Dr. Sharon McGuinness is the Executive Director of the European Chemicals Agency (ECHA) in Helsinki, Finland. A chemist and pharmacologist by training, she talks with Dr. Vera Köster from ChemistryViews at the Helsinki Chemicals Forum (HCF) about ECHA’s new roles and challenges, how collaboration is one of the Agency’s keys to success, and what role scientists from academia could play in European chemicals regulation.
If you had to describe ECHA in three words, what would they be?
It’s scientific, knowledgeable, and collaborative.
What do you like particularly about your job?
I have had a career in different regulations, and obviously started my career in chemicals, so it’s lovely to come to an organisation that is dedicated to the topic, but equally has really dedicated and committed individuals. It is allowing us to focus on the delivery of a single goal around the protection of health and the environment.
And that you are part of a European network, as well as part of a wider network, and hopefully through our work contributing to a better world.
What has changed since ECHA was founded in 2007?
We had our first task 17 years ago with REACH. The task there was to introduce and implement the REACH regulation. But, almost immediately, we were given lots of other tasks as an agency and as an organisation. I often think it’s a good sign when you get more things to do because you’re obviously doing something well, and people want you to do more of it.
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The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation is the main European Union (EU) law governing chemical substances. It aims to improve protection of human health and the environment through better identification of hazardous chemical properties, risk assessment, and control or phase-out of the most hazardous substances across the EU. Manufacturers and importers must register chemicals over 1 tonne per year with the European Chemicals Agency (ECHA), where substances are evaluated. ECHA identifies substances of very high concern for authorisation. Restrictions can be imposed on substances posing unacceptable risks, and information must be communicated throughout the supply chain. |
Over the next ten years, we got several new regulations such as the CLP regulation in 2008, the Biocidal Products Regulation in 2013, the Prior Informed Consent Regulations, which governs the trade of certain hazardous chemicals that are banned or severely restricted in the EU, and we’ve got lots of other additional work to support and implement.
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The CLP Regulation (Classification, Labelling and Packaging) is an EU regulation that standardises the classification and labelling of chemicals to ensure their safe use. It aligns the EU system with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). CLP requires manufacturers, importers, and downstream users to classify, label, and package substances and mixtures according to defined hazard criteria. It aims to enhance the protection of human health and the environment by providing clear and consistent information on the hazards of chemicals. |
The pace has changed really since 2017. We got about seven new legislations in the first ten years, and we got about six new legislations in the last six years. So on that basis, who knows what’ll happen in the next few years. We are expecting to get a lot more new legislation.
By 2023, the focus had expanded to areas like drinking water, cross-border health threats, and environmental action programs. Although, the agency’s focus has shifted we maintain our focus on scientific knowledge and risk assessment.
We are indeed shifting our focus from analysing individual chemicals and chemical groups to a more holistic, product-based approach. Instead of starting with a specific chemical and assessing its impact, we are now beginning with broader product families and working backwards to understand the chemical implications. This evolution allows a more integrated and comprehensive evaluation, reflecting an important shift in methodology and future direction. I think that’s an interesting change for us as an agency.
Moving onward, we will be driven by the Chemicals Strategy for Sustainability, the key pillar for delivering the European Green Deal’s commitment to zero-pollution, aiming for a “one substance, one assessment” approach to enhance cooperation and data reuse across EU agencies. New tasks include legislation on industrial emissions, end-of-life vehicles, hazardous substances, water frameworks, toy safety, persistent organic pollutants, medical devices, packaging waste, and the EU Common Data Platform for Chemicals.
So, do you think this is a good development?
I think it is a positive development, not only for the Agency, but I think for the overall chemicals framework. We are now bringing many of the same approaches together in a single agency where we can work synergistically and collectively to better meet the requirements of each piece of legislation.
How big has ECHA become?
It started in 2007 with 100 staff. We’re 600 now, more or less. So, it’s moving and obviously depending on the tasks, we may get additional resources.
600 is a large organisation. I suspect in many organisations, as in my own previous organisations, you might only have a few specialists in places; therefore, the fun of working with people like yourself in a wider area, getting to talk, getting to discuss with peers and colleagues is a really positive part of the Agency as well for me personally.
But maybe it’s also a challenge because you have to make sure that everyone is communicating in some way so that, as you said at the beginning, you have a good foundation on which to build other, new things.
It does. One of the opportunities is because we are used to change, so even though we had REACH, we had certain tasks and then we had more, so we’ve always been changing. So, in some sense it’s in our DNA. On the other hand, of course, we have to make sure that everybody is informed and engaged.
You saw the new ECHA strategy, the communication, the gauge, that’s as important internally as it is externally. We’ve often said that for some of these areas, for example, somebody who’s dealing with drinking water wants to see ECHA responding fully to drinking water. They don’t care if we’re doing REACH and everything else. So, it’s important for us to be able to show that drinking water is important in its own right, we’re delivering it to the fullest extent and REACH is being delivered to the fullest extent.
So, it does get complicated, but we have a lot of good networks. As I said, the underlying drive and the ability to interact and collaborate and communicate is already there. So, it’s a bit easier, I think, than if you were starting from scratch.
What about cooperation with other organisations?
We are part of the larger EU Agencies Network (EUAN), but we are also closely working, not just because of legislation, although that’s one of the drivers, with partners in the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), the European Center for Disease Control (ECDC), and the European Environment Agency (EEA). We regularly meet. That can be at a high level, at my own level, or it can be with colleagues on a day-to-day basis where we’re dealing with particular issues where there is an overlap.
Some of the legislation, for example on serious cross-border health threats, we are all involved in some way, so more and more some of the newer legislation will bring us into areas where we need to work with these agencies. Just on the one substance, one assessment proposal, there is more and more of a drive for us to cooperate and collaborate and also try to come to agreements so that we don’t end up with different decisions or views or opinions. So, the focus is very much on that interaction, as exemplified in our recent joint declaration on One Health.
And internationally? Is there also an idea to streamline things and harmonise things?
The OECD (Organisation for Economic Co-operation and Development) is obviously a place where we are very active, and we support the [European] Commission because we don’t have our own international program or plan. It’s done in conjunction with the Commission or in support of the Commission.
So, for example, in the OECD, we are involved in a lot of different places, including talking about the formats in which data are going to be used worldwide, talking about the differences in terms of test methods, so that a carcinogen in Europe is going to be tested the same as a carcinogen in Asia and wherever else. So this work is ongoing and it’s very much part and parcel of our own efforts.
We work with international partners such as the US Environmental Protection Agency (EPA), the Australian Industrial Chemicals Introduction Scheme (AICIS), the Environment and Climate Change Canada, the Chemical Management Policy Division in Japan in different areas. We have agreements, and we also work with them more on the science or the methodology or the thinking around risk assessment. So, there are many different parts to that.
Then one of the other tasks was around the instrument for pre-accession countries. We have an agreement with the Commission to support countries that are on the path to EU membership. At the moment, for example, we host visits or we support the Commission on capacity building and understanding. Another element is that we support the Commission in relation to pilot projects on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) in Africa. So, we have lots of different parts of this.
Figure 1. The new ECHA building in Helsinki, Finland. (© ECHA)
Are researchers in academia a group you also interact with, or is it mainly people in industry?
Industry is obviously a duty holder. It is an interested party, but it equally has to deliver to us, so clearly they are there.
We do interact with academics in different places, and that could be through the partnership for chemical risk assessment (PARC), which is bringing regulators and academics together. I think more and more as we look at different scientific topics, we start to see not just Member State regulators involved in the science and the thinking, but also more and more academics. So, it’s an area I suspect will be increasing.
The anticipation is that we have to bring academic information into the new common database, but to do that we have to make sure they know what we’re doing. So, with the new science goal of our strategy, that’s part of the desire to reach out and make them aware of the interests that we have.
We published a report last year on key areas of regulatory challenge. That, basically, was identifying types of hazards, types of chemistry, types of issues that we see research is needed on. So, again, we’re starting to reach out, and hopefully they can support us in the future as well. I think one of the areas for the future is what are the challenges around certain types of chemicals?
In the past, adding academic research data to the ECHA database has been challenging due to differences in data quality and reporting standards. Do you think that will change in the future, perhaps with the help of AI?
The new common data platform will allow academic data to come in. There is a lot of innovative and interesting scientific research ongoing, and we need more dedicated research in the areas that will help protecting our health and environment with the regulations in place today. We also need research to develop future chemicals regulations.
However, with all the different assessments, it can be a challenge when you have an academic study to be able to translate that into regulatory criteria. The academic study has been developed in a way that answers a good academic research question, but maybe the data that we need in regulation is missing, regulators often need something supplementary or tailor-made to use the research results for legal frameworks.
To pinpoint exactly this is the problem, and to inform and inspire the research community, we have identified scientific research needs and outlined them in the report “Key Areas of Regulatory Challenge”. This report not only lists topics for further research, but also highlights why these topics are of regulatory importance. So, we are trying to bridge that gap between academic research and regulatory science.
In addition, REACH decisions often involve public consultations, during which academics can provide input and feedback on proposed regulatory actions. Their comments and critiques can help shape the outcomes of REACH evaluations.
Can you give a few examples for key areas from the report?
ECHA has identified a number of priority areas for research to improve the regulatory relevance of scientific data. These include hazard identification for effects for which specific testing is lacking, such as neurotoxicity, immunotoxicity, and endocrine disruption; chemical pollution in the environment, including bioaccumulation, impacts on biodiversity, and exposure assessment; reducing animal testing through the use of alternative methods and supporting mechanistic toxicology studies; and gathering new information on chemicals, including polymers, nanomaterials, and analytical methods to support enforcement.
So last, but not least, a personal question: You are originally from Dublin and now living in Helsinki. What do you especially like about Helsinki or maybe miss about Dublin?
I like Helsinki and call it “my adopted city”. I started coming here in 2007, so it has certainly changed a lot in that time. I enjoy my work and I love what I do. I shouldn’t say this out loud, but I do. Working with all the people that I work with, it’s really pleasant.
I miss my family and friends of course, but Dublin is not that far away and there are lots of ways to keep connected. Some of my family is here, so I have a good balance because it’s not all work for me. I am reliving my youth in Helsinki a bit, going to the movies and concerts more than I used to.
Thank you very much for the interview and the insight into ECHA’s work.
Sharon McGuinness studied pharmacology and chemistry at University College Dublin, Ireland, and received her Ph.D. in pharmacology from the same university in 1990. She received a Diploma in Law from the Dublin Institute of Technology in 1995 and a Diploma in Company Direction from the Institute of Directors in 2016. Following a post-doctoral fellowship at the University of Arizona, Tucson, USA, she was a lecturer at the Royal College of Surgeons, Dublin, in 1993-94, worked at the European Chemicals Bureau in Ispra, Italy, until 1997, moved to the private sector with HP Inc., where she worked until 2006, and spent almost 17 years with the Irish Health and Safety Authority. She was also President of the Irish Society of Toxicology from 2010 to 2012 and the Irish representative on the ECHA Management Board from 2014 to 2021, serving as Chair from 2016 to 2020.
In June 2022, Sharon McGuinness was selected for the position of Executive Director of ECHA, succeeding previous Executive Director Bjorn Hansen, and took office in December 2022.
- European Chemicals Agency (ECHA), Helsinki, Finland
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