Great, I’ll gather detailed information on the proposed reprotoxic classification of CBD under review by the European Chemicals Agency (ECHA), with a focus on cosmetic applications—especially CBD flowers in Germany and extracts globally.

I’ll also look into UIVEC and CEHTRA’s positions, the implications of the classification on the CBD startup landscape, and what regulatory developments founders should be watching. I’ll incorporate relevant quotes and highlights from the public consultation process where possible.

I’ll let you know as soon as the article draft is ready.

CBD at Risk of ‘Reprotoxic’ Label in EU: Implications for Cannabis Cosmetic Startups

The European CBD industry is facing a pivotal regulatory moment. Cannabidiol (CBD) – widely used in wellness and cosmetic products – is under scrutiny by EU authorities for potential classification as a reproductive toxicant. In mid-2023, France’s health agency ANSES proposed that CBD be officially classified as a substance toxic to reproduction under the EU’s CLP (Classification, Labelling and Packaging) Regulation. This proposal, submitted in June 2023, recommends labeling CBD as a “presumed human reproductive toxicant,” i.e. placing it in Category 1B for reproductive toxicity (with hazard statement H360FD: “May damage fertility. May damage the unborn child.”) and also as a lactation hazard (H362: “May cause harm to breastfed children.”). Such a designation indicates a serious concern: it means regulators believe CBD could impair fertility or development based on available data. Here we explain the background of this proposal, the parallel reviews underway by European agencies, and what they mean for cannabis entrepreneurs in the cosmetics sector – from CBD skincare startups in Germany to hemp extract makers across Europe.

ANSES Proposal and ECHA’s CLP Review Process

ANSES’s classification dossier is built on animal study findings that linked high doses of CBD to reproductive and developmental harms. In studies on monkeys, rats, and mice, researchers observed adverse effects such as disrupted sperm development (spermatogenesis), reduced fertility, increased perinatal mortality, and neurodevelopmental problems in offspring exposed to CBD. Based on this evidence, ANSES urged that CBD be regarded as a reproductive toxin. If accepted, this would slot CBD into Category 1B of harmonized EU hazard classifications, meaning it is “presumed” to pose reproductive toxicity to humans.

Following ANSES’s lead, the European Chemicals Agency (ECHA) began the formal review under the CLP framework. ECHA’s Risk Assessment Committee (RAC) must evaluate the proposal and all evidence before deciding on the classification. As part of this process, ECHA held a public consultation from 17 March to 16 May 2025 to gather input from stakeholders across industries. The French hemp industry association UIVEC was among those actively engaging: UIVEC submitted a scientific contribution (with support from toxicology consultancy CEHTRA) aiming to refute or refine the proposal. According to UIVEC’s General Manager Zoé Demange, their submission – grounded in current scientific data and realistic exposure levels of CBD – seeks to “challenge a disproportionate classification and to defend CBD as a safe ingredient.” In other words, industry experts argue that the hazard identified by ANSES may not translate to actual risk for consumers at typical usage doses.

Now that the consultation has closed (as of 16 May 2025), ECHA’s RAC will review the feedback and any new data provided. Key questions remain under debate: Do the animal data justify classifying CBD as a high-level reproductive hazard? Or might the evidence be too limited or only relevant at extreme doses? UIVEC and CEHTRA emphasize that exposure context is crucial – e.g. the CBD levels that caused reproductive harm in rodents far exceed what normal consumers would absorb from a CBD face cream or supplement. They suggest that slapping a Category 1B toxic label on CBD would be an overreach not backed by real-world science, potentially conflating high-dose lab effects with negligible-risk cosmetic use. ECHA’s committee could consider such arguments when weighing if a gentler classification (or no classification) is warranted. However, it is important to note that under the CLP rules, hazard classification focuses on intrinsic properties (hazard potential) rather than typical exposure or risk. This means even if CBD is safe in common use, it could still receive a harsh hazard label if the scientific criteria are met.

Timing and next steps: The RAC is expected to discuss the CBD dossier in the coming months. A final RAC opinion on CBD’s classification could emerge by late 2025. If RAC endorses the Category 1B classification (or some variant of it), the European Commission can then add CBD to Annex VI of the CLP Regulation (the official EU list of classified hazardous substances). Such an amendment, via an ATP (Adaptation to Technical Progress) to the CLP, might be adopted in 2026. Typically, once a new classification is adopted, companies have a transitional period (often 18 months) to comply with labeling and packaging requirements. For CBD, this would mean that manufacturers and suppliers would need to update Safety Data Sheets and labels to carry the reproductive toxicity warnings. But the implications go far beyond paperwork for safety labels – they strike at the heart of whether CBD can be legally used in consumer products like cosmetics or foods.

Why a Reprotoxic Label Could Block CBD Cosmetics in Europe

If CBD is officially classified as a reproductive toxicant, it triggers strict consequences under EU product laws. Most notably, the EU Cosmetics Regulation (EC) No. 1223/2009 explicitly bans the use of substances classified as CMR (Carcinogenic, Mutagenic or Reprotoxic) in cosmetics as a general rule. In fact, any ingredient categorized as a Category 1A or 1B toxic for reproduction is automatically prohibited in cosmetic products (unless an exceptional authorization is granted under very stringent conditions). Category 2 (suspected CMR) substances are also presumptively banned unless later allowed after scientific review. This means that if CBD becomes a Category 1B reproductive toxicant, it would effectively be outlawed in cosmetics across the EU. Industry observers note that this would amount to a de facto ban on CBD-infused creams, lotions, and other beauty products, barring a special exemption. The same classification would also raise serious barriers for CBD’s use in foods or supplements – indeed, commentators have dubbed it an “effective ban” for the food and wellness sectors as well.

For cannabis entrepreneurs, this scenario is critical. Over the past few years, CBD has exploded onto the European cosmetics scene – featured in everything from anti-aging serums to spa balms – thanks to its reputed soothing and anti-inflammatory benefits. A reprotoxic classification would abruptly put a halt to this trend. Product development plans would need to be rethought: any formulas containing CBD might have to be reformulated to remove or replace it, or shelved entirely for the EU market. Market access would be cut off for existing CBD cosmetic lines, likely forcing products off shelves once the ban takes effect. Startups that built their brand around CBD skincare could face sunk costs and uncertain futures in Europe. Even beyond cosmetics, a toxic designation might influence regulators in adjacent domains (for example, reinforcing the European Food Safety Authority’s current hold on novel food authorizations for CBD ingestibles due to safety data gaps).

It’s worth noting that a regulatory ban on CBD in cosmetics would apply regardless of hemp origin or purity. The European Commission has clarified (after the landmark Kanavape case) that hemp-derived CBD itself is not considered a narcotic and thus not prohibited by narcotics laws. In fact, as of early 2025 the Commission explicitly stated that CBD (whether from hemp or synthetic) is not listed as a banned substance in the Cosmetics Regulation’s Annex II, so it has been legal to use CBD in cosmetics so long as THC content is only trace residual. This stance recently overruled attempts by some member states (like Portugal’s Infarmed) to pull CBD cosmetics from the market. However, a new classification as a CMR substance would automatically flip CBD’s status to “prohibited” in cosmetics by virtue of Article 15 of the regulation – a much more definitive barrier than the past legal debates over CBD’s narcotic status. In short, the conversation is shifting from narcotics law to chemicals safety law: the outcome of the reprotoxic hazard evaluation will decide CBD’s cosmetic future in Europe.

The SCCS Review: Can CBD Be Used Safely in Cosmetics?

In parallel to ECHA’s work, another crucial review is underway specifically examining CBD’s safety in cosmetics. The Scientific Committee on Consumer Safety (SCCS) – an expert panel advising the European Commission on cosmetic ingredients – has been tasked with assessing whether CBD can be used in cosmetics without harming consumers. This process began in June 2023, when the Commission, responding to divergent national approaches on hemp products, requested the SCCS to conduct a full safety evaluation of CBD (including establishing what level of Δ⁹-THC residue is safe in CBD-based cosmetics). A public call for data was issued to industry and stakeholders, with a window until September 30, 2024, to submit all relevant scientific information on CBD’s toxicity, exposure, and risk profile.

After gathering data, the SCCS in January 2025 agreed to move forward with a detailed risk assessment study on CBD. The committee will review toxicological data (covering areas like skin absorption, systemic exposure, genotoxicity, reproductive toxicity, etc.), evaluate typical consumer exposure from various cosmetic products, and aim to pinpoint maximum safe concentrations for CBD in different product types if possible. Crucially, the SCCS’s approach is risk-based – it will consider whether CBD can be used at certain levels without appreciable risk to users, as well as what impurities (like THC) need to be limited. The final SCCS opinion is expected by April 2026, after which the Commission could propose specific regulatory measures for CBD in cosmetics. For example, if the SCCS finds CBD safe below a certain percentage, the Commission might explicitly permit CBD up to that level (adding it to the allowed ingredient list with conditions), or conversely, if serious risks are identified, they could move to ban it outright via inclusion in Annex II (the banned substances list).

The outcome of the SCCS review will be highly influential. As UIVEC’s team noted, the “parallel reviews” by ECHA and SCCS are poised to play a decisive role in shaping the European CBD industry for years to come. Ideally, these two tracks will converge on a coherent policy. One optimistic scenario some in the industry hope for is that science-based limits set by the SCCS might avert a full ban – for instance, if the SCCS concludes that CBD is safe in cosmetics at concentrations (say) up to 0.3% with minimal THC, this data could inform regulators and perhaps temper the urgency to classify CBD as Category 1B. Indeed, UIVEC has expressed hope that emerging evidence from the Commission’s own review (the SCCS process) will “put the issue to bed” before an outright ban is cemented. However, it is also possible that the SCCS will echo some of ANSES’s concerns – for example, if they determine that no sufficiently safe level can be guaranteed for certain sensitive populations (pregnant women, infants, etc.), that would strengthen the case for strict regulation. Entrepreneurs should be prepared for either outcome.

Industry Perspectives: UIVEC & CEHTRA Challenge the Classification

The European hemp industry is not taking these developments passively. UIVEC (Union of Industrialists for the Valorization of Hemp Extracts), which represents non-intoxicating hemp extract producers in France and Europe, has been at the forefront of the response. In the public consultation that just concluded, UIVEC – with scientific input from CEHTRA’s toxicologists – submitted a detailed argument defending CBD’s safety profile. Their perspective, in summary, is that CBD should not be branded a serious reproductive hazard without solid, contextually relevant evidence.

UIVEC points out that current scientific data on CBD in humans does not show the dire effects seen in a handful of animal studies. The animal studies cited by regulators often involve extremely high doses or routes of administration not comparable to typical human use (for example, force-feeding rodents large CBD quantities daily). In practical cosmetic applications – a few drops of CBD oil on the skin, or a lotion with a fraction of a percent CBD applied topically – the systemic exposure is orders of magnitude lower. From UIVEC’s standpoint, the proposed classification is therefore “disproportionate”. They argue that it would stigmatize CBD with a hazard label that implies significant risk, even though real-world usage may pose minimal to no risk to reproduction.

To bolster their case, UIVEC and CEHTRA’s submission reportedly highlights recent studies and toxicological assessments that support CBD’s benign profile at low doses. They also emphasize the lack of observed reproductive issues in populations consuming pharmaceutical-grade CBD. (Notably, Epidyolex – a high-dose CBD medication for epilepsy – has been used in humans, including women of childbearing age, under medical supervision. While patients are cautioned to avoid use in pregnancy as a precaution, there has not been conclusive evidence of human birth defects or fertility impairment directly caused by CBD in clinical contexts.) Such points likely form part of the scientific counter-arguments aimed at persuading ECHA’s experts that CBD does not merit Category 1B classification, or at least that a more nuanced view is needed.

In addition to challenging the hazard evidence, the industry coalition underscores the economic and innovation impact of an onerous classification. Branding CBD as a reproductive toxicant would “[defend] CBD as a safe ingredient” – a phrase that encapsulates industry’s stance that CBD can continue to be used safely and responsibly. The hope is that regulators will consider a risk-based perspective and perhaps await the SCCS’s findings before making a final call. CEHTRA’s experts have likely provided ECHA with exposure modeling data showing how low typical consumer exposures are, which could question the scientific validity of treating CBD with the same strict category as known potent toxins.

It is important to note that not all stakeholders may share UIVEC’s view. Some public health voices caution that the absence of long-term human data means we should err on the side of caution – especially with vulnerable groups (expectant mothers, infants) potentially exposed to CBD through products. The classification decision ultimately hinges on the weight-of-evidence: if ECHA’s RAC is convinced the hazard is real and relevant, they may proceed with the classification despite industry objections. Nonetheless, the public consultation mechanism allows groups like UIVEC to put alternative interpretations and data on record, which could influence how strict the final outcome will be. The very inclusion of lactation hazard (H362) in ANSES’s proposal, for instance, shows regulators are concerned about CBD passing into breast milk and affecting infants. Industry experts might counter that such a scenario would require the mother to have extremely high bloodstream levels of CBD – again looping back to the exposure debate.

Key Dates and Strategic Considerations for CBD Entrepreneurs

For founders and operators of cannabis startups in Europe, especially those invested in CBD cosmetics or wellness products, it’s imperative to stay on top of these regulatory developments and plan accordingly. Here are some key dates and milestones to watch and strategic steps to consider:

• June 2023 – ANSES Dossier Submitted: The French agency’s proposal to classify CBD as Repr. 1B was the starting gun for the current regulatory review. Entrepreneurs should recognize this as the moment CBD’s safety came under formal EU scrutiny; many more regulatory dominoes (cosmetics safety review, novel food pauses, etc.) have followed.
• March 17 – May 16, 2025 – ECHA Public Consultation: This 60-day window allowed stakeholders to comment on the classification proposal. Industry players who provided input (like UIVEC) have helped ensure that the business and scientific perspective is heard by regulators. Strategy tip: If you missed this round, keep an eye out for any further consultations or calls for evidence (for example, when SCCS releases a draft opinion, there might be a public comment period). Being involved via industry associations can amplify your voice.
• May 27, 2025 – UIVEC Webinar: UIVEC is hosting an English-language webinar on May 27 at 10:00 AM CET, where president Ludovic Rachou and colleagues (including CEHTRA scientists) will present their official contribution and explain the broader regulatory context. This event is a prime opportunity for startups to get insights first-hand from those deeply involved. Founders should consider attending to better understand the nuances of the dossier, the arguments submitted, and the likely next steps from ECHA and the European Commission.
• Late 2025 (Projected) – ECHA RAC Opinion: While not fixed in stone, it’s expected that by the end of 2025 ECHA’s Risk Assessment Committee will vote on whether to formally classify CBD as proposed. This is a make-or-break moment – a positive RAC opinion in favor means the classification will almost certainly be adopted into law. Companies should prepare for the worst-case scenario: if RAC backs the reprotoxic classification, anticipate an EU legal amendment in 2026 banning CBD in cosmetics. In such a case, startups may need to pivot product lines (e.g. exploring non-CBD hemp derivatives like terpene or seed oil-based cosmetics that would remain legal), or shift focus to markets outside the EU. It would also be wise to communicate with investors and partners about this contingency, as it could impact business models and revenue projections.
• September 2024 – April 2026 – SCCS Safety Evaluation: The window for data submissions to SCCS closed in September last year, and the committee’s final opinion is due by April 2026. For entrepreneurs, this timeline means that throughout 2025 and early 2026, the scientific risk assessment of CBD is ongoing in the background. Strategy tip: Monitor updates from the SCCS (via the European Commission or trade bodies). If interim findings leak or a preliminary opinion emerges, gauge what it means for your products. For example, if indications are that “CBD is safe in rinse-off products up to X% but not in leave-on products” or other such nuances, you might adapt your product offerings accordingly (perhaps focusing on those categories deemed lower risk). The SCCS outcome could also provide a glimmer of hope – if positive – to counteract the CLP classification. The Commission has the power to grant exceptions to the cosmetics ban for CMR substances on a case-by-case basis, typically when the SCCS concludes an ingredient can be used safely under certain conditions. Businesses should be ready to leverage a favorable SCCS assessment (for instance, by reformulating to within safe concentration limits) to seek continued market access.
• Beyond 2026 – Regulatory Alignment and Enforcement: Should CBD be classified as a hazard and/or found unsafe for cosmetics, the enforcement would likely kick in via an updated regulation or directive. Mark your calendar for the expected dates of implementation: if an EU regulation banning CBD in cosmetics is published in mid-2026, it might apply from late 2027 (after a grace period). National regulators (like Germany’s BfR or France’s ANSM) would then enforce removal of non-compliant products. Strategic move: Plan an orderly transition – either phasing out CBD products or ensuring any CBD used is sourced and documented in compliance with whatever final rules (e.g. below THC limits, within safe concentrations, etc.). Also, consider having robust product safety data on hand; even if allowed to continue, companies might need to demonstrate compliance with new safety or labeling requirements (for example, providing reproductive toxicity warnings on SDS for bulk CBD, or warning labels for supplements as required under general chemicals law).
• Stay Agile and Informed: The CBD policy landscape in the EU is evolving rapidly. Entrepreneurs should stay updated via official sources and expert networks – follow ECHA and European Commission announcements, subscribe to industry news (many consultancies and associations provide regular regulatory updates), and remain engaged with hemp/cannabis business associations. Being caught off-guard by a regulatory change can be costly; proactive awareness is your best defense.

In this fluid situation, contingency planning is key. Some firms are already diversifying their product portfolios (for example, emphasizing hemp seed oil cosmetics, which are not affected by CBD’s status, or developing CBD-free versions of popular products) as a hedge against a possible ban. Others are investing in research – to generate safety data that could support their case or to explore alternative cannabinoids that might offer similar benefits without regulatory baggage.

Finally, it’s important to highlight the role of dialogue with regulators. The story of CBD’s acceptance in Europe is still being written, and entrepreneurs – especially those with scientific data or unique market insights – can play a part. Engaging in consultations, attending Commission workshops or SCCS open sessions, and working through industry bodies like UIVEC to provide evidence-based inputs can influence outcomes. As the UIVEC/CEHTRA initiative shows, the industry is not powerless; a reasoned, science-driven appeal can sometimes sway regulatory decisions or at least carve out more reasonable conditions.

Conclusion

The proposal to classify CBD as a reprotoxic substance under EU law has cast a cloud of uncertainty over the burgeoning CBD cosmetics sector. On one hand, regulators have a mandate to protect consumer health – and the animal data signaling potential reproductive harm from CBD has prompted a precautionary stance. On the other hand, industry advocates argue that CBD has been used by millions and “considered as not having psychotropic effect or any harmful effect on human health” in prior assessments, and that its risks can be managed. The next year or two will be decisive in determining which view prevails in policy.

For cannabis startup founders, the best course is to hope for the best but prepare for the worst. Pay attention to the science (both the red flags and the counter-evidence), fortify your product safety dossiers, and have a roadmap for regulatory compliance. The upcoming UIVEC webinar on May 27, 2025 is an excellent opportunity to deepen your understanding of this issue and hear directly from experts who contributed to the debate. Whether CBD in cosmetics will remain a viable business in the EU may hinge on the outcomes from ECHA’s and SCCS’s parallel reviews. By staying informed and engaged, entrepreneurs can navigate this evolving landscape – adapting their strategies to whatever new rules emerge, while continuing to champion innovation and consumer choice within the bounds of safety.

Join the meeting to stay informed by Zoé Demange here on 27. May https://us06web.zoom.us/webinar/register/WN_Ry75G0yAQV6l0QWVa1kFbQ#/registration

Sources:

• ANSES proposal and ECHA consultation details
• UIVEC/CEHTRA commentary on the classification (LinkedIn post by Zoé Demange)
• European Commission & SCCS status on CBD in cosmetics
• Regulatory analysis of implications for cosmetics and foods
• Context on EU cosmetics rules for CMR substances and industry responses.