NEWSLETTER

IFRA Standards Amendment, ECHA Consultation, Canada's Cosmetics Animal Testing Ban, Albania's Cannabis Legalisation, and More

Juenelle Muge
June 30, 2023

Notification of the 51st Amendment to the IFRA Standards

IFRA has announced the Notification of the 51st Amendment to the IFRA Standards.

The 51st Amendment includes the following updates: a revised guidance document for the use of the IFRA Standards, the IFRA Standards themselves, and an Annex that combines information from natural contributions and Schiff bases. Similar to previous Amendments, the IFRA Standards are based on the conclusions of the Expert Panel for Fragrance Safety, as found in the publicly available RIFM Safety Assessments. These documents will be accessible on a dedicated SharePoint site for a few months and will be published on the IFRA website within a week of the Notification.

The implementation timelines for the restriction/specification have been modified to be as follows:

For IFRA Standards prohibiting the use of ingredients :

  • For new creations: 2 months after the date of the Notification
  • For existing creations: 13 months after the date of the Notification

For IFRA Standards restricting or setting specifications for the use of ingredients:

  • For new creations: 13 months after the date of the Notification
  • For existing creations: 28 months after the date of the Notification

ECHA Public Consultation on Harmonised Classification and Labelling Proposals

The ECHA has initiated public consultations for two proposals regarding harmonised classification and labelling (CLH):

  • Piperonal; 1,3-benzodioxole-5-carbaldehyde (EC: 204-409-7; CAS: 120-57-0). This chemical is registered under REACH, and comments are open for health hazard classes.
  • Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (EC: 274-778-7; CAS: 70693-62-8). This is a biocide active substance, and comments are open for all hazard classes.

The consultations can be accessed on the ECHA website.UK-based businesses are encouraged to provide any relevant information they have on these proposals.

Scientific or technical information may be submitted directly to ECHA using their commenting webform before 11 August 11 2023.

Comments will be made public on ECHA's website.

Canada to Ban Animal Testing

Canada has passed measures through the Budget Implementation Act to ban cosmetics animal testing. The ban will prohibit the sale of cosmetic products that have been tested on animals and those that rely on new animal testing data.

The Canadian government worked closely with organisations such as the Humane Society International, Lush, The Body Shop, Cruelty Free International, Cosmetics Alliance Canada, and Animal Alliance Canada to implement this ban.

Jean-Yves Duclos, Minister of Health, Government of Canada, explains:

“Testing cosmetics on animals is both cruel and unnecessary. That is why we are proud to move forward on our promise to ban cosmetic animal testing and trade. Protecting animals now and in the future is something many Canadians have been advocating for and now, we can all be assured that cosmetics in Canada are cruelty-free, and we will continue to take all necessary measures to improve animal welfare.”

Albania Considers Legalising Cannabis Medical and Industrial Use

Albania is planning to legalise cannabis for medical and industrial purposes.

Minister of Health, Ogerta Manastirliu, explains:

“The purpose of this draft law is to regulate and guarantee the process of control and supervision of cultivation, production, processing and export of the cannabis, its by-products and final products.”

The decision comes after the Albanian government conducted a National Survey, which revealed that approximately 61 percent of citizens supported legalisation. The move is seen as a strategy to address the issue of growing and trafficking of cannabis, as legislation would allow authorities to better regulate and monitor the trade.

2nd Revision of the SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics

On 6 June 2023, the SCCS adopted the 2nd revision of the Guidance on the safety assessment of nanomaterials in cosmetics.

The Guidance highlights specific aspects that should be considered when testing and reporting data for nanomaterials, including the following:

  • Physicochemical characterisation
  • Exposure assessment
  • Hazard identification and dose-response characterisation
  • Risk assessment

Main changes in the 2nd revision

  • New sections have been introduced (solubility and dissolution rate, solubility in non-aqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, endocrine disruption),
  • The European Commission definition of nanomaterials applies
  • Annex 1 has been updated based on recently published literature
  • The section on read-across and grouping has been revised.
  • A text explaining when historical/existing data can be used has been included.

The Guidance is to be used in conjunction with general guidance for the submission of safety dossiers of cosmetic ingredients.

Upcoming GB Active Substance Expiry Dates

Biocidal products must be phased off the GB market

The active substance/product type combinations listed below are due to expire under the GB Biocidal

Products Regulation (GB BPR) on the following dates:

30 September 2023

  • (±)-5-amino-1-(2,6-dichloro-α,α,α,-trifluoro-p-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile
  • (1:1) (Fipronil) (CAS 120068-37-3 EC 424-610-5) in product type 18

30 June 2024

  • (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14
  • Chlorophacinone (CAS 3691-35-8 EC 223-003-0) in product type 14
  • Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8 (PHMB (1600;1.8)) (CAS 27083-27-8 /32289-58-0 EC n/a) in product types 2, 3 and 11

30 September 2024

  • cis-Tricos-9-ene, (Z)-Tricos-9-ene (Muscalure) (CAS 27519-02-4 EC 248-505-7) in product type 19

Once the approvals expire, the active substances can no longer be used in biocidal products of the relevant product types in Great Britain.

IFRA Forms Working Group to Establish Biodegradability Criteria for Fragrance Ingredients

The IFRA Environmental Task Force (ETF) has created a working group comprising environmental experts from the fragrance industry. Their objective is to scientifically determine reliable criteria and approaches that can support biodegradability statements related to fragrance ingredients.

The primary purpose of this initiative, outlined in the IFRA white paper, is to address commonly discussed questions within the supply chain regarding the use of the term "biodegradability."

The IFRA white paper, which presents scientifically robust criteria and approaches endorsed by IFRA experts, is now available to the public.

Interested parties can access the document on the IFRA website through the following link: https://ifrafragrance.org/docs/default-source/white-papers/ifra-white-paper-biodeg-statements_20230523_final.pdf?sfvrsn=3d90df6b_0

EU Proposes Regulatory Action on Nanomaterials in Cosmetics

On May 23, 2023, the European Union (EU)  issued a notification the World Trade Organisation (WTO) about proposed revisions to the list of prohibited substances (Appendix II) and restricted substances (Appendix III) for cosmetics under the EU Cosmetics Regulation (EC) No 1223/2009.

The EU Cosmetics Regulation defines a nanomaterial as “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 use of nanomaterials in cosmetic products are regulated as their small size and increased surface area can lead to increased reactivity with substances and pose potential risks to human health, including their potential to penetrate the skin.

The primary purpose of this revision is to address the use of certain nanomaterials in cosmetics. The proposal specifically includes the prohibition of colloidal silver and introduces limitations on hydroxyapatite.

Interested parties and stakeholders are invited  to provide their opinions and feedback on this proposal, with a deadline set for 22 July 2023.

The proposed revisions are expected to come into effect 20 days after their publication in the Official Journal of the European Union.

Store in Shanghai Granted First License for On-Site Personalised Cosmetic Production

Cosmetic store SkinCeuticals  is the first cosmetics store to receive an on-site personalised licence from the Shanghai Municipal Medical Products Administration, allowing their store to produce personalised cosmetics on-site.

To be eligible for the licence, applicants must meet the requirements under the Regulation for On-site Personalised Service Review of General Cosmetics in Pudong New Area.

Requirements include  being legally established with a valid business licence for the premises where on-site personalised cosmetic services will be provided, having relevant experience in cosmetics production quality management, and having completed product notification for the cosmetics used in on-site personalised services.

The Regulation emphasises the importance of whole-process risk assessment and risk control, establishing cosmetovigilance requirements such as monitoring adverse reactions, suitable venues and environmental conditions, qualified technicians and inspectors, and robust management systems for ingredient purchase inspection, service processes, quality control, equipment management, product inspection, and sample retention.

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