OUR SERVICES

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REGULATORY ASSESSMENT

It is imperative that an assessment of the regulatory journey of any product which is at the conceptualisation or early development stage should be mapped out with experts as early as possible. At AFR we have lost count of the cost (both financially and in terms of time and motivation) of the number of clients who first approached us at a point in a product’s evolution when key decisions had been made without any recourse to the regulatory landscape. Those uninformed decisions had not factored all relevant matters and were therefore the wrong ones, requiring significant retraction of work done, costs incurred and time lost.

The first stage of any new engagement at AFR is to go “back to basics” and make a root and branch assessment of the product and the manner in which it is manufactured, asking key questions at every touchpoint:

  • Is it likely to be a regulated product in X, Y or Z jurisdiction?
  • What are the chemical and botanical footprints of the ingredients and how do they manifest themselves in the end product?
  • Are there any inherent safety considerations within the product? Can they be mitigated? Have they been mitigated?
  • Are there any inherent safety considerations within the manufacturing process? Can they be mitigated? Have they been mitigated?
  • How will I gain regulatory approval for the product and protect the intellectual property within the product?
  • What are the likely costs and timeframes to market in differing jurisdictions?
  • How will I schedule the jurisdictional applications to ensure that the client commercialises the product in the swiftest time period?

NAVIGATING NOVEL FOOD REGULATIONS IN THE EUROPEAN UNION

At AFR we specialise in guiding companies through the intricate maze of Novel Food Regulations, offering expert guidance and solutions to ensure compliance and success in the modern food industry. We understand the challenges that food and beverage companies face in meeting the rigorous requirements imposed by the trans-national regulator covering all of the separate countries within the Union.

Our team of experienced regulatory experts provide a comprehensive range of services tailored to the unique needs of every client – from conducting safety assessments and facilitating regulatory approval, to developing accurate multi-jurisdictional labelling strategies and compliance documentation, AFR will assist you on every step of your journey.

Our goal is to streamline the process of bringing innovative food products to market, enabling our clients to harness the full potential of their creations, expand their market reach with confidence and deliver their unique products to consumers eager to be delighted with innovation and quality.

In a world where regulations are continually evolving, partnering with AFR ensures that your business does not simply comply with the necessary standards, but that it thrives in the ever-changing food industry, marking itself out in the eyes of the consumer as the trusted consumer goods company.

UNITED KINGDON REGULATED PRODUCTS – THE UK’S BESPOKE NOVEL FOOD PROCESS

With a wealth of experience and expertise in the food industry, we are your trusted partner when it comes to navigating the complex landscape of The UK’S Regulated Products. We understand that regulatory compliance is a cornerstone for success in this ever-evolving industry, and we are dedicated to helping companies meet and exceed these standards.

Our team of seasoned professionals is well-versed in the intricacies of food regulations, from labelling and safety requirements to quality control and product testing. We provide comprehensive solutions tailored to your unique needs, ensuring that your products not only comply with all relevant regulations, but also stand out for their quality and safety.

Our proven track record and deep industry knowledge make us the ideal choice for companies seeking to thrive within the UK’s Regulated Products requirements.

THE GRAS SYSTEM IN THE U.S.

For companies looking to enter the thriving U.S. food market, understanding and navigating the GRAS (Generally Recognized as Safe) framework is pivotal.

GRAS is a critical regulatory concept overseen by the U.S. Food and Drug Administration (FDA), which determines whether a substance is safe for consumption in food and food-related products. Navigating this framework can be complex and time-consuming, but our expertise and guidance can streamline the process.

At AFR we offer comprehensive assistance to help your company understand the intricate requirements of GRAS, from conducting safety assessments to preparing and submitting the necessary documentation for FDA approval. With our support, your business can confidently and efficiently bring new food products to the U.S. market, ensuring both consumer safety and compliance with regulatory standards, all within a timescale shorter than that experienced within the European markets (and often at lower cost).

ACCESSING THE CHINESE MARKET

Expanding into the Chinese market presents its own unique set of regulatory challenges and complexities. China’s regulatory framework is overseen by various government agencies, with the China Food and Drug Administration (CFDA) now merged into the National Medical Products Administration (NMPA) for pharmaceuticals, medical devices, and health supplements, and the China National Centre for Food Safety Risk Assessment (CFSA) overseeing food products.

The main challenges for companies looking to enter China include navigating a rapidly evolving regulatory environment, complying with intricate labelling and packaging requirements, understanding and adhering to product-specific regulations, and ensuring product safety and quality according to Chinese standards. Moreover, language and cultural differences can pose additional barriers for foreign businesses.

To help companies overcome these challenges, our team of regulatory experts specializes in the Chinese market. We offer extensive knowledge of China’s evolving regulatory landscape and can guide companies through product registrations, quality testing, and compliance procedures. Our expertise extends to understanding the unique preferences and expectations of Chinese consumers, which can be instrumental in successfully introducing products to this vast and diverse market. By partnering with our team, businesses will confidently navigate China’s regulatory complexities and position themselves for success in one of the world’s most dynamic, promising and, as yet, untapped markets.

ALTERNATIVE PROTEINS REGULATORY FRAMEWORK GUIDANCE

We provide invaluable guidance to companies within the alternative proteins sector, helping them overcome the unique hurdles and seize the vast opportunities presented by this burgeoning area of food technology.

We understand the complexities of developing and marketing innovative protein sources and can assist you at every step of their journey – you are doing this for the first time, at AFR we are not. From regulatory compliance and safety assessments to supply chain optimization and market strategies, we tailor services to each client’s specific needs.

By partnering with us, you will confidently navigate the ever-changing landscape of alternative proteins, ensuring that your products meet the highest standards of quality, safety, and sustainability – all under the umbrella of complete regulatory compliance – enabling you to thrive in a rapidly evolving market driven by consumer demand for more sustainable and ethical protein choices.

CELL CULTURED FOODS

By nature of its more efficient production process, cultivated meat has a variety of benefits over conventional animal agriculture. Prospective life cycle assessments indicate that cultivated meat uses significantly fewer resources and can reduce agriculture-related pollution and eutrophication. One study showed that cultivated meat, if produced using renewable energy, could reduce greenhouse gas emissions by up to 92% and land use by up to 90% compared to conventional beef. Commercial production is expected to occur entirely without antibiotics and is likely to result in fewer incidences of foodborne illnesses due to the lack of exposure risk from enteric pathogens.

Why are we describing the science of cultured meat? Because at AFR we do not simply deal with the end product, we drill down to a granular level (or in this instance, cell level) in order to understand the fundamentals of what you do and the origins of your product. It is in that way that we tailor the regulatory approach in multiple jurisdictions, advising on the launch sequencing to ensure that your income streams are maximised through regulatory sequencing.

At AFR we believe that over the next few decades, cultivated meat and other alternative proteins are predicted to take significant market share from the $1.7 trillion conventional meat and seafood industry. This shift will mitigate agriculture-related deforestation, biodiversity loss, antibiotic resistance, zoonotic disease outbreaks, and industrialised animal slaughter. The future is coming, and AFR can take you to it.

GENETICALLY MODIFIED FOODS

AFR’s comprehensive GM-services are tailored to genetically modified foods, offering expert guidance to food manufacturers in navigating the complex landscape of GM food regulations and compliance.

Our specialized services encompass GM regulatory compliance, risk assessment, precise labelling, consumer education, international trade compliance, advocacy and public relations support, innovative product development, and continuous regulatory updates.

With our in-depth expertise in GM foods, we empower our clients to produce, market and trade GM food products that not only adhere to the strictest safety and quality standards, but also ensure compliance with evolving regulatory requirements, enhancing consumer trust and facilitating your success in this dynamic industry.

UNDERSTANDING INGREDIENTS

Our extensive food analytical services assist food manufacturers in meeting compositional standards and complying with food safety and quality regulations. Our team of experienced experts specialises in interpreting and applying relevant food laws and regulations, ensuring your food products align with specific compositional standards. We are able to achieve this because members of our team not only excel in understanding foods, but in understanding the science behind foods, and one without the other is a half-baked cake – it has the right ingredients, but something was missing. At AFR nothing is missing, and you will want for nothing.

Our knowledge and experience means that we will provide guidance on recipe development (we have direct access to some of the world’s most respected development chefs and their kitchens), labelling compliance, quality control, and risk assessment, while also keeping you informed of evolving regulations. Additionally, we help with certifications, act as a liaison with regulatory authorities, and provide tailored training programs to guarantee that your products consistently meet the highest standards of safety, quality, and legal compliance in the food industry.

With our expertise, your food products will stand out as much for their adherence to the most stringent industry standards, as they will for their exceptional taste.

NAVIGATING FOOD SUPPLEMENTS REGULATIONS

We are well-versed in the dynamic dietary supplements industry, and we are here to assist companies in overcoming the regulatory hurdles, allowing you to flourish in this burgeoning market.

Our team of experts will provide comprehensive solutions tailored to the specific needs of supplement companies – from navigating complex international and national regulations, to ensuring product safety, quality, and compliance. At AFR we offer a holistic approach to meet the unique challenges of this industry.

Whether you are a start-up looking to bring a new supplement to market or an established company seeking to enhance your compliance processes, AFR should be your trusted partner. With our guidance, your business can confidently meet the rigorous standards of the dietary supplements industry and meet the growing demand for high-quality, safe, and effective wellness products.

NUTRITION AND HEALTH CLAIMS

The regulatory framework for nutrition and health claims is a critical aspect of the food and beverage industry, both in the UK and on the international stage. In the UK, as well as across the European Union, these claims are tightly regulated by the European Food Safety Authority (EFSA) and the UK Food Standards Agency (FSA). These regulatory bodies oversee the approval and substantiation of nutrition and health claims made on food products, ensuring that any statements about health benefits are scientifically supported and do not mislead consumers. Internationally, the regulatory landscape varies from one country to another, often requiring businesses to navigate a complex web of rules and guidelines.

The blurred lines between some health claims and medical claims often means that companies without the appropriate partners find themselves falling foul of the medical regulators – which often comes at very significant financial and reputational cost. At AFR we have established ourselves a leader in assisting companies to overcome these regulatory challenges. Our team of regulatory experts possess a deep and up-to-date understanding of the ever-evolving global regulatory environment.

As an AFR client you will receive comprehensive support in preparing and submitting all aspects of the Dossiers necessary for claim approval – from the design and instruction of scientific assessments to substantiate claims, to ensuring that product labelling and marketing materials comply with the intricate regulations of the instant jurisdictions. Our track record of success in obtaining approvals for nutrition and health claims, as well as our ability to adapt to the unique requirements of different regions, makes us the best choice for companies looking to navigate this complex regulatory landscape with confidence. By partnering with AFR you can be assured of regulatory compliance, consumer trust, and a competitive edge in the global marketplace.