Is Your Cosmetic Company Required to Report Under the Italian Sunshine Act?
Author
Sabrina Morgan is the Head of Global Compliance & Customer Delivery at Vector Health. She oversees global transparency reporting and international disclosure requirements along with the Italian Sunshine Act strategy. She also leads the global client delivery team dedicated to data integrity, compliance solutions, and regulatory alignment for pharmaceutical and MedTech organizations.
Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance
Cerchi supporto per la compliance al Sunshine Act?
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Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.
Italy’s cosmetics market is booming. According to recent data, the Italian cosmetics products market is projected to be worth USD 2.09 billion in 2025, with a forecast to grow to USD 2.75 billion by 2030, at a compound annual growth rate (CAGR) of ~5.6 %. This growth reflects Italy’s historic strength as a beauty-care manufacturing hub, a major share of Europe’s makeup and cosmetic output is produced here.
At the same time, demand is shifting: consumers are increasingly seeking natural formulations, premium, dermatologist-endorsed lines, and higher-margin “clean beauty” products. The rise of e-commerce and online retail has further accelerated this trend.
In short: cosmetic companies in Italy are thriving — but also increasingly intertwined with healthcare, dermatology, aesthetic clinics, and wellness professionals. That overlap raises an important question: Does the country’s transparency legislation, the Legge 62/2022 (the “Italian Sunshine Act”), apply to cosmetics?
The answer: Often yes, and certainly if your activities touch the health-care ecosystem.
When cosmetics companies are caught by the Sunshine Act
The core of the law addresses “impresa produttrice” (manufacturers/providers) that produce or market products or services “within the health sector.” Although the law gives priority to “medicines, medical devices, equipment,” it doesn’t stop there: any good or service commercialized in contexts related to human health, or provided with a link to healthcare professionals (HCPs) or healthcare organisations (HCOs) may be covered.
That means a cosmetics company is subject to disclosure obligations if and when it interacts with HCPs/HCOs, for example:
- Promoting dermocosmetic or aesthetic-medicine products via dermatologists, aesthetic physicians, pharmacies, or medical-cosmetic clinics.
- Sponsoring or organizing medical-aesthetic events, conferences or training, often requiring participation of doctors, dermatologists or pharmacists.
- Providing samples, professional kits, post-procedure skincare products, or other benefits to clinics, prescribers, or practitioners.
- Engaging HCPs or clinics as consultants, speakers, advisors, or as part of research, product evaluation, or clinical validation.
In these situations, especially when the value of benefits or transfers exceeds the law’s thresholds, the company must report under the rules set out in the Italian Sunshine Act.
Put plainly: being a “cosmetics company” does not automatically exempt you. What matters is whether your products or commercial practices intersect with the healthcare sector.
What the company must report (when covered)
If your cosmetic company qualifies under the Sunshine Act, you must disclose the following types of interactions (among others):
- Sponsorships, speaker or consultancy fees, honoraria.
- Gifts, product donations, samples for professional use.
- Travel, accommodation, training or educational support for professionals or clinics.
- Funding or support for scientific events, conferences, or continuing-education.
- Research collaborations, clinical evaluations, consultancy work — including for aesthetic medicine or dermocosmetics.
You must report who received the benefit (HCP or HCO), the nature and value of benefit, date and purpose, and any intermediaries. For more details on the exact information and format of reporting, check our FAQs answered by our expert lawyers.
Disclosure is typically mandatory when individual transfers exceed €100, or annual total to a given HCP exceeds €1,000. For organizations, thresholds are higher (e.g. €1,000 per transaction or €2,500 per year), but all reportable transfers must be logged.
Reports are submitted via the public registry managed by the Ministry of Health (“Sanità Trasparente”), rumored to be launched soon. Reporting cadence depends on the type of benefit (e.g. semi-annual for transfers of value, annual for shareholdings or IP-related income).
What this means for cosmetic companies, and why many may be surprised
Given how dynamic and health-adjacent the Italian cosmetics market is, many cosmetic and “cosmeceutical” brands may already be inadvertently subject to transparency obligations.
- If you market through dermatology clinics, aesthetic medicine centers, pharmacies or spas, you’re likely in scope.
- If you engage dermatologists, aesthetic physicians, pharmacists, or other HCPs for advisory, consultancy, content creation, or speaking, this is reportable.
- If you support or sponsor educational events, conferences, or professional meetings in aesthetic medicine or dermocosmetics, also reportable.
- Even providing “professional-use only” products or kits to clinics or prescribers may trigger reporting.
For many cosmetic companies, this may come off as a significant compliance burden, but also a chance to build trust, transparency, and credibility (particularly for premium or dermatologist-endorsed lines).
Ignoring these obligations isn’t just risky legally, it can also harm reputation, especially in a market where consumers are increasingly health- and ingredient-conscious.
How to assess whether you need to report, a quick checklist
Ask yourself:
- Are any of your products marketed in clinical, pharmacy, or medical-cosmetic settings (not retail)?
- Do you work with HCPs, clinics, or medical-aesthetic practitioners for marketing, consulting, research, or education?
- Do you sponsor or fund events, training, or professional meetings attended by healthcare professionals?
- Do you provide gifts, samples, or professional-use kits to clinics or practitioners?
- Do you pay honoraria, speaker fees, consultancy fees, or fund travel/education for healthcare professionals or organizations?
If the answer to any of these is “yes,” you likely fall under the scope of the Italian Sunshine Act, and you should prepare to report.
Final thoughts
Italy’s cosmetics industry is flourishing, supported by a strong heritage of craftsmanship, growing exports, and rising demand for premium, natural and dermatologist-endorsed products. But in such a dynamic and health-adjacent market, the boundaries between “beauty product” and “health product” blur quickly.
The legal guardrails introduced by the Italian Sunshine Act reflect this reality. Cosmetic companies in Italy cannot assume they’re exempt: if your business interacts with the healthcare ecosystem — through clinics, practitioners, educational events, or professional-use products — transparency and reporting are required.
In a landscape where consumers care more than ever about ingredients, ethics, and trust, compliance isn’t just a legal hurdle, it’s something that can give your company an edge and credibility, both in the eyes of your stakeholders and consumers.
Italy’s cosmetics market is booming. According to recent data, the Italian cosmetics products market is projected to be worth USD 2.09 billion in 2025, with a forecast to grow to USD 2.75 billion by 2030, at a compound annual growth rate (CAGR) of ~5.6 %. This growth reflects Italy’s historic strength as a beauty-care manufacturing hub, a major share of Europe’s makeup and cosmetic output is produced here.
At the same time, demand is shifting: consumers are increasingly seeking natural formulations, premium, dermatologist-endorsed lines, and higher-margin “clean beauty” products. The rise of e-commerce and online retail has further accelerated this trend.
In short: cosmetic companies in Italy are thriving — but also increasingly intertwined with healthcare, dermatology, aesthetic clinics, and wellness professionals. That overlap raises an important question: Does the country’s transparency legislation, the Legge 62/2022 (the “Italian Sunshine Act”), apply to cosmetics?
The answer: Often yes, and certainly if your activities touch the health-care ecosystem.
When cosmetics companies are caught by the Sunshine Act
The core of the law addresses “impresa produttrice” (manufacturers/providers) that produce or market products or services “within the health sector.” Although the law gives priority to “medicines, medical devices, equipment,” it doesn’t stop there: any good or service commercialized in contexts related to human health, or provided with a link to healthcare professionals (HCPs) or healthcare organisations (HCOs) may be covered.
That means a cosmetics company is subject to disclosure obligations if and when it interacts with HCPs/HCOs, for example:
- Promoting dermocosmetic or aesthetic-medicine products via dermatologists, aesthetic physicians, pharmacies, or medical-cosmetic clinics.
- Sponsoring or organizing medical-aesthetic events, conferences or training, often requiring participation of doctors, dermatologists or pharmacists.
- Providing samples, professional kits, post-procedure skincare products, or other benefits to clinics, prescribers, or practitioners.
- Engaging HCPs or clinics as consultants, speakers, advisors, or as part of research, product evaluation, or clinical validation.
In these situations, especially when the value of benefits or transfers exceeds the law’s thresholds, the company must report under the rules set out in the Italian Sunshine Act.
Put plainly: being a “cosmetics company” does not automatically exempt you. What matters is whether your products or commercial practices intersect with the healthcare sector.
What the company must report (when covered)
If your cosmetic company qualifies under the Sunshine Act, you must disclose the following types of interactions (among others):
- Sponsorships, speaker or consultancy fees, honoraria.
- Gifts, product donations, samples for professional use.
- Travel, accommodation, training or educational support for professionals or clinics.
- Funding or support for scientific events, conferences, or continuing-education.
- Research collaborations, clinical evaluations, consultancy work — including for aesthetic medicine or dermocosmetics.
You must report who received the benefit (HCP or HCO), the nature and value of benefit, date and purpose, and any intermediaries. For more details on the exact information and format of reporting, check our FAQs answered by our expert lawyers.
Disclosure is typically mandatory when individual transfers exceed €100, or annual total to a given HCP exceeds €1,000. For organizations, thresholds are higher (e.g. €1,000 per transaction or €2,500 per year), but all reportable transfers must be logged.
Reports are submitted via the public registry managed by the Ministry of Health (“Sanità Trasparente”), rumored to be launched soon. Reporting cadence depends on the type of benefit (e.g. semi-annual for transfers of value, annual for shareholdings or IP-related income).
What this means for cosmetic companies, and why many may be surprised
Given how dynamic and health-adjacent the Italian cosmetics market is, many cosmetic and “cosmeceutical” brands may already be inadvertently subject to transparency obligations.
- If you market through dermatology clinics, aesthetic medicine centers, pharmacies or spas, you’re likely in scope.
- If you engage dermatologists, aesthetic physicians, pharmacists, or other HCPs for advisory, consultancy, content creation, or speaking, this is reportable.
- If you support or sponsor educational events, conferences, or professional meetings in aesthetic medicine or dermocosmetics, also reportable.
- Even providing “professional-use only” products or kits to clinics or prescribers may trigger reporting.
For many cosmetic companies, this may come off as a significant compliance burden, but also a chance to build trust, transparency, and credibility (particularly for premium or dermatologist-endorsed lines).
Ignoring these obligations isn’t just risky legally, it can also harm reputation, especially in a market where consumers are increasingly health- and ingredient-conscious.
How to assess whether you need to report, a quick checklist
Ask yourself:
- Are any of your products marketed in clinical, pharmacy, or medical-cosmetic settings (not retail)?
- Do you work with HCPs, clinics, or medical-aesthetic practitioners for marketing, consulting, research, or education?
- Do you sponsor or fund events, training, or professional meetings attended by healthcare professionals?
- Do you provide gifts, samples, or professional-use kits to clinics or practitioners?
- Do you pay honoraria, speaker fees, consultancy fees, or fund travel/education for healthcare professionals or organizations?
If the answer to any of these is “yes,” you likely fall under the scope of the Italian Sunshine Act, and you should prepare to report.
Final thoughts
Italy’s cosmetics industry is flourishing, supported by a strong heritage of craftsmanship, growing exports, and rising demand for premium, natural and dermatologist-endorsed products. But in such a dynamic and health-adjacent market, the boundaries between “beauty product” and “health product” blur quickly.
The legal guardrails introduced by the Italian Sunshine Act reflect this reality. Cosmetic companies in Italy cannot assume they’re exempt: if your business interacts with the healthcare ecosystem — through clinics, practitioners, educational events, or professional-use products — transparency and reporting are required.
In a landscape where consumers care more than ever about ingredients, ethics, and trust, compliance isn’t just a legal hurdle, it’s something that can give your company an edge and credibility, both in the eyes of your stakeholders and consumers.
Author
Sabrina Morgan is the Head of Global Compliance & Customer Delivery at Vector Health. She oversees global transparency reporting and international disclosure requirements along with the Italian Sunshine Act strategy. She also leads the global client delivery team dedicated to data integrity, compliance solutions, and regulatory alignment for pharmaceutical and MedTech organizations.
Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.