The Use of Preservatives in Cosmetic Products
Preservatives are essential ingredients in cosmetic products. These ingredients prevent microbiological contamination of products and ensure that they remain safe during their use by consumers.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate

PRESERVATIVES IN COSMETIC PRODUCTS

The European Cosmetic Regulation ((EC) No 1223/2009) defines preservatives as substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product. In other words, a preservative is a natural or synthetic ingredient that is added to products to prevent them from spoiling.

For several decades, preservatives have been used safely in cosmetics. Preservatives are added to cosmetic and personal care products to reduce the risk of microbial contamination of the product and to ensure it remains suitable and safe during shelf-life and the period of its use by consumers. Without preservative ingredients, a cosmetic product would likely pose a risk to the consumer, have a very limited shelf life and would easily spoil. Microbiological contamination of products, especially those used around the eyes and on the skin, can cause irritation or infections.

There are several types of preservatives and they differ widely on their ability to preserve a cosmetic product. Only preservatives that undergo rigorous evaluation (including safety assessments and quality testing) and are considered safe are allowed for use in cosmetics.

But how do you select which preservative to use? The main goal is to use a minimum concentration to obtain optimal efficacy, while avoiding any safety issues associated with a particular preservative. The type of product, its intended use and application sites, consumer needs, type of packaging, water concentration, and interaction with other ingredients are some factors that need to be taken into account.

Cosmetic products placed on the European Union (EU) market may only contain preservatives that are listed in Annex V (list of preservatives allowed in cosmetic products) of the Regulation (EC) No 1223/2009 on cosmetic products, subject to conditions (e.g., concentration limits). Furthermore, according to this Regulation, cosmetic products must undergo a preservation challenge test.

Parabens, phenoxyethanol, chlorphenesin, triclosan, methylisothiazolinone and methylchloroisothiazolinone, DMDM hydantoin and benzoic acid are some of the most commonly used preservatives in cosmetic products.

If you wish to get more information on this or other subject, 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.

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 »