Endocrine Disruptors in EU Cosmetics: What's Coming Under Regulation 1223/2009 and How to Stay Ahead

The EU cosmetics industry has lived with Annex II and its list of prohibited substances for over a decade. What’s changed in the past three years isn’t the existence of restrictions — it’s the speed at which the European Commission is expanding them, specifically targeting substances with endocrine-disrupting properties.

Commission Delegated Regulation (EU) 2022/1181, which amended Annex VI of Regulation (EC) No 1223/2009 to restrict homosalate to a maximum of 7.34% in leave-on face products, wasn’t an isolated event. It was the first wave of a broader review, triggered by SCCS/1634/21, in which the Scientific Committee on Consumer Safety concluded that homosalate at previously common concentrations — often 10% or higher in SPF products — posed an unacceptable safety risk, in part because of its potential endocrine-disrupting properties.

For formulators, that one restriction forced the reformulation of an enormous number of SPF products across Europe. Oxybenzone (benzophenone-3) is already deep in SCCS evaluation territory. Octinoxate (ethylhexyl methoxycinnamate) — one of the most widely used UV filters on the continent — is under increasing scientific scrutiny. If you’re formulating with these UV filters at current typical-use levels, your risk register probably needs updating.

What EU Law Actually Means by “Endocrine Disruptor”

Under European Union law, there is no single universal legal definition of an endocrine disruptor that applies uniformly across all legislative frameworks. That’s the first thing most regulatory teams miss — and it creates gaps in compliance monitoring.

Under REACH (Regulation (EC) No 1907/2006), a substance can be identified as a Substance of Very High Concern (SVHC) under Article 57(f) if there is scientific evidence of probable serious effects to human health or the environment equivalent in concern to CMR substances — and endocrine disruptors that meet this threshold go onto the ECHA Candidate List. That list currently contains over 240 substances, with roughly one-third carrying endocrine-disrupting hazard designations.

Under Regulation (EC) No 1223/2009, the process works differently. The Commission restricts or prohibits substances based on SCCS opinions and harmonised classification decisions. There is no dedicated “endocrine disruptor” annex in cosmetics law. Instead, ED concerns feed into SCCS safety assessments, which in turn inform Commission decisions to amend Annex II (prohibited substances), Annex III (restricted substances), Annex V (preservatives), or Annex VI (UV filters).

The EU’s Chemicals Strategy for Sustainability, adopted in October 2020, added significant urgency. It committed the Commission to phasing out endocrine-disrupting substances from consumer products — including cosmetics — unless use can be demonstrated to be safe, with a specific focus on the most sensitive population groups: children, pregnant women, and people with compromised health. That political commitment is now showing up in the pace of SCCS mandates and Commission amendments.

Restrictions Already in Force: The Parabens and UV Filter Precedent

The endocrine-disruptor story in EU cosmetics didn’t start with UV filters. Parabens set the template.

Commission Regulation (EU) No 358/2014 restricted propylparaben and butylparaben in Annex V to a maximum of 0.14% each (expressed as acid), and prohibited both from leave-on products intended for use in the nappy area of children under 3 years of age. The restriction was explicitly tied to potential endocrine-disrupting effects on male reproductive development, as documented in SCCS/1017/14. That amendment also prohibited isopropyl- and isobutylparaben outright — removing them from Annex V entirely.

The lesson from the paraben amendments is one that European formulation teams keep relearning: the Commission doesn’t wait for full regulatory certainty before acting. It moves when the weight of scientific opinion supports precaution, particularly where sensitive populations are concerned. Brands that reformulated proactively before 2014 avoided the scramble. Those that waited had to revisit entire product lines under time pressure.

Triclosan tells a parallel story. Once ubiquitous in antibacterial hand washes and toothpastes, it now sits in Annex V with tightly constrained applications — 0.3% in toothpastes, 0.2% in hand soaps, 0.2% in body soaps and shower gels, with further restrictions applying to other product types. Its endocrine-disrupting properties and environmental persistence drove the regulatory trajectory.

And now homosalate has followed the same pattern. A UV filter used for decades at 10–15% in sunscreen formulations now carries a 7.34% maximum for face products under Regulation 2022/1181 — a reduction significant enough to alter SPF performance in products close to the old limit.

How the REACH-to-Cosmetics Pipeline Works in Practice

One thing European cosmetics manufacturers consistently underestimate is the predictive value of the ECHA Candidate List. It functions, in practice, as an early warning system for future cosmetics restrictions — typically with a 2–7 year lead time from SVHC designation to Commission action.

When ECHA adds a substance to the Candidate List under Article 57(f) — for properties of equivalent concern to CMRs, including endocrine disruption — that substance almost inevitably attracts an SCCS mandate if it’s used in cosmetic products. The timeline varies depending on SCCS workload and Commission prioritisation, but the direction of travel is consistent.

Several substances worth monitoring currently sit at earlier stages of this pipeline. Certain UV filters under SCCS evaluation have fragrance and photostabiliser applications that are widespread in European product lines. Some alkylphenol ethoxylates — used historically as surfactants and emulsifiers — carry ED-related SVHC designations and have cosmetics-relevant uses, though reformulation in this area has been ongoing for years. Phthalates with SVHC status, while primarily restricted through REACH Annex XVII, appear in cosmetics through fragrance compound declarations, and supply chain traceability here matters more than many brands realise.

The practical implication: your substance watch list should not be limited to Annex II of Regulation 1223/2009. A genuinely robust compliance function tracks the ECHA Candidate List (updated twice yearly), the ECHA Registry of Intentions (which signals upcoming SVHC proposals before they are formally adopted), and the SCCS work programme, which is publicly available and updated regularly. All three feeds are free to access and require only consistent attention.

What the SCCS Evaluation Backlog Signals for the Next 12–18 Months

The SCCS work programme is not particularly subtle about where the next round of restrictions is likely to land.

Oxybenzone (benzophenone-3) has been through multiple rounds of SCCS evaluation. At one point it represented a significant share of UV filter formulations across the EU. SCCS assessments have raised questions about systemic absorption and potential hormonal activity at concentrations used in full-body sunscreen application, and the Commission has been tracking this closely. The handling of homosalate — where an SCCS restriction recommendation was translated into a binding Annex VI amendment within roughly 18 months — is the reference case for how quickly this can now move.

It’s also worth watching developments at the intersection of the Green Deal and cosmetics law more broadly. The Commission has signalled interest in simplifying the comitology procedure for Annex amendments, which historically has been the rate-limiting step between SCCS opinion and legally binding restriction. If that simplification goes through, the window between a negative SCCS opinion and a binding restriction on your formulation narrows meaningfully.

For brands with SPF products or leave-on colour cosmetics formulated with UV filters at or near current legal maxima, the margin is tightening. And for any brand that hasn’t revisited its preservative system since 2014, it’s worth checking whether paraben combinations in multi-component formulations still sit comfortably within the restrictions as currently written.

Five Steps European Brands Should Take Before the Next Amendment Cycle

1. Map all formulations against the ECHA Candidate List. Don’t rely solely on Annexes II and III of Regulation 1223/2009. Every active formulation should be screened against the current SVHC Candidate List. Any match at or above 0.1% by weight in the finished product triggers Article 33 communication obligations under REACH — and creates a clear leading indicator for future cosmetics restrictions.

2. Build an ED risk characterisation section into your Product Safety Reports. The Product Safety Report (PSR) required under Article 10 and Annex I of Regulation 1223/2009 is where endocrine-disruptor assessment gaps most often surface during inspections. A dedicated section addressing ED potential, with reference to relevant SCCS opinions and ECHA hazard assessments, strengthens your PIF and demonstrates proactive safety governance to both DGCCRF inspectors and retail customers requiring technical due diligence.

3. Subscribe to SCCS mandate and opinion notifications. The SCCS posts mandates and preliminary opinions publicly before finalisation. Setting up a notification for new SCCS publications costs nothing and gives formulation teams 6–18 months of advance warning before Commission action follows.

4. Stress-test UV filter concentrations against post-2022 benchmarks. If current formulations use UV filters at concentrations that SCCS opinions have flagged as near or above safe limits, model the reformulation scenario now — before a Commission amendment forces it under time pressure. SPF reformulation with reduced UV filter concentrations typically requires 6–9 months of stability and efficacy validation. That’s not a timeline that accommodates last-minute regulatory surprises.

5. Tighten supplier declaration requirements for SVHC substances. Under REACH Article 33, article suppliers must respond to downstream user requests regarding SVHC content within 45 days. If your supplier declarations are generic statements of compliance without specific reference to Candidate List substances, they may not satisfy a notified body audit or a DGCCRF inspection. Update your supplier qualification questionnaires to require explicit SVHC screening confirmation at substance level.

Getting ahead of these restrictions requires formulation resources upfront. Getting caught behind them costs something considerably harder to recover: market access.

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The direction of travel here is unambiguous. The EU has committed — in the Chemicals Strategy for Sustainability, in the Green Deal, and in a series of binding Commission regulations — to removing endocrine-disrupting substances from consumer products systematically and over time. For cosmetics manufacturers, that means the relevant question is no longer whether more restrictions are coming. It’s which substances are next and how quickly. Map your portfolio against the SCCS pipeline, audit your PSRs for ED risk sections, and treat the ECHA Candidate List as standing operational intelligence. The manufacturers who navigate this well won’t be the ones who react fastest to each new Commission amendment — they’ll be the ones who saw it coming.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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