PIONEERING SOLUTIONS TO THE TOUGHEST FOOD LAW CHALLENGES
Areas of Practice
December 2014 is the date the most radical change in European food labelling law came into effect. Regulation EC No 1169/2011 or the Food Information Regulation for Consumers (FIRs) was put in place to harmonise labelling across the EU. This Regulation has a number of new implications in relation to mandatory nutrition declarations, changes in allergy labelling, and the presentation of voluntary information.
Legal Foods® has assessed hundreds of labels for compliance under the FIRs at EU and local levels (Member State) of implementation. Our unique experience with regulations and our understanding of the evolving interpretation of this legislation, can help ensure you labels are compliant.
We provide expert risk management regarding your current and future label design. As there are over 10,000 food labelling compliance failures raised every year in the UK ensuring your product are legal for sale is a priority. Enforcement can result in criminal prosecutions, fines or the removal of non-compliant goods or just a warning. The cost to business in terms of brand damage and a possible forced recall is significant. Knowing what breaches and how to negotiate with enforcement officers is the art of food law.
Our guidance and expertise in this area has been consistently demonstrated through our ability to defend against such adverse adjudications and prevent any future issues of non-compliance.
nutrition & health claims
The Nutrition & Health Claims Regulation has become a global litmus test for the importance of scientific efficacy underpinning European food law.
In 2007, Regulation (EC) No 1924/2006, better known as the Nutrition and Health Claims Regulation, came into force. The restrictions imposed by this Regulation dictate the marketing claims possible based on the composition and marketing of your product. Its reach is applicable in all commercial communications throughout the 28 Member States of the European Union.
Prior to its inception, Legal Foods® was already defending the use of health and nutrition claims for clients. We were instrumental in a number of the first approved health claim submissions and continue to find success in the submission of new clinical trial evidence.
Any non-compliance with the Regulation in a number of Member States including the UK can result in criminal as well as pecuniary sanctions against corporate businesses and/or their owners.
As a true leader in this field, Legal Foods® can assist your company deliver compliant yet competitive health and nutrition claims across all commercial media, be it online, broadcast, print copy, or on-pack.
novel foods & ingredients
The world of novel foods (foods not on the European market pre May 1997) have been significantly altered with the ‘new’ novel foods regulation (EC No 2015/2283) and related implementing legislation which have force of law from 1st January 2018.
If you’re looking to place on the European Market ingredients that maybe authorised for sale in a 3rd country such as the US, you should be aware such ingredients may be considered illegal in the EU (Novel). As such Legal Foods® can provide a full compliance check on your ingredients weather generic or branded and give guidance of their status on any one of the 28 Member States.
Simple issues such as dosage, the part of the plant used or manufacturing process can make the difference in the legality of your ingredients.
So don't take the risk without knowing the facts. Work with us and even where your product maybe viewed as novel we can assist on getting approval prior to placing the product on the market through a traditional use, substantial equivalence of full authorisation procedure.
With an in-house database of 1000’s of ingredients we are ready to provide the most accurate advice for this key area of food law.
traditional herbal medicines
According to Directive 2004/24/EC, traditional herbal medicinal products (THMP) have indications exclusively appropriate to THMP and, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment.
In order to gain a certificate of traditional use registration, a dossier/application must be submitted demonstrating specific and appropriate standards of safety and quality. Although it does not require full clinical trial data to support safety, traditional use must be demonstrated, i.e. such products must have been in medical use for at least 30 years, including 15 years in the EU.
Legal Foods® can aid in the development of a number of documents vital for the establishment of traditional herbal medicine registration including:
Gap analysis of existing data
Strategic construction and guidance on registration procedures
Writing of registration dossiers (CTD)
Expert reports to generate bibliographic and expert evidence for use in registration
Labelling/mock-up and patient information leaflet (PIL)
Planning and negotiation with authorities and manufacturers to ensure appropriate quality controls
In order to protect your business, Legal Foods® specialises in mitigating brand and sales damage resulting from any non-compliance with European or Member State legislation.
There are a number of agencies across the EU that ensure legal compliance with all relevant food legislation. The level of enforcement will depend upon many mitigating or exacerbating factors that are important to consider in mounting any regulatory defence.
Legal Foods® can provide a unique perspective on all 28 Member States due to its expertise and, more importantly, its unique involvement with competent authority agencies. Our intervention can extend sell-through periods, overturn incorrect medicinal product determinations, and challenge adverse analytical product analysis.
Our experience in dealing with forced product recalls results in a practical and measured approach to this stressful situation. We can help reduce the damage to your company’s reputation and, by liaising with regulators, ensure that future action takes a pragmatic commercially sensitive approach.
There are a number of challenges facing the industry such as health claims, new labelling, and compositional regulations. These changes are increasing investment in bringing compliant products to market. One of the biggest burdens is the taxation on your products, as this additional burden has a significant detriment to consumer purchasing and your bottom line.
In 2012 the UK government made a change to the VAT code on sports nutrition products, resulting in a 20% rise on a number of previously VAT-exempt high-protein products. Following a detailed review based on case law, we developed an expert guidance document helping our clients retain a zero rate for VAT.
As additional price challenges continue to exist across the food industry, we have the expertise to ensure your products meet the lowest legal exposure to taxes. The result of our intervention can be the retention of a pricing advantage over the competition—resulting in optimised profit margins and increased consumer demand for your product.
Legal Foods® can provide specialist advice on:
Ensuring correct compositional, labelling and on-pack claims to maintain specific tax banding.
VAT and duty guidance for third-country imports.
Assessment of and, if required, challenging VAT assessments though non-statutory clearance and tribunal defence.
food law training
Legal Foods® is the UK’s leading provider of online food-law training for regulatory affairs professionals. We offer a unique blend of online and in-house courses to help your business operate within the framework of European Union law.
If you’re looking for a flexible alternative to superficial conference-based presentations and company adverts, and require comprehensive, effective, and value-driven food law training, Legal Foods® is your first choice.
In today’s fast-paced world we don't always have the time to attend formal (in-house/face-to-face) training. Legal Foods® online learning courses make learning at your own pace, at your own time, and in your choice of environment just so simple. All courses are accessible 24 hours a day and are available through our click-pay-view system.
For those requiring group and face-to-face or tailored company specific training, Legal Foods® can meet all your needs.
Legal Foods® - Food Law Training. your choice anytime, anywhere!.
For over 10 years we have been offering a specialised service for the sports nutrition market. Our ‘Sports Legal’ unit offers a unique service tailored to those companies working in the sports nutrition space.
Sports nutrition is a unique category involving a certain type of language to connect to its consumers. It involves often compositions that are a complex mixture of proteins, botanicals and nutrients that may often be viewed in the EU as novel or even medicinal but lawful as foods outside of its jurisdiction.
Sports Legal® has a dedicated team of experts including brand developers, scientists and legal experts that handle formulation pre-screening, product and marking claims as well as labelling to ensure your products are the best they can be and understood for your intended audience.
Our mission in this food space has been to guarantee a tailor-made solution to each client by assessing projects from a local and pan-European perspective. We respect your sensitive trade data on proprietary blends, unique sale channel insights with the result of a trusted partnership in the sports nutrition category like no other.
Pilot trials – Do your products deliver?
One significant issue for food businesses is ensuring products really delivery their claimed benefits when made into a final product or even when purchased as a raw ingredient? The only way to know for sure in the absence of published data is to conduct a study. However, full-scale clinical trials can be expensive and can often lead to nothing commercially useful.
We have the ability to carry out confidential, small scale (<5 subjects), high quality and low cost feasibility trials as a stepping stone to larger clinical studies or simply to give you confidence in your formulation or an ingredients mechanism of action.
We can assess in response to a dietary intervention blood markers including glucose for Glycemic Index (GI) or load (GL), HbA1c, testosterone, cholesterol, immune markers, vitamin and mineral levels, and in addition conduct exercise performance trials. This saves you time, money and gives you some real assurance in product efficacy.
Of course we have partners in a number of academic institutions and Universities that we can utilise to ensure you are provided not mealy an interesting academic study but one that is tailored and fit for purpose i.e. communication of your products benefits.
Legal Foods® provides the bridge between academic understanding and the commercial realities of the food industry – helping you gain the information you need to realise the full potential of your product.