Call for Data: Safety of Cosmetic Ingredients

The Office for Product Safety and Standards (OPSS) would like to invite any interested parties, including academia, manufacturers of cosmetic products, producers of the substances concerned and consumer associations to submit any scientific information relevant to the safety assessment of cosmetic ingredients in the listfollowing below.

OPSS would like to evaluate the safety of these ingredients in cosmetic products due to their suspected endocrine disrupting properties. If ingredients will be used in products that may foreseeably be used by children or pregnant women, relevant data to support the safety and exposure estimates should be provided for these populations.ingredients.

Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation.

Note:

Note: The Scientific Advisory Group on Chemical Safety (SAG-CS) will use 70 kg as their default bodyweight assumption for adults in new safety assessments. This aligns with other UK groups, such as the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, who carry out chemical risk assessments across a range of sectors and have agreed that a default adult bodyweight of 70 kg is representative for the UK adult population. For more information, see Scientific Advisory Group on Chemical Safety in Consumer ProductsSAG-CS.

Please submit original study reports and literature in full for all data relied upon in the safety assessment. This is particularly important for the pivotal studies, those which support the critical No Observed Adverse Effect Level (NOAEL)Level (NOAEL) and point of departure and the dermal absorption value. OPSS takes the examination of data very seriously and will ensure independent scientific review of all information sent to us.

How to Submitsubmit Datadata 

Please submit relevant data by email to opss.safetyassessment@beis.gov.ukto: opss.safetyassessment@businessandtrade.gov.uk.

Note:

Deadline for Submission: 30 April 2025

Note:  The data submitted may be subjectedsubject to the Freedom of Information Act 2000. 2000.  Any confidential and commercially sensitive data should ONLY be submitted if it is relevant to the safety assessment. Any confidential and commercially sensitive data must be very clearly marked in a submission.submission. Any Any data that is not marked as confidential and /or commercially sensitive may be liable for release under an appropriate request.request.   

ListProstaglandins ofand Chemicalsprostaglandin analogues

1. Triclosan

   Prostaglandins (CASand 3380-34-5)

prostaglandin analogues are used in cosmetic products with the function of promoting eyelash growth. These types of eyelash growth products are increasingly available on the UK market and contain prostaglandin analogues such as:
• TriclocarbanIsopropyl closprostenate (CAS 101-20-2)157283-66-4)
• 4-MethylbenzylideneBimatoprost camphor (CAS 36861-47-9 / 38102-62-4)155206-00-1)
• SalicylicEthyl acidtafluprostamide (CAS 69-72-7)209860-87-7)
• Butylparaben (CAS 94-26-8)Norbimatoprost
• MethylparabenMethylamido (CASdihydro 99-76-3)noralfaprostal

Deadline

Due to their potency, intended use in the proximity of the eye and concerns raised by other scientific bodies / regulators over their safety, OPSS would like to evaluate the safety of these ingredients in cosmetic products.

Note: This call for Submission:data 15is Decembernot 2023limited to prostaglandin analogues mentioned in the list above. OPSS is seeking data on all relevant prostaglandin analogues used in cosmetic products.

Alpha and beta-arbutin

ForAlpha-arbutin further(CAS information,84380-01-8) pleaseand emailbeta-arbutin opss.safetyassessment@beis.gov.uk(CAS 497-76-7) are used as antioxidants, skin bleaching and skin conditioning agents in cosmetic products. OPSS has concerns regarding the risks associated with the use of these ingredients in cosmetic products due to their degradation to hydroquinone under common storage conditions. Hydroquinone is a known carcinogen, mutagen and a strong skin sensitiser which is prohibited from use in cosmetic products (except for entry 14 in Annex III of the UK cosmetics Regulation). As a result OPSS would like to evaluate the safety of these ingredients in cosmetic products.

DataVitamin ProtectionA

TheVitamin OfficeA derivatives such as retinol (CAS 68-26-8), retinyl acetate (CAS 127-47-9) and retinyl palmitate (CAS 79-81-2) are used in cosmetic products for Producttheir Safetyanti-aging and Standardsantioxidant properties. The major source of vitamin A exposure in the population is food and food supplements. As a result, any additional source of exposure, including cosmetic products, may exceed tolerable upper intake levels.  Therefore, there is a potential risk to human health arising from the use of vitamin A in cosmetic products when its concentration exceeds certain levels. As a result OPSS would like to evaluate the safety of these ingredients in cosmetic products.

Data protection   

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