Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

What Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance) requires

Commission Implementing Regulation (EU) 2023/972, adopted on 10 May 2023 and entering into force on the twentieth day following its publication in the Official Journal of the European Union (effective 6 June 2023), authorises the placing on the market within the Union of aqueous ethanolic extract of Labisia pumila as a novel food under Regulation (EU) 2015/2283. The novel food is authorised exclusively for use in food supplements as defined in Directive 2002/46/EC, intended for the adult population excluding pregnant and lactating women, at a maximum use level of 350 mg per day. Only the company Medika Natura Sdn. Bhd. is authorised to place the novel food on the Union market for a period of five years from 6 June 2023, unless a subsequent applicant obtains authorisation without reference to the protected scientific data or with the agreement of Medika Natura Sdn. Bhd. The scientific data contained in the application file - including pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test, and one year chronic toxicity test - shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Medika Natura Sdn. Bhd. Labelling of food supplements containing the novel food must bear a statement that they should only be consumed by persons above 18 years of age excluding pregnant and lactating women.

Pillar: Legal & IP Sovereignty · Authority: European Commission · Version: 1.0.0 · Last updated: 2023-05-17

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R0972

SHA-256 integrity: 75e76d46cda3f778519941fb300669698c0c56fcf848d12df0d0ecb3543e7d02

Primary Citations — 10 traced to source

• Article 1(1): 'Aqueous ethanolic extract of Labisia pumila is authorised to be placed on the market within the Union. Aqueous ethanolic extract of Labisia pumila shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.'
• Article 2: 'Only the company Medika Natura Sdn. Bhd. is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 6 June 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Medika Natura Sdn. Bhd.'

+ 8 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.

Access

• Discovery (free): /api/v1/nodes/eu-celex-32023r0972.json — 6-field metadata
• Vault (full node): /api/v1/vault/nodes/eu-celex-32023r0972.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
• Canonical URL: https://bidda.com/intelligence/eu-celex-32023r0972
• Back to registry: Browse all 10,099 compliance nodes