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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

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

Ministerial Decree 9th april 2008 occupational diseases for

which compensation is mandatory

Silicosis and Lung cancer in polmunary silicosis

Ministerial Decree 10th June 2014 duty to report a occupational diseases

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Italian legislation

D.P.R. 648/1956

D.M. 14 JANUARY 2008

Polmunar Silicosis

Lung Cancer

FIRST LIST

high probability

SILICE LIBERA CRISTALLINA

Second LIST

low probability

• Sclerodermia

• Arthritis

• LES

Third LIST Possibility

• vasculitis

•Wegener’s Granulomatosis

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Occupational Diseases

2008-2012

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RECOGNITION OF SILICOSIS (PERIOD 1999 – 2003)

YEAR 1999 2000 2001 2002 2003

COMPLAINTS

701

669

576

439

353

DECREASING TREND

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17.252

45.194

19.082

3.449712

65-74 75-79 80-88 89-94 95-99

Compensation for SILICOSIS Annual report INAIL 1999

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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.

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NETWORK ITALIANO SILICE (N.I.S.)

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

NIS Working Groups

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

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Group on Regulations

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Article 33 (REACH) Duty to communicate information on substances in articles

In the case of artificial stones, information under art.33 is not mandatory because silica doesn’t have harmonized

classification under CLP

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.

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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

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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

NIS observation

The provisions of art. 31

and 32 of REACH are not

applied to the article as

requested by REACH

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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).

ECHA Forum 13-practical issues for

enforcement

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.

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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.

Questi numeri non sembrano

tornare con quelli nelle tabelle

successive.. Forse si potrebbe

essere più generici:

….but several notifications of both

quartz and cristobalite as CARC

1A have been submitted to ECHA

CL inventory.

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CRISTOBALITE Self-classification No. of

Notifications

No. of Companies SIEF

(n° of

participants)

STOT RE 1 13 441 5 (353)

STOT RE 2 25 291 7 (273)

CARC 1 A 8 130 5 (126)

CARC 1 A; STOT SE 1

3 29 1 (27)

CARC 1A; STOT RE 1

1 19 1 (19)

CARC 2 1 1

ACUTE TOX 4; CARC 2 4 174 3 (173)

STOT SE 3 1 1

EYE IRRIT 2; STOT SE 3

1 3 1 (3)

Not Classified 24 73 6 (53)

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No. Of Notification

s Overall results

Single result SIEF Totality of SIEFs

Acute Tox 4 3 3

Acute Tox 4 Muta 2 Carc 2 2 52 50 2 52 Acute Tox 4 STOT RE 2 9 185 183 2 178

Acute Tox 4 Eye Irr. 2 Carc 1 A 1 1 Acute Tox 4 STOT RE 1 1 12 11 1 12 Stot RE 1 65 561 53 13 508 Stot RE 2 89 568 60 29 508 Eye Irr. 2 2 2 Eye Irr. 2 Skin Irr. 2 STOT SE 2 Stot RE 2 1 1 Carc 1 A STOT RE 1 4 15 2 2 13 Carc 1 A 4 133 1 3 132

Carc 1 A STOT RE 1 STOTSE 1 11 14 9 2 5 Carc 1 A STOT SE 2 2 5 1 4 Carc 1 A STOT SE 1 2 17 1 16 Carc 1 B 5 14 3 2 11 Carc 2 3 27 2 26 Carc 2 STOT RE 2 1 29 1 29 Carc 2 STOT RE 1 1 1 Not class. 67 501 19 453

Quartz

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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

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Thank you for your

kind attention

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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