Cosmetics & Personal Care | Monthly bulletin | September 2023
Eurofins bioskin is ISO 14155:2020
We are pleased to announce that Eurofins bioskin is now ISO 14155:2020 certified, a globally recognized certification of the ISO 14155 standard for the design, conduct, recording, and reporting of clinical investigations in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
Over the last 30 years Eurofins bioskin has built a reputation for excellence in providing clinical investigations in dermatology for medicinal products and for medical devices in dermatology (e.g. fillers, bandages for wounds, creams and ointments, and laser devices). Eurofins bioskin has innovative capabilities, a strong position in early phase studies and proof-of-concept models in international multi-center phase II–III studies, and unique expertise with its own in-house Research Center Dermatology RCD.
By achieving this level of certification, we have further strengthened our commitment to consistently deliver quality services to our customers for clinical investigations with medical devices.
Supervision of toothpaste in China
The State Administration for Market Regulation of China issued the Measures for the Supervision of Toothpaste (Directive No. 71 of the State Administration for Market Regulation), which will come into effect on the 1st December, 2023.
A total of 25 new provisions have been implemented, of which include:
- To clarify the definition of toothpaste and regulatory authorities. Toothpaste is defined as a paste product applied to the surface of human teeth in the way of friction, with the main purpose of cleaning; The State Food and Drug Administration and the departments responsible for drug supervision and administration at or above the county level are responsible for toothpaste supervision.
- Clarify the management requirements of toothpaste and toothpaste raw materials. It is stipulated that toothpaste shall implement record management, and new raw materials of toothpaste shall be registered according to the degree of risk.
- Continue to follow the current toothpaste production licensing system, and issue cosmetics production licenses for toothpaste production.
- Clear toothpaste efficacy management and labeling requirements. It is required that the efficacy claims of toothpaste should have sufficient scientific basis, and the content of toothpaste that should be labelled and prohibited.
The new regulations strictly limit the claims of the efficacy of toothpaste products such as caries prevention, plaque inhibition and anti-dentin sensitivity, in order to curb the occurrence of illegal claims of toothpaste. The new regulations also clarify how the content of toothpaste labels should be marked and what is prohibited, including "express or implied medical content".
We can provide consulting and commissioning services for the filing and registration of toothpaste products under the new regulations, and can provide services through cooperative institutions for the verification of toothpaste efficacy.
- Welcome to consult the record registration requirements of toothpaste management regulations.
- We can provide teeth whitening human efficacy tests.
- Regarding anti-inflammation, anti-allergy, anti-caries and other effects of toothpaste tests, our partner institutions can provide you with corresponding services.
Ensure the biodegradability of your cosmetic products
Biodegradation is the breakdown of matter into smaller parts and the eventual conversion into substances that are reused in biological cycles or accumulated in the environment.
The demand for biodegradable products from consumers has become increasingly prevalent in recent years, correlating with a general drive towards sustainability and corporate social responsibility. With more people focusing on the end-of-life (EOL) cycle of their products, it has become imperative to have an accurate system in place not only to validate degradability claims, but to assess toxicity of those degradation products and provide alternative solutions in cases where biodegradation is not favourable.
Biodegradability, disintegration, and compost tests are carried out in order to study the environmental and toxicological impact of materials. There are various standards and test methods.
Different local legislation governs the use of environmental claims. French legislation under the AGEC (Anti-Waste for a Circular Economy) law forbids the use of the term ‘biodegradable’ as a promotional term for plastics to prevent any misunderstanding and to reduce greenwashing.
You can rely on the Eurofins Cosmetics & Personal Care network of laboratories to assess the biodegradability of your products and use of environmental claims to ensure full compliance with the regulation.
