Global Food Regulatory SolutionsTM

Our team of food lawyers and scientists provides regulatory services in the fields of food, nutrition and cosmetics, with a strong focus on functional foods and ingredients and nutritional supplements. Since 2004, we have developed a significant expertise in food labeling and advertising issues (health and nutrition claims), product registration (novel foods, food supplements, food for special medical purposes, cosmetics, etc.), and product liability (withdrawals, recalls), among others.

Our regulatory practice is based on excellence, the ability to provide effective business counseling and creative solutions to our clients throughout all segments of the food chain, from concept to completion. 

 

Regulatory Services

Label and composition review and reformulation

Applying for regulatory clearance for use of food, drink, supplements and cosmetics in the EU, Asia/Pacific and the USA

Advising on food labeling and advertising issues, with a special focus on nutrition and health claims

Drafting opinions on the compliance status of food, drink, and cosmetics

Preparation of applications for authorization of novel foods, GRAS, food additives, etc.

Advising on questions relating to the marketing of GMOs and GMO-derived products

 

Drafting and negotiating license and distribution agreements relating to foodstuffs

Advising on food product liability

Providing general food and drink regulation advice

Advising in case of product recalls and withdrawals

Advice on classification of borderline products such as medical devices, cosmetics, food supplements, medicinal products, biocidal products

Registration of cosmetics, medical devices and other consumer goods

Representative Work

ASIA-PACIFIC

We advised a multinational ingredients manufacturer on the review of around 100 raw materials in Singapore

We represented a multinational nutritional products firm on an ingredient contamination issue in South Korea

We advised a multinational nutritional products firm on the commercialization of food supplements in Russia and Ukraine          

We advised a multinational ingredients manufacturers several aspects of the commercialization of an ingredient in Thailand, Malaysia, Philippines, Japan, South Korea, Australia, New Zealand and South Africa

We advised a multinational health products firm in connection with the possibility of combining cosmetics and food supplements in a single packaging in Singapore

We advised a multinational food firm on the use of label stickers in several Asia-Pacific jurisdictions

We represented a multinational health products firm in connection with the use of nutrition and health claims in Singapore, Malaysia, Vietnam and Indonesia

We represented one of the world's largest ingredients manufacturers with the use of colors in South Korea

We advised a multinational dairy in connection with the labeling of milk products in Indonesia

We represented one of Japan's largest food-processing companies in the impact of new GMO rules for their products in Russia

We advised a multinational food company on labeling of allergens in Singapore

We advised a spirits firm on maximum limits of contaminants spirits in Thailand

We advised a European multinational on novel food regulation in Japan, Korea, China, Australia and India

We advised a multinational nutritional supplement company on the marketing of probiotic products in Japan

We advised a multinational ingredients manufacturers several aspects of the commercialization of an ingredient in India, Taiwan and The Philippines  

EUROPEAN UNION

We represented the world's top dairy producer in a high profile application for the use of the term "probiotic" in the EU, coordinating the work in several EU countries

We represented one of the global leaders in the life science markets refuting a forthcoming Spanish policy directly affecting one of their top-grossing ingredients, by filing a complaint before the European Commission

We represented one of Japan's largest food-processing companies in the impact of new GMO rules for their products in Poland and Russia

We advised one of the world's leading companies in the healthcare and medical products industry with their communication strategy on health claims on their flagship line of products

We performed the regulatory due diligence in a multi-million dollar acquisition of a food ingredients producer by an animal by-products processing company

We represented one of the world's fruit and fruit juice manufacturers on the conformity of the labelling of their new products in several jurisdictions

We advised the world's number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labelling of their products, classified them and placed them on several EU countries

We represented a publicly traded pharmaceutical company based on several food policy issues such as advertising claims, withdrawals and recalls and the placing on the market of novel food

We advised one of the world's largest food ingredients companies on a high profile, highly confidential issue with one of their top-grossing products in a EU country

We assisted a food sector association in advocating a policy revision by the European Commission in relation to health claims

We helped one of the world's leading pharmaceutical companies with the negotiation with the authorities in connection with the withdrawal of one of their flagship products from the market

We helped several governments to draft several food safety policies

LATAM

We advised a multinational health products firm in connection with the registration of their protein products in Brazil

Sebastian R. Melchor

Sebastian Romero Melchor is the founder of the firm. Sebastian has a substantial experience in EU food regulatory matters, after serving in the European Commission and top-tier international law firms in Brussels. He is widely known in the industry as one of the leading professionals in the food and nutrition regulation and recognized as top tier food lawyer by LEGAL 500. Although not actively practicing, Sebastian remains associated with the firm and is available for occasional consultation.   

Lara Skoblikov

Lara Skoblikov is a partner based in Brussels working on a wide range of food regulatory and policy matters, including food supplements, labelling, nutrition and health claims, novel foods, import, hygiene and GMO, as well as the application of general principles of EU regulations and national jurisdictions. Prior to joining Food Compliance Int., Lara gained experience in an international law firm for several years, and the European Commission - DG Health.

Joris Geelen

Joris Geelen is a partner based in Brussels with an unrivaled knowledge of the scientific and regulatory aspects of botanicals used in food, supplements and other products. During his years at the Belgian Ministry of Health, he acquired a vast experience in notifications and mutual recognition procedures in the EU. He follows closely all developments on novel foods, quality and safety requirements for nutrients, plants and other substances.

Poon Wai Mun

Wai Mun Poon is FCI's Asia-Pacific coordinator based in Singapore. Since more than 10 years ago she works on food regulatory and policy matters in the APAC region. Wai Mun is a biotechnologist and graduated with a M.Sc. in Biopharmaceutical from the University of New South Wales