Search

In Europe, Directive 2010/63/EU aims to protect animals used for scientific purposes and reduce their use, asking institutions to commit in this direction. At the same time, the REACH regulation (EC 2006/1907) is based on the concept that it is important to develop alternative methods to test the toxicity of chemical substances. The intentions are good, but the results in terms of reducing animal use are limited. Following a publication by the American Environmental Protection Agency (EPA), scientific development has turned towards new horizons with the use of New Approach Methodologies (NAMs), which aim to study the mechanisms of chemical substances primarily using biological material of human origin. Today, the main institutions are all committed to building greater knowledge of these NAMs in order to make them robust and reliable for regulatory use. [ABSTRACT FROM AUTHOR]

The term "alternative methods" is now replaced by the New Approach Methodologies (NAMs). That's because in the past we usually looked for in vitro methods that could provide the same information that was gained through in vivo methods. Today, we aim to completely change the approach with a focus on the real biological mechanisms triggered by exogenous chemical substances through complex integrated systems based on human organoids and reconstructed human tissues. Even though there is consensus in considering NAMs as the future of toxicology, their use in the regulatory context is still difficult. REACH Regulation was the first legislative act to officially include the possibility of using non-conventional approach for risk assessment of chemicals. Annex XI describes how to adapt nonstandard information to comply with the requests of the other REACH annexes that need traditional in vivo tests. In addition, within REACH the definition of skin/eye irritation and skin sensitisation should be performed with in vitro methods first. Beyond this important contribution, REACH remains a regulation demanding many new tests on vertebrate animals. A recent publication demonstrates that until now REACH has requested the use of 4.2 million animals only for the definition of the repeated dose toxicity, reproductive and developmental toxicity, in spite of the acknowledgement of the limits of the in vivo tests that are often not useful to define specific problems caused to human health by chemicals. Therefore, change of the approach in toxicology is of the utmost importance to protect the human health and the environment. [ABSTRACT FROM AUTHOR]

The European Regulation 1907/2006 (REACH - Registration, Evaluation, Authorization and Restriction of Chemicals) obliges manufacture companies and import chemicals to assess the risks arising from their use and to take the necessary measures to manage the risks identified. The Chemical Safety Report provides an accurate assessment of hazards to human health and the environment necessary to prepare an exposure scenario for the "identified uses" of the substance. An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life cycle and how the manufacturer or importer controls, or recommends downstream users to control the 'exposure to humans and the environment. Firms therefore need specific skills. The spectrum of toxicological risk is extremely large, the information required in some cases are very complex and undoubtedly require a thorough knowledge in toxicology and environmental industry. The expertise and experience in toxicology of the occupational physician in this case may become useful in the environmental field as well as another familiar figure of relevant importance is the occupational hygienist who develop exposure scenarios for workers and their duuses experience for the exposure scenarios for the consumer. It provides an obvious involvement of medical toxicologists and occupational hygienists for public tasks of control and inspection of chemical safety reports and, locally, even the accuracy of risk that arise from this. [ABSTRACT FROM AUTHOR]

The article focuses on the impact of regulations that affect the rules on health and safety at work linked to the chemical risk assessment in Italy. It is important to ensure the right training to the workers as the old rules on classification, labeling and packaging of hazardous substances will be abrogated. Moreover, an employer can use the safety data sheet and labeling as tools in exchanging information.

The article discusses a study related to the European Union which adopted regulations (EC) REACH, and (EC) CLP to manage the chemicals. Topics discussed include REACH requires for evaluation and management of risks which are related to the use of chemical substances, CLP provides for the classification, labeling and packagings of dangerous substance, and European downstream regulations including health and safety laws.

Con l'emanazione del Regolamento CE 1907/2006 (REACH) prima e del Regolamento CE 1272/2008 poi il quadro normativo Europeo riguardante le sostanze e le miscele chimiche ha subito dei cambiamenti sostanziali che ricadranno inevitabilmente anche nell'attività di gestione e valutazione del rischio chimico negli ambienti di lavoro. In particolare il regolamento 1272/2008 riguardante i nuovi criteri di classificazione imballaggio ed etichettatura per sostanze e miscele pericolose ha previsto l'adozione del GHS (Globally Harmonized System of classification labelling and packaging of chemicals) e questo comporta una modifica dei limiti sperimentali adottati finora per la definizione della pericolosità delle sostanze, con conseguente modifica di etichettatura: pittogrammi, frasi di rischio (hazard statement) e consigli di prudenza (precautionary statement). Le schede dati di sicurezza (SDS), già modificate con riferimento all'allegato II del REACH, sono state recentemente oggetto di un nuovo regolamento Europeo, il Reg. CE n. 453/2010, che va a sostituire completamente l'allegati II del REACH e modifica in modo evidente le schede proprio per tener conto delle nuove regole di classificazione ed etichettatura delle sostanze e delle miscele. Le tempistiche di attuazione dei diversi regolamenti riguardo la commercializzazione, classificazione ed etichettatura di sostanze e miscele, fanno si che attualmente, e fino al 2018, la situazione sul mercato possa essere talvolta poco chiara (etichettature e classificazioni diverse) e questo richiede la conoscenza di quegli elementi della normativa che consentono di orientarsi nella identificazione del rischio per consentire la sua opportuna gestione, particolarmente in ambiente di lavoro. [ABSTRACT FROM AUTHOR]