New Restriction on the Use of Benzophenone-3 in Cosmetics
Benzophenone-3 was part of a priority list of potential endocrine disruptors established by the European Commission in 2019. The SCCS was asked to assess the safety of this ingredient and the European Cosmetics Regulation will be amended in accordance with the SCCS assessment conclusions.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate

BENZOPHENONE-3

Benzophenone-3 is a benzophenone derivative that is used in cosmetics and personal care products as a light stabilizer, UV absorber and UV filter.

According to the Cosmetics Regulation (No. 1223/2009), Benzophenone-3 is included in the list of UV filters allowed in cosmetic products (Annex VI, entry 4). Benzophenone-3 can be used as an UV filter in sunscreen products at concentrations up to 6% in ready for use preparation. It is also allowed in other cosmetic products to avoid formulation decay due to light, at concentrations up to 0.5%.

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), which included Benzophenone-3. The European Commission’s Scientific Committee on Consumer Safety (SCCS) was asked to assess its safety. Stakeholders submitted scientific evidence (during the call for data) aiming to demonstrate the safety of Benzophenone-3 as an UV filter in cosmetic products.

On its opinion, the SCCS concluded that the use of Benzophenone-3 up to a maximum concentration of 6% in sunscreen products (in the form of body cream, sunscreen propellant spray or pump spray) is not safe for the consumer. On the other hand, the use of this ingredient as a UV filter (up to 6%) is considered safe in face cream, hand cream and lipsticks. Moreover, the use of Benzophenone-3 to avoid formulation decay was also considered safe for the consumer at concentrations up to 0.5%.

The SCCS determined that a maximum concentration of 2.2% of Benzophenone-3 as a UV-filter can be considered safe in body creams, in propellant sprays and in pump sprays (provided that there is no additional use of this ingredient at 0.5% in the same cosmetic formulation to protect such formulation). In these types of sunscreen products, Benzophenone-3 is used at 0.5% to protect formulation. The concentration of this ingredient as an UV-filter should not exceed 1.7% in body creams, in propellant sprays and in pump sprays. (for more information, see previous post)

UPCOMING AMENDMENT TO COSMETICS REGULATION

On October 14th 2021, the European Commission has communicated to the WTO (World Trade Organization) a draft Regulation to introduce new use restrictions for two UV filters (Benzophenone-3 and Octocrylene).

Following the SCCS opinions, the European Commission states that “it can be concluded that there is a potential risk to human health arising from the use of Benzophenone-3 and Octocrylene as UV filters in cosmetic products in the concentrations currently allowed. Therefore, the use of Benzophenone-3 and Octocrylene should be restricted to the maximum concentrations proposed by the SCCS “. Regulation (EC) No 1223/2009 will be amended accordingly.

In sum, the current maximum concentration allowed for Benzophenone-3 will be lowered from 6% to 2.2% when used in body products (including propellant and pump spray products).

Reasonable periods of time will be granted to the industry in order to:

  • make the necessary adjustments to product formulations and comply with new requirements, and
  • withdraw cosmetic products which do not comply with those requirements.

The amendments to the Regulation will enter into force 20 days after its publication in the Official Journal of the European Union.

If you wish to get more information 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 Benzophenone-3 (CAS No 131-57-7, EC Nº 205-031-5). SCCS/1625/20. 2021.

further
reading

news & updates

EU Ecolabel adoption and recognition are on the rise

The Ecolabel certification is a comprehensive program focused on fostering sustainable practices. It evaluates products based on life cycle assessments, where every phase of said life cycle must abide by strict standards to attain the Ecolabel certification. The overarching objective of this certification is minimizing environmental harm from production or consumption activities.

Read More »
news & updates

SCCS preliminary opinion on Citral sensitization endpoint

Ingredients: CITRAL

Date of publication: 27/03/2024

On March 27 2024, the Scientific Committee on Consumer Safety (SCCS) published the Preliminary Opinion on the safety of Citral in cosmetic products. The deadline for comments is set to June 2, 2024.

Read More »
cosmetic products

UK proposes ban of wet wipes containing plastic 

The UK has proposed, on April 24, 2024, a regulation titled The Environmental Protection (Wet Wipes Containing Plastic) (England) Regulations 2024, to the World Trade Organization (WTO). The regulation aims to eliminate the supply and sale of plastic-containing wet wipes, including cosmetic ones. The public can offer comments on the draft until June 23, 2024, with adoption expected in September of the same year.

Read More »
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 »