Medical and pharmaceutical products use a variety of raw materials such as rubber, palm oil and wood. These can be found, for example, in cellulose for absorbent pads or latex gloves. The problem is that these commodities are often cultivated in deforested areas, which poses a threat to the environment and living creatures. 

The increasing deforestation and its negative impact on our environment is no longer a secret. Currently, the raw materials for everyday products are often grown in deforested areas, which means that a forest or forest-like area has been transformed into a field, for example. This poses a threat to the habitat of various animal and plant species and some groups of people, as well as to biodiversity in general.      

The EU Deforestation Regulation (EUDR) aims to counteract this trend. Companies that work with, trade or process certain products must provide evidence of the areas from which the resources originate. This regulation applies to trade in the following products and many of their derivatives: coffee, cocoa, cattle, rubber, timber, soy, and palm oil. This article provides an insight into why the regulation may also affect medical and pharmaceutical companies. 

EUDR Affected Medical Products    

There are two aspects to bear in mind when taking a closer look at EUDR regulation. Firstly, not only the seven raw materials mentioned are subject to EU regulation, but also certain, but not all, derived products. A detailed list of the affected products can be found in Annex I of the EUDR regulation. The second aspect is whether the manufacturing companies are subject to regulation based on a certain company size and a certain turnover in the European market. An overview of which companies must comply with the EUDR can be found on the osapiens HUB for EUDR product page.    

Subject to EUDR: Latex gloves, absorbent pads and surgical supplies

Latex gloves and absorbent pads are among the most commonly used products in the medical sector. As they are generally made of natural rubber or cellulose (wood), they are subject to the EUDR. The same applies to some disposable surgical products, such as surgical gowns, hoods and masks, which are also made of cellulose. The company that trades, manufactures, imports or exports these products is highly likely to be covered by the EU Regulation.

Which products could additionally be affected  

Although the EUDR affects all seven commodities mentioned above, it does not necessarily affect every product that contains these materials or every company that uses or purchases these products. This depends, for example, on whether the product is traded or “consumed”, such as printer paper in the office or soap in the staff toilet. Nevertheless, it makes sense to take a look at the products in which the resources were used in order to clarify the second step: Is my company subject to the EUDR for this product?  

Natural rubber in medical applications    

Of all the raw materials covered by the EUDR, rubber is probably the one that can be found in most medical and pharmaceutical products. It is a versatile material that can occur, for example, in the above-mentioned latex gloves, catheters and medical balloons. It can also be used in tubes for infusions or artificial respirators or for blood collection, in plasters or even in rubber membranes for artificial hearts. Natural rubber can also be contained in some hospital bed mattresses or in the tires of wheelchairs, for example. The versatile use and increasing demand for rubber may lead to further deforestation and conversion of forest areas into rubber plantations.   

Silicone is often used as an alternative to natural rubber in products. These products are therefore not affected by the EUDR.  

Palm oil in health care    

Palm oil is one of the main drivers of global deforestation. The fact that palm oil is used in some hazelnut spreads, for example, is now widely known. However, this commodity can also be found in some products in the healthcare sector, for example in glycerin-based medicines made from palm oil or in wound dressings and plasters. Palm oil can also be used in hand sanitizers or in soaps, shampoos, ointments, or creams. Especially in this case, it is important to distinguish whether the products in question are traded (in which case they are subject to the EUDR) or whether they are neither processed nor traded (in which case they are not subject to the EUDR).   

Wood in Medical and Pharmaceutical Products    

It is obvious that wood as a product can be problematic when it comes to deforestation-free supply chains. In the healthcare sector, wood products and processed wood can be found in various places, for example in tongue depressors or swabs, as well as in incontinence pads made from cellulose. In the case of wooden furniture or bed frames, the first step is also to clarify the regulation: Does the company manufacture the furniture and sell it on (potentially subject to EUDR) or does the company buy the furniture for its own use (not subject to EUDR)?   

Soy, cattle and coffee in healthcare    

The ingredients soy, coffee and cattle are also included in the EUDR-relevant products, although not all downstream products of these commodities are subject to EU regulation on deforestation-free supply chains. Neither tofu nor soy milk or soy yoghurt are affected by the EUDR. These products, as well as coffee and meat, are less commonly found in pharmaceutical products. Some medicines are made with bovine gelatine, but here again it is important to check: Is the company trading the medicines in any way (subject to the EUDR) or not?  

With the implementation of the EUDR, companies that trade in one of these commodities or derived products made from them must prove that the resource comes from a deforested area.  

Properly Preparing for the EUDR    

One of the biggest challenges of the EUDR is the complexity and the large amount of data required for implementation. To cope with this, affected companies need to rethink their methods of obtaining, processing, analyzing and managing data. A software solution that digitizes and automates these processes is essential for timely and easy regulatory compliance: osapiens HUB for EUDR.  

This holistic software solution maps all relevant aspects of EUDR and ensures efficient and, above all, legally compliant compliance. The Software-as-a-Service (SaaS) solution platform from osapiens, the osapiens HUB, is ideally suited for this purpose. It offers a platform on which solutions for due diligence regulations such as the German Supply Chain Due Diligence Act (LkSG) and the EUDR are integrated. Aspects along the entire supply chain are included and all stakeholders are taken into account. Many years of experience and practical testing of the solution in a wide range of companies and industries guarantee efficient and legally compliant implementation of the regulation on deforestation-free supply chains in the corporate strategy.     

Legally compliant implementation    

Compliance is a key issue in the implementation of a regulation. Therefore, osapiens works closely with the German legal company Graf von Westphalen. The lawyers specialize in the regulatory aspects of sustainability reporting to ensure maximum legal security.     

Another key factor is the compatibility of the software with the IT systems provided by the EU, such as the Information System (IS), which contains all due diligence declarations, or the EU’s Single Window environment, which is used for the real-time exchange of customs information, among other things.    

All in one software platform: the osapiens HUB    

The osapiens HUB provides companies with support for the implementation of various ESG regulations, such as the EUDR, as well as data management and analysis on a single platform. This offers several advantages, as data is managed centrally, and companies can see all relevant aspects at a glance. As a result, the requirements of ESG regulations can be met and implemented quickly and easily – an important step towards sustainable business practices.