ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of June 10, 2020 No. 344

About approval of Sanitary regulations about placement in the market and use of biocidal products

Based on Item b) article 6 of the Law No. 277/2018 on chemicals (The official monitor of the Republic of Moldova, 2019, Art. No. 49-58, 109) and article 6 of the Law No. 10/2009 on the state supervision of public health (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183), with subsequent changes, DECIDES: the Government

This resolution partially shifts Regulations (EU) No. 528/2012 of the European parliament and Council of May 22, 2012 about placement in the market and use of biocidal means published in the Official magazine of the European Union by L 167 of June 27, 2012, CELEX: 32012R0528, with the last amendments made by the Delegated regulations (EU) 2024/1398 of the Commission of March 14, 2024.

1. Approve Sanitary regulations about placement in the market and use of biocidal products it (is applied).

2. Declare invalid the Order of the Government No. 564/2009 about approval of Sanitary regulations on establishment of conditions of placement in the market of biodestructive products (The official monitor of the Republic of Moldova, 2009, Art. No. 144-147, 630), with subsequent changes.

3. To impose control of execution of this resolution on the National agency of public health, National agency on regulation of nuclear, radiological and chemical activities and the National agency on safety of foodstuff.

4. This resolution becomes effective after 180 days from the date of publication.

5. This resolution voids from the date of accession of the Republic of Moldova to the European Union.

Countersign: Minister of Health, work and social protection

Viorika Dumbrevyanu

Minister of Agriculture, regional development and environment

Ion Perzhu

 

Approved by the Order of the Government of the Republic of Moldova of June 10, 2020, No. 344

Sanitary regulations about placement in the market and use of biocidal products

The preamble is excluded according to the Order of the Government of the Republic of Moldova of 08.10.2025 No. 671

I. General provisions

1. The purpose of these Regulations is improvement of functioning of the domestic market by harmonization of regulations of placement and use of biocidal products, with simultaneous ensuring high level of health protection of the person, animals and the environment. Provisions of these Regulations are based on the principle of precaution which aim ensuring health of human health, animals, and also environmental protection.

2. These Regulations establish the regulations concerning:

1) uses of the List of active agents which can be used in biocidal products, established at the European Union level which is shifted by the order of the Minister of Health;

2) procedures of registration of biocidal products before their placement in the market;

2-1) simplified procedures of registration of biocidal products;

3) placements in the market of the products processed by biocides.

4) recognitions of the permissions issued in one of the countries of the European Union.

3. These Regulations are applied to the biocidal products and products processed by biocides.

4. The list of groups and types of biocidal products which enter scope of these Regulations are stated in annex No. 1.

5. Requirements of these Regulations are not applied:

1) to the medicinal sterns regulated by the Order of the Government No. 311/2012 about approval of the Regulations establishing conditions of regulation of preparation, introduction on the market and uses of the forages containing medicinal substances;

2) to the medical products regulated by the Law No. 102/2017 on medical products;

3) to medicines of veterinary appointment and drugs for the person, the regulated Law No. 119/2018 on medicines of veterinary appointment and Legal No. 1409/1997 on drugs;

4) to feed additives for animals, the regulated Order of the Government No. 27/2020 about approval of Veterinary health requirements concerning additives in sterns for animals, and also to the sterns regulated by the Order of the Government No. 910/2020 about approval of Veterinary health requirements to sterns for animals;

5) to hygiene of foodstuff, including the animal origin regulated by the Law No. 296/2017 on general requirements of hygiene of foodstuff and the Order of the Government No. 435/2010 on approval of Special rules of hygiene of foodstuff of animal origin;

6) to the nutritional supplements regulated by the Order of the Government No. 229/2013 about approval of Sanitary regulations about nutritional supplements;

7) to food fragrances and ingredients with vkusoaromatichesky properties, held for use in food, the regulated Order of the Government No. 1245/2018 about approval of sanitary regulations about vkusoaromatichesky additives and some food ingredients with vkusoaromatichesky properties for use in and on food and about the smoking fragrances used or held for use in and on food;

8) to the means of phytosanitary appointment regulated the Law No. 119/2004 on means of phytosanitary appointment;

9) to the cosmetic products regulated by the Order of the Government No. 1207/2016 about approval of Sanitary regulations about cosmetic products;

10) to the safety of toys regulated by the Order of the Government No. 808/2015 about approval of the Technical regulation about safety of toys;

11) to the products used as repellents (for scaring away) or attractants (for attraction) harmful organisms;

12) the biocidal products used as technological adjuvants.

6. Without prejudice to Item provisions 4, if the biocidal product enters scope of one of the specified regulations and is held for use for the purpose of, not covered regulations regulating them, apply provisions of these Regulations.

7. Except some opposite requirements provided by these Regulations or other regulations, these Regulations do not mention the requirement of the acts regulating:

1) safety and health of workers on workplace which are regulated by the Law No. 186/2008 on health protection and labor safety and the Order of the Government No. 80/2012 on the minimum requirements on health protection and labor safety on temporary or portable building sites;

2) the health protection and protection of workers against the risks connected with availability of chemicals on workplace, regulated the Order of the Government No. 640/2024 about approval of the Regulations on health protection and protection of workers against the risks connected with availability of chemical agents on workplace;

3) the quality of the water intended for consumption by the person, regulated by the Sanitary standards on quality of drinking water approved by the Order of the Government No. 934/2007;

4) classification, marking and packaging of substances and mixes thus as it is established by the Law No. 277/2018 on chemicals;

5) protection of workers against the risks connected with impact of biological substances on workplace;

6) the political base in the field of water regulated by the Order of the Government No. 890/2013 about approval of the Regulations on quality requirements of the environment for surface water;

7) the protection of workers against the risks connected with impact of cancerogenic or mutagen substances on workplace, regulated the Order of the Government No. 1079/2023 about obligatory routine medical examinations of workers;

8) the resistant organic pollutants regulated according to the Stockholm convention on resistant organic pollutants ratified by the Law No. 40/2004;

9) registration, assessment, authorization and restriction of the chemicals regulated by the Law No. 277/2018 on chemicals;

10) the misleading and comparative advertizing;

11) export and import of dangerous chemicals;

12) use of pesticides;

13) the substances doing harm to ozone layer;

14) animal protection, used in the scientific purposes which is provided with the Law No. 211/2017 on protection of the animals used in experimental or other scientific purposes;

15) industrial emissions.

Requirements of Items 101-108 are not applied to transportations of biocidal products by railway, road, navigable transportation (internal or sea) or air transport.

8. Requirements of these Regulations do not limit or do not prohibit use of biocidal products for the drinking water intended for public supply.

9. Removal of active agents and biocidal products is performed according to the Law No. 209/2016 on waste.

10. For the purpose of these Regulations, the used concepts mean the following:

1) biocidal product - according to the determination stated in the subitem 23) of article 4 of the Law No. 277/2018 on chemicals;

2) microorganism - the microbiological, cellular or not cellular unit capable to replication or transfer of genetic material, as, for example, the lowest mushrooms, viruses, bacteria, yeast, mold, seaweed, protozoa and helminths, microscopic parasites;

3) active agent - according to the determination stated in the subitem 28) of article 4 of the Law No. 277/2018 on chemicals;

4) the substance causing the reasons for concern - the inactive substance having characteristic capability to cause, directly or in more long-term future, collateral influences per capita, mainly, on vulnerable groups, animals or the environment and which is present or is developed in biocidal product in sufficient concentration to create risks of approach of such influence.

Except for case when there are other reasons for concern, such substance is:

a) the substance classified as dangerous or corresponding to criteria of classification as the Provision, dangerous according to requirements, about classification, marking and packaging of substances and mixes as it is determined in the subitem 21) of article 4 of the Law No. 277/2018 on chemicals, and which is present at biocidal product in concentration because of which the product is considered dangerous;

b) the substance corresponding to criteria for its determination as resistant organic pollutant (further - SOZ) or corresponding to criteria for its recognition resistant, bioaccumulative and toxic (further - SAT) or very resistant and very bioaccumulative (further - PERSONS);

5) harmful organism - organism, including pathogenic activators which presence is undesirable or which exert adverse effect per capita, on its activities or on the products used or made by it, on animals or on the environment;

6) remaining balance - the substance which is present in or at products of plant or animal origin, in water resources, in drinking water, in foodstuff, in sterns for animals or in other place in the environment, resulted from use of biocidal product, including metabolites or reaction products or disintegration of such substance;

7) placement in the market - any delivery of biocidal product or the processed product for sale or use in trading activity, on paid or free basis;

8) introduction on the market - the first placement in the market of biocidal product or the processed product;

9) use - the transactions which are carried out by biocidal product including storage, loading unloading, mixing and application, except for the any kinds of activities of this kind which are carried out for export of biocidal product or the processed product;

10) the processed product - any substance, mix or product which was processed by one or several biocidal products or which specially contain them;

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