ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of December 31, 2009 No. 925

About approval of Sanitary regulations about new foodstuff

Based on article 11 of the Law on foodstuff No. 78-XV of March 18, 2004. (The official monitor of the Republic of Moldova, 2004, Art. No. 83-87, 431), article 6 of the Law on the State supervision of public health No. 10-XVI of February 3, 2009. (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183) and for the purpose of ensuring high level of protection of health of the population DECIDES: the Government

1. Approve Sanitary regulations about new foodstuff it (is applied).

2. To impose control over the implementation of this Resolution on the Ministry of Health, work and social protection and the Ministry of Agriculture, regional development and the environment.

Approved by the Order of the Government of the Republic of Moldova of December 31, 2009 , No. 925

Sanitary regulations about new foodstuff

The sanitary regulations about new foodstuff (in dalneyshemreglament) are brought into accord with requirements of Regulations (EU) No. 258/97 of the European Parliament and Council of January 27, 1997 about new foodstuff and ingredients (JO L 43, 14.2.97, items 1), with the changes made by Regulations (EC) No. 1829/2003 of the European Parliament and Council of September 22, 2003 (JO L268, on October 18, 2003, the item 1) and Regulations (EC) No. 1882/2003 of the European Parliament and Council of September 29, 2003 (JO L 284, on October 31, 2003, the item 1), and also with requirements of Regulations (EC) No. 1852/2001 of the September 20, 2001 determining rules of provision and maintaining confidentiality of information specified according to Regulations of the European Parliament and Council (EU) to No. 258/97.

Chapter I. General provisions

1. These Regulations establish introduction regulations on the market of the Republic of Moldova of new foodstuff for the purpose of guaranteeing high level of health protection of the person and consumer interests, at the same time providing effective functioning of the domestic market.

2. In these Regulations the concepts provided by the Law on foodstuff No. 78-XV of March 18, 2004 are applied.

3. These Regulations are applied in case of placement in the market of the new foodstuff which was not used before enforcement of these Regulations in food of the person, in significant amount in the Republic of Moldova which is subdivided into the following categories:

a) foodstuff with the new specially changed or primary molecular structure;

b) the foodstuff allocated from microorganisms, mushrooms (pleseny), seaweed or their isolates;

c) foodstuff from plants or allocated from plants or from animals, except for the foodstuff consisting of plants or allocated from the plants or animals received by traditional methods of reproduction or reproduction, and foodstuff which have use history in safe conditions (if nonconventional technology of reproduction which was not used before enforcement of these Regulations was applied to plant or animal);

d) foodstuff to which the production process which was not used as popular before enforcement of these Regulations was applied, leading to essential changes of structure or structure of foodstuff which influence nutritional value, metabolism or level of undesirable substances.

4. Use of foodstuff only as the permitted nutritional supplement or as a part of the permitted nutritional supplement is insufficient in order that it was possible to establish whether it was used in significant amount in food of the person in the country before enforcement of these Regulations. At the same time, in case foodstuff was used only as the permitted nutritional supplement or as a part of the permitted nutritional supplement before this date, it can be placed in the market after this date for use in the same quality, without its recognition by new foodstuff.

5. Provisions of these Regulations are not applied to:

a) to foodstuff in that case and in that measure when they are used as:

nutritional supplements;

food fragrances;

the extraction solvents used in case of production of foodstuff;

food fermental medicines;

vitamins and minerals for use in the foodstuff intended for consumption in food;

b) to foodstuff to which operation of the Law on biological safety No. 755-XV of December 21, 2001 and the Order of the Government No. 1153 of September 25, 2003 extends. "About approval of the Regulations on issue of permissions to the types of activity connected with testing, production, use and realization of genetically modified organisms".

Chapter II. Requirements to new foodstuff

6. Foodstuff to which action of these Regulations extends shall meet the following requirements:

a) not raise any questions concerning safety for health of the consumer under normal conditions of consumption;

b) not mislead the consumer by method of their representation or by the provided consumption method;

c) not differ from foodstuff which they will replace in any aspect which can be unprofitable for the consumer from the point of view of nutritiousness.

7. For the purpose of placement in the domestic market of new foodstuff of the procedure, provided by Items 8-9, 13-17 and 20-25 of these Regulations, are applied according to the criteria provided in Item 6 of these Regulations and with the requirements provided in the specified Items.

8. The physical person or legal entity responsible for placement in the domestic market of new foodstuff, directs the application to the National agency of the public health which is the administrative authority subordinated to the Ministry of Health, work and social protection.

9. Are applied to the statement specified in Item 8 of these Regulations:

a) necessary information, including copies of acts of the conducted researches, and any other materials which can show that foodstuff corresponds to the criteria provided in Item 6 of these Regulations;

b) relevant proposals on representation and labeling of foodstuff according to requirements of Chapter IV of these Regulations;

c) short file.

10. All expenses, files, including expenses on the researches, necessary for creation, proving that new foodstuff answers the criteria stated in Item 6 of these Regulations become covered at the expense of the physical persons or legal entities responsible for placement in the domestic market of the declared new foodstuff.

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