CBD legal in Germany

We wanted to know from the Federal Institute for Drugs and Medical Devices (BfArM) “whether CBD could be bought legally in Germany”,

The Federal Institute for Drugs and Medical Devices (BfArM) is an independent higher federal authority within the scope of business of ​​the Federal Ministry of Health. It is responsible for approval, improvement of the safety of medicinal products, risk identification and evaluation of medical devices and the monitoring of narcotic and basic substances.

This is the opinion of bfarm.de on the legality of CBD oil in Germany:

With the Act on Amendments to narcotics legislation and other acts, which came into force on 10 March 2017, the legislators have changed the position of cannabis in Appendices I to III to § 1 para. 1 Narcotics Act (BtMG).

The narcotics law has since differentiated between cannabis under Appendix III (medical use) and cannabis under Appendix I (non-medical use). Appendix I also provides for exemptions for industrial hemp (see points (b) and (d) under the position of cannabis).

According to point b under the item Cannabis in Appendix I to § 1 (1) BtMG, plants and parts of plants belonging to the genus cannabis are excluded from the provisions of the narcotics legislation if they come from cultivation in European Union countries with certified seeds (hemp) or do not exceed a THC content of 0.2% and related activity (except cultivation) is solely for commercial or scientific purposes, which excludes abuse for intoxication purposes.

This exemption also applies to preparations derived from plants and parts of plants, provided that they fulfil the conditions set out above.

As the permit-free circulation is restricted to commercial or scientific purposes, unprocessed or processed (for example, only dried and shredded) parts of plants must not be delivered to the final consumer.

This does not apply to preparations containing processed hemp of the aforementioned varieties, even if small amounts of residual THC originating from the parts of the plant are still present.

However, a condition for the supply to the final consumer is that abuse for intoxication purposes can be excluded. The BfR limit values ​​may be invoked if oral intake of the product is intended:

http://www.bfr.bund.de/de/presseinformation/2000/07/bgvv_empfiehlt_richtwerte_fuer_thc__tetrahydrocannabinol__in_hanfhaltigen_lebensmitteln-884.html

The cannabis extracts you request (CBD oil/CBD isolate, editor’s note) may – from a narcotics legislation standpoint – only be handed over to the final consumer if the extracts are exclusively extracted from hemp (< 0.2% THC or EU variety) and the end products contain the aforementioned BfR THC reference values.

Please note that the aforementioned exemption only applies to products without medical purpose.

Products from cannabis or industrial hemp which are intended for medical purposes are, from a narcotics legislation standpoint, only transportable and prescriptive if the conditions of Appendix III to § 1 para. 1 BtMG are fulfilled (“only from an arable crop grown for medicinal purposes under State control in accordance with Articles 23 and 28 (1) of the 1961 Single Convention on Narcotic Drugs“).

Excerpt from the BfR opinion on “THC in feed from hemp and hemp products with regard to animal health and carryover in food of animal origin”

http://www.bfr.bund.de/cm/343/thc-in-futtermitteln-aus-hanf-und-hanferzeugnissen.pdf

3.2 Estimates of farm animal THC intake as shown in Table 2 and EFSA 2011, levels of THC in hemp grown for fibre are typically 0.04-0.1% on average; only a few (3.6%) exceed the legally stipulated maximum content of 0.2% THC in the TM.

As Regulation (EC) No 1420/98 only allows the cultivation of hemp varieties containing no more than 0.2% of THC in the EU, this value is used as a basis for the subsequent estimation of the daily THC intake of farm animals (Table 5).

For the calculation of the proportion of hemp and hemp products in the ration of livestock, the quantities used in the literature (marked in gray) or the quantities known for comparable feeds (marked in italics) were used.

Table 5:

Model calculation of the daily uptake of THC for livestock (mg/kg LM) on hemp and hemp products with a content of 0.2% THC/kg (TM) Max. Proportion of hemp products in the ration (%TM) Calculated THC uptake (mg/kg of live weight) Chicken Dairy cow Beef Pork 1.9 KG kg 550 kg KG 350 kg KG 75 kg KG Hemp product Chicken Dairy cow Beef Pork THC (%)* daily max. Feed intake (TM) 120 g daily max. Feed intake (TM) 20 kg daily max. Feed intake (TM) 15 kg daily max. Feed intake (TM) 3 kg Hemp seeds 20 5 14 5 0.2 25 4 12 4 Hemp cakes 20 14 20 5 0,2 25 10 17 4 Hemp extract shreds 20 20 10 0,2 25 17 8 Hemp fodder 70 70 0,2 51 60 Hemp straw 7 10 0.2 5 9 Hemp oil 12 1 0.2 15 1 gray: used amounts in feeding studies (c.f. Table 1)

Italic:

model intake via feed corresponding to the usual quantities of comparable feed *Reference TM, according to Regulation (EC) No 796/2004, Appendix I The model of THC in Table 5, calculated using hemp and hemp products with a THC content of 0, 2% is between 1 and 60 mg/kg LM for livestock. The amount of THC absorbed by livestock is about 10- to 600-fold above the oral intake of 0.1 and 50 mg/kg LM in rodents, at which point endocrine effects could be observed.

The BfR has no information on whether hemp is fed to farm animals as green fodder.

Assuming that hemp is given as complete feed to ruminants and assumes a volume of 70% in the ration, the result is an expected high THC intake of 51-60 mg/kg LM (worst case).

Experience has shown that THC has a species-specific dose-response relationship. However, little is known about toxicological effects (e.g., on fertility, immune system, digestive tract) of different doses of THC in livestock.

Therefore, taking into account the species-specific sensitivities of a THC intake of livestock, as shown in Table 5, it must be considered possible that the hemp and hemp products contaminated with livestock THC levels of 0.2% impairs animal health.