LA CORRETTA APPLICAZIONE DELLE NORMATIVE EUROPEE ED EXTRAEUROPEE PER UNA RAPIDA COMMERCIALIZZAZIONE INTERNAZIONALE DI PRODOTTI CHIMICI. RICERCA DI OTTIMIZZAZIONE DEL PERCORSO

The doctoral thesis is the results of an applied research performed in a chemical company part of a joint research project with the University of Macerata. The research is primarily concerned in an analysis of the main regulations regarding issues related to marketed or manufactured chemicals substances, both in European and non-European Countries. The research mainly concerned an analysis of the most important Regulations regarding issues related to marketed or manufactured chemical substances, both in European and non-European countries. In the first part of the research i have described and analyzed the mainly reference Regulations in Europe. Firstly i have analyzed the Regulation (EC) No. 1907/2006 (REACH), the implementing provisions of which are based on the precautionary principle. Manufacturers, importers and downstream users are required to use or place on the market substances that do not adversely affect environment or human health: the burden of proof on Chemical Safety is delegated to various components part of industry, and not to those of Authority. The aim of the Regulation is to ensure a high level of safety for human health and environment. In general, the companies producing or importing more than a quantitative threshold of 1 tonne of chemical substances per year must register them: if the level of the substances exceeds 10 tonnes, they must produce a chemical safety report. They should also check if the substances are subject to authorization, restriction, or they are present on the “Candidate list” of substances” for authorization, and possibly carrying out the obligations arising therefrom. The subsequent Regulation (EC) 1272/2008 (CLP) concerns on the classification, labeling and packaging of substances and mixtures. It takes inspiration from the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and determines some changes compared to the previous regulations. The classification can be harmonized or determined by registrants, but cannot modify the classes established by the first one. One of the most obvious , even for consumers, are the new warning labels that contain the rhomboid shape borrowed from the GHS pictograms and the numerous indications about the dangers and the precautions to be taken. Regulation (EU) 649/2012 (PIC) has a particular interest for the companies that mainly trade with non-Europen buyers. It follows the implementation of the Rotterdam Convention (2004), and determines that the labelling and packaging procedures of all exported chemicals must follow the dictates of the European regulations, consequently producing a costly effort for the companies. In the definition of chemicals also it includes the chemical category of mixtures which, in practice, must be labeled if exported, and have an SDS in the same manner intended for the Community market. for the substances listed in the Annexes of the Regulation one needs to make the notification for export or the request of “explicit consent”. In the subsequent section of the thesis some of the roles that can be taken in context of the REACH Regulation have been analyzed. In particular, i have focalized my attention on the rules downstream user, distributor and producer of articles, covered by the company in which it was made part of the doctoral work. Particular interest was directed to the consequently obligations arising from these rules. A specific part of the research was devoted to analyze some regulations of no-European highly commercial nations that have directives with many points of contact with the European ones: the relevant Chinese regulations, such as CHINA REACH and CHINA GHS; similar directives adopted by South Korea, such as K-REACH and KOREA GHS. The “poison centers” (CAV), structures that are extremely important for managing risks of public health, they are involved in the management of emergencies of different type, and for this reason they have comprehensive and reliable database that allows an immediate evaluation of the materials or products when consumers or workers have been exposed for occupational or accidental reasons to dangerous chemicals. There is an ongoing European harmonization of about CAV, but actually each countries independently manages own poison center, and the information about dangerous chemical preparations. In the present work, besides the Italian situation, i have analyzed the situations of some European countries regulations, such as France, Germany and Great Britain. In fact, under the Article 45 of the CLP, importers and downstream users are obliged to inform the each state authority of the necessary information to prevent or manage health emergencies. Finally, in addition to some special applicative situations faced during the period of stage, i have studied the main methods of calculation of used in the exposure assessment. These methods are very important because they allow the production of exposure estimates that are used in building exposure scenarios and risk characterization necessaries for the chemical safety assessment. The methods use mathematical algorithms, and are divided in different levels of accuracy. Their aim is to make reliable assessments when data are not available from real measurements, which are often very onerous for companies and fail to cover the many identified uses. The thesis work has been an applied research executed in a chemical industry, but it is important to underline that for the companies that provides chemical products and markets with non-European markets is crucial a deep knowledge of the legal regulation. A product complies with multiple legal regulatory aspects, they not only avoid disciplinary situations, but allow that the marketing of those products cannot be slowed down or hampered by various non-compliance or failure to update. The rules undergo frequent adjustments consequent to the technical progress, and also the company must always keep up because subjected at frequent check deadline. The algorithms used in the exposition models are particularly important for downstream users. They can be used to perform any “scaling” operations, but it will became more important whether for every mixtures the exposure scenarios will be obligatory required: today the regulation allows to use the exposure scenarios of the single dangerous substances contained in the mixtures. The importance of the exposure scenarios of all type of components will became more important in 2017: in fact, in accordance to the "REACH-EN-FORCE-5" the competent authorities shall specifically take care of these aspects.