Pharmaceutical and chemical micropollutants: standards to be met - or better yet - anticipated

After human consumption of pharmaceutical products, discharges from chemical and pharmaceutical production and/or packaging plants are the second-largest source of pharmaceutical micropollutants in the environment. This is why pharmaceutical manufacturers must comply with the today's standards, and use innovative solutions to take action ahead of new chemical and pharmaceutical micropollutant standards that will soon be introduced.

The presence of drug residues in wastewater effluents (salicylic acid in particular) was first identified in the USA during the 1970s, and subsequent advances in chemical analysis techniques soon made it possible to detect many more.

They are now referred to as micropollutants because, despite the fact that they occur in very low concentrations (nanograms per liter in some cases), their toxicity, persistence and bioaccumulation potential make them likely to impact negatively on the natural environment and living organisms, including humans. More than 110,000 micropollutants are listed in the relevant European regulations.

Since the 1990s, the issue has been addressed within a legislative and regulatory framework put in place to protect the healthy ecological status of aquatic environments. A set of standards governing pharmaceutical micropollutants has been developed by the European Union, and in France, these major directives are included in five-year micropollutant plans that set out clear rules for water quality monitoring. The third of these plans ended in 2021. At the end of the chain, prefectorial decrees specify the list of products targeted, together with their corresponding threshold values.

Anticipating new standards for pharmaceutical and chemical micropollutants

It is the responsibility of pharmaceutical and chemical manufacturers to comply with the current standards governing the discharge of pharmaceutical micropollutants in process water, and to act ahead of those that will be introduced in the future.

The ultimate purpose of these regulations is primarily to eradicate micropollutants from the environment, so it is only logical that the regulatory regime will continue to develop until such time as their use is entirely banned. For the companies concerned, this poses a major challenge, especially since the list of priority micropollutants changes regularly as scientific knowledge advances.

Many of these pharmaceutical micropollutants have yet to be identified as such, or have as yet undefined environmental impacts. This is the reason why current European legislation has tightened the obligation on companies to conduct environmental risk assessments. These assessments are the direct responsibility of the industrial companies concerned, and must be conducted well before a product is marketed. 

They form part of what is generally referred to as corporate environmental responsibility and accountability, which is a regulatory obligation on manufacturers that extends well beyond issues of corporate image.

Existing technical solutions

The best way forward is to set your own standards on the basis of your business activity and the toxicity of the substances you use. The standards should also address the characteristics of the natural environment into which discharges are made, because their impact on a minor river in a natural park will be very different from their impact on major rivers, such as the Rhône or Seine. The dilution effect and even local population pressure can differ greatly from one area to another.

To act effectively in advance to ensure full compliance with all these obligations, manufacturers can rely on the support of innovative solutions. That means taking action at the earliest stage of product development to apply solutions that exceed the current standards for pharmaceutical micropollutant control. It also means taking action in terms of detection by using integrated biomonitoring tools, and treating discharges accordingly. Leveraging innovation is an effective way of ensuring full compliance with European Commission guidelines and demonstrating the company's will to lead by example in terms of environmental effectiveness. 

To learn more about micropollutants, view our webinar on this issue.