When is it justified to use very hazardous chemicals?

Introduction

Over the past months, several of us at ChemSec have participated in different panel debates and workshops on the essential use concept. Examples described as “essential” in those debates range from “world peace” to stain repellent treatments for sofas. While we definitely welcome this new element in chemicals regulation, we see a need to focus the debate.

Let’s do an experiment. Ask yourself, or anyone around you: What is essential? You will probably find yourself lost in an interesting, but seemingly never-ending, discussion.

Instead, ask: Which products are so essential that they need to be used even if they contain chemicals that may harm human health or the environment? You will most likely get a very different reply.

Obviously, asking the right questions is key to focusing the debate. We have more ideas on how to do this, which we will return to, but first a small recap of how it all started.

Can the formula that saved the ozone layer be successful again?

The essential use concept is by no means new. The best example can be found in the international agreement on ozone depleting compounds from 1987: the Montreal Protocol. This agreement limits the use of ozone depleting compounds to essential uses only, and for those of us who grew up seeing the ozone hole as the main threat to our future, it looks like the concept has been a success.

Since the 2015 Madrid Statement, where scientists emphasized the urgency to phase out the group of PFAS chemicals, there have been several scientific publications proposing to introduce an essential use concept in chemicals policy.

In 2019, the European Council of Ministers called on the Commission to develop an action plan to eliminate all non-essential uses of PFAS. This was later stated in the proposed restriction of all PFAS, currently being developed by five member states jointly.

However, the real “break-through” of the essential use concept came with the publication of the chemical strategy, in the autumn of 2020. The strategy made clear that “essential use” will play an important role in chemicals regulation to “ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives available from the standpoint of environment and health”.

Now, it was no longer only about the PFAS chemicals, but all the “most harmful chemicals”. According to the timed list of actions, criteria for essential use should be defined by 2022.

Shouldn’t REACH have fixed this already?

There are mechanisms in place in the REACH restriction and authorization processes, meant to strictly limit the use of the most hazardous chemicals. This is done by taking both availability of alternatives and socioeconomic considerations into account. Authorization should only be given if there are no alternatives available, and if the socioeconomic benefits outweigh the risk.

However, the Commission has been repeatedly accused – by us and others – of favoring the company applying to use the hazardous chemical, while disfavoring alternative producers as well as human health and the environment in their decisions. The perspective of producers of alternatives have not been acknowledged, and the financial implications for the applicant have been favored over harm to human health and the environment.

Even the EU Court of Justice have ruled against the Commission, in cases that were brought to court for obviously overstepping the aims and mandate of REACH.

One current example is the case of using cancer causing lead chromates in paints for road markings. In several member states, these substances have been phased-out and alternatives have been successfully used for many years. Still, the Commission allowed continued use.

Another example considers chromium six, used to dye wool. Also in this case, alternatives have been used by many companies for a long time. Still, the expert committee did not dare to challenge the applicant’s arguments regarding aesthetic and quality aspects of the alternatives, and proposed continued use.

In addition, the processes have been lengthy and resource intensive, without being able to provide what public authorities need to make legitimate and coherent decisions. Not much return of investment, considering the vast spending of public resources.

There is a need to limit the use of the most hazardous chemicals more efficiently than has been done so far in REACH. Two aspects are key to efficiency:

1. Decide in favor of protecting human health and the environment over financial implications for industry

It should go without saying, but looking back, this is not how it has worked out. Masking profits for industry as “job opportunities” cannot be valid when it comes to the most hazardous substances. Substances of concern need to be phased out more efficiently – regardless of economic implications. The essential use concept can differentiate when we should accept substances of high concern in products and processes, and when we should not.

2. Limit the cases being brought up in expert committees

Make the process more efficient by pre-defining categories as non-essential, thereby limiting the number of cases needing to be discussed in expert committees.

So what could the essential use determination process look like?

We recommend the use of a step-wise approach, based on a number of questions. The purpose of these questions is create a gateway, allowing only the cases that may actually qualify as essential use to pass through.

We propose that the Commission apply this approach and make lists of products or uses regarded and disregarded as essential throughout the step-wise approach, to facilitate for both companies and policymakers.

1. Is the product or process in question used for…?

• Luxury
• Convenience
• Decoration or purely aesthetic purposes
• Leisure
• Play/toys
• Cosmetics
• Home gardening

If the answer is yes, the use is regarded as non-essential. The product or use does not fulfill any basic human need, nor is it essential for the functioning of our society.

If the answer is no, continue to question 2:

2. Is the product or process in question used for…?

• Hygiene
• Cleaning
• Personal care
• Childcare
• Textiles (excluding personal protective equipment)
• Clothes, apparel and shoes
• Furniture
• Food contact material
• Sport products
• Etc.

If the answer is yes, it’s regarded as non-essential use. The function these products fulfills – for example hygiene – might be essential. However, these categories represent products that are ubiquitous in our everyday life, and where the presence of high concern chemicals is unwanted.

One of the aims with the essential use concept is to ensure that consumer products don’t contain harmful chemicals. Moreover, there are products without substances of concern within all these categories on the market. Therefore, there is no need to allow the use of substances of concern in these products.

If the answer is no, continue to question 3:

3. Does the product or process belong to any of the categories listed below, or a very similar category?

• Medical devices
• Medicinal products
• Products for military operations
• Energy production and storage
• Transportation
• Communication
• Etc.

If the answer is yes, the product or process might be regarded as essential. Move on to question 4.

If the answer is no, it’s regarded as non-essential use.

4. Is the product or process itself essential for the overall functioning of society?
   Note that not all products within essential use categories (see question 3) are essential. For example, not all products within the medical device category are essential to fulfill the core service of this category. These uses are not regarded as essential.

If the answer is yes, move on to question 5.

If the answer is no, it’s regarded as non-essential use.

5. Are there alternative chemicals or other ways to achieve a similar end function at product level?
   Note that the alternative does not need to be equally performing, nor does the cost for the applicant have to be equal, as long as the end function on product level fulfills the essential function.

If the answer is yes, it’s regarded as non-essential use.

If the answer is no, the case moves to an expert committee.

An expert committee is now to look at the case, evaluate it, and conclude if the product is essential to society or not. If the use is regarded as essential and the substance falls under REACH, companies producing or importing an essential product with an SVHC (Substance of Very High Concern) should send in an application for authorization and the “normal” authorization process should follow.

All expert committees need to ensure that the continued use is as limited as possible in terms of applications, volumes, and time applied for by the applicant.

Along with this structured approach, we also want to send you off with a number of Dos and Don’ts, to keep it all on track:

Dos and Don´ts