PFAS – Unsafe ‘Forever Chemicals’ used in Cosmetic Products
PFAS, also called ‘forever chemicals’, are widely used around the globe in everyday consumer products, like non-stick cookware, food packaging, cosmetics and clothes. Nevertheless, these chemicals are potentially harmful for health and the ecosystem. Recent studies estimated that more than 50% of the cosmetics sold in the US and Canada might contain PFAS.

WHAT ARE PFAS?

PFAS stands for per- and polyfluoroalkyl substances and are a man-made group of chemicals. There are more than 4,700 different PFAS. These chemicals are manufactured and used in a wide variety of industries all over the world. PFAS can be found in food packaging, commercial household products (e.g., nonstick products like Teflon, polishes, waxes, paints, etc.) and drinking water (typically located and associated with a specific facility). PFAS can even be present in living organisms, like fish, animals and humans, in which these compounds have the ability to build up and persist over time.

People can be exposed to PFAS through food, which was contaminated through soil, food packaging or equipment. People can also be exposed if these chemicals are released during normal use, biodegradations, or disposal of consumer products that contain PFAS. Occupational exposure is also possible.

PFOA (perfluorooctanoic acid) and PFOS (perfluorooctane sulfonic acid) are the most studied substances among the PFAS family. GenX and PFBS (perfluorobutane sulfonic acid) also fall in the PFAS chemicals category. PFBS has been used to replace PFOS. GenX is a trade name for a technology that is used to make high performance fluoropolymers without using PFOA.

PFOA and PFOS can cause reproductive, developmental, liver, kidney and immunological effects in laboratory animals, and both are known to cause tumors in animals. As PFAS can accumulate in the human body (and stay for long periods of time), the level of these chemicals may increase to the point where it produces adverse health effects. Epidemiologic studies have shown that PFAS elicited increased cholesterols levels among exposed populations, among other findings related with infant birth weight, effects on the immune system, cancer (PFOA) and thyroid hormone disruption (PFOS). PFBS orally administered to animals produced thyroid hormone disruption effects (pathway particularly sensitive to PFBS) and affected reproductive organs and fetal development, for example.

People exposed to high levels of PFAS and vulnerable population groups (children and elderly) are most at risk of adverse health impacts.

STUDY ON PFAS PRESENT IN COSMETICS IN NORTH AMERICA

PFAS are added to cosmetic to increase their durability and water resistance, since they possess properties like hydrophobicity and a film-forming ability. It is estimated that more than 50% of the cosmetics sold in the U.S and Canada might contain PFAS. The presence of PFAS chemicals in cosmetics “may pose a risk to human health through direct and indirect exposure, as well as a risk to ecosystem health throughout the lifecycle of these products”.

A recent study conducted by researchers from the University of Notre Dame tested 231 cosmetic products, mainly mascaras and lipsticks, that are commonly used on a daily basis. The researchers found that 63% of foundations, 55% of lip products (62% of liquid lipsticks) and 47% of mascaras contained fluorine (which is an indicator of PFAS). Foundations produced the highest median total fluorine. Cosmetic products which commonly claim to be “long-lasting” or “water-resistant” (e.g. foundations, liquid lipsticks, water-proof mascaras) were found to have higher fluorine levels.

Out of the 231 products analyzed, only 8% had PFAS on the list of ingredients, exposing a gap in U.S. and Canadian labelling laws. Researchers state that “better labelling and government oversight of harmful chemicals in personal care products are needed”.

U.S. NEW BILL

Although PFOA and PFOS have been voluntarily phased out by industry (especially in the U.S.), they are still persistent in the environment.

June this year, U.S. Senators (Susan Collins and Richard Blumenthal) have introduced the bill No PFAS in Cosmetics Act, which bans the use of PFAS (intentionally added) substances in cosmetic. This Bill directs the Food and Drug Administration (FDA) to issue a proposed rule to ban the intentional addition of PFAS in this type of products. The No PFAS in Cosmetic Act states: “Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a proposed rule to ban the use of intentionally added perfluoroalkyl and polyfluoroalkyl substances in cosmetics. Not later than 90 days after issuing the proposed rule, the Secretary shall finalize such rule”.

PFAS IN EUROPE

The European Food Safety Authority (EFSA) has evaluated the toxicity of PFAS and established a new safety threshold for the main chemicals of this group. The tolerable weekly intake (TWI) was set at 4.4 nanograms per kilogram of body weight per week. The Panel concluded that “parts of the European population exceed this TWI, which is of concern”.

EFSA considers that toddlers and other children are the most exposed population groups and that exposure during pregnancy and breastfeeding is the main contributor to PFAS levels in this population.

Some PFAS bring benefits to the society, like those used in medical devices and personal protective equipment for workers. The European Commission considers that the “concept of essential uses – which has been proposed to be applied to PFAS – would help identify uses critical for society and allow them only if suitable alternatives are not available”.

The Regulation (EC) No. 1223/2009 on cosmetic products is going to be revised by the European Commission until the end of 2022. Actions on certain ingredients, including PFAS, are expected. According to EU regulation, there are several PFAS (such as PFOA) that are prohibited in cosmetic products (included in Annex II).

If you wish to know more about PFAS regulation, manufacturing alternatives and its implication in human health, do not hesitate to contact us at info@criticalcatalyst.com.

References:

  1. Whitehead H, Venier M, Wu Y, Eastman E, Urbanik S, Diamond M, Shalin A, Schwartz-Narbonne H, Bruton T, Blum A, Wang Z, Green M, Tighe M, Wilkinson J, McGuinness S, Peaslee G. Fluorinated Compounds in North American Cosmetics. 2021. Published by American Chemical Society.
  2. No PFAS in Cosmetics Act. Senate of the United States. 117th Congress, 1st Session. Available from: https://www.collins.senate.gov/sites/default/files/No%20PFAS%20in%20Cosmetics%20Act_0.pdf
  3. Risk to human health related to the presence of perfluoroalkyl substances in food. European Food Safety Authority Panel on Contaminants in the Food Chain (EFSA CONTAM Panel). Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6223
  4. Commission Staff Working Document – Poly and perfluoroalkyl substances (PFAS). 2020. European Commission. Available from: https://ec.europa.eu/environment/pdf/chemicals/2020/10/SWD_PFAS.pdf

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 »