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On June 25, 2025, the European Chemicals Agency (ECHA) added three compounds—two linear siloxanes and one reactive azo dye—to the Candidate List of Substances of Very High Concern (SVHCs) under the REACH Regulation. This brings the list to a historic high of 250 entries. The new additions are characterized by high persistence and bioaccumulation (vPvB) or reproductive toxicity, and primarily affect the cosmetics, automotive care, and textile sectors. This move creates immediate reporting, notification, and safety data sheet updating obligations for companies that manufacture, import, or use these compounds. Table of contents Regulatory context Added substances and toxicological profile Regulatory implications for the industry Actualización REACH: ECHA Incorpora 3 nuevas Sustancias 1. Regulatory context The Candidate List constitutes the preliminary step to the eventual inclusion of a substance in Annex XIV (Authorization List). Its extension reflects the strategy of the European Union to strengthen the protection of human health and the environment through the progressive substitution of hazardous substances. For the industrial sector, each update involves assessing the internal chemical inventory and verifying the supply chain to prevent non-compliance. 2. Added substances and toxicological profile Substance (common name) CAS / EC Reason for inclusion Common uses* 1,1,1,3,5,5,5-Heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane 17928-28-8 / 241-867-7 vPvB, art. 57(e) Fragrances, cosmetics, coatings Decamethyltetrasiloxane 141-62-8 / 205-491-7 vPvB, art. 57(e) Personal care products, lubricants, waxes Reactive Brown 51 (Na/K salt) — / 466-490-7 Toxic to reproduction, art. 57(c) Textile dyes and finishes *Summary information based on official ECHA communication and sectoral summaries. 3. Regulatory implications for the industry Duty to provide information (Article 33 REACH) : Suppliers must inform customers and consumers about the presence of any of these SVHCs in articles when the concentration exceeds 0.1% w/w. Notification to ECHA (Article 7.2) : Manufacturers and importers of articles with SVHC above the threshold must notify the agency within a maximum of six months – 25 December 2025 for this update. Safety Data Sheet (SDS) Update : All affected SDS must reflect the new classification and risk management measures. SCIP and ecolabeling : Items containing these substances must be declared under the SCIP (Waste Framework Directive) and are, in principle, excluded from the EU Ecolabel. At BELAB Services, we support our clients throughout the entire regulatory lifecycle: gap analysis, physicochemical and toxicological testing, multilingual MSDS development, SCIP notifications, and technical advocacy in authorization processes. To learn how our methodology can be integrated into your chemical management system, please contact us at consult@belabservices.com .

Between April and May 2025, the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) , the expert body advising the UK Office for Product Safety and Standards (OPSS) , issued three separate opinions reassessing the safety of (i) formaldehyde-releasing preservatives, (ii) the UV filter homosalate , and (iii) the UV filter 4-methylbenzylidene camphor (4-MBC) . The conclusions point to imminent regulatory changes under the amended UK Cosmetic Products Regulation (UK CPR 1223/2009)  and will require reformulation of numerous cosmetic products. Table of contents Regulatory Context and Methodological Scope Formaldehyde-Releasing Preservatives: From 0.05 % to 10 ppm Homosalate: Safe up to 10 % Under Conditions 4-MBC: No Safe Level Established Conclusion SCCS on 4-MBC, formaldehyde and homosalate releasers in cosmetics 1. Regulatory Context and Methodological Scope Following the UK’s departure from the EU, Regulation (UK) No 1223/2009 on cosmetic products remains in force, but its technical interpretation now rests with the SAG-CS. The new opinions are based on: Systematic reviews  of published toxicological data and industry dossiers. Risk assessments  built on margin-of-safety (MoS) calculations and derived systemic exposure doses (SED). Application of the precautionary principle  whenever the data are insufficient to ensure consumer safety. 2. Formaldehyde-Releasing Preservatives: From 0.05 % to 10 ppm Current Status Free formaldehyde is banned outright (Annex II, entry 1577), yet several Annex V preservatives can release it in situ. Whenever free formaldehyde exceeds 0.05 % (500 ppm) , the label must state “contains formaldehyde”. Key SAG-CS Findings Aspect Detail Clinical evidence Allergic reactions reported below 0.05 %. Toxicological conclusion The 0.05 % threshold does not  protect sensitised individuals. Recommendation Lower the labelling trigger to 10 ppm (0.001 %)  for both leave-on and rinse-off products. The group considers current analytical methods robust enough to monitor these levels and believes the measure will address cumulative daily exposure 3. Homosalate: Safe up to 10 % Under Conditions Regulatory Framework Homosalate is listed in Annex VI (entry 3) as a UV filter permitted up to 10 % . Opinion Highlights Exposure data : Real-world concentrations ≤ 10 % in sunscreens yield SPF 10–50. Endocrine-disruption evidence : In vitro  assays show oestrogenic/anti-androgenic activity, but in vivo  relevance is limited. Risk assessment : MoS > 100 using a NOAEL of 100 mg kg-¹ bw day-¹; no significant adverse effects in repeated-dose studies. Conclusion:  Homosalate is safe up to 10 %  in all dermal applications evaluated, provided purity specifications are met and nanoparticle exposure is controlled 4. 4-MBC: No Safe Level Established 4-MBC (currently allowed up to 4 % under Annex VI, entry 19) is under review for potential thyroid- and oestrogen-disrupting effects. Data gaps : Absence of updated genotoxicity and reproductive-toxicity studies. Current SED : ≈ 4-fold higher than in previous assessments, drastically lowering the MoS. Outcome : Available evidence does not  allow derivation of a safe concentration. Industry is requested to submit a full toxicological package; otherwise, restrictions or withdrawal are anticipated 5. Implications for Manufacturers and Responsible Persons Ingredient Group Recommended Actions Formaldehyde releasers • Reformulate or justify ≤ 10 ppm free formaldehyde. • Implement residual-formaldehyde testing on finished batches. • Update labels in anticipation of Annex V changes. Homosalate • Verify purity and absence of endocrine-active contaminants. 4-MBC • Consider alternative UV filters (e.g., octisalate, octocrylene). • Suspend development of new products with 4-MBC until a definitive opinion is published. Conclusion SAG-CS Opinions 16, 17 and 18 reinforce the UK’s move toward a continuously updated, risk-based regulatory model. The drastic reduction of the free-formaldehyde threshold and the uncertainty surrounding 4-MBC foreshadow significant reformulation demands, whereas retention of homosalate at 10 % highlights the UK regulator’s flexibility compared with the EU’s more conservative stance. Companies will need to adapt compliance strategies and strengthen post-marketing surveillance to safeguard consumer safety and commercial viability in the dynamic post-Brexit landscape.

The European Chemicals Agency (ECHA) has taken a significant step towards consolidating and improving the transparency of chemical information in the European Union with the addition of the revamped Classification and Labelling Inventory to its ECHA CHEM platform. Table of contents New classification and labeling inventory at ECHA CHEM A step closer to more transparent regulation ECHA integrates the new classification and labeling inventory into its ECHA CHEM platform New classification and labeling inventory at ECHA CHEM This updated inventory brings together more than 4,400 harmonized European classifications and nearly seven million notifications submitted under the REACH Regulation, resulting in data on approximately 350,000 substances. The integration aligns with the initial launch of ECHA CHEM in January 2024, which already offered access to over 100,000 REACH registration dossiers. With this update, users can visually view classification by substance, easily identify the entry with the highest level of consensus, and understand the specific origin of information, improving the traceability and understanding of regulatory data. Furthermore, the redesign incorporates the new CLP hazard classes, following the latest European legislative changes. In future versions, ECHA plans to incorporate additional tools such as APIs to facilitate automated data access. Mercedes Viñas, Director of Submissions and Interaction at ECHA, emphasized that this development represents "an important milestone in the development of a comprehensive database for all chemical information collected by the Agency." Mike Rasenberg, Director of Hazard Assessment, emphasized that “hazard classifications are critical to regulatory risk management, and this enhanced inventory provides greater clarity on companies' current and future obligations.” A step closer to more transparent regulation ECHA CHEM is emerging as the leading platform for public access to chemical information in Europe. Among the planned future developments is the inclusion of summaries of regulatory decisions adopted by ECHA under legislation such as REACH, which will further strengthen the transparency of the European chemicals control system.

On June 3, 2025, the European Commission published a new regulatory measure that strengthens the protection of occupational health against hazardous chemical substances. Regulation (EU) 2025/1090 officially includes two industrial solvents—N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)—in Annex XVII of the REACH Regulation, marking their prohibition for certain uses as of December 23, 2026. Both substances are classified as toxic to reproduction (category 1B) under the CLP Regulation (EC No. 1272/2008), which poses a serious risk to human fertility and embryonic development. Their current use is primarily in industrial settings, particularly in the formulation of agrochemicals, pharmaceuticals, and specialized chemicals. Table of contents What does this restriction entail? What should companies do? A clear sign of regulatory tightening REACH: EU restricts the use of two reprotoxic solvents in industrial applications What does this restriction entail? The measure establishes that, starting in December 2026, DMAC and NEP may not be marketed or used in concentrations equal to or greater than 0.3% unless: DNEL limit values are included in safety data sheets (SDS) and chemical safety reports; Effective risk management measures are implemented in the workplace; Ensure that worker exposure remains below the specified DNEL values. The defined DNEL values are as follows: Substance DNEL Inhalation Dermal DNEL DMAC 13 mg/m³ 1.8 mg/kg bw/day NEP 4.0 mg/m³ 2.4 mg/kg bw/day For very specific uses, such as the production of artificial fibers using DMAC as a solvent, the regulation allows for an additional period of adaptation: until June 2029. What should companies do? Manufacturers, importers, and downstream users should urgently review their mixtures and processes if they work with these substances. It will be essential to: Evaluate the concentrations present in marketed or used products; Adapt SDSs to updated requirements; Apply appropriate technical controls and specific training to personnel; Re-evaluate the feasibility of use or consider safer substitutions. A clear sign of regulatory tightening This decision is part of a growing trend in European chemical policy: strengthening regulations on CMR substances (carcinogenic, mutagenic, or reprotoxic), especially those still widely used in key sectors. The Commission has emphasized that the protection of workers and the environment is a priority in the upcoming comprehensive reform of REACH, scheduled for 2026.

On 4 June 2025, the UK Department for Environment, Food and Rural Affairs (Defra) introduced a new policy aimed at strengthening the risk management of perfluoroalkyl substances (PFAS), adopting an interim approach focused on PMT characteristics . (Persistent, Mobile and Toxic) and vPvM (Very Persistent and Very Mobile). This approach represents a significant shift from the traditional model based exclusively on PBT (Persistent, Bioaccumulative and Toxic) and vPvB (Very Persistent and Very Bioaccumulative) criteria, recognizing that some PFAS, although not fully conforming to these schemes, still represent a considerable risk due to their high persistence and ability to move in the environment. Table of contents Why a new approach? A tool for prevention Towards more preventive regulation United Kingdom, PFAS Regulation: New Approach Based on Persistence and Mobility Why a new approach? PFAS are substances widely used in industrial and consumer applications that, due to their chemical structure, degrade very slowly in nature. This persistence, coupled with their high mobility, facilitates their presence in groundwater, aquatic ecosystems, and even remote regions, far removed from their original sources. However, many of these substances escape regulatory restrictions because they do not show significant bioaccumulation or demonstrated toxicity, despite their constant presence in the environment. The new PMT/vPvM conceptual framework seeks to fill this gap, allowing for the identification and prioritization of substances that, while not falling into the current categories, require further risk assessment and potential regulatory action. In particular, this methodology could be applied in the preparation of restriction dossiers under REACH in the United Kingdom, providing additional criteria to justify their control. A tool for prevention This development does not yet entail a regulatory change: the formal PMT/vPvM criteria have not yet been officially incorporated into the UK REACH Regulation or its equivalent classification system (GB CLP). However, Defra has indicated that the concept will serve as a basis for future assessments and will allow risk management to be adapted to cases where existing models are insufficient. The United Kingdom has also confirmed its active participation in the discussions of the United Nations Globally Harmonized System (GHS), where the international inclusion of this category as a new hazard class is being discussed. If the GHS approves its inclusion, the United Kingdom could consider its implementation in national legislation. Towards more preventive regulation The development of the PMT/vPvM concept represents a step toward a more preventive chemical policy, aligned with the emerging challenges of environmental pollution. With this measure, the United Kingdom seeks not only to better manage current risks but also to anticipate future crises arising from the global dispersal of extremely persistent substances.

Ottawa, May 19, 2025. Health Canada has released a Notice to Stakeholders outlining the changes it intends to make to its Cosmetic Ingredient Hotlist , the administrative list that indicates which substances are prohibited or restricted in cosmetic products sold in the country. The notice comes three months before the official draft goes out for public comment and offers manufacturers and distributors the opportunity to review their formulas in advance. Table of contents What is the Cosmetic Ingredient Hotlist? New proposed additions Changes to ingredients already listed Other corrections and substances “on the radar” Next steps What should manufacturers do? New Hotlist of Cosmetic Ingredients in Canada: Controls and Prohibited Substances What is the Cosmetic Ingredient Hotlist? The Hotlist isn't a regulation in itself, but it acts as a warning sign: if a substance is listed on it, the sale of the cosmetic could violate Canada's Food and Drugs Act or the Cosmetic Regulations . The last update was published in February 2025; the ongoing review is in response to "evolving scientific evidence" and data from market notifications received since then. New proposed additions Health Canada is proposing to add three ingredients to the restricted list due to their carcinogenic potential or sensitization risks: Substance Reason for inclusion Proposed restriction Basic Violet 4 Increased exposure reported in the market Concentration limits according to product type Basic Blue 7 Carcinogenic risk similar to the previous one Concentration limits according to product type Polyaminopropyl Biguanide (PHMB) Lung risk from inhalation and skin sensitization Prohibited in aerosols; maximum concentrations in topical applications Changes to ingredients already listed Among the reviews are: Symphytum spp. (comfrey) – The exception for S. officinale is eliminated after hepatotoxic alkaloids were detected. Brucine and its salts – Moved from restricted to completely banned due to acute toxicity and neurotoxicity. Imperatorin – Eliminates its specific entry and is now controlled under the furocoumarin category. Furocoumarins – These will be banned as added ingredients; only natural traces will be permitted, and the limit will apply to all leave-on products, not just tanning lotions. Other corrections and substances “on the radar” The agency will also adjust synonyms, CAS numbers, and errata, and identifies eleven chemical groups—including parabens, salicylates, and certain terpenes—that remain under review by the Chemicals Management Plan and could lead to future restrictions. Next steps May–August 2025 : Companies should analyze the impact and prepare adjustments. August 2025 : Publication of the official draft and opening of a 60-day public consultation . Following the consultation, Health Canada will respond to the comments and publish the final Hotlist on its website. Throughout the process, the agency reminds us that it can intervene immediately if it receives data indicating a serious health risk. What should manufacturers do? Review formulas and safety data sheets to detect the substances mentioned. Evaluate the supply chain and plan alternatives that meet the new limits. Subscribe to Health Canada's cosmetics mailing list to receive alerts and participate in the consultation. "Those who market cosmetics in Canada should not wait for the final update: if there is a potential for harm, sales should cease immediately," Health Canada warns in its advisory. Government of Canada With these proposals, Canada strengthens its cosmetic safety framework and aligns itself with the international trend of limiting potentially hazardous compounds, encouraging the industry to innovate in safer and more transparent formulations. Contact a Canadian cosmetics regulation expert

The European Commission has notified the World Trade Organization (WTO) of the draft regulation that will amend Regulation (EC) 1223/2009 to incorporate the substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) by the 22nd Adaptation to Technical Progress (ATP 22) of the CLP Regulation. Internally, this package of changes is known as "Omnibus VIII" and consolidates the European policy of "zero tolerance" toward high-risk substances in cosmetics. Table of contents Regulatory framework in context Why “Omnibus VIII”? Main technical innovations Compliance schedule Conclusion Omnibus VIII and CMR Restrictions: which will reshape the cosmetics market starting in 2026 Regulatory framework in context Article 15 of Cosmetic Regulation (EC) 1223/2009 : prohibits the use of CMR 1A/1B/2 except in justified exceptions. CLP Regulation (EC) 1272/2008 – ATP 22 (Reg. 2024/2564) : updates the classification of 27 substances, seven of which directly affect the cosmetics sector. Omnibus VIII takes these new classifications and transfers them to Annexes II (prohibition), III (restrictions), IV (colorants) and V (preservatives) of the Cosmetics Regulation, ensuring harmonious application throughout the internal market. Why “Omnibus VIII”? Since 2019, the Commission has published an annual "Omnibus" to rapidly adapt the Cosmetics Regulation to successive CLP amendments. The 2025 package is the eighth edition, and non-compliant products must be withdrawn from the market from the date of application. Main technical innovations Substance or group Regulatory action Scientific/regulatory basis Sodium perborate, potassium perborate and other derivatives Unification and prohibition in Annex II CMR 1B classification and rationalization of duplicate entries. Silver (macroscopic, powder and nano forms) - Nano and bulk silver: prohibited - Micronized silver: permitted only under SCCS conditions (e.g. 0.2% in lip balms) New classification Repr. 2 and SCCS opinion 27 Mar 2024. Hexyl salicylate Restriction in Annex III (0.2%–2% depending on category) Repr. Classification 2 and SCCS opinion 25 Oct 2024. O-Phenylphenol + sodium salt Revised entry in Annex V with differentiated limits (0.2% in rinse, 0.15% in leave-on) Classification Carc. 2 and SCCS opinion 25 Oct 2024. 20+ CMR substances without industrial defense Added to Annex II (total ban) Lack of exemption requests; automatic application of Article 15. Compliance schedule The regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will be applicable on 1 May 2026. There is no coexistence period for the sale of stocks, so after that date, any product containing off-specification substances must be withdrawn or reformulated. Conclusion Omnibus VIII represents the consolidation of the European strategy to eliminate, or severely restrict, all CMR substances from cosmetic products. The May 1, 2026, horizon offers a limited but sufficient window of opportunity if planning begins now. Compliance is not just a legal obligation: it's an opportunity to strengthen consumer confidence and position ourselves as a safe and responsible brand in the European market.

The European Commission has taken a further step in protecting consumer health with the publication of Regulation (EU) 2025/877, known as Omnibus VII , which amends Regulation (EC) 1223/2009 on cosmetic products. The regulation, dated May 12 and published in the Official Journal of the EU on May 13, 2025, updates the list of prohibited substances and introduces significant changes that will affect manufacturers, importers, and distributors in the cosmetics sector. Table of contents Why was this new Omnibus necessary? Main news Implementation schedule Impact on the industry Conclusion Why was this new Omnibus necessary? Every year, the EU automatically adapts the Cosmetics Regulation to the latest update of the CLP Regulation (1272/2008) on the classification and labeling of chemical substances. Delegated Regulation (EU) 2024/197 reclassified numerous ingredients as carcinogens, mutagens, or toxic for reproduction (CMR). To ensure legal consistency and a high level of protection, Omnibus VII moves these classifications to the annexes of Regulation 1223/2009, prohibiting their use in cosmetics with limited exceptions. Main news Exchange rate Key detail Consequence New emblematic ban Trimethylbenzoyl Diphenylphosphine Oxide (TPO) is no longer permitted in artificial nail systems (previously 5% max.). Reformulate all gels/polishes that contain it. Mass addition to Annex II Twenty-one CMR substances are added, including tetrabromobisphenol-A, transfluthrin, clothianidin, bisphenol AF, 4-methylimidazole, dibutyltin oxide and several organophosphate photoinitiators. Total ban on any gathering. Technical amendment Entry 1580 (cymoxanil) is corrected to include alternate chemical name and additional CAS. Clarifies inspections and prevents legal loopholes. Deletions in Annex III Entry 311 (TPO) is removed. “Restricted” use disappears; it becomes prohibited. (The full list of CAS and references 1731–1751 is given in the Annex to the Regulations.) Implementation schedule Entry into force : 20 days after publication → June 2, 2025 . Mandatory applicability : September 1, 2025 (coincides with the validity of the CLP classification 2024/197). From that date, no products containing these added substances may be legally marketed in the EU. Impact on the industry Immediate reformulation : Product managers must review formulas and eliminate the affected substances. Product Information File (PIF) Update : Incorporate revised safety assessments and replacement tests. Inventory management : plan withdrawals or liquidations before September 1. Supply chain : Require updated composition certificates from raw material suppliers. Labeling and claims : Check that there is no reference to ingredients that are already prohibited and that the section on misleading statements is not violated. Conclusion Regulation (EU) 2025/877 reinforces the trend toward "zero tolerance" for CMR substances in cosmetics and requires the industry to accelerate the transition to safer formulations. Compliance by September 1, 2025 , not only avoids sanctions but also preserves European consumer confidence in a market where safety is the top priority. Contact an expert in cosmetic regulation

The United Kingdom (UK) has notified the World Trade Organization (WTO) of its intention to amend Regulation (EC) No 1223/2009 , as applied to Great Britain, to limit the concentration of benzophenone-3 (BP-3) in various cosmetic products. The proposal—notified by notification G/TBT/N/GBR/102 of 8 May 2025—is based on the recent opinion of the Scientific Advisory Group on Chemical Safety (SAG-CS), which concluded that the substance is safe within specific thresholds. This article summarizes the comparative regulatory framework (UK-EU), sets out the toxicological rationale, and assesses the technical and commercial implications of the measure. Table of contents 1. Introduction 2. Comparative regulatory framework 3. Scientific basis 4. Schedule and comment procedure 5. Implications for industry and commerce 6. Conclusions UK Proposal to Restrict Benzophenone-3 in Cosmetic Products: Regulatory Alignment, Toxicological Evidence and Market Outlook (2025) 1. Introduction Benzophenone-3 (also known as oxybenzone; CAS 131-57-7) is a broad-spectrum UV filter used to protect skin and stabilize cosmetic formulations. However, its potential endocrine activity and findings of phototoxicity have prompted successive regulatory reviews to ensure a high level of public health protection. 2. Comparative regulatory framework 2.1 European Union Since the adoption of Regulation (EU) 2022/1176, the EU has limited BP-3 to 6% in facial products and 0.5% when used as a stabilizer; in 2022, it also introduced a limit of 2.2% for body applications, following opinion SCCS/1625/21. 2.2 United Kingdom Following Brexit, the UK maintains Regulation (EC) 1223/2009 as "retained EU" legislation and amends it through Statutory Instruments (SI). Notification G/TBT/N/GBR/102 announces the "Draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025" , which introduces the same thresholds recommended by the SAG-CS: Product category Proposed BP-3 boundary Facial creams, hand creams, and lip products 6% w/w Extensive body application (lotions, sprays) 2.2% w/w Use as a UV stabilizer 0.5% w/w Adoption is expected on July 21, 2025 , entry into force on January 21, 2026 , and a transitional period until July 21, 2026, to exhaust previously marketed stocks. 3. Scientific basis SAG-CS/Opinion 14 (October 2024) evaluated in vitro, in vivo, and in silico data on the toxicokinetics, endocrine-disrupting potential, and phototoxicity of BP-3. The panel concluded: Dermal safety : margins of exposure (MoE) ≥ 100 for concentrations of 6% (facial use) and 2.2% (body use). Aggregate exposure : The simultaneous contribution as a filter and as a stabilizer (0.5%) remains below the derived Acceptable Exposure Level (AED). Recommendation : Adopt differentiated limits by application area to minimize the daily systemic dose (SED) and prevent photoallergenic events. 4. Schedule and comment procedure The UK has opened a 60-calendar-day period— until 7 July 2025 —for receiving technical comments through the UK TBT Enquiry Point ( tbtenquiriesuk@businessandtrade.gov.uk ). The measure will subsequently be incorporated into domestic law through a separate SI detailing the affected HS codes and the penalties for non-compliance. 5. Implications for industry and commerce Alignment with the EU : Convergence of limit values reduces technical barriers for products exported to/from the EU, simplifying safety dossiers and bilingual labeling. Reformulation : Manufacturers still using concentrations > 6% must adjust matrices and validate photochemical stability by January 21, 2026. Inventory management : Distributors have an additional six months (until July 21, 2026) to clear stock, requiring sell-through strategies and document traceability. International trade : By notifying the amendment via the WTO-TBT, the UK is fulfilling its transparency obligations and providing third countries with the opportunity to justify equivalences or raise specific concerns. 6. Conclusions The British proposal consolidates the global regulatory trend toward stricter levels of BP-3, based on recent toxicological evidence and the need to harmonize post-Brexit standards with the European acquis. Successful implementation will depend on the cosmetics industry's ability to reformulate in a timely manner and on continued monitoring of new scientific evidence on emerging UV filters. Official references WTO – TBT Committee : Notification G/TBT/N/GBR/102 (8 May 2025). WTO Center SAG-CS : Final Opinion on Benzophenone-3 in Cosmetic Products (Oct 24, 2024). UK Government Commission Regulation (EU) 2022/1176 amending Annex VI to Regulation (EC) 1223/2009 (28 June 2022). EUR-Lex Contact a Comsetic Regulatory Expert

The Sun Protection Factor (SPF) measures a cosmetic product's ability to protect the skin from UVB ultraviolet radiation, which causes sunburn and, in the long run, cellular damage. Beyond its technical effectiveness, all sunscreens must comply with a rigorous regulatory framework that guarantees their safety, stability, and truthful labeling. In the European Union, the marketing of sunscreens is governed by Regulation (EC) No. 1223/2009 on cosmetic products and by the European Commission's guidelines for the "in vivo reference method" for determining SPF. In the United States, the FDA classifies sunscreens as "over-the-counter" and requires specific clinical studies for each SPF level, as well as clear water-resistance statements. This guide will address, in a streamlined and practical way, both the fundamentals of SPF (mechanisms of action, filter types, and evaluation criteria) and the main legal and labeling requirements in the most relevant markets, so you can design, develop, or select safe formulas that comply with current regulations. Table of contents What is SPF (Sun Protection Factor) and how is it measured? Differences between UVA and UVB protection, and why both are important Comparison between UVA and UVB radiation 7 Common Myths About Using Sunscreen Practical recommendations for consumers: how to choose and apply sunscreen correctly Recommendations for formulating companies: regulatory compliance, labeling and testing Conclusion Do you need expert support? Guía completa sobre protectores solares: SPF, UVA/UVB, regulaciones e innovaciones What is SPF (Sun Protection Factor) and how is it measured? The Sun Protection Factor (SPF) is an index that indicates the effectiveness of a sunscreen in protecting the skin against UVB radiation (the main cause of sunburn). By definition, SPF is determined in the laboratory by comparing the amount of UV radiation required to produce minimal redness ( minimal erythemal dose , MED) on sunscreen-protected skin with that on unprotected skin. In simple terms, an SPF of 30 means that it would take ~30 times longer for the skin to redden with the product applied than without it, under the same conditions. To obtain this measurement, a standard amount of 2 mg/cm² of product is applied to the skin of volunteers and exposed to controlled UV light until mild redness occurs. It's important to understand that SPF primarily refers to UVB protection; UVA protection isn't reflected by the SPF number. A higher SPF indicates greater UVB blockage, but the difference in protection isn't linear. For example, SPF 15 blocks about 93% of UVB rays, SPF 30 about 96-97% , SPF 50 about 98% , and SPF 100 about 99% . In practice, this means that going from SPF 30 to SPF 50 only reduces the UVB radiation reaching the skin by a few percentage points (letting through ~3% vs ~2%), although that apparent 1% difference means that 50% more UVB radiation reaches the skin with SPF 30 than with SPF 50. The following graph illustrates the proportion of UVB blocked by different SPF levels: Porcentaje aproximado de radiación UVB bloqueada por distintos valores de SPF (datos para UVB). Se aprecia que a partir de SPF 30-50 la ganancia en protección es marginal, pero significativa para exposiciones prolongadas. There's no direct relationship between SPF and duration of protection: a higher SPF doesn't mean you can stay in the sun longer without reapplying. All sunscreens degrade with exposure to the sun, water, or sweat, so it's recommended to reapply every two hours at most, regardless of the SPF. Additionally, the SPF number assumes a generous application of the product; in real life, many people apply less, achieving less effective protection than the stated SPF. Therefore, using at least SPF 30 (high) or 50 (very high) daily and reapplying frequently is key to adequate protection. Differences between UVA and UVB protection, and why both are important Diferencias entre la protección UVA y UVB, y por qué ambas son importantes Diagram of the penetration of different wavelengths of light into the skin. The purple portion (approximately <320 nm) corresponds to UVB, which remains mostly in the epidermis, while the pink portion (320-400 nm, UVA) penetrates deeper into the dermis. Ultraviolet light from the sun is composed primarily of UVA and UVB rays . Although both are invisible to us, they have key differences: Wavelength range UVB covers approximately 280 to 320 nm, while UVA ranges from ~320 to 400 nm. Within UVA, a distinction is sometimes made between short UVA (320-340 nm) and long UVA (340-400 nm). Proportion in sunlight About 95% of the UV radiation reaching the Earth's surface is UVA, and about 5% is UVB. This is because the ozone layer filters out most of the most energetic UVB radiation, while UVA radiation passes through the atmosphere almost unimpeded. Skin penetration UVB rays have shorter wavelengths and penetrate only the superficial layers of the skin (epidermis). They are very energetic but do not reach the deep dermis. In contrast, UVA rays (longer wavelengths) penetrate deeper into the dermis, where they damage collagen and elastin fibers. Biological effects UVB rays are primarily responsible for sunburn or acute skin redness. They also induce delayed tanning by stimulating melanin production and can directly damage the DNA of skin cells, significantly contributing to the development of skin cancer . UVA rays, on the other hand, cause an immediate tan (oxidation of existing melanin), but this is more deceptive , as the damage is not immediately visible. UVA rays generate free radicals in the skin that cause photoaging (wrinkles, dark spots, and loss of elasticity) and also contribute to the long-term risk of skin cancer . For a long time, it was believed that UVA rays did not cause serious damage, but today we know that they can indirectly cause DNA damage and increase the likelihood of cancer. Variation and scope UVB intensity varies depending on the time of day and season; it is highest at midday and in summer, and virtually nonexistent at dawn/dusk or in winter at high latitudes. UVA rays, on the other hand, are present year-round and throughout the day with a relatively constant intensity. In addition, UVA rays pass through clouds and glass: even on cloudy days or under indirect shade, UVA radiation reaches the skin, and glass in windows or cars blocks most UVB rays but lets most UVA rays pass through. In short, both types of UV rays are harmful , and it's essential to protect yourself from both. A good sunscreen should be "broad spectrum," meaning it can filter out both UVB and UVA rays. If we only protect ourselves against UVB (reflected by the SPF), we could avoid sunburn but still receive significant doses of UVA that accelerate skin aging and contribute to skin cancer , so when choosing a sunscreen, we should look for indications of UVA protection in addition to the SPF. Comparison between UVA and UVB radiation UVB (B = “Burning”) UVA (A = “Aging”) Approximate wavelength 280 – 320 nm (UVB) 320 – 400 nm (UVA; UVA-II 320-340, UVA-I 340-400) Percentage of UV that reaches the ground ~5% ~95% Skin penetration Superficial (epidermis) Deep (up to the dermis) Main effects Erythema (burn), vitamin D synthesis, direct DNA damage, skin cancer Immediate tanning, aging (wrinkles, spots), indirect DNA damage, skin cancer Diurnal/seasonal variation Maximum at midday and in summer; very low in winter or in the early/late hours Relatively constant all day and year round Ability to pass through glass Very low (glass blocks almost all UVB) High (passes through windows and clouds easily) Current regulations on photoprotection (EU requirements 2024 and beyond) In the European Union , sunscreens are regulated as cosmetic products and must comply with current safety and labeling regulations. Although there is no specific European law for SPF, there are recommendations and technical standards widely adopted by the industry. Highlights of the current regulations (updated to 2024) include: Minimal UVA efficacy The European Commission recommends (and in practice requires for labeling as "UVA") that UVA protection have a minimum value of at least 1/3 of the declared SPF . In other words, if a product is SPF 30, it should provide a UVA protection factor (UVA protection factor, measured by specific methods) of at least 10. This requirement ensures proportional protection against UVA rays, which have historically been neglected in some products. In addition, the sunscreen must reach a critical wavelength of 370 nm, ensuring coverage in the long UVA spectrum. Products that meet these criteria can display the UVA symbol (the letters "UVA" in a circle) on the packaging, indicating to the consumer that it offers broad-spectrum protection in accordance with European standards. SPF labeling and categories In Europe, SPF is typically labeled with standardized numbers and in protection categories. Claims of SPF above 50+ (50 plus) are not permitted on the label, even if the actual measured SPF exceeds 60. Categories are typically divided into low (SPF < 15), medium (15-25), high (30-50), and very high (50+). For example, an SPF 30 product would be considered "high protection," and an SPF 50+ product would be considered "very high." It is also regulated that misleading terms such as "total protection" or "total screen" are not used, as no product blocks 100% of UV radiation. List of permitted UV filters EU cosmetic regulations ( Regulation EC 1223/2009 , Annex VI) maintain a list of authorized UV filter ingredients, with their maximum concentrations. Formulators may only use sunscreens that have been evaluated and approved by the European regulatory authority. For example, commonly approved filters include avobenzone, octocrylene, Homosalate, and others, each with its own limits. This list is periodically updated; recently (until 2024), new filters have been introduced and others have undergone safety reviews. Efficacy and testing requirements To support the declared SPF, manufacturers must perform standardized testing (e.g., ISO 24444:2019 for in vivo SPF). Likewise, to claim UVA protection and use the UVA logo, they must perform UVA-PF testing (either in vivo using the PPD method or equivalent in vitro tests, e.g., ISO 24443 ). If claims such as “water resistant” are made, a water resistance test must be carried out (e.g., 40 or 80 minutes of immersion according to COLIPA protocols) and the product must indicate how to use it correctly to maintain that protection. Since 2022-2024, the EU has reinforced the importance of these tests: a product that does not meet the 1/3 UVA/SPF criterion or has not been adequately tested could be considered mislabeled or even unsafe by consumer authorities. Other labeling provisions The packaging must include usage recommendations (e.g., “reapply frequently, especially after swimming or sweating”), the expiry date (period after opening) indicating the product’s shelf life, and the list of ingredients with special indication of the presence of nanoparticles (e.g., “ Titanium Dioxide (nano) ” if titanium dioxide is used in nano form, as required by the EU). These measures aim to inform consumers and ensure correct use and transparency of the product. In other regions, there are differences: for example, in the US, sunscreens are considered over-the-counter (OTC) products , and the FDA regulates permitted filters and "Broad Spectrum" labeling differently, requiring a certain UVA absorption ratio but without a numerical UVA-PF index as such. However, globally, the regulatory trend is similar: ensuring both UVA and UVB protection, robust efficacy testing, and clear communication so the user understands how to use the product. In 2024, Europe maintains one of the strictest standards in terms of spectrum width and diversity of permitted filters, encouraging continued innovation in this field. Improvements in photostability and synergies Another line of innovation has been improving the photostability of organic (chemical) filters. A landmark example was the stabilization of avobenzone (a UVA-1 filter) by combining it with other photostable filters to prevent rapid degradation. Today, high-quality formulations often combine multiple filters that complement each other: for example, a single product may contain a powerful UVA filter , a broad-spectrum filter and UVB filters such as octocrylene, homosalate, etc., achieving a reinforced broadspectrum effect. Additionally, technologies such as filter encapsulation (entrapping the filter in a microscopic matrix) are used to reduce skin absorption and improve stability, or combinations of organic filters with mineral filters (titanium dioxide, zinc oxide) to obtain the benefits of both. New filters and approvals New filters have appeared on the European market in recent years. Each innovation typically requires extensive safety studies before regulatory approval, but once approved, they offer formulators more tools to create lighter, clearer, and more effective sunscreens. It's worth mentioning that in markets like the US, the approval of new filters has been slower (filters that are common in Europe have not been approved for years), but recently there's been a global trend toward harmonizing the availability of these ingredients given the recognition of their importance. Textures and functional cosmetics Innovation is not only emerging in the active ingredients, but also in the product form. Sunscreens have emerged with very light, cosmetically pleasing textures (e.g., water-based gels, transparent mists, solid sticks) to improve adherence for the consumer. Antioxidant ingredients (vitamin E, C, niacinamide) have also been incorporated into the formulas for additional protection against free radicals generated by radiation, and "booster" ingredients that enhance the effectiveness of the SPF. Even gradual release technologies or longer water and sweat resistance are being explored, with extreme sports or prolonged outdoor use in mind. Focus on safety and environment Recent innovations consider not only efficacy but also safety for humans and the environment . Research is underway to identify filters that do not cause irritation or sensitization to sensitive skin, nor are they harmful to marine life. The debate over UV filters and coral reefs has prompted the search for "reef-friendly" filters. Some tourist destinations have banned ingredients like oxybenzone due to their environmental impact. In response, many modern formulations avoid certain controversial filters and use alternatives with better environmental profiles. Similarly, mineral filters (zinc and titanium), especially in non-nano form or with special coatings, are promoted as options with a lower environmental impact, although they come with the challenge of not leaving a whitening effect on the skin. In short, the sunscreen industry is moving toward products that are more effective across the entire UV spectrum, more comfortable to use, and safer , relying on the advanced chemistry of new filters and constant formulation improvements. These innovations benefit both consumers (better protection and user experience) and professionals and regulators by facilitating compliance with increasingly demanding sun protection standards. 7 Common Myths About Using Sunscreen Despite educational campaigns, many myths and misconceptions persist about when and how to use sunscreen. Clarifying these myths is essential so that the public can make the most of sun protection. Below, we debunk some of the most common myths: Myth 1: “If I use sunscreen, I won’t tan.” Sunscreen doesn't completely prevent tanning, but it filters out some of the UV radiation to make the process safer and slower. Tanning is the skin's defense response to UV damage (melanin darkens to absorb radiation), and therefore indicates damage . With sunscreen, you can tan gradually, but it will reduce the risk of sunburn, premature aging, and cancer. A healthy tan doesn't actually exist; any tan is a sign of accumulated damage. It's recommended to always use sunscreen (at least SPF 30) and moderate your sun exposure, seeking shade during peak hours. Your skin will tan more slowly, but will be more protected. Myth 2: “Only SPF 50 (or higher) protects me; lower SPFs are useless.” Any sunscreen with SPF 15 or higher can be effective if applied correctly and in sufficient quantity . The difference between SPF 30 and SPF 50 in percentage of UVB blocked is small (approximately 97% vs. 98%). A properly applied SPF 30 may protect better than a poorly applied SPF 50. The important thing is to choose an SPF appropriate for the situation (minimum 30 for everyday use, 50 for prolonged outdoor activities) and apply the correct dose. SPF 50 doesn't mean you can spend twice as much time in the sun as with SPF 25, as it's not linear, and both require reapplying periodically. In short, a high SPF offers more protection but isn't invincible; a medium SPF also offers good protection if used correctly. You should never let your guard down with any SPF. Myth 3: “A very high SPF lasts all day, there’s no need to reapply.” I wish it were true. No sunscreen lasts all day. Chemical filters degrade with UV exposure, and any product (chemical or mineral) can be removed by sweat, water, and rubbing against clothing or towels. An SPF 50+ applied at 9 a.m. will no longer provide that protection by midday if it's not reapplied. All dermatologists recommend reapplying at least every two hours, or immediately after swimming or sweating heavily. This applies even to products labeled "water-resistant": water resistance doesn't mean it lasts indefinitely; it simply means that it retains some of its SPF after 40 to 80 minutes in the water, but much of the protection is lost when you get out and towel off. Therefore, no sunscreen is "all-powerful"; reapplication and avoiding overexposure are still necessary with any SPF. Myth 4: “Makeup with SPF replaces sunscreen.” Many cosmetics (foundations, tinted moisturizers) include SPF in their formulas, which is beneficial. However, relying on makeup with SPF alone can be insufficient. The main reason is that we don't apply enough makeup to achieve the stated SPF protection . SPF is calculated at 2 mg/cm², a much thicker layer than that typically used with foundation or powder. Furthermore, few makeup products offer adequate UVA protection. Ideally, you should use a dedicated sunscreen under your makeup, and consider the SPF of the makeup as an extra . If you're only going to be outdoors for a short time, SPF 30 makeup may offer partial protection, but for extended exposure, it's best to play it safe and apply a generous amount of real sunscreen. Myth 5: “If I have brown (or dark) skin, I don’t need sunscreen.” It's true that darker skin tones have more melanin, which provides natural protection equivalent to ~SPF 13 (depending on the skin tone) and makes sunburn less common. But no skin tone is immune to UV damage. People with darker skin types can also suffer from photoaging , uneven hyperpigmentation, and, although less common, skin cancer (melanoma and others) due to accumulated damage. In fact, skin cancers in dark-skinned people are often detected late due to the false belief that "I don't burn." All skin types need protection ; the difference will be in how easily they burn (a very fair person should use a very high SPF and reapply religiously; a dark-skinned person may not burn easily, but their skin still ages and suffers damage if not protected). Furthermore, current sunscreens are usually translucent and don't leave a noticeable white cast, so there's no aesthetic excuse not to use them on dark skin. Myth 6: “If it’s cloudy or I’m in the shade, I don’t need sunscreen.” False. Up to 80% of UV radiation can penetrate light cloud cover. Even if the heat isn't perceived on cloudy days, UV rays (especially UVA rays) still reach the sun and can cause damage. Many mild sunburns occur on cool days or when the sun is shining through the clouds because people don't protect themselves, thinking "there's no sun." Likewise, in the shade, one is protected from direct radiation, but diffuse radiation reflected by the environment still exists. Sand, water, and even light-colored walls reflect UV rays. Therefore, even in the shade on the beach, it is recommended to wear sunscreen. The same is true when driving or standing indoors near windows in bright daylight, as UVA rays penetrate glass. In short, 365-day-a-year sun protection is the advice of dermatologists: adapt the SPF to the UV intensity of each day, but don't skip it entirely because it's cloudy or you spend mostly in the shade. Myth 7: “Sunscreens are dangerous/toxic” This myth encompasses several concerns. Regarding cancer , there is no scientific evidence that regular sunscreen use causes cancer; on the contrary, it has been shown to prevent certain skin cancers by reducing the accumulated harmful radiation dose. Some studies in cells or animals have indicated compounds that may have weak hormonal effects (e.g., oxybenzone), but regulatory authorities evaluate these data and establish safe concentrations. The formulations undergo rigorous safety testing. Regarding vitamin D , it's true that UVB rays help synthesize it in the skin, but using sunscreen doesn't cause significant deficiency in most people. This is because no one applies sunscreen perfectly at all times or in all areas (so some UV radiation always reaches us to produce vitamin D), and we can also obtain vitamin D from diet or supplements if needed. The benefits of sun protection in preventing cancer and aging far outweigh any minimal impact on vitamin D. Finally, regarding allergies or toxicity: modern sunscreens are quite refined, and there are mineral or sensitive skin options for those wary of chemicals. In conclusion, sunscreens are safe when used as directed and are a crucial public health tool. (There are more myths, but the above are some of the most common. The important thing is to seek reliable information and follow the recommendations of dermatology professionals.) Practical recommendations for consumers: how to choose and apply sunscreen correctly To get the most out of sunscreen, consumers should consider several factors when choosing and using the product . Here are some practical recommendations: Prefers “broad spectrum” formulas Make sure the packaging indicates both UVB and UVA protection. Look for the circular UVA symbol (on European products) or the phrase "broad spectrum" on other markets. This ensures that the product meets minimum UVA protection standards, in addition to the UVB SPF. Choose an SPF suitable for your activity For everyday use (everyday city activities, walking to work, etc.) , SPF 30 or higher is typically recommended. If you're going to be outdoors for long periods of time, playing sports at the beach or in the mountains, opt for SPF 50+ and reapply frequently. Remember that higher SPFs offer more protection but aren't foolproof —don't prolong your sun exposure thinking that sunscreen makes you invulnerable. Take into account your skin type If you have sensitive skin or allergies, consider using physical/mineral sunscreens (zinc oxide or titanium dioxide) or hypoallergenic formulas, as they tend to be better tolerated. If you have oily or acne-prone skin, look for non-comedogenic , oil-free products, such as mattifying gels or fluids. For dry skin, a cream with hydrating ingredients will be helpful. For darker skin, you may prefer sheer or tinted formulas to avoid any white cast from mineral filters. Check water resistance if needed If you're going to be swimming, doing intense sports, or sweating, choose a water-resistant sunscreen. These indicate that they retain some of their protection after a certain amount of time in the water (40 or 80 minutes), which is essential for water activities or exercise. Still, remember that "water-resistant" doesn't mean "waterproof": you'll need to reapply after getting wet or drying off. Check the expiration date Sunscreens expire ; their filters can degrade over time. Use products within the date indicated (or within 12, 18, etc., after opening, according to the PAO symbol). An expired sunscreen may have lost its effectiveness. Also, store it in a cool place away from direct sunlight when not in use to prevent premature deterioration. When applying sunscreen: Apply sufficient quantity This is perhaps the most important and underrated step. SPF efficacy is determined at ~2 mg/cm², which is roughly equivalent to one teaspoon for the face/neck or about 30 ml (a shot glass) to cover an adult body in a bathing suit . A good rule of thumb is the “two-finger rule” : for each area (each arm, each leg, torso, back, face/neck), apply two lines of cream along your index and middle fingers as a guide to the approximate amount needed. Don’t skimp on the product; applying less drastically reduces protection. Apply evenly Spread the sunscreen evenly over the entire exposed area. Don't forget frequently overlooked areas : ears, neck, back of the hands, insteps of the feet, hairline, lips (use lip balm with SPF), and behind the knees. Ask for help for tricky areas like the back. Careless application can leave unprotected patches that will burn. Application time Apply sunscreen about 20-30 minutes before sun exposure, especially if it's a chemical sunscreen, so it has time to absorb properly. If you use a mineral sunscreen, the protection is effective immediately upon application, but it's also helpful to apply it beforehand to ensure full coverage. If you're going to wear makeup, apply sunscreen first, let it sit for a few minutes, and then apply your makeup. Reapply frequently As explained in the myths section, sunscreen diminishes over time. Reapply at least every two hours under normal conditions. If you're at the beach, pool, or exercising in intense sun, it's advisable to reapply every 90 minutes. And always reapply after swimming, toweling off, or sweating profusely (even if the product is water-resistant). Keep sunscreen handy to replenish throughout the day. To avoid ruining your makeup when reapplying, you can use sprays or mists on your face, or powders with SPF, but be sure to apply enough or wear a hat for maximum protection. Combine with other protective measures Sunscreen shouldn't be your only defense. Maximize protection by also wearing appropriate clothing (a wide-brimmed hat, UV sunglasses, long clothing, or UPF-protected fabric if possible) and seeking shade during the most intense hours of sunlight (between 12:00 and 16:00). Remember that the day's UV index can help you plan: if it's very high/extreme, limit your exposure even if you're wearing sunscreen. Sunscreen works best as part of a comprehensive sun protection strategy. By following these tips, consumers can significantly reduce the risks associated with sun exposure. The key is consistency (daily protection, even on cloudy days) and generous, repeated application of the product. Your skin's long-term health will thank you for it. Recommendations for formulating companies: regulatory compliance, labeling and testing For professionals and companies that develop and market sunscreens, in addition to the scientific aspects, it is crucial to comply with regulations and ensure the quality and efficacy of the final product. Here are some key recommendations for formulators in the sunscreen cosmetics sector: Comply with ingredient regulations Verify that all UV filters in the formula are authorized by the regulations of the destination market . In the EU, only filters listed in Annex VI of the Cosmetics Regulation may be used, within their permitted concentrations. Stay up-to-date with regulatory updates. If you formulate for global markets, be aware of the differences: e.g., in the U.S., the range of filters approved by the FDA is more limited. Offering "global" formulas may require adjusting filters based on the region. Balance the formula for broad spectrum From the formula design, be sure to include a combination of filters that achieves the goal of UVA PF ≥ 1/3 SPF . This often involves combining high-performance UVB filters with deep UVA filters. Use spectral absorption data from each filter to synergistically cover the 290-400 nm spectrum as evenly as possible. Also, remember to achieve a critical wavelength ≥ 370 nm to be able to claim UVA protection in Europe. Photostability and compatibility Check the photostability of the filter combination. Some filters can degrade each other (for example, avobenzone is stabilized with octocrylene, but may degrade without stabilizers). Conduct UV exposure tests on the formulation to ensure that the SPF and UVA-PF are maintained after hours of irradiation (many standards require measuring SPF in vitro after irradiating the sample with a standard UV dose to assess stability). Also check the chemical compatibility of the filters with other ingredients (certain emulsifiers, perfumes, or plant extracts can interact with filters, affecting color or odor over time). Mandatory efficacy trials Plan and execute the tests necessary to validate the claims : SPF The reference method is the in vivo test in volunteers (minimum 10 subjects) applying 2 mg/cm² and determining the SPF by comparative MED (ISO 24444). Alternatively, in vitro methods (ISO 24443 uses spectrophotometry) can help in the development stages, but most authorities still require in vivo data for labeling. GRAPE If you're using the UVA logo, perform the in vitro UVA-PF test (e.g., ISO 24443 method or the in vivo PPD method ISO 24442). Make sure you get a UVA-PF value ≥ 1/3 of the SPF. Also, check the critical wavelength with a spectrophotometer (ISO 29063 method) to confirm that you achieve ≥ 370 nm. Water resistance: If you're going to claim "Water Resistant" or "Very Water Resistant," carry out the appropriate test (usually measuring the SPF before and after standardized immersion in water, according to COLIPA/ISO guidelines). Only make these claims if the results meet the criteria (e.g., maintaining at least 50% of the SPF after two 20-minute immersions for "water resistant"). Stability and security In addition to UV efficacy, like any cosmetic , physical-chemical stability tests must be carried out (resistance to temperature cycles, centrifugation, etc.), packaging compatibility (that the plastic of the tube does not interact with the formula), and microbiological tests (antimicrobial challenge) given that these are products that can become contaminated with frequent use on the beach, etc. Likewise, conduct usage or sensitivity studies on people (irritation, allergy, ophthalmological tests if for the face) to validate that the product is well tolerated. Clear and standard-compliant labeling On the packaging, follow the labeling recommendations: Clearly indicate the SPF and category (“High,” “Very High,” etc., optionally). Include the circled UVA symbol if applicable (and only if applicable, meaning you passed the tests). Incorrect labeling could be considered false advertising and result in penalties. Add usage instructions : “apply 20 minutes before,” “reapply every 2 hours,” “use generously,” “for external use only – avoid contact with eyes,” etc., to educate the user on proper use. Many markets require some standard phrases (“reapply frequently,” “avoid prolonged sun exposure even with sunscreen,” “keep babies out of direct sunlight,” etc.). Complete list of ingredients (INCI) , including the [nano] label on physical filters if they are nanoparticles. And don't forget the batch number, expiration date or PAO, and contents (ml). Quality and batch control Implement rigorous quality control during production to ensure that each batch of sunscreen actually meets the labeled SPF. Variations in raw materials or processes could affect performance (e.g., particle size of a mineral filter, or strength of an organic filter). Ideally, conduct in vitro SPF testing on pilot batches regularly, and at least one in vivo test on a commercial batch occasionally, to ensure consistency. Also monitor shelf-life stability of batches throughout their shelf life. Documentation for authorities Prepare and maintain an up-to-date Product Information File (PIF) with all formula, safety, and efficacy data. In the EU, this includes the cosmetic safety report and toxicological evaluations of each ingredient (paying special attention to UV filters, ensuring the combined concentrations comply with the law). Have SPF/UVA test reports ready. This way, you can transparently demonstrate compliance during any inspection or request from health authorities. Innovation and differentials From a technical marketing perspective, highlighting innovations can provide a competitive edge. But make sure any innovative claims are supported: for example, if you say "protects against blue light," you should have studies or filters that effectively cover up to 400–500 nm, or if you say "respects the oceans," you should have avoided ingredients banned by local regulations (such as Hawaii) and perhaps undergone eco-toxicological tests. Communication must be responsible so as not to create new myths or create consumer confusion. Ultimately, the task for formulating companies is twofold : on the one hand, scientific and technical , to develop an effective and safe product; on the other, regulatory and educational, to comply with laws while guiding the user in proper use through labeling. A well-formulated and properly tested sunscreen not only prevents burns and skin damage, but also builds trust among consumers and healthcare professionals, strengthening the brand's reputation and contributing to public health. Conclusion In this guide, we've reviewed in detail what SPF is and how it's measured, the importance of covering both UVB and UVA radiation, key regulatory requirements in the European Union (and comparisons with the US), and the latest innovations in filters. We also debunk common myths and offer practical recommendations for both consumers and formulators. Understanding and correctly applying these concepts not only guarantees the effectiveness of your formulas, but also protects the health of your users and ensures regulatory compliance. Do you need expert support? If you want to design, validate, or launch a sunscreen with all the guarantees of effectiveness and compliance with legislation, contact BELAB Services today . Our team of cosmetics and regulatory specialists will support you throughout every phase of the project to ensure your products meet the highest standards of quality and safety. contacta hoy mismo con BELAB Services

An OTC (Over-the-Counter) Monograph from the U.S. Food and Drug Administration (FDA) is the set of technical and legal requirements that allow an over-the-counter drug to be marketed without having to submit an individual New Drug Application (NDA). In practice, it acts as a "cookbook" for the industry: if the product complies exactly with the applicable monograph, the FDA considers it generally recognized as safe and effective (GRASE) and can go directly to market. Table of contents Contents of a monograph Regulatory pathways for an OTC drug CARES Act Reform (2020) Advantages for your company ¿Qué es una Monografía OTC de la FDA? Contents of a monograph Each monograph is published by therapeutic category (analgesics, antacids, sunscreens, etc.) and details: Permitted active ingredients and their maximum/minimum concentrations. Indications for use (for what ailment or symptom it can be advertised). Routes of administration and dosage . Required formulations and quality tests . Legends and labeling format (Drug Facts) that must appear literally on the package. Regulatory pathways for an OTC drug Option Summary When to use OTC Monograph Dependent on full compliance with the monograph (without prior FDA review). Products whose formulas and labeling fit 100% into an existing category. NDA / ANDA Individual review by the FDA (similar to a prescription drug). New ingredients, dosages, or presentations that do not fit into a monograph. CARES Act Reform (2020) On March 27, 2020, the CARES Act added Section 505G to the FD&C Act and modernized the monograph system: It replaced the slow regulatory process with Administrative Orders (proposed, final, and interim). Launched the OMUFA fee program, which funds the review and streamlines the timeline. It gave the FDA the power to issue expedited orders when imminent safety risks arise. Advantages for your company Faster market entry : without waiting for an NDA approval. Lower regulatory costs : the “recipe” already defines what is necessary to demonstrate safety and efficacy. Transparency and predictability : All requirements are public and updated by the FDA. Flexibility : If you need to innovate outside of the monograph, you can always opt for the NDA route. Complying with the appropriate OTC Monograph is the most efficient way to launch OTC medications in the U.S. Knowing its scope and limitations will allow your company to plan development, labeling, and market strategy from day one. Contacta con un experto en medicamentos OTC

In February 2025, the U.S. Food and Drug Administration (FDA) added nine Food‑Contact Substance Notifications (FCNs) to its Inventory of Effective Notifications. These additions include antimicrobial solutions, microbiological control agents in beverages, functional pigments, and microfibrillated cellulose pulp used as a component of paper packaging. Each FCN is legally effective only for the manufacturer or supplier identified in the notification, pursuant to Section 409(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act). Table of contents 1. Regulatory framework of the FCN 2. Main technical innovations 3. Implications for the industry 4. Belab Services operational recommendations Conclusion Official references FDA: 9 New Substances Added to FCN 1. Regulatory framework of the FCN The FCN program allows the marketing of substances intended for food contact materials when the FDA concludes, following a 120-day premarket review, that the proposed application is safe. The effectiveness of the notification—and therefore the marketing authorization—is restricted to the notifying company and its customers, requiring other manufacturers of the same substance to submit their own dossier if they wish to use it under identical conditions. 2. Main technical innovations The technological relevance of the nine new FCNs is summarized below without reproducing the structure of the primary source: Antimicrobial and microbiological control agents Chlorine dioxide (FCN 2395, Energis Solutions, 25-Feb-2025): authorized for processing water for meat, fish, fruits, vegetables, cereals and nuts with a maximum residue of 3 ppm. Dimethyl dicarbonate (FCN 2414, LANXESS Corp., 19-Feb-2025): Approved as an antimicrobial agent in ready-to-drink alcoholic beverages (≤15% v/v), up to 250 ppm, cross-referenced to 21 CFR 172.133. Functional pigments Fluorphlogopite pearlescent pigments (FCN 2407, Nihon Koken Kogyo, 04-Feb-2025): colorants for polymers in contact with food, up to 5% w/w, excluding uses with breast milk or infant formula. Tricyclodecanedimethanol (FCN 2408, Metlac SpA, 04-Feb-2025): cyclic triol used as an intermediate for coating varnishes, expanding the range of monomers approved for metal cans. Microfibrillated cellulose (MFC) Five separate notifications (FCN 2409‑2413) cover microfibrillated cellulose pulp (CAS 65996‑61‑4) from different manufacturers – Stora Enso Oyj, Sappi Biochemtech BV, Evergreen Packaging LLC, Borregaard AS and Fiberlean Technologies – with effective dates between 08 and 12‑Feb‑2025. The approvals allow its use as an additive, raw material or coating in food papers and boards, up to 100% of the formulation, excluding contact with breast milk or infant formula. 3. Implications for the industry Manufacturer exclusivity : Each FCN protects only the notifier's supply chain. Operators wishing to source from alternative suppliers must verify that the substance originates from the listed entity or, failing that, process a new FCN. Material Trends : The surge in MFC requests confirms the growing interest in fiber-based packaging solutions with barrier performance and a lower carbon footprint. Regulatory convergence : US authorisation of fluorphlogopite pigments or triols for varnishes may facilitate, but not guarantee, conformity assessments in other jurisdictions such as the EU (Regulation (EU) 10/2011) if an equivalent toxicological support dossier is submitted. 4. Belab Services operational recommendations Dependency Mapping : Identify which critical substances in your packaging depend on unique FCNs and secure contracts that guarantee traceability to the authorized manufacturer. EU-US Crosswalk Assessment : For projects seeking to market in both markets, work with our Brussels and Washington teams to assess the equivalence of specific migration limits and dietary exposure. Regulatory Oversight : Incorporate a continuous monitoring system for FDA inventory; changes such as limit restatements or FCN withdrawals can directly impact supply continuity. Conclusion The nine new notifications reinforce the FDA's trend toward accommodating highly effective microbiological control technologies and next-generation cellulosic materials. This expansion of the Inventory confirms the agility of the FCN mechanism for introducing innovations in food packaging , always under the premise of a rigorous toxicological evaluation and with the individual responsibility of the manufacturer as its central axis. Official references FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2414. FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2395. FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2407. FDA. Inventory of Effective Food-Contact Substance Notifications , general list (accessed 22-Apr-2025) . FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2409 Contact a cosmetic regulation expert.