The European regulatory landscape for chemicals regulation has changed beyond recognition over the past two decades. Burkwith Associates managing director Murray Smedley takes a look back and considers what the future may bring as his company celebrates 20 years of providing regulatory support.
Having held various technical roles working closely with test houses on several registration projects, Murray appreciates the importance of providing clear and concise advice in supporting commercial decisions. With the increasing complexity and coordination of EU processes, he sees a need to specialize in regulatory support.
Murray decided to set up a new business and in May 2002 Burkwith Associates was formed. Now based near the original location in the village of West Berkwith in Lincolnshire, UK, the pragmatic approach remains unchanged and is a consistent feature throughout the work of the team of 12 staff. The same cannot be said for the regulatory regime in which his business provides support and advice!
Murray recalls, “In 2002 our work was largely focused on local national support. Many EU laws were in their infancy and were interpreted in different ways by member states. Communication with authorities often includes meetings and open discussions to agree on the most appropriate method for applications that are printed and posted….little formatting and no electronic submissions. Back then, data handling was considered a physical exercise!
To ensure a fully consistent and comparable approach, EU ‘Directives’ have been replaced and regularly amended over time into ‘Regulations’ which specify compliance and enforcement requirements in a more detailed and prescriptive manner.
The EU-wide process for the identification, evaluation and control of substances – known as REACH – first became a legal requirement in 2007, closely followed by the harmonization of classification and labeling of preparations (CLP) in 2009.
The Plant Protection Products Directive was replaced in the same year by Regulation 1107/2009 and in 2012 was equivalent to Biocides (Biocidal Products Regulation). The new regulation for Fertilizers and Biostimulants (FPR) comes into effect in July 2022.
New chemical regulations often make significant and costly demands on industry, and it is important that authorities publish formal guidance to give clear advice on how to achieve compliance.
In addition, regulations are constantly reviewed and revised, often demanding new or additional data and evaluations. It’s fair to say the regulatory landscape is constantly moving!
Murray added “As an industry, we recognize and understand the importance of a clear process and robust scientific evaluation to enable a transparent and logical conclusion of any evaluation process. Frustratingly, such decisions are routinely delayed due to differences in interpretation of requirements and inconsistencies in conclusions. Additionally, we see the authority as increasingly under resourced, thereby extending the assessment period.”
In providing the best service, Barkwith Associates recognizes the importance of both a deep understanding of current requirements and keeping up to date with any impending changes and how this may affect the advice and support they provide to their clients. Murray himself is actively involved in several industry associations, providing input and feedback to regulators.
A significant number of substances have been phased out over the past 20 years, many identified as highly toxic to humans and the environment, while others have not had the financial support to finance their progress through increasingly expensive regulatory processes. With current challenges including evaluating substances for endocrine disrupting properties and the need to protect individuals considered candidates for replacement, Murray is keen to highlight the importance of balance and proportionality.
“Today, those seeking to place new chemicals on the market must first assess their impact on human health and the environment to determine whether they provide any beneficial effects on our food production or control harmful and harmful pests. While we must ensure that the effects of potentially hazardous chemicals are limited as far as possible, we must include an element of sensitivity and proper consideration of their benefits in the regulatory process”.
Berkwith’s core activities focus on the provision of advice, dossier preparation and liaison with authorities for customers who must comply with regulations applicable to plant protection products, biocides, fertilizers and more general chemicals.
Berkwith Associates’ team includes specialists with specialist knowledge and extensive experience, providing support to larger clients who already have a good knowledge of such complex requirements but may not have the in-house expertise to comply with the often tight deadlines set by the EU and GB. Authority.
Despite rising costs and greater barriers, Murray also recognizes the importance of the services it offers to innovative and small enterprises. Murray explains “opportunities remain for such small businesses, who must recognize the regulatory process as a key element within their R&D program. Our fixed price service targets such clients and we recommend our input as early as possible in product development.” .
So what changes can we see in the next 20 years?
For plant protection products, Murray sees that the biggest challenge for Europe will be to ensure a balance between sustainable and safe food production, with a more considered approach towards managing environmental impacts throughout the food chain rather than focusing on limitations on the chemical inputs needed to deliver. High yield and improved crop quality, grown in an ever-shrinking area. He would like to see further reductions in the regulatory barriers currently in place for biopesticides (including pheromones and naturally occurring compounds) and non-pesticide ingredients needed to achieve this.
Similarly, authorities should place greater emphasis on the socio-economic value of biocides and other chemicals, ensuring that comparative risks, hazards and viable alternatives are fully considered before imposing restrictions.
Regarding Great Britain’s position, Murray commented “While we continue to support compliance with both the EU and GB regulatory processes equally, it is my view that any significant changes or deviations in chemical legislation in GB could limit the potential for and from our largest trading partner. products.
Whatever the next 20 years, Barkwith Associates continues to provide a pragmatic approach with clarity and precision and the company welcomes the opportunity to discuss your requirements.
All images: Berkwith Associates Ltd
For more information For services offered by Barkwith Associates visit www.barkwithassociates.com or for initial discussion, email firstname.lastname@example.org
published International Pest Control – May/June 2022
the class: Company News, Company Profile