REACH

REACH

REACH Regulation

REACH Regulation, entered into force on June 1st 2007 in whole Europe, and is the result of a long discussion during the late nineties between European Legislators and the European chemical industry soon after the publication of the White Paper Document in February 2001.

The new regulation represents a real "revolution" about European policy concerning the chemical safety. REACH Regulation tries to recover important "gaps" of knowledge concerning the hazards and risks of chemical substances and some lack of knowledge within their supply chain of chemicals manufactured and marketed in Europe.

REACH’s primary aim 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. REACH regulation emphasizes the Risk evaluation of substances (as such, in preparation or in articles) asking them to be Registered (the so called “Registration dossier”) 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 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).

The pre-registered substances (phase-in substances) benefits 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: > 1000 Tpa or CMR or Dangerous for the environment
  • 30 May 2013: > 100 <1000 Tpa
  • 30 May 2018: > 1 < 100 Tpa

After that phase we have encountered the First Deadline (November 30, 2010) and ss.

Over 260 Consortiums had been created in the First Deadline (November 30, 2010) as a voluntary action to share data and share all registration costs.

We are now in the Second Deadline (May 30, 2013) and deeply involved in “intermediates”.

Very crucial was the registration of substances (in the end 4.071 substances were registered) 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
  • Possible evaluation by Member States
  • Registration number assignment
  • Authorisation process for SVHC = Substance of Very High Concern
  • Possible restrictions

REACH is complemented by the Regulation for Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation, which entered into force on January 20, 2009).

CLP Regulation incorporates the classification criteria and labelling rules agreed at United Nations level for a so-called Globally Harmonised System of Classification and Labelling of Chemicals (GHS). GHS is based on the principle that the same hazards should be described and labelled in the same way all around the world.