Baby lotions, oils, and diaper creams are some of the most sensitive types of cosmetics in the EU. Because babies’ skin is different from adults’ skin, is more prone to irritation, and is used more often, baby cosmetics (0–3 years) have to go through stricter safety tests than adult cosmetics. Because of this, making a Cosmetic Product Safety Report (CPSR) for baby care products requires not only following EU Regulation 1223/2009 but also being careful and following the SCCS Notes of Guidance (12th Revision).
This guide will go over the things that brands, safety assessors, and formulators need to think about when making a CPSR for baby oils, lotions, and diaper creams. We will look at the toxicological, dermatological, and regulatory requirements that make infant products different. We will also give you useful information about testing, labeling, and documentation, as well as formulation restrictions.
Why infant skin needs a different safety lens
Skin structure, barrier & TEWL in early life
Compared to adult skin, baby skin is thinner, has less developed lipid layers, and has less keratinization. This barrier isn’t fully formed, which makes babies lose more water through their skin (TEWL) and makes them more sensitive to irritants, allergens, and chemicals. Because of this, the CPSR needs to take into account higher systemic absorption and use conservative safety margins when figuring out how much exposure to infant cosmetics there is.
Infant skin exhibits heightened permeability, alongside variations in immune response and microbiome equilibrium. Babies’ skin microbiota is still growing, which makes their skin more sensitive to things like preservatives, fragrances, and surfactants. Also, the enzymes in baby skin aren’t fully developed yet, so detoxification isn’t as effective as it is in adults. These factors together make it more likely that there will be local irritation and systemic toxicity. This makes it even more important to use conservative exposure modeling and be careful about the ingredients you choose when writing the CPSR.
The nappy area as a special exposure scenario (occlusion, higher pH, hydration)
The nappy area is a special case in safety checks. The constant covering of diapers makes the skin more hydrated, raises the pH level, and often makes existing irritation worse. Under these worst-case conditions, products like diaper creams need to be tested because absorption may be much higher. Safety assessors need to carefully model exposure, taking into account how often it happens and how well the skin holds up.
The chemical environment created by the diaper is also very important. When urine and feces stay on the skin for a long time, they raise the skin’s pH, which breaks down the natural acid mantle and makes it less protective. This biochemical change makes it easier for both good and bad ingredients to get through. Diaper materials can also cause friction, which can make irritation and microlesions worse. This means that diaper creams and oils should be tested not only for normal topical safety but also for use on skin that is inflamed or damaged. This usually means stricter safety margins, more toxicological references, and sometimes even specific dermatological test data to show that the product is safe to use with diapers.
The EU framework you must satisfy
CPR 1223/2009 & Annexes in practice (II–VI) for baby care
The EU Cosmetics Regulation (1223/2009) sets the standard for compliance. Annex II and Annex VI list substances that are not allowed or are only allowed in certain amounts. Many of these substances have specific rules for children under three. These are things like preservatives, substances that affect hormones, and allergens in scents. The CPSR says that these annexes must be followed for baby lotions, oils, and creams.
SCCS Notes of Guidance (12th rev): what assessors expect for children’s
The 12th revision of the SCCS Notes of Guidance talks directly about products for babies. It is the job of assessors to:
- Use more safety factors in margins of safety (MoS)
- Use exposure models that take into account the body surface area-to-weight ratios of infants.
- Think about the total exposure from all the baby products you use every day.
To meet EU standards, every infant CPSR must include these points.
Microbiological quality: Category 1 limits for products intended for <3 years
Microbiological standards for infant cosmetics are in Category 1. The rules are very strict:
- Total aerobic microbial count (TAMC): ≤ 100 CFU/g or ml
- No Pseudomonas aeruginosa, Staphylococcus aureus, or Candida albicans
This means that strong preservative systems and PET (challenge tests) are necessary to show that something is microbiologically safe.
Building Part A (Cosmetic Product Safety Information) for baby products
Complete quantitative formula + impurities
Every CPSR must include the full product composition, with exact percentages. For infant cosmetics, impurities must also be carefully considered—for example, polycyclic aromatic hydrocarbons (PAHs) in mineral oils must be excluded or proven to be below detection limits.
Raw material specs & purity; CoA requirements per NoG Appendix 6.
Each raw material should be supported with a certificate of analysis (CoA), detailing purity, grade, and compliance with pharmacopeial standards. For sensitive populations like infants, safety assessors rely heavily on robust raw material documentation.
Stability, compatibility & PET/Challenge testing design tailored to Category-1
Stability studies should confirm product integrity over the intended shelf life. Preservative efficacy testing (PET) must follow Category 1 requirements, ensuring pathogens are absent and preservative systems are strong enough to withstand contamination.
Fragrance documentation
If fragrance is included, full composition and IFRA certificates must be provided. The EU’s 2023 allergen update (Reg. 2023/1545) requires expanded allergen labeling, so infant products must either avoid fragrance or prove compliance with the stricter labeling rules.
Packaging & potential NIAS; suitability for frequent application to the nappy area.
Packaging must be safe, inert, and suitable for frequent handling. Safety assessors should evaluate potential non-intentionally added substances (NIAS) and confirm that packaging will not leach harmful compounds, especially under occluded conditions in the nappy area.
Building Part B (Safety Assessment) with infant-specific exposure
Selecting NOAEL/PoD & calculating MoS with infant-appropriate external/internal exposure
Toxicological profiles must be built using NOAEL (No Observed Adverse Effect Level) or other points of departure. Margins of safety should be calculated based on infant-specific systemic exposure doses (SED), taking into account higher surface area-to-body weight ratios.
When to apply additional assessment factors for babies
For infants, assessors may apply additional safety factors beyond the standard MoS of 100. This is especially important for substances with potential endocrine, neurological, or sensitizing effects.
Aggregate exposure considerations
Babies are often exposed to multiple products daily—lotions, oils, wipes, and creams. CPSRs must reflect this aggregate exposure, not just single-product use, and evaluate cumulative systemic absorption.
Formulation watch-outs & common restrictions for 0–3 years
Preservatives
Preservatives are critical to ensuring microbiological stability, but in infant products, their use is heavily restricted. Phenoxyethanol remains one of the few preservatives with wide acceptance. The SCCS confirmed that concentrations up to 1% are safe, even for children under three years. Nevertheless, safety assessors must still consider cumulative exposure, since phenoxyethanol may be present in multiple infant products used daily. In contrast, methylisothiazolinone (MI) and the MCI/MI blend have been associated with high rates of sensitization and are prohibited in leave-on products. Their use is only permitted in rinse-off products, and even then, concentrations must not exceed 0.0015%. When compiling a CPSR, assessors must demonstrate not just legal compliance but also justify why a chosen preservative system is suitable for infant skin, often supported by preservative efficacy testing (PET) data.
Parabens
Parabens have long been debated in cosmetics, and their regulation is especially strict for baby care. Butyl- and propylparaben are specifically banned in leave-on products for the nappy area in children under three, due to concerns over potential endocrine activity and higher absorption under occlusion. Other parabens, such as methyl- and ethylparaben, may still be allowed within restricted concentrations, but assessors must provide a clear toxicological justification. In practice, many brands choose to reformulate without parabens to avoid consumer mistrust, even when permitted. The CPSR must carefully note which parabens are present, their exact concentration, and whether their use is compatible with infant-specific regulatory limits.
Keratolytics/Salicylic acid
Salicylic acid is prohibited in cosmetic products for children under three, with one narrow exception: it may function as a preservative in rinse-off shampoos. Its keratolytic activity makes it unsuitable for leave-on infant products, as it could compromise an already delicate skin barrier. Safety assessors also need to pay attention to botanical extracts containing salicylates, such as willow bark, which may unintentionally introduce salicylic acid into a formulation. In a CPSR, even trace levels must be identified and evaluated, ensuring they do not exceed permitted limits or contribute to overall systemic exposure.
Fragrance & allergens
Fragrance is one of the most common sources of sensitization, and for this reason, fragrance-free formulations are strongly recommended for baby cosmetics. If fragrance is included, it must comply with the expanded allergen labeling rules under Regulation (EU) 2023/1545, which increased the number of declarable allergens from 24 to more than 80. This means even small traces of common allergens such as limonene, linalool, or geraniol must be declared when present above thresholds. From a CPSR perspective, assessors must review the full fragrance composition, evaluate allergen levels, and confirm that labeling is accurate and compliant. For infant products, regulators and assessors typically expect fragrance to be minimized or avoided altogether.
Zinc oxide in diaper creams
Zinc oxide is one of the most widely used active ingredients in diaper creams due to its protective and soothing properties. The SCCS has confirmed that non-nano zinc oxide is safe in concentrations up to 25% in leave-on products. This makes it a cornerstone ingredient for protecting infant skin against moisture and irritation. However, the nano form of zinc oxide is subject to restrictions because of inhalation concerns; it cannot be used in sprays, aerosols, or powders where respiratory exposure is possible. A CPSR for a diaper cream must clearly state whether the zinc oxide used is nano or non-nano, provide supporting particle size data, and demonstrate that the form used is safe for topical application in infants.
Essential oils & botanicals
Essential oils and botanicals, even those commonly regarded as gentle, must be approached with caution in infant cosmetics. Oils like chamomile, lavender, or calendula can provide soothing effects, but they also carry allergenic potential due to their natural chemical constituents. For example, linalool and farnesol, common in essential oils, are recognized allergens and fall under the expanded EU allergen labeling list. When essential oils are used, concentrations must be kept very low, and toxicological justification is required. Safety assessors must also consider batch-to-batch variability of natural extracts, which can affect allergen content. In most cases, conservative use is recommended, and fragrance-free or allergen-minimized formulations are considered the gold standard for infant safety.
Claim & test strategy (“dermatologically tested on sensitive skin”)
Designing tolerant in-use tests under dermatological/pediatric oversight
Claims related to skin tolerance are crucial in infant products, since parents and caregivers look for reassurance that a cream or lotion has been properly tested. While ethical concerns prevent direct testing on infants, dermatological testing on adults with sensitive skin or under pediatric supervision in controlled caregiver studies can provide supporting evidence. These in-use tests are designed to simulate real conditions of product application, assessing redness, irritation, or allergic responses. Including results from such studies in the CPSR and marketing claims strengthens the product’s credibility and demonstrates responsible formulation practices.
Substantiating “hypoallergenic,” “pediatrician-approved,” “0+” responsibly
Marketing claims must be clear, accurate, and backed by evidence. Absolute terms such as “allergen-free” are discouraged, since almost any substance has the potential to cause an allergic reaction in certain individuals. Instead, brands should use responsible alternatives such as “formulated for sensitive skin” or “tested under dermatological control.” Claims like “pediatrician-approved” must be supported with documentation from pediatric experts or clinical testing under pediatric oversight. Likewise, labels such as “0+” should be justified in the CPSR, confirming that exposure calculations, ingredient restrictions, and microbiological limits meet the specific needs of newborns. Substantiated, transparent claims build consumer trust and protect brands from regulatory scrutiny.
Labeling & documentation
Allergen labeling per 2023/1545
The allergen labeling requirements were significantly updated in 2023, expanding the list of fragrance allergens that must be disclosed on product labels. For infant cosmetics, this change is particularly relevant, as parents expect complete transparency. Even when used in small amounts, allergens above the legal threshold must be declared on both packaging and online product listings. This ensures that caregivers can make informed decisions about what they apply to their babies’ skin. In the CPSR, assessors must cross-check the formulation against the new list of over 80 allergens and verify that all required declarations are present and compliant.
Safety monitoring & cosmetovigilance loop for baby products
Regulatory responsibility does not end once a product is launched. Companies must maintain an active cosmetovigilance system, monitoring for any reported adverse effects such as rashes, redness, or allergic reactions. This includes documenting complaints, conducting investigations, and updating safety assessments when necessary. For infant products, where even minor reactions can be alarming to parents, cosmetovigilance plays a critical role in maintaining both compliance and consumer trust. The CPSR and PIF must include a clear process for handling post-market safety data, demonstrating that the brand is prepared to take corrective actions if required.
Submission & timelines
PIF & CPNP notification checklist for baby products
Every infant product must have a complete Product Information File (PIF) and be notified on the Cosmetic Products Notification Portal (CPNP) before being placed on the EU market.
Typical lead times (stability, PET, panel tests) & common blockers.
- Stability testing: 3–6 months
- Preservative efficacy tests: 4–8 weeks
- Dermatological testing: variable, typically 6–8 weeks
- Common blockers: incomplete raw material data, insufficient impurity documentation, allergen labeling errors
Frequently Asked Questions
Q1: Can you use phenoxyethanol in baby lotions?
Yes, up to 1%, as confirmed by SCCS.
Q2: Is it okay to use essential oils in baby products?
Yes, but only in small amounts and with a warning about allergens.
Q3: Are all baby cosmetics free of parabens?
There are some leave-on products for the nappy area that are not allowed to have butyl and propylparaben.
Q4: Is it okay for diaper creams to have zinc oxide in them?
Yes, you can use non-nano zinc oxide up to 25%.
Q5: Do we need to test baby cosmetics on skin?
Not required by law, but strongly suggested to back up claims of tolerance.
Conclusion
Preparing a CPSR for baby lotions, oils, and diaper creams requires stricter scientific rigor than adult products. From barrier-immature infant skin and occlusive diaper environments to microbiological safety and aggregate exposure, every element must be handled with precision.
By following EU Regulation 1223/2009 and the SCCS Notes of Guidance (12th revision), brands can demonstrate compliance and protect infant health. With robust CPSRs, baby cosmetics not only meet legal requirements but also reassure parents that their products are truly safe for the most delicate consumers.
Certified Cosmetics supports brands in compiling CPSRs and PIFs for infant cosmetics, ensuring your products meet both regulatory standards and consumer expectations.
