• The organization and planning of inspections (annual programs).
• Specific challenges with online sales inspections.
• Expectations of the authorities regarding compliance.
• Consequences and follow-up actions, with concrete examples.
• Some key statistics on inspections in Belgium.

“Certifying environmental excellence: Opportunities and future perspectives of the EU Ecolabel for cosmetics products”

Consumers are increasingly looking for healthy and sustainable cosmetics. The EU Ecolabel is a means for businesses to enhance their innovation and competitiveness, while offering reliable eco-friendly alternatives to conventional cosmetics, and empowering consumers’ sustainable consumption choices.

The EU Ecolabel, the official European Union voluntary label for environmental excellence, has become the worldwide reference voluntary certification for green goods and services recognized for its rigorous standards/criteria and its contribution to promoting sustainability. In the case of cosmetics, EU Ecolabel criteria guarantee products with low toxicity to aquatic organisms, biodegradable ingredients, restricted use of hazardous substances, minimized and easy-to-recycle packaging, renewable ingredients of sustainable origin and good performance.

The EU Ecolabel encourages innovation and creates new market opportunities, also by being part of the sustainability programmes of big market players. It helps businesses stand out, gain visibility, and attract consumers who are increasingly focused on making sustainable choices.

Moreover, the EU Ecolabel helps unlocking Green Public Procurement opportunities, as the label complies with the requirements of the related EU law and can be used in procurement practices.

Finally, the EU Ecolabel is a safe investment and a simplification tool for companies as it means compliance with new and forthcoming EU legislation (Directive on Empowering Consumers for the Green Transition and Green Claims Directive Proposal) impacting sustainability labels and green claims.

Nanomaterials are widely applied in cosmetics products and following the Cosmetic Regulation, those must be included in the annual report on the use of nanomaterials in cosmetics produced by the European Commission. This was implemented to allow monitoring of the current situation, ensuring the EU regulation is keeping pace with innovation, in particular regarding the potential of nanotechnologies. One first challenge while addressing the EU Cosmetic regulation regards the definition of nanomaterials. Despite a common recommendation for a definition adopted by the European Commission (EC Recommendation 2011/696/EU) and updated in 2022, several sectorial definitions currently coexist at the EU, causing discrepancies among sectors and along the value chains. To overcome this issue, the adoption of a cross sectorial definition has been proposed. This presentation will review the differences among the current EU recommendation of a nanomaterial definition, the current definition under the cosmetic sectors and the challenges and opportunities the cosmetic industry will face if the current EU recommendation is finally implemented in the cosmetic sector.

Nanotechnology has become a common technological field in the cosmetics industry, offering advanced formulations with enhanced efficacy and solubility, improved stability, and targeted delivery of active ingredients. However, the unique properties of nanomaterials—such as their nanoscale dimensions, increased surface area, and potential bioactivity—raise significant health, environmental, and ethical concerns.

The EU Cosmetics Regulation, with several updates and amendments, has introduced more and more specific definitions for nanoparticles as well as stricter requirements for the use of nanomaterials, focusing on comprehensive safety assessments, transparent labeling, and mandatory notification through the Cosmetic Products Notification Portal (CPNP). The regulation explicitly defines nanomaterials and mandates detailed risk assessments that consider their unique physicochemical properties and potential interaction with biological systems.

Despite these advancements, several challenges persist. The lack of standardized testing methods for nanoscale ingredients complicates compliance, while discrepancies between EU and non-EU regulatory frameworks hinder global harmonization. Furthermore, the long-term toxicity, and probable systemic toxicity,  of certain nanomaterials call for continuous scientific and regulatory updates. On top, the EU Green Deal poses another dimension of challenge to nanomaterials.

The explicit definitions for nanomaterials allow for the choice of materials that do not fall into the regulation restrictions but may have very similar properties, especially for skin delivery of active substances. Such systems, as liposomes or nanoemulsions (that would be considered nanotechnological e.g. for the pharma regulations), can maintain the benefits of nanotechnology without the regulatory implications, due to their Generally Recognized As Safe and non bio-persistent nature.

Next Generation Risk Assessment (NGRA) ab initio was applied to evaluate whether repeated exposure to 2.5% (w/w) HC Yellow No. 13 (HCY13) hair dye under non-oxidative conditions is safe. A physiologically based pharmacokinetic model for dermal exposure estimated internal liver concentrations (C_{max liver}), ranging from 0.0024 to 0.36 µM. Multiple in silico tools consistently identified hepatotoxic alerts associated with HCY13, possibly attributed to its trifluoromethyl group, known to interfere with hepatic lipid metabolism and induce fat accumulation (steatosis). Targeted in vitro bioactivity tests guided by the Adverse Outcome Pathway network for liver steatosis were conducted. Human stem cell-derived hepatic cells were exposed to varying concentrations of HCY13 for 72 hours. The expression of 11 lipid metabolism-related marker genes (AhR, PPARα, LXRα, APOB, ACOX1, CPT1A, FASN, SCD1, DGAT2, CD36, and PPARγ) and triglyceride accumulation, the phenotypic hallmark of steatosis, were evaluated. Using PROAST software, in vitro Point of Departure (PoD_NAM) values were determined for each biomarker. Given that all POD_NAM values exceeded the predicted C_{max liver} values, it is expected that 2.5% (w/w) HCY13 would not trigger liver steatosis under the assumed conditions of use. This study demonstrates the feasibility of using an animal-free NGRA approach to assess whether the use of HCY13 is protective for human health against steatosis, thereby supporting regulatory decision-making based on advanced humane scientific approaches.

Laboratory of Toxicology, Department of Pharmacological and Biomolecular Sciences ‘Rodolfo Paoletti’, Università degli Studi di Milano, Milan, Italy

Immunotoxicity assessment has long relied on animal models, raising ethical concerns and questions about their relevance to human health. This lecture will highlight modern alternatives such as in vitro methods, human-based studies, adverse outcome pathways (AOPs), and computational modeling, which offer improved predictive accuracy and regulatory potential despite ongoing challenges.  Case studies, including AOP-based skin sensitization assessments and whole blood cytokine pyrogen assays, showcase the success of non-animal methods. However, further research is needed in areas like respiratory sensitization, developmental immunotoxicology, and microphysiological systems.  The presentation will conclude with recommendations to advance non-animal methods (NAMs), emphasizing AOP frameworks and urging their broader adoption to enhance safety assessment practices in the 21st century.

On 27 July 2023, the European Commission published Regulation (EC) 2023/1545 updating the labelling of allergens in cosmetics. In this presentation,  we will provide a comprehensive overview of the key regulatory changes introduced by this new legislation and practical examples and best practices to facilitate the efficient implementation of these provisions by industry to ensure that their products comply with the new requirements.

Vincent will explore the most recent advancements in AI and their potential to address key challenges in regulatory processes. Through a journey from simple use cases to more sophisticated AI systems, he will map out the evolving AI landscape and share valuable lessons learned from real-world implementations.