REGOLAMENTO (CE) N. 1907/2006 DEL PARLAMENTO EUROPEO E DEL CONSIGLIO 18th of December 2006 as featured in the Gazzetta Ufficiale dell’Unione Europea L.136/3 of the 29/5/2007
The aim of the regulation is to launch a unique system of registration and evaluation of some 30,000 “existing” (ie those introduced on the market before September 1981) and “new” (since September 1981) chemicals, in order to ensure a higher level of protection of human health and the environment. With the new system, the producer and importer of a substance from countries outside the EU – on its own or as part of a formulation – in amounts equal to or greater than one tonne per year is required to “register” at the European Chemicals Agency.
REQUIREMENTS FOR PRODUCERS
All chemical manufacturers will have to prepare for recording a technical dossier, which specify information on intrinsic properties – physico-chemical, toxicological and ecotoxicological – and the uses of the aforementioned substances. It ‘also required the preparation of a report on Chemical Safety, which shows the risk assessment of substances.
The Agency is responsible for the evaluation of the technical files and the competent authorities of the Member States, under the coordination of the Agency, will provide assessment of substances, with the right to request additional information than those reported in the technical file.
Substances with particular properties dangerous to human health – the CMR (carcinogenic, mutagenic or toxic for reproduction) of categories 1 and 2 – or to the environment – the PBT (persistent, bioaccumulative, toxic) and vPvB (very persistent and bioaccumulative) – as well as other substances of “similar concern”, such as endocrine modulators, will be subject to an authorization system.
This procedure requires that, according to each specific use, production and import of such substances has to be authorized in advance.
REQUIREMENTS FOR USERS
Not only producers, but also downstream users of chemicals are involved in the REACH process: the latter in fact have an obligation to “use” substances under the “identified uses” from the supplier and within the “exposure scenarios” communicated by each supplier, ensuring the transmission of exact and complete information on substances and preparations along the supply chain.