Call for Data: Safety of Cosmetic Ingredients
OPSS would like to invite any interested parties to submit any scientific information relevant to the safety assessment 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 list 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.
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.
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 Products.
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) 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.
Call for Data: Nanomaterials in Cosmetics
OPSS would like to invite any interested parties, to submit any scientific information relevant to the safety assessment of nanomaterials used in cosmetics.
Background
Article 16 of the UK Cosmetics Regulation requires that cosmetic products containing nanomaterials must be notified to the Secretary of State at least six months prior to being placed on the market. These notifications may be completed via the Submit Cosmetic Product Notification (SCPN) portal. In the case of nanomaterials not listed in Annex IV, V and VI, notifications must include additional data on the safety of the nanomaterial for use in cosmetic products, as detailed in Article 16.
Request
The Office for Product Safety and Standards (OPSS) would like to invite any interested parties, including academia, manufacturers of cosmetic products / raw materials and consumer associations to submit any scientific information relevant to the safety assessment of the below listed nanomaterials (or surface functionalised variants, alloys, or other related variants) used in cosmetics.
- Platinum (nano)
- Copper (nano)
- Silver (nano), colloidal silver (nano)
- Gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano)
- Silica (nano), hydrated silica (nano), silica silylate (nano), silica dimethyl silylate (nano)
- Lithium magnesium sodium silicate (nano)
- Hydroxyapatite (nano)
Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Guidance on the Safety Assessment of Nanomaterials in Cosmetics.
The UK is taking steps towards the safety assessment of certain cosmetic materials post-Brexit. The Office for Product Safety and Standards (OPSS), an arm of the country’s Department for Business and Trade, has launched two calls for data on cosmetic nanomaterials and cosmetic ingredients that are suspected endocrine disruptors, respectively. The OPSS is inviting interested parties, including academia, manufacturers of cosmetic products and raw materials, and consumer associations to submit any scientific information relevant to the safety assessment of several nanomaterials – or surface functionalised variants, alloys or other related variants – used in cosmetics.
These include nano-form platinum, copper, silver, colloidal silver, gold, colloidal gold, gold thioethylamino hyaluronic acid, silica, hydrated silica, silica silylate, silica dimethyl silylate, lithium magnesium sodium silicate and hydroxyapatite. The deadline for information on nano-form silica, hydrated silica, silica silylate, silica dimethyl silylate is 27 June 2025, while all other substances have a deadline of 22 December 2023.
For endocrine disruptors, the list of chemicals of interest includes triclosan, triclocarban, 4-methylbenzylidene camphor, salicylic acid, butylparaben and methylparaben, with a 15 December 2023 deadline for submission. Relevant parties are encouraged to submit, by email, original study reports and literature in full for all data relied upon in the safety assessment. They are also advised that the UK’s Scientific Advisory Group on Chemical Safety (SAG-CS) now uses 70kg as its default bodyweight assumption for adults in new safety assessments, which is considered representative for the UK adult population.
The OPSS has indicated that – depending on the results of the scientific review – it will take necessary action to ensure the safety of consumers. This includes, but is not limited to “prohibiting or restricting specific ingredients if a risk to human health is identified”.
In cosmetics products, nanomaterials are insoluble or biopersistent and intentionally manufactured materials with one or more external dimensions (or an internal structure,)on the scale from 1nm to 100nm. They are subject to close scrutiny by regulatory authorities because of potential risks associated with their size. Endocrine-disrupting chemicals, meanwhile, are natural or human-made chemicals that may mimic, block, or interfere with the body’s hormones.
The UK isn’t the only geography cracking down on potential endocrine disruptors at present. In June, the European Union added further limitations to Annex V of the EU Cosmetics Regulation for the preservatives triclocarban and triclosan – both of which are also included in the UK’s safety assessment data call-out.
Expected to enter into force in the EU by the end of 2023, triclocarban will only be allowed in cosmetic products (except for mouthwash) up to a maximum concentration of 0.2%; triclosan will be banned in mouthwash; and toothpaste with triclocarban or triclosan will have to bear the warning ‘not to be used for children under six years of age’. From the date of enforcement, there will be an eight month period for new products placed on the market to company and a 17 month period for existing products on the market.
European Union
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published on May 16, 2023, the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of the guidance is on cosmetic ingredients, but it notes that “some guidance is also indirectly given for the safety assessment of finished products.” The guidance includes a section on “special consideration for certain cosmetic ingredients” that addresses specific ingredients, including nanomaterials. It addresses:
- Definition of nanomaterial: Under Article 2 (1) (k) of the Cosmetic Regulation, “nanomaterial” means “an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.” The guidance notes that it is likely that this definition will be aligned with the EC’s June 10, 2022, Recommendation on the definition of nanomaterial. According to the guidance, “[t]he Regulation therefore mainly covers those nanomaterials that are intentionally produced and are insoluble/poorly-soluble or biopersistent (e.g., metals, metal oxides, carbon materials, etc.), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions, etc.).”
- Potential safety issues of nanomaterials: According to the guidance, as a general principle, certain specific attributes should add a further degree of safety concern. SCCS notes that it has published more specific Guidance on Risk Assessment of Nanomaterials (SCCS/1611/19, under revision), which is an update of a previous guidance published in 2012 (SCCS/1484/12), a Memorandum on the Relevance, Adequacy and Quality of the Data Expected in Safety Dossiers on Nanomaterials (SCCS/1524/13), and a checklist for the applicants submitting dossiers on nanomaterials as cosmetic ingredients (SCCS/1588/17). The guidance states: “In general, a number of reviews have concluded that the existing risk assessment paradigm, in use for conventional chemicals, should in principle be also applicable to engineered nanomaterials. However, it has also been pointed out that the current testing methods may need certain adaptations to take account of the special features of nanomaterials.”
- Required information for nanomaterials: The guidance lists aspects that “deserve special attention.” According to the guidance, a full dataset “would be preferable.” The guidance states that at a minimum, in addition to safety data on the core nanomaterial, SCCS would require information/data on each material used for surface modification/coating of the nanomaterial to indicate that it is safe for use in the intended cosmetic product; data on physicochemical properties of the surface-modified/coated nanomaterial to show that they have not significantly changed compared to either the same material when uncoated, or with a different surface modification/coating that has already been assessed safe by SCCS; data on dermal penetration, stability of the surface modification/coating, and (photo)catalytic activity, where relevant; and data on interaction of nanomaterial with cells (cellular uptake).
The Fate of Glitter
All that glitters is … plastic. Millions of items are adorned with glitter, from baubles to wrapping paper. Christmas is not Christmas without sparkly accessories and flamboyant decorations, but is it really? Modern glitter originated in 1934, when an American farmer named Henry Ruschmann created a way of cutting mylar and plastic sheets into tiny shapes. He formed Meadowbrook Inventions, which today is still one of the main global suppliers of glitter.
The majority of commercial products that contain glitter, whether these are single use items, such as Christmas cards, or more permanent items such as Christmas tree decorations, use inorganic glitter – chiefly plastics such as polyethylene terephthalate (PET) and also polyvinyl chloride (PVC). Glitter is usually layered with other materials, such as aluminium to provide extra sparkle. Underneath the microscope, it is possible to see the huge variation of glitter shapes and sizes: hexagons, squares, rectangles and even hearts and stars ranging from 6.25 millimetres (0.25 inches) to a truly tiny 0.05 millimetres (0.002 inches).
Glitter is not fabulous (for marine life). Most people now understand that microplastics, such as fibres from clothes or microbeads in facial scrubs, are dangerous to sea life. Glitter is a microplastic too, classed as a primary type of microplastic as the particles are less than 5 millimetres (0.2 inches) in size and have been purposely manufactured to be of microscopic size.
Glitter can enter seas and oceans from rivers, via wastewater from our homes and via run-off from landfill sites. Although many microplastics are removed at wastewater treatment plants, a huge amount of microplastics still find their way through to the oceans. The size of these particles means they are easily consumed by small marine organisms, who cannot discriminate between particles of food and plastic. Microplastic particles attract inorganic and organic chemicals to adhere to them, such as polychlorinated biphenyls (PCB’s, which have been banned since 1979) and toxic heavy metals.
A big risk to wildlife comes from the bioaccumulation of these toxins in the food chain – as recently highlighted in the final episode of the BBC’s Blue Planet II television programme on Earth’s oceans, which showed how young dolphins have been found dead, possibly killed by toxins accumulated in their mother’s milk.
Glitter is hard to dispose of. Knowing the problems posed by glitter, you may be wondering what now to do with it all. This is a difficult question to answer, as whichever way you dispose of it there is a chance it will end up in the oceans. Most importantly, do not wash glitter down the sink. Instead, try reusing the glitter (or item adorned with it) for a future festive project. This still does not eliminate the risk, merely potentially prolonging the moment it enters the ocean. So what to do?
There are guilt-free glitter alternatives. In line with the 2017 ban on microbeads in toiletries, there have recently been calls to ban glitter. This has been met with some resistance and accusations that this represents scientists “wanting to take the sparkle out of life”. But we don’t have to go all the way from bling to bland.
Just as manufacturers of facial scrubs are looking at using natural exfoliating materials, such as apricot or walnut husks, glitter manufacturers have now started producing biodegradable glitter, available from many online stores (such as Glitterevolution and Ecoglitterfun). Biodegradable glitter is made from the cellulose of plants, such as the eucalyptus tree, grown on land unsuitable for food crops using sustainable forestry initiatives that require little water. On top of that, it is also compostable – truly an eco-glitter. By using EWG’s resources, consumers can educate themselves about the potential health and environmental impacts of their cosmetic choices, and take steps to reduce their exposure to harmful chemicals. The organization’s efforts also serve to promote transparency in the cosmetics industry, encouraging brands to prioritize the use of safe and sustainable ingredients. Overall, EWG is an important tool for anyone seeking to navigate the complex world of cosmetics and make informed, responsible choices for themselves and the planet.
