Infarmed orders the withdrawal of (more) cosmetics containing CBD, but the measure raises doubts about compliance with European regulations

Infarmed – National Authority for Medicines and Health Products IP has ordered the immediate withdrawal from the market of several cosmetic products containing cannabidiol (CBD), arguing that they do not comply with European legislation by using CBD from extracts, tinctures and resins of the cannabis plant. The measure affects brands SVR, Naturasor and Dermacol, whose products have been identified, and those responsible have been notified by the Portuguese regulator. The decision comes at a time when the CBD cosmetics market is rapidly expanding and is widely sought after by consumers. In this analysis, we take an in-depth look at the impact ofthe withdrawal of these products from the market, the questions it raises about the harmonization of rules in the European Union and the impact of this restriction on the free movement of goods. CannaReporter® asked Infarmed about these measures yesterday, but has not yet received a response.

The market for cosmetic products containing cannabidiol (CBD) has shown significant growth in Portugal, driven mainly by consumer demand and recognition of the beneficial properties of CBD. However, despite the high level of adoption by users and the growing supply from various brands, Infarmed has ordered the withdrawal from the Portuguese market of several cosmetic products containing CBD, arguing that they do not meet the legal requirements for their marketing and insisting that they contain ingredients that are considered narcotic products and are therefore prohibited.

According to three information circulars issued on February 10, 2025, Infarmed suspended the marketing of several products of the brands SVR, Naturasor and Dermacol, because they contain CBD extracted directly from extracts, resins or tinctures of the cannabis plant. According to European regulations (Regulation (EC) No. 1223/2009 and Regulation (EU) No. 655/2013), cosmetic products cannot contain narcotics as ingredients, according to entry 306 of Annex II of Regulation 1223/2009. According to Infarmed, the inclusion of CBD or other cannabinoids, which occur naturally in the cannabis plant, is not permitted, because they are obtained through the preparation of extracts or tinctures of Cannabis or its resin – even though, for all intents and purposes, it is legal in other member states where CBD is purified from resins, tinctures or extracts of certified industrial hemp plants, whose THC content is a maximum of 0,3%, to be subsequently used as a cosmetic ingredient.

Products withdrawn from the market

Infarmed identified that products from the SVR, Naturasor and Dermacol brands contained CBD obtained from extracts, resins or tinctures of the cannabis plant and that the presence of this ingredient violates current regulations, which consequently led to the withdrawal of the following products:

• SVR: CBD Ampoule Resist.
• Naturasor: Origin – CBD Hot Cream, Origin – CBD Cold Cream, Origin – Natural Oil Blend CBD (10%, 20%, 30%) and Origin – Natural Oil Blend 15% CBD + Melatonin.
• Dermacol: BB Cream CBD Light, BB Cream CBD Medium, CBD Mascara and CBD Lipstick no. 3.

According to the published circulars, the entities responsible for these products have been notified and instructed to cease distribution in the national market with immediate effect. CannaReporter® has asked all these brands for clarification to better understand the situation and what their plans are to respond to this occurrence, but has not yet received a response.

O rational behind these withdrawals

It is precisely Regulation (EC) No. 1223/2009 that is used by Infarmed to justify the withdrawal of these products from the market. This is because the European legislation has an annex, which establishes the products that are prohibited from being included in the ingredients of cosmetic products. This annex contains entry No. 306, relating to “Narcotic drugs: all substances listed in Tables I and II of the Single Convention on Narcotic Drugs, signed in New York on 30 March 1961”.

Infarmed appears to be identifying Cannabidiol derived from Extracts, Tinctures or Resins as a narcotic, whereas in the Cosmetic Ingredients Database (CosIng), this annotation does not appear. It is important to note that the entry itself was added to CosIng by Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) four years ago, after KannaVape's victory at the CJEU.

CBD products have been withdrawn from the Portuguese market from time to time, justified precisely by the rational explained above, with the manufacturers of these products being notified by the regulator to withdraw the products from the market. This is due to cannabidiol and the understanding that has already been made known through the Information Circular 014/CD/100.20.200 of February 11, 2022, in which the President of Infarmed makes it clear that the inclusion of ingredients in the Cosmetic Ingredient Database does not mean that they are approved or authorized. Infarmed also informs that “the inclusion of CBD or other cannabinoids, which exist naturally in the cannabis plant, is not permitted, as they are obtained through the preparation of extracts or tinctures of Cannabis or its resin”.

However, Article 9 of Regulation (EC) No 1223/2009 states that Member States may not refuse or restrict the marketing of cosmetic products that comply with the requirements of the regulation. Therefore, Infarmed's interpretation of the origin of CBD may be creating a regulatory barrier for products that use purifications essentially composed of CBD, derived from extracts of the hemp plant.

Apparently, Infarmed considers that purified CBD from hemp extracts is not eligible to be used as an ingredient in cosmetic products, claiming that it is included in entry 306 of Annex II of Regulation 1223/2009.

However, if this is the case, this inclusion should also be included in the Cosmetic Ingredients Database (CosIng), namely through an annotation demonstrating that these ingredients are, in fact, covered by the prohibition set out in Annex II of Regulation 1223/2009. If this is not the case, it may be possible to ask whether Infarmed is using the strictly necessary and scientifically valid restrictive measures to defend its purpose of safeguarding public health.

In fact, there appears to be no technical or legal basis to substantiate the position of Infarmed, to whom CannaReporter® has already requested additional clarification on this issue.

Traces of prohibited substances and good manufacturing practices

Another point that raises some questions is the application of Article 17 of the same regulation, which allows the unintentional presence of small quantities of prohibited substances if these are unavoidable due to the manufacturing process, storage or migration from packaging, as long as they comply with good manufacturing practices. This article could allow for the presence of traces of cannabinoids in products, without this automatically resulting in their withdrawal from the market.

On the other hand, good manufacturing practices defined in the European regulation ensure that cosmetic products are manufactured according to strict quality standards, which also raises questions about whether Infarmed's decision could be considered excessively restrictive in the broader context of European regulation.

With these measures, Infarmed is setting a precedent that could have a major impact on the marketing of CBD cosmetics in Portugal, leading brands to reformulate their products to use only synthetic cannabidiol. However, this approach also raises questions about the alignment of Portuguese regulations with the European market and the need for broader recognition of CBD extracted from the plant as a safe and effective ingredient in cosmetics.

Yesterday, CannaReporter® sent an email with several questions to the Infarmed Press Office, but up until the time of publication of this article, it had not yet received a response.

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Antonio João Costa

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I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.

I can be contacted by email at joao.costa@cannareporter.eu

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