ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of September 10, 2009 No. 564

About approval of Sanitary regulations on establishment of conditions of placement in the market of biocidal products

Based on part (2) Article 6 and part (3) article 72 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) DECIDES: the Government

1. Approve Sanitary regulations on establishment of conditions of placement in the market of biocidal products it (is applied).

2. The Ministry of Health, work and social protection is the national authority competent of regulation of the mode of production of biocidal products for placement in the market.

3. To physical/legal entities - producers and/or importers to inform till July 1, 2010 in writing the Ministry of Health on biocidal products which they make or implement, according to the form given in appendix No. 9 to the specified Regulations.

4. 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.

5. This Resolution becomes effective within 30 days from the date of publication.

 

Countersign: first Deputy Prime Minister, Minister of Economy and Trade

Igor Dodon

Minister of Health

Larisa Katrinich

Minister of Agriculture and food industry

Anatoliye Gorodenko

Minister of Ecology and Natural Resources

Violeta Ivanov

Sanitary regulations on establishment of conditions of placement in the market of biodestructive products

Sanitary regulations on establishment of conditions of placement in the market of biodestructive products (further - Regulations) provisions of the Directive of the European Parliament and Council No. 98/8/CE of February 16, 1998 about the realization of biodestructive products published in the Official magazine of the European Union No. L 123 of April 24, 1998, p. 1, with subsequent changes and amendments take root.

I. General provisions

1. These Regulations establish the procedure of registration and placement of biodestructive products in the consumer market.

2. In the context of these Regulations the used concepts mean the following:

a) the registration certificate - the administrative registration document issued by the National agency of public health based on the submitted application and intended for placement of biodestructive product in the market of the Republic of Moldova;

b) the standard form - the technical specification on group of biodestructive products of similar appointment for use by certain category of users. Products of this group shall contain similar active agents with identical characteristics, and on structure shall not differ from the registered earlier biodestructive product, except for some derivatives which are not influencing degree of potential risk and efficiency of these products in any way;

c) formulyator - if the biodestructive product is made in the country, - the producer of biodestructive product or the person living in the country and appointed by the producer as the exclusive representative;

d) harmful organism - any organism, whose presence or effects caused by it are undesirable to people, their life activities or for products which they use or make, for animals or for the environment;

e) the participant - the producer, the manufacturer or association which gave notification;

f) medicine - the mix or solution received from two or more substances;

g) producer: the manufacturer of active substance / the biodestructive product made in the country or the person living in the country and appointed by the producer as the exclusive representative or if the representative is not appointed - the importer of active substance / biodestructive product to the country;

h) biodestructive products - the active agents and medicines containing one or several active agents provided in the form in which they are delivered to the consumer intended for destruction, keeping, neutralization of harmful organisms, the prevention of their activity or fight against them in any manner as a result of chemical or biological impact;

i) biodestructive products of reduced risk - the biodestructive product containing in quality of active agents one or several substances entered in the List of the approved active agents and requirements for their entering into category of biodestructive products of reduced risk (appendix No. 11 to these Regulations) which do not contain any problem substances;

j) the allowing letter - the document signed by holders/holders of the relevant data protected by the current legislation in which it is specified that these data can be used by the National agency of public health for the purpose of state registration or for the purpose of receipt of sanitary permission to biodestructive product, according to these Regulations;

k) applicant:

producer or formulyator which constituted notification;

the association of the producers and/or formulyator living in the country, appointed by the producer and/or formulyator which constituted collective notification;

l) active agent - substance or microorganism, including virus or mushroom which make general or purposeful impact on harmful organisms or counteracts them;

m) new active agent - active agent which at the time of approval of these Regulations was not specified in appendices No. 10-12, and any other substance which is not specified in appendix No. 13 to these Regulations;

n) the main substance - the substance entered in the List of the approved main substances and the accompanying requirements (appendix No. 12 to these Regulations) used in other products except pesticides, but which is applied marginally as biodestructive product directly or as a part of the product created based on substance and simple thinner and which is not subject to direct sale for use as biodestructive product;

o) problem substance - any substance other than active agent in which the capability of harmful effects on people, animals or the environment is inherent and which enters or can be part of biodestructive product, the concentration sufficient for creation of similar effects;

p) residual substance - one or several substances which are present at biodestructive product which remain after use, including their metabolites and products received as a result of their degradation or reaction.

3. These Regulations are applied to the biodestructive products classified according to appendix No. 1 to these Regulations.

4. The exception of provisions of these Regulations is constituted by the following chemicals and products which are determined or provided by scope of the following regulation:

a) the medicines regulated by the Law on medicines No. 1409-XIII of December 17, 1997 with subsequent changes and amendments;

b) the medical products regulated by the Order of the Government No. 96 of January 29, 2007. "About establishment of conditions of placement in the market and uses of medical products";

c) the nutritional supplements determined by the Law on foodstuff No. 78-XV of March 18, 2004;

d) materials and products which enter direct contact with foodstuff, including raw milk, pasteurized milk, dairy products, products on egg basis, fish products;

e) nutrients (additive to food) for animals;

f) nutritional supplements in forage for animals;

g) cosmetic products;

h) products for protection of plants.

II. Competent authorities by assessment and supervision of biodestructive products before their placement in the market

5. The national agency of public health is responsible for:

a) assessment of biodestructive products and biodestructive products of reduced risk:

- on types of products 1-23, specified in appendix No. 1 to these Regulations, in the part concerning their impact on human body;

- on types of products 1, 2, 4 - disinfectants for the surfaces adjoining to food products, 5, of 6, of 7, of 8, of 9, of 10, of 11, of 12, 13 and 14 - rodenticides against nonagricultural rodents, 18 - insecticides, acaricides and products against other nonagricultural arthropods, 19 - nonagricultural repulsiva and baits, 20 - products for protection of food, 21, 22 - the liquids used for embalming and taxidermy of human corpses - specified in appendix No. 1 to these Regulations, regarding efficiency;

b) forming of Commission of experts in cooperation about the National agency on safety of foodstuff and Environmental protection agency;

c) organization of Technical secretariat;

d) the edition of administrative documents on placement in the market of new biodestructive products, with observance of the operating assessment procedures;

e) issue of registration certificates for placement in the market of new biodestructive product based on estimative expert opinions by results of assessment of all risks connected with each active agent and with each potentially dangerous substance, which are present at biodestructive product;

f) accounting of any unacceptable essential effects, efficiency evaluation of biodestructive product and benefit as a result of its use, before decision making about registration;

g) determination of the means and procedures designed to provide accomplishment of all obligations of the National agency of public health regarding correct informing applicants, the public about biodestructive products;

h) the organization and coordination of inventory count at the national level of all biodestructive products which are already placed in the market;

i) ensuring administrative and technical base of Technical secretariat for implementation of the powers;

j) the approved development of the National registry of bidestruktivny products;

k) creation of answers to possible claims from customers;

l) submission of offers to the emitting bodies for review and cancellation of administrative documents in the course of inventory count of biodestructive products based on which the biodestructive products which are not conforming to requirements of these Regulations are implemented;

m) supervision of the biodestructive products placed in the market on types of products 1, of 2, 4 - disinfectants for the surfaces adjoining to forage for animals, 5, of 6, of 7, of 8, of 9, of 10, of 11, of 12, 13 and 14 - rodenticides against nonagricultural rodents, 18 - insecticides, acaricides and products for fight against other nonagricultural arthropods, 19 - nonagricultural repulsiva and baits, 20 - products for protection of food, 21, 22 - the liquids used for embalming and taxidermy of human corpses - specified in appendix No. 1 to these Regulations.

6. For the purpose of accomplishment of the powers the National agency of public health cooperates with bodies of the central public management and if necessary, can request their opinion on these or those questions.

7. The national agency of public health participates in national and international actions in this sphere.

8. The bodies and experts involved to consideration of the file if necessary provide confidentiality of information and data.

9. Meetings of Commission of experts are convened by Technical secretariat.

10. All meetings are recorded.

11. If for any reason it becomes clear that the expert does not carry out the obligations assigned to him, it is allowed to petition before the Ministry for its replacement with other representative.

12. Copies of registration certificates and the sanitary conclusions or other issued documents are archived by Technical secretariat for 10-year storage duration.

13. The technical secretariat performs the following functions:

a) accepts the documents necessary for registration and permission of bidestruktivny products from applicants;

b) provides complete and correct information to applicants concerning requirements for receipt of registration certificates or sanitary permissions;

c) distributes to experts technical files for the analysis and assessment;

d) if the technical file does not correspond to the conditions necessary for the procedure of the analysis and assessment, informs the applicant concerning need of amendment and refining of the file;

e) directs results of process of assessment for decision making;

f) constitutes the documents necessary for the current activities;

g) develops and administers the National registry of biodestructive products;

h) requests the separate label and technical card of safety for biodestructive product if they are not applied to this biodestructive product;

i) the sample of substance, product or packaging can request;

j) will organize and provides archiving of documents according to provisions of these Regulations;

k) provides to applicants standard format of the form for notification of biodestructive products for the purpose of creation of the national inventory list of the biodestructive products which are already placed in the market;

l) provides acceptance and processing of forms of notifications within the national inventory list of biodestructive products;

m) constitutes and manages the electronic database, both for inventarizovanny, and for new biodestructive products;

n) carries out any other activities for request of the National agency of public health.

14. The national agency is responsible for safety of foodstuff:

for assessment of biodestructive products and biodestructive products of reduced risk, in part:

- types of products 1-23, specified in appendix No. 1 to these Regulations, in respect of influence on health of animals;

- types of products 3, 4 - disinfectants for the surfaces adjoining to forage for animals, 14 - rodenticides against agricultural rodents, 15, 16, 17, 18 - insecticides, acaricides and means of fight against other agricultural arthropods, 19 agricultural repulsiva and baits, 20 - products for protection of forages for animals, 22 - liquids, ispoluyemy for embalming and taxidermy of corpses of animals, 23, - specified in appendix No. 1 to these Regulations, from the point of view of efficiency;

for supervision of the biodestructive products placed in the market on types of products: 3, 4 - disinfectants for the surfaces adjoining to forage for animals, 14 - rodenticides against agricultural rodents, 15, 16, 17, 18 - insecticides, acaricides and means of fight against other agricultural arthropods, 19 - agricultural repulsiva and baits, 20 - products for protection of forages for animals, 22 - the liquids used for embalming and taxidermy of corpses of animals, 23, - specified in appendix No. 1 to these Regulations.

15. Ceased to be valid according to the Order of the Government of the Republic of Moldova of 18.01.2019 No. 12

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info