of January 20, 2017 No. 9
About approval of Sanitary standards and the rules "Hygienic Safety of Remedies of Plants"
Based on article 13 of the Law of the Republic of Belarus of January 7, 2012 "About sanitary and epidemiologic wellbeing of the population", paragraph two of subitem 8.32 of Item 8 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:
1. Approve the enclosed Sanitary standards and the rules "Hygienic Safety of Remedies of Plants".
2. This resolution becomes effective in fifteen working days after its signing.
First Deputy Minister
D.L.Pinevich
Approved by the Resolution of the Ministry of Health of the Republic of Belarus 20.01.2017 No. 9
1. These Sanitary standards and the rules "Hygienic Safety of Remedies of Plants" (further - Sanitary standards and rules) establish the hygienic requirements to remedies of plants aimed at safety of health of the population.
2. Requirements of these Sanitary standards and rules are obligatory for observance by state bodies, other organizations, including individual entrepreneurs, physical persons.
3. The state sanitary inspection behind respect for these Sanitary standards and rules is performed according to the legislation of the Republic of Belarus.
4. Perpetrators bear responsibility according to legal acts of the Republic of Belarus for violation of requirements of these Sanitary standards and rules.
For the purposes of these Sanitary standards and rules the main terms and determinations in the values established by the Law of the Republic of Belarus of January 7, 2012 "About sanitary and epidemiologic wellbeing of the population" are used (The national register of legal acts of the Republic of Belarus, 2012, No. 8, 2/1892), the Law of the Republic of Belarus of December 25, 2005 "About protection of plants" in edition of the Law of the Republic of Belarus of July 18, 2016 (The national register of legal acts of the Republic of Belarus, 2006, No. 6, 2/1174; National legal Internet portal of the Republic of Belarus, 21.07. 2016, 2/2396).
5. Safety and harmlessness of remedies of plants are determined by toxicological indicators and hygienic requirements.
6. Toxicological indicators of remedies of plants include:
acute, subacute and chronic toxicity, the specific and remote effects of impact on health of the person (allergenicity, immunotoxicity, reproductive toxicity, teratogenecity, mutagenicity, carcinogenicity, embriotoxity). In addition for biological medicines - data on pathogenicity for warm-blooded animals (virulence, toxicity, toxigenicity), disbiotichesky action, toxicity in case of intranasal receipt, structure of kontaminantny microflora;
availability of toxic impurity in preparative form of remedies of plants;
capability to metabolism of active ingredients of remedies of plants in organism of mammals, habitat objects with formation of toxic metabolites;
danger class, according to the hygienic classification established by the international legal acts constituting the regulatory legal base of the Customs union and the Common economic space.
7. Hygienic requirements of safety of remedies of plants include:
hygienic standard rates on active ingredients of remedies of plants in objects of the habitat and vegetable products: admissible daily dose, threshold limit value, the most admissible level of residual quantities, approximate safe level of impact, approximate admissible concentration;
regulations of application on the most dangerous component;
justification of terms of expectation (in days before harvesting after the last processing);
availability of residual amounts of active ingredients of remedies of plants in agricultural products and other objects of the habitat;
risk assessment to health of the population and the remedies of plants working in case of application taking into account the maximum consumption rates, frequency rate and different technologies of application;
justification of the terms of safe exit working for the processed sites (territories);
availability of methods of analytical control of active ingredients of remedies of plants in agricultural products and objects of the habitat.
8. The class of danger of remedies of plants is established by the limiting criterion of harmful action determining the greatest health hazard of the person. In cases if the limiting criterion is toxicity of metabolite, the class of danger is established on its metabolite.
9. Are not allowed to application of remedy of plants, not passed toksikologo-hygienic assessment according to the procedure, established by the legislation of the Republic of Belarus.
10. Are not allowed to application in personal subsidiary farms of remedy of plants, relating to:
to extremely dangerous and highly hazardous chemical compounds (1 and 2 classes of danger);
to strong allergens (1 class of danger);
to chemical compounds with extremely strong irritating and irritativny action (1 class of danger);
To 1 class of danger on mutagenicity, teratogenecity, reproductive toxicity, embriotoxity and carcinogenicity.
11. When implementing the state sanitary inspection behind application of remedies of plants it is carried out:
the analysis of data on availability of state registration and inclusion in the State register of remedies of the plants and fertilizers allowed for use in the territory of the Republic of Belarus;
assessment of observance of recommendations of the manufacturer and the regulations necessary for safe application of remedies of plants (information of the tare label with recommendations of the producer about application, marking compliance on packaging and the tare label to the established class of danger, consumption rate, objects and cultures of application, availability and use of the individual protection equipment recommended by the producer);
assessment of observance of requirements of these Sanitary standards and rules and other technical regulatory legal acts on application of remedies of plants.
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