1. Product Description

• Product Name: Broad-Spectrum CBD Oil (20%, 25%, 30%) with Piperine
• Description: A sublingual CBD oil designed as an oral care cosmetic product. Contains phytocannabinoids, terpenes, piperine to enhance CBD absorption, and vitamin E-rich sunflower oil as an antioxidant.
• Intended Use: Oral care; applied sublingually.
• Physical Form: Liquid, housed in a 10 ml dark-colored glass bottle with a dosing pipette.
• Packaging: Glass bottle approved by Commission Regulation (EU) no. 10/2011, equipped with a dosing pipette.

2. Product Claims

• Anti-Stress Series:
  • High concentrations (20%, 25%, 30%) suitable for nighttime use.
  • Can be used for sleep enhancement, deep relaxation, and stress reduction.
  • Effective for both chronic pain and muscle pain, although individual results may vary.
• Supporting Scientific Evidence:
  • Singh K, et al. Emerging Therapeutic Potential of Cannabidiol (CBD) in Neurological Disorders: A Comprehensive Review. Behav Neurol. 2023 Oct 12; 2023:8825358. doi: 10.1155/2023/8825358. PMID: 37868743; PMCID: PMC10586905.

3. Product Safety Report (CPSR)

Part A: Safety Information

• Quantitative and Qualitative Composition:

  • INCI Ingredients:
    • Helianthus Annuus Seed Oil
    • Caprylic/Capric Triglyceride
    • Cannabidiol (CBD) – Derived from extract or tincture or resin of cannabis
    • Piper Nigrum Seed Extract
  • Available in 20%, 25%, and 30% CBD concentrations.

• Physical/Chemical Characteristics and Stability:

  • Store at 15°C to 25°C in a dry, dark, and cool environment.
  • Shelf life: Up to 3 years unopened; use within 12 months after opening.

• Microbiological Quality:

  • Complies with microbiological quality standards for oils.

• Impurities, Traces, and Packaging:

  • Glass bottle packaging, compliant with EU standards.
  • Heavy metal check performed under DIN EN 13657:2003-01 standards.

• Normal and Reasonably Foreseeable Use:

  • Administration: Sublingual application by placing oil under the tongue for 3-5 minutes.

• Exposure to the Cosmetic Product:

  • Recommended dosage: 2-5 drops under the tongue, twice per day, half an hour before dinner and 10 minutes before bedtime.

Part B: Safety Assessment

Prepared by: Charalambos Georgiou, Chemical Engineer

• Safety Assessment for Broad-Spectrum CBD Oil with Piperine
  This product is produced under stringent quality and safety standards and contains phytocannabinoids, terpenes, piperine for enhanced absorption, and vitamin E-rich sunflower oil as an antioxidant. Based on available scientific data, the product is considered safe when used as directed.

• Manufacturing Process and Quality Control
  The CBD oil and piperine extracts are produced using cold ethanol extraction in a c-GMP compliant facility. Carrier oils meet ISO 22000 and ISO 9001 standards. The final formulation is prepared on a small scale under controlled conditions, using sterilized equipment.

• Storage Conditions
  All products are stored in a shared environment designed to prevent exposure to humidity and sunlight, maintaining long-term stability.

• Safety Profile and Precautions
  While the product is generally well-tolerated, users should follow recommended dosages and consult a physician if taking other medications, especially if they experience side effects such as drowsiness, dry mouth, diarrhea, decreased appetite, and nausea. Rare but serious allergic reactions may occur.

  CBD can interfere with liver enzymes (cytochrome P450), which may affect the metabolism of certain medications. Consult a healthcare provider before use if taking medications like:

  • Antiepileptics
  • Antidepressants
  • Antipsychotics
  • Anticoagulants
  • Opioids
  • Benzodiazepines
  • Steroids
  • NSAIDs

Conclusion
The Broad-Spectrum CBD Oil with Piperine Anti-Stress Series is formulated and produced under strict regulatory and quality control conditions. It is safe for general use; however, users are advised to follow usage guidelines and seek medical advice if on other medications.

Signature:
Charalambos Georgiou, Chemical Engineer

4. Proof of Effect

• Documentation of Scientific Research:
  • Bergamaschi MM et al. Safety and side effects of cannabidiol: A review of clinical data and relevant animal studies. Current Drug Safety, 2017; 12(2): 81-90.
  • Verywell Health. (2023). “CBD Oil: Uses, Benefits, Side Effects, Dosage, Precautions”. Retrieved from https://www.verywellhealth.com/cbd-oil-benefits-uses-side-effects-4174562
  • Verywell Mind. (2023). “Common CBD Side Effects You Should Understand”. Retrieved from https://www.verywellmind.com/cbd-oil-side-effects-4174569
  • Harvard Health. (2023). “CBD and other medications: Proceed with caution”. Retrieved from https://www.health.harvard.edu/blog/cbd-and-other-medications-proceed-with-caution-2021010721722
  • Mayo Clinic. (2023). “CBD: Safe and effective?”. Retrieved from https://www.mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/is-cbd-safe-and-effective/faq-20446700
  • (2023). “What to Know About Products Containing Cannabis and CBD”. Retrieved from https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

5. Labeling

• Label Includes:
  • Product name and concentration (e.g., 20% (2000 mg), 25% (2500 mg), 30% (3000 mg)).
  • Full ingredient list in INCI format.
  • CPNP registration number for each concentration.
  • Usage instructions and recommended dosage.
  • Precautionary statements and side effects.
  • Manufacturer details and batch number.
  • Net contents (10 ml).
  • Storage conditions and shelf-life.
  • Vegan and other specific labels as applicable.

6. Data on Animal Testing

• Compliance: No animal testing was conducted on the final product or ingredients, in compliance with EU cosmetic regulations.