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Legal framework for the distribution of cannabidiol in Germany

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Published on August 23, 2016 by http://www.alternative-drogenpolitik.de/2016/08/23/rechtliche-rahmenbedingungen-fuer-den-vertrieb-von-cannabidiol-in-deutschland/ 

The deputy Dr. Harald terpene (Alliance 90 / The Greens) has asked a question on the legal status of cannabidiol in the German Bundestag. Question Rationale: CBD should be available on prescription . Here the question and the answer of the Federal Government.

Source: German Bundestag Printed Matter 18/8659 ; 18th legislature 03/06/2016; Written questions with the commitments of 30 May 2016 the week answers the federal government

47th MP Dr. Harald terpene (Alliance 90 / The Greens)

Under what legal conditions and taking into account the recommendation of the Committee of Experts on medical prescription in accordance with § 53 paragraph 2 of the Medicines Act (AMG) of 19 January 2016 that cannabidiol prescription in accordance with § 48 AMG is to be assumed, must cannabidiol (CBD), for example in the forms 10-percent CBDExtrakt the manufacture of cosmetics, 1-percent CBD portion in hemp seed oil (as a body oil), CBD as a natural part of Nutzhanfblütentee and other Nutzhanfprodukten that are intended to be eaten, hemp seed oil (or other foods) with added 0.5 -prozentigem CBD and loose Nutzhanfblüten with 1.5-percent CBD portion are currently sold in Germany, and which limits be adopted for CBD compared to tetrahydrocannabinol (THC) in foods and cosmetics?

Answer by Parliamentary State Secretary Dr. Maria Flachsbarth from June 2, 2016

On the subject of food:

For hemp foods containing cannabidiol, there are no specific provisions applicable to foodstuffs. The general rules, in particular Regulation (EC) no. 178/2002 (so-called. Basic Regulation in Food Law) and the Food and Feed Code.Thereafter, it is especially forbidden foods that are not safe to manufacture or place on the market. Food business operators must ensure conformity of the marketed by them with the relevant legislation in the context of their duty of care.The enforcement of food law is for the competent authorities of the countries in Germany.

The Federal Institute for Risk Assessment (BfR) has announced that exist for CBD in hemp foods other than for tetrahydrocannabinol no health-based guideline (Health-based Guidance Values, HBGV). In this respect there is no basis for the establishment of limit values for CBD in hemp foods. Products containing CBD containing extracts from the hemp plant, are – provided they have no pharmacological effect – classified as a novel food in the EU. Novel foods should be placed on the market if they are to health evaluation and approval.

On the subject of cosmetic products:

Cosmetic products are regulated at the level of the European Union to Regulation (EC) no. 1223/2009. There are no material specific rules in the Regulation to CBD. Considerations to the European Commission is not aware of the federal government. The regulation defines cosmetic products as substances or mixtures, which are intended, with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or to come into contact with the teeth and the mucous membranes of the oral cavity, and namely to perfume to view exclusively or mainly to cleaning them, changing their appearance, to protect them, to keep them in good condition or correcting body odors.
For classification as a cosmetic product is in each individual case on the basis of a concrete product to examine whether the vast cosmetic purpose is given.

Under the Regulation, available on the market cosmetic products under normal or reasonably foreseeable conditions of use for human health must be safe. Before the initial deployment of a cosmetic product on the market a safety assessment is carried out. The so-called responsible person (usually the manufacturer or importer) must make available to the relevant documents for official controls. In the safety review all the ingredients of a cosmetic product shall be considered.

On the subject of drugs:

Recommendations of the Committee of Experts on medical prescription in accordance with § 53 of the Medicines Act only concern aspects of the prescription of drugs.

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Author: Cenedella.de

Philip J. Cenedella IV - The 2-continent Cannabis Consultant. First and foremost, I am a Patient Advocate since 1977. I have also served as a Board of Director for the World Trade Center San Diego, as a Lead Consultant for Deutsche Telekom's Executive Board, Founded the Dayton Human Trafficking Accords and have been a C-Level Business Development Executive for over 3 decades. From California, now residing in Germany and providing professional business development services to firms from North America, Europe and worldwide. I support the work of United States Congressman Dana Rohrabacher (pictured below at ICBC Berlin) and the BERLIN PEACE ACCORDS which call for an end to the world war on Cannabis. https://cenedella.de/berlin-peace-accords Consulting Services: Sales and Business Development - all facets, C-level, ethical and professional Assist with Strategic Direction - but focused on its implementation Professionally represent your firm - at conventions, sales meetings, and events Research - licensing, compliance, distribution networks and qualify potential partners I am your resource, on the ground in Europe! Philip J. Cenedella IV Call +1.888.206.3264 USA / +49.0.151.720.16752 GERMANY Skype: philip.j.cenedella / eMail: phil@cenedella.de

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