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Food Industry

Dáil Éireann Debate, Wednesday - 14 July 2021

Wednesday, 14 July 2021

Questions (390, 391, 392, 393, 394, 395)

Pauline Tully

Question:

390. Deputy Pauline Tully asked the Minister for Health if cold pressed cannabidiol food supplements derived from the EU hemp crop are regulated as traditional foods in Ireland; if the Food Safety Authority of Ireland advises Irish hemp farmers and producers that these products do not require a novel food authorisation from the European Food Safety Authority; and if he will make a statement on the matter. [31313/21]

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Pauline Tully

Question:

391. Deputy Pauline Tully asked the Minister for Health if Irish farmers and producers of cold pressed cannabidiol food supplements made from hemp would continue to have access to EU markets for their products in the event that the European Commission would require those specific products to be authorised by European Food Safety Authority in accordance with EU Novel Food regulation 2015/2283; and if he will make a statement on the matter. [31314/21]

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Pauline Tully

Question:

392. Deputy Pauline Tully asked the Minister for Health the reason Irish authorities require Irish hemp farmers and processors to submit EU novel food authorisation applications for agricultural foods based solely on the extraction solvents used in their production when those solvents are already specifically pre-authorised by European authorities within the EU novel good regulatory framework given that Regulation (EU) 2015/2283 states that the extraction solvents falling within the scope of Directive 2009/32/EC of the European Parliament and of the Council should be excluded from the scope of novel food regulation; and if he will make a statement on the matter. [31315/21]

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Pauline Tully

Question:

393. Deputy Pauline Tully asked the Minister for Health if his attention has been drawn to the clarifications by the European Commission (details supplied) regarding the novel food authorisation applications of Irish hemp farms and businesses in which the Commission again explains specifically for Ireland that cannabidiol food and food supplements produced from any part of the EU hemp crop including the flowers and leaves are considered to be legal agricultural food products by the European Commission; and if he will make a statement on the matter. [31316/21]

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Pauline Tully

Question:

394. Deputy Pauline Tully asked the Minister for Health the reason the Health Products Regulatory Authority is requiring Irish hemp farmers and producers to formally confirm that they will destroy the flowers and leaves of their 2021 hemp crops considering that these farmers and producers are at present progressing EU novel food authorisation applications at the insistence of the Food Safety Authority of Ireland and that further clarifications was provided by the EU Commission which his attention was drawn to on 22 February 2021 (details supplied); and if he will make a statement on the matter. [31317/21]

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Pauline Tully

Question:

395. Deputy Pauline Tully asked the Minister for Health if his attention has been drawn to the fact that hemp derived cannabidiol food supplements cannot be made from the seeds, fibres and stalks of the hemp plant; and if he will make a statement on the matter. [31318/21]

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Written answers (Question to Health)

I propose to take Questions Nos. 390 to 395, inclusive, together.

The Department of Health issues the licences for the cultivation of hemp in Ireland. The Health Products Regulatory Authority (HPRA) processes the applications received for such licences, on behalf of the Department of Health. The applications are assessed against what is legally permitted under the current Misuse of Drugs legislative framework.

This legislation states that cannabis and its derivatives are controlled by virtue of the Misuse of Drugs framework. Under the Misuse of Drugs Acts, cannabis means any part of the plant of the genus cannabis but excludes the following after separation from the rest of the plant:

- the mature stalk and fibre produced from it; and

- the seeds.

Any other part of the plant not explicitly excluded under the Act is cannabis for the purposes of the Act. As such, only the seed, mature stalk or fibre of the hemp plant may legally be supplied onwards. As a consequence, other parts of the plant must be destroyed.

Consideration as to whether a product contains a substance controlled under the Misuse of Drugs framework falls under the remit of officers authorised under the Misuse of Drugs legislative framework, which include, officers of the Revenue Commissioners and An Garda Síochána.

When hemp-derived products are placed on the market as ‘food’ in line with the General Food Law (Regulation (EC) No. 178/2002), numerous other regulations pertaining to the EU food legislation may apply, and are enforced by official agencies under service contract to the Food Safety Authority of Ireland. The flowers/buds of the Cannabis plant fall outside the definition of food in Regulation (EC) No. 178/2002 as they are considered narcotic drugs in line with the UN Single Convention on Narcotic Drugs 1961. Therefore the marketing of cannabis flowers or buds on their own as food in the EU is not permitted. While hemp seeds do not naturally produce or contain cannabinoids including cannabidiol (CBD), there may be varying levels of cannabinoids found in fibres and stalks of the hemp plant.

Ireland does not consider CBD derived from legally-cultivated hemp by cold pressing as a novel food. This means cold-pressed CBD from legally-cultivated hemp can be sold as food in Ireland without requiring a novel food authorisation, subject to compliance with all other applicable food legislation. However, where cannabis-derived CBD products have been refined by purification, concentration, etc., they are considered novel foods that must be authorised in accordance with Regulation (EU) 2015/2283 prior to marketing. The rationale for this position is not related to the legal use of authorised extraction solvents, but is due to the potential safety threats posed by the higher concentration of desirable components and possible co-purified undesirable components, where they do not have a significant history of consumption prior to 1997. This general position has been agreed by all EU Member States as expressed in the entry for “Cannabinoids” in the EU Novel Food Catalogue ec.europa.eu/food/food/novel-food/novel-food-catalogue_en .

The addition of synthetic or concentrated forms of plant-derived CBD to a hemp seed-derived food in order to boost the levels of CBD also makes that final food a novel food which must be authorised in accordance with Regulation (EU) 2015/2283 before it can be placed on the EU market.

Question No. 391 answered with Question No. 390.
Question No. 392 answered with Question No. 390.
Question No. 393 answered with Question No. 390.
Question No. 394 answered with Question No. 390.
Question No. 395 answered with Question No. 390.
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