Pharma & Natural Cosmetics: Greenwashing Risk 2026
The pharma and natural cosmetics sector is one of the highest-risk industries for warning letters and enforcement action: consumers are particularly sensitive to health-related claims and sustainability promises, and the combination of medicinal-product regulation and cosmetics law creates a dense web of substantiation requirements. The EmpCo Directive (EU 2024/825) significantly raises the transparency and evidence bar from 27 September 2026. Generic claims such as "natural healing" or "plant-based active ingredients" are inadmissible without scientific substantiation or third-party certification (Annex I No. 2 UCPD as amended by EmpCo). Under Section 5 UWG and the EmpCo Directive (EU 2024/825), even the term "natural" can be misleading where a product contains added flavourings or thickeners, irrespective of whether those additives are legally classified as "of natural origin". More broadly, generic sustainability claims for cosmetics products without transparent supply chains or recognised certificates are equally exposed under § 5 UWG (UCPD Art. 6) — a principle reinforced by the EmpCo Directive (EU 2024/825) and therefore a key European reference for the industry. Beyond EmpCo, manufacturers operating in the EU must also comply with EU Cosmetics Regulation 1223/2009, which requires that any cosmetic claim be substantiated by evidence retained in the product information file. The EmpCo Directive adds a per-se ban on claims of climate neutrality achieved solely through offsetting (Annex I No. 4a UCPD): manufacturers must instead demonstrate concrete reduction measures and provide transparent documentation. To ensure legally compliant marketing, every claim must be supported by clinical studies, recognised certifications (NaTrue, COSMOS) or independent assessments, and a complete ingredient list using INCI nomenclature must be provided. A focus on verifiable facts and the avoidance of misleading promises are the cornerstones of legally sound positioning in the pharma and natural cosmetics sector.
Typical claims in Pharma & Natural Cosmetics
- „natural healing"
- „plant-based active ingredients"
- „biodegradable"
- „dermatologically tested"
- „microplastic-free"
Concrete examples (red/amber)
- "Natural pain therapy" without clinical study or regulatory approval
- "Organic active ingredient" without organic certificate (NaTrue, COSMOS)
- "Dermatologically tested" without disclosure of test method and testing institution
EmpCo-compliant alternatives
Recommendations
- Demonstrate HMG (Homeopathic Medicinal Products) approval or equivalent regulatory authorisation for efficacy claims
- Present COSMOS or NaTrue certification for natural cosmetics products
- Cite clinical studies with clear results and disclosed methodology
- Provide a complete ingredient list using INCI nomenclature
- Substantiate environmental compatibility through independent testing institutes (e.g. Cradle to Cradle)
Recognised certificates
Frequently asked questions
What does the EmpCo Directive mean for my marketing claims?
From 27 September 2026, the EmpCo Directive (EU 2024/825, amending UCPD Annex I No. 2) prohibits generic claims without recognised substantiation. Terms such as "natural", "plant-based" or "gentle" must be backed by certificates or studies. Under EU Cosmetics Regulation 1223/2009, cosmetic product claims must additionally be substantiated by evidence held in the product information file.
May I continue to advertise with "dermatologically tested"?
Yes, but you must disclose the test method and the name of the independent testing institute. A bare assertion is inadmissible under EmpCo Annex I No. 2 (UCPD) and the EU Cosmetics Regulation 1223/2009 claim-substantiation requirements.