No Images? Click here May 2017 New Regulation for Novel Food – Transitional Regulation for Tobacco ProductsThe new and fully revised Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act [FSA]; SR 817.0), including a large range of new ordinances, entered into force on May 1, 2017. The food industry is being granted more liberties in connection with food innovations, yet also more responsibilities with regard to health protection and protection from consumer deception. The revision has further aligned regulations in Switzerland with those of the EU in an attempt to reduce trade barriers. Apart from various regulatory changes in connection with labelling and classification of products, two integral novelties of the revision are the new "novel food" concept and the removal of tobacco products from the foodstuffs legislation. Novel Food The main goal of the abolition of the positive principle is to foster innovation. However, in order not to jeopardize consumers by allowing any new foodstuffs to enter the market without prior authorization and in order to comply with EU standards, new foodstuffs that bear a potential risk will require a so-called «novel food» authorization. Article 15 of the new Ordinance on Foodstuffs and Utility Articles (SR 817.02) contains a comprehensive list of attributes making a foodstuff novel, such as, for example, a food with a new or altered molecular structure or with certain microorganisms. Novel food further includes foodstuffs that were not used broadly as an alimentary component on the Swiss market before 1997 (the year the Novel Food Regulation [Regulation (EC) 258/97] of the EU came into force), foodstuffs containing Nano material as well as foodstuffs gained from cloned animals (but not their offspring). Extraction solvents, food enzymes, food additives and aromas do not qualify as novel foods and do not require authorization. The authorization requirements for genetically modified foodstuffs, additives and processing aids continue to be dealt with by the legislation on genetically modified organisms (Gene Technology Act; SR 814.91). The Swiss authorization system provides for more protection of trade secrets than the one of the EU, as the Swiss authorizations are generally granted on an individual basis and cannot be used by other market players. However, authorizations are only granted for five years. After that, they are added to an annex of the Novel Food Regulation and can be used by everyone, permitting players to benefit from the innovations of others. Annex 1 to the new Novel Food Ordinance (SR 817.022.2) contains a list of novel foods marketable without previous authorization. It contains, inter alia, a list of three insect types: flour worms (in larval stage), adult crickets and adult European migratory locusts. The use of insects continues to gain an increasing role in food production. Tobacco Products The TPA was originally supposed to enter into force no later than 2019. However, the Federal Council's draft of the TPA was rejected by both chambers of the parliament, which means the draft is back with the Federal Council for revision. According to a timeline published by the Federal Office for Public Health, the parliamentary consultation on the new draft will take place in 2019 and the final vote of the parliament is planned for the end of 2020. In 2021, the Federal Council is supposed to draft the respective ordinances based on the TPA which would then be likely to enter into force in mid-2022. In order for the current Ordinance on Tobacco (OTab, SR 817.06) not to be without a legal basis until the enactment of the new TPA, the revised FSA provides that a number of provisions of the old FSA shall stay in effect for tobacco products during a transitional period of four years. Main changes in the planned TPA will include restriction of advertisement and promotion of tobacco products and limitation of according sponsoring. A particular challenge will be for the legislator to classify and regulate novel tobacco products, especially products that have the potential to significantly reduce the risk of smoking-related diseases, such as nicotine-containing e-cigarettes and products that heat rather than burn the tobacco. The legislator will have to make a decision in principle as to whether these risk-reduced tobacco products should be regulated as restrictively as conventional cigarettes. In any case, based on the Federal Council's draft TPA (as rejected by the parliament) one can expect that the definition of «tobacco products» will include and regulate e-cigarettes with and (at least partially) such without nicotine. Under the current legislation, marketing nicotine-containing liquids for e-cigarettes in Switzerland is prohibited (while the import of such «e-liquids» for personal use remains permitted). Until the new TPA is in force, the currently applicable tobacco regulation will remain in force based on the old FSA and three of its ordinances. Those three ordinances are the Tobacco Ordinance (OTab, SR 817.06), its related Ordinance on Combined Health Warnings on Tobacco Products (SR 817.064) and the Ordinance on Foodstuffs and Utility Articles (FSO, SR 817.02). Another part of the tobacco regulation, namely the Act for the Protection from Passive Smoking (SR 818.31) and the respective ordinance (SR 818.311), are based directly on constitutional provisions and, therefore, not affected by the recent law-making process. Enforcement Authorities Fig.: Expected foodstuffs and tobacco legislation concept de lege ferenda Authors: Dr. Stefan Kohler und Ann Sofie Benz VISCHER AG The publisher cannot be held liable for the correctness, completeness and topicality of any contents or presentations in this News Alert. Copyright © 2016 VISCHER AG; Basel/Zürich. All rights reserved. |