Position on Impact ofPharmaceuticals andPersonal Care Products in theEnvironment

Background
Pharmaceuticals and personal care products (PCPs) can enter the environment throughseveral different pathways. The source of most active pharmaceutical ingredients (APIs)
detected in aquatic ecosystems is normal patient and consumer use and excretion following
the use of medicines that are taken to address medical conditions, 1 while PCP ingredientscan enter the environment from washing off products from the body during cleansing
activities.1
As a leading global consumer health company, we recognize that human health andenvironmental health are inextricably linked. Our goal is to help people take care ofthemselves and their loved ones everyday while also protecting the planet. To do this, wetake proactive steps to assess and address pharmaceuticals and personal care products inthe environment as part of our ambition to create products that support the health and wellbeing of both people and our planet.
Our Approach
We are committed to the proactive risk assessment of our APIs and personal careingredients that may enter aquatic and terrestrial ecosystems. We do this by:•Conducting environmental risk assessments (ERAs) on APIs and ingredientsused in our products to understand any possible impacts in the environment
ERAs can range from exposure assessments and screening for characteristics ofpersistence, bioaccumulation and toxicity (PBT) for low-volume products2 to more
extensive risk assessments that determine predicted no-effect concentrations(PNECs) based on environmental toxicology tests.

1
2

Environmental Safety Aspects of Personal Care Products, https://doi.org/10.1897/09-104.1
Products that result in a predicted surface water concentration of less than 0.01 µg/L

Position on Impact of Pharmaceuticals and Personal Care Products in the Environment•Advancing the science of assessing the environmental impacts of personalcare products
For our personal care products that are susceptible to entering the environment, there
is no regulatory-mandated or established and standardized industry ERA
methodology. Therefore, we developed and patented, a science-based method toassess the potential aquatic impacts of formulations under development. Thismethod, referred to as Global Aquatic Ingredient Assessment ToolTM (GAIA), helps
ensure that our products meet our product stewardship standards designed tominimize environmental impacts. Using GAIA, ingredients are scored on a 100-point
scale using available data on inherent PBT and other environmental safety properties.
A higher score indicates more favorable environmental safety characteristics. Whenpublished data are not available, we use modeled data and reduce GAIA scores toaccount for uncertainty. More information regarding our GAIA approach can be foundat Kenvue.com. Our GAIA method to evaluating ingredients has also been publishedin a peer-reviewed journal.3

We are committed to controlling the concentrations of active pharmaceuticalingredients that may enter the environment from our manufacturing plants.
At our manufacturing plants handling active pharmaceutical ingredients, we monitor ourwastewater using a variety of methods (e.g., analytical testing, mass balance calculations andwhole effluent testing). We provide secondary wastewater treatment, at a minimum, for ourmanufacturing plants, and treatment may also include advanced technologies that target
removal of APIs from wastewater
We are committed to collaborating with suppliers and educating patients andconsumers to help mitigate concentrations of active pharmaceutical ingredients in theenvironment.
As outlined in our Responsibility Standards for Suppliers, suppliers to Kenvue are expected tooperate in a sustainable and environmentally responsible manner, including continuallyworking to reduce the environmental impacts of their operations and implementing programs
to manage wastewater that ensure compliance and mitigate impacts to the environment. We
verify supplier environmental performance through a comprehensive approach including: onsite audits conducted by Kenvue environmental professionals; supplier scans through
EcoVadis, a sustainability ratings firm that evaluates companies’ environmental and social
responsibility; and through membership in the Pharmaceutical Supply Chain Initiative, whichsets common standards for responsible supply chain practices.
We educate patients and consumers on how to locate disposal options and instruct them onproper disposal methods to limit environmental impact. We do this through several outreachefforts including participation in the MyOldMeds initiative in the United States andMEDSDISPOSAL in the EU. We are also a member of the Pharmaceutical Product3Reducing the environmental risks of formulated personal care products using an end-of-life scoring and ranking system for
ingredients: Method and case studies, https://doi.org/10.1016/j.jclepro.2018.01.140

Position on Impact of Pharmaceuticals and Personal Care Products in the Environment

Stewardship Working Group, which is the largest extended producer responsibility (EPR)
organization in the United States dedicated to the proper collection and disposal of unused
and/or expired medicines as well as used sharps.
We believe in the power of partnerships to accelerate the advancement of science. We
demonstrate this belief by proactively collaborating with other commercial partners.
We often partner with our peers in the pharmaceutical and personal care products industries
to drive progress on these issues. For example, we are contributing to the European-basedInter Associations Initiative Pharmaceuticals in the Environment Task Force, which createdthe Eco-Pharmaco-Stewardship framework to address pharmaceuticals in the environment(PiE). This includes an approach to extended environmental risk assessments forpharmaceuticals. For more information on this effort, visit the Association of the EuropeanSelf-Care Industry (AESGP) website4.
Last Updated: April 20234

https://aesgp.eu/eco-pharmaco-stewardship