Safety & Compliance

Our Commitment to Safety & Compliance

EU Cosmetics Regulation (EC) No 1223/2009 | CPNP Registered

Section 1

Intended Use & Product Classification

All Icelandic Elements CBD oils and topicals are classified and marketed exclusively as cosmetic products under EU Cosmetics Regulation (EC) No 1223/2009. Our products are intended for external topical application to the skin only.

They are not intended for ingestion, inhalation, or oral use of any kind. Our products are designed to complement normal skincare routines and do not claim to diagnose, treat, cure, or prevent any disease or medical condition. All product communications — including labelling, website copy, and marketing materials — are strictly limited to cosmetic properties and general skincare use.

Important: Icelandic Elements products are cosmetic products only. No medicinal, therapeutic, or health claims are made or implied. Where CBD (Cannabidiol) is included, it is used strictly as a cosmetic ingredient in compliance with EU cosmetic regulations and is not presented as having any medicinal effect.

Section 2

Directions for Use

To use any Icelandic Elements topical product safely and effectively:

  • Apply a small amount of product to clean, dry skin.
  • Massage gently until fully absorbed.
  • Use as required as part of your daily skin or body care routine.
  • Avoid excessive application.
  • Wash hands after use if the product has been applied to areas other than the hands.
Section 3

General Warnings & Precautions

The safety of our customers is our highest priority. Before using any Icelandic Elements product, please read the following warnings and precautions carefully. These apply to all products in our range, including those containing Cannabidiol (CBD).

External Use Only

All Icelandic Elements products are formulated exclusively for external topical use on the skin. Under no circumstances should any product be ingested, inhaled, or applied to the inside of the mouth, nose, or ears.

Do Not Apply to Damaged or Compromised Skin

Do not apply any Icelandic Elements product to broken, irritated, inflamed, infected, or otherwise damaged skin. Application to compromised skin may increase absorption rates and could result in adverse reactions. If you have a skin condition, open wounds, or active dermatological issues, consult a healthcare professional before use.

Avoid Sensitive Areas

Avoid contact with the eyes, eyelids, lips, and all mucous membranes. These areas have significantly thinner skin and greater sensitivity. In the event of accidental eye contact, rinse thoroughly with clean, lukewarm water for several minutes. If irritation persists, seek medical attention.

Adverse Reactions

Discontinue use immediately if you experience redness, irritation, itching, burning, swelling, or any other adverse skin reaction. If symptoms persist or worsen, consult a qualified healthcare professional or pharmacist. Do not continue use while experiencing an adverse reaction.

Regulatory Note: The Responsible Person for all Icelandic Elements cosmetic products under EU Cosmetics Regulation (EC) No 1223/2009 is Adotta CBD Reykjavik EU B.V., Nieuwe Vlissingseweg 190, 4335JG Middelburg, Netherlands. If you experience an adverse reaction to any of our products, we encourage you to report it to us directly so that we may fulfil our ongoing safety monitoring obligations.

Section 4

Pregnancy, Breastfeeding & Sensitive Populations

We apply an enhanced precautionary approach to vulnerable populations, given that the safety of certain cosmetic ingredients in these groups has not been fully established through clinical research. We believe it is always better to err on the side of caution.

Pregnancy

As a precautionary measure, Icelandic Elements products — including those containing Cannabidiol (CBD) — are not recommended for use during pregnancy. While CBD is used in our products as a topical cosmetic ingredient at assessed safe concentrations, the transdermal absorption of cannabinoids and their potential effects during pregnancy have not been sufficiently studied to permit a confident safety recommendation for pregnant individuals. We therefore advise against use throughout pregnancy.

Breastfeeding

Similarly, use of Icelandic Elements products while breastfeeding is not recommended as a precautionary measure. Individuals who are breastfeeding and wish to use any of our products should first consult their healthcare provider or midwife for personalised guidance.

Skin Sensitivities & Allergies

Individuals with known skin sensitivities, contact allergies, eczema, psoriasis, rosacea, or other dermatological conditions are advised to consult a qualified healthcare professional or dermatologist prior to use. We recommend performing a full patch test (see Section 7) before incorporating any new product into your routine.

Elderly Individuals

Skin in older adults may be more sensitive or have reduced barrier function. We recommend starting with a small amount on a discreet area of skin and monitoring for any reaction before broader use.

Please note: This guidance is provided in the interest of consumer safety and does not constitute medical advice. If you are uncertain whether our products are suitable for you, please consult a qualified healthcare professional before use.

Section 5

Medical Conditions & Medication Use

While Icelandic Elements products are cosmetics intended for external use only, we recognise that some individuals manage ongoing medical conditions or take prescription or over-the-counter medications that may affect skin sensitivity or absorption.

Underlying Medical Conditions

If you have an underlying medical condition — particularly conditions affecting the skin, immune system, liver, or endocrine system — we recommend consulting a healthcare professional before incorporating any new cosmetic product into your routine.

Prescription & Over-the-Counter Medication

If you are currently taking prescription medication, particularly any that are applied topically or that affect skin permeability (such as topical corticosteroids, retinoids, or certain antifungal treatments), we advise speaking with your prescribing clinician or pharmacist before using our products alongside them.

CBD & Medication Interactions

Although our CBD products are applied topically and not ingested, and absorption through intact skin is generally considered low at cosmetic concentrations, we believe in full transparency. If you have any concerns about CBD in the context of your personal health situation or medications, please seek independent medical advice. Icelandic Elements does not make any claims regarding the interaction of our topical products with medications.

This guidance is provided to support individual suitability and consumer safety. It does not constitute medical advice.

Section 6

Children & Vulnerable Users

Icelandic Elements products are formulated and intended for adult use only. They are not suitable for use on or by children.

Age Suitability

Our products are not intended for use by individuals under the age of 18. The safety assessments within our Product Safety Reports are conducted on the basis of adult physiology.

Safe Storage

Keep all Icelandic Elements products out of the reach of children at all times. Store products in a secure location where children cannot access them, particularly products in small containers or with pump dispensers that may attract curiosity.

Accidental Ingestion

If a child accidentally ingests any Icelandic Elements product, do not induce vomiting. Contact your local poison control centre, accident and emergency department, or emergency services immediately. Take the product packaging with you so that medical personnel can identify all ingredients.

All Icelandic Elements products carry the mandatory 'Keep out of reach of children' statement on product labelling in accordance with EU Cosmetics Regulation (EC) No 1223/2009, Annex III.

Section 7

Skin Sensitivity & Patch Testing

Even products formulated with the highest quality ingredients can cause reactions in individuals with particular sensitivities. We strongly recommend patch testing before first use of any new Icelandic Elements product.

How to Perform a Patch Test

  1. 1Select a discreet area of skin, such as the inner forearm or behind the ear.
  2. 2Apply a small amount — approximately the size of a 5p coin — of the product to the test area.
  3. 3Leave the product on the skin undisturbed for 24 hours. Do not wash the area during this period.
  4. 4After 24 hours, inspect the area carefully for any signs of redness, itching, swelling, or irritation.
  5. 5If no adverse reaction occurs after 24 hours, the product is likely suitable for broader use.
  6. 6If any reaction occurs at any point during the test period, remove the product by rinsing with clean water and do not proceed with use.

Allergen Transparency

All ingredients are listed on our product labelling and product pages using INCI (International Nomenclature of Cosmetic Ingredients) nomenclature. Fragrance allergens present above regulatory thresholds are individually identified within the ingredient list. If you have a known allergy to a specific ingredient, please review the full INCI list before use and consult an allergist or dermatologist if you are unsure.

Section 8

Storage & Handling

Correct storage and handling of your Icelandic Elements products ensures their safety, efficacy, and longevity throughout the stated product lifespan.

Storage Conditions

  • Store all products in a cool, dry place away from direct sunlight and heat sources.
  • Avoid storing products in humid environments such as bathrooms where condensation is frequent, as this can degrade formulations and compromise packaging integrity.
  • Ideal storage temperature is between 5°C and 25°C.
  • Do not expose products to extreme cold or freeze them, as this may alter the texture or stability of the formulation.

Container Handling

  • Ensure the container is tightly closed or capped after every use to prevent contamination and oxidation.
  • Do not dilute products or mix them with other cosmetics unless specifically instructed to do so.
  • Avoid introducing water or other substances into the product container, as this can promote microbial growth.
  • Do not transfer products into unlabelled containers.

Expiry & Period After Opening (PAO)

Do not use any Icelandic Elements product after its expiry date or beyond the Period After Opening (PAO) indicated on the packaging. The PAO is shown as an open jar symbol followed by a number and the letter M — for example, 12M means the product should be used within 12 months of first opening.

Travel & Transport

When travelling with Icelandic Elements products, ensure lids and caps are secured tightly. Changes in air pressure during air travel may cause some products to leak. We recommend placing products in a sealed bag when travelling by air.

Batch traceability: Every Icelandic Elements product carries a batch number on its packaging. In the event of a quality concern or adverse reaction, please retain the packaging and note the batch number so that we can conduct a thorough investigation as part of our post-market safety obligations.

Section 9

Ingredient Transparency & Regulatory Compliance

All ingredients used across the Icelandic Elements range are listed using INCI (International Nomenclature of Cosmetic Ingredients) nomenclature on both product packaging and our website, in full compliance with EU cosmetic labelling requirements.

Where Cannabidiol (CBD) is included as an ingredient, it is derived from hemp (Cannabis Sativa L.) and is used strictly as a cosmetic ingredient within the concentration limits established by our Cosmetic Product Safety Reports.

Our products are notified via the CPNP and supported by comprehensive safety documentation within the PIF, including toxicological assessments and systemic exposure evaluations appropriate for topical use.

Section 10

Regulatory Notice

Icelandic Elements products are cosmetic products intended for topical use only and are presented in full accordance with applicable EU cosmetic legislation under Regulation (EC) No 1223/2009.

All product claims and communications are strictly limited to cosmetic properties and general skincare use. No medicinal, therapeutic, pharmacological, or health claims are made or implied for any product in our range, including those containing Cannabidiol (CBD).

The designated Responsible Person for all Icelandic Elements cosmetic products is Adotta CBD Reykjavik EU B.V., Nieuwe Vlissingseweg 190, 4335JG Middelburg, Netherlands (www.icelandicelements.com). This entity is legally accountable for the safety, compliance, and post-market surveillance of all products placed on the market under EU Cosmetics Regulation (EC) No 1223/2009. Full documentation, including the Product Information File (PIF) and Cosmetic Product Safety Report (CPSR), is maintained and available to competent authorities upon request.