Ministry of agriculture and rural development ministry of health

In light of Approval Report No 142005 from 17 December 2014, drawn up by the General Directorate for the Food Industry,

pursuant to the provisions of Articles 1, 2 and 3 of Law No 491/2003 regarding medicinal and aromatic plants, as well as honey bee products, with its subsequent amendments and additions,

On the grounds of Article 1(3) of Decision No 1185 of 29 December 2014 regarding the organisation and operation of the Ministry of Agriculture and Rural Development and Article 7(4) of Government Decision No 144/2010 regarding the organisation and operation of the Ministry of Health, with its subsequent modifications and supplementation, and in accordance with the provisions of Decision No 1016/2004 of the Romanian Government regarding measures for organising and carrying out the exchange of information in the field of technical standards and regulations, as well as the rules regarding information society services between Romania and the other Member States of the European Union, as well as the European Commission, with the subsequent modifications and supplementation,

Within the meaning of this Order, the following terms are defined as follows:

1. plant preparation - the process defined in accordance with Article 1(2)(b) of Law No 491/2003 regarding medicinal and aromatic plants, as well as honey bee products, with its subsequent amendments and additions;

2. plant processing - transformation of the raw materials obtained by processing into finished products, which are sold as medicines, cosmetics, food supplements, condiments and foods;

3. commercialisation of medicinal and aromatic plants, which are partially processed or processed into food supplements - the marketing of food supplements in accordance with the legal provisions regarding notification and retailing, namely any sale-purchase and import-export operations whose purpose is to provide food supplements to a third party, except for those intended to be used for scientific research and laboratory analyses;

4. pre-dosed food supplements - capsules, tablets, other similar forms, pills containing powder, ampoules containing liquid, dropper bottles and other similar forms of liquids and powders or chopped-up plants intended to be used in small, units of measure quantities.

(1) It is prohibited to process and sell food supplements which contain plants that are mentioned in Annex 1 - Genera and species of plants whose parts or derivatives are not permitted to be used in food supplements.

(2) It is prohibited to process and sell food supplements which contain species of algae, lichens and fungi that are not mentioned in Annex 2 and/or species of medicinal and aromatic plants that are not mentioned in Annex 3.
Article 3

(1) Any finished product obtained by preparing and processing medicinal and aromatic plants will only undergo commercialisation on the basis of a Notification Approval issued by the National Service for Medicinal and Aromatic Plants and Honey Bee Products, hereafter referred to as S.N.P.M.A.P.S., within the National Institute for Research and Development for Food Bioresources - IBA Bucharest; this Approval will be obtained according to the Procedure in force, for notifying finished products based on medicinal and aromatic plants and honey bee products that must be reported by the operators in the field as food supplements, products for internal or external use with the exception of cosmetic products, approved by Order No 1946 of 17 December 2014 of the Ministry of Agriculture and Rural Development.

(2) Vegetables, fruit, aromatic plants and seeds that are commonly used for nourishment may be used as ingredients in food supplements.

(3) Products that have already been notified and are available on the market, which do not comply with the requirements of this Order, may only be sold until the stocks are depleted, but for no longer than 12 months from the date when this Order comes into force; during this time, measures need to be taken for their re-notification.

(1) The labelling of medicinal and aromatic plants used on an 'as is' basis, which are partially processed or processed as pre-dosed food supplements must also include the common name, if any, as well as the scientific name, and must comply with the regulations in force with regard to packaging and labelling.

(2) Commercialisation of medicinal and aromatic plants used on an 'as is' basis, which are partially processed or processed as pre-dosed food supplements, without being pre-packaged is prohibited.
Article 6

Annexes 1-3 are an integrated part of this order.

As of the date when this Order comes into force, Order No 244/401 of 22 April 2005 of the Ministry of Agriculture and Rural Development and the Ministry of Health with regard to the preparation, processing and commercialisation of medicinal and aromatic plants used on an 'as is' basis, which are partially processed or processed as pre-dosed food supplements, published in the Official Gazette of Romania, Part I, No 456 of 30 May 2005, will be repealed.

This Order will be published in the Official Gazette of Romania, Part I.