On February 15 2012 EU Regulation 125/2012 was published in the EU Official Journal, which adds eight substances to the authorisation list included in Annex XIV of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.

Once a substance has been included on the Annex XIV list, its placing on the market and use within the European Union is prohibited after a 'sunset date'. If a company wishes to continue using the substance after that date, it must apply for specific authorisation.

The eight substances newly on the list, which are all deemed to be carcinogenic and/or toxic for reproduction, are:

  • diisobutyl phthalate (DIBP);
  • diarsenic trioxide;
  • diarsenic pentaoxide;
  • lead chromate;
  • lead sulfochromate yellow (CI Pigment Yellow 34);
  • lead chromate molybdate sulphate red (CI Pigment Red 104);
  • tris (2- chloroethyl) phosphate (TCEP); and
  • 2,4- dinitrotoluene (2,4-DNT).

Companies wishing to request authorisation have until:

  • August 21 2013 to submit an application for DIBP;
  • February 21 2014 for TCEP and 2,4-DNT; and
  • November 21 2013 for the other five substances.

Without authorisation, DIBP will be banned on February 21 2015, TCEP and 2,4-DNT on August 21 2015 and the other five substances on May 21 2015.

Downstream users (ie, users that make use of the substances in the course of their activities) may use such substances only for uses that have been authorised. Even in such a case, they must obtain the substance from a company that was granted an authorisation for that use and stay within the conditions of that authorisation.

Annex XIV does not, as such, ban articles which already incorporate the substances in the list from being imported into the European Union from third countries. If such a ban arises, it must be laid out in Annex XVII, not Annex XIV, of the REACH Regulation.

On February 10 2012 EU Regulation 109/2012 was published in the Official Journal, adding new substance restrictions to Annex XVII (which will enter into force on June 1 2012). The new restrictions concern, in particular, newly classified entries concerning substances that will be prohibited for sale to the general public. The EU list of chemicals that are restricted in some way – ranging from a full ban on all products placed on the EU market to restrictions on certain types of product – is found in Annex XVII of the REACH Regulation. New EU Regulation 109/2012 amending Annex XVII contains key entries on nickel and borate.

Annex XVII lists chemicals that are carcinogenic, mutagenic or reprotoxic. It needs to be updated to take into account substances that have been newly classified as carcinogenic, mutagenic or reprotoxic. In a February 13 2012 statement on the publication of the amended Annex XVII, the Nickel Institute (representing producers) noted that it includes restrictions for 138 classified nickel substances, preventing their sale for consumer use.

For further information on this topic please contact Reshad Forbes at Van Bael & Bellis by telephone (+32 2 647 73 50), fax (+32 2 640 64 99) or email ([email protected]).