of October 18, 2016 № 109
About approval of the Procedure for development, approval, change and use of single sanitary and epidemiologic and hygienic requirements and procedures
For the purpose of realization of Item 3 of article 57of the Agreement on the Eurasian Economic Union of May 29, 2014 and according to Item 53 of appendix № 1 to the Regulations of work of the Euroasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 № 98, Council of the Eurasian economic commission decided:
Members of council of the Eurasian economic commission:
From the Republic of Armenia
From the Republic of Belarus
From the Republic of Kazakhstan
From the Kyrgyz Republic
From the Russian Federation
Approved by the Decision of Council of the Eurasian economic commission of October 18, 2016 №109
1. This Procedure is developed according to Item 3 of article 57 of the Agreement on the Eurasian Economic Union of May 29, 2014 and establishes requirements to development, approval, change and use of single sanitary and epidemiologic and hygienic requirements (further – single health requirements) and procedures.
2. Single health requirements and procedures are developed, affirm, change and are applied to products (goods) which are subject to the state sanitary and epidemiological surveillance (control) (further – controlled products), and are directed to the prevention of harmful effects on human body of factors of the habitat and providing favorable conditions for life activity of the person.
3. Single health requirements are developed on the basis:
a) scientific research, including risk assessment of harmful effects on human body of factors of the habitat;
b) international and regional standards, managements and (or) recommendations.
4. Single health requirements and procedures affirm Board the Eurasian economic commission (further – the Commission).
Development and change of single health requirements and procedures are performed by the Commission based on offers of state members.
5. Single health requirements and procedures are applied:
a) in case of production and the address of controlled products;
b) for the organization and implementation of production supervision concerning controlled products;
c) when implementing the state sanitary and epidemiological surveillance (control) concerning controlled products according to the legislation of state members of the Eurasian Economic Union (further respectively – state members, the Union) and acts of the Commission;
d) for ensuring sanitary and epidemiologic wellbeing of the population;
e) for holding sanitary and anti-epidemic (preventive) actions;
e) for development and introduction of temporary sanitary measures;
g) for state registration of separate types of controlled products;
h) for carrying out social and hygienic monitoring;
i) for conducting sanitary and epidemiologic examination (sanitary and hygienic examination, inspections, researches, testing, toxicological, hygienic and other types of estimates) controlled products;
j) in case of risks assessment to health of the population in case of impact on human body of factors of the habitat.
6. The single health requirements and (or) procedures approved in accordance with the established procedure join in the developed drafts of technical regulations of the Union and in the accepted technical regulations of the Union according to the Procedure for development, acceptance, change and cancellation of technical regulations of the Eurasian Economic Union approved by the Commission.
a) the address (letter) containing the relevant proposal;
b) scientific reasons for the offer on development (change) of the single health requirements, including the analysis of compliance offered to development of single health requirements (changes of single health requirements) to international standards, managements and (or) recommendations;
c) data on methods of researches (testing) and (or) measurements approved according to the legislation of state members or the offered methods of researches (testing) and (or) measurements in case of absence or impossibility of use of the available methods.
8. In case of need modification of single health requirements to products concerning which the technical regulation of the Union is accepted and (or) in procedures state members in addition to materials, the stipulated in Item 7 presents About, represent the offer on modification of the corresponding technical regulation of the Union to the Commission.
9. The commission within 10 working days from the date of receipt of the address together with materials, the stipulated in Item 7 presents About, sends to state member the notification on acceptance of materials for consideration and on inclusion of question in the draft of the agenda of the regular meeting of subcommittee on sanitary measures under Advisory committee for technical regulation, use of sanitary, quarantine phytosanitary and veterinary and sanitary measures (further – subcommittee).
In case of representation of materials, the stipulated in Item 7 presents About, not in full the Commission in the specified time returns them to state member with reasons for refusal in acceptance.
10. The commission within 20 working days from the date of the direction to state member of the notification specified in Item 9 of this Procedure prepares based on the materials provided by state member the draft decision of the Commission about modification of single health requirements and (or) procedures (further – the draft decision of the Commission) which is subject to consideration at the regular meeting of subcommittee.
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