SECTION I
THE CLP REGULATION

CLP Regulation and REACH Regulation: links, implementation and control in Italy

Regolamento CLP e Regolamento REACH: collegamenti, attuazione e controllo in Italia

Pietro Pistolese^I; Luigia Scimonelli^II

^IDirezione Generale della Prevenzione Sanitaria, Ministero della Salute, Rome, Italy
^IICentro Nazionale Sostanze Chimiche, Istituto Superiore di Sanità, Rome, Italy

Address for correspondence

SUMMARY

In the last years the European policy for the management of chemicals is deeply changed after entering into force of the European Regulations (EC) no. 1907/2006 and (EC) no. 1272/2008. The implementation of the two Regulations requests a strong effort both from the enterprises and from national and regional institutions. The activities already realised or that are planned for the implementation of one of them could support the implementation of the other one. The crucial point is the creation of the surveillance coordination through a network that involves also the professional figures currently present in the border areas in order to check the compliance with the European legislation of substances on their own, in mixtures or in articles before they are put on European market.

Key words: REACH, CLP, enforcement, substances, implementation.

RIASSUNTO

Negli ultimi anni la politica europea di gestione delle sostanze chimiche è profondamente cambiata con l'entrata in vigore dei Regolamenti europei (CE) no. 1907/2006 e (CE) no. 1272/2008. L'attuazione dei due Regolamenti richiede un grande sforzo sia da parte delle imprese che delle istituzioni nazionali e regionali. In particolare, si sottolinea che alcune attività poste in essere per l'attuazione di uno di essi sono a sostegno anche dell'implementazione dell'altro. Punto cruciale è la realizzazione del coordinamento in materia di vigilanza per mezzo della rete di controlli che coinvolga anche le figure professionali attualmente presenti nell'area di frontiera, al fine di verificare la conformità alle norme europee delle sostanze in quanto tali o contenute in miscele o articoli prima della loro immissione sul mercato europeo.

Parole chiave: REACH, CLP, attuazione, sostanze chimiche, controllo.

INTRODUCTION

In recent years the European politic management of chemicals is deeply changed. From one side the new European Regulation (EC) no. 1907/2006 [1] concerning the registration, the evaluation and the authorisation of chemicals (REACH), has created a new European system of chemical management that has the main target to increase the knowledge of the risks linked to the majority of substances already put on the market. The registration system created by REACH asks the same information both for a substance already on the market at June 2008 (called phase-in substance) and for a new substance at June 2008 (called non-phase-in substance), anyway it is foreseen a transitional period for the registration of phase-in substances. The REACH Regulation introduces an authorisation procedure for the substances of very high concern that are listed in Annex XIV to REACH and it collects in its Annex XVII the restriction measures already foreseen from the previous directive on this matter (Directive 76/769/EEC [2]). On the other side the European Community is committed to contribute to the global harmonisation of the criteria for classification and labelling of substances and mixtures within the United Nations [3]. This commitment has requested a regulatory activity aiming at transferring the new criteria defined at the United Nations level to the European existing system on classification and labelling. The European Regulation (EC) no. 1272/2008 [4] concerning the new criteria of classification, labelling and packaging of substances and mixtures, called CLP Regulation, indicates in the transitional provisions that the new rules are applied to substances from 1 December 2010 and then to mixtures from 1 June 2015.

LINKS BETWEEN THE REACH AND CLP REGULATIONS

There are several links between the REACH and the CLP Regulations because some dispositions under REACH are applied whether or not the substance is classified and how it is classified.

These common points are described below:

On the other way round, in the CLP Regulation there are some mandatory requests based on what it is the substance or mixture status under REACH. Below some examples are reported:

IMPLEMENTATION OF THE REACH AND CLP REGULATIONS IN ITALY

As mentioned above the two REACH and CLP Regulations are linked each other and they both modify the European chemical management policy, therefore both the national activities and the industries actions already realised or planned to be carried out in the future for the implementation of one of them could support the implementation of the other.

The implementation of the two Regulations needs a huge effort from the enterprises because, in particular, the REACH is based on the principle that industry should manufacture, import, use or place on the market substances ensuring that, under reasonably foreseeable conditions, the human health and the environment are not adversely affected. Instead the new CLP criteria of the classification and labelling require the enterprises to update in a short time for example the software used to determinate classification, labelling or to the safety signs on the workplace. In addition the enterprises should respect the provisions of other pieces of legislation linked with the classification criteria and that now can have an impact on some substances or mixtures that before were out of the scope.

On the other hand also the national institutions are called to do a strong effort related to the implementation of the two regulations. Indeed, even if a European Regulation does not need a national application law the Member State has to create specific instruments to assure the implementation of the new European rules, and it has to evaluate whether some economic resources are needed.

The Italian institutions are committed for the REACH implementation since 2007. The instruments that were created to implement the REACH will be useful also for the CLP Regulation. With the law no. 46/2007 [8] the Ministry of Health was designated as Competent Authority (CA) for REACH Regulation instead the legal basis for designation of CLP Competent Authority does not exist yet. The REACH CA cooperates with the Ministry of Environmental and the Ministry of Economic Development and receives the technical support from the National Centre for Chemical Substances (CSC) located within the National Institute of Health in Italy (ISS) and from the National Institute of Environmental Protection and Research (ISPRA). It is important to underline that the CSC was instituted in order to have a national reference point which give scientific support in the framework of REACH implementation. Other than the above mentioned national institutions, also the Regional level supports the REACH implementation. These different administrations are coordinated by a coordination technical committee, formally defined [9, 10]. The Committee meetings are planned at least three time per year and the Committee has 6 working groups:

In order to support activities concerning the inspections the Regions have as focal point a technical groups within inter-regional prevention management (CIP).

Furthermore the Italian Law no. 46/2007 assigned for each year the financial resources to every Ministries and Institutes above mentioned.

Another instrument defined in order to implement the REACH Regulation is the creation of a surveillance network. This network is based on the coordination between the Ministry of Health and the Regions and it is based on the State-Regions Agreement [11]. According to this Agreement every Region or autonomous Province has to implement the Agreement in his legal organisation. At the moment, 13 Regions and 1 autonomous Province have already done this step and they have individuated the "control authority" that will be dedicated to the inspections in his own territory. As interesting element, most of these Regions have underlined that the REACH control authorities it is also the control authorities implementing the CLP Regulation.

A key element of the surveillance network creation is to clarify the involvement of the different border authorities in the REACH implementation.

Another specific instrument necessary to implement the two regulations at national level is an appropriate penalties system which has to ensure transparency, impartiality and consistency of the single Member State enforcement activities, with a view to imposing effective, proportionate and dissuasive penalties for REACH and CLP non-compliances. In Italy the national Decree no. 133/2009 [12] sets up the penalties system for the REACH non-compliances. The Decree establishing the penalties for CLP non-compliances has not been emanated yet, however the legislative process is ongoing.

The penalties for the non-compliance with REACH provisions are both administrative and criminal and this is foreseen also for the CLP penalties system. The maximum level of the REACH sanctions is related to non-compliance with the authorisation and restriction provisions as it is foreseen the prison until three months. Different administrative sanction levels are foreseen in the Decree no. 133/2009 for others REACH non-compliances. Some examples are reported below:

In the context of the adaptation of the previous national legislation on chemicals according to the new REACH provisions, it has been necessary to modify the national Decree no. 52/97 that implemented the Directive (EEC) 67/548. The main change was the deletion of the national notification unit, because the registrations of chemicals are now collected by ECHA. The modification has been done through the Decree no. 145/2008 which also introduced a new element useful for both the REACH and the CLP inspections. This element indicates the need to establish a fee to be applied to the inspected company. This choice has the following justification: in the past the inspections were conducted by the Ministry of Health and the ISS to verify the compliance with the rules of the substances and mixture classification and the labelling and with the notification duty under Directive (EEC) no. 67/548 and the financial coverage was assured by the notification fees. With the entering into force of the REACH Regulation the registration fees are managed by ECHA, thus the future inspections concerning the respect of the CLP and REACH provisions are not foreseen to be financed. The Italian Decree no. 145/2008 introduces the fees application concept on inspections. The fees are now established in a default amount of 2000 €, but a future Ministerial Decree will specify the criteria to apply the fees.

In order to implement the two regulations other activities have been done with the cooperation among the different institutions indicated in the national Decree of the 22 November 2007. Below these activities are briefly described:

The picture drawn above shows the infrastructure created at national level to support REACH implementation. Of course this infrastructure will work also to support the CLP implementation: for example the REACH technical committee of coordination could be the meeting point to discuss the management of the CLP issues and agree possible solutions. However, as anticipated previously, at while the REACH CA has been appointed (Ministry of Health), the CA for CLP has not been designated yet. For the sake of continuity, who managed the old classification and labelling legislation should continue to manage the same matter.

Even in absence of an official appointment, several activities related to CLP implementation have been already carried out in Italy. To give an example, the CLP helpdesk is managed by the CSC and is currently working.

The collection of useful information to support anti-poisoning centres activities set forth in Article 45 of the CLP Regulation is based on dangerous preparation archive created in the 2000 under the Directive 1999/45/EC [15]. Up to now, one million and half notifications on dangerous mixtures and detergents (independently from their classification) have been submitted by about five thousand companies (Figure 1 and Figure 2).

Furthermore the access to the database have been granted to 9 Italian anti-poisoning centres.

The information required for the notification are listed in the Table 1.

This database is going to be revised since the European Commission is working to define on harmonized core set data and a common format that the importers and downstream users will have to use.

A good example of collaboration between different levels that work to ensure safety of products on the market and the respect of the chemical legislation is the Italian activity on methanol.

In the 2007 after an accident occurred to a consumer after skin application of a mixture of unknown composition, the anti-poisoning centre of Milan (Niguarda Ca'Grande Hospital) communicated to the ISS and the Ministry of Health that this dangerous preparation was not in the archive. The effects that the patient showed were after attributed to the methanol action. Taking into consideration that other cases were later identified also by other anti-poisoning centres, that a national law of 1982 prohibits the presence of methanol in detergents, cosmetics and paints, Italy would like to promote a European action on the basis of a socio-economic and a risk management option analyses. Italy has just committed to submit a proposal for a new classification of the methanol as toxic for reproduction (development) Category 1B.

The CSC offers different implementation tools which are present in its website (www.iss.it/cnsc/):

ITALIAN INSPECTION NETWORK FOR REACH AND CLP

The REACH and CLP inspections could be either carried out together or separately, thus the Italian enforcement authorities for REACH and CLP are not necessary the same. In Italy while the controls on classification and labelling of substances and mixtures are a duty of the Regions since 1978 (Law 23 December 1978 no. 833) [16], it was necessary to establish an agreement between State and Regions in order to define the control Authorities for REACH. This agreement indicates that the Regions, as it was for the old legislation on chemicals enforcement, have a main role for REACH inspections.

Different legal steps are needed to define enforcement control authorities for REACH at regional level. At present 13 Regions and 1 Province autonomous have already been appointed it and in most cases this authority is also in charge of CLP controls (Table 2).

It is important the transparency of these appointments in order to make easy the improvement of the coordination promoted from the ECHA Forum with respect to both the other EU Member States enforcement authorities and to the national ones, to the national CA and ultimately to the inspectors.

The Competent Authority (Ministry of Health) has supported Regions with financial resources for the establishment of regional inspectors accesses to the REACH-IT system of ECHA. Furthermore the CA has organized two trainings for trainers who will then in turn train REACH inspectors. After these national events three macro-regional events (north, south, centre of Italy) were held for inspectors, with a financial support of the CA.

To complete the picture, the inspections were also performed at central level, according to the ENFORCE 1 program of ECHA Forum and will continue to be conducted with the participation of the CA. In some of these central inspections regional inspectors can join the inspection team in order to make practical experience. In the future most part of the REACH and CLP inspections will be conducted by the regional authorities.

CONCLUSIONS

In light of the new system of management of chemicals as substance on their own, in mixtures or in articles a huge effort has been done at both institutional level and enterprise level. Industries need to be supported in order to make them aware of the new rules and the upcoming deadlines. It is important to underline that the Italian landscape is populated mainly by medium and small enterprises that more than ever need to be supported by new professional figures, category associations and public institutions in order to be competitive and correctly apply the new chemicals legislation. This is the main reason why the Ministry of Health as Competent Authority collaborates with the Ministry of Instruction in order to encourage training activities at different levels. The introduction within the educational system, starting from secondary school up to post-graduate level, of specific courses will have an important impact on creating new resources for both the enterprises and the public institutions and will help to increase the general knowledge and awareness of the general public on this matter.

The coordination of inspections is a crucial point. The first step is to define clearly all inspection network by individuating in each Region and Province autonomous the local enforcement authority. It is important to define the annual inspections national programme according to the future programmes defined by ECHA Forum and taking into consideration the specific territorial needs.

In addition it is necessary to define procedures to involve the control authorities present at the border areas in order to improve the controls on substances, mixtures and articles before they enter the European market.

Finally it is desirable a strong cooperation and an effective management to make all different actors involved both in the implementation and in the enforcement of the REACH and CLP achieving a good functioning of "Italian system" within the European activity on new policy on chemicals management.

Acknowledgements

The authors thank Antonella D'Angioli for editorial assistance.

Conflict of interest statement

There are no potential conflicts of interest or any financial or personal relationships with other people or organizations that could inappropriately bias conduct and findings of this study.

References

1. European Parliament and Council. Regulation (EC) no. 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) no. 793/93 and Commission Regulation (EC) no. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L 396, 30 December 2006. Available from: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:136:0003:0280:EN:PDF.         

2. European Council. Directive 76/769/EEC of 27 July 1976 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. Official Journal of the European Union L 262, 27 September 1976.         

3. United Nations. Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Third revised edition. New York and Geneva: UN; 2009. Available from: www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html).         

4. European Parliament and Council. Regulation (EC) no. 1272/2008 of 16 December 2008 concerning the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) no. 1907/2006. Official Journal of the European Union L 353, 31 December 2008.         

5. European Commission. Regulation (EU) no. 453/2010 of 20 May 2010 amending Regulation (EC) no. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union L 133, 31 May 2010.         

6. European Council. Directive 67/548/EEC of 27 June 1967 concerning the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Community L 196, 16 August 1967.         

7. European Parliament and Council. Directive 1999/45/EC of 31 May 1999 concerning the approximation of laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Official Journal of the European Community L 200, 30 July 1999.         

8. Italia. Legge 6 aprile 2007 n. 46 Conversione in legge, con modificazioni, del decreto legge 15 febbraio 2007, no. 10, recante disposizioni volte a dare attuazione ad obblighi comunitari ed internazionali. Gazzetta Ufficiale n. 84, 11 aprile 2007.         

9. Italia. Ministero del Lavoro, della Salute e delle Politiche Sociali. Decreto interministeriale 22 novembre 2007. Piano di attivitaà e utilizzo delle risorse finanziarie di cui all'articolo 5 bis del decreto legge 15 febbraio 2007, n. 10, convertito in legge, con modificazioni, dalla legge 6 aprile 2007, n. 46, riguardante gli adempimenti previsti dal Regolamento (CE) n. 1907/2006. Gazzetta Ufficiale n. 12, 15 gennaio 2008.         

10. Italia. Ministero del lavoro, della salute e delle politiche sociali. Decreto Nomina dei componenti del Comitato tecnico di coordinamento di cui all'articolo 7 del decreto interministeriale del 22 novembre 2007. Available from: www.salute.gov.it/imgs/C_17_normativa_1808_allegato.pdf.         

11. Italia. Conferenza permanente per i rapporti tra lo stato, le regioni e le provincie autonome di Trento e Bolzano. Accordo 29 ottobre 2009. Accordo, ai sensi dell'articolo 4 del decreto legislativo 28 agosto 1997, n. 281, tra il Governo, le Regioni e le Provincie Autonome di Trento e Bolzano concernente il sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907 del Parlamento europeo e del Consiglio concernente la registrazione, la valutazione, l'autorizzazione e la restituzione delle sostanze chimiche (REACH). Gazzetta Ufficiale n. 285, 7 dicembre 2009.         

12. Italia. Decreto legislativo 14 Settembre 2009, n. 133. Disciplina sanzionatoria per la violazione delle disposizioni del Regolamento (CE) n. 1907/2006. Gazzetta Ufficiale n. 222, 24 settembre 2009.         

13. Italia. Ministero dello Sviluppo Economico. Decreto ministeriale 13 marzo 2009. Programmi di sviluppo sperimentale riguardanti innovazioni di prodotto e/o di processo volte a sostituire e/o eliminare le sostanze chimiche "estremamente preoccupanti", di cui all'articolo 57 del Regolamento CE 1907/2006 (REACH). Gazzetta Ufficiale n. 82, 8 aprile 2009.         

14. Italia. Ministero dell'Istruzione, dell'Università e della Ricerca. Decreto interministeriale 16 giugno 2010. Approvazione delle linee guida per l'istituzione di un Master universitario di secondo livello in REACH. Gazzetta Ufficiale n. 164, 16 luglio 2010.         

15. Italia. Decreto legislativo 14 marzo 2003, n. 65 Attuazione delle Direttive 1999/45/CE e 2001/60/CE relative alla classificazione, all'imballaggio e all'etichettatura dei preparati pericolosi. Gazzetta Ufficiale n. 87, 14 aprile 2003 (Suppl. Ord. n. 61).         

16. Italia. Legge 23 dicembre 1978, n. 833. Istituzione del Servizio Sanitario Nazionale. Gazzetta Ufficiale n. 360, 28 dicembre 1978 (Suppl. Ord.          ).

17. Italia. Abruzzo. Delibera Giunta Regionale 22 marzo 2010, n. 242. Recepimento Accordo, ai sensi dell'art. 4 del decreto legislativo 28/3/1997 n. 281 tra il Governo, le Regioni e le Province Autonome di Trento e Bolzano concernente il sistema di controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907/2006. Bollettino Ufficiale n. 28, 30 aprile 2010.         

18. Italia. Calabria. Delibera Giunta Regionale 28 gennaio 2010, n. 26. Costituzione Autorità Regionale competente in materia di Controlli e Vigilanza per gli adempimenti previsti dal Regolamento 1907/2006 "Reach" e s.m.i. Bollettino Ufficiale 1 marzo 2010, Parti I e II, n. 4.         

19. Italia. Campania. Delibera Giunta Regionale 23 marzo 2010, n. 372. Recepimento dell'accordo tra lo Stato e le Regioni e le Province autonome di Trento e Bolzano del 29/10/2009 concernente il sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento (CE) n. 1907/2006. Available from: burc.regione.campania.it/.         

20. Italia. Emilia Romagna. Delibera Giunta Regionale 8 febbraio 2010, n. 356. Recepimento dell'Accordo tra il Governo, le Regioni e le Province autonome di Trento e Bolzano recante l'adozione del Sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento (CE) n. 1907/2006. Bollettino Ufficiale 17 marzo 2010 n. 47, parte II.         

21. Italia. Lazio. Delibera Giunta Regionale 1 giugno 2010, n. 272. Recepimento dell'accordo 29 ottobre 2009 tra il Governo le Regioni e le Province Autonome di Trento e Bolzano sul sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907/2006. Bollettino Ufficiale 28 giugno 2010, n. 24, Parti I e II.         

22. Italia. Liguria. Delibera Giunta Regionale 5 marzo 2010, n. 397. Recepimento dell'Accordo tra il Governo, le Regioni e le Province autonome di Trento e Bolzano recante l'adozione del Sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento (CE) n. 1907/2006. Available from: www.bur.liguriainrete.it/.         

23. Italia. Marche. Delibera Giunta Regionale 15 marzo 2010, n. 562. Recepimento dell'accordo 29 ottobre 2009 tra Governo Regioni e Province autonome di Trento e Bolzano sul sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907/2006. Available from: http://213.26.167.158/bur/10/29.2603/deliberazioni_della_ giunta/70.html.         

24. Italia. Piemonte. Delibera Giunta regionale 16 marzo 2010, n. 30-13526. Recepimento dell'Accordo del 29.10.09 tra il Governo, le Regioni e le Province Autonome di Trento e Bolzano sancito in sede di Conferenza Stato-Regioni recante l'adozione del Sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento (CE) n. 1907/06. Bollettino Ufficiale 8 aprile 2010, n. 14.         

25. Italia. Puglia. Delibera Giunta Regionale 15 marzo 2010, n. 729. Istituzione dell'Autorità competente regionale per l'attuazione del Regolamento (CE) n. 1907/2006 (REACH) e della normativa in materia di classificazione, etichettatura ed imballaggio di sostanze e preparati pericolosi. Recepimento dell'Accordo tra Stato, Regioni e Province Autonome del 29 ottobre 2009. Bollettino Ufficiale 7 aprile 2010, n. 61.         

26. Italia. Toscana. Delibera Giunta Regionale 22 marzo 2010, n. 346. Recepimento dell'accordo 29 ottobre 2009 tra Governo Regioni e Province autonome di Trento e Bolzano sul sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907/2006. Available from: www.regione.toscana.it/regione/multimedia/RT/documents/2010/12/21/b0a26966a498638250543127804e9bec_deliberagiuntaregionale3462010.pdf.         

27. Italia. Trento. Delibera Giunta Provinciale 16 aprile 2010, n. 848. Recepimento dell'accordo 29 ottobre 2009 tra Governo Regioni e Province autonome di Trento e Bolzano sul sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907/2006. Available from: www.regione.taa.it/bollettino/default.aspx.         

28. Italia. Umbria. Delibera Giunta Regionale 25 gennaio 2010, n. 80. Recepimento dell'accordo 29 ottobre 2009 tra Governo Regioni e Province autonome di Trento e Bolzano sul sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento CE n. 1907/2006. Available from: www.regione.umbria.it/Mediacenter/FE/CategoriaMedia.aspx?idc=5&user=3,23,24,25.         

29. Italia. Valle d'Aosta. Delibera Giunta Regionale 14 maggio 2010, n. 1298. Recepimento dell'Accordo tra lo Stato e le Regioni e le Province Autonome di Trento e Bolzano del 29/10/2009 concernente il sistema dei controlli ufficiali e relative linee di indirizzo per l'attuazione del Regolamento (CE) n. 1907/2006 del 18/12/2006 (REACH). Individuazione dell'Autorità Competente regionale. Bollettino Ufficiale 15 giugno 2010, n. 25.         

30. Italia. Veneto. Delibera Giunta Regionale 2 marzo 2010, n. 523. Adempimenti regionali per l'attuazione del sistema Reach (Registrazione, Valutazione, Autorizzazione e Restrizione delle sostanze chimiche). Individuazione dell'Autorità regionale competente e degli altri organismi di supporto. Bollettino Ufficiale 30 marzo 2010, Anno XLI, n. 27.         

Address for correspondence:
Luigia Scimonelli
Ministero della Salute, Direzione Generale della Prevenzione Sanitaria, Ufficio IV
Via Giorgio Ribotta 5
00144 Roma, Italy
E-mail: reach2@sanita.it

Submitted on invitation.
Accepted on 12 April 2011.