European Parliament Vote to Revise the Regulation on the Classification, Labelling and Packing of Chemicals (CLP).
On April 23rd, 2024, Members of the European Parliament approved by a large majority to revise the regulation on the Classification, Labelling, and Packaging of chemicals (CLP) (1272/2008). This vote signifies a crucial step in strengthening the future of natural ingredients utilised in cosmetics and fragrances.
The CLP Regulation is a European Union regulation that standardises the classification and labelling of chemicals to ensure their safe use. It was introduced to replace the Dangerous Substances Directive (DSD) and the Dangerous Preparations Directive (DPD), aligning the EU regulations with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
Cosmetics Europe and the International Fragrance Association (IFRA) welcomed the vote, the regional director for Europe at IFRA, Aurelie Perrichet said “We are pleased that the trilogue negotiations have produced an agreement that puts to the fore the need for clear scientific grouping of substances for harmonised classification and labelling…It enhances legal certainty whilst making grouping a workable approach – which is important given how much group restrictions will likely affect the perfumer’s palette”.
The amendments to the CLP regulation seek to improve the identification and classification of chemical hazards, improving hazard communication through means such as mandatory formatting guidelines (e.g. minimum font size and colour requirements), introducing new provisions for chemicals sold in refillable containers and voluntary digital labelling. Additionally, the amendments aim to rectify any ambiguities within the CLP regulation, particularly concerning online sales and poison centre notifications.
As a component of the CLP regulation revision package, the Commission approved a delegated act incorporating definitions and criteria. These additions facilitate the existing classification of substances and mixtures that are endocrine disruptors (ED); persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); persistent, mobile and toxic (PMT); or very persistent and very mobile (vPvM) into recognised hazard classes. Following scrutiny by the European Parliament and Council, this act was officially published in the EU Official Journal on March 31st, 2023, and became effective on April 20th 2023.
The CLP Amendment also incorporates provisions specifically regulating the classification of substances containing more than one constituent, known as 'MOCS'. Such substances would undergo evaluation based on available data concerning both their known constituents and the substance itself. Exemptions include MOCs extracted from plants or plant parts (essential oils) that remained unaltered chemically.
The Therapeutic Goods Administration (TGA) Adopts the 2021 Sunscreen Standard Into Therapeutic Goods Legislation.
From July 1st 2024, all newly registered sunscreen products listed in the Australian Register of Therapeutic Goods (ARTG) must adhere to the guidelines outlined in the 2021 (Australian/New Zealand Standard (AS/NZS) 2604:2021), also referred to as the 2021 Sunscreen Standard.
The 2021 Sunscreen Standard is published by Standards Australia and outlines the testing and labelling criteria for sunscreens available in the Australian market. The standard details the specific tests methods and requirements to be used for determining broad spectrum, sun protection factor (SPF) and water resistance in sunscreen products.
Existing aerosol and spray pump packs already listed in the ARTG before July 1st 2024, will be granted a one-year transition period to meet the updated labelling requirements specified in the 2021 Sunscreen Standard.
Furthermore, all existing sunscreen products already listed in the ARTG before July 1st 2024, will be given a five-year transition period. During this time, they can choose to comply with either the testing requirements outlined in the 2021 Sunscreen Standard or adhere to the standards set in previous editions.
China Has Extended the Deadline for Submitting the Full Cosmetic Safety Assessment Report Until May 2025.
On April 22nd, 2024, China's National Medical Products Administration (NMPA) issued a notice outlining measures aimed at enhancing the management of cosmetic safety assessments. The NMPA notices details the implementation of classified management for cosmetic safety assessment data and eligible ordinary cosmetics may have their safety assessments streamlined, with enterprises permitted to submit essential safety assessment conclusions. The detailed safety assessment reports will be maintained by the cosmetic enterprises for future reference.
The NMPA also allows cosmetic registrants and filers to continue submitting simplified safety assessment reports meeting the criteria outlined in the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition) until May 1st, 2025. This provision aims to prevent redundant investment of enterprise resources.
It was previously stated that starting from May 1st, 2024, cosmetic registrants and filers would transition from simplified product safety assessment reports to complete versions. Extending the deadline for complete cosmetic safety assessments offers enterprises additional time and flexibility to ensure their products meet safety standards, while also alleviating the burden of research and regulatory compliance.
This extended period should be utilised effectively by preparing for and adapting to the forthcoming stringent safety assessment requirements. This proactive approach will be essential for maintaining long-term regulatory compliance and achieving success in the market.
Finland Proposes New CLH Classification for Hydrogen Peroxide
Last week, the European Chemicals Agency (ECHA) released Finland's proposal to modify the harmonised classification and labelling (CLH) of Hydrogen peroxide (CAS no: 7722-84-1). The registry of CLH intentions until outcome catalogues the submissions and suggestions received by ECHA, concerning the introduction or modification of harmonised classification and labelling for a substance. Manufacturers, importers, or downstream users are responsible for classifying and labelling hazardous substances and mixtures, both to safeguard human health and the environment at a high standard.
Below is the existing harmonised classification for hydrogen peroxide in Annex VI of the CLP Regulation 1272/2008:
Ox. Liq. 1 - H271: May cause fire or explosion; strong oxidiser
Acute Tox. 4 - H302: Harmful if swallowed
Acute Tox. 4 - H332: Harmful if inhaled
Skin Corr. 1A - H314: Causes severe skin burns and eye damage
The amended classification proposed by Finland includes the addition of Acute Tox. 3, H301: Toxic if swallowed and Aquatic Chronic 3, H412: Harmful to aquatic life with long lasting effects.
More information on the proposed concentration limits for hydrogen peroxide can also be found here.
SCCS (Scientific Committee on Consumer Safety) Preliminary Opinion on Triphenyl Phosphate Open for Comments Until June 2024
Triphenyl Phosphate (CAS No. 204-112-2, EC No. 115-86-6) is listed in the European database for cosmetic substances and ingredients (CosIng) with the function of 'plasticiser' and is used to soften or render various synthetic polymers more pliable, facilitating deformation, spreading, or manipulation.
Triphenyl Phosphate remains unregulated under the Cosmetic Regulation (EC) No. 1223/2009. During the data call, stakeholders provided scientific evidence to substantiate the safety of Triphenyl Phosphate as a plasticiser in nail products. Consequently, the Commission has tasked the SCCS with conducting a safety assessment of Triphenyl Phosphate based on the information provided.
In cosmetic products, Triphenyl Phosphate finds application in nail products such as polishes, enamels, or manicuring preparations. Additionally, it serves as a fire retardant and plasticiser in various industrial and consumer materials.
The SCCS has concluded the following:
1. In light of the data provided and taking under consideration the concerns related to the potential endocrine-disrupting properties of Triphenyl Phosphate, does the SCCS consider Triphenyl Phosphate safe when used as a plasticiser in nail products up to a maximum concentration of 5%?
Based on the currently available information, it is not possible for the SCCS to conclude on the safety of Triphenyl phosphate because the genotoxicity potential cannot be excluded.
2. Alternatively, what is according to the SCCS the maximum concentration considered safe for the use of Triphenyl Phosphate in nail products?
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3. Does the SCCS have any further scientific concerns with regard to the use of Triphenyl Phosphate in nail products?
The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Triphenyl phosphate for the environment.
The full opinion on Triphenyl Phosphate is available here.
