CBD: What the ANSES 2025 proposal changes for brands and customers

By 2025, the CBD sector in France is poised to reach a new milestone with the recent guidelines from ANSES (the French Agency for Food, Environmental and Occupational Health & Safety). This proposal aims to classify cannabidiol as a substance toxic to human reproduction, thus significantly altering the legal framework and the commercial future of CBD products. Between strengthened health and safety measures, regulatory uncertainties, and evolving legislation, both producers and consumers are questioning the consequences. What concrete steps can be taken from these announcements? How does this reclassification affect the market, buyer safety, and consumer rights? Here is a detailed overview of the main aspects of the proposal. Context and Scope of the ANSES Proposal ANSES, the French agency responsible for health and safety, presented its proposal in early 2024 to establish a new toxicity classification for certain molecules derived from hemp, including CBD. This approach doesn’t just concern the pure substance: it directly impacts the marketing, formulation, and even communication surrounding CBD products. The stated objective is to protect the population from any potential risks related to toxicity to human reproduction. This direction implies a profound overhaul of CBD regulations in France. The usual distinction between natural and synthetic derivatives could evolve, complicating the legal framework governing the CBD sector. What changes are coming to CBD regulations? The ANSES proposal initiates a shift towards increased monitoring of permitted THC levels, as well as enhanced vigilance across the entire CBD distribution chain. To delve deeper into the legal status of this molecule, it is relevant to refer to the detailed analyses on The fact that CBD is not considered a medicine under current legislation. This tightening of the legal framework translates into the implementation of new requirements: mandatory warnings, additional labeling constraints, and possible restrictions on certain formats (for example, highly concentrated oils). The administrative procedures required to obtain or renew a commercial authorization are expected to increase, complicating the daily operations of those involved in the CBD industry.

Strengthening health controls on manufacturing batchesRequirement to indicate potential toxicity to human reproduction Systematic review of cannabinoid-rich formulations Impacts on the CBD industry in France The CBD industry will have to fundamentally rethink its structure. Producers, importers, and distributors will have to guarantee exemplary traceability to meet the new standards. This often involves reviewing internal processes, but also investing in additional tools for analyzing THC levels and contaminants. Several players are already anticipating this shift: expanding their ranges of low-CBD products, specializing in clean-label extraction, or using independent certifications to reassure customers about the safety of their products. Influence of the toxic classification on innovation Technical innovation is also under new pressure. Many R&D teams are now seeking to design CBD-based products with concentrations that comply with future recommended limits. Particular emphasis is being placed on food and cosmetic preparations intended for vulnerable populations, such as pregnant women or those with underlying health conditions, who could be denied access to CBD if the toxic classification were applied indiscriminately.While this unstable context may slow down some innovative projects, it also stimulates experimentation with synergies between different plant extracts, limiting direct exposure to pure cannabidiol. It’s important to remember that CBD is generally not classified as a medicine by the authorities, except in specific cases, which raises important questions about the boundary between cosmetics, food supplements, and therapeutic use; an aspect analyzed in detail on the recognition of CBD as a medicine under different regulatory contexts. Consequences for consumers: what rights, what guarantees?

Consumer rights regarding CBD are directly affected by the need to ensure safe use and a transparent level of information. If the proposal is adopted, instructions for use will have to include explicit statements about toxicity to human reproduction, following a logic similar to that of conventional pharmaceutical products. Enhanced vigilance will govern the dispensing of CBD-based products in physical stores and online. To ensure the safety of their purchases, individuals should prioritize products with official labels or certificates of analysis. Certain formats may also be restricted for specific groups, particularly pregnant or breastfeeding women. Enhanced labeling regarding reproductive toxicity Priority access to factual information on the exact composition of products Right to a refund or withdrawal in case of proven non-complianceTowards harmonized legislation?

The debate initiated by

ANSES comes as several European countries also seek to clarify the legal status of CBD . A coordinated legislative evolution could foster a more consistent approach to CBD regulation, thus preventing fragmentation of the European market. The harmonization would focus on the precise scientific definition of risks related to toxicity for human reproduction,

the establishment of a single threshold for tolerated THC, and the creation of accelerated procedures to validate new CBD-based productsthat meet all health requirements.

• Implications for transparency and customer trust
• For customers, the future regulation of CBD could strengthen trust in operators who comply with standards. The availability of reliable information on side effects or
• reproductive toxicity will promote informed choices, reducing the areas of uncertainty that are still too frequent in this rapidly expanding market. A key challenge lies in educating the general public and prescribers: explaining why the

legal framework is evolving, how the

THC thresholds are determined, and on what basis the toxic classification is based. This is a strategic lever for limiting misinformation and restoring the sector’s credibility. Comparative table: current situation vs. Impact of the ANSES proposal Criteria

Current situation After the ANSES proposalAccepted THC thresholds Up to 0.3% Possible reduction to a more restrictive threshold

Toxicological classification

Not listed as toxicReproductive toxicity highlighted Labeling requirements Standardized information Specific warnings required Authorization process Relatively flexible Strengthened and selective procedure Frequently asked questions about the ANSES proposal and CBD regulation

What does the classification of toxicity to human reproduction proposed by ANSES mean? ANSESwants to include CBDin a category of substances identified as having

potential toxicity to human reproduction

This entails new labeling requirements on packaging, in-depth studies on long-term risks, and enhanced information, particularly for pregnant women. Explicit warnings on products Access restrictions for certain vulnerable groups How might the ANSES proposal change CBD regulations in France? The proposal includes stricter sales and manufacturing conditions forCBD-based products.

We will likely see the establishment of new THC thresholds and increased

• administrative controls across the entire
• CBD sector.
• Stricter standards on THC levels

Increased quality control checks

in laboratories What new rights will consumers have after the reform comes into effect? Consumerswill have more precise information on the safety and compositionof

CBD-based products. Their right to clear informationwill be protected, and they will be able to request the withdrawal or replacement of products deemed non-compliant by the competent authorities. Detailed information on each batch Possibility of appeal

to the control bodies

What are the economic consequences for the CBD sector in France? The CBD sector will face additional costs for analysis and

regulatory compliance. Some small operators could be penalized by the increased complexity of the procedures, while organized structures focusing on transparency and safetycould see their reputation strengthened with the public.

Julien( Rédacteur en chef spécialisé en CBD )