HSEP News Bulletin by Gabriele Heller, Senior Manager Product Safety at Marabu and ESMA HSEP Chair.
EU regulation 1907/2006 on Registration, Evaluation and Authorisation of Chemicals (REACH) requires chemical substances placed on the EU market in amounts exceeding 1 t per year to be registered at the European Chemical Agency (ECHA) in Helsinki. Certain substances, like for example substances obtained from natural sources, are exempted from registration.
The regulation entered into force in June 2007. Manufacturers and importers (M/I) of substances in the scope of the regulation, who informed ECHA until December 2008 that they manufacture or import a substance (“pre-registration”), were however allowed to delay their registration until the end of the relevant transition period set out in the regulation. The regulation sets out three transition periods, depending on the amount manufactured or imported. The last transition period, related to substances manufactured or imported in amounts between 1 and 100 t per year and per M/I, is running out on the 1st of June 2018.
Based on the pre-registrations, ECHA expects 15,000-25,000 substances to be registered until that date. The current state, however, is that only 8,230 substances have been registered so far. As substances that haven’t been registered are no longer allowed to be placed on the market after the 1st of June, foreseeably the manufacture or import of many pre-registered substances will be stopped by then, which means that those substances will no longer be available.
Printing inks are manufactured by mixing raw materials. A raw material may be a substance or a mixture of substances. Proceeding from the situation outlined above, ink manufacturers may no longer obtain some of the raw materials they use after 1/6/2018. This will concern primarily highly specialised, low-volume additives, as the deadlines for registration of substances sold in higher amounts, which is the case for example with solvents, monomers, and pigments, run out in 2010, respectively 2013.
Depending on which and how many raw materials will no longer be available after 1/6/2018, ink supplier development departments are facing a high workload for the next 1-2 years, as they will have to search for substitutions. However, ink manufacturers still do not know which raw materials may be concerned, as raw material suppliers in most cases refuse to give a clear answer to this question.
Printers should be therefore aware that some products they use may no longer be available in the same quality they got accustomed to. Some products also may disappear from the market completely when no other raw material with the necessary technical properties is available.