EAS Asia hosts in-depth session on regulatory
and scientific issues for borderline products
EAS Strategic Advice kicked off 2010 with a successful workshop on Friday, 15 January at the Singapore Management University. Companies from across Indonesia, Malaysia and Singapore attended the interactive full-day workshop focused on the positioning of borderline health supplement products. Four senior EAS experts covered a wide range topics pertaining to regulatory and scientific support for health supplements in Asian and European markets.
Patrick Coppens, EAS expert on European food law, presented a comprehensive session on the classification of health supplements and medicines from European and US perspectives. He demonstrated that the main determining factor to differentiate supplements from medicinal products is the intended use of the product as illustrated by its health claims. In addition, various other factors, including presentation, form, product composition and marketing messages, are taken into account by the authorities in the classification of a product. It was followed by a lively discussion on the classification ‘fate’ of new bioactive ingredients, belonging to the food or medicine category.
“The distinction between a health supplement and a medicinal product is usually not made based on the form (e.g. tablet or powder) and composition; the predominant basis of this decision is the intended use,” clarified Patrick.
Continuing the topic of product classification, Wai Mun Poon, EAS expert on Asian health supplement regulations, talked about the classification of botanical health supplements. She indicated that companies should understand the different regulatory systems in ASEAN, China and Taiwan to minimise business risk of botanical supplements classified under herbal medicine or medicine categories. The issue of regulatory obstacles in combining botanicals with other health supplement ingredients was actively discussed.
Pieter Lagae, EAS Regulatory Advisor, took the audience through key concepts and the application procedures of the European Nutrition and Health Claims Regulation. Patrick Coppens then explained the challenging situation currently in Europe where many health claims for bioactive substances, such as probiotics and botanicals, were given a negative opinion by the European Food Safety Authority, while only the majority of claims for vitamins and minerals received a positive opinion.
Following this, Wai Mun Poon highlighted the regulatory requirements for marketing health claims in key ASEAN and some Asian markets. Ms Poon pointed out that marketing personnel should take note that most ASEAN national regulatory authorities only allow a fixed list of nutrient-function claims, and that China and Taiwan have a list of permissible health claims with stringent requirements. She also provided an update on the regulatory harmonisation process for the health supplement sector in the regional governmental effort towards an ASEAN market. The companies also expressed their hope to see the development of a single ASEAN health supplement market.
In the afternoon, Dr Daniel Tsi, Regional Director of EAS Asia, explained the process and criteria for scientific substantiation of health claims. Drawing from international experience in health claims substantiation, especially the CODEX Alimentarius, Europe and US, he pointed out that substantiation standard based on the totality of scientific evidence is high. Increasingly it will be necessary for small or medium-sized enterprises (SME) to collaborate with ingredient suppliers and government research institutes in order to meet the mark. Dr Tsi also discussed the future health claims substantiation requirements in ASEAN, “In line with CODEX international standard, the level of scientific evidence expected in ASEAN should be in proportion to the type of claims,” he explained. During the discussion session, the biggest concern of the participants related to how SMEs can afford human studies and that a balanced regulatory approach in addressing health claims in ASEAN is necessary for the sector to thrive and contribute to ASEAN growth.
In response to the evolving regulatory environment across Asia and the attention grabbing topic of health claims in Europe, EAS is offering two unique guides http://www.eas.asia/Publications.aspx to help companies build sound regulatory strategies for marketing nutritional and health supplement products in Asia and Europe.
The EAS guide Marketing Health Supplements, Fortified & Functional Foods in Asia: Legislation & Practice covers national and regional rules for health supplements, fortified and functional foods. These include 10 national rules for adding vitamins and minerals to food and health supplements; the use of herbs and other functional ingredients; and analyses of the current labelling, claims and ASEAN health supplement regulatory harmonisation.
The latest in the EAS HOW TO series also pertains to health claims and is available to buy online in pdf format for those who missed out on the intensive workshop. HOW TO apply the Nutrition and Health Claims Regulationgives a full overview of the history and coverage of the claims regulation, but most importantly it offers practical advice on complex claims interpretation issues with examples and answers to frequently asked questions. The EFSA dossier submission advice section also includes an invaluable checklist with criteria to assess dossier strength.
EAS provides strategic consulting advice on European, Asian and international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe and Asia. EAS also advises governments, trade associations and companies on the impact of European, Asian and global policy.
EAS has offices in Brussels, Italy and Singapore. EAS-Italy is a branch of EAS located in northern Italy to follow EFSA developments in Parma closely.
For more information on EAS Europe contact EAS, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0) 2 218 14 70, email firstname.lastname@example.org or visit www.eas.eu For information on EAS Asia contact EAS Strategic Advice Pte Ltd, 3 Killiney Road, 07- 04 Winsland House I, Singapore 239519, tel: (+65) 68 38 12 70, email: email@example.com or visit www.eas.asia