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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of September 2, 2009 No. 538

About approval of Sanitary regulations about additives to food

(as amended on 25-04-2024)

Based on part (5) article 14 of the Law No. 306/2018 on safety of foodstuff (The official monitor of the Republic of Moldova, 2019, Art. No. 59-65, 120), Art. 6 of the Law No. 10-XVI of February 3, 2009 on the state supervision of public health (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183) and for the purpose of ensuring higher level of protection of health of the population DECIDES: the Government

This resolution shifts the Directive (EU) 2002/46 European parliament and Council of June 10, 2002 about rapprochement of the legislation of EU member states concerning nutritional supplements published in the Official magazine of the European Union by L 183 of July 12, 2002 with the last amendments made by Regulations (EU) 2021/418 Commissions of March 9, 2021 about modification of the Directive 2002/46/EC of the European parliament and Council concerning the niacinamide of riboside of chloride and magnesium of citrate of malate used in case of production of nutritional supplements and also concerning the units of measure used for copper.

1. Approve Sanitary regulations about additives to food it (is applied).

2. The additives to food registered in the Republic of Moldova before adoption of this Resolution and not corresponding to this regulating document can be placed in the market for no more than 12 months from coming into force of this Resolution.

3. To impose control over the implementation of this Resolution on the Ministry of Health.

Prime Minister

Zinaida Grechany

Countersigns:

Minister of Health

 

Larisa Katrinich

Approved by the Order of the Government of the Republic of Moldova of September 2, 2009, No. 538

Sanitary regulations about additives to food

The sanitary regulations about additives to food (further - Regulations) shift the Directive 2002/46/EC of the European Parliament and Council of June 10, 2002 about harmonization of precepts of law of state members concerning biological additives to food published in the Official magazine of the European Union of L 183 of July 12, 2002.

I. General provisions

1. These Regulations are applied to the additives to food placed in the market as foodstuff and provided as such without damage to provisions of the national legal system of rather new foodstuff.

2. Additives to food are placed in the market only in the type which is packed up by the producer.

3. These Regulations are not applied to medicines in that type in what they are determined in the Law No. 1409-XIII of December 17, 1997 on medicines (The official monitor of the Republic of Moldova, 1998, Art. No. 52-53, 368).

4. For the purpose of these Regulations the concepts provided in the Law No. 306/2018 on safety of foodstuff are applied (The official monitor of the Republic of Moldova, 2019, Art. No. 59-65, 120), with subsequent changes, about foodstuff, and also the stated below concepts which are determined as follows:

a) nutrients mean the following substances:

vitamins;

minerals;

b) substances with food or physiological effect, others than nutrients - chemically certain substances having food or physiological properties, the nutrients and substances having exclusively pharmacological properties except for stated above;

c) plants and medicines from plants - the ingredients consisting of plants or isolated from them, the nutrients and substances except for stated above with food or physiological effect, others than nutrients which have food or physiological properties, except for plants and medicines from the plants having pharmacological properties and intended only for the therapeutic purposes;

d) daily recommended dose of nutrients (SRD) - the daily amount of nutrients specified in appendix No. 3 to these Regulations which is used as general reference meaning for expression of percent of vitamins and minerals;

e) daily portion for the use - the amount of additive to food recommended by the producer for the daily use;

f) recommended level of consumption of nutrients - daily consumption of nutrients which corresponds to requirements of absolute majority of foreign healthy faces of the certain national group specific on age, sex, intensity of work, the physiological status;

g) additive to food is the foodstuff intended for amendment of regular food allowance and which is the concentrated source of nutrients or one or combination of nutritious or other substances with food or physiological effect and extended in dosage form, that is in the form of, for example, capsules, tablets, pastils, pills and other similar forms, the dosed powders, ampoules with liquids, bubbles with drops and other similar forms of the liquids and powders intended for acceptance in the measured quantities.

5. Ceased to be valid according to the Order of the Government of the Republic of Moldova of 28.06.2023 No. 442

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