ECHA

Since the late 1970s, the Italian central administration has been devolving the enforcement activities concerning chemical substances and mixtures under Directives 67/548/CE and then the 99/45/CE to the Prevention Departments of the Regional Public Health and to the Environment Protection Agencies Services. However 30 years later, the entry into force of the new REACH Regulation requested a more complex approach to enforcement and its management; a redefinition of the roles and competencies between the central and the local administrations took place in late November 2007 [1]. "To coordinate and harmonise the REACH enforcement in Italy", says Mariano Alessi from the Italian Ministry of Health, "we created a new governing body: the REACH technical committee.

Its organisational structure clearly indicates to what extend REACH is relevant and important to central authorities. Indeed, the committee includes four ministries and other technical taskforces [2] headed by the competent authority: the Ministry of Health. Research institutes also joined the Committee as we needed to set up a national network of laboratories to support the inspection activities: the CSC (National Center for Chemicals) and the Institute for Environmental Protection and Research (ISPRA). Last, but not least, the local operational structure of enforcement represented nineteen regions and two autonomous provinces, which were included in the REACH committee."

Mariano Alessi. Image copyright: Mariano Alessi.

Furthermore, a state-regions framework agreement to manage enforcement at a local level was published in the Italian Official Journal in December 2009, followed in June 2011 by the first National Plan for enforcement to implement REACH ENFORCE-2 by the end of 2011. However, the enforcement activities had already started as Italy had from March 2010 to April 2011, taken part in REACH ENFORCE-1, the first Forum enforcement exercise. Indeed, by September 2010, pending the negotiations for the framework agreement with the regions, the central authorities trained and accredited almost 120 REACH inspectors as well as organising the training of 60 CLP inspectors. Another group of 100 inspectors is actually being trained to achieve the target of 220 accredited inspectors.

"Our inspectors are highly skilled professionals, apart from the fact that they all have a sound scientific background, allow me to say that the competitive advantage of our inspectors is that they are also in charge of a variety of surveillance and inspection activities related to the health and safety in workplaces, solvents, cosmetics, paints, adhesives, plant protection products, detergents and environmental protection as a whole. In this respect, REACH and CLP are just a part of a bigger picture. For this reason, their inspections go beyond the mere checking of the formal aspects of the compliance with the laws. Their surveillance is factual, and for example, they could ask for the reason why a substance or a mixture has been labeled as not hazardous", reports Celsino Govoni, the representative of the regions in the REACH technical committee.

To encourage good practice and raise awareness of REACH and CLP obligations from the industry, the Italian authorities have prioritised a strong communication approach based on a variety of information activities. In some regions, inspectors have organised information days, workshops and meetings. In other cases, companies have been pre-informed by the inspectors themselves on the surveillance activities that would take place. The National Enforcement Plan detailing the target groups and the substances and mixtures that will be under surveillance is a public document available on the internet. Regions have also set up an extensive network of local helpdesks for companies and consumers. "In general, within the framework of the enforcement project REACH-EN-FORCE-1, the Italian companies have responded positively to the inspections but we must highlight the fact that there is still much do to meet REACH safety data sheet requirements and use-related duties", says Govoni.

Celsino Govoni. Image copyright: Celsino Govoni.

The second enforcement project REACH-EN-FORCE-2 only started in October 2011 and is still ongoing. The priority has been given to those SMEs producing items such as paints, surfactants, detergents, varnishes, and more generally CMRs cat.1,2 and substances very toxic for the aquatic environment. Italy is also still working on the launch of a series of substance-specific inspection campaigns on the amount of polycyclic-aromatic hydrocarbons (PAHs) that can be present within extender oils and on the determination of the hexavalent chromium content of cement with the collaboration of the Customs authorities.

For the time being, in the Italian territory, companies are requested to pay a fee of 2 000 euros for each inspection. The fine for the breach of law may vary from 2 000 to 150 000 euros in severe cases and could also include imprisonment of up to 90 days. The chemical sector in Italy - with a turnover of about 53 billion euros in 2010 - represents the third main producer of chemicals in Europe. Almost four thousand companies employ approximately 115 000 people while SMEs account for 41% of the total value of production. Companies are mainly located in the northern regions of Lombardy – the EU region with the highest density of chemical industries [3] - Veneto, Piedmont, Emilia Romagna and Tuscany.

Image of the map: Pre-registrations in Italy by region. Source: ECHA, 2008.

[1] On 22 November 2007, the Italian government issued a Law Decree concerning the activity planning and the use of financial resources referred to in Article 5-bis of Legislative Decree 15 February 2007, No 10, converted into law with amendments 6 April 2007 (L46/07) concerning the obligations provided for in Regulation (EC) No 1907/2006 of the European Parliament and Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

[2] NAS (Anti Sophistication task force), NOE (Operational Ecological task force), ISPESL (Institute for Prevention and Safety at Work), USMAF (Maritime, Air and Border Health departments) and Customs.

[3] Source: Federchimica "The Chemical Industry in Italy", Milano 2011.

Interview by Lisa Locchi