Disposable Mouth Guard - 500.000 pieces - OTG in Copenhagen, Denmark. Applicable laws and approvals Tested and approved according to the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004, Commission Regulation (EU) No 10/2011 of 14 January 2011 on Overall migration, Sensorial examination odour and taste test, Specific migration of Ethylene glycol & Diethylene glycol, Specific migration of Antimony, Specific migration of Acetaldehyde, Specific migration of Terephthalic Acid, Specific migration of Heavy Metal, and affects all producing, importing, using, or placing products on the European market. Disposable mouth guards we provide are comply with (EU) No 10/2011.