DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of May 21, 2019 No. 78

About modification of Section 20 of Chapter II of Single sanitary and epidemiologic and hygienic requirements to products (goods) which are subject to sanitary and epidemiological surveillance (control)

According to Item 2 of article 57 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 20 of appendix No. 2 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Board of the Eurasian economic commission solved:

1. Make to Section 20 Chapters II of Single sanitary and epidemiologic and hygienic requirements to products (goods) which are subject to sanitary and epidemiological surveillance (control), No. approved by the Decision of the Commission of the Customs union of May 28, 2010 299, of change according to appendix.

2. Determine that:

a) the address of disinfectants on customs area of the Eurasian Economic Union in the presence of the certificate on state registration granted concerning them to the introduction of this Decision in force is performed before the termination of term of its action;

b) provided by Items 1.8.1 and 2.3 of appendix to Section 20 of Chapter II of Single sanitary and epidemiologic and hygienic requirements to products (goods) which are subject to sanitary and epidemiological surveillance (control) requirements to the repellent means relating to the dermatological individual protection equipment from impact of biological factors (insects) used in the conditions of industrial production become effective from the effective date decisions of the Council of the Eurasian economic commission providing entering into the technical regulation of the Customs union "About safety of individual protection equipment" (TR CU 019/2011) of changes in part of establishment of requirements to toxicity, safety and physical and chemical indicators of such means.

3. This Decision becomes effective after 180 calendar days from the date of its official publication.

Appendix

to the Decision of Board of the Eurasian economic commission of May 21, 2019 No. 78

The changes made to Section 20 of Chapter II of Single sanitary and epidemiologic and hygienic requirements to products (goods) which are subject to sanitary and epidemiological surveillance (control)

1. To state Section 20 of Chapter II in the following edition:

"Section 20. Requirements to disinfectants

1. Scope

1. This Section is applied to disinfectants in the form of the different preparative forms intended for professional application, retail sale (from goods items of 2801 - 2853, 2901 - 2942, 3307, 3604 and 3808 CN FEA EEU), except for the means applied in veterinary science and agricultural industry.

2. Determinations

2. For the purposes of this Section concepts which mean the following are used:

"safety of disinfectant" - lack of harm for health of the person, animals, the environment in case of target use of disinfectant and observance of the recommended security measures;

"disinsection means" - the means (chemical, biological) intended for holding destructive actions concerning arthropods for the purpose of decrease in their number;

"dezinfektologichesky examination" - the procedure of consideration and assessment of the materials characterizing disinfectant (including results of laboratory, tool, biological, natural researches and testing of chemical composition, safety, efficiency, and also accompanying disinfectant of regulating, methodical and instructive documentation), performed for the purpose of protection of life or health of the person, the prevention of the actions misleading consumers. The expert opinion is result of dezinfektologichesky examination;

"disinfectants" - the means intended for carrying out disinfection (disinfectants), presterilizing cleaning, sterilization (the sterilizing means), disinsection (insecticidal, pedikulitsidny, acaricidal means), deratization (deratization means) and also repellent means;

"disinfectant" - the means applied to destruction of microorganisms in objects (on objects) the environment;

"active ingredient" - the chemical which is part of disinfectant and providing its efficiency;

"deratization means" - the means applied to decrease in number of rodents to acceptable level or to their destruction;

"the address of disinfectant" - processes of development, registration, production, transportation, realization, application, utilization and (or) destruction of disinfectant;

"pedikulitsidny means" - the means applied to killing of louses, their eggs and larvae;

"preparative form" - the disinfectant, ready to application on purpose, consisting of active ingredient or mix of active ingredients and functional components;

"the application mode" - the set of factors, conditions, technologies of use of disinfectant ensuring efficiency and safety of disinfectant;

"repellent means" - the means intended for scaring away of arthropods (including the dermatological individual protection equipment from impact of biological factors (insects) used in the conditions of industrial production) or rodents;

"means of presterilizing cleaning" - the means intended for removal from the medical products of the proteinaceous, fatty and other pollution interfering sterilization or reducing its efficiency;

"the sterilizing means" - the means intended for destruction of microorganisms of all types (including bacteria, viruses, mushrooms) at all stages of their development;

"efficiency of disinfectant" - the absolute or relative measure characterizing the reached level of sterilization, disinfection, disinsection, deratization.

3. Safety requirements of disinfectants

3. Safety of disinfectants is ensured by observance of requirements to normative indicators of toxicity and safety of disinfectants according to appendix.

4. Assessment of safety of preparative forms, working solutions of disinfectants is performed based on data:

a) about toxicological safety and efficiency of working solutions of disinfectants;

b) about chemical and physical properties of disinfectants (including volatility, stability, compatibility with other connections) (data are represented by the manufacturer);

c) about assessment of danger of disinfectants (data of the Food and Agriculture Organization of the United Nations, World Health Organization (in the presence), the European Union or Environmental protection agency of the USA (EPA));

d) about the toxicological characteristic of components of preparative form (fillers, emulsifiers, stabilizers, solvents, etc.) with indication of for each of them the existing standard, or registration in the REACH system (Registration, Evaluatio№and Authorisatio№of CHemicals - the international regulations regulating production and turnover of all chemicals, including their obligatory registration), or CAS numbers (Chemical Abstracts Service - division of American Chemical Society which is engaged in information collection about chemicals), and also names according to IUPAC (International Union of Pure and Applied Chemistry);

e) about acute toxicity in case of introduction in stomach;

e) about acute toxicity when drawing on skin;

g) about acute inhalation toxicity;

h) about acute toxicity in case of introduction in abdominal cavity;

i) about irritant action on skin and mucous membrane of eye;

j) about the sensibilizing action;

k) about cumulative action;

l) about skin rezorbtivnom action;

m) about subacute inhalation toxicity;

o) about subacute toxicity in case of intragastric receipt;

o) about chronic toxicity in case of intragastric receipt;

p) about influence on organoleptic properties of water (smell, smack);

c) about hygienic standard rates (threshold limit values or approximate safe levels of impact) of active ingredients in air of the working area, in atmospheric air of the inhabited places, in water of water objects (it is not required for active ingredients which are not classified as dangerous by parameters of acute toxicity in case of intragastric, skin, inhalation receipt in organism, on capability to have irritating, skin резорбтивным, the sensibilizing, reprotoksichny, mutagen, cancerogenic action);

r) about hygienic standard rates (threshold limit values) of products of transformation of active ingredients, harmful impurity and products of transformation under the influence of active ingredients in water of water objects (for means of disinfecting of waters of all types);

s) about availability of data on the remote effects (mutagen activity, cancerogenic, embriotoksichesky, teratogenic and gonadotoksichesky action, influence on endocrine system);

t) about real danger in the recommended modes of application;

x) about efficiency of preparative forms of disinfectants.

5. It is not allowed to use as active ingredients chemicals concerning which the Rotterdam convention on the procedure of prior reasonable consent is applied to separate dangerous chemicals and pesticides in international trade of September 10, 1998 and the appendix A and B to the Stockholm convention on resistant organic pollutants of May 22, 2001.

4. Dezinfektologichesky examination

6. The procedure for the organization and conducting dezinfektologichesky examination is determined according to the legislation of state members.

7. For conducting dezinfektologichesky examination by the manufacturer, either seller (importer), or person authorized by the manufacturer the file including is created:

a) disinfectant compounding;

b) documents according to which the goods are made (standards, specifications, regulations, technological instructions, specifications, compoundings, the information about structure), certified according to the legislation of state member in which state registration is carried out (for the goods made out of customs area of the Union), or certified by the manufacturer (for the goods made on customs area of the Union);

c) the instruction (the draft of the instruction) for use of disinfectant containing general information about it, its appointment, active ingredients, the toxicological characteristic, preparation of working solutions, the recommendation about application, data on security measures and first aid in case of poisoning with disinfectant about utilization methods;

d) the document containing data on disinfectant methods of quality control (including control method of active ingredient);

e) certificate of stability (expiration date) of disinfectant;

e) label sample;

g) the document containing the toxicological characteristic of active ingredient, the main components and preparative form, hygienic standard rates in environment objects (water, air, the soil) (it is not required for active ingredients which are not classified as dangerous by parameters of acute toxicity in case of intragastric, skin, inhalation receipt in organism, on capability to have irritating, skin резорбтивным, the sensibilizing, reprotoksichny, mutagen, cancerogenic action);

h) the document containing data on control methods of active ingredient and (or) products of its transformation in environment objects (water, air, the soil);

i) the material safety data sheet of chemical products (MSDS) of active ingredient and disinfectant and (or) the safety data sheet (including data on the remote effects (mutagen activity, cancerogenic, embriotoksichesky, teratogenic and gonadotoksichesky action, influence on endocrine system));

j) the document containing data on safety of nanomaterials in case of their availability as a part of disinfectant;

k) the document containing results of research of efficiency and safety of disinfectant;

l) the document containing data on measures of safe handling of disinfectant (the document according to which the goods, or the material safety data sheet of chemical products are made);

m) sample of preparative form in packaging of the manufacturer with appendix of the sampling report (tests) (for the goods made on customs area of the Union);

o) standard sample of active ingredient of disinfectant.

8. Following the results of dezinfektologichesky examination the expert opinion on possibility of state registration of disinfectant on customs area of the Union containing the following data is drawn up:

a) name of disinfectant (preparative form);

b) manufacturer of preparative form;

c) manufacturer of active ingredients of disinfectant;

d) toxicological characteristic of disinfectant, its working solutions and preparative forms;

e) main results of chemical analysis, biological control, efficiency evaluation and safety of disinfectant;

e) purpose of disinfectant;

g) disinfectant scope.

9. The reasonable conclusion about impossibility of state registration of disinfectant is issued in the following cases:

a) non-presentation of stipulated in Item 7 these Sections of documents or samples;

b) identification by results of carrying out researches:

uses in disinfectant as active ingredients of the prohibited chemicals;

lack of efficiency of disinfectant;

discrepancies of disinfectant to the indicators provided by appendix to this Section.

5. Packaging and marking of disinfectants

10. Packing of disinfectants shall be performed according to requirements of documents according to which they are made, or to requirements of manufacturers. Packaging shall ensure safety of disinfectants in case of storage and their transportation during expiration date.

11. Packaging of disinfectants with pH less 2,0 of unit and more 11, in unit shall be supplied with the special device for their safe pouring.

12. Marking of the packed-up disinfectants is applied directly on their consumer packaging, labels, labels attached to packaging by the method ensuring its safety.

13. Marking of the packed-up disinfectant shall contain the following information:

a) name and purpose of disinfectant;

b) names and content of active ingredients;

c) name and location (address of the legal entity) of the manufacturer;

d) designation of the document according to which disinfectant is made (in the presence);

e) nominal amount of disinfectant in consumer packaging (net weight or amount);

e) recommendations about use of disinfectant (for the means intended for retail sale);

g) storage conditions;

h) date of production (month, calendar year) and expiration date (months, years) or record "It is suitable to... (month, calendar year)";

i) pictograms for the proper handling with disinfectant (if necessary);

j) precautionary measures during the work with disinfectant, first aid in case of poisoning (for the means intended for retail sale).

14. In case of the address of disinfectants on customs area of the Union marking is put in Russian and in the presence of relevant requirements in the legislation of state members in state language (state languages) of state member in the territory of which disinfectants are implemented.".

2. To add Section 20 of Chapter II with appendix of the following content:

"Appendix

to Section 20 of Chapter II

Single sanitary and epidemiologic

and hygienic requirements

to products (goods) which are subject

to sanitary and epidemiologic

to supervision (control)

NORMATIVE INDICATORS

TOXICITY AND SAFETY OF DISINFECTANTS

The used reducings:

C20 - saturant concentration of vapors in case of 20 °C;

DL50 - average lethal dose;

Limac - threshold of sharp action;

Limsubac - threshold of subacute action;

BAU - bespropellentny aerosol package;

DV - active ingredient;

DS - disinfectant;

MPI - treatment and prevention facilities;

MEOK - the minimum effective disinfecting concentration;

Obuva.n.m. - approximate safe level of impact in atmospheric air of the inhabited places;

ОБУВр.з. - approximate safe level of impact in air of the working area;

ODUV. - approximate admissible level in water of water objects of economic and drinking and cultural and community water use;

Oduz.k.p. - approximate admissible level of pollution of integuments;

Pdka.n.m. - threshold limit value in atmospheric air of the inhabited places;

ПДКбасс. - threshold limit value in water of swimming pools and aquaparks;

PDKV. - threshold limit value in water of water objects of economic and drinking and cultural and community water use;

Pduz.k.p. - maximum permissible level of pollution of integuments;

Pdkr.z. - threshold limit value in air of the working area;

SIZ - individual protection equipment;

TsTD - cytotoxic action.

1. Indicators of toxicity and safety of disinfectants

1.1. Disinfectants

Purpose of means	The researched indicators	Normative indicators		Application conditions
		indicator size	classification assessment
1	2	3	4	5
1.1.1. Means for disinfection of surfaces of rooms, tough furniture, devices and devices, linen, footwear, ware of the dining room, laboratory and from under allocations, toys (except soft), the sanitary equipment, objects of patient care, allocations, refuse chutes, dustbins (processing methods: wiping, irrigation, soaking and immersion), waste
1.1.1.1. Disinfectants in the form of concentrate, liquids, powder, granules, tablets, gel and in other ready forms	Acute toxicity in case of introduction in stomach (DL 50, mg/kg)	> 150 (> 50 - 2000)	3 - 4 (3 - 4)	To specialists using SIZ (respirator, rubber gloves)
		> 5000 (> 2000)	4 (5)	To specialists and the population in life
	Acute toxicity when drawing on skin (DL 50, mg/kg)	> 500 (> 200 - 2000)	3 - 4 (3 - 4)	To specialists using SIZ (respirator, rubber gloves)
		> 2000 (> 2000)	4 (5)	To specialists and the population in life

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