Compliance

Hemp (species: Cannabis sativa L) contains over 120 known cannabinoids. Chemical compounds which exhibit a range of physiological effects in humans. Whilst many claims are made about the benefits, little evidence exists to support them. As such, most cannabinoids remain under investigation to establish the necessary evidence.

Cannabidiol (CBD) can be derived from most parts of the hemp plant. They are selectively extracted, concentrating CBD and removing or reducing other chemical component e.g. Tetrahydrocannabinol (THC), Tetrahydrocannabinol Acid (THC-a), Tetrahydrocannabivarin (THC-v) and Cannabinol (CBN) which are psychoactive, defining them as controlled drugs under The Misuse of Drugs Act 1971 and should not be present in any consumer product. However, hemp is generally regarded as containing low levels of these typically found compounds.

Cannabidiol (CBD) and other minor cannabinoids such as Cannabigerol (CBG), are non-psychoactive and are therefore not controlled drugs – but are individually classified as Novel Foods. A food supplement product containing CBD must not exceed <1mg combined of any controlled drug when tested by an independent & accredited laboratory and inorder to prove this it is necessary to deploy highly sensitive analytical methods that are embedded within our quality approach.

In the UK it is Illegal to possess, grow, harvest, supply, produce, import and/or export any type of Cannabis plant (including Hemp) without an appropriate Home Office licence. Every country has its own Narcotic regulations and we take care to ensure compliance in each market we operate.

 

Our products are not ‘synthetic’. All our CBD ingredients are ‘Phytoactive’ – this means they are only derived from the hemp leaf and are subject to a number of rigorous quality & safety checks from testing of ingredients using cutting edge analytical technologies to scrutinising of finished product artwork/labelling by our compliance team of compliance experts, all of which is subject to enforcement by the UK Trading Standards Agency. All our products carry Assured Advice from Hertfordshire Trading Standards, our Primary Authority Provider. As the first products in UK with consent to be placed onto the market you can be assured of their provenance, quality and compliance to existing regulations.

Most importantly no medical claims should be implied and/or suggested regarding any CBD product, unless authorised by the UK Medicines & Healthcare Products Regulatory Agency (MHRA).

Cosmetics
CBD is regulated under the EU cosmetics Regulation (1223/2009). Cosmetic products must not contain any controlled drug, cannabis resin or broad spectrum CBD distillate. This highlights the importance of provenance.

Since the regulation on cosmetics products came into force in July 2013, a Responsible Person (RP) must be designated for each cosmetic product placed on the EU market. The Responsible Person upholds a manufacturers compliance on behalf of the European authorities and therefore makes sure the product is safe for intended use.

Food Supplements
Ingestible cannabinoids such as CBD oils are classified as Novel Foods throughout the UK & EU. This means that any business intending to sell CBD based food products must align with a validated Novel Food application from the Food Standards Agency (FSA and/or EFSA). If by the 31 March 2021 a business does not hold, as a minimum, a validated application then those products will not be allowed to remain on the market. Our products are aligned with TTS Pharma’s Novel Food Application 2019/1458 – the first application to be submitted by any UK company.

The UK General Food Law is designed to protect our consumers by ensuring products meet both UK & EU Food Standards Agencies & Home Office guidelines for ‘Quality’ & ‘Safety’.

Furthermore, the UK Home Office has issued guidance that a CBD based food product will be classified as a drug if it contains >1mg or 0.0001% (combined) of Tetrahydrocannabinol (THC), Tetrahydrocannabinol Acid (THC-a), Tetrahydrocannabivarin (THC-v) and Cannabinol (CBN) combined. Consumers should verify this with their preferred brand using appropriately sensitive testing methods to ensure the product is compliant & legal.

Physical
CBD products that contain unknown or undisclosed levels of controlled cannabinoids known to have psychoactive effects i.e. Tetrahydrocannabinol (THC), Tetrahydrocannabinol Acid (THC-a), Tetrahydrocannabivarin (THC-v) or Cannabinol (CBN) have potentially dangerous implications for the consumer in a range of settings such as driving to operating machinery.

Contamination & Safety Risk
CBD derived from an uncontrolled source, depending on its origin & safety screening processes, can contain high levels of harmful toxins and/or contaminants e.g. benzopyrenes, hydrocarbons, heavy metals, pesticides, mycotoxins etc. absorbed from the local farming environment that could lead to serious health issues.

Independent analysis of our products has demonstrated the absence of these and all EU identified harmful impurities.

Professional Sports People
Athletes should seek professional guidance before using CBD as part of recovery regime in order to avoid being at risk of failing mandatory screenings – despite CBD itself being exempt from the World Anti-Doping Agency’s (WADA’s) list of banned substances.

The Endopure family respect, and are proud to work within, regulatory frameworks throughout our chain and will only offer products which are ‘exempt’ from the Misuse of Drugs Act 1971 and are in full compliance with both UK Home Office & UK/EU Regulators.

For us, science is integral to consumer safety & consistent high product quality. Our Cosmetic & Food ranges undergo extensive analysis by Fera Science – one of the world’s leading & respected food testing facilities who operate one of the UK’s only government accredited laboratories; www.fera.co.uk