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Is Baobab a Novel Food according a legislation of Ukraine?

Ноябрь 28, 2018 By: Профессиональная Юридическая Группа Category: Консультации по отдельным видам деятельности

According to Commission Decision of 27 June 2008 No 2008/575/EC (http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008D0575) - Baobab is a Novel Food in interpretation of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31997R0258). Ukraine is not a EU member, and, accordingly, these Decision and Regulation do not directly apply to the territory of Ukraine. However, in accordance with the Comprehensive strategy of implementation of Chapter IV (Sanitary and phytosanitary measures) of Section IV "Trade and trade-related issues" of Association agreement between Ukraine on the one hand and the European Union, the European Atomic Energy Community and their member states on the other hand, approved by the disposition of the Cabinet of Ministers of Ukraine dated February 24, 2016, No. 228-p, the task of the Cabinet of Ministers of Ukraine is, in particular, the implementation of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients in 2020 (planned implementation year). At the same time, the definition of the concept of the novel food product or ingredient is contained in paragraph 49 of Part 1 of Article 1 of the Law of Ukraine "On basic principles and requirements for the safety and quality of food products" of December 23, 1997, No. 771/97-ВР (hereinafter - the Law of Ukraine No. 771/97-BP): a novel food or ingredient is a food product or ingredient that is significantly different from the usual foods or ingredients present on the market that should be judged from the point of view of its effect on the health of the consumer. The criteria that distinguish the novel food product or ingredient from usual are the following (Part 3 of Article 38 of the Law of Ukraine No. 771/97-BP): 1) a food product or ingredient does not have a history of safe consumption in Ukraine and has a significant change and/or effect as a result of: the application of the animal and/or plant cultivation process that was previously not used for these purposes; production by applying a production process that has not previously been used for this type of product or ingredient; 2) a food product or ingredient does not have a history of safe consumption in Ukraine but has a history of safe consumption in another country/countries and a significant change and/or impact. The term "history of safe consumption" refers to data on the consumption of a food or ingredient as an element of a normal diet of a population of a country or part of a country that does not include data on the negative effects of such a product or ingredient on human health. Such data may, in particular, include results of scientific research, statistical observations (Part 4 of Article 38 of the Law of Ukraine No. 771/97-BP). The term "significant change and/or the effect of a food or ingredient" means the change and/or the effect of a food product or ingredient that, according to the market operator's experience and/or according to scientific data, exceeds more than 100 percent of the normal value (that is, encountered earlier) variations in the usual food products or ingredients or those variations that have occurred in the already registered novel food products or ingredients, such parameters: 1) composition, structure, nutritional value of a food product or ingredient, its physiological effect; 2) the way in which the food product or ingredient is metabolized in the human body; 3) the safety of food product or ingredient. New food products do not include unprocessed foods that do not have a history of safe consumption in Ukraine but have a history of safe consumption in other countries or parts thereof (Part 6 of Article 38 of the Law of Ukraine No. 771/97-BP). Also, according to Paragraph 84 of Part 1 of Article 1 of the Law of Ukraine No. 771/97-BP, the technical regulation is a normative legal act approved by a decision of the Verkhovna Rada of Ukraine, the Cabinet of Ministers of Ukraine, joint or individual decisions of the European legislatures - the European Commission, the European Council, European Parliament, which defines the characteristics of products or related processes or production methods, as well as requirements for services, including relevant provisions, which are mandatory. The technical regulations may also include requirements for terminology, labels, packaging, marking or labeling applicable to a particular product, process or production method. In the absence of a technical regulation regarding a particular object of regulation approved by a decision of the Verkhovna Rada of Ukraine or the Cabinet of Ministers of Ukraine, the European Union technical regulation, if any, is applicable.

Proceeding from the foregoing, if baobab is a processed food product - it can be considered the novel food for the definition of this concept in the legislation of Ukraine, and also on the basis of application of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients applied on the basis of Paragraph 84 of Part 1 of Article 1 of the Law of Ukraine No. 771/97-ВР. If baobab is an unprocessed food and at the same time has a history of safe consumption in other countries or parts thereof (for example, in the countries of the European Union) - it does not belong to the novel food on the basis of Part 6 of Article 38 of the Law of Ukraine No. 771/97-ВP. According to Paragraph 1 of Part 2 of Article 29 of the Law of Ukraine No. 771/97-ВР, the novel food products are subject to state registration as objects of sanitary measures.

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