Hype over hemp as a veterinary feed additive?

Lately, across Europe there is a perceived popularity surrounding cannabis and, in particular, its component cannabidiol (CBD). Some media reports claim miraculous effects of CBD for human health, while animals are also identified as a target group for the consumption of CBD. However, not everything that is desirable from a marketing point of view is also legally feasible. This article examines whether – and under what conditions – CBD can be marketed for animal use. The discussion applies to the legal situation in the EU, but focuses on the factual and legal situation in Germany. This may vary from the legal practice and administration of justice in other member states.

The substance CBD

Along with tetrahydrocannabinol (THC), CBD is a main component of the cannabis plant. While THC is psychotropically effective, CBD is said to have anti-inflammatory, anticonvulsant, antiemetic, anxiolytic, hypnotic or antipsychotic effects. CBD is often touted as a cure for anxiety, stress, depression, insomnia, pain, inflammation or even serious diseases such as cancer. However, critics doubt that the effects of CBD go beyond those of a placebo. Its efficacy in animals is even more uncertain.

Regulatory framework

The European Court of Justice (ECJ) decided on 19 November 2020 (Case C-663/18) that CBD, when it is extracted from the Cannabis sativa plant in its entirety and not solely from its fibre and seeds, is not a drug within the meaning of the Single Convention on Narcotic Drugs. However, this does not give companies carte blanche to market it. The question is how CBD intended for animal consumption is to be classified within the legal framework applicable in the EU. To answer this, the definitions of the product categories under consideration should be examined: ‘feed material’, ‘compound feed’, ‘feed additive’ and ‘veterinary medicinal product.’

Feed materials are products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures. Compound feed is a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed.

Feed additives are substances, microorganisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Article 5 para 3 Regulation (EC) No 1831/2003 and listed/ described below:

• Favourably affect the characteristics of feed 
• Favourably affect the characteristics of animal products 
• Favourably affect the colour of ornamental fish and birds 
• Satisfy the nutritional needs of animals 
• Favourably affect the environmental consequences of animal production 
• Favourably affect animal production, performance or welfare, particularly by affecting the gastrointestinal flora or digestibility of feeding stuffs, or 
• Have a coccidiostatic or histomonostatic effect.

A veterinary medicinal product, as defined in Regulation (EU) 2019/6 on veterinary medicinal products (which will replace Directive 2001/82/ EC as from 28 January 2022), is:

• Any substance or combination of substances that are presented as having properties for treating or preventing disease in animals (= medicinal product by presentation), or
• Any substance or combination of substances that may be used in or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action (= medicinal product by function).

Veterinary medicinal products and feed additives need a marketing authorisation, making the market entry of such products in the EU laborious, lengthy and expensive. By contrast, feed materials and compound feed can be placed on the EU market without prior authorisation. It is therefore likely that distributors of CBD products for animal consumption would prefer to declare such products as (compound) feed. This can only be done if (isolated) CBD or extracts of cannabis containing CBD can be classified as ‘feed material’.

Commission Regulation (EU) 2017/1017 on the catalogue of feed materials considers ‘hemp seed’, ‘hemp expeller’, ‘hemp oil’, ‘hemp flour’ and ‘hemp fibre’ to be ‘feed material’ – CBD or hemp extract containing CBD are not listed. Since Commission Regulation (EU) 2017/1017 is not a closed list of permitted feed materials, it may mean that CBD or hemp extract with CBD could be considered feed materials. The courts must clarify the legal status of CBD products for animal consumption.

Recent case law and other developments

German courts are frequently confronted with the legal classification of CBD-containing products. Most cases concern CBD for human consumption and so far the trend is to classify such products as ‘novel food’ within the meaning of Regulation (EU) 2015/2283 if CBD has been extracted or isolated from the cannabis plant.^[1] The case law corresponds with the – although legally non-binding – EU novel food catalogue. This indicates that extracts of Cannabis sativa and derived products containing cannabinoids, such as CBD, are considered novel foods since a history of consumption has not been demonstrated.^[2]

The result is that such CBD products are currently not legally marketable as food for animals in the EU since this would require an authorisation as novel food that currently does not exist. Furthermore, in summer 2020 the European Commission suspended applications for CBD to be authorised as novel food, stating that CBD and other extracts from the cannabis plant would be better regulated as narcotics under the United Nations Single Convention on Narcotics. In view of the ECJ decision on 19 November 2020, however, it is clear that the first novel food applications for the use of CBD in the human sector will have to be considered in the medium term – the first marketable CBD foods may be accessible in the near future.

The developments on CBD for human consumption do not directly affect the use of CBD in veterinary healthcare products. However, CBD products for animals are facing stricter regulation than anticipated. According to the Administrative Court of Munich^[3], CBD containing hemp extract must be classified as a feed additive and therefore requires an appropriate authorisation. Hemp extracts containing CBD would not meet animals’ nutritional needs and therefore could not be regarded as ‘feed materials’, says the judgement. However, according to advertising, the product would intentionally be added to feed in order to favourably affect animal welfare and therefore meets the definition of ‘feed additive’ as stipulated in Art. 2 para 2 lit a, 5 para 2 lit f Regulation (EC) No 1831/2003.

The Administrative Court of Schleswig^[4] took a similar view: hemp oils that have not been obtained by pressing hemp seeds, plant hemp seeds and parts of the plant, as well as hemp extracts, are to be classified as feed additives. This also applies if CBD is presented as promoting wellbeing and improving tiredness and fatigue, says the court. The Higher Administrative Court of Münster^[5] also came to the conclusion that the CBD oil disputed in the specific case had to be classified as a feed additive on the basis of the advertising claims, which state that its purpose was to positively influence the wellbeing of the animals.

While the trend in German jurisprudence in the human sector is towards classifying CBD as novel food, the trend in the veterinary sector is towards feed additives. However, this does not mean that a classification of CBD as a veterinary medicinal product is generally o the table. In particular, the following must not be overlooked: according to where a veterinary medicinal product as defined in this regulation also falls within the scope of Regulation (EC) No 1831/2003, and there is a conflict between Regulation (EU) 2019/6 and Regulation (EC) No 1831/2003, Regulation (EU) 2019/6 shall prevail. In other words: If a product falls under both the definition of a veterinary medicinal product and the definition of a feed additive, the result is that the stricter law applies.

In many cases, classification of CBD products as medicinal products is expected in view of the ill-considered advertising claims suggesting a preventive or therapeutic effect for some diseases. The borderline between wellbeing claims (= feed additive) and preventive or therapeutic claims (= veterinary medicinal product) is narrow. Regardless of whether an authorisation as feed additive or veterinary medicinal product is needed, given the unclear evidence of the effects attributed to CBD, it will not be easy to obtain. However, if proof of efficacy is provided, a qualification of its effect as pharmacological may be plausible.

In view of the conflict-of-laws clause in article 3 of Regulation (EU) 2019/6, it remains to be seen if the only way to legally market CBD products for animal consumption will be to get authorisation as veterinary medicinal products, since products that are effective have to be classified as medicinal products by function. German case law has not yet had to address this issue, as the effectiveness of the products in question has remained unclear in the cases so far.

Conclusion

There are many legal hurdles blocking the distribution of CBD for animal consumption in the EU. Should the trend in German case law prevail across the EU, an authorisation as feed additive will be required. In a worst case scenario, an authorisation as a veterinary medicinal product would be needed. Since both alternatives require proof of e cacy, the provision of which seems questionable, the fate of CBD products for animal consumption remains unclear. The hype surrounding CBD in the veterinary sector could end as quickly as it began.

References:

^[1] Higher Administrative Court Mannheim, 16 October 2019, 9 S 535/19; Higher Administrative Court Lüneburg, 12 December 2019, 13 ME 320/19; Higher Administrative Court Münster, 23 January 2020, 13 B 1423/19; Administrative Court Schwerin, 20 May 2020, 7 B 394/20.

^[2] European Commission. Novel food catalogue. Available at: Novel food catalogue (europa.eu) (accessed 1 October 2021)

^[3] Decision from 13 May 2020, M 26 S 19.3205.

^[4] Decision from 21 July 2020, 1 B 86/20.

^[5] Decision from 9 March 2021, 9 B 1566/20.