Company Profile…Barkwith brings regulatory clarity
The European regulatory landscape for the control of chemicals has changed beyond recognition over the last two decades. Murray Smedley, Managing Director of Barkwith Associates takes a look back and considers what the future might bring as his Company celebrates 20 years of providing regulatory support.
Having held a variety of technical roles working closely with testing houses on a number of registration projects, Murray appreciated the importance of providing clear and concise advice in supporting commercial decisions. With increasing complexity and harmonisation of EU processes, he could see a need to specialise in regulatory support was on the horizon.
Murray Smedley, Managing Director of Barkwith Associates Limited
Murray took the plunge to set up a new business and in May 2002 Barkwith Associates was formed. Now situated near to the original location of the village of West Barkwith in Lincolnshire, UK, the pragmatic approach remains unchanged and is a consistent feature throughout the work of the team of 12 staff. The same certainly cannot be said of the regulatory regimes within which his business provides support and advice!
Murray recalls, âIn 2002 our work was focused largely on local national support. Many EU Laws were in their infancy and interpreted in a variety of ways by Member States. Communications with the authorities often included meetings and open discussions to agree the most appropriate approach to applications which were printed and posted ⊠.with little formatting and no electronic submissions. Back then, data handling was considered a physical exercise!â
To ensure a fully consistent and comparable approach, EU âDirectivesâ have been replaced and regularly amended over time into âRegulationsâ which specify requirements to achieve compliance and enforcement in a more detailed and prescriptive way.
The EU-wide process for identification, assessment and control of substances – known as REACH – first became a legal requirement in 2007, closely followed in 2009 by the harmonisation of classification and labelling of preparations (CLP).
The Plant Protection Products Directive was replaced by the Regulation 1107/2009 in the same year and the equivalent for Biocides (the Biocidal Products Regulation) in 2012. The newest Regulation for Fertilisers and Biostimulants (the FPR) comes into effect in July of 2022.
New chemical Regulation often places significant and costly demands on industry, and it is critical that the authorities release formal guidance to provide clear advice on how compliance can be achieved.
In addition, Regulations are constantly reviewed and amended, often demanding new or additional data and assessments. It is fair to say the regulatory landscape is constantly moving!
The team of specialists provide clear, concise and pragmatic support
Murray adds âAs an industry, we appreciate and understand the importance of a clear process and robust scientific assessment to enable a transparent and logical conclusion to any evaluation process. Frustratingly, such decisions are regularly delayed due to differences in interpretation of the requirements and inconsistencies in conclusions. Additionally, we see the Authorities as being increasingly under resourced, leading to the extension of evaluation deadlines.â
In providing the very best service, Barkwith Associates recognises the importance of both a deep understanding of the current requirements and keeping up to date with any impending changes and how these may impact on the advice and support they provide to their clients. Murray himself is actively involved in a number of Industry Associations, providing input and feedback to the Regulators.
The last 20 years have seen the removal of a significant number of substances, many identified as highly toxic to humans and the environment, whilst others simply did not have the financial support to fund their progress through the increasingly costly regulatory processes. With current challenges including the requirement to assess substances for endocrine disrupting properties and defending those considered as Candidates for Substitution, Murray is keen to highlight the importance of balance and proportionality.
The number of active ingredients available to pest controllers has fallen dramatically whilst the data requirements and associated cost for new and re-registered products have risen significantly
âToday, those looking to place new chemicals on the market must first assess their effects on human health and the environment ahead of any beneficial effects they provide to our food production or the control of damaging and harmful pests. Whilst we need to ensure the impact of potentially dangerous chemicals is limited as far as possible, we must include an element of sensibility and include due consideration of their benefits within the regulatory processâ.
Barkwithâs core activities remain centred around the provision of advice, preparation of Dossiers and liaison with Authorities for clients who must comply the Regulations applied to Plant Protection Products, Biocides, Fertilisers and also more general chemicals.
The team at Barkwith Associates includes experts 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 skills to comply with often tight deadlines set by the EU and GB Authorities.
Despite increasing costs and greater hurdles, Murray also recognises the importance in the services they offer to innovative and smaller enterprises. Murray explains âopportunities remain for such smaller businesses, who must recognise the regulatory process as a key component within their R&D programme. Our fixed price service is aimed at such clients and we would recommend our input as early as possible in the development of productsâ.
So what changes might we see over the next 20 years?
Barkwith Associatesâ modern head office near Lincoln UK
For Plant Protection Products, Murray sees the greatest challenge for Europe will be to ensure a balance between sustainable and secure food production, with a more considered approach toward managing environmental impacts throughout the food chain rather than focusing solely on restrictions to chemical inputs necessary to provide high yields and improved quality of crops, grown in an ever-decreasing area. He would like to see further reductions in the regulatory hurdles currently in place for biopesticides (including pheromones and naturally occurring compounds) and non-pesticidal materials as necessary to achieve this.
Similarly, authorities should place a greater emphasis on socio-economic value of biocides and other chemicals, ensuring comparative risks, hazards and viable alternatives are fully considered before restrictions are placed.
Concerning the position in Great Britain, Murray comments âWhilst our support continues to comply equally to both the EU and GB regulatory processes, it is my opinion that any significant changes or divergence in chemical legislation in GB is likely to restrict opportunities in the flow of goods to and from our largest trading partner.
Whatever the next 20 years may bring, Barkwith Associates continues to provide a pragmatic approach with clarity and precision and the company welcomes the opportunity to discuss your requirements.
All Photos: Barkwith Associates Limited
For more information on the services provided by Barkwith Associates visit www.barkwithassociates.com or for an initial discussion, email info@barkwithassociates.com
Published in International Pest Control â May/June 2022
Category: Company news, Company Profile
