1. Product Description

• Product Name: Broad-Spectrum CBD Oil (3%, 5%, 10%, 15%) 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

• 3% and 5%: Suitable for beginners. Promotes general wellness and relaxation.
• 10% and 15%: Advanced options for personalized dosing based on individual needs.
• Athletic Use: Specifically designed for athletes and overall well-being.
  • Promotes relaxation, concentration, and mood enhancement.
  • Beneficial for recovery from combat sports and weight lifting.
• Supporting Scientific Evidence:
  • Boychuk DG, et al. (2015). The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. Journal of Oral & Facial Pain and Headache, 29(1), 7-14.
  • Russo EB. (2008). Cannabinoids in the management of difficult to treat pain. Therapeutics and Clinical Risk Management, 4(1), 245-259.
  • Nagarkatti P, et al. (2009). Cannabinoids as novel anti-inflammatory drugs. Future Medicinal Chemistry, 1(7), 1333-1349.
  • Zurier RB, et al. (2016). Cannabinoids, inflammation, and fibrosis. The FASEB Journal, 30(11), 3682-3689.
  • Crippa JA, et al. (2011). Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. Journal of Psychopharmacology, 25(1), 121-130.
  • Blessing EM, et al. (2015). Cannabidiol as a potential treatment for anxiety disorders. Neurotherapeutics, 12(4), 825-836.
  • Babson KA, et al. (2017). Cannabis, cannabinoids, and sleep: a review of the literature. Current Psychiatry Reports, 19(4), 23.
  • Linares IM, et al. (2019). Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test. Brazilian Journal of Psychiatry, 41(1), 9-14.

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 3%, 5%, 10%, and 15% 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, after breakfast and before training or studying.

• Toxicological Profile:
  According to available scientific evidence, CBD is not lethal and does not cause a fatal overdose. CBD lacks significant effects on the brainstem, making it much safer than substances like opioids, which can impact breathing and heart rate. Although generally safe, CBD may cause side effects, including dry mouth, drowsiness, nausea, diarrhea, and appetite changes. Users are advised to follow recommended dosages responsibly and consult a physician if taking other medications.

Part B: Safety Assessment

Prepared by: Charalambos Georgiou, Chemical Engineer

The safety assessment confirms that the product is generally safe, even in larger doses. However, adherence to recommended usage guidelines is advised.

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 are cold-pressed to meet ISO 22000 and ISO 9001 standards, and all materials used are certified for food and cosmetic grade.

The final product is formulated on a small scale under controlled conditions, using sterilized equipment and a clean laboratory maintained daily with isopropyl and grain alcohol for sanitizing surfaces and glassware, respectively.

Storage Conditions:
All finished products and raw materials are stored in a shared environment, away from humidity and sunlight.

Safety Profile and Precautions:
CBD may cause rare allergic reactions, such as rash, itching, or difficulty breathing. It can also interfere with liver enzymes (cytochrome P450), affecting certain medications (e.g., antiepileptics, antidepressants, opioids). Consult a healthcare provider before use if taking these medications, and monitor liver function for prolonged use.

Conclusion:
The Broad-Spectrum CBD Oil with Piperine meets strict regulatory and quality control standards. It is safe for general use, but users should follow guidelines and consult healthcare providers if on other medications.

4. Proof of Effect

• Scientific References:
  • 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: CBD Oil Benefits, Uses, and Side Effects
  • Harvard Health: CBD and Other Medications – Proceed with Caution
  • Mayo Clinic: CBD – Safe and Effective?
  • FDA: What to Know About Products Containing Cannabis and CBD

5. Labeling

• Label Includes:
  • Product name and concentration (e.g., 3% (300 mg), 5% (500 mg), 10% (1000 mg), 15% (1500 mg))
  • Full ingredient list in INCI format
  • CPNP registration number for each concentration
  • Usage instructions, dosage recommendations, and precautions
  • 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

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

This Product Information File (PIF) is intended for regulatory authorities to ensure the Broad-Spectrum CBD Oil with Piperine meets compliance and safety standards.