1. Product Description

Product Name:
Magic Pair: 5% CBG + 5% CBD, Full Extract Cannabis Oil Blend with Piperine

Description:
This sublingual CBG and CBD oil blend is formulated to promote balance, reduce inflammation, alleviate pain, and support overall well-being. Sourced from CBG and CBD mixed cannabis flowers grown under the sun in Chania, Crete, this blend combines the therapeutic properties of both cannabinoids. The inclusion of piperine, an extract from black pepper, enhances the bioavailability of CBG and CBD, providing users with more effective absorption. The blend of Cretan olive oil and black sesame oil serves as the carrier, supporting relaxation and wellness for both day and night use.

Intended Use:
For oral care and overall wellness support. Sublingual administration promotes relaxation, stress reduction, and helps alleviate pain, supporting a calm mind and body.

Physical Form:
Liquid oil, housed in a 10 ml dark-colored glass bottle to protect against UV light degradation. The product includes a precise dosing glass pipette.

Packaging:
The 10 ml dark-colored glass bottle is compliant with Commission Regulation (EU) no. 10/2011 for materials in contact with food. The packaging is fitted with a glass dosing pipette, ensuring precise and controlled administration.

2. Product Claims

5% CBG (Cannabigerol):
CBG offers gentle relaxation and stress relief, calming the mind and promoting emotional balance. Known as the “mother of cannabinoids,” it supports the body’s endocannabinoid system to maintain homeostasis.

5% CBD (Cannabidiol):
CBD is well-known for its wellness-promoting benefits. It helps reduce inflammation, alleviate pain, and provide overall stress relief, making it ideal for holistic well-being.

Key Benefits:

• Promotes balance, relaxation, and stress reduction.
• Reduces inflammation and helps alleviate pain.
• Supports overall wellness, mood enhancement, and tranquility.
• Suitable for both day and night use to maintain emotional and physical balance.

Synergistic Effects of CBG and CBD:
CBG and CBD are believed to enhance each other’s therapeutic effects when combined, with CBG potentially improving the absorption of CBD. The blend works to promote relaxation, reduce inflammation, and support overall well-being.

Scientific Support for Claims:

1. Cascio MG, et al. (2010). Cannabinoid control of the sleep-wake cycle: potential therapeutic uses. Nature Reviews Neuroscience, 11, 782-792.
2. Russo EB. (2011). Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. British Journal of Pharmacology, 163(7), 1344-1364.
3. Morales P, et al. (2017). Molecular targets of the phytocannabinoids: a complex picture. Pharmacological Reviews, 69(4), 935-960.
4. Izzo AA, et al. (2009). Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends in Pharmacological Sciences, 30(10), 515-527.

3. Product Safety Report (CPSR)

Part A: Safety Information

Quantitative and Qualitative Composition:

INCI Ingredients:

• Sesamum Indicum Seed Oil (Carrier oil: black sesame oil, enhancing absorption)
• Olea Europaea Fruit Oil (Carrier oil: Cretan olive oil, known for its soothing properties)
• Cannabigerol (CBG) (Active cannabinoid ingredient)
• Cannabidiol (CBD) (Active cannabinoid ingredient)
• Piper Nigrum Seed Extract (Piperine, enhances cannabinoid absorption)

Active Ingredients:

1. Cannabigerol (CBG)

   • CAS No.: 25654-31-3
   • ECHA No.: 846-444-6
   • Molecular formula: C21H32O2
   • Molecular weight: 316.49 g/mol

2. Cannabidiol (CBD)

   • CAS No.: 13956-29-1
   • ECHA No.: 689-176-3
   • Molecular formula: C21H30O2
   • Molecular weight: 314.46 g/mol

Physical/Chemical Characteristics and Stability:
The product is stable when stored at temperatures between 15°C and 25°C, in a dry, cool, and dark environment to prevent degradation. It has a shelf life of up to 3 years unopened and 12 months once opened, provided it is stored correctly.

Microbiological Quality:
Produced in compliance with microbiological quality standards for oils, ensuring a pathogen-free product. Manufacturing adheres to strict GMP protocols.

Impurities, Traces, and Packaging:
The packaging, a dark-colored glass bottle, complies with Commission Regulation (EU) no. 10/2011, ensuring it is safe for food and cosmetic use. A comprehensive heavy metal analysis was conducted according to DIN EN 13657:2003-01 standards, confirming the absence of hazardous impurities.

Normal and Reasonably Foreseeable Use:
Sublingual administration: 2-5 drops are placed under the tongue for 3-5 minutes twice daily. This allows cannabinoids to be absorbed directly into the bloodstream through the mucous membranes.

Exposure to the Cosmetic Product:
The sublingual administration method ensures efficient absorption via the mucous membranes under the tongue. The recommended dosage is 2-5 drops twice per day.

Toxicological Profile:
Both CBG and CBD are considered non-toxic with a very low risk of overdose. Side effects may include dry mouth, drowsiness, diarrhea, and nausea. More serious adverse effects, such as allergic reactions and drug interactions (e.g., with anticoagulants, antidepressants, and NSAIDs), are rare but possible. Users should consult with a healthcare provider if taking other medications.

Part B: Safety Assessment

Manufacturing Process:

The manufacturing process adheres to strict cGMP standards. The CBG and CBD extracts are derived from mixed cannabis flowers via cold ethanol extraction, preserving the integrity of the cannabinoids and terpenes while minimizing degradation. Piperine is also extracted using cold ethanol from organic black pepper.

Carrier Oils:
The black sesame oil and Cretan olive oil are cold-pressed to preserve their nutritional and therapeutic properties. Both oils are sourced from ISO 22000 and ISO 9001 certified suppliers.

Formulation and Cleaning Procedures:
The final product is formulated in a small-scale, closed-loop system under sterile conditions. All surfaces and equipment used in the production process are meticulously cleaned and sanitized. The facility undergoes daily cleaning with special attention to sanitation protocols:

• Surfaces and Equipment: All working surfaces are cleaned with Isopropyl Alcohol (IPA, 70% concentration) to ensure sterility, preventing any microbial contamination.
• Glassware: All glass pipettes, bottles, and measuring tools are sanitized with grain ethanol (95%) to eliminate any impurities or potential residues from previous formulations.
• Vacuuming and Mopping: The laboratory floor is vacuumed and mopped using a robotic vacuum cleaner that operates with HEPA filters to ensure thorough removal of dust and contaminants. This process is repeated twice daily, maintaining a clean and sterile environment.

Access to the laboratory is restricted, with only trained personnel wearing protective uniforms permitted to enter. Regular monitoring of temperature, humidity, and cleanliness ensures compliance with GMP protocols.

Storage:
All finished products and raw materials are stored in a controlled environment away from sunlight and humidity. The storage area is maintained at optimal conditions to preserve product integrity.

4. Proof of Effect

Scientific References:

1. Cascio MG, et al. (2010). Cannabinoid control of the sleep-wake cycle: potential therapeutic uses. Nature Reviews Neuroscience, 11, 782-792.
2. Russo EB. (2011). Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. British Journal of Pharmacology, 163(7), 1344-1364.
3. Morales P, et al. (2017). Molecular targets of the phytocannabinoids: a complex picture. Pharmacological Reviews, 69(4), 935-960.
4. Izzo AA, et al. (2009). Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends in Pharmacological Sciences, 30(10), 515-527.

5. Labeling

The label will include:

• Product name and concentration (5% CBG, 5% CBD)
• Full ingredient list in INCI format
• CPNP registration number: 4680818
• Usage instructions, dosage recommendations, and precautions
• Manufacturer details, batch number, and net contents (10 ml)
• Storage conditions and shelf-life
• Vegan certification where applicable

6. Data on Animal Testing

No animal testing was conducted on the final product or its ingredients, in compliance with EU cosmetic regulations. This product is cruelty-free.

7. Safety Profile and Conclusion

Prepared by:
Charalambos Georgiou, Chemical Engineer

The safety assessment concludes that Magic Pair 5% CBG + 5% CBD oil blend is safe for general use when applied according to the recommended dosage. All ingredients have been reviewed for safety, and the product is manufactured under cGMP standards. Users should follow dosage guidelines and consult healthcare professionals if using other medications.

This PIF is designed to meet all European regulatory standards, including compliance with CPNP registration, safety assessments, and packaging requirements.