Notification of food supplements in Romania

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1 Notification of food supplements in Romania Ioana Ratescu 1.- Legal background First regulations regarding food supplements were enacted through Emergency Government Ordinance no. 97/2001 regarding the production, circulation and commercialization of foodstuffs ( EGO 97/2001 ) and Law no. 57/2002 approving EGO 97/2001. EGO 97/2001 still in force provides that the Public Health Ministry is empowered to issue regulations regarding food supplements and fortifying foods and that Regulation must set rules on fortifying, food restoration through the addition of nutrients, as well as the rules on the manufacturing and commercialization of food supplements containing nutrients. Such regulation must state the recommended daily amount of nutrients. Nevertheless, the issue of food supplements was regulated at national level in 2005 on the basis of: (i) Joint Order no. 243/402/2005 of the Minister of Agriculture, Forests and Rural Development and Health Minister; (ii) Joint Order no. 1228/244/63/2005 of the Minister of Agriculture, Forests and Rural Development, Health Minister and President of the National Sanitary Veterinary and Food Safety Authority; and (iii) Health Minister Order no. 1069/2007. The existence of the three above-mentioned orders generated many difficulties in the notification and commercialization of food supplements for economic agents envisaging to notify and sell food supplements in Romania. 2.- Notification requirements According to Public Health Minister Order no. 1069/2007 approving the Norms on food supplements ( Order 1069/ 2007 ) creating the legal frame for application of Directive 2002/46/EC on food supplements 1, food supplements represent foodstuffs the purpose ( 1 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. 1

2 of which is to supplement the normal diet and which are concentrated sources of nutrients and other substances with a nutritional or a physiological effect, alone or in combination, marketed in doze form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar forms of liquids or powders designed to be taken in measured small unit quantities. Food supplements may consist of nutrients (vitamins and minerals) alone or nutrients in combination with other substances. According to Directive 2002/46, to facilitate efficient monitoring of food supplements, the manufacturer or the person placing on the market a food supplement shall notify the competent authority of that placing on the market, by forwarding a model of the label used for the product. Moreover, Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in food supplements which comply with Directive 2002/46. Therefore, competent authorities of the Member States are not entitled to set up further (documentation) requirements. Apparently, such requirements were significantly supplemented by Romania as far as the notification of food supplements not exclusively consisting of nutrients is concerned Notification before the Health Ministry As per Order 1069/2007, the Health Ministry represents the competent authority for the notification of food supplements consisting exclusively of nutrients (such as vitamins and minerals), such nutrients being synthetically obtained. The procedure before the Health Ministry is simplified and has a rather informative purpose (no actual analysis of the product is made), along with the principles enshrined under Directive 2002/46. The procedure consists of submitting a notification form together with a template of the label in hard and soft copy and the Health Ministry issues the form attesting the registration of the notification within 48 hours from submission of the notification. However, in the case of products not exclusively consisting of vitamins and minerals, but also containing other synthetically obtained ingredients, the product is not to be notified to the Health Ministry Notification before the Institute of Food Bio-Resources Minister of Agriculture, Forests and Rural Development, Health Minister and President of the National Sanitary Veterinary and Food Safety Authority Order no. 1228/244/63/2005 approving the Technical Norms on the commercialization of predosed food supplements of animal and vegetal origin and/or of their mixtures with 2

3 vitamins, minerals and other nutrients ( Order 1228/2005 ) states the technical rules applicable to the commercialization of the following categories of products: (i) animal and vegetal extracts and other processed products of animal and vegetal origin; (ii) mixtures of vegetal and animal extracts, their mixtures with vitamins and/or minerals, including mixtures of vitamins and/or minerals with medicinal and aromatic plants, animal origin products, microorganisms, amino acids, fats of vegetal and animal origin and other nutrients; (iii) bee products, mixtures of bee products and/or mixtures of bee products with medicinal and aromatic plants and/or other products of animal origin and/or essential oils, vitamins, minerals and other nutrients; (iv) other products scientifically proven to be food supplements, which are not covered by Order 1069/2007 and Agriculture, Forests and Rural Development Minister and Public Health Minister Order no. 244/401/2005 on the processing and commercialization of medicinal and aromatic plants used as such, partially processed under the form of pre-dosed food supplements. According to Order 1228/2005, the above-mentioned products may be commercialized only further to a prior notification to the Institute of Food Bio-Resources ( IFB ) or other similar institutes located in different cities in Romania which are mentioned under Order 1228/2005. Therefore, depending on the composition of the foodstuffs, one of the above-mentioned authorities may have competence in relation to the notification of a food supplement. A particular emphasis will be placed in the following on the notification procedure before the IFB, due to its specific characteristics and requirements. 3.- Notification procedure before the IFB 3.1. General considerations With a view to performing the notification procedure, the manufacturer, the importer or the authorized representative of the manufacturer should submit the notification file to the IFB. The notification file will include the following documentation: the notification application for the product; a copy of the certificate of registration with the Trade Registry; the product presentation sheet, specifying that the product falls within the categories of products mentioned under points (i)-(iv) above, or, in the case of imported products, the conformity certificate and the country of origin; the quantitative and qualitative list of ingredients for the product; 3

4 physical-chemical and microbiological analysis bulletin issued by a laboratory accredited by a third party; the label of the product in Romanian language; the packaging certificate, issued in accordance with the legislation in force. In fact, this packaging certificate represents a certificate confirming that the product complies with the legislation in force. The above-mentioned documents (except for the label of the product) may be also filed in English language. In case the product is commercialized as food supplement in other countries, such information may be also filed with the IFB. Based on the notification file, the IFB will issue the notification certificate for the product. The notification certificate will be granted within 10 calendar days as from the date of submission of the file (provided all required documents are submitted). In case there are notification files for which no certificates were granted, the Interministerial Technical Committee for medicinal and aromatic plants will asses, evaluate and decide the applicable measures from a technical standpoint. The product may not be marketed until the date of issuance of the certificate. The food supplements already notified do not require any other notification. The notification certificate will include the following: - the IFB heading; - series and number under which it was registered with the IFB; - date of issuance; - name of the product for which it was granted; - identification particulars of the applicant for the respective product; - name, surname and signature of the person proposing the issuance of the notification certificate; - name, surname and signature of the legal representative of the IFB, as well as its seal. The number of the notification certificate will be used on all commercial documents, including in the numbering of the notification certificate for the product Specificities of the notification procedure Apart from the documentation specifically provided under Order 1228/2005, the applicant is also required to provide a so-called statement of commitment. On the basis of this statement of commitment, the applicant should attest as to the product s manufacturing according to applicable standards, as well as its engagement to communicate to the IFB additional information and data that may become available to it at any time. This obligation imposed on the applicant actually goes beyond the possibilities of the Member States as set described in Art 10 of Directive 2002/46. 4

5 In relation to the list of ingredients, and in particular the use of the "excipients" in the product, applicants are required to provide the quantities of all ingredients used in the products. It appears that a statement that an ingredient is used in accordance with technological requirements and/or in compliance with specific legislation may not suffice. According to IFB s requirements, any ingredient present on the label of the product should be quantitatively provided in the notification application. Moreover, the IFB requests information regarding the type of "flavours" used in the product. In one specific case, it was sufficient to indicate the use of "flavours" in the product, without any additional information as to the nature of aromas being required. However, the quantity of aroma used in the product needs to be stated, as this also qualifies as an ingredient used in the product. By proceeding like this, the IFB would be provided with the full recipe of the product which in the majority of cases qualifies as a secret, confidential and publicly inaccessible information, the consequence being, in case of failure to provide the necessary information, the rejection of the notification application. However, a successful solution might be the provision of the nutritional information giving an overview about the content of the most important ingredients, along with a letter explaining the legal situation on EU-level (in case the product is already legally sold in different EU-member states). 4.- Conclusion We may therefore conclude that the requirements imposed under Order 1228/2005 go far beyond the notification requirements provided for under Directive 2002/46/EC and may affect the goal of this Directive, which consists in the free movement of such products and the creation of equal conditions of competition in the context of the functioning of the internal market. Apparently, there are many more other countries (apart from Romania) which set up hurdles for the placing on the market of food supplements which are not in line with European law. 5

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