Is European Cosmetic Regulation Enough? A Critical Perspective from Conscious Formulation

Although the European Cosmetic Regulation (EC) No. 1223/2009 is considered one of the most advanced regulatory frameworks in the world, it still presents relevant shortcomings. This document analyzes the main weaknesses of the current legal system, especially from the perspective of those of us committed to clean, responsible, and evidence-based formulas.

1. Substance-by-substance evaluation, not real-life combinations

The regulation evaluates the safety of ingredients individually, without considering potential combined or cumulative effects — the so-called "cocktail effect." This phenomenon arises when multiple ingredients, which may appear safe on their own, interact in the human body or environment, generating unexpected effects. The issue is worsened by the reality of daily cosmetic use: a person may use 6 to 12 products a day (cleanser, serum, cream, sunscreen, makeup, perfume, deodorant, etc.), all with different chemical compositions. Combined and repeated exposure to these substances, even in low doses, can lead to long-term cumulative effects. However, current legislation does not require testing for such combinations nor considers this realistic exposure scenario.

2. Limited focus on endocrine disruptors                                         

There is currently no definitive list or clear system for identifying and restricting endocrine-disrupting chemicals (EDCs) in cosmetics. Despite increasing scientific consensus on the risks posed by substances such as BHT, certain UV filters, and phthalates, many of these are still legally permitted under specific concentration limits.

This gap has been critically examined by Spanish researchers, particularly in Andalusia, where specialized laboratories focus on toxicity, public health, and environmental exposure. Notably, Dr. Nicolás Olea, professor of Radiology and Public Health at the University of Granada, has been a leading voice in the study of endocrine disruptors. His research highlights the cumulative exposure to low-dose chemical mixtures—often found in personal care products—as a risk factor for hormonal imbalances and chronic diseases.

Olea’s work, along with that of other European scientists, has pushed for more stringent regulatory measures and the inclusion of real-life exposure scenarios in safety assessments. However, cosmetic legislation still lacks a harmonized mechanism to respond to this growing body of evidence.

3. Tolerance for controversial ingredients                                                

Despite growing scientific scrutiny, several controversial compounds remain permitted in cosmetic products under EU Regulation (EC) No. 1223/2009. These ingredients are often subject to concentration limits or specific usage restrictions, yet are still allowed in formulas — even when evidence suggests potential risks to human health or the environment.

• Phenoxyethanol: A widely used preservative, often positioned as a safer alternative to parabens. However:

• Studies have raised concerns about potential neurotoxicity at high doses, especially in infants.

• It can also cause skin irritation and sensitization in sensitive individuals.

• The EU Scientific Committee on Consumer Safety (SCCS) currently allows it up to 1%, but the debate around its use continues.

• Aluminum compounds (e.g., aluminum chlorohydrate in deodorants): Used for their antiperspirant effect, they block sweat ducts. But:

• Aluminum has been studied for a possible link to neurotoxicity and breast cancer, although the evidence remains inconclusive.

• The SCCS concluded that data on percutaneous absorption is insufficient, leading to ongoing concerns over chronic exposure in sensitive areas like the underarms.

• Formaldehyde releasers (e.g., DMDM hydantoin, imidazolidinyl urea): These are preservatives that slowly release formaldehyde, a known carcinogen and sensitizer.

• Although formaldehyde itself is banned in cosmetics, these slow-release compounds are still allowed under strict limits.

• They are a common trigger for contact dermatitis and are under increasing regulatory and consumer pressure.

• Certain UV filters (e.g., Octinoxate, Oxybenzone): Still permitted in sunscreens and skincare for their ability to block UVB radiation. However:

• Linked to endocrine disruption in animal studies and coral reef damage in marine environments.

• Banned in places like Hawaii and Palau for environmental reasons, but still allowed in the EU within strict maximum concentrations.

4. Environmental impact: a major unresolved issue                                   

One of the most significant blind spots in current cosmetic regulation is its lack of environmental accountability. While EU Regulation (EC) No. 1223/2009 focuses primarily on human health and product safety, it does not require cosmetic brands to prove that their formulas are biodegradable, non-persistent, or safe for aquatic ecosystems.

This regulatory gap allows the legal use of ingredients that are:

• Non-biodegradable, meaning they do not break down easily in the environment.

• Persistent, meaning they remain in soil or water for long periods.

• Bioaccumulative, meaning they build up in living organisms over time.

• Aquatically toxic, meaning they harm marine life even at low concentrations.

Examples include certain UV filters (like octinoxate and oxybenzone), silicones (e.g., cyclopentasiloxane), microplastics, and some quaternary ammonium compounds used in hair conditioners and preservatives. Many of these are not filtered by wastewater treatment plants and end up directly in rivers, oceans, and soil — contributing to water pollution, coral bleaching, or hormonal disruption in wildlife.

Despite growing awareness and scientific evidence, the cosmetic regulation does not impose penalties or environmental requirements for such substances — unless they are classified and restricted through other frameworks, like:

• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

• CLP (Classification, Labelling and Packaging of Substances and Mixtures)

• EU Green Deal & Chemicals Strategy for Sustainability (in progress)

But cosmetics themselves are not evaluated holistically for their environmental impact — unlike detergents, paints, or pesticides, which require eco-toxicological dossiers under their respective regulations.

As a result, many everyday personal care products — shampoos, conditioners, sunscreens, body lotions — contribute silently to chemical pollution, with no obligation for brands to reformulate or disclose the environmental impact of their ingredients.

This reality challenges the idea of “clean beauty,” which often focuses on what is absent (e.g., parabens or sulfates) but does not necessarily address environmental persistence, toxicity to aquatic organisms, or wastewater impact.

5. Lack of transparency in fragrances and traceability                                 

Ingredients listed as "parfum" or "aroma" can conceal dozens — sometimes hundreds — of substances under a single label, many of which may be allergenic or potentially toxic. Despite this, brands are not legally required to disclose their full fragrance composition, unless a component belongs to the list of declarable allergens regulated in the EU.

Additionally, there is no obligation to indicate the origin of ingredients — whether they are petrochemical, plant-based, or biotech-derived — which limits the consumer's ability to make informed choices aligned with personal values or sensitivities.

While synthetic molecules often receive criticism for being "artificial," in many cases they are less allergenic and more stable than natural extracts. Nature-identical or lab-synthesized compounds can be purer, free of trace allergens or contaminants found in natural ingredients (e.g., essential oils), which are complex mixtures. However, the toxicological origin of many reactions (irritations, sensitizations, endocrine activity) is not always traceable — partly due to the lack of full disclosure and limited research on cumulative exposure.

Moreover, fragrance ingredients — especially those classified as CMR (carcinogenic, mutagenic, or reprotoxic) — are subject to review under Annex II and III of the EU Cosmetic Regulation. While some are restricted or banned, others remain in use under concentration thresholds, raising concerns about long-term low-dose exposure.

There’s also a striking contrast between cosmetic labelling and CLP Regulation (Classification, Labelling and Packaging), which governs chemical safety in Europe. If cosmetics were subject to the same hazard pictograms as household or industrial products (e.g., flammable, irritant, toxic), many would bear alarming symbols. However, the Cosmetic Regulation exempts products from CLP labelling, despite often sharing ingredients with regulated chemical categories.

This inconsistency creates a false sense of safety, as the absence of danger symbols on a cosmetic product doesn’t necessarily mean it is free from risk — it simply means it falls under a different legal framework with softer communication obligations.

6. Animal testing ban with exceptions                                                          

While the European Union bans animal testing for finished cosmetic products and ingredients under Regulation (EC) No. 1223/2009 and Directive 2003/15/EC, there are notable exceptions and grey areas that compromise the integrity of this ban:

• REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) may require animal testing to assess chemical safety for worker protection or environmental exposure, even if those substances later appear in cosmetics.

• Imported ingredients from third countries may still involve animal testing, especially in jurisdictions that legally mandate it.

• European brands exporting to countries that require animal testing (e.g., China) may submit their products for such tests to comply with those markets' regulations. Despite this, they often retain cruelty-free claims within the EU, as the animal testing is not carried out for the purpose of EU market approval.

This creates a regulatory loophole: companies can maintain a “not tested on animals” status in Europe, even if the same formulas are subject to animal testing abroad. Consumer-facing certifications may not always reflect these cross-border practices, leading to misleading perceptions of cruelty-free status.

As a result, ethical formulators and conscious brands are increasingly choosing to avoid markets or regulatory pathways that require animal testing, and to demand full transparency across all supply chains.

7. Slow and reactive update process                                                       

One of the biggest structural weaknesses in current EU cosmetic regulation is the slowness and reactivity of its update process. The inclusion of new substances in the restricted or banned lists (Annex II and III) often takes years, even in cases where there is mounting scientific evidence of risk.

Although the REACH system (Registration, Evaluation, Authorisation and Restriction of Chemicals) actively monitors over 12,000 substances, only a very small number are evaluated and updated annually in the specific context of cosmetic legislation.

This means the system is more reactive than preventive, and science often moves faster than regulation. By the time an ingredient is reviewed, debated, and finally restricted or banned, it may have been in widespread use for a decade or more.

Why are controversial ingredients still allowed?                                   

Because under current EU legislation:

• Safety is assessed in isolation, focusing on individual ingredients, not the complex combinations used in real-life routines.

• The system is built on threshold-based toxicology, assuming that a substance is safe below a certain dose — without accounting for cumulative exposure, daily repetition, or synergistic effects.

• The regulatory process is slow and bureaucratic, requiring extensive documentation, industry consultation, and committee approval — which delays action on emerging risks.

As a result, many controversial substances remain legally compliant, even when they raise scientific, environmental, or ethical concerns.

Conscious formulation goes further                                    

As a result, many controversial substances remain legally compliant, even when they raise scientific, environmental, or ethical concerns. Brands that formulate with awareness and responsibility are choosing to:

• Anticipate regulation, not just follow it.

• Avoid ingredients with unresolved toxicological profiles.

• Commit to cleaner, safer, and more transparent formulas, even if the law does not yet require it.

References:

1. European Commission – SCCS Notes of Guidance 12th Revision (2023)

2. European Commission – Animal Testing Ban

3. REACH Regulation and Animal Testing

4. Cruelty Free International – The loopholes in global cruelty-free claims

5. ECHA – Endocrine disruptors under REACH & CLP

6. EU Cosmetic Regulation – Annex II & III

7. ECHA – CMR substances in consumer products

8. CLP Regulation – European Chemicals Agency

9. Research by Dr. Nicolás Olea – University of Granada

10. Endocrine Society – EDCs and Human Health

11. UNEP – Environmental & health effects of synthetic cosmetics (2024)

12. ECHA – Endocrine disruptors under REACH & CLP

13. OECD – Environmental Risk Assessment of Chemicals (2021)

14. Plastic Soup Foundation – Hidden plastics in cosmetics (2022)

15. European Commission – SCCS Opinions & updates (May 2023)

16. PMC – The dark side of beauty: in-depth analysis (2024)

17. Butylparaben – SVHC classification (ECHA)