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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of September 15, 2016 No. 1056

About approval of Sanitary regulations about food enzymes

(as amended of the Order of the Government of the Republic of Moldova of 18.12.2017 No. 1090)

Based on part (2) Article 6 and part (3) article 72 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), with subsequent changes and amendments, parts (9) article 9 of the Law No. 78-XV of March 18, 2004 on foodstuff (The official monitor of the Republic of Moldova, 2004, Art. No. 83-87, 431), with subsequent changes and amendments, and also for the purpose of ensuring higher level of protection of health of the population DECIDES: the Government

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

2. This resolution becomes effective after 6 months of co of day of publication in the Official monitor of the Republic of Moldova.

3. To impose control over the implementation of this resolution on the Ministry of Health, work and social protection.

Prime Minister

Paweê Phillip

Countersign:

deputy. Prime Minister, Minister of Foreign Affairs and European Integration

 

Andrey Galbur

Minister of Health

Ruksanda Glavan

Minister of Justice

Vladimir Chebotar

Approved by the Order of the Government of September 15, 2016, No. 1056

Sanitary regulations about food enzymes

The sanitary regulations about food enzymes (further – Regulations) state Regulations (EC) No. 1332/2008 of the European Parliament and Council of December 16, 2008 about food enzymes and about change of the Directive of Council 83/417/EEC, the Regulations (EU) to No. 1493/1999 of Council, the Directive 2000/13/EC, the Directive 2001/112/EC and Regulations (EC) No. 258/97, of the European Union published in the Official magazine of L 354 of December 31, 2008.

Chapter I. Subject, scope of application and determinations

1. These Regulations establish rules concerning the food enzymes used in foodstuff including concerning such enzymes used as technological additives for the purpose of ensuring effective functioning of the domestic market, providing at the same time the high level of protection of health of the population and high level of consumer protection, including protection of consumer interests and fair practice in trade in food, taking into account environment protection.

For this purpose these Regulations provide:

1) the national list of the approved food enzymes (further - the national list);

2) conditions of use of food enzymes in foodstuff;

3) rules of labeling of the food enzymes realized as such.

2. Scope of application

1) Provisions of these Regulations are applied to the food enzymes determined in Item 3.

2) Action of these Regulations does not extend to food enzymes if they are used in production:

a) the nutritional supplements falling under action of the Sanitary regulations on nutritional supplements approved by the Order of the Government No. 229 of March 29, 2013;

b) technological additives.

3) These Regulations are applied, without violating the specific rules concerning use of food enzymes:

a) in specific foodstuff;

b) in other purposes, except the purposes provided by these Regulations.

4) Provisions of these Regulations are not applied to the microbic cultures which are traditionally used for production of foodstuff and also to it which can make in a random way enzymes, but not used especially for their obtaining.

3. Determinations

1) In these Regulations the determinations established by the Law No. 78-XV of March 18, 2004 on foodstuff, and also the Sanitary regulations on nutritional supplements approved by the Order of the Government No. 229 of March 29, 2013 are applied.

2) also following determinations Are applied:

a) food enzyme - means the product received from plants, animals or microorganisms or from their derivatives including the products received in the course of fermentation with use of microorganisms:

which contains one or more enzymes capable to catalyze specific biochemical reaction; and

which is added to foodstuff for accomplishment of technological function at any stage of production process, conversion, preparation, processing, packaging, transportation or storage of foodstuff;

b) food fermental medicine - means use of one formula consisting of one or several food enzymes which includes such substances as nutritional supplements and/or other food ingredients for simplification of their storage, sale, standardization, dilution or dissolution.

Chapter II. The national list of the approved food enzymes

4. Only food enzymes included in the national list can be placed in the market as such and be applied in foodstuff according to the regulations and conditions of use provided in the subitem 2) of Item 7.

5. Placement in the market of food enzyme or foodstuff at which there is food enzyme is forbidden if use of food enzyme does not correspond to these Regulations and measures for its implementation.

6. Food enzyme can be included in the national list only in that case when it corresponds to the following conditions:

1) does not cause, according to available scientific proofs, any doubts concerning its safety for health of consumers at the offered use level;

2) there is justified technological requirement; and

3) its use does not mislead the consumer. False representation of the consumer is connected with the aspects concerning the nature, freshness and quality of the used ingredients, natural nature of product or production process or nutritious properties of product.

7. Contents of the national list of food enzymes:

1) the Food enzyme corresponding to conditions stipulated in Item 6, can be included in the national list.

2) When entering food enzyme into the national list the following is specified:

a) name of food enzyme;

b) characteristics of food enzyme, including origin and criteria of purity;

c) foodstuff to which food enzyme can be added;

d) conditions under which food enzyme can be used; in cases when it is pertinent, any maximum level for food enzyme is not fixed. In this case food enzyme is used according to the principle of quantum satis;

e) availability of restrictions on direct sale of food enzyme to the final consumer;

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