Food Regulatory SIG Chair Mel Bulger interviewed Ruth Birt about her career in Food Regulatory Affairs.
How did you start your career in the food industry and what motivated you to join?
I was good at maths and science at school but when I had to complete forms for university, I really had no idea what I wanted to do. My school encouraged studying medicine, accountancy or law so I was considering accountancy, but a new, dynamic chemistry teacher encouraged a few of us to visit the Food Science Department at the University of Strathclyde Open Day. I went along and I was so taken by the taste and texture of cucumber and banana polystyrene-like pieces (the early development stage of freeze-drying), and the possibilities with different technologies, I was hooked. I decided to study Food Science. My time at university made me realise that I was a little heavy handed in the labs., so I was unsure about a lab-based role in the industry. As jobs were tricky to secure in Scotland at the time, I then took a business diploma, specialising in Operations Management, to broaden my potential for a job. I was called for interview by a food company in Liverpool that had a brewing business and a nutrition business. I was not quite sure exactly what the job would entail, but I knew it was not lab-based, and I needed a job, so I was up for the challenge.
How did you decide on regulatory affairs?
I did not really choose Regulatory Affairs (RA), it found me. My first job title was Information Officer in the nutritional business which specialised in medical foods. When I arrived, several of the senior personnel then seemed to pass me little bits of their ‘paper-based’ tasks that I think they thought were ‘information’. My role and responsibilities developed from there, especially because I was keen to learn. Digesting all the legislative requirements for the registration, supply and reimbursement of the foods in different markets across the world became a key part of my role, as well as supporting the product development staff with advice on permitted ingredients and additive levels, while supporting Research and Development (R & D) and Marketing with searching for research and clinical papers (online access only came years later!). Label development, the co-ordination of the label review across different disciplines and liaison with the external printers seemed to fall on my lap too. As some products for rare disorders go to only a few patients in the country, we even did our own in-house label generation (on a dot matrix printer) for some products. Having a role in a small but growing business offered me fantastic experience. After 15 years in Liverpool, having reached the level of Regulatory Affairs Manager, I returned to Glasgow and then set up my own Regulatory Affairs consultancy.
Would you choose to go into the same field again?
Absolutely! I would not change my career path at all. I moved up the management ladder in the 15 years I spent in this first company, which had expanded and grown, allowing me to gain experience in a raft of additional specialist sectors such as food supplements, gluten-free foods, baby foods and sports foods. I did not spend my days sitting reading pages of dry regulations; I had the chance to travel widely, not only to the European Commission in Brussels, to support industry discussions on developing EU Regulations, but also further afield. I visited several European countries, attending technical meetings to learn of developments which would impact Codex Alimentarius Standards; I was part of an audit team visiting different production facilities in USA, to ensure the personnel understood their obligations under the UK/EU Regulations, and also met with the FDA to explain the complexity of the medical condition behind a specialist infant formula being registered for use in the US. My attendance at Codex meetings took me from Bonn, in Germany, to Thailand. When I decided to set up my own Regulatory Affairs consultancy, the contacts made, and the expertise gained in setting up a regulatory department, stood me in good stead to be able to service my clients. Since much of my training had been on-the-job, or via short training courses, I then completed a Masters in Food Law to formalise my education after setting up my consultancy.
What is the main purpose of regulatory affairs to you?
At the early stage of the role, there is much to learn, regulations to understand and more questions than answers. Everything seems very black and white. A key skill is the ability to understand, assimilate and summarise the relevant aspects to then direct colleagues in their work, but opportunities also exist to help shape future legislation by responding to consultations, presenting the difficulties faced by industry, or offer a different perspective. The role of the RA professional is to ensure the consumer is protected i.e. to ensure full compliance with all relevant legislation relating to the product being put on the market. Under the Food Safety Act 1990, it is the responsibility of the Food Business Operator (FBO) to ensure that any product placed on the UK market is safe. The RA professional plays a key role for the business in this objective. As expertise and confidence grows, the role supports the business in going after opportunities and when crises hit.
How well understood do you think the field is by those not practicing?
I do not think the area of regulatory affairs is well understood by others. We are often seen as those who just hinder the marketing department. I believe it is key to have the RA personnel in at the earliest stage of product development, even at concept stage, since items can be discussed and ironed out along the way i.e. from the initial product development stage, through clinical or acceptability trials, to the label design. Then there will be fewer disappointments when a product is soon to be launched and, for example, specific packaging or claims or labelling statements are proposed, and it is then too late to generate data to substantiate what everyone wants to claim!
Why did you join the IFST and how did you get involved in the Food Regulatory Special Interest Group (SIG)?
I joined IFST as a student member when at university. I kept up my subscription but only became more active, at Scottish Branch Committee level, later in my career, taking on the role of Secretary a few times, Chair for many years and currently in the Vice Chair role. One of the key benefits of IFST membership is the ability to network with other like-minded food professionals. The IFST Community will allow this to happen more easily, but I have recently joined the Food Regulatory SIG to play my part in the planning of events and webinars, to promote our profession. especially to those at the start of their careers. and to share knowledge on emerging themes.
Where do you see the next big challenges coming from for the industry, given the impacts of EU Exit, Prepacked for Direct Sale (PPDS), High in Fat, Salt, Sugar (HFSS) foods etc.?
I believe Brexit may bring some opportunities, but I am concerned that the high standards of the current UK food system may end up being diluted, as a result of trade deals, which may be brokered. We have seen food security issues and instability in supply chains, due to the war in Ukraine, which demonstrates the fragility of our food chain systems. This situation is compounded by the reduced enforcement capability, a result of lack of resources and under investment in recent years. Already we are seeing divergence in UK legislation, for example in the area of contaminants versus the regulations we worked with at EU level, for many years. Companies need to be on top of this and monitor such changes.
Natasha’s Law resulted from the death of a consumer. Do you think regulations are too reactive?
It is very difficult in life to predict all eventualities. I think that the ability to act quickly, in light of a consumer or patient safety incident, is one of the great benefits of the UK regulatory system.
What are the typical requests you are asked in your role?
As a regulatory consultant, I offer different levels of support to clients, and their requests are rarely the same. The level of advice needed for a new entrant to the UK market will be very different from a request from a client who has their own in-house regulatory personnel, but may be seeking a second opinion or wish to debate those ‘grey’ areas in the legislation which are open to interpretation. As I focus in the specialist foods area, advice on exactly where a product should be positioned, and thus the appropriate legislation and restrictions, is a common request. What can and cannot be said around nutrition and health claims, and how these must be substantiated, has been a hot topic since the EU legislation was introduced in 2006; I anticipate more questions. now the UK has resumed responsibility. for our own claims and novel food lists, but this may also bring new opportunities. I can be used as a ‘second pair of hands’ when whole product ranges require labels to be updated, as happened when the Food Labelling to Consumers (FIC) Regulations were introduced. I am often asked to support a client on their interactions with the Department of Health and Social Care (DHSC) if there are challenges at notification stage, which is a legal requirement for infant formulae and medical foods, when a product is placed on the UK market for the first time. There is never a dull moment!