REACH entered into force on 1 June 2007. As a Regulation it became directly effective in the Member States. Since it has also been adopted by the European Economic Area (EEA) countries, Iceland, Norway and Liechtenstein, it is effective in these countries as well.
REACH replaced a number of regulations and directives concerning existing substances and the notification of new substances. Core elements of REACH are registration and authorisation. After certain deadlines set by the Regulation, substances, including Petroleum Substances, can no longer be manufactured and/or imported if they have not been registered. 30 November 2010 was the final deadline for the registration of phase-in substances manufactured or imported in quantities of 1.000 t/a or more at least once after 1 June 2007. This deadline also applied to substances that are Carcinogenic, Mutagenic or Reprotoxic, and manufactured or imported in quantities reaching 1 t/a or more as well as to substances which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC that are manufactured or imported in quantities reaching 100 t/a or more. In addition, Carcinogenic, Mutagenic or Reprotoxic substances, are substances that are Persistent, Bioaccumulative and Toxic or very Persistent and very Bioaccumulative.Substances of “equivalent concern” may become subject to an authorisation procedure. However, some of these substances are exempt from the authorisation process; e.g. Petroleum Substances that are used as fuel in fixed or mobile combustion units.
All phase-in substances had to be pre-registered with the European Chemical Agency by 1 December 2008.
For phase-in non-CMR substances manufactured and/or imported in lower quantities the remaining registration deadlines are as follows:
Manufactured and/or imported volume of
- 31 May 2013
- 31 May 2018
Non-phase-in substances need to be registered before they are manufactured or first imported into the EEA. Registrants will need to go through an inquiry process in accordance with Art. 26 of the REACH Regulation. Affected legal entities should also see the guidance on this process that ECHA has made available on its website.
Regulation (EC ) 1272/2008 on Classification, Labelling and Packaging, the so-called CLP Regulation entered into force on 20 January 2009, replacing Directive 67/548/EEC (Dangerous Substances Directive, the “DSD”), Directive 1999/45/EC (Dangerous Preparations Directive), and REACH Title XI (Classification & Labelling). All substances will have to be classified and labelled in accordance with the CLP Regulation by 30 November 2010 irrespective of their production or import volume. Registration Dossiers submitted before the registration deadline of 30 November 2010 will have to include classification in accordance with both the DSD and the CLP. Importers and manufacturers with volumes less than 1,000 t/a need to notify the ECHA of their classification in accordance with the CLP Regulation by 4 January 2011.