The REACH regulation (1906/2006/EC)

The REACH regulation, entered into force in 2007, is the result of a long discussion between the European Legislator and the European chemical industry started since the publication of the White Paper Document in February 2001.
The new regulation represents a real "revolution" about the European policy concerning the chemical safety; the law tries to recover important "gaps" of knowledge concerning the hazards and risk of chemical substances and some lack of knowledge within their supply chain of chemicals manufactured and marketed in Europe.
The main REACH target is to evaluate the risks posed by chemical substances starting with the knowledge of their intrinsic properties (hazards), for human beings (workers exposure, consumers direct exposure or humans via the food chain) and for the environmental compartments (water, air, soils) as for eco-toxicity, bioaccumulation, persistence properties. The REACH regulation therefore emphasizes the Risk evaluation of substances (as such, in preparation or in articles) asking them to be registered and in some cases authorized starting from a basic level of 1 tonnage per year (tpa) per each legal entity (chemical manufacturer or importer).
The complementary CLP regulation (EC/1272/2008) completes such approach taking into consideration the requirements for the classification, labeling and packaging of substances and mixtures and hence giving the rules to communicate such information along the chemical supply chain.
The first operative phase of the REACH application ended on December 2, 2008 with the conclusion of pre-registration period. During such period (started on June 1st, 2008) some chemical substances (essentially those already covered by an EINECS entry) had been communicated by companies to ECHA (European Chemical Agency).
We are now in the SIEFs (Substance Information Exchange Forum) period; all companies within a given SIEF (called potential registrants of the same substance) must share relevant safety information to reach a joint registration of the given substance avoiding testing repetition.
Some like 150 consortia had already been formed as a voluntary action to share data and share all registration costs.
The pre-registered substances (phase-in substances) benefit of three delayed registration periods on the basis of the manufactured/imported tonnage (per year) and on their hazard classification (in some cases):

• 30 November 2010 > di 1000 tpa or CMR or Dangerous for the environment but > 100 tpa
• 30 May 2013 > 100 tpa
• 30 May 2018 > 1 tpa

Very crucial is the registration of substance (some thousands) included in the first deadline (November 30, 2010); this is due to the extended testing program foreseen for such chemicals and in some cases in relation of theirs heavy classification.

In general, after a registration submission, the following phases are expected:

• Completeness check by ECHA
• Evaluation by Member States
• Registration number delivery
• Authorisation process for SVHC = Substance of Very High Concern
• Possible use restrictions