Table 1.
Specifications for extracts of rosemary (E 392) according to Commission Regulation (EU) No 231/2012 and JECFA (2016‐tentative)
| Commission Regulation (EU) No 231/2012 | JECFA (2016‐tentative) | |
|---|---|---|
| Definition | Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification |
Rosemary extract is obtained from ground dried leaves of Rosmarinus officinalis L using food‐grade solvents, namely, acetone or ethanol. Solvent extraction is followed by filtration, solvent evaporation, drying and sieving to obtain a fine powder. Additional concentration and/or precipitation steps followed by deodorisation, decolourisation and standardisation using diluents and carriers of food grade quality maybe included to produce the final product. Rosemary extract is characterised by its content of phenolic diterpenes, carnosic acid and carnosol, the principal antioxidative agents. Other antioxidant components present include triterpenes and triterpenic acids. Rosemary extract is identified by the total content of carnosol and carnosic acid as a ratio of reference volatile compounds which are responsible for flavour. The product of commerce can be standardised to a total carnosic acid and carnosol content up to 33% |
| Description | Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised | Beige to light brown powder |
| Assay | Not less than 5% of the total carnosic acid and carnosol | |
| Identification | ||
| Reference antioxidative compounds: phenolic diterpenes | Carnosic acid (C20H28O4) and Carnosol (C20H26O4) (which comprise not less than 90% of the total phenolic diterpenes) | |
| Reference key volatiles: | Borneol, Bornyl Acetate, Camphor, 1,8‐Cineol, Verbenone | |
| Density: | > 0.25 g/mL | |
| Solubility: | Insoluble in water | Insoluble in water; soluble in oil. |
| Purity | ||
| Loss of drying: | < 5% | Not more than 5% (80° under vacuum, 4 h) |
| Residual solvents: |
Acetone: Not more than 50 mg/kg Ethanol: Not more than 500 mg/kg |
|
| Arsenic: | Not more than 3 mg/kg | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg | Not more than 2 mg/kg |
| 1 – Extracts of rosemary produced from dried rosemary leaves by acetone extraction (generic specifications applicable) | ||
| Description | Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid. | |
| Identification | ||
| Content of reference antioxidative compounds | ≥ 10% w/w, expressed as the total of carnosic acid and carnosol | |
| Antioxidant/Volatiles — Ratio |
(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by gas chromatography–mass spectrometry detection, ‘GC‐MSD’) |
Total % of carnosic acid and carnosol/Total % of reference volatiles: (‐)‐borneol, (‐)‐bornyl acetate, (‐)‐camphor, 1,8‐Cineole (eucalyptol) and verbenone: not less than 15 |
| Purity | ||
| Residual solvents | Acetone: Not more than 500 mg/kg | |
| 2 – Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide (not in JECFA specifications) | ||
| Description | Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer | |
| Identification | ||
| Content of reference antioxidative compounds | ≥ 13% w/w, expressed as the total of carnosic acid and carnosol | |
| Antioxidant/Volatiles — Ratio |
(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by gas chromatography–mass spectrometry detection, ‘GC‐MSD’) |
|
| Purity | ||
| Residual solvents | Ethanol: Not more than 2% | |
| 3 – Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary (generic specifications applicable). | ||
| Description | Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray‐dried | |
| Identification | ||
| Content of reference antioxidative compounds | ≥ 5% w/w, expressed as the total of carnosic acid and carnosol | |
| Antioxidant/Volatiles — Ratio |
(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by gas chromatography–mass spectrometry detection, ‘GC‐MSD’) |
Total % of carnosic acid and carnosol/Total % of reference volatiles: (‐)‐borneol, (‐)‐bornyl acetate, (‐)‐camphor, 1,8‐Cineole (eucalyptol) and verbenone: not less than 15 |
| Purity | ||
| Residual solvents | Ethanol: Not more than 500 mg/kg | |
| 4 – Extracts of rosemary decolourised and deodorised, obtained by a two‐step extraction using hexane and ethanol (not in JECFA specifications) | ||
| Description | Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray‐dried | |
| Identification | ||
| Content of reference antioxidative compounds | ≥ 5% w/w, expressed as the total of carnosic acid and carnosol | |
| Antioxidant/Volatiles – Ratio |
(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by gas chromatography– mass spectrometry detection, ‘GC‐MSD’) |
|
| Purity | ||
| Residual solvents | Hexane: not more than 25 mg/kg Ethanol: Not more than 500 mg/kg | |