Are Parabens Dangerous? The Direct Answer
Based on current regulatory science, methylparaben and ethylparaben — the most widely used parabens in cosmetics — are considered safe at concentrations up to 0.4% in finished products. Whether parabens are harmful at cosmetic-use concentrations has been independently assessed by the EU Scientific Committee on Consumer Safety, the US Cosmetic Ingredient Review, and Health Canada — each reviewing the full available body of evidence and reaching the same conclusion.
The fear of parabens traces back almost entirely to a single 2004 study that detected parabens in breast tumour tissue. What most people were never told is what that study actually concluded — and what it explicitly did not. This article goes back to the original research, reads it as it was written, and examines what two decades of independent scientific review have found since.
| Question | What the Science Says |
|---|---|
| Do parabens cause breast cancer? | No causal link has been established. Multiple regulatory reviews have not confirmed a cancer risk at authorised concentrations. |
| Are parabens endocrine disruptors? | Parabens have weak oestrogenic activity — 1,000 to 1,000,000 times weaker than the body's own oestrogen. At cosmetic-use concentrations, no endocrine disruption risk has been confirmed by regulators. |
| Are parabens banned in the EU? | Not entirely. Methylparaben and ethylparaben remain approved at up to 0.4%. Five parabens with insufficient safety data are prohibited. |
| What did the 2004 study actually show? | That parabens can be detected in breast tissue. It did not investigate causality, had no control group, and could not identify the source of the parabens detected. |
| Is "paraben-free" a safety claim? | Not a scientifically substantiated one. EU guidelines state that free-from claims should not imply approved ingredients are unsafe. |
| Do parabens occur naturally? | Yes. Parabens are naturally present in many fruits and vegetables, including blueberries, carrots, and olives. |
The Bottom Line
- The 2004 Darbre study — the source of almost all paraben fear — detected parabens in breast tissue. It did not establish causality, had no healthy control group, and its own authors stated it could not imply parabens caused the tumours.
- Parabens have weak oestrogenic activity, but at 1,000 to 1,000,000 times weaker than the body's own oestrogen, this has not translated into a confirmed endocrine risk at cosmetic concentrations in over 20 years of regulatory review.
- The EU SCCS, US CIR, and Health Canada have each independently reviewed the evidence and confirmed methylparaben and ethylparaben as safe at authorised concentrations.
- Five parabens have been prohibited in the EU — not because they were found dangerous, but because insufficient safety data existed to complete a full assessment. Absence of data is not evidence of harm.
- Parabens occur naturally in many foods and plants. They are among the most studied preservative compounds in cosmetic science, with a safety record spanning over 80 years of use.
- The "paraben-free" label is a marketing response to a misread study — not a safety standard. EU cosmetic claims regulation explicitly discourages implying that lawfully approved ingredients are unsafe.
In This Article
- What parabens are and what they do in skincare
- The 2004 Darbre study — what it actually said
- What the Darbre study did not and could not show
- Parabens and oestrogenic activity — putting the numbers in context
- 20 years of regulatory review — what the science committees concluded
- The EU position — what is approved, what is prohibited, and why
- Parabens occur in nature — the fact most people have never heard
- The "paraben-free" label — marketing or safety claim?
- Frequently asked questions
What Parabens Are and What They Do in Skincare
Parabens are esters of p-hydroxybenzoic acid — a naturally occurring compound found in many plants and foods. The name "paraben" is a contraction of para-hydroxybenzoate. In cosmetics, the most commonly used parabens are methylparaben, ethylparaben, propylparaben, and butylparaben, named according to the length of their alkyl chain.
Their function in a formula is straightforward: they are preservatives. They inhibit the growth of bacteria, yeasts, and moulds in cosmetic products, extending shelf life and protecting consumers from microbial contamination. A moisturiser that contains water — which is almost every moisturiser — is a nutrient-rich environment in which microorganisms can grow rapidly under the right conditions. Without a preservative system, that product poses a genuine safety risk to the person using it.
Parabens have been used in cosmetics since the 1920s — over a hundred years. They work across a broad pH range, are stable under a wide range of processing conditions, and have been extensively studied. Before 2004, the question of whether parabens are safe was largely settled: they were considered one of the best-characterised and most reliable preservative options available to formulators, with a safety record spanning eight decades of widespread human use.
Why Parabens Became the Dominant Cosmetic Preservative
Parabens became widely used because they combine several practically important properties: broad-spectrum antimicrobial activity against bacteria, yeasts, and moulds; compatibility with a wide pH range; stability to heat and light; low sensitisation rates at cosmetic-use concentrations; and a cost profile that made them accessible across product price points. Whether parabens are safe was, for most of the 20th century, a largely settled question — answered affirmatively by an 80-year safety record of widespread human use.
Then, in January 2004, a paper was published in the Journal of Applied Toxicology by Dr. Philippa Darbre and colleagues at the University of Reading. It would change the commercial landscape of cosmetic preservation more profoundly than any study before or since — not because of what it found, but because of what the public was told it found.
The 2004 Darbre Study — What It Actually Said
The Darbre et al. (2004) paper, published as "Concentrations of Parabens in Human Breast Tumours" in the Journal of Applied Toxicology, had a specific and limited objective: to determine whether parabens could be detected in breast tumour tissue using high-pressure liquid chromatography and tandem mass spectrometry.
The study examined tissue samples from 20 patients with breast cancer. It found that parabens could be extracted from those samples and detected intact — meaning they had not been fully metabolised. Methylparaben and propylparaben were present at the highest concentrations, though there was enormous variation: methylparaben ranged from undetectable to 5,134.5 ng/g across samples.
That is what the study showed: parabens are present in breast tumour tissue. That finding was significant — it demonstrated that parabens can reach breast tissue via dermal absorption and remain detectable there. The study called for further research to understand the route of entry, the persistence of parabens in tissue, and whether concentrations differed between cancerous and healthy tissue.
What the Study's Authors Actually Concluded
The Darbre et al. paper concluded: "These studies demonstrate that parabens can be found intact in the human breast and this should open the way technically for more detailed information to be obtained on body burdens of parabens and in particular whether body burdens are different in cancer from those in normal tissues."
The study called for more research. It did not conclude that parabens cause breast cancer. It did not compare paraben concentrations in tumour tissue to concentrations in healthy tissue. It did not examine whether paraben levels were higher in women with breast cancer than in women without. These are the questions that would need to be answered to begin establishing any causal relationship — and none of them were addressed.
The media response to the paper's publication bore almost no relationship to its actual content. Headlines declared that parabens had been found in breast tumours as though this constituted evidence of harm. The nuance — that detection is not causation, that the study had no control group, that the authors themselves called only for further research — was absent from almost all coverage.
What the Darbre Study Did Not and Could Not Show
Understanding the limitations of the 2004 study is essential to evaluating the paraben controversy accurately. These are not minor methodological quibbles — they are fundamental to what the study could and could not demonstrate.
No Control Group
The study examined breast tissue from 20 women with breast cancer. It did not examine breast tissue from healthy women. Without a control group, it is impossible to determine whether the paraben concentrations found in tumour tissue were higher, lower, or the same as those in healthy breast tissue. A finding that parabens are present in cancerous tissue means nothing about causality if parabens are equally present in non-cancerous tissue — which subsequent research has suggested is likely, given that parabens are present in many foods and enter the body through multiple routes.
Source of Parabens Could Not Be Identified
The study could not determine where the parabens detected in the tissue came from. The authors themselves acknowledged this: the study could not identify either the route of entry or the source. Parabens are present in food, pharmaceuticals, and personal care products. A paraben found in breast tissue cannot be attributed to cosmetic use without further investigation that the study did not conduct.
No Causal Mechanism Was Investigated
The study detected parabens. It did not investigate whether those parabens had any effect on the tumour cells, whether they contributed to tumour development, or whether they were associated in any way with clinical outcomes. Dr. Darbre and colleagues explicitly did not claim that parabens or underarm products caused the cancers in the patients studied.
"Scientists found parabens in breast tumours — proof that they cause cancer."
The study found parabens could be detected in breast tumour tissue — the same way caffeine, ibuprofen, or dietary phytoestrogens could potentially be detected in tissue. Detection is not causation. The study had no healthy control group, could not identify the source of the parabens, and its authors explicitly stated the findings could not be taken to imply the parabens caused the tumours.
No Correlation with Known Risk Factors
A subsequent, larger study by Barr et al. (2012), also led by Dr. Darbre and published in the same journal, examined 160 tissue samples from 40 women. It found no correlations between paraben concentrations and age, length of breastfeeding, tumour location, or tumour oestrogen receptor content — the variables one would expect to correlate with paraben levels if cosmetic use were the source. Dr. Darbre herself stated explicitly: "The fact that parabens were detected in the majority of the breast tissue samples cannot be taken to imply that they actually caused breast cancer in the 40 women studied."
The study's lead author, in a direct public statement, said the findings could not imply causality. The clean beauty industry built a multi-billion pound market on the implication that they did.
Parabens and Oestrogenic Activity — Putting the Numbers in Context
The second major concern about parabens — separate from the breast cancer detection story — is their weak oestrogenic activity. Parabens can bind to oestrogen receptors. They have been shown in laboratory studies to activate oestrogen-sensitive gene expression and stimulate the growth of oestrogen-responsive cell lines. This is real. It is not disputed. The relevant question is: at what potency, and at what concentrations does this matter?
The EU SCCS's extended opinion on parabens addresses this directly. The oestrogenic potency of parabens increases with the length of their alkyl chain: methylparaben is the weakest, butylparaben and isobutylparaben are the strongest within the approved group. At all points, however, the oestrogenic activity of parabens remains between 1,000 and 1,000,000 times weaker than the body's own oestrogen — 17β-estradiol — depending on the specific paraben and the assay used.
| Paraben | Oestrogenic Potency vs. 17β-Estradiol | EU Status |
|---|---|---|
| Methylparaben | ~1,000,000× weaker | Approved — up to 0.4% |
| Ethylparaben | ~1,000,000× weaker | Approved — up to 0.4% |
| Propylparaben | ~10,000–100,000× weaker | Approved — up to 0.14% combined with butyl |
| Butylparaben | ~1,000–10,000× weaker | Approved — up to 0.14% combined with propyl |
| Isopropylparaben | Higher relative activity | Prohibited — insufficient safety data |
| Isobutylparaben | Higher relative activity | Prohibited — insufficient safety data |
For context: phytoestrogens — naturally occurring compounds in soy, flaxseed, and many other plant foods — also bind to oestrogen receptors. Genistein, a phytoestrogen in soy, has oestrogenic activity at concentrations that make methylparaben's activity, at cosmetic-use levels, negligible by comparison. Foods rich in phytoestrogens are generally considered health-promoting. The selective concern about paraben oestrogenicity — while ignoring dietary phytoestrogen exposure — reflects a pattern of risk perception that is not grounded in comparative toxicology.
The Body's Own Oestrogen — A Reference Point
A pre-menopausal woman's circulating oestradiol levels are typically between 100 and 400 pg/mL, rising to around 200–500 pg/mL at ovulation. The oestrogenic activity of methylparaben at cosmetic-use concentrations, given its potency relative to endogenous oestrogen, contributes an exposure that regulatory toxicologists have consistently assessed as not clinically significant. The body's own hormonal production is orders of magnitude more estrogenically active than topical methylparaben at 0.4%.
20 Years of Regulatory Review — What the Science Committees Concluded
The Darbre study was published in 2004. In the two decades since, the question of whether parabens are safe in cosmetic products has been reviewed, analysed, and contextualised by independent scientific committees in multiple jurisdictions. Here is what those reviews have found.
EU Scientific Committee on Consumer Safety (SCCS)
The SCCS has issued multiple opinions on parabens since 2004, each reviewing the full body of available evidence. Their consistent position: methylparaben and ethylparaben, at the maximum authorised concentrations, are considered safe for human health. For propylparaben and butylparaben, the SCCS has recommended lower concentration limits (0.14% combined) in a cautious approach that reflects the greater oestrogenic potency of these longer-chain parabens — not a finding that they are harmful at the reduced limit. Five other parabens have been prohibited — not because they were found to cause harm, but because insufficient data existed to complete a full safety assessment.
US Cosmetic Ingredient Review (CIR)
The CIR — an independent expert panel that systematically reviews cosmetic ingredient safety — has repeatedly reviewed parabens and consistently concluded that they are safe as used in current cosmetic formulations. The CIR's assessments consider the full toxicological profile including oestrogenic activity, skin penetration data, and cumulative exposure estimates.
Health Canada
Health Canada currently permits parabens in cosmetics, with no paraben-specific entries on the Cosmetic Ingredient Hotlist as of 2025 updates. The regulatory assessment has not identified a risk to consumers from parabens in cosmetic products at the concentrations at which they are used.
"Regulators are banning parabens because they have been found to be dangerous."
The EU has prohibited five specific parabens due to insufficient safety data — not because they were found to cause harm. The regulatory principle here is precautionary: where data is inadequate to complete a safety assessment, prohibition is the default. This is categorically different from a finding of danger. Methylparaben and ethylparaben, with extensive safety data, remain approved across all major markets.
The SCCS issued a new opinion on methylparaben as recently as December 2023 (SCCS/1652/23), requesting additional dermal penetration data to refine the safety assessment. This represents normal, ongoing regulatory scrutiny — not a safety alert. Regulatory bodies continuously review new evidence; requesting updated data is standard practice, not an indication that an ingredient has been found unsafe.
The EU Position — What Is Approved, What Is Prohibited, and Why
The EU Cosmetics Regulation (EC No 1223/2009) governs preservative use through Annex V — the positive list of permitted preservatives with their concentration limits. The paraben provisions in Annex V reflect the SCCS's differentiated, evidence-based approach.
| Paraben | EU Status | Maximum Concentration | Rationale |
|---|---|---|---|
| Methylparaben | ✅ Permitted | 0.4% (alone) / 0.8% (in blend) | Extensive safety data; SCCS confirmed safe at limit |
| Ethylparaben | ✅ Permitted | 0.4% (alone) / 0.8% (in blend) | Extensive safety data; SCCS confirmed safe at limit |
| Propylparaben | ✅ Permitted | 0.14% (combined with butyl) | Greater oestrogenic potency; cautious limit applied |
| Butylparaben | ✅ Permitted | 0.14% (combined with propyl) | Greater oestrogenic potency; cautious limit applied |
| Isopropylparaben | ❌ Prohibited | — | Insufficient safety data to complete assessment |
| Isobutylparaben | ❌ Prohibited | — | Insufficient safety data to complete assessment |
| Phenylparaben | ❌ Prohibited | — | Insufficient safety data to complete assessment |
| Benzylparaben | ❌ Prohibited | — | Insufficient safety data to complete assessment |
| Pentylparaben | ❌ Prohibited | — | Insufficient safety data to complete assessment |
This is a graduated, evidence-based regulatory framework — not a blanket ban or a safety alarm. The EU's approach illustrates precisely how sophisticated regulatory science works: differentiate by evidence quality and potency, set cautious limits where uncertainty exists, and prohibit only where assessment cannot be completed.
The overall blend cap of 0.8% — applying to all permitted parabens combined — provides an additional safety margin for products that use multiple parabens in combination. This is cumulative exposure management, not crisis response.
Parabens Occur in Nature — The Fact Most People Have Never Heard
One of the more striking ironies of the paraben controversy is that parabens — branded by the clean beauty industry as the epitome of synthetic chemical danger — are naturally occurring compounds found in many foods that are considered health-promoting.
Methylparaben (methyl 4-hydroxybenzoate) occurs naturally in blueberries. Propylparaben is found in carrots. Various parabens are present in olives, strawberries, and other plant foods. The p-hydroxybenzoic acid from which all parabens are derived is a phenolic compound widely distributed in the plant kingdom.
The Blueberry Paradox
Blueberries are frequently cited in clean beauty circles as a beneficial, antioxidant-rich natural ingredient — rightly so. Blueberries also naturally contain methylparaben. If the logic of paraben-free skincare were applied consistently, blueberries would need a warning label. The selective application of "natural = good, chemical = bad" to cosmetics while consuming the same compounds in food illustrates the internal inconsistency of the clean beauty framework.
The parabens used in cosmetics are produced synthetically — because commercial-scale extraction from natural sources is not economically viable. But they are chemically identical to the parabens that occur in nature. The compound is the same; the production route differs. This is the definition of nature-identical, a category that the clean beauty industry's binary natural/synthetic framework does not accommodate.
The "Paraben-Free" Label — Marketing or Safety Claim?
The "paraben-free" label became ubiquitous on cosmetic packaging within a few years of the 2004 study. It now appears on products across every price point and category. It has become so normalised that many consumers assume paraben-free is simply better — a given — without ever having examined why. The question of whether parabens are safe at cosmetic-use concentrations has been thoroughly examined by independent regulatory bodies; the label, however, has been interpreted differently in consumer markets.
The commercial context is worth understanding. A brand that removes parabens and labels itself paraben-free signals alignment with consumer concern, differentiates from competitors, and commands a premium — all without being required to demonstrate that the alternative preservative system is safer, more effective, or better studied. The preservatives that replaced parabens in many formulations — phenoxyethanol, certain essential oil extracts, synthetic nature-identical compounds — are in many cases newer, less extensively studied, and in some cases more sensitising.
"Paraben-free — because we care about your health."
The EU's Technical Document on Cosmetic Claims explicitly states that free-from claims should not be used to suggest that the absence of an ingredient makes a product safer, unless the brand can demonstrate that the ingredient poses a genuine risk at the concentrations typically used. For approved parabens at their regulated limits, that standard cannot be met against the available scientific evidence. The "paraben-free" label may imply a safety concern not supported by current regulatory consensus.
This is not an argument that parabens are perfect or that no further research is needed. Science is an ongoing process, and regulatory bodies appropriately continue to review new data. The SCCS's 2023 request for updated dermal penetration data on methylparaben is an example of the system working correctly. The argument is that the leap from "this study detected parabens in tumour tissue" to "therefore paraben safety in skincare is in question and products should be labelled accordingly" was not a scientific conclusion — it has contributed to a significant commercial shift that the underlying evidence did not warrant.
Key Clinical Insight
Consumers who avoid parabens in cosmetics may be doing so based on a fundamental misreading of a study whose own lead author has publicly stated that its findings cannot be taken to imply causality. Meanwhile, the preservative alternatives used in paraben-free formulations — including phenoxyethanol and certain nature-identical systems — are in many cases less well-characterised by long-term safety data. The 20-year safety record of methylparaben is itself a significant piece of evidence. Data accumulated over decades of widespread human use is, in many ways, more informative than any laboratory study conducted under idealised conditions.
Frequently Asked Questions
Based on current regulatory assessments from the EU SCCS, US CIR, and Health Canada, methylparaben and ethylparaben are considered safe at concentrations up to 0.4% in cosmetic products. Multiple independent reviews conducted over 20 years have not confirmed a cancer or endocrine disruption risk at the authorised use levels. Propylparaben and butylparaben are approved at lower limits (0.14% combined) reflecting a cautious approach to their slightly higher oestrogenic potency — not a finding of harm at the reduced limit.
No. The study detected parabens in breast tumour tissue from 20 patients. It had no control group of healthy tissue for comparison, could not identify the source of the parabens detected, and did not investigate any causal mechanism. The study's lead author explicitly stated that its findings could not be taken to imply that parabens caused the breast cancer in the patients studied. The study called for more research — it did not conclude that parabens are carcinogenic.
Parabens have weak oestrogenic activity — meaning they can bind to oestrogen receptors to a small degree. This activity is between 1,000 and 1,000,000 times weaker than the body's own oestrogen (17β-estradiol), depending on the specific paraben. At cosmetic-use concentrations, regulatory bodies have not confirmed a meaningful endocrine disruption risk from the permitted parabens. The body's own hormonal activity, and phytoestrogen exposure from food, are orders of magnitude more estrogenically significant.
Five parabens — isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben — are prohibited in the EU because insufficient safety data exists to complete a full risk assessment. This is a precautionary measure, not a finding of harm. The EU's regulatory framework defaults to prohibition when adequate data is unavailable, regardless of whether harm has been demonstrated. Methylparaben and ethylparaben, with extensive data supporting their safety, remain fully approved.
Yes. Methylparaben occurs naturally in blueberries. Various parabens are present in carrots, olives, strawberries, and other plant foods. The p-hydroxybenzoic acid from which parabens are derived is widely distributed in the plant kingdom. The parabens used in cosmetics are produced synthetically (because natural extraction is not commercially viable at scale), but they are chemically identical to the naturally occurring compounds — nature-identical.
Not necessarily. The EU cosmetic claims guidelines explicitly state that free-from claims should not be used to imply that approved ingredients are unsafe. The preservative alternatives used in paraben-free formulations have not necessarily been subject to equivalent depth of long-term safety evaluation. Some, like phenoxyethanol, are newer and less extensively characterised than methylparaben's 80-year safety record. Paraben-free is a marketing claim, not a safety standard.
Conclusion
The paraben controversy is one of the clearest examples in modern cosmetics of a scientific finding being separated from its context and used to generate commercial advantage. The 2004 Darbre study was a legitimate piece of preliminary research that called for further investigation. Its finding — that parabens can be detected in breast tissue — was presented to consumers as evidence that parabens cause breast cancer. It was not. Its own authors said it was not.
In the two decades since, independent scientific committees in the EU, the US, and Canada have reviewed the full body of available evidence on whether parabens are safe for cosmetic use. Their consistent conclusion, across multiple reviews and updated opinions, is that methylparaben and ethylparaben at their authorised concentrations are considered safe. Propylparaben and butylparaben are approved at cautiously reduced limits. Five parabens with insufficient data have been prohibited — as they should be, under a precautionary regulatory framework.
None of this constitutes a clean bill of health for every paraben under every circumstance, in perpetuity. Science does not work in perpetuities. It works in current best evidence, subject to revision. Current evidence supports paraben safety in skincare within regulated limits, while ongoing review continues as part of standard regulatory practice. The current best evidence, as assessed by multiple independent expert bodies over 20 years, does not support the consumer-level concern that has reshaped an entire industry. It supports continued use of approved parabens at approved concentrations, continued scientific review, and a regulatory framework that is already functioning as intended.
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Explore the CollectionContinue Reading — Clean Beauty & Misinformation Series
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- Synthetic vs. Natural: Why the Distinction Is Scientifically Meaningless
- The Truth About Preservatives in Skincare
- The EWG Skin Deep Database: Why Hazard Is Not the Same as Risk
- Silicones in Skincare: The Evidence Behind the Most Misunderstood Ingredient
Scientific References
- Darbre, P.D., Aljarrah, A., Miller, W.R., Coldham, N.G., Sauer, M.J., Pope, G.S. (2004). Concentrations of parabens in human breast tumours. Journal of Applied Toxicology, 24(1), 5–13. doi:10.1002/jat.958
- Barr, L., Metaxas, G., Harbach, C.A.J., Savoy, L.A., Darbre, P.D. (2012). Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum. Journal of Applied Toxicology, 32(3), 219–232. doi:10.1002/jat.1786
- Scientific Committee on Consumer Safety (SCCS). (2010). Opinion on parabens. SCCS/1348/10. European Commission.
- Scientific Committee on Consumer Safety (SCCS). (2021). Opinion on propylparaben. SCCS/1623/20. European Commission.
- Scientific Committee on Consumer Safety (SCCS). (2023). Opinion on methylparaben. SCCS/1652/23. European Commission.
- Scientific Committee on Consumer Products (SCCP). (2005). Extended Opinion on the safety evaluation of parabens. SCCP/0873/05. European Commission.
- Burnett, C.L., et al. (2020). Safety Assessment of Methylparaben as Used in Cosmetics. International Journal of Toxicology, 39(S1), 5S–97S.
- European Commission. (2013). Regulation (EC) No 655/2013 — Common Criteria for cosmetic claims.
- European Commission. (2017). Technical Document on Cosmetic Claims. Working Group on Cosmetic Claims.
- Health Canada. (2025). Cosmetic Ingredient Hotlist — updated assessments. Canada.
- Harvey, P.W., Everett, D.J. (2004). Significance of the detection of esters of p-hydroxybenzoic acid (parabens) in human breast tumours. Journal of Applied Toxicology, 24(1), 1–4. doi:10.1002/jat.957
- Byford, J.R., Shaw, L.E., Drew, M.G.B., Pope, G.S., Sauer, M.J., Darbre, P.D. (2002). Oestrogenic activity of parabens in MCF7 human breast cancer cells. Journal of Steroid Biochemistry and Molecular Biology, 80(1), 49–60.
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