NEWSLETTER

Key Regulatory Updates on Formaldehyde in Hair Products, European Cosmetic Ingredients, and More

Ed-Alun Jones
July 2, 2023

FDA Proposes Ban on Formaldehyde in Hair-straightening Products

The US Food and Drug Administration has proposed a ban on formaldehyde and other formaldehyde-releasing chemicals as an ingredient in hair smoothing or hair straightening products.

The proposal was put forward this month following an open letter earlier this year from Congresswomen Shontel Brown (Ohio) and Congresswomen Ayanna Pressley (Massachusetts) calling for an FDA investigation into the health risks posed by chemical hair straighteners.

Formaldehyde is a colourless, flammable gas used in a wide range of household products including medicines and cosmetics. According to the National Cancer Institute, formaldehyde  is highly toxic and repeated exposure can cause eye, skin, lung and throat irritation. It is also linked to certain cancers.
While some products may not contain formaldehyde as a main ingredient, they may contain other ingredients that when heated are converted into formaldehyde, for example methylene glycol, commonly found in hair-straightening products.

Pressley comments:

"The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health — especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti-Black hair sentiment.”

She continues

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health. The administration should finalise this rule without delay.”

Current US federal law does not prohibit the use of formaldehyde, but companies have a legal responsibility to ensure the safety of their products.

The proposal, if implemented, would establish a federal ban on the use of formaldehyde and other formaldehyde-releasing chemicals in hair smoothing or hair straightening products marketed in the US.

The target date for the FDA’s proposed ban is April.

ECHA Begins Publishing REACH Restriction Proposal Advice

The European Chemicals Agency (ECHA) has decided to make its advice on the enforceability of REACH restriction proposals public.

The first official published advice was on the proposal to restrict creosote and related substances in treated wood.  

In October 2022 the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) submitted the Annex XV report concerning the proposal for eight chemicals involving creosote. The restriction proposal aims to reduce the risks of public health and environmental hazards arising from reuse or secondary use of these substances.

The ECHA enforcement forum have issued the following advice:

  1. The definition of “reuse”, “secondary use”, “treated” or “second-hand market” might require further explanation. A more precise definition will minimise different interpretations by duty holders and enforcement authorities and reduce available loopholes
  2. A limit value for restricted substances should be set in case analysis is required to verify compliance of the conditions of the restriction proposal.
  3. An analytical method to determine the restricted polycyclic aromatic hydrocarbons (PAHs) that could appear in the treated wood should be devised.

Biocidal Products to be Phased Off NI Market

Following withdrawal of support under the EU Biocidal Products Regulation (EU BPR), the European Commission has issued a decision not to approve the following active substance/product type combinations.

  • Dialuminium chloride pentahydroxide (CAS 12042-91-0 EC 234-933-1) in product type 2
  • Sodium N-(hydroxymethyl)glycinate (CAS 70161-44-3 EC 274-357-8) in product type 6
  • Reaction mass of titanium dioxide and silver chloride (CAS n/a EC n/a) in product types 1, 2, 6, 7, 9, 10 and 11
  • (benzyloxy)methanol (CAS 14548-60-8 EC 238-588-8) in product type 13
  • Silver chloride (CAS 7783-90-6 EC 232-033-3) in product type 1
  • 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO) (CAS 7747-35-5 EC 231-810-4) in product types 6 and 13
  • cis-1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC) (CAS 51229-78-8 EC 426-020-3) in product types 6 and 13
  • Methenamine 3-chloroallylochloride (CTAC) (CAS 4080-31-3 EC 223-805-0) in product types 6, 12 and 13

Biocidal products containing these active substances in the relevant product types can no longer be supplied in Northern Ireland after 23 March 2024, or used in Northern Ireland after 23 September 2024.

New treated articles containing these active substances in the relevant product types may not enter the supply chain or be imported into Northern Ireland after 19 September 2023. Treated articles that have entered the market before this date can continue to be supplied and used.

GB BPR defines a 'treated article' as: 'any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products'

The full decision may be accessed here.

GB Active Substance Renewal SUbmission Deadlines

Under the GB Biocidal Products Regulations (GB BPR), active substance approvals expire unless a renewal application is submitted at least 550 days before their expiry date.

The 550-day deadline is upcoming for the following active substances/product types:

28 December 2023

  • 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (Tebuconazole) (CAS 107534-96-3 EC 403-640-2) in product types 7 and 10
  • 2-bromo-ethanoic acid (Bromoacetic acid) (CAS 79-08-3 EC 201-175-8) in product type 4
  • 3-iodo-2-propynylbutylcarbamate (IPBC) (CAS 55406-53-6 EC 259-627-5) in product type 6
  • 3-phenoxybenzyl-2-(4-ethoxyphenyl)-2-methylpropylether (Etofenprox) (CAS 80844-07-1 EC 407-980-2) in product type 18
  • Benzoic acid (CAS 65-85-0 EC 200-618-2) in product types 3 and 4
  • Copper sulphate pentahydrate (CAS 7758-99-8 EC 231-847-6) in product type 2

29 March 2024

  • Nonanoic acid (Pelargonic acid) (CAS 112-05-0 EC 203-931-2) in product type 2

29 March 2025

  • (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine (Clothianidin) (CAS 210880-92-5 EC 433-460-1) in product type 18
  • 2-methyl-2H-isothiazol-3-one (MIT) (CAS 2682-20-4 EC 220-239-6) in product type 13
  • Glutaral (Glutaraldehyde) (CAS 111-30-8 EC 203-856-5) in product types 2, 3, 4, 6, 11 and 12
  • N-(trichloromethylthio)phthalimide (Folpet) (CAS 133-07-3 EC 205-088-6) in product types 7 and 9

Any person, company or task force may apply for renewal. If a renewal application is not submitted, approvals will expire and the active substances mays no longer be used in bioicdal products of the relevant product types in GB.

EU Cosmetic Ingredient Ban

Last month the European Commission published the Commission Regulation (EU) 2023/1490 amending Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying various substances as carcinogenic, mutagenic or toxic for reproduction (CMR).

Under Article 15 of the EU Cosmetics Regulation (EC) 1223/2009, all substances classified as CMR are prohibited in cosmetic products. The EU Cosmetics Regulation allows the use of CMR substances classified under category 2, where an evaluation by the Scientific Committee on Consumer Safety SCCS has been carried out and concludes that these substances are safe for use in cosmetic products.

Regulation 2023/1490 classified the listed substances as CMR substance.

Therefore, all these substances have been added to Annex II to Regulation (EC) 1223/2009 and are prohibited in cosmetic products from 1 December 2023.

  • Dibutyltin bis(2-ethylhexanoate) (CAS No. 22673-19-4)
  • Dibutyltin di(acetate) (CAS No. 1067-33-0)
  • Tellurium dioxide (CAS No. 7446-07-3)
  • 2,4,6-tri-tert-butylphenol (CAS No. 732-26-3)
  • 4,4’-sulphonyldiphenol; bisphenol S (CAS No. 80-09-1)
  • Benzophenone (CAS No. 119-61-9)
  • Quinoclamine (ISO); 2-amino-3-chloro-1,4- (CAS No. 78-11-5)
  • Perfluoroheptanoic acid; tridecafluoroheptanoic acid (CAS No. 375-95-1)
  • Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate (CAS No. 196291-22-7)
  • 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts
  • 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
  • Theophylline (CAS No. 58-55-9)
  • 1,3,5-triazine-2,4,6-triamine; melamine (CAS No. 108-78-1)
  • Fluopicolide (ISO) (CAS No. 239110-15-7)
  • N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram (CAS No. 862197-63-0)
  • Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]
  • Cumene (CAS No. 98-82-8)
  • 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate

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