US Accountability Office Urges FDA to Strengthen Efforts to Implement MoCRA
The US Government Accountability Office (GAO) is calling upon the FDA to strengthen its efforts in implementing the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA), aimed at expanding regulatory authority for heightened oversight of cosmetic safety.
MoCRA mandates the FDA to take specific actions, such as establishing standards for detecting asbestos in talc, by designated dates through December 2025. However, the GAO asserts that the FDA's current approach lacks comprehensive planning, leading to gaps in addressing harmful cosmetic ingredients. Notably, the GAO notes the absence of an implementation plan for MoCRA and points out deficiencies in aligning with leading practices, crucial for the success of agency reforms.
To accommodate industry adjustments, a six-month delay has been granted, permitting companies to register their cosmetic facilities and product listings in accordance with the new obligations outlined in MoCRA.
Research findings underscore potential health risks associated with certain substances found in cosmetics. Manufacturers often incorporate these substances for specific functions, such as using parabens as preservatives to inhibit microorganism growth. A GAO spokesperson highlights concerns about eye shadows containing parabens, linked to potential interference with the endocrine system, and shampoos with fragrances triggering skin allergic reactions.
The GAO report further emphasises the unintentional presence of substances like asbestos in talc or as manufacturing byproducts, with asbestos inhalation being associated with mesothelioma, a type of cancer affecting internal organ linings.
Critical shortcomings in organisational aspects are highlighted by the GAO, citing the FDA's chief scientist, who acknowledges using MoCRA as a roadmap for implementation efforts. However, the GAO criticises MoCRA for lacking details on interim steps and deadlines, essential for effective project management.
The FDA's chief scientist admits that strategic workforce plans, vital for ensuring the agency has personnel with the necessary skills, were not developed due to a focus on meeting immediate MoCRA deadlines. The GAO recommends a more comprehensive approach, including strategic planning, to better ensure successful MoCRA implementation and promote overall cosmetic safety.
Drawing from US Census data indicating a substantial $43 billion revenue from cosmetics in 2021, the GAO's recommendations include a seven-point plan. The FDA Commissioner is urged to ensure that the Office of the chief scientist:
- Develops an implementation plan for MoCRA with a detailed timeline and interim steps for completing all requirements within statutory deadlines.
- Reports on key milestones for all MoCRA requirements.
- Develops processes for data and evidence collection to measure the agency's MoCRA implementation efforts against new law requirements.
- Assesses the effects of implementing all MoCRA provisions on the current and future workforce.
- Develops a multiyear strategic workforce plan identifying necessary personnel and capacity, including skills and competencies, to implement all MoCRA requirements.
- Develops a plan to enhance diversity, equity, inclusion, and accessibility in recruiting and hiring additional staff for MoCRA implementation.
- Adopts effective recruitment and hiring practices, incorporating customised strategies for highly specialised and hard-to-fill positions into a multiyear strategic workforce plan for MoCRA implementation.
The FDA has concurred with these recommendations, signaling a commitment to fortifying efforts for comprehensive cosmetic safety oversight.
China Eases Process for Compound Ingredient Submission Codes
In a recent update to the Cosmetic Ingredients Safety Information Submission Platform, China has streamlined the application process for submission codes, specifically for compound ingredients. This amendment follows a series of regulatory developments aimed at improving the efficiency of cosmetic registration and notification procedures.
Background:
The Provisions for Management of Cosmetic Registration and Notification Dossiers mandate the submission of ingredient safety information during cosmetic registration and notification.
On March 27, 2023, the National Medical Products Administration (NMPA) extended the transition period for cosmetic ingredient safety information submissions to January 1, 2024.
From September 2023, the China National Institutes for Food and Drug Control (NIFDC) introduced three guidelines related to safety information submission and cosmetic formula filing.
Earlier Challenges:
The initial update in September restricted compound ingredients from obtaining new submission codes through the platform.
This led to complications during the cosmetic product registration and notification process, requiring registrants and notifiers to submit safety-related information for ingredients without submission codes using scanned copies of paper documents.
Recent Positive Update:
As of November 1, 2023, the Cosmetic Ingredients Safety Information Submission Platform underwent another update.
The platform now reinstates the functionality for applying submission codes specifically for compound ingredients.
Registrants and notifiers can utilise both existing and newly acquired submission codes for compound ingredients during the cosmetic product registration and notification process.
This revision aims to address challenges faced by industry stakeholders, offering a more streamlined and adaptable approach to compliance with cosmetic regulations in China.
EU Active Substance Notification Deadline: A Call to Action for Specific Chemicals
The European Chemicals Agency (ECHA) issues a critical invitation for active substance notification in the EU Review Programme. Companies are urged to submit notifications promptly to support active substances, such as: Chlorine dioxide generated from Tetrachlorodecaoxide complex (TCDO) by acidification (CAS n/a EC n/a) in product types 02 and 04 - Deadline: 20 October 2024
COP28 Initiative Aims to Harness Sargassum in Cosmetics and Beyond
At the recent COP28 in Dubai, maritime nations gathered to address the escalating challenge of sargassum, a troublesome brown seaweed causing environmental havoc along coastlines. Characterised by rapid spread and harmful greenhouse gas emissions upon washing ashore, sargassum poses threats to coastal ecosystems, resulting in adverse economic, environmental, and health impacts.
Recognising an "economic opportunity" in sargassum, a coalition led by the EU and the Dominican Republic organised the “COP 28 Sargassum Panel — Urgency and Opportunities for Action and Investment.” This collaborative effort brought together governments from Barbados, the Dominican Republic, and Mexico, along with regional entities such as the Caribbean Community and the Central American Commission on Environment and Development. Private sector representatives also joined the discussions.
The European Commission highlighted the escalating accumulations of sargassum on shores, impacting key coastal ecosystems. The COP28 forum builds upon previous initiatives, including the EU-Caribbean Sargassum conference and the EU-CELAC summit, where global leaders pledged collective efforts to combat sargassum in the Caribbean.
The EU launched the initiative "Turning sargassum into an economic opportunity" at COP28, aiming to integrate sargassum into the circular economy. This comprehensive plan encompasses monitoring, research, and resource mobilisation to maximise impact.
Carbonwave, a pioneer in developing ultra-regenerative, plant-based biomaterials from seaweed, is at the forefront of finding innovative solutions for sargassum. Beyond its applications in cosmetics, Carbonwave explores uses in vegan leather and as an algae fertiliser. SeaBalance, a cosmetic emulsifier derived from sargassum, has been developed by Carbonwave, offering a natural and eco-friendly alternative to traditional emulsifiers.
The initiative not only focuses on the economic potential of sargassum but also emphasises sustainable practices. Carbonwave emphasises the need to extract beneficial components from sargassum while preserving its essential elements throughout the extraction process.
South Korean cosmetic manufacturer BioSpectrum uncovered the potential of Sargassum fusiforme, a specific type of sargassum known as hijiki. Extracts from this edible variety were found to induce melanogenesis, indicating applications in improving hair color loss and vitiligo by stimulating melanin synthesis.
In another dimension, the National Research Foundation of Korea delved into the nutraceutical uses of Sargassum spp. extract, unveiling insights into the seaweed's potential role in promoting healthy aging.
The scale of the sargassum challenge is underscored by Carbonwave, estimating an annual bloom of 20–30 megatons in the Caribbean. This massive bloom leads to methane emissions, biodiversity loss, and a 35% decline in Caribbean tourism before the pandemic.
As part of the effort to mitigate the impact of sargassum, Biesterfeld, a global distributor of plastics, rubber, and specialty chemicals, took exclusive distribution rights for Carbonwave’s SeaBalance 2000 product in the DACH region, Poland, and the Baltic States, expanding its reach across Europe. This collaboration aims to address the environmental challenges posed by sargassum while creating innovative solutions for various industries, including cosmetics.
Indonesia Revises Cosmetics Import Certificate Process
In a recent regulatory update, Indonesia has revised the time requirements for obtaining cosmetics import certificates, aiming to streamline the importation process. The key change involves the replacement of SKI Border with SKI Post Border as the mandatory import certificate for cosmetics entering Indonesia.
Key Terms:
- SKI Border: An import certificate for goods entering Indonesian territory, mandatory before the goods are released from the customs area.
- SKI Post Border: An import certificate for goods entering Indonesian territory, obtainable either before or after the goods are released from the customs area.
Regulatory Amendments:
- On November 8, 2023, the Indonesian Agency for Drug and Food Control (BPOM) introduced amendments to the Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia.
- These amendments, effective from December 8, 2023, impact the entry requirements for imported drugs, including cosmetics, and food products.
Updated Requirements:
- According to the revised regulation, importers of cosmetic products must now obtain an import certificate (SKI Post Border) either before or within seven days after the goods are released from the customs area.
- Importing drugs, cosmetics, and food items not specified in the SKI Post Border certificate is strictly prohibited in Indonesia.
This regulatory enhancement aims to provide greater flexibility in the importation process while ensuring compliance with Indonesian regulations governing the entry of cosmetics into the country. Industry stakeholders should take note of these changes to facilitate smooth and compliant import procedures
Non-Approval Decisions for Unsupported Active Substances: Implications Unveiled for Specific Chemicals
Following unsuccessful attempts to garner support for specific active substance/product type combinations in the EU Review Programme, these active substance/product type combinations will now be subject to an EU non-approval decision:
- Silver-polyethylenimine-chloride (CAS n/a EC n/a) in product types 01, 02, and 09
- Garlic, ext. Extractives and derivatives from Allium sativum, Liliaceae (CAS 8008-99-9 EC 232-371-1) in product type 19
- Biphenyl-2-ol (CAS 90-43-7 EC 201-993-5) in product type 07
- Glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin) (CAS 164907-72-6 EC 403-950-8) in product types 02 and 04
- Poly(oxy-1,2-ethanediyl), .alpha.-[2-(didecylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (“Bardap 26”) (CAS 94667-33-1 EC n/a) in product types 02, 04, and 10
- Brandy (CAS n/a EC n/a) in product type 19
- 2,2-dibromo-2-cyanoacetamide (DBNPA) (CAS 10222-01-2 EC 233-539-7) in product type 02
- Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis (CAS 7782-50-5 EC n/a) in product type 02
