Cited by 29Essential Oils and Antimicrobial ActivityPharmaceutical Quality and CounterfeitingPhytochemistry Medicinal Plant Applications

Evaluation of Marketed Rosemary Essential Oils (Rosmarinus officinalis L.) in Terms of European Pharmacopoeia 10.0 Criteria

Open access
BARAK, Timur Hakan, BÖLÜKBAŞ, Elif, BARDAKCI, Hilal·2023·Turkish Journal of Pharmaceutical Sciences

Abstract

Objectives: Various pure rosemary essential oil containing commercial products are in demand for their health-promoting and cosmetic claims in Türkiye. Although they are natural and harmless, they should be in compliance with European Pharmacopoeia (EP) criteria. Therefore, in this study, 15 rosemary oil samples sold in pharmacies, herbal shops, and online platforms in Türkiye were investigated in terms of "Rosemary Oil" EP 10.0. monograph criteria. In the current study, we aimed to evaluate the current quality status of rosemary essential oils in the Turkish market. Materials and Methods: Appearance, fatty oils and resinified essential oils, relative density, refractive index, optical rotation, and acid value tests were performed according to EP 10.0 and compared with the given standards. In addition, thin layer chromatography (TLC) and gas chromatography-mass spectrometry (GC-MS) analysis were conducted on all samples for advanced understanding of their phytochemical profile and harmony with EP standards. Results: GC-MS analysis. Results demonstrated that none of the samples from the Turkish rosemary essential oil market fully complied with the EP rosemary oil monograph standards. Conclusion: Considering our data, it was revealed that enhanced regulations and auditing mechanisms are needed to improve the quality of products. When the difference between the sources of purchase is assessed, pharmacies are still better locations to obtain such products.

Integrity signals

Registry

Crossref · 10.4274/tjps.galenos.2022.78010

Cites

15 of 15 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

3 of 20 cited sources checked · 3 supported · 0 flagged

  • Findingown data
    § A7 A8 A9 A10

    Only samples P4, A5, and A10 had acid values within the acceptable range.

    “only three samples calculated (P4, A5, and A10) were in acceptable range after triple measurement.”
    Quote in the paperSubstantial claim
  • Findingown data
    § RESULTS

    Only samples P4 and P5 declared the oil's chemotype on their labels.

    “only samples P4 and P5 indicated the chemotype of the oil in the label.”
    • Also stated in: § A7 A8 A9 A10 · plain
      “only two of the evaluated products (P4 and P5) contain a label that indicates the chemotype of the ingredient”
    Quote in the paperSubstantial claim
  • Findingown data
    § Abstract

    GC-MS analysis identified between 83.1% and 96.9% of the constituents in every sample.

    “83.1 to 96.9% of the ingredients of all samples were determined via GC-MS analysis.”
    • Also stated in: § TLC analysis · plain
      “where 83.1 to 96.9% of the ingredients were determined for all samples.”
    Quote in the paperNot a substantial claim
  • Findingown data
    § Abstract

    None of the fifteen rosemary essential oil products from the Turkish market met all criteria of the EP 10.0 rosemary oil monograph.

    “Results demonstrated that none of the samples from the Turkish rosemary essential oil market fully complied with the EP rosemary oil monograph standards.”
    • Also stated in: § CONCLUSION · plain
      “results revealed that none of the samples was in full compliance with the monograph.”
    • Also stated in: § A7 A8 A9 A10 · plain
      “None of the samples was entirely fitting with the monograph requirements.”
    Quote in the paperSubstantial claim
  • Findingown data
    § A7 A8 A9 A10

    A6 oil lacks limonene.

    “However, limonene is absent in the oil”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 8
  • May combine two claims. 16
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § A7 A8 A9 A10

    Nearly all almond and safflower oil samples from the Turkish market were reported to lack quality according to EP criteria.

    “Nearly all of the almond and safflower oil samples from the Turkish market were reported as lacking quality in terms of EP criteria.11,12”
    Quote in the paperNot a substantial claim2 of 2 sources checked
    • cites [11] 11. Berkkan A, Dede Türk BN, Pekacar S, Ulutaş OK, Deliorman Orhan D. Evaluation of marketed almond oils [Prunus dulcis (Mill.) D.A. Webb] in terms of European Pharmacopoeia Criteria. Turk J Pharm Sci. 2022;19:322-329. source
    • cites [12] 12. Deliorman Orhan D, Pekacar S, Ulutaş OK, Özüpek B, Sümmeoğlu D, Berkkan A. Assessment of commercially safflower oils (Carthami Oleum Raffinatum) in terms of European Pharmacopoeia Criteria and their weight control potentials. Turk J Pharm Sci. 2022;19:273-279. source
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § A7 A8 A9 A10

    Some researchers found no limonene in rosemary oil samples from different locations.

    “However, some researchers determined absence of limonene in rosemary oil samples from different locations.18,19”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [18] 18. Sharma Y, Schaefer J, Streicher C, Stimson J, Fagan J. Qualitative analysis of essential oil from French and Italian varieties of rosemary (Rosmarinus officinalis L.) grown in the Midwestern United States. Anal Chem Lett. 2020;10:104-112. source
    • cites [19] 19. Jardak M, Elloumi-Mseddi J, Aifa S, Mnif S. Chemical composition, anti-biofilm activity and potential cytotoxic effect on cancer cells of Rosmarinus officinalis L. essential oil from Tunisia. Lipids Health Dis. 2017;16:190. source
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    A6 had slightly lower cineole and slightly higher p-cymene than expected.

    “Cineole content of A6 sample is slightly lower than expected, while p-cymene content is slightly higher.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    A6 was the sample most consistent with the Moroccan/Tunisian GC profile, with 9 of 12 required ingredients matching the monograph.

    “A6 was determined as the most coherent sample with GC profile given in monograph for Moroccon/Tunisian type, 9 of the ingredients out of 12 requirements for these samples were consistent with the monograph.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    All pharmacy samples had refractive index within the accepted range, while three samples from other sources (A1, A4, A9) were outside it.

    “All samples from pharmacies displayed refractive index in the accepted range; however, three samples from other sources (A1, A4, and A9) were found to be out of range.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given
    § Abstract

    Every sample was registered as a cosmetic product in Türkiye through the Ministry of Health.

    “All of the samples were licensed as cosmetic products in Türkiye via the Ministry of Health.”
    • Also stated in: § Materials · plain
      “All products are registered as cosmetics by the Turkish Ministry of Health.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    Only sample P5 fell outside the optical rotation range; all other samples met the pharmacopoeia requirement.

    “Results indicated that only one sample (P5) was out of the range and all other samples fulfilled the requirements of the pharmacopeia.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    All pharmacy samples passed the TLC test, whereas four of ten samples from other sources (A2, A3, A7, A8) failed the TLC requirements.

    “Results of the TLC test indicate that all the samples from pharmacies passed the test; in contrast, four of ten samples obtained from sales sources other than pharmacies (A2, A3, A7, and A8) failed to compensate for the TLC test requirements stated in EP.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    Cineole is the major component of both chemotypes; only A2 had enough cineole (44.7%) to meet the Moroccan/Tunisian criteria, while all other samples had cineole between 8.4% and 36.2%.

    “Cineole is the major ingredient of both chemotypes; however, only A2 sample was measured to contain sufficient cineole to meet the criteria of Moroccon/Tunusian type with 44.7%, all other samples had cineole content between 8.4 and 36.2%.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    Limonene content was the parameter most often outside the EP requirement, with only 3 samples fitting it.

    “Limonene contents of the samples were most out of reach parameter, only 3 of the samples fitted with EP requirement”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    Samples A1, A2, and A4 had limonene contents within limits, at 3%, 3.17%, and 2.99%, respectively.

    “A1, A2, and A4-coded samples were found convenient with limits, 3, 3.17, and 2.99%, respectively.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    Nine samples contained no limonene at all, and three samples exceeded the upper limit.

    “Results showed that 9 of the samples do not contain limonene at all, while 3 of the samples contain greater than the upper limit.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    A2 had 8 positive results, followed by P1, P2, and A8 with 7 positive results.

    “A2 followed A6 with 8 positive results and P1, P2, and A8 were measured with 7 positive results.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data
    § A7 A8 A9 A10

    A9 was the most out-of-spec sample, matching only one ingredient of the GC profile requirements.

    “A9 was designated as most out of spec sample consistent with only one ingredient of the GC profile requirements.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Premisecitation
    § Relative density, refractive index, optical rotation, and acid value

    EP 10.0 sets the refractive index of rosemary oil between 1.464 and 1.473.

    “1.464 and 1.473 for refractive index”
    • Also stated in: § A7 A8 A9 A10 · hedged
      “the monograph indicates that the refractive index of rosemary oil must be between 1.464 and 1.473.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [5] 5. EDQM. European Pharmacopoeia, 10 th ed.; EDQM: Strasbourg, France, 2019.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § Relative density, refractive index, optical rotation, and acid value

    All experiments were run in triplicate, and results were reported as average with standard deviation.

    “All experiments were conducted in triplicate and results were given with average and standard deviation (SD).”
    • Also stated in: § A7 A8 A9 A10 · plain
      “All test were done in triplicate and results were given in average ± standard deviation (SD)”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § A7 A8 A9 A10

    R. officinalis has several chemotypes that are strongly influenced by geography.

    “R. officinalis is one of these species that has been detected for several different chemotypes highly affected from geographical impacts.15”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] 15. Chalchat, JC, Garry RP, Michet A, Benjilali B, Chabart JL. Essential oils of rosemary (Rosmarinus officinalis L.). The chemical composition of oils of various origins (Morocco, Spain, France). J Essent Oil Res. 1993;5:613-618. source
  • May combine two claims.

    Premisecitation
    § A7 A8 A9 A10

    For the Spanish type, α-pinene and cineole are major components with ranges of 18-26% and 16-25%, respectively.

    “α-Pinene and cineole are determined as major components with the range of 18-26% and 16-25%, respectively.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] 5. EDQM. European Pharmacopoeia, 10 th ed.; EDQM: Strasbourg, France, 2019.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § CONCLUSION

    EP 10.0 describes two chemotypes of rosemary oil.

    “EP 10 . 0 mentions two different chemotypes of rosemary oil.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] 5. EDQM. European Pharmacopoeia, 10 th ed.; EDQM: Strasbourg, France, 2019.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation
    § A7 A8 A9 A10

    EP requires limonene content of 2.5-5% for the Spanish type and 1.5-4% for the Moroccan/Tunisian type.

    “Spanish and Moroccon/Tunisian types need to be 2.5-5% and 1.5-4%, respectively.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [5] 5. EDQM. European Pharmacopoeia, 10 th ed.; EDQM: Strasbourg, France, 2019.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation
    § A7 A8 A9 A10

    For the Moroccan/Tunisian type, cineole is the dominant major ingredient at 38-55%, and α-pinene is 9-14%.

    “For the Moroccon/Tunisian type, cineole is determined as the dominant major ingredient in the range between 38 and 55%, while α-pinene content was determined between 9 and 14%.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] 5. EDQM. European Pharmacopoeia, 10 th ed.; EDQM: Strasbourg, France, 2019.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductcitation
    § GC-MS analysis

    GC-MS component identification used retention index comparison against n-alkanes, relative retention times with authentic samples, and mass spectra from NIST14 and Wiley7 libraries and MS literature.

    “Identification of the essential oil components was completed by comparison of their RRI calculated against n-alkanes and relative retention times with those of authentic samples and mass spectra obtained from NIST14 and Wiley7 mass spectra libraries as well as MS literature data was used for the identification.6”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [6] 6. Abu Zarga MH, Al-Jaber HI, Baba Amer ZY, Sakhrib L, Al-Qudah MA, Al- humaidi JY, Abaza IF, Afifi, FU. Chemical composition, antimicrobial and antitumor activities of essential oil of Ammodaucus leucotrichus growing in Algeria. J Biol Act Prod Nat. 2013;3:224-231. source
22 of 22
  • The paper relies on this without support.

    The 15 samples are an adequate number to represent the Turkish rosemary essential oil market.

    “Although there are many more commercial products of rosemary essential oil in the Turkish market, 15 samples were studied to have adequate number.”
  • The paper relies on this without support.

    For samples without chemotype labels, evaluating them against the most proximate chemotype in the monograph is appropriate.

    “However, chemotype information was mentioned only two of the samples, whereas other samples were evaluated according to most proximate one in the pharmacopeia.”
2 of 2

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Density values differ between the results summary and Table 1

    Major

    For the same ordered samples, the results summary gives P2 a density of 0.876 and A1 a density of 0.893; Table 1 instead gives means of 0.79 and 0.74. These differences exceed the precision of the printed values.

  • Named density-compliant sample falls below the stated range

    Major

    The text names A8 as meeting the 0.895-0.920 density range, while Table 1 gives A8 a mean of 0.89. The same table also gives in-range means for P4 and A2, neither of which is named.

  • More than three samples meet the acid-value limit

    Major

    The stated maximum is 1, but Table 1 lists nine samples at or below that limit: P4 and A2-A8 and A10. The text names only three.

  • The reported GC-MS coverage range excludes two table values

    Minor

    The paper gives 96.9% as the upper end of the identified-component range, but Table 2 reports totals of 97.3% and 98.7%.

4 of 4

Cites

Flagged first, then by citations

Research works printed but not linked: 3

  1. Pesen Özdoğan F, Orhan N, Ergun F. Studies on the conformity of Hibiscus sabdariffa L. samples from Turkish market to European Pharmacopeia. FABAD J Pharm Sci. 2011;36:25-32.
  2. Tombul AG, Orhan N, Sezik E, Ergun F. Morphologic, anatomical, and chromatographic studies on Eucalyptus (L'Hér.) samples from the market. FABAD J Pharm Sci. 2012;37:79-87.
  3. Renda G, Tevek F, Korkmaz B, Yaylı N. Comparison of the Alchemilla L. samples from Turkish Herbal Market with the European Pharmacopoeia 8.0. Fabad J Pharm Sci. 2017;42:167-177.

Cited by

Sorted by citations

Authors
BARAK, T. H., BÖLÜKBAŞ, E., & BARDAKCI, H.
Affiliations
Acıbadem University (TR)
Corresponding author
BARAK, Timur Hakan
Venue
Turkish Journal of Pharmaceutical Sciences
Published
2023-08-22
Volume
20
Issue
4
Pages
253-260
ISSN
  • 1304-530X (ISSN-L)
  • 2148-6247
OpenAlex
W4309878663
Cited by
29
References
15
Citations by year
2026: 10 · 2025: 10 · 2024: 6 · 2023: 3
FWCI
2.53
Type
journal article
Language
en
Open access
Locations
  • Turkish Journal of Pharmaceutical Sciences (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Türkiye Bilimsel ve Teknolojik Araştırma Kurumu (2209 - A)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Essential Oils and Antimicrobial Activity
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Phytochemistry Medicinal Plant Applications
Keywords
rosemary essential oil, Rosmarinus officinalis, quality control, phytochemical composition, essential oil adulteration, acid value, herbal product quality

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