An overview of current practices for regulatory risk assessment with lessons learnt from cosmetics in the European Union

Arnesdotter, Emma; Rogiers, Vera; Vanhaecke, Tamara; Vinken, Mathieu

doi:10.1080/10408444.2021.1931027

Cited by 9 publications

(3 citation statements)

References 133 publications

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“…This study has a few limitations. First, the biological performance of this anti-fogging solution could be examined using in vitro (reconstructed human epidermis), and in vivo skin contact testing in animals and human studies (Arnesdotter et al, 2021;Choksi et al, 2019;Filaire et al, 2022;Hardwick et al, 2020;Nabarretti et al, 2022;Pistollato et al, 2021;Riebeling, Luch & Tralau, 2018). While this could be considered routine diligence, it is prudent to emphasize both the waxes and PETG are generally regarded as safe (GRAS) and are used in current product (e.g., lip balm) formulations routinely.…”

Section: Discussionmentioning

confidence: 99%

Durability and physical characterization of anti-fogging solution for 3D-printed clear masks and face shields

Gadhar,

Chechang,

Sales

et al. 2023

PeerJ Materials Science

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Background The COVID-19 pandemic brought forth the crucial roles of personal protective equipment (PPE) such as face masks and shields. Additive manufacturing with 3D printing enabled customization and generation of transparent PPEs. However, these devices were prone to condensation from normal breathing. This study was motivated to seek a safe, non-toxic, and durable anti-fogging solution. Methods We used additive 3D printing to generate the testing apparatus for contact angle, sliding angle, and surface contact testing. We examined several formulations of carnauba wax to beeswax in different solvents and spray-coated them on PETG transparent sheets to test contact and sliding angle, and transmittance. Further, the integrity of this surface following several disinfection methods such as detergent, isopropyl alcohol, or water alone with gauze, paper towels, and microfiber, along with disinfectant wipes, was assessed. Results The results indicate a 1:2 ratio of carnauba to beeswax in Acetone optimally generated a highly hydrophobic surface (contact angle 150.3 ± 2.1° and sliding angle 13.7 ± 2.1°) with maximal transmittance. The use of detergent for disinfection resulted in the complete removal of the anti-fogging coating, while isopropyl alcohol and gauze optimally maintained the integrity of the coated surface. Finally, the contact surface testing apparatus generated a light touch (5,000 N/m2) that demonstrated good integrity of the antifogging surface. Conclusions This study demonstrates that a simple natural wax hydrophobic formulation can serve as a safe, non-toxic, and sustainable anti-fogging coating for clear PPEs compared to several commercial solutions.

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Section: Discussionmentioning

confidence: 99%

Durability and physical characterization of anti-fogging solution for 3D-printed clear masks and face shields

Gadhar,

Chechang,

Sales

et al. 2023

PeerJ Materials Science

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“…Considering the endpoint of skin irritation/corrosion, at first the IATA approach for Skin Corrosion and Irritation could be used [ 141 ] an in vivo test for skin irritation according to the Draize method shall only be conducted if in vitro methods are not applicable for the substance (gases or aerosols) or if in vitro studies are not enough for classification [ 142 ]. The in vivo test may be carried out in accordance with the most appropriate guidelines (OECD 404, OPPT 870.2500) [ 143 , 144 ].…”

Section: Challenges Associated With Data Requirements Endpointsmentioning

confidence: 99%

Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health

Wend,

Zorrilla,

Freimoser

et al. 2024

Environ Health

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Plant protection measures are necessary to prevent pests and diseases from attacking and destroying crop plants and to meet consumer demands for agricultural produce. In the last decades the use of chemical pesticides has largely increased. Farmers are looking for alternatives. Biopesticides should be considered a sustainable solution. They may be less toxic than chemical pesticides, be very specific to the target pest, decompose quickly, and be less likely to cause resistance. On the other hand, lower efficacy and higher costs are two disadvantages of many biopesticides. Biopesticides include macroorganisms, natural compounds and microorganisms. Microbial pesticides are the most widely used and studied class of biopesticides. The greatest difference between microbial and chemical pesticides is the ability of the former to potentially multiply in the environment and on the crop plant after application. The data requirements for the European Union and the United States Environmental Protection Agency are highlighted, as these regulatory processes are the most followed in regions where local regulations for biopesticide products are not available or vague. New Approach Methods already proposed or harmonized for chemical pesticides are presented and discussed with respect to their use in evaluating microbial pesticide formulations. Evaluating the microbials themselves is not as simple as using the same validated New Approach Methods as for synthetic pesticides. Therefore, the authors suggest considering New Approach Method strategies specifically for microbials and global harmonization with acceptability with the advancements of such approaches. Further discussion is needed and greatly appreciated by the experts.

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“…Depending on the tonnage of chemicals placed onto a market, the standard information requirements for the hazard assessment vary significantly: the higher the tonnage, the more detail is needed in the dossier. For chemicals with tonnages > 1 and up to 10 t/year, the same minimum information is required as for non-authorised cosmetics ingredients (with the acute toxicity in some circumstances) [2,5].…”

Section: Introduction To the Legislative Requirements For Cosmetics I...mentioning

confidence: 99%

The Skin Sensitisation of Cosmetic Ingredients: Review of Actual Regulatory Status

Bialas¹,

Zelent-Kraciuk²,

Jurowski

2023

Toxics

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All cosmetics products must be safe under foreseeable conditions of use. Allergenic responses are one of the most frequent adverse reactions noted for cosmetics. Thus, the EU cosmetics legislation requires skin sensitisation assessment for all cosmetics ingredients, including the regulated ones (for which the full toxicological dossier needs to be analysed by the Scientific Committee on Consumer Safety (SCCS)) and those (perceived as less toxic) which are assessed by industrial safety assessors. Regardless of who performs the risk assessment, it should be carried out using scientifically and regulatory body-accepted methods. In the EU, reference methods for chemical toxicity testing are defined in the relevant Annexes (VII–X) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Recommendations for Skin Sensitization (Skin Sens) testing are provided in Annex VII, and this particular endpoint information is required for all EU-registered chemicals. Historically, in vivo animal and human methods have been used. Both raise ethical doubts, and some of them cause practical problems in the objective analysis of skin sensitising potency. Previous decades of huge effort have resulted in the regulatory acceptance of the alternative Skin Sens IATA (Integrated Approaches to Testing and Assessment) and NGRA (Next Generation Risk Assessment). Regardless of the testing issues, a serious sociological problem are observed within the market: the consumer assumes the presence of strong sensitisers in cosmetics formulations and insufficient risk management tools used by the industry. The present review aims to provide an overview of methods for assessing skin sensitisation. Additionally, it aims to answer the following question: what are the most potent skin sensitisers used in cosmetics? The answer considers the mechanistic background along with the actual regulatory status of ingredients and practical examples of responsible industry solutions in the area of risk management.

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An overview of current practices for regulatory risk assessment with lessons learnt from cosmetics in the European Union

Abstract: with details of the nature of the infringement. We will investigate the claim and if justified, we will take the appropriate steps.

Cited by 9 publications

References 133 publications

Durability and physical characterization of anti-fogging solution for 3D-printed clear masks and face shields

Durability and physical characterization of anti-fogging solution for 3D-printed clear masks and face shields

Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health

The Skin Sensitisation of Cosmetic Ingredients: Review of Actual Regulatory Status

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