancer and other diseases held in S. Margherita Ligure in 2002, a group of professionals working in different Italian institutions have proposed to establish a coordination, called Network Italian Silica (NIS), to deal with the conceptual and practical challenges related to occupational exposure to crystalline silica (evaluated carcinogenic to humans by the IARC in 1997) and the related diseases. In 2003 ISS, ISPESL and INAIL became members of the Network and technical working groups were established. 7

8 NETWORK ITALIANO SILICE (N.I.S.) NIS Working Groups Established in 2002 and composed of : Italian Regions and autonomous provinces Italian Workers Compensation Agency (INAIL + ISPESL) Universities and research centers (Florence and Turin) National Institute of Health (ISS) Regulations Health Surveillance Research Best Practice or guidelines Epidemiology Industrial Hyghiene 8

9 Group on Regulations Compliance with European regulations on chemical substance, mixtures and articles and the italian regulations on safety and health at workplaces Reg. 1907/2006 / CE on registration evaluation, autorizathion and restriction of chemical substances (Reg. REACH) Reg. 1272/2008/CE on classification labeling and packaging of chemical substance and mixture (Reg. CLP) D.lgs. 81/2008 on safety and health at workplaces 9

10 Article 33 (REACH) Duty to communicate information on substances in articles 1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. In the case of artificial stones, information under art.33 is not mandatory because silica doesn t have harmonized classification under CLP 10

11 ARTIFICIAL STONES crystalline silica is the main constituent of new composite materials containing 70-90% or more of free crystalline silica(>%quartz/cristobalite) and 7-8% polyester resin as well as pigments and additives widely used for the production of kitchen countertops, bathrooms, floors and wall cladding, etc. available on the market under a variety of trade names The only information provided by the manufacturers concern environmental certifications BUT Because silica hasn t CLP classification, the manufactures aren t obliged to give hazard information 11

12 NIS observation Occurrence of severe silicosis in workers (occupational exposure during installation/cutting): Italian Peripheral Health Bodies reported cases of serious silicosis of workers exposed to dust released during the cutting of artificial stones articles. Risk Management Measures seems to be not adequate Safety Data Sheets not available Hazard informations not required The provisions of art. 31 and 32 of REACH are not applied to the article as requested by REACH 12

13 ECHA Forum 13-practical issues for enforcement At ECHA Forum 13 plenary meeting (November 2012 ) the Italian representatives brought the case of RCS in artificial stones, also reporting on NIS observation, to the attention of Forum. Subject of issue Duty to communicate information down the supply chain for crystalline silica containing composite materials (artificial stones). With regards to REACH duty to communicate information down the supply chain, Italy would like to ask for Forum advice on the possibility to apply the provisions of REACH Article 32 to crystalline silica containing composite materials which revealed the above serious shortcomings related to occupational exposure control measures. In those case, a technical information sheet should be supplied by article producers, containing, in particular, measures to reduce workers exposure to the notified carcinogen, according to Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work. 13

14 Summarized Elements for consideration of ECHA Forum Artificial stones products are articles according to REACH. They are not designed to release RCS under reasonably foreseeable use, but they can release them not intentionally during their use and lifecycle Professional conditions of use (in particular the act of cutting with consequent release of silica dust) are not covered by the reasonably foreseeable ones, thus registration requirements are not applicable to the above articles. Silica does not have at present a CLH according to CLP but ECHA CL inventory currently contains notifications for quartz, and notifications for cristobalite. REACH Articles 32 and 33 (Duty to communicate hazard informations down the supply chain for substances on their own or in mixtures or in articles for which a safety data sheet is not required) are not applicable. 14

15 Self-classification CRISTOBALITE No. of Notifications No. of Companies SIEF (n of participants) STOT RE (353) STOT RE (273) CARC 1 A (126) CARC 1 A; STOT SE (27) CARC 1A; (19) STOT RE 1 CARC ACUTE TOX 4; CARC (173) STOT SE EYE IRRIT 2; (3) STOT SE 3 Not Classified (53) 15

16 Quartz No. Of Notification s Overall results Acute Tox Single result SIEF Totality of SIEFs Acute Tox 4 Muta 2 Carc Acute Tox 4 STOT RE Acute Tox 4 Eye Irr. 2 Carc 1 A 1 1 Acute Tox 4 STOT RE Stot RE Stot RE Eye Irr Eye Irr. 2 Skin Irr. 2 STOT SE 2 Stot RE Carc 1 A STOT RE Carc 1 A Carc 1 A STOT RE 1 STOTSE Carc 1 A STOT SE Carc 1 A STOT SE Carc 1 B Carc Carc 2 STOT RE Carc 2 STOT RE

17 FORUM-13: discussion& conclusions Discussion at/after Forum-13: The provision of information under Article 32 of the REACH Regulation was seen as an obligation in all cases where the supplier would not have to supply a safety data sheet (SDS) in accordance with Article 31 of the REACH Regulation. As the Carcinogen Directive is under revision an occupational exposure limit would be available soon. The comments expressed that the issue should be tackled by the OSH legislation, in particular the CAD. Forum Conclusion as adopted on 30 May 2013 and included in Manual of conclusions (MoC) The Forum agreed to consider the health issues arising from exposure to respirable crystalline silica released during the cutting of silica containing articles (e.g. tiles) should be examined under the scope of the protection of workers from the risks related to exposure to carcinogens or mutagens at work Directive 2004/37/EC and not under the REACH Regulation 17

18 Now the NIS is publishing the new guidelines which will contain the results of all the working groups and we will happy to share our results with European or Extraeuropean Groups declaring interest on these items Thank you for your kind attention 18