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MI/MIT Deadline Approaches - February 2017


Previously methylisothiazolinone was listed as an authorised preservative under Annex V, entry 57, of the regulation at a limit of 100ppm (0.01%). Since the amendment of the regulation on the 22nd July 2016 the grace period has almost ended. From the 12th February 2017, no leave-on cosmetics containing methylisothiazolinone shall be placed and made available on the Union market. This means that all leave-on products containing Methylisothiazolinone should be removed from the market prior to this date. You can find the relevant resources to this update at the following addresses:

Scientific Committee on Consumer Safety (SCCS) opinion on the safety of Methylisothiazolinone (sensitisation only):

http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_178.pdf

Commission Regulation (EC) 2016/1198 amending Annex V : http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2016.198.01.0010.01.ENG

If you do need to change the preservative system in your products to comply with the change, it will be necessary to complete challenge and stability testing with the new formulation and have it reassessed by a Safety Assessor. MSL can help facilitate this change if required and speed up the process using our specially adapted, abbreviated test methods. Please contact us for further details. <strong>Rinse-off update</strong> As of today the limit on Methylisothiazolinone in Rinse-off products remains at 100 ppm (0.01%). The process of reducing this to the SCCS recommended 15ppm (0.0015%) is still ongoing and has not been finalised.

Information on the previous consultation process can be found here:

http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8740&lang=en&title=Public-consultation-on-Methylisothiazolinone-%28MI%29-in-the-framework-of-Regulation--%28EC%29-No%2E-1223%2F2009----rinse-off-cosmetic-products