There was some initial disappointment but soon thereafter the atmosphere improved considerably and many students and visitors began attending regularly for classes in English, French, or chemistry – though only those from outside could access some services such as taxi services in an emergency situation were allowed inside a school building to learn these subjects in greater depth than ever. As reported by CannaReporter and Infarmed, Portugal’s National Authority for Medicines and Health Products (IP) issued orders that require several cosmetic products containing cannabidiol (CBD) from being immediately pulled from market as they fail to abide with European Union (EU) legislation by using CBD obtained through extracts, tinctures or resins from cannabis plants. Measures have been taken against SVR, Naturasor and Dermacol products identified and those responsible notified by Portuguese regulator. This decision comes at a time when CBD cosmetics market is rapidly expanding and highly desired among consumers. This analysis takes an in-depth look at the impact of Infarmed’s withdrawal of products from the market and any questions it raises about harmonisation within European law and how this might impede free movement of goods. CannaReporter inquired with Infarmed yesterday but is yet to receive their response regarding these measures.
Cosmetic products containing cannabidiol (CBD) have experienced rapid expansion in Portugal due to increased consumer interest and recognition of its beneficial properties. Yet despite widespread user adoption and rising supply from various brands, Infarmed has ordered withdrawal from Portuguese market of several cosmetic products containing CBD as it does not meet legal requirements and contains ingredients considered narcotic products that violate regulations for marketing them legally.
According to three information circulars issued on February 10, 2025 by Infarmed, its marketing of several products under the brands SVR, Naturasor and Dermacol with CBD extracted directly from extracts, resins or tinctures of cannabis has been suspended. Under European regulations (Regulation (EC) No 1223/2009 and Regulation (EU) No 655/2013), cosmetic products that include narcotic products as ingredients cannot fall within entry 306 of Annex II to Regulation 1223/2009, according to entry 306. According to Infarmed, using CBD or cannabinoids found naturally within cannabis plants as cosmetic ingredients is forbidden, due to them originating in extracts/tinctures of Cannabis/resin; although for all intents and purposes this practice is legal in other member states where CBD purification from resins/tinctures/extracts of certified industrial hemp plants with THC contents no higher than 0.3% is done as purifying agents before being further used as cosmetic ingredients.
Product Recall in Market
Infarmed discovered products under the SVR, Naturasor and Dermacol brands that contained CBD extracted from extracts or resins of cannabis plants which violate current regulations; consequently these were removed from sale:
SVR stands for CBD Ampoule Resist.
Naturasor offers Origin – CBD Hot Cream, Origin – CBD Cold Cream and Origin’s Natural Oil Blend CBD (10%, 20% & 30%) plus 15% + Melatonin as options from Naturasor; Dermacol offers Light CBD BB Cream Medium CBD Mascara & Lipstick No 3 from Naturasor and Origin respectively.
Circulars released to CannaReporter(r) indicate that those responsible have been informed to immediately cease distribution on the national market with immediate effect. CannaReporter has reached out to these brands in order to understand more clearly their plans in regard to this occurrence but have received no reply so far.
Regulation (EC) No 1223/2009 provides Infarmed with justification for withdrawing these products from the market, since its Annex establishes which substances cannot be included as ingredients of cosmetic products; specifically entry No 306 of this Annex describes “Narcotic drugs listed in Table I or II of the Single Convention on Narcotic Drugs, signed at New York on 30 March 1961”.
Infarmed appears to identify Cannabidiol-containing Extracts, Tinctures or Resins as narcotic, while CosIng does not bear such annotation. Furthermore, KannaVape won its case before the Court of Justice for European Union four years ago which required CosIng to add this entry as evidence in support of KannaVape’s case in CosIng.
CBD products have been pulled periodically from Portuguese market due to the explanation above, with manufacturers of such products receiving notice by regulator to pull their goods from sale. Cannabidiol and its significance as an ingredient have already been made clear through Information Circular 014/CD/100.20.200 of February 11 2022 by Infarmed’s President who clarifies that inclusion of ingredients in the Cosmetics Ingredient Database does not indicate approval or authorization; additionally they inform that cannabinoids found naturally within cannabis plants are prohibited due to extraction methods utilizing extracts/tinctures of Cannabis resin resulting from cultivation practices; furthermore it does not permit their inclusion as they cannot be obtained via cultivation methods as these sources produce compounds with greater levels than cannabinoids found naturally found naturally within plants themselves and therefore cannot be included into this information circular due to implications on Infarmed’s interpretation that inclusion does not indicate approval or authorization or authorization but only presence within it does mean.
Article 9 of Regulation 1223/2009 stipulates that Member States cannot restrict cosmetic product sales that meet its requirements; Infarmed’s interpretation of CBD may therefore create regulatory hurdles for products using purifications composed largely of CBD extracted from hemp plants.
According to Infarmed’s calculations, purified CBD extracted from hemp extracts should not be considered eligible as an ingredient in cosmetic products as per Entry 306 in Annex II of Regulation 1223/2009.
However, in such an instance, these inclusions should also be recorded in CosIng through annotations that shows they meet Annex II’s restrictions of Regulation 1223/2009. Otherwise it might be reasonable to question if Infarmed is using only necessary and scientifically validated restrictive measures to defend its purpose of safeguarding public health.
CannaReporter(r) has already requested additional clarification from Infarmed on this matter. However, no technical or legal foundation seems to support Infarmed’s claims on this subject matter.
Traces of Prohibited Substances and Good Manufacturing Practices
One aspect that raises some confusion concerns the application of Article 17 of this regulation, which allows the unintentional presence of small quantities of banned substances due to manufacturing processes, storage conditions or migration from packaging so long as these comply with good manufacturing practices – this would include any trace amount of cannabinoids found within products without automatically leading to their withdrawal from sale on the market.
Under European regulation, however, good manufacturing practices ensure cosmetic products meet stringent quality standards, prompting questions as to whether Infarmed’s decision could be seen as excessively restrictive in light of these requirements.
By taking these measures, Infarmed is setting an important precedent that could significantly reshape the marketing of CBD cosmetics in Portugal, leading brands to reformulate their products to use only synthetic cannabidiol instead of using botanical sources such as CBD extracted from plants for cosmetic ingredients. Yet this approach also raises issues regarding compliance between Portuguese regulations and European market requirements, and more widely acknowledged safety of plant sourced CBD for use as ingredients within cosmetic products.
CannaReporter(r) sent several questions via email to Infarmed Press Office yesterday afternoon; as of publishing time of this article they had not heard back yet.
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