The new Level VI mandate also defines exemptions for EPS products. Noting that the current voluntary EU CoC Tier 1 and Tier 2 standards do not distinguish between direct and indirect operation, direct operation EPS standards do not apply if it is a device that requires Federal Food and Drug Administration listing and approval as a medical device in accordance with section 360c of title 21 or it is a direct operation, AC-DC external power supply with nameplate output voltage less than 3V and nameplate output current greater than or equal to 1,000mA that charges the battery of a product that is fully or primarily motor operated.