Globally, crypto assets are largely unregulated, with national operators in the EU only required to show controls for combating money laundering.
Representatives from the European Parliament and EU states thrashed out a deal late on Thursday on its Markets in Crypto-assets (MiCA) law.
"Today we put order in the Wild West of crypto assets and set clear rules for a harmonised market," said Stefan Berger, a German centre-right lawmaker who led negotiations.
"The recent fall in the value of digital currencies shows us how highly risky and speculative they are and that it is fundamental to act," Berger said.
Crypto markets have tumbled this year as investors worried about rising interest rates, leading to the collapse of the terraUSD stablecoin and the freezing of withdrawals and transfers by major crypto firms Celsius Network and Voyager Digital. read more
Bitcoin, the biggest token, has slumped some 70% since its November record of $69,000, dragging down the overall market.
The landmark regulation confirms the EU's role as a standard-setter for digital issues, EU states said.
"Crypto-asset service providers will have to respect strong requirements to protect consumers' wallets and become liable in case they lose investors' crypto-assets," they added.
The new law will need formal rubberstamping by the European Parliament and EU states to become law, followed by an implementation period. read more
It gives issuers of crypto assets and providers of related services a "passport" to serve clients across the EU from a single base.
Holders of stablecoins - a type of crypto designed to hold a steady value - will be offered a claim at any time and free of charge by the issuer, with all stablecoins supervised by the bloc's banking watchdog.
Robert Kopitsch, secretary general of the Blockchain for Europe lobby group that includes the major exchanges Binance and Crypto.com, said the rules were "a mixed bag" adding the group feared "that stablecoins will basically have no ways to be profitable."
However, Coinbase Global Inc , a major global crypto exchange, said in a blog on Friday the comprehensive new framework was "exciting," providing regulatory certainty to the market, and raising industry standards.
"A harmonised single set of rules for the entire EU will enable us to invest, accelerate, and scale our growth efforts across the entire bloc."
AFME, a financial markets industry body, said the rules would reduce fragmentation and underpin the development of a robust and well-functioning market.
More clarity is needed, however, to ensure that custodians of crypto assets are only on the hook in cases of negligence or misconduct, and not for events beyond their control, such as a nation state hack, AFME said.
Many states have long opposed including non-fungible tokens (NFTs), digital assets representing objects from art to videos.
But under pressure from EU lawmakers, Thursday's compromise foresees that NFTs will be excluded "except if they fall under existing crypto-asset categories".
Brussels will assess within 18 months whether standalone rules are needed for NFTs.
National regulators will be responsible for licensing crypto firms, but they will have to keep the EU's securities watchdog ESMA informed about large operators.
ESMA will develop standards for crypto companies to disclose information on their environmental and climate footprint.
The United States and Britain, two major crypto centres, have yet to approve similar rules. read more
Circle, the company behind the major USD Coin stablecoin called the rules "a significant milestone."
"While no comprehensive body of rules is perfect ... it nonetheless provides practical solutions to issues that other jurisdictions are just beginning to grapple with," it wrote in a blog.