SCCS Preliminary Opinion on Genistein and Daidzein
The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary opinion on the use of Genistein and Daidzein in cosmetic products. The deadline for comments was set at 14 March 2022.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

GENISTEIN AND DAIDZEIN

Genistein (CAS number: 446-72-0) and Daidzein (CAS number: 486-66-8) are isoflavones, which are phenolic compounds classified as phytoestrogen. Phytoestrogens are plant-derived compounds structurally similar to 17β-estradiol (steroid hormone produced primarily by the ovaries during reproductive lifespan). Isoflavones can be naturally found in legumes (soybeans, chickpeas, fava beans), in fruits and nuts (e.g., peanuts).

In cosmetics and personal care products, Genistein and Daidzein are used as skin conditioning agents. Both ingredients are usually used in leave-on formulations. Genistein and Daidzein are not currently included in the annexes of the European Cosmetics Regulation (No. 1223/2009), which means that their use is not restricted in cosmetic products placed in the European Union (EU).

In early 2019, a priority list of 28 potential endocrine disruptors (not already covered by the bans of cosmetic regulation) was established by the Commission. From these 28 substances, 14 were considered as higher priority (Group A) and the other 14 were included in the low priority group (Group B). The public call for data for the considered higher priority substances was carried out in 2019. Genistein and Daidzein were included in the mentioned group for which the call of data took place. (see previous post)

During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Genistein and Daidzein in cosmetic products. The European Commission asked the Scientific Committee on Consumer Safety (SCCS) to carry out a safety assessment on these two substances considering the information provided.

NEW SCCS PRELIMINARY OPINION

This month, the SCCS has published its preliminary opinion on the use of Genistein and Daidzein in cosmetic products.

Considering the potential endocrine disrupting properties of phytoestrogens and the relevant data available, the SCCS concluded that the use of Genistein in cosmetic products up to a maximum concentration of 0.007% is safe. However, the SCCS was not able to carry out risk assessment to concluded on the safety of the use of Daidzein in cosmetic product, as the currently available information is not sufficient to exclude the potential genotoxic effects of this ingredient.

The SCCS preliminary opinion is open for comments until 14 March 2022.

If you wish to get more information on the safety of cosmetic ingredients, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Scientific Committee on Consumer Safety (SCCS). Opinion on Genistein and Daidzein. SCCS/1641/22. 2022.

further
reading

medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
parfum_fragrance_allergen_1
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »